Sample records for obtaining institutional review

  1. Expediting the Institutional Review Board Process for Exercise Protocols

    ERIC Educational Resources Information Center

    Macfarlane, Pamela A.; Looney, Marilyn A.

    2011-01-01

    All researchers who use human participants in their study must obtain permission from their appropriate Institutional Review Board (IRB). Once the IRB application enters the review process, a decision is made regarding the type of review it should receive: Level I administrative (exempt), Level II subcommittee (expedited), or Level III full board…

  2. 21 CFR 56.112 - Review by institution.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Review by institution. 56.112 Section 56.112 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL INSTITUTIONAL REVIEW BOARDS IRB Functions and Operations § 56.112 Review by institution. Research covered by these...

  3. 77 FR 11555 - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    ... either http://www.regulations.gov or http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinical...] Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Continuing Review After Clinical Investigation Approval; Availability AGENCY: Food and Drug Administration...

  4. Is conflict of interest becoming a challenge for institution-based institutional review boards?

    PubMed

    Freedman, Ralph S; McKinney, Ross

    2013-08-01

    Expansion of business relationships between academic institutions and their leaders and industry have become a reality, whereas media attention regarding conflict of interest (COI) at academic institutions has raised concerns about possible erosion of public trust. The Institutional Review Board (IRB) should collaborate with institutional COI committees to ensure that research with human subjects is in compliance with various applicable federal regulations. The IRB and COI committee should take additional independent action as necessary under their separate mandates to protect the welfare, safety, and rights of human subjects and to include limits on protocols affected by significant financial interests of the institution or its decision makers. If unable to review research due to an intrainstitutional conflict, the local IRB should consider transferring the study review and oversight to an external unaffiliated institutional or central IRB. A process for involvement of an executive institutional IRB is proposed. ©2013 AACR.

  5. 32 CFR 219.112 - Review by institution.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 2 2014-07-01 2014-07-01 false Review by institution. 219.112 Section 219.112 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.112 Review by institution. Research covered by this policy that...

  6. 45 CFR 46.112 - Review by institution.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 1 2013-10-01 2013-10-01 false Review by institution. 46.112 Section 46.112 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.112 Review by institution...

  7. 45 CFR 46.112 - Review by institution.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Review by institution. 46.112 Section 46.112 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.112 Review by institution...

  8. 45 CFR 690.112 - Review by institution.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 3 2014-10-01 2014-10-01 false Review by institution. 690.112 Section 690.112 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.112 Review by institution. Research covered by this policy that has been...

  9. 45 CFR 690.112 - Review by institution.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 3 2012-10-01 2012-10-01 false Review by institution. 690.112 Section 690.112 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.112 Review by institution. Research covered by this policy that has been...

  10. 45 CFR 46.112 - Review by institution.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 1 2011-10-01 2011-10-01 false Review by institution. 46.112 Section 46.112 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.112 Review by institution...

  11. 45 CFR 46.112 - Review by institution.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 1 2012-10-01 2012-10-01 false Review by institution. 46.112 Section 46.112 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.112 Review by institution...

  12. 45 CFR 690.112 - Review by institution.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 3 2013-10-01 2013-10-01 false Review by institution. 690.112 Section 690.112 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.112 Review by institution. Research covered by this policy that has been...

  13. 45 CFR 46.112 - Review by institution.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 1 2014-10-01 2014-10-01 false Review by institution. 46.112 Section 46.112 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.112 Review by institution...

  14. Institutional review board-based recommendations for medical institutions pursuing protocol approval for facial transplantation.

    PubMed

    Siemionow, Maria Z; Gordon, Chad R

    2010-10-01

    Preliminary outcomes from the previous nine face transplants performed since 2005 have been encouraging and have therefore led to a rise in the number of medical centers interested in establishing face transplant programs worldwide. However, until now, very little literature has been published providing surgeons the necessary insight on how to (1) prepare a protocol for institutional review board approval and (2) establish a face transplant program. The authors' face transplant team's experience with the institutional review board at the Cleveland Clinic, beginning in 2002, was critically reviewed in a detailed, retrospective manner. The purpose was to identify and define certain criteria necessary for both the institutional review board approval process and face transplant program establishment. In 2002, unprecedented efforts from within the authors' plastic surgery department led to the world's first institutional review board approval for face transplantation, in 2004. As a result, 4 years later, the authors' face transplant team performed the nation's first successful near-total face and maxilla transplant. Every surgical department hoping to establish a face transplant program must realize that this endeavor requires both tremendous financial and long-term commitments by its medical institution. These transplants should be performed only within university-based medical centers capable of orchestrating a specialized, talented, multidisciplinary team. More importantly, facial composite tissue allotransplantation possesses an unmatched level of complexity and therefore requires most centers to prepare a carefully detailed protocol using these institutional review board-based guidelines.

  15. Central institutional review board review for an academic trial network.

    PubMed

    Kaufmann, Petra; O'Rourke, P Pearl

    2015-03-01

    Translating discoveries into therapeutics is often delayed by lengthy start-up periods for multicenter clinical trials. One cause of delay can be multiple institutional review board (IRB) reviews of the same protocol. When developing the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT; hereafter, NN), the National Institute of Neurological Disorders and Stroke (NINDS) established a central IRB (CIRB) based at Massachusetts General Hospital, the academic medical center that received the NN clinical coordinating center grant. The 25 NN sites, located at U.S. academic institutions, agreed to required CIRB use for NN trials. To delineate roles and establish legal relationships between the NN sites and the CIRB, the CIRB executed reliance agreements with the sites and their affiliates that hold federalwide assurance for the protection of human subjects (FWA); this took, on average, 84 days. The first NN protocol reviewed by the CIRB achieved full approval to allow participant enrollment within 56 days and went from grant award to the first patient visit in less than four months. The authors describe anticipated challenges related to institutional oversight responsibilities versus regulatory CIRB review as well as unanticipated challenges related to working with complex organizations that include multiple FWA-holding affiliates. The authors anticipate that CIRB use will decrease NN trial start-up time and thus promote efficient trial implementation. They plan to collect data on timelines and costs associated with CIRB use. The NINDS plans to promote CIRB use in future initiatives.

  16. Are CT scans obtained at referring institutions justified prior to transfer to a pediatric trauma center?

    PubMed

    Benedict, Leo Andrew; Paulus, Jessica K; Rideout, Leslie; Chwals, Walter J

    2014-01-01

    To assess whether pediatric trauma patients initially evaluated at referring institutions met Massachusetts statewide trauma field triage criteria for stabilization and immediate transfer to a Pediatric Trauma Center (PTC) without pre-transfer CT imaging. A 3-year retrospective cohort study was completed at our level 1 PTC. Patients with CT imaging at referring institutions were classified according to a triage scheme based on Massachusetts statewide trauma field triage criteria. Demographic data and injury profile characteristics were abstracted from patient medical records and our pediatric trauma registry. A total of 262 patients with 413 CT scans were reviewed from 2008 to 2011. 172 patients scanned (66%, 95% CI: 60%, 71%) met criteria for immediate transfer to a pediatric trauma center. Notably, 110 scans (27% of the total performed at referring institutions) were duplicated within four hours upon arrival to our PTC. GCS score <14 (45%) was the most common requirement for transfer, and CT scan of the head was the most frequent scan obtained (53%). The majority of pediatric trauma patients were subjected to CT scans at referring institutions despite meeting Massachusetts trauma triage guidelines that call for stabilization and immediate transfer to a pediatric trauma center without any CT imaging. © 2014.

  17. Institutional Oversight of the Graduate Medical Education Enterprise: Development of an Annual Institutional Review

    PubMed Central

    Amedee, Ronald G.; Piazza, Janice C.

    2016-01-01

    Background: The Accreditation Council for Graduate Medical Education (ACGME) fully implemented all aspects of the Next Accreditation System (NAS) on July 1, 2014. In lieu of periodic accreditation site visits of programs and institutions, the NAS requires active, ongoing oversight by the sponsoring institutions (SIs) to maintain accreditation readiness and program quality. Methods: The Ochsner Health System Graduate Medical Education Committee (GMEC) has instituted a process that provides a structured, process-driven improvement approach at the program level, using a Program Evaluation Committee to review key performance data and construct an annual program evaluation for each accredited residency. The Ochsner GMEC evaluates the aggregate program data and creates an Annual Institutional Review (AIR) document that provides direction and focus for ongoing program improvement. This descriptive article reviews the 2014 process and various metrics collected and analyzed to demonstrate the program review and institutional oversight provided by the Ochsner graduate medical education (GME) enterprise. Results: The 2014 AIR provided an overview of performance and quality of the Ochsner GME program for the 2013-2014 academic year with particular attention to program outcomes; resident supervision, responsibilities, evaluation, and compliance with duty‐hour standards; results of the ACGME survey of residents and core faculty; and resident participation in patient safety and quality activities and curriculum. The GMEC identified other relevant institutional performance indicators that are incorporated into the AIR and reflect SI engagement in and contribution to program performance at the individual program and institutional levels. Conclusion: The Ochsner GME office and its program directors are faced with the ever-increasing challenges of today's healthcare environment as well as escalating institutional and program accreditation requirements. The overall commitment of

  18. Preparing Protocols for Institutional Review Boards.

    ERIC Educational Resources Information Center

    Lyons, Charles M.

    1983-01-01

    Introduces the process by which Institutional Review Boards (IRBs) review proposals for research involving human subjects. Describes the composition of IRBs. Presents the Nuremberg code, the elements of informed consent, the judging criteria for proposals, and a sample protocol format. References newly published regulations governing research with…

  19. Institutional ethics review of clinical study agreements

    PubMed Central

    DuVal, G

    2004-01-01

    Accordingly, it is necessary that some independent body have the authority both to review research contracts for compliance with norms of subject protection and ethical integrity, and to reject studies that fail to meet ethical standards. Such review should take place prior to the start of research, not later. Because of its expertise and authority, the institutional ethics review board (IRB or REB) is the appropriate body to undertake such review. Much recent commentary has focused on contractual restrictions on the investigator's freedom to publish research findings. The Olivieri experience, and that of other investigators, has brought freedom of publication issues into sharp focus. Clinical study agreements also raise a number of other ethical issues relating to human subjects and research integrity, however, including disclosures relating to patient safety, data analysis and reporting, budget, confidentiality, and premature termination of the study. This paper describes the ethical issues at stake in structuring such agreements and suggests ethical standards to guide institutional ethics review. PMID:14872068

  20. 45 CFR 690.112 - Review by institution.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.112 Review by institution. Research covered by this policy that has been... the institution. However, those officials may not approve the research if it has not been approved by...

  1. 45 CFR 690.112 - Review by institution.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.112 Review by institution. Research covered by this policy that has been... the institution. However, those officials may not approve the research if it has not been approved by...

  2. Institutional Collaboration on MOOCs in Education--A Literature Review

    ERIC Educational Resources Information Center

    Nortvig, Anne-Mette; Christiansen, René B.

    2017-01-01

    This literature review seeks to outline the state of the art regarding collaboration between educational institutions on Massive Open Online Courses (MOOCs) launched in Europe and in the US for the past 10 years. The review explores enablers and barriers that influence national institutional MOOC collaboration, and looks into how existing…

  3. Meeting the Challenge: The National Cancer Institute's Central Institutional Review Board for Multi-Site Research.

    PubMed

    Massett, Holly A; Hampp, Sharon L; Goldberg, Jacquelyn L; Mooney, Margaret; Parreco, Linda K; Minasian, Lori; Montello, Mike; Mishkin, Grace E; Davis, Catasha; Abrams, Jeffrey S

    2018-03-10

    The National Institutes of Health (NIH) issued a new policy that requires a single institutional review board (IRB) of record be used for all protocols funded by the NIH that are carried out at more than one site in the United States, effective January 2018. This policy affects several hundred clinical trials opened annually across the NIH. Limited data exist to compare the use of a single IRB to that of multiple local IRBs, so some institutions are resistant to or distrustful of single IRBs. Since 2001, the National Cancer Institute (NCI) has funded a central IRB (CIRB) that provides human patient reviews for its extensive national cancer clinical trials program. This paper presents data to show the adoption, efficiencies gained, and satisfaction of the CIRB among NCI trial networks and reviews key lessons gleaned from 16 years of experience that may be informative for others charged with implementation of the new NIH single-IRB policy.

  4. 32 CFR Appendix G to Part 275 - Releasing Information Obtained From Financial Institutions

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 2 2013-07-01 2013-07-01 false Releasing Information Obtained From Financial Institutions G Appendix G to Part 275 National Defense Department of Defense (Continued) OFFICE OF THE... FINANCIAL PRIVACY ACT OF 1978 Pt. 275, App. G Appendix G to Part 275—Releasing Information Obtained From...

  5. 32 CFR Appendix G to Part 275 - Releasing Information Obtained From Financial Institutions

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 2 2011-07-01 2011-07-01 false Releasing Information Obtained From Financial Institutions G Appendix G to Part 275 National Defense Department of Defense (Continued) OFFICE OF THE... FINANCIAL PRIVACY ACT OF 1978 Pt. 275, App. G Appendix G to Part 275—Releasing Information Obtained From...

  6. 32 CFR Appendix G to Part 275 - Releasing Information Obtained From Financial Institutions

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 2 2012-07-01 2012-07-01 false Releasing Information Obtained From Financial Institutions G Appendix G to Part 275 National Defense Department of Defense (Continued) OFFICE OF THE... FINANCIAL PRIVACY ACT OF 1978 Pt. 275, App. G Appendix G to Part 275—Releasing Information Obtained From...

  7. 32 CFR Appendix G to Part 275 - Releasing Information Obtained From Financial Institutions

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 2 2014-07-01 2014-07-01 false Releasing Information Obtained From Financial Institutions G Appendix G to Part 275 National Defense Department of Defense (Continued) OFFICE OF THE... FINANCIAL PRIVACY ACT OF 1978 Pt. 275, App. G Appendix G to Part 275—Releasing Information Obtained From...

  8. 13 CFR 142.36 - Can I obtain judicial review?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Can I obtain judicial review? 142.36 Section 142.36 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION PROGRAM FRAUD CIVIL REMEDIES ACT REGULATIONS Decisions and Appeals § 142.36 Can I obtain judicial review? If the initial...

  9. Institutional review board challenges related to community-based participatory research on human exposure to environmental toxins: A case study

    PubMed Central

    2010-01-01

    Background We report on the challenges of obtaining Institutional Review Board (IRB) coverage for a community-based participatory research (CBPR) environmental justice project, which involved reporting biomonitoring and household exposure results to participants, and included lay participation in research. Methods We draw on our experiences guiding a multi-partner CBPR project through university and state Institutional Review Board reviews, and other CBPR colleagues' written accounts and conference presentations and discussions. We also interviewed academics involved in CBPR to learn of their challenges with Institutional Review Boards. Results We found that Institutional Review Boards are generally unfamiliar with CBPR, reluctant to oversee community partners, and resistant to ongoing researcher-participant interaction. Institutional Review Boards sometimes unintentionally violate the very principles of beneficence and justice which they are supposed to uphold. For example, some Institutional Review Boards refuse to allow report-back of individual data to participants, which contradicts the CBPR principles that guide a growing number of projects. This causes significant delays and may divert research and dissemination efforts. Our extensive education of our university Institutional Review Board convinced them to provide human subjects protection coverage for two community-based organizations in our partnership. Conclusions IRBs and funders should develop clear, routine review guidelines that respect the unique qualities of CBPR, while researchers and community partners can educate IRB staff and board members about the objectives, ethical frameworks, and research methods of CBPR. These strategies can better protect research participants from the harm of unnecessary delays and exclusion from the research process, while facilitating the ethical communication of study results to participants and communities. PMID:20637068

  10. 34 CFR 97.112 - Review by institution.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Review by institution. 97.112 Section 97.112 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.112 Review by...

  11. Nocturnal enuresis: A topic review and institution experience

    PubMed Central

    DiBianco, John Michael; Morley, Chad; Al-Omar, Osama

    2014-01-01

    The objective is to provide a review of nocturnal enuresis (NE), including its epidemiology, etiology, pathophysiology, evaluation, and current management. We also set to provide further insight on the treatment of this condition from the experience derived from patients cared for at our tertiary-care institution. NE affects approximately 15% of all children at 5-year-old, affecting boys more frequently than girls. At our large university tertiary pediatric urology center, NE and incontinence, in general, is one the most common chief complaints prompting urologic care. In this review, we examine the condition in detail, highlighting specific goals of the initial evaluation and treatment. We contrast the commonly implemented treatment recommendations, available from the literature with strategies we have found valuable from our extensive experience in treating patients with this disorder. Using current urologic reference textbooks, book chapters, Medline, journal articles and reviews describing the many aspects of NE were reviewed in order to describe NE and the current practices at our institution. Although, this is not a systematic literature review, it includes relevant available research, institutional experience and urological expert opinion and current practices at a tertiary state health facility. The treatment of NE remains a challenge for many pediatricians and pediatric urologists. This likely stems from the multiple possible etiologies of the disorder. We have established a treatment algorithm at our institution, which we have found successful in the majority of our patients. This consists of starting patients on urotherapy, then offering both the enuresis alarm device and medication therapy as first line treatments, and finally adding anticholingerics for combination therapy. Our hope is with further research the treatment of NE will continue to improve. PMID:25506580

  12. STARS Quarterly Review. Fall 2012: The Role of Institutional Diversity

    ERIC Educational Resources Information Center

    Urbanski, Monika

    2012-01-01

    The Fall 2012 SQR: "The Role of Institutional Diversity," explores how the diversity of STARS institutions has changed over time and how participation in STARS according to institution type compares to U.S. demographics. Findings in this review suggest that the institutional characteristics that make higher education institutions…

  13. Effects of local institutional review board review on participation in national practice-based research network studies.

    PubMed

    Finch, Stacia A; Barkin, Shari L; Wasserman, Richard C; Dhepyasuwan, Niramol; Slora, Eric J; Sege, Robert D

    2009-12-01

    To describe the process and outcomes of local institutional review board (IRB) review for 2 Pediatric Research in Office Settings (PROS) studies. Pediatric Research in Office Settings conducted 2 national studies concerning sensitive topics: (1) Child Abuse Recognition Experience Study (CARES), an observational study of physician decision making, and (2) Safety Check, a violence prevention intervention trial. Institutional review board approval was secured by investigators' sites, the American Academy of Pediatrics, and practices with local IRBs. Practices were queried about IRB rules at PROS enrollment and study recruitment. Pediatric Research in Office Settings practices in 29 states. Eighty-eight PROS practices (75 IRBs). Main Exposure Local IRB presence. Local IRB presence, level of PROS assistance, IRB process, study participation, data collection completion, and minority enrollment. Practices requiring additional local IRB approval agreed to participate less than those that did not (CARES: 33% vs 52%; Safety Check: 41% vs 56%). Of the 88 practices requiring local IRB approval, 55 received approval, with nearly 50% needing active PROS help, many requiring consent changes (eg, contact name additions, local IRB approval stamps), and 87% beginning data collection. Median days to obtain approval were 81 (CARES) and 109 (Safety Check). Practices requiring local IRB approval were less likely to complete data collection but more likely to enroll minority patients. Local IRB review was associated with lower participation rates, substantial effort navigating the process (with approval universally granted without substantive changes), and data collection delays. When considering future reforms, the national human subject protections system should consider the potential redundancy and effect on generalizability, particularly regarding enrollment of poor urban children, related to local IRB review.

  14. The Role of Universities and Other Institutions in Successful Entrepreneurship: Some Insights from a Literature Review

    ERIC Educational Resources Information Center

    Zarate-Hoyos, German A.; Larios-Meoño, Fernando

    2015-01-01

    The purpose of this paper is to analyze the role of universities and other institutions in successful entrepreneurship. Insights are obtained following a literature review approach. Case studies from the United States (New York startup), Spain (Mondragon), and Germany provide strong evidence that universities are very instrumental in the creation,…

  15. Variability of the institutional review board process within a national research network.

    PubMed

    Khan, Muhammad A; Barratt, Michelle S; Krugman, Scott D; Serwint, Janet R; Dumont-Driscoll, Marilyn

    2014-06-01

    To determine the variability of the institutional review board (IRB) process for a minimal risk multicenter study. Participants included 24 Continuity Research Network (CORNET) sites of the Academic Pediatric Association that participated in a cross-sectional study. Each site obtained individual institutional IRB approval. An anonymous questionnaire went to site investigators about the IRB process at their institution. Twenty-two of 24 sites (92%) responded. Preparation time ranged from 1 to 20 hours, mean of 7.1 hours. Individuals submitting ≤3 IRB applications/year required more time for completion than those submitting >3/year (P < .05). Thirteen of 22 (59%) study sites received approval with "exempt" status, and 6 (27%) approved as "expedited" studies. IRB experiences were highly variable across study sites. These findings indicate that multicenter research projects should anticipate barriers to timely study implementation. Improved IRB standardization or centralization for multicenter clinical studies would facilitate this type of practice-based clinical research.

  16. Framing Student Perspectives into the Higher Education Institutional Review Policy Process

    ERIC Educational Resources Information Center

    Poth, Cheryl; Riedel, Alex; Luth, Robert

    2015-01-01

    It is necessary and desirable to enhance student learning in higher education by integrating multiple perspectives during institutional policy reviews, yet few examples of such a process exist. This article describes an institutional assessment policy review process that used a questionnaire to elicit 269 students' perspectives on a draft policy…

  17. 40 CFR 26.1112 - Review by institution.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Review by institution. 26.1112 Section 26.1112 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

  18. 40 CFR 26.1112 - Review by institution.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Review by institution. 26.1112 Section 26.1112 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

  19. 40 CFR 26.1112 - Review by institution.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Review by institution. 26.1112 Section 26.1112 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

  20. 40 CFR 26.1112 - Review by institution.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Review by institution. 26.1112 Section 26.1112 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

  1. 40 CFR 26.1112 - Review by institution.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Review by institution. 26.1112 Section 26.1112 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

  2. 28 CFR 512.13 - Institutional Review Board.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... concerns and evaluate objectively a research proposal's impact on, and relevance to, inmates and to the... interest exists for the BRRB chairperson on a particular research proposal, the Assistant Director... ADMINISTRATION RESEARCH Research § 512.13 Institutional Review Board. (a) The Bureau of Prisons' central...

  3. 28 CFR 512.13 - Institutional Review Board.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... concerns and evaluate objectively a research proposal's impact on, and relevance to, inmates and to the... interest exists for the BRRB chairperson on a particular research proposal, the Assistant Director... ADMINISTRATION RESEARCH Research § 512.13 Institutional Review Board. (a) The Bureau of Prisons' central...

  4. Juvenile catamenial pneumothorax: institutional report and review.

    PubMed

    Inoue, Takashi; Chida, Masayuki; Inaba, Hirohisa; Tamura, Motohiko; Kobayashi, Satoru; Sado, Tetsu

    2015-06-13

    Catamenial pneumothorax (CP) is a type of spontaneous pneumothorax due to thoracic endometriosis occurring in reproductive women, and usually involves the right side of the thorax showing diaphragm lesions. For the present study, we defined juvenile CP (JCP) as patients with CP who were 19 years old and younger. Institutional findings and a systematic literature review are presented. We retrospectively enrolled all patients with CP treated at our institutions from January 2002 to June 2013. In addition, we conducted a search of medical literature published using the PubMed and Japanese Ichushi databases with "catamenial pneumothorax" as the search term. Thirteen female patients with CP, 1 on the left side, were treated at our institutions. The patient with left-side CP was classified as JCP, while that was also identified in 29 of 451 CPs reported in our literature review. Pneumothorax occurred more frequently on the left side in JCP as compared to usual CP (p<0.01). There was a significantly lower ratio of JCP cases with diaphragm lesions as compared to usual CP (p<0.01). Significant laterality was not seen in JCP patients and fewer had diaphragm lesions as compared to usual CP. JCP may be a new entity of CP.

  5. [Role of Institutional Review Boards for multi-centre studies in national health services research - a cross-sectional study of the effort to obtain secondary ethical approvals for the DACAPO study].

    PubMed

    Blecha, Sebastian; Thomann-Hackner, Kathrin; Brandstetter, Susanne; Dodoo-Schittko, Frank; Seboek, Philipp; Apfelbacher, Christian; Graf, Bernhard M; Bein, Thomas

    2015-09-01

    Health services research (HSR) is of fundamental importance for the continuous improvement of preventive, diagnostic or therapeutic measures. The conduct of multi-centre HSR studies requires that ethical approval by Institutional review boards (IRB's) is obtained. We documented the effort, the complexity and the man power necessary to obtain secondary ethical approval for a national HSR in Germany ("Surviving the Acute Respiratory Distress Syndrome" [DACAPO-study]). Having obtained a primary ethical approval by the IRB of Regensburg University, the time, correspondence, necessity for amendments, corrections, or additional costs by 34 IRB's for 64 participating study centers was documented. The complete obtainment was found to be time consuming and associated with a high workload and man power. A time span of seven month was needed to receive votes from all IRB's. The median time span was 25,5 days (25 %/75 % percentile 13 and 42 days, respectively). Requirements in terms of corrections or amendments were inhomogeneous and frequent changes were necessary. There were additional fees for secondary votes of 4328,40 €. Total costs for the study center Regensburg were 21.193,40 € (2,6 % of the grant volume). Obtaining all ethical approvals for a multi-centre observational HSR study in Germany is complex and time consuming. Various and inhomogeneous formalities may delay the plan and realization of HSR. A Homogenization and simplification of the procedure of ethics votes should be discussed. © Georg Thieme Verlag KG Stuttgart · New York.

  6. A rapid evidence review on the effectiveness of institutional health partnerships.

    PubMed

    Kelly, Ema; Doyle, Vicki; Weakliam, David; Schönemann, Yvonne

    2015-12-14

    Institutional Health Partnerships are long-term, institution to institution partnerships between high income and low and middle income countries which seek to build capacity and strengthen health institutions in order to improve health service delivery and outcomes. Funding for Institutional Health Partnerships has increased in recent years. This paper outlines a rapid evidence review on the effectiveness of this modality. A rapid evidence review of published and grey literature was conducted. Content relating to the effectiveness of working in partnership and methods and frameworks used were extracted and analysed. The results of this analysis were used to structure a discussion regarding the next steps to strengthen the evidence base for the effectiveness of institutional health partnerships. The evidence review, including citation mapping, returned 27 published papers and 17 grey literature documents that met all of the inclusion criteria. Most of the literature did not meet the high standards of formal academic rigour and there was no original research amongst this literature that specifically addressed the effectiveness of institutional health partnerships. This was not surprising given institutional health partnerships do not lend themselves easily to case control studies and randomised control trials due to their high level of diversity and operation in complex social systems. There was, however, a body of practice based knowledge and experience. Evidence for the effectiveness of Institutional Health Partnerships is thin both in terms of quantity and academic rigour. There is a need to better define and differentiate Institutional Health Partnerships in order to measure and compare effectiveness across such a diverse group. Effectiveness needs to be measured at the level of individual partnerships, the bodies that facilitate partnership programmes and the level of health service delivery. There is a need to develop indicators and frameworks that specifically

  7. Ethical international research on human subjects research in the absence of local institutional review boards.

    PubMed

    Bhat, S B; Hegde, T T

    2006-09-01

    International health-related research on human subjects entails unique ethical responsibilities and difficulties. Often, these difficulties are augmented by the lack of a local ethical review infrastructure. In a recent cross-national study conducted by us, three critical components of ethical regulation were identified--external oversight, local oversight and subject involvement--and integrated into the study design. These three concepts are outlined and established as an important aspect of ensuring ethical coherence in the local context, particularly when reviews by the local institutional review boards cannot practically be obtained. The three levels of ethical oversight identified are suggested to be the framework within which future field studies on human subjects are developed and a standard for maintaining ethical rigorousness in research on humans.

  8. Why Public Comments Matter: The Case of the National Institutes of Health Policy on Single Institutional Review Board Review of Multicenter Studies.

    PubMed

    Ervin, Ann-Margret; Taylor, Holly A; Ehrhardt, Stephan; Meinert, Curtis L

    2018-03-06

    In 2014, the National Institutes of Health (NIH) requested public comments on a draft policy requiring NIH-funded, U.S.-based investigators to use a single institutional review board (sIRB) for ethical review of multicenter studies. The authors conducted a directed content analysis and qualitative summary of the comments and discuss how they shaped the final policy. Two reviewers independently assessed support for the policy from a review of comments responding to the draft policy in 2016. A reviewer conducted an open text review to identify prespecified and additional comment themes. A second researcher reviewed 20% of the comments; discrepancies were resolved through discussion. The NIH received 167 comments: 65% (108/167) supportive of the policy, 23% (38/167) not supportive, and 12% (21/167) not indicating support. Clarifications or changes to the policy were suggested in 102/167 comments (61%). Criteria for selecting sIRBs were addressed in 32/102 comments (31%). Also addressed were IRB responsibilities (39/102; 38%), cost (27/102; 26%), the role of local IRBs (14/102; 14%), and allowable policy exceptions (19/102; 19%). The NIH further clarified or provided additional guidance for selection criteria, IRB responsibilities, and cost in the final policy (June 2016). Local IRB reviews and exemptions guidance were unchanged. In this case study, public comments were effective in shaping policy as the NIH modified provisions or planned supplemental guidance in response to comments. Yet critical knowledge gaps remain and empirical data are necessary. The NIH is considering mechanisms to support the establishment of best practices for sIRB implementation.

  9. Success of University Student Volunteers in Obtaining Consent for Reviewing Private Health Information for Emergency Research.

    PubMed

    Kramer, Adam I; Stephenson, Elizabeth; Betel, Adam; Crudden, Johanna; Boutis, Kathy

    2017-01-01

    This study aimed to determine the success of university student volunteers in obtaining consent from parents to allow review of their child's personal health information (PHI) for emergency research screening. This study also aimed to examine the variables associated with successful consent. This was a prospective cross-sectional study conducted at a pediatric emergency department (ED). University students, who functioned as delegates of the health information custodian, approached parents for consent. Of 2,506 parents, 1,852 (73.9%) provided consent to allow review of their child's PHI for research screening. Variables associated with successful consent were high (≥12 months) versus low (<12 months) volunteer experience (OR = 2.0), research related (vs. unrelated) to the child's chief complaint (OR = 2.0), child treated regularly by specialists at the study institution (OR = 1.7), and ED presentation mid-week vs. weekend (OR = 1.7) and morning vs. evening presentation (OR = 1.4). When approached by a university student volunteer, about 25% of parents declined to have their child's PHI reviewed for research screening. This model of obtaining consent may put some emergency research at risk for selection bias. Variables that increase the odds of successful consent can be considered in program design to improve the effectiveness of this model.

  10. Institutional framework for integrated Pharmaceutical Benefits Management: results from a systematic review

    PubMed Central

    Hermanowski, Tomasz Roman; Drozdowska, Aleksandra Krystyna; Kowalczyk, Marta

    2015-01-01

    Objectives In this paper, we emphasised that effective management of health plans beneficiaries access to reimbursed medicines requires proper institutional set-up. The main objective was to identify and recommend an institutional framework of integrated pharmaceutical care providing effective, safe and equitable access to medicines. Method The institutional framework of drug policy was derived on the basis of publications obtained by systematic reviews. A comparative analysis concerning adaptation of coordinated pharmaceutical care services in the USA, the UK, Poland, Italy, Denmark and Germany was performed. Results While most European Union Member States promote the implementation of selected e-Health tools, like e-Prescribing, these efforts do not necessarily implement an integrated package. There is no single agent who would manage an insured patients’ access to medicines and health care in a coordinated manner, thereby increasing the efficiency and safety of drug policy. More attention should be paid by European Union Member States as to how to integrate various e-Health tools to enhance benefits to both individuals and societies. One solution could be to implement an integrated “pharmacy benefit management” model, which is well established in the USA and Canada and provides an integrated package of cost-containment methods, implemented within a transparent institutional framework and powered by strong motivation of the agent. PMID:26528099

  11. Research Ethics: Institutional Review Board Oversight of Art Therapy Research

    ERIC Educational Resources Information Center

    Deaver, Sarah P.

    2011-01-01

    By having their research proposals reviewed and approved by Institutional Review Boards (IRBs), art therapists meet important ethical principles regarding responsibility to research participants. This article provides an overview of the history of human subjects protections in the United States; underlying ethical principles and their application…

  12. 42 CFR 480.116 - Notice to individuals and institutions under review.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... AND HUMAN SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS ACQUISITION, PROTECTION, AND DISCLOSURE OF QUALITY IMPROVEMENT ORGANIZATION REVIEW INFORMATION Utilization and Quality Control Quality... institutions under review with the following information— (a) The title and address of the person responsible...

  13. Institutional Ethical Review and Ethnographic Research Involving Injection Drug Users: A Case Study

    PubMed Central

    Small, Will; Maher, Lisa; Kerr, Thomas

    2014-01-01

    Ethnographic research among people who inject drugs (PWID) involves complex ethical issues. While ethical review frameworks have been critiqued by social scientists, there is a lack of social science research examining institutional ethical review processes, particularly in relation to ethnographic work. This case study describes the institutional ethical review of an ethnographic research project using observational fieldwork and in-depth interviews to examine injection drug use. The review process and the salient concerns of the review committee are recounted, and the investigators’ responses to the committee’s concerns and requests are described to illustrate how key issues were resolved. The review committee expressed concerns regarding researcher safety when conducting fieldwork and the investigators were asked to liaise with the police regarding the proposed research. An ongoing dialogue with the institutional review committee regarding researcher safety and autonomy from police involvement, as well as formal consultation with a local drug user group and solicitation of opinions from external experts, helped to resolve these issues. This case study suggests that ethical review processes can be particularly challenging for ethnographic projects focused on illegal behaviours, and that while some challenges could be mediated by modifying existing ethical review procedures, there is a need for legislation that provides legal protection of research data and participant confidentiality. PMID:24581074

  14. Applying the institutional review board data repository approach to manage ethical considerations in evaluating and studying medical education

    PubMed Central

    Thayer, Erin K.; Rathkey, Daniel; Miller, Marissa Fuqua; Palmer, Ryan; Mejicano, George C.; Pusic, Martin; Kalet, Adina; Gillespie, Colleen; Carney, Patricia A.

    2016-01-01

    Issue Medical educators and educational researchers continue to improve their processes for managing medical student and program evaluation data using sound ethical principles. This is becoming even more important as curricular innovations are occurring across undergraduate and graduate medical education. Dissemination of findings from this work is critical, and peer-reviewed journals often require an institutional review board (IRB) determination. Approach IRB data repositories, originally designed for the longitudinal study of biological specimens, can be applied to medical education research. The benefits of such an approach include obtaining expedited review for multiple related studies within a single IRB application and allowing for more flexibility when conducting complex longitudinal studies involving large datasets from multiple data sources and/or institutions. In this paper, we inform educators and educational researchers on our analysis of the use of the IRB data repository approach to manage ethical considerations as part of best practices for amassing, pooling, and sharing data for educational research, evaluation, and improvement purposes. Implications Fostering multi-institutional studies while following sound ethical principles in the study of medical education is needed, and the IRB data repository approach has many benefits, especially for longitudinal assessment of complex multi-site data. PMID:27443407

  15. Situational variables and institutional violence: a systematic review of the literature.

    PubMed

    Gadon, Lisa; Johnstone, Lorraine; Cooke, David

    2006-09-01

    The impact of violence on institutions is not hard to discern: staff and patients are physically injured and may become psychologically disturbed, property is destroyed, and regimes and programs are disrupted and thereby impoverished. Furthermore, violent individuals are not only incarcerated for longer but are held in more expensive and more restrictive conditions. In order to manage institutional violence, risk factors need to be identified. Research directed at understanding institutional violence has tended to focus on person-centered explanations. However, human behavior does not occur in a vacuum of internal drives and motivations; situational factors are also relevant. A focus on situational risk factors may provide an additional means for managing institutional violence. The primary aim of this systematic review was to examine research that measured the impact of situational factors on institutional violence. The relationships among physical, verbal and/or sexual face-to-face violence and situational factors in prisons and closed psychiatric settings were reviewed. A descriptive and in-depth analysis of previous research findings was carried out. Findings indicated that a range of situational factors may impact on institutional violence. Methodological issues that influence the confidence that can be placed on these findings are considered. The implications of the findings are outlined.

  16. A Systematic Review of Neighborhood and Institutional Relationships Related to Education

    ERIC Educational Resources Information Center

    Johnson, Odis, Jr.

    2012-01-01

    This review explores the conceptualization and measurement of neighborhood and institutional relationships related to children's educational outcomes in neighborhood effects research. The review's analysis first summarizes early statements about neighborhood and school relationships within the field. The analysis next situates neighborhood and…

  17. 40 CFR 166.34 - EPA review of information obtained in connection with emergency exemptions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 false EPA review of information obtained in... PESTICIDES UNDER EMERGENCY CONDITIONS Specific, Quarantine, and Public Health Exemptions § 166.34 EPA review of information obtained in connection with emergency exemptions. EPA shall review information...

  18. 75 FR 70268 - Submission for OMB Review; Comment Request; NIH NCI Central Institutional Review Board (CIRB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ... number. Proposed Collection: Title: NIH NCI Central Institutional Review Board (CIRB). Type of... is absent of conflicts of interest with the protocols under review. Tools utilized to accomplish this... information on workflow and processes of CIRB operations as well as a non-disclosure agreement. A conflict of...

  19. Institutional ethical review and ethnographic research involving injection drug users: a case study.

    PubMed

    Small, Will; Maher, Lisa; Kerr, Thomas

    2014-03-01

    Ethnographic research among people who inject drugs (PWID) involves complex ethical issues. While ethical review frameworks have been critiqued by social scientists, there is a lack of social science research examining institutional ethical review processes, particularly in relation to ethnographic work. This case study describes the institutional ethical review of an ethnographic research project using observational fieldwork and in-depth interviews to examine injection drug use. The review process and the salient concerns of the review committee are recounted, and the investigators' responses to the committee's concerns and requests are described to illustrate how key issues were resolved. The review committee expressed concerns regarding researcher safety when conducting fieldwork, and the investigators were asked to liaise with the police regarding the proposed research. An ongoing dialogue with the institutional review committee regarding researcher safety and autonomy from police involvement, as well as formal consultation with a local drug user group and solicitation of opinions from external experts, helped to resolve these issues. This case study suggests that ethical review processes can be particularly challenging for ethnographic projects focused on illegal behaviours, and that while some challenges could be mediated by modifying existing ethical review procedures, there is a need for legislation that provides legal protection of research data and participant confidentiality. Copyright © 2013 Elsevier Ltd. All rights reserved.

  20. Medical education research and IRB review: an analysis and comparison of the IRB review process at six institutions.

    PubMed

    Dyrbye, Liselotte N; Thomas, Matthew R; Mechaber, Alex J; Eacker, Anne; Harper, William; Massie, F Stanford; Power, David V; Shanafelt, Tait D

    2007-07-01

    To compare how different institutional review boards (IRBs) process and evaluate the same multiinstitutional educational research proposal of medical students' quality of life. Prospective collection in 2005 of key variables regarding the IRB submission and review process of the same educational research proposal involving medical students, which was submitted to six IRBs, each associated with a different medical school. Four IRBs determined the protocol was appropriate for expedited review, and the remaining two required full review. Substantial variation existed in the time to review the protocol by an IRB administrator/IRB member (range 1-101 days) and by the IRB committee (range 6-115 days). One IRB committee approved the study as written. The remaining five IRB committees had a median of 13 requests for additional information/changes to the protocol. Sixty-eight percent of requests (36 of 53) pertained to the informed consent letter; one third (12 of 36) of these requests were unique modifications requested by one IRB but not the others. Although five IRB committees approved the survey after a median of 47 days (range 6-73), one committee had not responded six months after submission (164 days), preventing that school from participating. The findings suggest variability in the timeliness and consistency of IRB review of medical education research across institutions that may hinder multi-institutional research and slow evidence-based medical education reform. The findings demonstrate the difficulties of having medical education research reviewed by IRBs, which are typically designed to review clinical trials, and suggest that the review process for medical education research needs reform.

  1. Enhancing Proof Writing via Cross-Institutional Peer Review

    ERIC Educational Resources Information Center

    Ernst, Dana C.; Hodge, Angie; Schultz, Andrew

    2015-01-01

    In the Spring of 2011, two of the authors of this paper taught number theory courses at their respective institutions. Twice during the semester, students in each class submitted proofs of two to three theorems to be peer reviewed by students in the other class. Each student wrote anonymous and formal referee reports of the submitted theorems,…

  2. Cooperative Institute for Research in the Atmosphere (CIRA) Requirements Review

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Zurawski, Jason, W; Mace, Kathryn, P

    2016-08-11

    In August 2016 The Energy Sciences Network (ESnet) and Colorado State University (CSU) organized a review to characterize the networking requirements of the Cooperative Institute for Research in the Atmosphere (CIRA) located on the campus of Colorado State University. Several key findings highlighting the results from the review were discovered, with benefits to improve the overall scientific process for CIRA and CSU.

  3. Lapse in Institutional Animal Care and Use Committee Continuing Reviews.

    PubMed

    Tsan, Min-Fu; Grabenbauer, Michael; Nguyen, Yen

    2016-01-01

    The United States federal animal welfare regulations and the Public Health Service Policy on Humane Care and Use of Laboratory Animals require that institutional animal care and use committees (IACUCs) conduct continuing reviews of all animal research activities. However, little is known about the lapse rate of IACUC continuing reviews, and how frequently investigators continue research activities during the lapse. It is also not clear what factors may contribute to an institution's lapse in IACUC continuing reviews. As part of the quality assurance program, the Department of Veterans Affairs (VA) has collected performance metric data for animal care and use programs since 2011. We analyzed IACUC continuing review performance data at 74-75 VA research facilities from 2011 through 2015. The IACUC continuing review lapse rates improved from 5.6% in 2011 to 2.7% in 2015. The rate of investigators continuing research activities during the lapse also decreased from 47.2% in 2012 to 7.4% in 2015. The type of IACUCs used and the size of animal research programs appeared to have no effect in facility's rates of lapse in IACUC continuing reviews. While approximately 80% of facilities reported no lapse in IACUC continuing reviews, approximately 14% of facilities had lapse rates of >10% each year. Some facilities appeared to be repeat offenders. Four facilities had IACUC lapse rates of >10% in at least 3 out of 5 years, suggesting a system problem in these facilities requiring remedial actions to improve their IACUC continuing review processes.

  4. Spotlight on Ethics: Institutional Review Boards as Systemic Bullies

    ERIC Educational Resources Information Center

    Carr, Caleb T.

    2015-01-01

    Bullying, often considered an interpersonal or intergroup behaviour, has not been explored as an unintended artefact of organisational structure. Institutional review boards (IRBs), the 'human research ethics committees' at US universities, help oversee the protection of human research subjects, particularly in the social sciences within…

  5. Concordance between local, institutional, and central pathology review in glioblastoma: implications for research and practice: a pilot study.

    PubMed

    Gupta, Tejpal; Nair, Vimoj; Epari, Sridhar; Pietsch, Torsten; Jalali, Rakesh

    2012-01-01

    There is significant inter-observer variation amongst the neuro-pathologists in the typing, subtyping, and grading of glial neoplasms for diagnosis. Centralized pathology review has been proposed to minimize this inter-observer variation and is now almost mandatory for accrual into multicentric trials. We sought to assess the concordance between neuro-pathologists on histopathological diagnosis of glioblastoma. Comparison of local, institutional, and central neuro-oncopathology reporting in a cohort of 34 patients with newly diagnosed supratentorial glioblastoma accrued consecutively at a tertiary-care institution on a prospective trial testing the addition of a new agent to standard chemo-radiation regimen. Concordance was sub-optimal between local histological diagnosis and central review, fair between local diagnosis and institutional review, and good between institutional and central review, with respect to histological typing/subtyping. Twelve (39%) of 31 patients with local histological diagnosis had identical tumor type, subtype and grade on central review. Overall agreement was modestly better (52%) between local diagnosis and institutional review. In contrast, 28 (83%) of 34 patients had completely concordant histopathologic diagnosis between institutional and central review. The inter-observer reliability test showed poor agreement between local and central review (kappa statistic=0.12, 95% confidence interval (CI): -0.03-0.32, P=0.043), but moderate agreement between institutional and central review (kappa statistic=0.51, 95%CI: 0.17-0.84, P=0.00003). Agreement between local diagnosis and institutional review was fair. There exists significant inter-observer variation regarding histopathological diagnosis of glioblastoma with significant implications for clinical research and practice. There is a need for more objective, quantitative, robust, and reproducible criteria for better subtyping for accurate diagnosis.

  6. How to do human-subjects research if you do not have an institutional review board.

    PubMed

    Rice, Todd W

    2008-10-01

    Biomedical research with human subjects has expanded outside of traditional medical centers and hospitals into other health care entities, such as rehabilitation facilities, free-standing out-patient treatment centers, and even home-health agencies. Regardless of the location, federal regulations mandate that all human-subjects research must be overseen by an institutional review board (IRB) or ethics committee to ensure the research abide by the Code of Federal Regulations. Consequently, all human-subjects research must be reviewed and approved by an IRB prior to initiation of any research procedures. Unfortunately, many of these nontraditional research facilities do not have easy access to an IRB. This does not render such research exempt from federal oversight. Clinicians at these facilities have viable options for obtaining IRB approval and legally conducting such research. This paper outlines the available options and their pros and cons.

  7. Nature-based interventions in institutional and organisational settings: a scoping review.

    PubMed

    Moeller, Chris; King, Nigel; Burr, Viv; Gibbs, Graham R; Gomersall, Tim

    2018-04-26

    The objective of this review was to scope the literature on nature-based interventions that could be conducted in institutional settings where people reside full-time for care or rehabilitation purposes. Systematic searches were conducted across CINAHL, Medline, Criminal Justice Abstracts, PsycINFO, Scopus, Social Care Online and Cochrane CENTRAL. A total of 85 studies (reported in 86 articles) were included. Four intervention modalities were identified: Gardening/therapeutic horticulture; animal-assisted therapies; care farming and virtual reality-based simulations of natural environments. The interventions were conducted across a range of settings, including inpatient wards, care homes, prisons and women's shelters. Generally, favourable impacts were seen across intervention types, although the reported effects varied widely. There is a growing body of literature on nature-based interventions that could be applied to a variety of institutional settings. Within most intervention types, there is sufficient research data available to perform full systematic reviews. Recommendations for future systematic reviews are offered.

  8. Impact of Institutional Review Board Practice Variation on Observational Health Services Research

    PubMed Central

    Green, Lee A; Lowery, Julie C; Kowalski, Christine P; Wyszewianski, Leon

    2006-01-01

    Objective To describe, qualitatively and quantitatively, the impact of a review by multiple institutional review boards (IRBs) on the conduct of a multisite observational health services research study. Data Source and Setting Primary data collection during 2002, 2003, and 2004 at 43 United States Department of Veterans Affairs (VA) primary care clinics. Design Explanatory sequential mixed methods design incorporating qualitative and quantitative elements in sequence. Data Collection and Abstraction Methods Field notes and documents collected by research staff during a multisite observational health services research study were used in thematic analysis. Themes were quantified descriptively and merged with timeline data. Principal Findings Approximately 4,680 hours of staff time over a 19-month period were devoted solely to the IRB process. Four categories of phenomena impacting research were observed: Recruitment, retention, and communication issues with local site principal investigators (PIs). Local PIs had no real role but were required by IRBs. Twenty-one percent of sites experienced turnover in local PIs, and local PI issues added significant delay to most sites.Wide variation in standards applied to review and approval of IRB applications. The study was designed to be qualified under U.S. government regulations for expedited review. One site exempted it from review (although it did not qualify for exemption), 10 granted expedited review, 31 required full review, and one rejected it as being too risky to be permitted. Twenty-three required inapplicable sections in the consent form and five required HIPAA (Health Insurance Portability and Accountability Act of 1996) consent from physicians although no health information was asked of them. Twelve sites requested, and two insisted upon, provisions that directly increased the risk to participants.Multiple returns for revision of IRB applications, consent documents, and ancillary forms. Seventy-six percent of

  9. American Gastroenterological Association Institute technical review on the management of gastric subepithelial masses.

    PubMed

    Hwang, Joo Ha; Rulyak, Stephen D; Kimmey, Michael B

    2006-06-01

    This literature review and the recommendations therein were prepared for the American Gastroenterological Association Institute Clinical Practice and Economics Committee. The paper was approved by the Committee on January 19, 2006, and by the AGA Institute Governing Board on April 20, 2006.

  10. Measuring Diversity in Higher Education Institutions: A Review of Literature and Empirical Approaches

    ERIC Educational Resources Information Center

    Widiputera, Ferdi; De Witte, Kristof; Groot, Wim; van den Brink, Henriëtte Maassen

    2017-01-01

    This paper reviews studies on diversity in higher education institutions and suggests empirical approaches to measure diversity. "Diversity" in this paper refers to the internal and external differences among academic programs and institutions. As the empirical literature is relatively salient about how to measure diversity in higher…

  11. Institutional Review Board approval and innovation in urology: current practice and safety issues.

    PubMed

    Sundaram, Varun; Vemana, Goutham; Bhayani, Sam B

    2014-02-01

    To retrospectively review recent publications describing novel procedures/techniques, and describe the Institutional Review Board (IRB)/ethics approval process and potential ethical dilemmas in their reporting. We searched PubMed for papers about innovative or novel procedures/techniques between 2011 and August 2012. A query of titles/abstracts in the Journal of Urology, Journal of Endourology, European Urology, BJU International, and Urology identified relevant papers. These results were reviewed for human studies that described an innovative technique, procedure, approach, initial series, and/or used new technology. In all, 91 papers met criteria for inclusion; 25 from the Journal of Endourology, 14 from the Journal of Urology, nine from European Urology, 15 from the BJU International and 28 from Urology. IRB/ethics approval was given for an experimental procedure or database in 24% and 22%, respectively. IRB/ethics approval was not mentioned in 52.7% of studies. Published IRB/ethics approvals for innovative techniques are heterogeneous including database, retrospective, and prospective approvals. Given the concept that innovations are likely not in the legal or ethical standard of care, strong consideration should be given to obtaining IRB/ethics approval before the actual procedure, instead of approval to merely report database outcomes. © 2013 The Authors. BJU International © 2013 BJU International.

  12. The impacts of institutional child sexual abuse: A rapid review of the evidence.

    PubMed

    Blakemore, Tamara; Herbert, James Leslie; Arney, Fiona; Parkinson, Samantha

    2017-12-01

    While awareness of institutional child sexual abuse has grown in recent years, there remains limited understanding of its occurrence and outcomes as a distinct form of abuse. Drawing on research commissioned by the Australian Royal Commission into Institutional Responses to Child Sexual Abuse, this article presents a rapid review of available evidence on the impacts of institutional abuse on victim/survivors. Literature searches identified 75 sources spanning international peer reviewed work and reports to Government that document or quantify the impacts of mostly historical child sexual abuse occurring in religious, educational, sporting and residential or out-of-home care settings. Consistent with child sexual abuse in other contexts, institutional child sexual abuse is found to be associated with numerous, pervasive and connected impacts upon the psychological, physical, social, educative and economic wellbeing of victims/survivors. Further, institutional child sexual abuse is associated with vicarious trauma at the individual, family and community level, and with impacts to the spiritual wellbeing of victims/survivors of abuse that occurs in religious settings. The identified literature suggests the trauma of institutional child sexual abuse may be exacerbated by the interplay of abuse dynamics in institutional settings, which may reduce or impede circumstances supporting disclosure, belief, support and protection from future harm. Acknowledging the limitations of the present study and the available evidence, this narrative synthesis provides insights into the complex impacts of institutional child sexual abuse. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. 77 FR 52704 - Notice of Submission for OMB Review; Institute of Education Sciences; Early Childhood...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ... DEPARTMENT OF EDUCATION Notice of Submission for OMB Review; Institute of Education Sciences... for Education Statistics (NCES) within the Institute of Education Sciences (IES) of the U.S... Statistics (NCES) within the Institute of Education Sciences (IES) of the U.S. Department of Education (ED...

  14. A Case for Limiting the Reach of Institutional Review Boards

    ERIC Educational Resources Information Center

    Hessler, Richard M.; Donnell-Watson, D. J.; Galliher, John F.

    2011-01-01

    Institutional review boards (IRBs) governing social and behavioral research seem to systematically exceed the guidelines established by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. We examine a clandestine study of prostitution and another of employment discrimination and conclude that IRBs,…

  15. 42 CFR 480.116 - Notice to individuals and institutions under review.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... AND HUMAN SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS ACQUISITION, PROTECTION, AND DISCLOSURE OF QUALITY IMPROVEMENT ORGANIZATION INFORMATION Utilization and Quality Control Quality... institutions under review with the following information— (a) The title and address of the person responsible...

  16. 42 CFR 480.116 - Notice to individuals and institutions under review.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... AND HUMAN SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS ACQUISITION, PROTECTION, AND DISCLOSURE OF QUALITY IMPROVEMENT ORGANIZATION INFORMATION Utilization and Quality Control Quality... institutions under review with the following information— (a) The title and address of the person responsible...

  17. 42 CFR 480.116 - Notice to individuals and institutions under review.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... AND HUMAN SERVICES (CONTINUED) QUALITY IMPROVEMENT ORGANIZATIONS ACQUISITION, PROTECTION, AND DISCLOSURE OF QUALITY IMPROVEMENT ORGANIZATION INFORMATION Utilization and Quality Control Quality... institutions under review with the following information— (a) The title and address of the person responsible...

  18. Quality Assurance Peer Review Chart Rounds in 2011: A Survey of Academic Institutions in the United States

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Lawrence, Yaacov Richard, E-mail: yaacovla@gmail.com; Department of Radiation Oncology, Sheba Medical Center, Tel HaShomer; Sackler School of Medicine, Tel Aviv University

    Purpose: In light of concerns regarding the quality of radiation treatment delivery, we surveyed the practice of quality assurance peer review chart rounds at American academic institutions. Methods and Materials: An anonymous web-based survey was sent to the chief resident of each institution across the United States. Results: The response rate was 80% (57/71). The median amount of time spent per patient was 2.7 minutes (range, 0.6-14.4). The mean attendance by senior physicians and residents was 73% and 93%, respectively. A physicist was consistently present at peer review rounds in 66% of departments. There was a close association between attendancemore » by senior physicians and departmental organization: in departments with protected time policies, good attendance was 81% vs. 31% without protected time (p = 0.001), and in departments that documented attendance, attending presence was 69% vs. 29% in departments without documentation (p < 0.05). More than 80% of institutions peer review all external beam therapy courses; however, rates were much lower for other modalities (radiosurgery 58%, brachytherapy 40%-47%). Patient history, chart documentation, and dose prescription were always peer reviewed in >75% of institutions, whereas dosimetric details (beams, wedges), isodose coverage, intensity-modulated radiation therapy constraints, and dose-volume histograms were always peer reviewed in 63%, 59%, 42%, and 50% of cases, respectively. Chart rounds led to both minor (defined as a small multileaf collimator change/repeated port film) and major (change to dose prescription or replan with dosimetry) treatment changes. Whereas at the majority of institutions changes were rare (<10% of cases), 39% and 11% of institutions reported that minor and major changes, respectively, were made to more than 10% of cases. Conclusion: The implementation of peer review chart rounds seems inconsistent across American academic institutions. Brachytherapy and radiosurgical procedures

  19. Understanding Faculty Needs: An Institutional Imperative.

    ERIC Educational Resources Information Center

    O'Hara, Leonard F.

    1996-01-01

    Describes the importance of obtaining faculty support to ensure success in college reform efforts, and reviews strategies for improving institutional climate. Discusses a survey instrument designed to measure faculty perceptions of college atmosphere and developed as part of the Fourth Paradigm Governance Model. Includes a sample faculty…

  20. Variations in institutional review board processes and consent requirements for trauma research: an EAST multicenter survey

    PubMed Central

    Nahmias, Jeffry; Brakenridge, Scott; Jawa, Randeep S; Holena, Daniel N; Agapian, John Varujan; Bruns, Brandon; Chestovich, Paul J; Chung, Bruce; Nguyen, Jonathan; Schulman, Carl I; Staudenmayer, Kristan; Dixon, Rachel; Smith, Jason W; Bernard, Andrew C; Pascual, Jose L

    2018-01-01

    Oversight of human subject research has evolved considerably since its inception. However, previous studies identified a lack of consistency of institutional review board (IRB) determination for the type of review required and whether informed consent is necessary, especially for prospective observational studies, which pose minimal risk of harm. We hypothesized that there is significant inter-institution variation in IRB requirements for the type of review and necessity of informed consent, especially for prospective observational trials without blood/tissue utilization. We also sought to describe investigators’ and IRB members’ attitudes toward the type of review and need for consent. Eastern Association for the Surgery of Trauma (EAST) and IRB members were sent an electronic survey on IRB review and informed consent requirement. We performed descriptive analyses as well as Fisher’s exact test to determine differences between EAST and IRB members’ responses. The response rate for EAST members from 113 institutions was 13.5%, whereas a convenience sample of IRB members from 14 institutions had a response rate of 64.4%. Requirement for full IRB review for retrospective studies using patient identifiers was reported by zero IRB member compared with 13.1% of EAST members (p=0.05). Regarding prospective observational trials without blood/tissue collection, 48.1% of EAST members reported their institutions required a full IRB review compared with 9.5% of IRB members (p=0.01). For prospective observational trials with blood/tissue collection, 80% of EAST members indicated requirement to submit a full IRB review compared with only 13.6% of IRB members (p<0.001). Most EAST members (78.6%) stated that informed consent is not ethically necessary in prospective observational trials without blood/tissue collection, whereas most IRB members thought that informed consent was ethically necessary (63.6%, p<0.001). There is significant variation in perception and practice

  1. 75 FR 1790 - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: IRB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-13

    ....gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default...] Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval; Availability AGENCY: Food and Drug Administration, HHS...

  2. Uncertainty about effects is a key factor influencing institutional review boards' approval of clinical studies.

    PubMed

    Wao, Hesborn; Mhaskar, Rahul; Kumar, Ambuj; Miladinovic, Branko; Guterbock, Thomas; Hozo, Iztok; Djulbegovic, Benjamin

    2014-10-01

    To investigate factors, which influence institutional review boards' (IRBs') decision to approve or not approve clinical studies, a nationwide vignette-based online survey of IRB members was conducted. A factorial design was used, whereby seven aspects of each hypothetical study were randomly varied in 15 phrases in each vignette to produce unique vignettes. Participants indicated the degree of study approval and described factors influencing approval decision. Qualitative responses were thematically content analyzed. Sixteen themes were obtained from 208 participants from 42 institutions. Uncertainty, adherence, study design, and harms were frequently and intensely cited to influence study approval. Analysis of two extreme subgroups (approvers vs. nonapprovers) showed that uncertainty influenced approval decisions, odds ratios (OR) = 3.5 (95% confidence interval [CI], 1.3-9.8) and OR = 3.2 (95% CI, 1.1-8.9), respectively, based on theme frequency and theme intensity, ignoring multiple observations per person. Taking into consideration multiple observations per person, similar results were obtained for uncertainty: OR = 8.9 (95% CI, 0.93-85.4). Perceived uncertainty about benefits and harms of a proposed intervention is a key driver in IRB members' approval of clinical trials. This, in turn, calls for improved standardization in the communications of information on benefits and harms in the research protocols considered by the IRBs. Published by Elsevier Inc.

  3. Are central institutional review boards the solution? The National Heart, Lung, and Blood Institute Working Group's report on optimizing the IRB process.

    PubMed

    Mascette, Alice M; Bernard, Gordon R; Dimichele, Donna; Goldner, Jesse A; Harrington, Robert; Harris, Paul A; Leeds, Hilary S; Pearson, Thomas A; Ramsey, Bonnie; Wagner, Todd H

    2012-12-01

    The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health convened a working group in June 2011 to examine alternative institutional review board (IRB) models. The working group was held in response to proposed changes in the regulations for government-supported research and the proliferation of multicenter clinical trials where multiple individual reviews may be inefficient. Group members included experts in heart, lung, and blood research, research oversight, bioethics, health economics, regulations, and information technology (IT). The group discussed alternative IRB models, ethical concerns, metrics for evaluating IRBs, IT needs, and economic considerations. Participants noted research gaps in IRB best practices and in metrics. The group arrived at recommendations for process changes, such as defining specific IRB performance requirements in funding announcements, requiring funded researchers to use more efficient alternative IRB models, and developing IT systems to facilitate information sharing and collaboration among IRBs. Despite the success of the National Cancer Institute's central IRB (CIRB), the working group, concerned about the creation costs and unknown cost-efficiency of a new CIRB, and about the risk of shifting the burden of dealing with multiple IRBs from sponsors to research institutions, did not recommend the creation of an NHLBI-funded CIRB.

  4. New Cancer Prevention and Control Central Institutional Review Board Established | Division of Cancer Prevention

    Cancer.gov

    The NCI Central Institutional Review Board (CIRB) Initiative announced the establishment of the Cancer Prevention and Control (CPC) CIRB January 14, extending the benefits of centralized review to investigators participating in clinical trials sponsored by the Division of Cancer Prevention (DCP). |

  5. Time required for institutional review board review at one Veterans Affairs medical center.

    PubMed

    Hall, Daniel E; Hanusa, Barbara H; Stone, Roslyn A; Ling, Bruce S; Arnold, Robert M

    2015-02-01

    Despite growing concern that institutional review boards (IRBs) impose burdensome delays on research, little is known about the time required for IRB review across different types of research. To measure the overall and incremental process times for IRB review as a process of quality improvement. After developing a detailed process flowchart of the IRB review process, 2 analysts abstracted temporal data from the records pertaining to all 103 protocols newly submitted to the IRB at a large urban Veterans Affairs medical center from June 1, 2009, through May 31, 2011. Disagreements were reviewed with the principal investigator to reach consensus. We then compared the review times across review types using analysis of variance and post hoc Scheffé tests after achieving normally distributed data through logarithmic transformation. Calendar days from initial submission to final approval of research protocols. Initial IRB review took 2 to 4 months, with expedited and exempt reviews requiring less time (median [range], 85 [23-631] and 82 [16-437] days, respectively) than full board reviews (median [range], 131 [64-296] days; P = .008). The median time required for credentialing of investigators was 1 day (range, 0-74 days), and review by the research and development committee took a median of 15 days (range, 0-184 days). There were no significant differences in credentialing or research and development times across review types (exempt, expedited, or full board). Of the extreme delays in IRB review, 80.0% were due to investigators' slow responses to requested changes. There were no systematic delays attributable to the information security officer, privacy officer, or IRB chair. Measuring and analyzing review times is a critical first step in establishing a culture and process of continuous quality improvement among IRBs that govern research programs. The review times observed at this IRB are substantially longer than the 60-day target recommended by expert panels

  6. [Ethic review on clinical experiments of medical devices in medical institutions].

    PubMed

    Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining

    2011-07-01

    Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.

  7. A caution to Native American institutional review boards about scientism and censorship.

    PubMed

    Askland, Andrew

    2002-01-01

    Native American Institutional Review Boards (IRBs) promote the health and welfare of tribes by reviewing protocols for research studies that focus on their tribes. The benefits of approved protocols should not be overstated lest good studies disappoint because they do not satisfy unachievable expectations. IRBs also should avoid the temptation to censor the outcomes of those studies. Science relies on candor and clarity about results and methods to move forward.

  8. Effect of Clinical and Attitudinal Characteristics on Obtaining Comprehensive Medication Reviews.

    PubMed

    Farris, Karen B; Salgado, Teresa M; Aneese, Nadia; Marshall, Vincent D; Pendergast, Jane F; Frank, Jessica; Chrischilles, Elizabeth A; Doucette, William R

    2016-04-01

    Comprehensive medication reviews (CMRs) consist of in-depth reviews of patients' medications to identify effectiveness or safety problems and often generate cost savings for individuals. Despite their advantages, CMRs are not widely obtained. Previous studies found that older age, female sex, and experience of side effects were associated with obtaining a medication review. To quantify the association between attitudinal and clinical factors with intention and predict future behavior to obtain a CMR among Medicare Part D beneficiaries. A sample of Medicare Part D beneficiaries from 1 health care plan (n = 660) completed a 14-item survey over the telephone assessing factors that were hypothesized to affect their intention and behavior to obtain a CMR. The survey collected medication use history and health care information with the medication user self-evaluation tool, health status, adherence, intention to obtain a CMR, and demographic characteristics. Subjects subsequently were informed that they could obtain a CMR from their pharmacies. Claims data were obtained that indicated which subjects received a CMR. Two dependent variables were predicted: intention to schedule a CMR using a multivariate linear regression model and receipt of a CMR using a logistic regression and including intention as a predictor variable. The mean age of participants was 76.6 (SD = 7.61) years; 71% were female; and participants took an average of 5.2 (SD = 3.18) medications. The intention to have a CMR was 2.85 (SD = 1.41) on a 5-point scale, and 5.6% of the participants actually had a CMR. Worrying about medications doing more harm than good, number of pharmacies where participants obtained their medications from, number of medications, and number of medical conditions predicted intention to obtain a CMR. Patients who perceived their health status to be poorer compared with others their age were more likely to have a CMR. Intention to obtain a CMR was not associated with receipt of a CMR

  9. Pediatric colonic volvulus: A single-institution experience and review.

    PubMed

    Tannouri, Sami; Hendi, Aditi; Gilje, Elizabeth; Grissom, Leslie; Katz, Douglas

    2017-06-01

    Pediatric colonic volvulus is both rare and underreported. Existing literature consists only of case reports and small series. We present an analysis of cases (n=11) over 15 years at a single institution, focusing on workup and diagnosis. This was an institutional review board approved single-institution retrospective chart review of 11 cases of large bowel volvulus occurring over 15 years (2000-2015). In our series, the most common presenting symptoms were abdominal pain and distention. Afflicted patients often had prior abdominal surgery, a neurodevelopmental disorder or chronic constipation. Of the imaging modalities utilized in the 11 patients studied, colonic volvulus was correctly diagnosed by barium enema in 100% of both cases, CT in 55.6% of cases and by plain radiography of the abdomen in only 22.2%of cases. Colonic volvulus was confirmed by laparotomy in all cases. The cecum (n=5) was the most often affected colonic segment, followed by the sigmoid (n=3). Operative treatment mainly consisted of resection (63.6%) and ostomy creation (36.4%). Colopexy was performed in 18.2% of cases. Plain abdominal radiography may be performed as an initial diagnostic study, however, it should be followed CT or air or contrast enema in children where there is high clinical suspicion and who do not have indications for immediate laparotomy. CT may be the most specific and useful test in diagnosis of colonic volvulus and has the added advantage of detection of complications including bowel ischemia. We demonstrate a range of diagnostic and therapeutic modalities for pediatric colonic volvulus. This underscores the need for further study to draft standard best practices for this life-threatening condition. Prognosis Study: Level IV. Study of a Diagnostic Test: Level III. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Determinants of Teachers' Attitudes towards E- Learning in Tanzanian Higher Learning Institutions

    ERIC Educational Resources Information Center

    Kisanga, Dalton H.

    2016-01-01

    This survey research study presents the findings on determinants of teachers' attitudes towards e-learning in Tanzanian higher learning institutions. The study involved 258 teachers from 4 higher learning institutions obtained through stratified, simple random sampling. Questionnaires and documentary review were used in data collection. Data were…

  11. Time Required for Institutional Review Board Review at One Veterans Affairs Medical Center

    PubMed Central

    Hall, Daniel E.; Hanusa, Barbara H.; Stone, Roslyn A.; Ling, Bruce S.; Arnold, Robert M.

    2015-01-01

    IMPORTANCE Despite growing concern that institutional review boards (IRBs) impose burdensome delays on research, little is known about the time required for IRB review across different types of research. OBJECTIVE To measure the overall and incremental process times for IRB review as a process of quality improvement. DESIGN, SETTING, AND PARTICIPANTS After developing a detailed process flowchart of the IRB review process, 2 analysts abstracted temporal data from the records pertaining to all 103 protocols newly submitted to the IRB at a large urban Veterans Affairs medical center from June 1, 2009, through May 31, 2011. Disagreements were reviewed with the principal investigator to reach consensus. We then compared the review times across review types using analysis of variance and post hoc Scheffé tests after achieving normally distributed data through logarithmic transformation. MAIN OUTCOMES AND MEASURES Calendar days from initial submission to final approval of research protocols. RESULTS Initial IRB review took 2 to 4 months, with expedited and exempt reviews requiring less time (median [range], 85 [23–631] and 82 [16–437] days, respectively) than full board reviews (median [range], 131 [64–296] days; P = .008). The median time required for credentialing of investigators was 1 day (range, 0–74 days), and review by the research and development committee took a median of 15 days (range, 0–184 days). There were no significant differences in credentialing or research and development times across review types (exempt, expedited, or full board). Of the extreme delays in IRB review, 80.0% were due to investigators' slow responses to requested changes. There were no systematic delays attributable to the information security officer, privacy officer, or IRB chair. CONCLUSIONS AND RELEVANCE Measuring and analyzing review times is a critical first step in establishing a culture and process of continuous quality improvement among IRBs that govern research

  12. Review of Army Research Laboratory Programs for Historically Black Colleges and Universities and Minority Institutions

    ERIC Educational Resources Information Center

    National Academies Press, 2014

    2014-01-01

    "Review of Army Research Laboratory Programs for Historically Black Colleges and Universities and Minority Institutions" examines the ways in which historically black colleges and universities and minority institutions have used the Army Research Laboratory (ARL) funds to enhance the science, technology, engineering, and mathematics…

  13. 75 FR 49938 - Proposed Collection; Comment Request; NIH NCI Central Institutional Review Board (CIRB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-16

    ... Institutional Review Board (CIRB). Type of Information Collection Request: Existing Collection in Use Without an... level of reviewer and board member satisfaction and is absent of conflicts of interest with the... operations as well as a non-disclosure agreement. A conflict of interest form is completed occasionally or...

  14. Institutional Conflict of Interest Policies at U.S. Academic Research Institutions.

    PubMed

    Resnik, David B; Ariansen, J L; Jamal, Jaweria; Kissling, Grace E

    2016-02-01

    Institutional conflicts of interest (ICOIs) occur when the institution or leaders with authority to act on behalf of the institution have conflicts of interest (COIs) that may threaten the objectivity, integrity, or trustworthiness of research because they could impact institutional decision making. The purpose of this study was to gather and analyze information about the ICOI policies of the top 100 U.S. academic research institutions, ranked according to total research funding. From May-June 2014, the authors attempted to obtain ICOI policy information for the top 100 U.S. academic research institutions from publicly available Web sites or via e-mail inquiry. If an ICOI policy was not found, the institutions' online COI policies were examined. Data on each institution's total research funding, national funding rank, public versus private status, and involvement in clinical research were collected. The authors developed a coding system for categorizing the ICOI policies and used it to code the policies for nine items. Interrater agreement and P values were assessed. Only 28/100 (28.0%) institutions had an ICOI policy. ICOI policies varied among the 28 institutions. Having an ICOI policy was positively associated with total research funding and national funding ranking but not with public versus private status or involvement in clinical research. Although most U.S. medical schools have policies that address ICOIs, most of the top academic research institutions do not. Federal regulation and guidance may be necessary to encourage institutions to adopt ICOI policies and establish a standard form of ICOI review.

  15. "It's like Tuskegee in reverse": a case study of ethical tensions in institutional review board review of community-based participatory research.

    PubMed

    Malone, Ruth E; Yerger, Valerie B; McGruder, Carol; Froelicher, Erika

    2006-11-01

    Community-based participatory research (CBPR) addresses the social justice dimensions of health disparities by engaging marginalized communities, building capacity for action, and encouraging more egalitarian relationships between researchers and communities. CBPR may challenge institutionalized academic practices and the understandings that inform institutional review board deliberations and, indirectly, prioritize particular kinds of research. We present our attempt to study, as part of a CBPR partnership, cigarette sales practices in an inner-city community. We use critical and communitarian perspectives to examine the implications of the refusal of the university institutional review board (in this case, the University of California, San Francisco) to approve the study. CBPR requires expanding ethical discourse beyond the procedural, principle-based approaches common in biomedical research settings. The current ethics culture of academia may sometimes serve to protect institutional power at the expense of community empowerment.

  16. Conducting systematic reviews of association (etiology): The Joanna Briggs Institute's approach.

    PubMed

    Moola, Sandeep; Munn, Zachary; Sears, Kim; Sfetcu, Raluca; Currie, Marian; Lisy, Karolina; Tufanaru, Catalin; Qureshi, Rubab; Mattis, Patrick; Mu, Peifan

    2015-09-01

    The systematic review of evidence is the research method which underpins the traditional approach to evidence-based healthcare. There is currently no uniform methodology for conducting a systematic review of association (etiology). This study outlines and describes the Joanna Briggs Institute's approach and guidance for synthesizing evidence related to association with a predominant focus on etiology and contributes to the emerging field of systematic review methodologies. It should be noted that questions of association typically address etiological or prognostic issues.The systematic review of studies to answer questions of etiology follows the same basic principles of systematic review of other types of data. An a priori protocol must inform the conduct of the systematic review, comprehensive searching must be performed and critical appraisal of retrieved studies must be carried out.The overarching objective of systematic reviews of etiology is to identify and synthesize the best available evidence on the factors of interest that are associated with a particular disease or outcome. The traditional PICO (population, interventions, comparators and outcomes) format for systematic reviews of effects does not align with questions relating to etiology. A systematic review of etiology should include the following aspects: population, exposure of interest (independent variable) and outcome (dependent variable).Studies of etiology are predominantly explanatory or predictive. The objective of reviews of explanatory or predictive studies is to contribute to, and improve our understanding of, the relationship of health-related events or outcomes by examining the association between variables. When interpreting possible associations between variables based on observational study data, caution must be exercised due to the likely presence of confounding variables or moderators that may impact on the results.As with all systematic reviews, there are various approaches to

  17. Knowledge and awareness regarding biomedical waste management in dental teaching institutions in India- A systematic review

    PubMed Central

    Kapoor, Daljit; Nirola, Ashutosh; Kapoor, Vinod

    2014-01-01

    Objectives: Proper handling, treatment and disposal of biomedical wastes are important elements in any health care setting. Not much attention has been paid to the management of Biomedical Waste (BMW) in recent years, in dental colleges and hospitals in India. The present systematic review was conducted to assess knowledge and awareness regarding BMW management among staff and students of dental teaching institutions in India. Material and Methods: A systematic review of relevant cross-sectional studies was conducted regarding BMW management in India in dental teaching institutions in India. Six studies were finally included in the present review after conducting both electronic and manual search like Pubmed, EMBASE etc. and after making necessary exclusions. Potential biases were addressed and relevant data was extracted by the concerned investigators. Results: Six studies were finally included in the review. Colour coding of wastes was not done by 67% of the subjects in one of the studies conducted in Haryana. Almost all the subjects agreed to the fact that exposure to hazardous health care waste can result in disease or infection in another study. According to another study reports, none of the respondents was able to list the legislative act regarding BMW when asked. Conclusions: The results of the present review showed that knowledge and awareness level of subjects was inadequate and there is considerable variation in practice and management regarding BMW. There is a great need for continuing education and training programmes to be conducted in dental teaching institutions in India. Key words:Biomedical waste, knowledge, awareness, dentists, institution. PMID:25593667

  18. Knowledge and awareness regarding biomedical waste management in dental teaching institutions in India- A systematic review.

    PubMed

    Kapoor, Daljit; Nirola, Ashutosh; Kapoor, Vinod; Gambhir, Ramandeep-Singh

    2014-10-01

    Proper handling, treatment and disposal of biomedical wastes are important elements in any health care setting. Not much attention has been paid to the management of Biomedical Waste (BMW) in recent years, in dental colleges and hospitals in India. The present systematic review was conducted to assess knowledge and awareness regarding BMW management among staff and students of dental teaching institutions in India. A systematic review of relevant cross-sectional studies was conducted regarding BMW management in India in dental teaching institutions in India. Six studies were finally included in the present review after conducting both electronic and manual search like Pubmed, EMBASE etc. and after making necessary exclusions. Potential biases were addressed and relevant data was extracted by the concerned investigators. Six studies were finally included in the review. Colour coding of wastes was not done by 67% of the subjects in one of the studies conducted in Haryana. Almost all the subjects agreed to the fact that exposure to hazardous health care waste can result in disease or infection in another study. According to another study reports, none of the respondents was able to list the legislative act regarding BMW when asked. The results of the present review showed that knowledge and awareness level of subjects was inadequate and there is considerable variation in practice and management regarding BMW. There is a great need for continuing education and training programmes to be conducted in dental teaching institutions in India. Key words:Biomedical waste, knowledge, awareness, dentists, institution.

  19. The Effect of Computer Automation on Institutional Review Board (IRB) Office Efficiency

    ERIC Educational Resources Information Center

    Oder, Karl; Pittman, Stephanie

    2015-01-01

    Companies purchase computer systems to make their processes more efficient through automation. Some academic medical centers (AMC) have purchased computer systems for their institutional review boards (IRB) to increase efficiency and compliance with regulations. IRB computer systems are expensive to purchase, deploy, and maintain. An AMC should…

  20. E-recruitment based clinical research: notes for Research Ethics Committees/Institutional Review Boards.

    PubMed

    Refolo, P; Sacchini, D; Minacori, R; Daloiso, V; Spagnolo, A G

    2015-01-01

    Patient recruitment is a critical point of today's clinical research. Several proposals have been made for improving it, but the effectiveness of these measures is actually uncertain. The use of Internet (e-recruitment) could represent a great chance to improve patient enrolment, even though the effectiveness of this implementation is not so evident. E-recruitment could bring some advantages, such as better interaction between clinical research demand and clinical research supply, time and resources optimization, and reduction of data entry errors. It raises some issues too, such as sampling errors, validity of informed consent, and protection of privacy. Research Ethics Committees/Institutional Review Boards should consider these critical points. The paper deals with Internet recruitment for clinical research. It also attempts to provide Research Ethics Committees/Institutional Review Boards with notes for assessing e-recruitment based clinical protocols.

  1. A Review of Cash Management Policies, Procedures and Practices of Mississippi's Institutions of Higher Learning.

    ERIC Educational Resources Information Center

    Mississippi State Legislature, Jackson. Performance Evaluation and Expenditure Review Committee.

    This report to the Mississippi Legislature presents the findings of a review of the cash management policies, procedures, and practices of the State Board of Trustees of Institutions of Higher Learning (IHL). The methodology involved review of: applicable Mississippi statutes; standards promulgated by the National Association of College and…

  2. Some Visual Literacy Initiatives in Academic Institutions: A Literature Review from 1999 to the Present

    ERIC Educational Resources Information Center

    Blummer, Barbara

    2015-01-01

    The ubiquitousness of images in the digital era highlights the importance of individuals' visual communication skills in the 21st Century. We conducted a literature review of visual literacy initiatives in academic institutions to illustrate best practices for imparting these skills in students. The literature review identified five categories of…

  3. Changes in average length of stay and average charges generated following institution of PSRO review.

    PubMed Central

    Westphal, M; Frazier, E; Miller, M C

    1979-01-01

    A five-year review of accounting data at a university hospital shows that immediately following institution of concurrent PSRO admission and length of stay review of Medicare-Medicaid patients, there was a significant decrease in length of stay and a fall in average charges generated per patient against the inflationary trend. Similar changes did not occur for the non-Medicare-Medicaid patients who were not reviewed. The observed changes occurred even though the review procedure rarely resulted in the denial of services to patients, suggesting an indirect effect of review. PMID:393658

  4. The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review Boards?

    PubMed

    Barker, Roger A; Carpenter, Melissa K; Forbes, Stuart; Goldman, Steven A; Jamieson, Catriona; Murry, Charles E; Takahashi, Jun; Weir, Gordon

    2018-05-08

    Stem cell-based clinical interventions are increasingly advancing through preclinical testing and approaching clinical trials. The complexity and diversity of these approaches, and the confusion created by unproven and untested stem cell-based "therapies," create a growing need for a more comprehensive review of these early-stage human trials to ensure they place the patients at minimal risk of adverse events but are also based on solid evidence of preclinical efficacy with a clear scientific rationale for that effect. To address this issue and supplement the independent review process, especially that of the ethics and institutional review boards who may not be experts in stem cell biology, the International Society for Stem Cell Research (ISSCR) has developed a set of practical questions to cover the major issues for which clear evidence-based answers need to be obtained before approving a stem cell-based trial. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

  5. Characterization of the peer review network at the Center for Scientific Review, National Institutes of Health.

    PubMed

    Boyack, Kevin W; Chen, Mei-Ching; Chacko, George

    2014-01-01

    The National Institutes of Health (NIH) is the largest source of funding for biomedical research in the world. This funding is largely effected through a competitive grants process. Each year the Center for Scientific Review (CSR) at NIH manages the evaluation, by peer review, of more than 55,000 grant applications. A relevant management question is how this scientific evaluation system, supported by finite resources, could be continuously evaluated and improved for maximal benefit to the scientific community and the taxpaying public. Towards this purpose, we have created the first system-level description of peer review at CSR by applying text analysis, bibliometric, and graph visualization techniques to administrative records. We identify otherwise latent relationships across scientific clusters, which in turn suggest opportunities for structural reorganization of the system based on expert evaluation. Such studies support the creation of monitoring tools and provide transparency and knowledge to stakeholders.

  6. Grounded Theory: Managing the Challenge for Those Facing Institutional Review Board Oversight

    ERIC Educational Resources Information Center

    O'Connor, Mary Katherine; Netting, F. Ellen; Thomas, M. Lori

    2008-01-01

    The authors examine one of the earliest systematic forms of qualitative inquiry to identify some of the boundaries needed in grounded theory designs to provide a small corner of clarity in the discourse about what is acceptable science from the Institutional Review Board (IRB) perspective. Beginning with an overview of grounded theory research as…

  7. Understanding bureaucracy in health science ethics: toward a better institutional review board.

    PubMed

    Bozeman, Barry; Slade, Catherine; Hirsch, Paul

    2009-09-01

    Research involving human participants continues to grow dramatically, fueled by advances in medical technology, globalization of research, and financial and professional incentives. This creates increasing opportunities for ethical errors with devastating effects. The typical professional and policy response to calamities involving human participants in research is to layer on more ethical guidelines or strictures. We used a recent case-the Johns Hopkins University/Kennedy Kreiger Institute Lead Paint Study-to examine lessons learned since the Tuskegee Syphilis Study about the role of institutionalized science ethics in the protection of human participants in research. We address the role of the institutional review board as the focal point for policy attention.

  8. Understanding Bureaucracy in Health Science Ethics: Toward a Better Institutional Review Board

    PubMed Central

    Bozeman, Barry; Hirsch, Paul

    2009-01-01

    Research involving human participants continues to grow dramatically, fueled by advances in medical technology, globalization of research, and financial and professional incentives. This creates increasing opportunities for ethical errors with devastating effects. The typical professional and policy response to calamities involving human participants in research is to layer on more ethical guidelines or strictures. We used a recent case—the Johns Hopkins University/Kennedy Kreiger Institute Lead Paint Study—to examine lessons learned since the Tuskegee Syphilis Study about the role of institutionalized science ethics in the protection of human participants in research. We address the role of the institutional review board as the focal point for policy attention. PMID:19608947

  9. Evolutionary institutionalism.

    PubMed

    Fürstenberg, Dr Kai

    Institutions are hard to define and hard to study. Long prominent in political science have been two theories: Rational Choice Institutionalism (RCI) and Historical Institutionalism (HI). Arising from the life sciences is now a third: Evolutionary Institutionalism (EI). Comparative strengths and weaknesses of these three theories warrant review, and the value-to-be-added by expanding the third beyond Darwinian evolutionary theory deserves consideration. Should evolutionary institutionalism expand to accommodate new understanding in ecology, such as might apply to the emergence of stability, and in genetics, such as might apply to political behavior? Core arguments are reviewed for each theory with more detailed exposition of the third, EI. Particular attention is paid to EI's gene-institution analogy; to variation, selection, and retention of institutional traits; to endogeneity and exogeneity; to agency and structure; and to ecosystem effects, institutional stability, and empirical limitations in behavioral genetics. RCI, HI, and EI are distinct but complementary. Institutional change, while amenable to rational-choice analysis and, retrospectively, to criticaljuncture and path-dependency analysis, is also, and importantly, ecological. Stability, like change, is an emergent property of institutions, which tend to stabilize after change in a manner analogous to allopatric speciation. EI is more than metaphorically biological in that institutional behaviors are driven by human behaviors whose evolution long preceded the appearance of institutions themselves.

  10. Institutional Effectiveness: How Well Are Hispanic Serving Institutions Meeting the Challenge?

    ERIC Educational Resources Information Center

    Murphy, Joel

    2013-01-01

    The literature describes various approaches that community colleges use to achieve institutional effectiveness; however there is no information about how Hispanic Serving Institutions (HSIs) go about this process. The purpose of this article is to review some principles and processes of accountability and to describe the strategic review and…

  11. 19 CFR 206.64 - Institution of investigation or review; publication of notice; and availability for public...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... AND BILATERAL SAFEGUARD ACTIONS, MARKET DISRUPTION, TRADE DIVERSION, AND REVIEW OF RELIEF ACTIONS Investigations For Action in Response to Trade Diversion; Reviews of Action Taken § 206.64 Institution of... modification in the action taken by them against the People's Republic of China pursuant to consultation...

  12. 45 CFR 46.304 - Composition of Institutional Review Boards where prisoners are involved.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 1 2012-10-01 2012-10-01 false Composition of Institutional Review Boards where prisoners are involved. 46.304 Section 46.304 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Additional Protections Pertaining to Biomedical and Behavioral...

  13. 45 CFR 46.304 - Composition of Institutional Review Boards where prisoners are involved.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 1 2011-10-01 2011-10-01 false Composition of Institutional Review Boards where prisoners are involved. 46.304 Section 46.304 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Additional Protections Pertaining to Biomedical and Behavioral...

  14. 45 CFR 46.304 - Composition of Institutional Review Boards where prisoners are involved.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 1 2014-10-01 2014-10-01 false Composition of Institutional Review Boards where prisoners are involved. 46.304 Section 46.304 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Additional Protections Pertaining to Biomedical and Behavioral...

  15. 45 CFR 46.304 - Composition of Institutional Review Boards where prisoners are involved.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Composition of Institutional Review Boards where prisoners are involved. 46.304 Section 46.304 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Additional Protections Pertaining to Biomedical and Behavioral...

  16. 45 CFR 46.304 - Composition of Institutional Review Boards where prisoners are involved.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 1 2013-10-01 2013-10-01 false Composition of Institutional Review Boards where prisoners are involved. 46.304 Section 46.304 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Additional Protections Pertaining to Biomedical and Behavioral...

  17. Institutional pathology consultation.

    PubMed

    Tsung, Jeffrey S H

    2004-03-01

    Sun Yat-Sen Cancer Center is the only cancer center in Taiwan. The hospital maintains a policy, and the division of oncology makes a concerted effort to obtain and review pertinent pathologic specimens in all patients who had pathologic diagnosis performed at other institution before rendering therapy. A 1-year retrospective study was undertaken to assess the frequency of discordant diagnosis of our second-opinion pathology slide review and determine its impact on patient care. Discrepancies were classified into four basic categories: A) no diagnostic disagreement; B) no diagnostic disagreement but pertinent information not included, such as tumor size, lymphovascular invasion, perineural invasion, histologic grading, margin status, extracapsular spread in metastatic lymph nodes; and C) major diagnostic disagreement, which was defined as follows; 1) change from benign to malignant, 2) change from malignant to benign, 3) a different type of neoplasm, and 4) change in N and M classification in TMN staging framework. Of 715 cases, a total of 673 (94%) showed no discrepancy. However, 35 of 673 (5.2%) cases failed to offer pertinent information (category B). Major disagreement was found in 42 16%) cases (category C). This study illustrated the fact that second pathology slide review prior to therapy can identify a small group of cases that result in a major change in their therapeutic plan. Admittedly, the review of pathology slides involves additional time and effort for both consulting and referring institutions. It can ensure quality medical care and limit medicolegal liability. As the Association of Directors of Anatomic and Surgical Pathology recommended, second pathology review should be standard practice. It is necessary that our major Pathology Association and Societies adopt a strong position on this matter to influence government or insurance company to pay for this service rendered by pathologists.

  18. An institutional review board-based clinical research quality assurance program.

    PubMed

    Lad, Pramod M; Dahl, Rebecca

    2013-01-01

    Despite the acknowledged importance of quality assurance in the clinical research process, the problem of how such a program should be implemented at the level of an academic teaching hospital or a similar institution has not been addressed in the literature. Despite the fact that quality assurance is expected in programs which certify and accredit Institutional Review Boards (IRBs), very little is known about the role of the IRB in programs of clinical research quality assurance. In this article we consider the definition of clinical research quality assurance, and describe a program designed to achieve it. The key elements of such a program are education at the site level, which has both mandatory and voluntary components, and an auditing and monitoring program, which reinforces the education on quality assurance. The role of the IRB in achieving the program goals and the organizational placement of the quality assurance program within the IRB structure and function are important items of discussion.

  19. Implementation of Blended Learning in Higher Learning Institutions: A Review of the Literature

    ERIC Educational Resources Information Center

    Ma'arop, Amrien Hamila; Embi, Mohamed Amin

    2016-01-01

    While many educational premises including higher learning institutions favor blended learning over traditional approach and merely online learning, some academicians are still apprehensive about teaching in blended learning. The aim of this review is to synthesize the available evidence in the literature on challenges faced in implementing blended…

  20. 20 CFR 404.1617 - Reasonable efforts to obtain review by a qualified psychiatrist or psychologist.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...)). Where it does not have sufficient resources to make the necessary reviews, the State agency must attempt to obtain the resources needed. If the State agency is unable to obtain additional psychiatrists and psychologists because of low salary rates or fee schedules it should attempt to raise the State agency's levels...

  1. 20 CFR 416.1017 - Reasonable efforts to obtain review by a qualified psychiatrist or psychologist.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...)). Where it does not have sufficient resources to make the necessary reviews, the State agency must attempt to obtain the resources needed. If the State agency is unable to obtain additional psychiatrists and psychologists because of low salary rates or fee schedules it should attempt to raise the State agency's levels...

  2. 20 CFR 404.1617 - Reasonable efforts to obtain review by a qualified psychiatrist or psychologist.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...)). Where it does not have sufficient resources to make the necessary reviews, the State agency must attempt to obtain the resources needed. If the State agency is unable to obtain additional psychiatrists and psychologists because of low salary rates or fee schedules it should attempt to raise the State agency's levels...

  3. 20 CFR 416.1017 - Reasonable efforts to obtain review by a qualified psychiatrist or psychologist.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...)). Where it does not have sufficient resources to make the necessary reviews, the State agency must attempt to obtain the resources needed. If the State agency is unable to obtain additional psychiatrists and psychologists because of low salary rates or fee schedules it should attempt to raise the State agency's levels...

  4. 20 CFR 416.1017 - Reasonable efforts to obtain review by a qualified psychiatrist or psychologist.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...)). Where it does not have sufficient resources to make the necessary reviews, the State agency must attempt to obtain the resources needed. If the State agency is unable to obtain additional psychiatrists and psychologists because of low salary rates or fee schedules it should attempt to raise the State agency's levels...

  5. 20 CFR 404.1617 - Reasonable efforts to obtain review by a qualified psychiatrist or psychologist.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...)). Where it does not have sufficient resources to make the necessary reviews, the State agency must attempt to obtain the resources needed. If the State agency is unable to obtain additional psychiatrists and psychologists because of low salary rates or fee schedules it should attempt to raise the State agency's levels...

  6. 20 CFR 416.1017 - Reasonable efforts to obtain review by a qualified psychiatrist or psychologist.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...)). Where it does not have sufficient resources to make the necessary reviews, the State agency must attempt to obtain the resources needed. If the State agency is unable to obtain additional psychiatrists and psychologists because of low salary rates or fee schedules it should attempt to raise the State agency's levels...

  7. 20 CFR 404.1617 - Reasonable efforts to obtain review by a qualified psychiatrist or psychologist.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...)). Where it does not have sufficient resources to make the necessary reviews, the State agency must attempt to obtain the resources needed. If the State agency is unable to obtain additional psychiatrists and psychologists because of low salary rates or fee schedules it should attempt to raise the State agency's levels...

  8. 77 FR 48129 - National Institute of Standards and Technology Performance Review Board Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-13

    ... Institute of Standards and Technology Performance Review Board (NIST PRB) and supersedes the list published on September 9, 2011. DATES: The changes to the NIST PRB membership list announced in this notice are... Standards and Technology, (301) 975-3000 or by email at [email protected]nist.gov . SUPPLEMENTARY INFORMATION...

  9. Pediatric Critical Care Telemedicine Program: A Single Institution Review.

    PubMed

    Hernandez, Maria; Hojman, Nayla; Sadorra, Candace; Dharmar, Madan; Nesbitt, Thomas S; Litman, Rebecca; Marcin, James P

    2016-01-01

    Rural and community emergency departments (EDs) often receive and treat critically ill children despite limited access to pediatric expertise. Increasingly, pediatric critical care programs at children's hospitals are using telemedicine to provide consultations to these EDs with the goal of increasing the quality of care. We conducted a retrospective review of a pediatric critical care telemedicine program at a single university children's hospital. Between the years 2000 and 2014, we reviewed all telemedicine consultations provided to children in rural and community EDs, classified the visits using a comprehensive evidence-based set of chief complaints, and reported the consultations' impact on patient disposition. We also reviewed the total number of pediatric ED visits to calculate the relative frequency with which telemedicine consultations were provided. During the study period, there were 308 consultations provided to acutely ill and/or injured children for a variety of chief complaints, most commonly for respiratory illnesses, acute injury, and neurological conditions. Since inception, the number of consultations has been increasing, as has the number of participating EDs (n = 18). Telemedicine consultations were conducted on 8.6% of seriously ill children, the majority of which resulted in admission to the receiving hospital (n = 150, 49%), with a minority of patients requiring transport to the university children's hospital (n = 103, 33%). This single institutional, university children's hospital-based review demonstrates that a pediatric critical care telemedicine program used to provide consultations to seriously ill children in rural and community EDs is feasible, sustainable, and used relatively infrequently, most typically for the sickest pediatric patients.

  10. Role of institutional entrepreneurship in building adaptive capacity in community-based healthcare organisations: realist review protocol

    PubMed Central

    Iyengar, Sweatha; Katz, Aaron; Durham, Jo

    2016-01-01

    Introduction Over the past 3 decades, there has been a substantial shift to the marketisation of government-funded health services. For organisations traditionally buffered from the competitive pressures of for-profit enterprises, such as community-based organisations, this means developing the capacity to adapt to competitive tendering processes, shifting client expectations, and increasing demands for greater accountability. Drawing on ideas of institutional entrepreneurship, we believe that attempts to build adaptive capacity require the transformation of existing institutional arrangements. Key in this may be identifying and fostering institutional entrepreneurs—actors who take the lead in being the impetus for, and giving direction to, structural change. This study focuses on the strategies used by institutional entrepreneurs to build adaptive capacity in the community-based healthcare sector. Methods and analysis The research will use an adapted rapid realist review. The review will find underlying theories that explain the circumstances surrounding the implementation of capacity-building strategies that shape organisational response and generate outcomes by activating causal mechanisms. An early scoping of the literature, and consultations with key stakeholders, will be undertaken to identify an initial programme theory. We will search for relevant journal articles and grey literature. Data will be extracted based on contextual factors, mechanisms and outcomes, and their configurations. The analysis will seek patterns and regularities in these configurations and will focus on confirming, refuting or refining our programme theory. Ethics and dissemination The study does not involve primary research and, therefore, does not require formal ethical approval. However, ethical standards of utility, usefulness, feasibility, propriety, accuracy and accountability will be followed. The results will be written up according to the Realist and Meta-Review Evidence

  11. Towards a balanced approach to identifying conflicts of interest faced by institutional review boards.

    PubMed

    Kaur, Sharon; Balan, Sujata

    2015-10-01

    The welfare and protection of human subjects is critical to the integrity of clinical investigation and research. Institutional review boards (IRBs) were thus set up to be impartial reviewers of research protocols in clinical research. Their main role is to stand between the investigator and her human subjects in order to ensure that the welfare of human subjects are protected. While there is much literature on the conflicts of interest (CIs) faced by investigators and researchers in clinical investigations, an area that is less explored is CIs that may affect members of IRBs during the institutional ethics review of clinical investigations. This article examines the notion of CIs in clinical research and attempts to develop a framework for a clearer and more balanced approach to identifying CIs that may influence members of IRBs and impede their independence. It will also apply the proposed framework to demonstrate how IRBs possess, or at least may appear to possess, forms of financial CIs and non-financial CIs. The proper identification and management of these CIs is critical to preserving the integrity of clinical investigations and achieving the primary aim of human subjects protection.

  12. Institutional Computing Executive Group Review of Multi-programmatic & Institutional Computing, Fiscal Year 2005 and 2006

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Langer, S; Rotman, D; Schwegler, E

    The Institutional Computing Executive Group (ICEG) review of FY05-06 Multiprogrammatic and Institutional Computing (M and IC) activities is presented in the attached report. In summary, we find that the M and IC staff does an outstanding job of acquiring and supporting a wide range of institutional computing resources to meet the programmatic and scientific goals of LLNL. The responsiveness and high quality of support given to users and the programs investing in M and IC reflects the dedication and skill of the M and IC staff. M and IC has successfully managed serial capacity, parallel capacity, and capability computing resources.more » Serial capacity computing supports a wide range of scientific projects which require access to a few high performance processors within a shared memory computer. Parallel capacity computing supports scientific projects that require a moderate number of processors (up to roughly 1000) on a parallel computer. Capability computing supports parallel jobs that push the limits of simulation science. M and IC has worked closely with Stockpile Stewardship, and together they have made LLNL a premier institution for computational and simulation science. Such a standing is vital to the continued success of laboratory science programs and to the recruitment and retention of top scientists. This report provides recommendations to build on M and IC's accomplishments and improve simulation capabilities at LLNL. We recommend that institution fully fund (1) operation of the atlas cluster purchased in FY06 to support a few large projects; (2) operation of the thunder and zeus clusters to enable 'mid-range' parallel capacity simulations during normal operation and a limited number of large simulations during dedicated application time; (3) operation of the new yana cluster to support a wide range of serial capacity simulations; (4) improvements to the reliability and performance of the Lustre parallel file system; (5) support for the new GDO

  13. Investigators’ Successful Strategies for Working with Institutional Review Boards

    PubMed Central

    Cartwright, Juliana C.; Hickman, Susan E.; Nelson, Christine A.; Knafl, Kathleen A.

    2014-01-01

    This study was designed to identify successful strategies used by investigators for working with their Institutional Review Boards (IRBs) in conducting human subjects research. Telephone interviews were conducted with 46 investigators representing nursing, medicine, and social work. Interview transcripts were analyzed using qualitative descriptive methods. Investigators emphasized the importance of intentionally cultivating positive relationships with IRB staff and members, and managing bureaucracy. A few used evasive measures to avoid conflict with IRBs. Few successful strategies were identified for working with multiple IRBs. Although most investigators developed successful methods for working with IRBs, further research is needed on how differences in IRB culture affect human subjects protection, and on best approaches to IRB approval of multi-site studies. PMID:23813748

  14. A desk review on institutional and non-institutional organizations active in the field of migrant's health in the WHO European Region.

    PubMed

    Ingrosso, Loredana; Schmidt, Tanja; Sherally, Jamila; Dembech, Matteo; Barragan Montes, Sara; Sa Machado, Rita; Annunziata, Giuseppe; Rezza, Giovanni; Severoni, Santino

    2015-01-01

    Migrants have problematic access to health-care; non-institutional organizations (NGOs), as well as institutional bodies may play a role in facilitating their access to mainstream health care. Our research reviews actions that address the need of migrants in terms of health care in order to understand how, where, and who participates in this effort. Data were from desk or web research, declaration from organisations and their websites, information from WHO Country Offices. 154 NGOs were identified in the WHO European Region. 58% were direct health care providers while the remaining provided either mediation services or were part of a network organization. 173 national institutes (GOVs) were found; less than the 20% were directly or indirectly involved in health care, whereas the majority were involved in research, policy development, international relations and human rights. Some gaps, a certain fragmentation and lack of coordination were identified. WHO can play an overarching role in the exchange of expertise and harmonisation of the efforts in this field.

  15. Political and institutional influences on the use of evidence in public health policy. A systematic review.

    PubMed

    Liverani, Marco; Hawkins, Benjamin; Parkhurst, Justin O

    2013-01-01

    There is increasing recognition that the development of evidence-informed health policy is not only a technical problem of knowledge exchange or translation, but also a political challenge. Yet, while political scientists have long considered the nature of political systems, the role of institutional structures, and the political contestation of policy issues as central to understanding policy decisions, these issues remain largely unexplored by scholars of evidence-informed policy making. We conducted a systematic review of empirical studies that examined the influence of key features of political systems and institutional mechanisms on evidence use, and contextual factors that may contribute to the politicisation of health evidence. Eligible studies were identified through searches of seven health and social sciences databases, websites of relevant organisations, the British Library database, and manual searches of academic journals. Relevant findings were extracted using a uniform data extraction tool and synthesised by narrative review. 56 studies were selected for inclusion. Relevant political and institutional aspects affecting the use of health evidence included the level of state centralisation and democratisation, the influence of external donors and organisations, the organisation and function of bureaucracies, and the framing of evidence in relation to social norms and values. However, our understanding of such influences remains piecemeal given the limited number of empirical analyses on this subject, the paucity of comparative works, and the limited consideration of political and institutional theory in these studies. This review highlights the need for a more explicit engagement with the political and institutional factors affecting the use of health evidence in decision-making. A more nuanced understanding of evidence use in health policy making requires both additional empirical studies of evidence use, and an engagement with theories and approaches

  16. Political and Institutional Influences on the Use of Evidence in Public Health Policy. A Systematic Review

    PubMed Central

    Liverani, Marco; Hawkins, Benjamin; Parkhurst, Justin O.

    2013-01-01

    Background There is increasing recognition that the development of evidence-informed health policy is not only a technical problem of knowledge exchange or translation, but also a political challenge. Yet, while political scientists have long considered the nature of political systems, the role of institutional structures, and the political contestation of policy issues as central to understanding policy decisions, these issues remain largely unexplored by scholars of evidence-informed policy making. Methods We conducted a systematic review of empirical studies that examined the influence of key features of political systems and institutional mechanisms on evidence use, and contextual factors that may contribute to the politicisation of health evidence. Eligible studies were identified through searches of seven health and social sciences databases, websites of relevant organisations, the British Library database, and manual searches of academic journals. Relevant findings were extracted using a uniform data extraction tool and synthesised by narrative review. Findings 56 studies were selected for inclusion. Relevant political and institutional aspects affecting the use of health evidence included the level of state centralisation and democratisation, the influence of external donors and organisations, the organisation and function of bureaucracies, and the framing of evidence in relation to social norms and values. However, our understanding of such influences remains piecemeal given the limited number of empirical analyses on this subject, the paucity of comparative works, and the limited consideration of political and institutional theory in these studies. Conclusions This review highlights the need for a more explicit engagement with the political and institutional factors affecting the use of health evidence in decision-making. A more nuanced understanding of evidence use in health policy making requires both additional empirical studies of evidence use, and an

  17. The Internet as Paradigm. 1997 Annual Review of the Institute for Information Studies.

    ERIC Educational Resources Information Center

    Institute for Information Studies, Queenstown, MD.

    Each year, the Institute for Information Studies publishes an Annual Review--a collection of commissioned papers that provide a variety of perspectives on a particular topic relating to the impact of communications and information technology. The articles in this 8th edition focus on the impact of the Internet not only on society and in society…

  18. Glucose Meters: A Review of Technical Challenges to Obtaining Accurate Results

    PubMed Central

    Tonyushkina, Ksenia; Nichols, James H.

    2009-01-01

    , anemia, hypotension, and other disease states. This article reviews the challenges involved in obtaining accurate glucose meter results. PMID:20144348

  19. 42 CFR 84.43 - Quality control records; review by the Institute; revocation of approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 1 2013-10-01 2013-10-01 false Quality control records; review by the Institute; revocation of approval. 84.43 Section 84.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY...

  20. 42 CFR 84.43 - Quality control records; review by the Institute; revocation of approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Quality control records; review by the Institute; revocation of approval. 84.43 Section 84.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY...

  1. 42 CFR 84.43 - Quality control records; review by the Institute; revocation of approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Quality control records; review by the Institute; revocation of approval. 84.43 Section 84.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY...

  2. 42 CFR 84.43 - Quality control records; review by the Institute; revocation of approval.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Quality control records; review by the Institute; revocation of approval. 84.43 Section 84.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY...

  3. 42 CFR 84.43 - Quality control records; review by the Institute; revocation of approval.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Quality control records; review by the Institute; revocation of approval. 84.43 Section 84.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY...

  4. 76 FR 70151 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

  5. Fostering Child Development by Improving Care Quality: A Systematic Review of the Effectiveness of Structural Interventions and Caregiver Trainings in Institutional Care.

    PubMed

    Hermenau, Katharin; Goessmann, Katharina; Rygaard, Niels Peter; Landolt, Markus A; Hecker, Tobias

    2017-12-01

    Quality of child care has been shown to have a crucial impact on children's development and psychological adjustment, particularly for orphans with a history of maltreatment and trauma. However, adequate care for orphans is often impacted by unfavorable caregiver-child ratios and poorly trained, overburdened personnel, especially in institutional care in countries with limited resources and large numbers of orphans. This systematic review investigated the effects of structural interventions and caregiver trainings on child development in institutional environments. The 24 intervention studies included in this systematic review reported beneficial effects on the children's emotional, social, and cognitive development. Yet, few studies focused on effects of interventions on the child-caregiver relationship or the general institutional environment. Moreover, our review revealed that interventions aimed at improving institutional care settings have largely neglected violence and abuse prevention. Unfortunately, our findings are partially limited by constraints of study design and methodology. In sum, this systematic review sheds light on obstacles and possibilities for the improvement in institutional care. There must be greater efforts at preventing violence, abuse, and neglect of children living in institutional care. Therefore, we advocate for combining attachment theory-based models with maltreatment prevention approaches and then testing them using rigorous scientific standards. By using approaches grounded in the evidence, it could be possible to enable more children to grow up in supportive and nonviolent environments.

  6. Role of institutional entrepreneurship in building adaptive capacity in community-based healthcare organisations: realist review protocol.

    PubMed

    Iyengar, Sweatha; Katz, Aaron; Durham, Jo

    2016-03-24

    Over the past 3 decades, there has been a substantial shift to the marketisation of government-funded health services. For organisations traditionally buffered from the competitive pressures of for-profit enterprises, such as community-based organisations, this means developing the capacity to adapt to competitive tendering processes, shifting client expectations, and increasing demands for greater accountability. Drawing on ideas of institutional entrepreneurship, we believe that attempts to build adaptive capacity require the transformation of existing institutional arrangements. Key in this may be identifying and fostering institutional entrepreneurs--actors who take the lead in being the impetus for, and giving direction to, structural change. This study focuses on the strategies used by institutional entrepreneurs to build adaptive capacity in the community-based healthcare sector. The research will use an adapted rapid realist review. The review will find underlying theories that explain the circumstances surrounding the implementation of capacity-building strategies that shape organisational response and generate outcomes by activating causal mechanisms. An early scoping of the literature, and consultations with key stakeholders, will be undertaken to identify an initial programme theory. We will search for relevant journal articles and grey literature. Data will be extracted based on contextual factors, mechanisms and outcomes, and their configurations. The analysis will seek patterns and regularities in these configurations and will focus on confirming, refuting or refining our programme theory. The study does not involve primary research and, therefore, does not require formal ethical approval. However, ethical standards of utility, usefulness, feasibility, propriety, accuracy and accountability will be followed. The results will be written up according to the Realist and Meta-Review Evidence Synthesis: Evolving Standards guidelines. Once completed

  7. The match between institutional elderly care management research and management challenges - a systematic literature review.

    PubMed

    Kokkonen, Kaija; Rissanen, Sari; Hujala, Anneli

    2012-11-08

    Elderly care practice and its management together with policy and research play a crucial role in responding to increasing challenges in institutional care for elderly people. Successful dialogue between these is necessary. The purpose of this systematic literature review is to compare how institutional elderly care management research meets the care challenges currently emphasized in international long-term care policy documents. This paper was based on a systematic literature review. After screening 1971 abstracts using inclusion/exclusion criteria, 58 refereed articles published between 2000 and 2010 remained for analysis. The articles were analyzed using theory-based content analysis by comparing the results to the framework based on analysis of international long-term care management policy documents. The current challenges of long-term care management identified from policy documents were Integrated Care Management, Productivity Management, Quality Management, Workforce Management and ICT Management. The research on institutional elderly care management responded somewhat to the challenges mentioned in policy documents. However, some of the challenges were studied broadly and some were paid only minor attention. Further, only few studies focused on the core items of challenges addressed in policy documents. Institutional care management research needs to focus more on challenges in integrated care, productivity, ICT and division of labor. Managers, researchers and policy-makers should assume more active collaborative roles in processes of research, policymaking and policy implementation. In addition managers' and policymakers' scientific literacy needs to be enhanced.

  8. The match between institutional elderly care management research and management challenges - a systematic literature review

    PubMed Central

    2012-01-01

    Background Elderly care practice and its management together with policy and research play a crucial role in responding to increasing challenges in institutional care for elderly people. Successful dialogue between these is necessary. The purpose of this systematic literature review is to compare how institutional elderly care management research meets the care challenges currently emphasized in international long-term care policy documents. Methods This paper was based on a systematic literature review. After screening 1971 abstracts using inclusion/exclusion criteria, 58 refereed articles published between 2000 and 2010 remained for analysis. The articles were analyzed using theory-based content analysis by comparing the results to the framework based on analysis of international long-term care management policy documents. Results The current challenges of long-term care management identified from policy documents were Integrated Care Management, Productivity Management, Quality Management, Workforce Management and ICT Management. The research on institutional elderly care management responded somewhat to the challenges mentioned in policy documents. However, some of the challenges were studied broadly and some were paid only minor attention. Further, only few studies focused on the core items of challenges addressed in policy documents. Conclusions Institutional care management research needs to focus more on challenges in integrated care, productivity, ICT and division of labor. Managers, researchers and policy-makers should assume more active collaborative roles in processes of research, policymaking and policy implementation. In addition managers’ and policymakers’ scientific literacy needs to be enhanced. PMID:23137416

  9. Computer Security for Commercial Nuclear Power Plants - Literature Review for Korea Hydro Nuclear Power Central Research Institute

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Duran, Felicia Angelica; Waymire, Russell L.

    2013-10-01

    Sandia National Laboratories (SNL) is providing training and consultation activities on security planning and design for the Korea Hydro and Nuclear Power Central Research Institute (KHNPCRI). As part of this effort, SNL performed a literature review on computer security requirements, guidance and best practices that are applicable to an advanced nuclear power plant. This report documents the review of reports generated by SNL and other organizations [U.S. Nuclear Regulatory Commission, Nuclear Energy Institute, and International Atomic Energy Agency] related to protection of information technology resources, primarily digital controls and computer resources and their data networks. Copies of the key documentsmore » have also been provided to KHNP-CRI.« less

  10. Patients come from populations and populations contain patients. A two-stage scientific and ethics review: The next adaptation for single institutional review boards.

    PubMed

    Knopman, David; Alford, Eli; Tate, Kaitlin; Long, Mark; Khachaturian, Ara S

    2017-08-01

    For nearly 50 years, institutional review boards (IRB) and independent ethics committees have featured local oversight as a core function of research ethics reviews. However growing complexity in Alzheimer's clinical research suggests current approaches to research volunteer safety is hampering development of new therapeutics. As a partial response to this challenge, the NIH has mandated that all NIH-funded multi-site studies will use a single Institutional Review Board. The perspective describes a joint program to provide a single IRB of record (sIRB) for phases of multi-site studies. The approach follows two steps. One, an expert Scientific Review Committee (SRC) of senior researchers in the field will conduct the review principally of scientific merit, significance, feasibility, and the likelihood of meaningful results. The second step will be the IRB's regulatory and ethics review. The IRB will apply appropriate regulatory criteria for approval including minimization of risks to subjects and risks reasonable in relation to anticipated benefits, equitable subject selection, informed consent, protections for vulnerable populations, and application of local context considerations, among others. There is a steady demand for scientific, ethical and regulatory review of planned Alzheimer's studies. As of January 15, 2017, there are nearly 400 open studies, Phase II and III, industry and NIH sponsored trials on disease indications affecting memory, movement and mood in the US. The effort will initially accept protocols for studies of Alzheimer's disease, dementia, and related disorders effecting memory, movement and mood. Future aims will be to provide scientific review and, where applicable, regulatory and ethical review in an international context outside North America with sites possibly in Asia, Europe and Australia. Copyright © 2017 the Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

  11. Institutional Review Boards at Very High Research Activity Universities: An Opportunity for Social Workers

    ERIC Educational Resources Information Center

    Cannon, Clare; Buttell, Frederick

    2015-01-01

    Objectives: This study investigated to what degree social work was represented in the position of chair of social-behavioral institutional review boards (IRBs) at very high research activity (VHRA) universities in the United States. Method: We collected data on IRB rosters for all 108 schools designated by the Carnegie Foundation as VHRAs in the…

  12. Challenges in Credentialing Institutions and Participants in Advanced Technology Multi-institutional Clinical Trials

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Ibbott, Geoffrey S.; Followill, David S.; Molineu, H. Andrea

    The Radiological Physics Center (RPC) has functioned continuously for 38 years to assure the National Cancer Institute and the cooperative groups that institutions participating in multi-institutional trials can be expected to deliver radiation treatments that are clinically comparable to those delivered by other institutions in the cooperative groups. To accomplish this, the RPC monitors the machine output, the dosimetry data used by the institutions, the calculation algorithms used for treatment planning, and the institutions' quality control procedures. The methods of monitoring include on-site dosimetry review by an RPC physicist and a variety of remote audit tools. The introduction of advancedmore » technology clinical trials has prompted several study groups to require participating institutions and personnel to become credentialed, to ensure their familiarity and capability with techniques such as three-dimensional conformal radiotherapy, intensity-modulated radiotherapy, stereotactic body radiotherapy, and brachytherapy. The RPC conducts a variety of credentialing activities, beginning with questionnaires to evaluate an institution's understanding of the protocol and their capabilities. Treatment-planning benchmarks are used to allow the institution to demonstrate their planning ability and to facilitate a review of the accuracy of treatment-planning systems under relevant conditions. The RPC also provides mailable anthropomorphic phantoms to verify tumor dose delivery for special treatment techniques. While conducting these reviews, the RPC has amassed a large amount of data describing the dosimetry at participating institutions. Representative data from the monitoring programs are discussed, and examples are presented of specific instances in which the RPC contributed to the discovery and resolution of dosimetry errors.« less

  13. Does Strict Adherence to the Ponseti Method Improve Isolated Clubfoot Treatment Outcomes? A Two-institution Review.

    PubMed

    Miller, Nancy H; Carry, Patrick M; Mark, Bryan J; Engelman, Glenn H; Georgopoulos, Gaia; Graham, Sue; Dobbs, Matthew B

    2016-01-01

    Despite being recognized as the gold standard in isolated clubfoot treatment, the Ponseti casting method has yielded variable results. Few studies have directly compared common predictors of treatment failure between institutions with high versus low failure rates. We asked: (1) is the provider's rigid adherence to the Ponseti method associated with a lower likelihood of unplanned clubfoot surgery, and (2) at the institution that did not adhere rigidly to Ponseti's principles, are any demographic or treatment-related factors associated with increased likelihood of unplanned clubfoot surgery? After institutional review board approval, a consecutive series of patients with a diagnosis of isolated clubfoot who underwent treatment between January 2003 and December 2007 were identified. At Institution 1, 91 of 133 patients met the eligibility criteria and were followed for a minimum of 2 years compared with 58 of 58 patients at Institution 2. At Institution 1, 16 providers managed care using a conservative casting approach based on the Ponseti method. However, treatment was adapted by the provider(s). At Institution 2, one orthopaedic surgeon managed care with strict adherence to the Ponseti method. Surgical indications at both institutions included the presence of a persistent equinovarus foot position while standing. A chart review was used to collect data related to proportion of patients undergoing unplanned additional treatment for deformity recurrences after Ponseti casting, demographics, and treatment patterns. The proportion of subjects who underwent unplanned major surgical intervention was greater (odds ratio [OR], 51.1; 95% CI, 6.8-384.0; p < 0.001) at Institution 1 (60 of 131, 47%) compared with Institution 2 (two of 91, 2%). There was no difference (p = 0.200) in the proportion of patients who underwent additional casting, repeat tendo Achilles lengthening, and/or anterior tibialis tendon transfer only (minor recurrence) at Institution 1 (nine of 131, 7

  14. Mock Institutional Review Board: Promoting Analytical and Reasoning Skills in Research Ethics.

    PubMed

    Dols, Jean Dowling; Hoke, Mary M; Rauschhuber, Maureen L

    Although it is critical that nurses possess ethical reasoning skills for research, there is limited information on effective strategies to develop these skills in graduate health care students. A research study analyzing educational interventions including the effect of online human subjects training followed by a mock institutional review board simulation demonstrated that knowledge acquisition is not enough to acquire the ethical reasoning skills needed to implement health care research. Situational context is also needed to envision the application of ethical principles.

  15. Research ethics policies and practices in health research institutions in sub-Saharan African countries: results of a questionnaire-based survey.

    PubMed

    Zielinski, Chris; Kebede, Derege; Mbondji, Peter Ebongue; Sanou, Issa; Kouvividila, Wenceslas; Lusamba-Dikassa, Paul-Samson

    2014-05-01

    To describe the state of research ethics policies and practices in health research institutions in sub-Saharan African countries. A structured questionnaire was used to solicit information on research ethics from health research institutions. Forty-two sub-Saharan African countries. Key informants from the health research institutions. Existence of institutional ethics review policies and mechanisms. About half (51%) of respondent institutions reported having policies on research ethics and 58% had written policies requiring that researchers obtain informed consent of research participants. About one-third of respondent institutions (34%) had established ethics review committees, 42% required that studies went through ethics review committees and 46% had linkages with national or regional ethics organisations. Regarding operating procedures for ethics review committees, 53% had adopted standard operating procedures. Less than one-quarter of respondent institutions reported having policies in place to monitor ongoing research. Of the institutions that monitored ongoing research, 34% did an annual ethical review and 74% required a periodic written report. Only 36% provided any type of ethics training for staff, including those conducting health research and those who were not members of the ethics review committee. There are substantial gaps in the capacity of health research institutions in the WHO African Region to undertake ethical review of studies before, during and after studies conducted. There is a need to strengthen such capacity in order to ensure the wellbeing of individuals enrolled in studies and that of communities that host these studies. © The Royal Society of Medicine.

  16. Development of a Domain Analysis Model for Electronic Institutional Review Board Systems: A Feasibility Study

    ERIC Educational Resources Information Center

    He, Shan

    2013-01-01

    Clinical research plays a vital role in producing knowledge valuable for understanding human disease and improving healthcare quality. Human subject protection is an obligation essential to the clinical research endeavor, much of which is governed by federal regulations and rules. Institutional Review Boards (IRBs) are responsible for overseeing…

  17. 77 FR 52702 - Notice of Submission for OMB Review; Institute of Education Sciences; Early Childhood...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ... DEPARTMENT OF EDUCATION Notice of Submission for OMB Review; Institute of Education Sciences... Education Sciences (IES) of the U.S. Department of Education (ED), is a survey that focuses on children's... or mailed to U.S. Department of Education, 400 Maryland Avenue SW, LBJ, Washington, DC 20202-4537...

  18. 76 FR 53685 - National Institutes of Health

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review... data collection projects, the Center for Scientific Review (CSR), National Institutes of Health (NIH... for public comment. The National Institutes of Health may not conduct or sponsor and the respondent is...

  19. 20 CFR 404.1617 - Reasonable efforts to obtain review by a qualified psychiatrist or psychologist.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... qualified psychiatrist or psychologist. 404.1617 Section 404.1617 Employees' Benefits SOCIAL SECURITY... Responsibilities for Performing the Disability Determination Function § 404.1617 Reasonable efforts to obtain... perform these reviews, which are a basic State agency responsibility, and where appropriate, the State...

  20. 20 CFR 416.1017 - Reasonable efforts to obtain review by a qualified psychiatrist or psychologist.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... qualified psychiatrist or psychologist. 416.1017 Section 416.1017 Employees' Benefits SOCIAL SECURITY... Responsibilities for Performing the Disability Determination Function § 416.1017 Reasonable efforts to obtain... perform these reviews, which are a basic State agency responsibility, and where appropriate, the State...

  1. 77 FR 17462 - Notice of Submission for OMB Review; Institute of Education Sciences; Quick Response Information...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-26

    ... DEPARTMENT OF EDUCATION Notice of Submission for OMB Review; Institute of Education Sciences; Quick Response Information System (QRIS) 2012-2015 System Clearance SUMMARY: The National Center for Education Statistics (NCES) Quick Response Information System (QRIS) consists of the Fast Response Survey...

  2. Practice-based learning and improvement for institutions: a case report.

    PubMed

    Kirk, Susan E; Howell, R Edward

    2010-12-01

    In 2006, the University of Virginia became one of the first academic medical institutions to be placed on probation, after the Accreditation Council for Graduate Medical Education (ACGME) Institutional Review Committee implemented a new classification system for institutional reviews. After University of Virginia reviewed its practices and implemented needed changes, the institution was able to have probation removed and full accreditation restored. Whereas graduate medical education committees and designated institutional officials are required to conduct internal reviews of each ACGME-accredited program midway through its accreditation cycle, no similar requirement exists for institutions. As we designed corrective measures at the University of Virginia, we realized that regularly scheduled audits of the entire institution would have prevented the accumulation of deficiencies. We suggest that institutional internal reviews be implemented to ensure that the ACGME institutional requirements for graduate medical education are met. This process represents practice-based learning and improvement at the institutional level and may prevent other institutions from receiving unfavorable accreditation decisions.

  3. Costs and inconsistencies in US IRB review of low-risk medical education research.

    PubMed

    Kano, Miria; Getrich, Christina M; Romney, Crystal; Sussman, Andrew L; Williams, Robert L

    2015-06-01

    Advances in communication technologies over the last two decades have transformed the way medical education research is conducted, creating opportunities for multi-institution national and international studies. Although these studies enable researchers to gain broader understandings of educational processes across institutions, they increase the need for multiple institutional review board (IRB) reviews to ensure the protection of human subjects. This study describes the process of obtaining multiple IRB approvals of the same protocol for a multi-site, low-risk, medical education research project in the USA. The burden of obtaining those reviews and their consistency are assessed. The associated time and costs, and implications for the research process are detailed. Following review by the investigators' parent institution IRB, the project team circulated a uniform protocol for conduct of a low-risk, medical education survey to the IRBs of 89 US medical schools for review. The processes and time required to obtain approvals were recorded to estimate associated research team personnel costs. Approval could not be obtained from five IRBs as a result of insurmountable procedural barriers. A total of 67 IRBs eventually deferred to the parent IRB determination. The remaining IRBs required a variety of additional procedural processes before ultimately agreeing with the original determination. The personnel costs associated with obtaining the 84 approvals amounted to US$121,344. Considering the value of multi-site designs to address a range of research questions, enhance participant diversity and develop representative findings, solutions must be found to counter inefficiencies of current IRB review processes for low-risk research, such as that usually conducted in medical education. Although we acknowledge that local review is an essential protective measure for research involving identifiable communities that are uniquely susceptible to social or economic harm, this

  4. 19 CFR 206.64 - Institution of investigation or review; publication of notice; and availability for public...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 19 Customs Duties 3 2014-04-01 2014-04-01 false Institution of investigation or review; publication of notice; and availability for public inspection. 206.64 Section 206.64 Customs Duties UNITED STATES INTERNATIONAL TRADE COMMISSION NONADJUDICATIVE INVESTIGATIONS INVESTIGATIONS RELATING TO GLOBAL...

  5. 19 CFR 206.64 - Institution of investigation or review; publication of notice; and availability for public...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 19 Customs Duties 3 2013-04-01 2013-04-01 false Institution of investigation or review; publication of notice; and availability for public inspection. 206.64 Section 206.64 Customs Duties UNITED STATES INTERNATIONAL TRADE COMMISSION NONADJUDICATIVE INVESTIGATIONS INVESTIGATIONS RELATING TO GLOBAL...

  6. Is Routine Pathologic Evaluation of Sebaceous Cysts Necessary?: A 15-Year Retrospective Review of a Single Institution.

    PubMed

    Gargya, Vipul; Lucas, Heather D; Wendel Spiczka, Amy J; Mahabir, Raman Chaos

    2017-02-01

    A question arose in our practice of whether all cysts considered sebaceous should be sent for pathologic evaluation. To address this controversial topic, we performed a retrospective study of our single institution's histopathology database. A natural language search of the CoPath database across the institution was undertaken using the diagnosis of sebaceous cyst, epidermal cyst, epidermoid cyst, epithelial cyst, infundibular cyst, pilar cyst, trichilemmal cyst, and steatocystoma. A surgical pathologic review of all specimens with one of these preexcision diagnoses was included in the 15-year retrospective study of 1998 to 2013. All slides were confirmed to have undergone histopathologic review, and the preexcision diagnoses were compared with the postexcision diagnoses. Chart review was undertaken in instances of a diagnosis of malignancy. A total of 13,746 samples were identified. Forty-eight specimens had histopathologic diagnosis of malignancy, for an incidence of 0.3% and with the most common malignancy being squamous cell carcinoma. Chart review showed that for all cases, the surgeons reported uncertainty with regard to the diagnosis because of history or physical characteristics, or both. In addition, a comprehensive literature review showed results consistent with our data and illustrated 19 cases during the past 10 years in which most of the findings were squamous cell carcinoma. We propose the recommendation that routine pathologic evaluation of sebaceous cysts is necessary only when clinical suspicion exists.

  7. External review for promotion and tenure in schools of nursing.

    PubMed

    Reilly, L; Carlisle, J; Mikan, K; Goldsmith, M

    1996-10-01

    To obtain information about external review for tenure and/or promotion, the faculty affairs committee in a large nursing program located in the southeastern United States conducted a survey among programs that award a doctoral degree in nursing. Research questions focused on general tenure and promotion policies, policies and procedures regarding the use of external review, and perceived advantages and disadvantages of external review. A 22-item survey was sent to 53 institutions with a total of 34 usable surveys being returned. Findings revealed that a majority of the schools used external review, especially for tenure decisions and promotion to the associate and professor rank. Promotion and tenure criteria from individual schools were usually sent to reviewers along with the candidates' curriculum vitae and manuscripts. Candidates usually participated in the selection of external reviewers, but contact with reviewers was usually instituted by the administration within the institution. It was also felt that the advantage of external review far outweighed any disadvantages.

  8. 77 FR 25995 - Notice of Submission for OMB Review; Institute of Education Sciences; Baccalaureate and Beyond...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-02

    ... DEPARTMENT OF EDUCATION Notice of Submission for OMB Review; Institute of Education Sciences.... Department of Education, 400 Maryland Avenue SW, LBJ, Washington, DC 20202-4537. Copies of the proposed... Education, 400 Maryland Avenue SW, LBJ, Washington, DC 20202-4537. Requests may also be electronically...

  9. Engaging patients and stakeholders in research proposal review: the patient-centered outcomes research institute.

    PubMed

    Fleurence, Rachael L; Forsythe, Laura P; Lauer, Michael; Rotter, Jason; Ioannidis, John P A; Beal, Anne; Frank, Lori; Selby, Joseph V

    2014-07-15

    The inaugural round of merit review for the Patient-Centered Outcomes Research Institute (PCORI) in November 2012 included patients and other stakeholders, as well as scientists. This article examines relationships among scores of the 3 reviewer types, changes in scoring after in-person discussion, and the effect of inclusion of patient and stakeholder reviewers on the review process. In the first phase, 363 scientists scored 480 applications. In the second phase, 59 scientists, 21 patients, and 31 stakeholders provided a "prediscussion" score and a final "postdiscussion" score after an in-person meeting for applications. Bland-Altman plots were used to characterize levels of agreement among and within reviewer types before and after discussion. Before discussion, there was little agreement among average scores given by the 4 lead scientific reviewers and patient and stakeholder reviewers. After discussion, the 4 primary reviewers showed mild convergence in their scores, and the 21-member panel came to a much stronger agreement. Of the 25 awards with the best (and lowest) scores after phase 2, only 13 had ranked in the top 25 after the phase 1 review by scientists. Five percent of the 480 proposals submitted were funded. The authors conclude that patient and stakeholder reviewers brought different perspectives to the review process but that in-person discussion led to closer agreement among reviewer types. It is not yet known whether these conclusions are generalizable to future rounds of peer review. Future work would benefit from additional data collection for evaluation purposes and from long-term evaluation of the effect on the funded research.

  10. Practice-Based Learning and Improvement for Institutions: A Case Report

    PubMed Central

    Kirk, Susan E.; Howell, R. Edward

    2010-01-01

    Background In 2006, the University of Virginia became one of the first academic medical institutions to be placed on probation, after the Accreditation Council for Graduate Medical Education (ACGME) Institutional Review Committee implemented a new classification system for institutional reviews. Intervention After University of Virginia reviewed its practices and implemented needed changes, the institution was able to have probation removed and full accreditation restored. Whereas graduate medical education committees and designated institutional officials are required to conduct internal reviews of each ACGME–accredited program midway through its accreditation cycle, no similar requirement exists for institutions. Learning As we designed corrective measures at the University of Virginia, we realized that regularly scheduled audits of the entire institution would have prevented the accumulation of deficiencies. We suggest that institutional internal reviews be implemented to ensure that the ACGME institutional requirements for graduate medical education are met. This process represents practice-based learning and improvement at the institutional level and may prevent other institutions from receiving unfavorable accreditation decisions. PMID:22132290

  11. Institutional Policy and Its Abuses

    ERIC Educational Resources Information Center

    Bogue, E. G.; Riggs, R. O.

    1974-01-01

    Reviews the role of institutional policy, cites frequent abuses of institutional policy, and delineates several principles of policy management (development, communication, execution and evaluation). (Author/PG)

  12. 78 FR 46593 - National Eye Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute... personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel; NEI K99 Review. Date... Person: Brian Hoshaw, Ph.D. Scientific Review Officer, National Eye Institute, National Institutes of...

  13. Institutional ethics policies on medical end-of-life decisions: a literature review.

    PubMed

    Lemiengre, Joke; de Casterlé, Bernadette Dierckx; Van Craen, Katleen; Schotsmans, Paul; Gastmans, Chris

    2007-10-01

    The responsibility of healthcare administrators for handling ethically sensitive medical practices, such as medical end-of-life decisions (MELDs), within an institutional setting has been receiving more attention. The overall aim of this paper is to thoroughly examine the prevalence, content, communication, and implementation of written institutional ethics policies on MELDs by means of a literature review. Major databases (Pubmed, Cinahl, PsycINFO, Cochrane Library, FRANCIS, and Philosopher's Index) and reference lists were systematically searched for all relevant papers. Inclusion criteria for relevance were that the study was empirically based and that it focused on the prevalence, content, communication, or implementation of written institutional ethics policies concerning MELDs. Our search yielded 19 studies of American, Canadian, Dutch and Belgian origin. The majority of studies dealt with do-not-resuscitate (DNR) policies (prevalence: 10-89%). Only Dutch and Belgian studies dealt with policies on pain and symptom control (prevalence: 15-19%) and policies on euthanasia (prevalence: 30-79%). Procedural and technical aspects were a prime focus, while the defining of the specific roles of involved parties was unclear. Little attention was given to exploring ethical principles that question the ethical function of policies. In ethics policies on euthanasia, significant consideration was given to procedures that dealt with conscientious objections of physicians and nurses. Empirical studies about the implementation of ethics policies are scarce. With regard to providing support for physicians and nurses, DNR and euthanasia policies expressed support by primarily providing technical and procedural guidelines. Further research is needed whether and in which way written institutional ethics policies on MELDs could contribute to better end-of-life care.

  14. Proposal Auto-Categorizer and Manager for Time Allocation Review at Space Telescope Science Institute

    NASA Astrophysics Data System (ADS)

    Porter, Sophia; Strolger, Louis-Gregory; Lagerstrom, Jill; Weissman, Sarah

    2016-01-01

    The Space Telescope Science Institute annually receives more than one thousand formal proposals for Hubble Space Telescope time, exceeding the available time with the observatory by a factor of over four. With JWST, the proposal pressure will only increase, straining our ability to provide rigorous peer review of each proposal's scientific merit. Significant hurdles in this process include the proper categorization of proposals, to ensure Time Allocation Committees (TACs) have the required and desired expertise to fairly and appropriately judge each proposal, and the selection of reviewers themselves, to establish diverse and well-qualified TACs. The Panel Auto-Categorizer and Manager (PACMan; a naive Bayesian classifier) was developed to automatically sort new proposals into their appropriate science categories and, similarly, to appoint panel reviewers with the best qualifications to serve on the corresponding TACs. We will provide an overview of PACMan and present the results of its testing on five previous cycles of proposals. PACMan will be implemented in upcoming cycles to support and eventually replace the process for constructing the time allocation reviews.

  15. Justification and authority in institutional review board decision letters.

    PubMed

    Clapp, Justin T; Gleason, Katharine A; Joffe, Steven

    2017-12-01

    While ethnographic study has described the discussions that occur during human subjects research ethics review, investigators have minimal access to the interactions of ethics oversight committees. They instead receive letters stipulating changes to their proposed studies. Ethics committee letters are central to the practice of research ethics: they change the nature of research, alter the knowledge it produces, and in doing so construct what ethical research is and how it is pursued. However, these letters have rarely been objects of analysis. Accordingly, we conducted a qualitative analysis of letters written by American institutional review boards (IRBs) overseeing biomedical and health behavioral research. We sought to clarify how IRBs exercise their authority by assessing the frequency with which they provided reasons for their stipulations as well as the nature of these reasons. We found that IRBs frequently do not justify their stipulations; rather, they often leave ethical or regulatory concerns implicit or frame their comments as boilerplate language replacements, procedural instructions, or demands for missing information. When they do provide justifications, their rationales exhibit substantial variability in explicitness and clarity. These rhetorical tendencies indicate that the authority of IRBs is grounded primarily in their role as bureaucratic gatekeepers. We conclude by suggesting that greater attention to justification could help shift the basis of the IRB-researcher relationship from compliance to mutual accountability. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  16. 77 FR 19267 - Notice of Submission for OMB Review; Institute of Education Sciences; Study of Promising Features...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-30

    ... DEPARTMENT OF EDUCATION Notice of Submission for OMB Review; Institute of Education Sciences; Study of Promising Features of Teacher Preparation Programs; Phase 1--Recruitment SUMMARY: This... experimental study of the effect on student learning of teachers who have experienced certain types of clinical...

  17. Measurement of Perceived Service Quality in Higher Education Institutions: A Review of HEdPERF Scale Use

    ERIC Educational Resources Information Center

    Silva, Danilo Soares; de Morales, Gustavo Hermínio Salati Marcondes; Makiya, Ieda Kanashiro; Cesar, Francisco Ignácio Giocondo

    2017-01-01

    Purpose: This study aims to find evidence of the HEdPERF scale use for measuring the perceived service quality from the perspective of students in higher education institutions (HEIs) worldwide. Design/methodology/approach: A systematic review of the literature was conducted to find evidence of the scale use in articles published between January…

  18. 77 FR 75640 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Omnibus Review... Programs Review Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive...

  19. 75 FR 44272 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Initial Review Group; Subcommittee G... Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 6116 Executive Blvd...

  20. 76 FR 57063 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-15

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Initial Review Group, Subcommittee F..., Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, NIH...

  1. 75 FR 3240 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Initial Review Group, Subcommittee F... Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 6116 Executive Blvd...

  2. Action Research, Assessment, and Institutional Review Boards (IRB): Conflicting Demands or Productive Tension for the Academic Librarian?

    ERIC Educational Resources Information Center

    Farrell, Robert

    2014-01-01

    This article puts forward an "assessment/action research/publication" cycle that integrates aspects of the assessment, research, and Institutional Review Board (IRB) processes to provide academic librarians with a systematic approach for balancing competing workplace demands and give library managers a roadmap for creating a…

  3. 77 FR 58110 - Notice of Submission for OMB Review; Institute of Education Sciences; NPEFS 2011-2014: Common...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-19

    ... DEPARTMENT OF EDUCATION Notice of Submission for OMB Review; Institute of Education Sciences; NPEFS 2011-2014: Common Core of Data (CCD) National Public Education Financial Survey SUMMARY: The National Public Education Financial Survey (NPEFS) is an annual collection of state-level finance data that...

  4. Research ethics and Institutional Review Boards. The influence of moral constraints on emotion research.

    PubMed

    Sontag, Michael

    2012-01-01

    Researchers in the twenty-first century face a set of challenges unknown to researchers a half century ago--the need to justify the moral acceptability of their research methods through formal review processes. However, the role that moral constraints play in the development and demise of scientific theories has largely gone unappreciated. The rise of Institutional Review Boards (IRB) in the 1960s compounded the impact of moral constraints on scientific research and on the theories that develop out of such highly monitored research. To demonstrate the effects of moral constraints on scientific theory and research, this paper offers a history and analysis of the interaction between evolving moral standards and twentieth century emotion theory. Recommendations regarding IRB reform are also reviewed. The paper concludes by arguing that, while appropriate IRB reform is important, it cannot eliminate the need for careful reflection on the broader forces that shape scientific practice and understanding.

  5. Facilitating and Hindering Factors in the Realization of Disabled Children's Agency in Institutional Contexts: Literature Review

    ERIC Educational Resources Information Center

    Olli, Johanna; Vehkakoski, Tanja; Salantera, Sanna

    2012-01-01

    Disabled children's opportunity to act as agents may be compromised because adults have the power to choose who are entitled to express agency. Disabled children spend much time in institutions and with professionals of different fields. The aim of this literature review was to find out which factors facilitate or hinder the realization of…

  6. Readability of patient education materials in ophthalmology: a single-institution study and systematic review.

    PubMed

    Williams, Andrew M; Muir, Kelly W; Rosdahl, Jullia A

    2016-08-03

    Patient education materials should be written at a level that is understandable for patients with low health literacy. The aims of this study are (1) to review the literature on readability of ophthalmic patient education materials and (2) to evaluate and revise our institution's patient education materials about glaucoma using evidence-based guidelines on writing for patients with low health literacy. A systematic search was conducted on the PubMed/MEDLINE database for studies that have evaluated readability level of ophthalmic patient education materials, and the reported readability scores were assessed. Additionally, we collected evidence-based guidelines for writing easy-to-read patient education materials, and these recommendations were applied to revise 12 patient education handouts on various glaucoma topics at our institution. Readability measures, including Flesch-Kincaid Grade Level (FKGL), and word count were calculated for the original and revised documents. The original and revised versions of the handouts were then scored in random order by two glaucoma specialists using the Suitability Assessment of Materials (SAM) instrument, a grading scale used to evaluate suitability of health information materials for patients. Paired t test was used to analyze changes in readability measures, word count, and SAM score between original and revised handouts. Finally, five glaucoma patients were interviewed to discuss the revised materials, and patient feedback was analyzed qualitatively. Our literature search included 13 studies that evaluated a total of 950 educational materials. Among the mean FKGL readability scores reported in these studies, the median was 11 (representing an eleventh-grade reading level). At our institution, handouts' readability averaged a tenth-grade reading level (FKGL = 10.0 ± 1.6), but revising the handouts improved their readability to a sixth-grade reading level (FKGL = 6.4 ± 1.2) (p < 0.001). Additionally, the

  7. How US institutional review boards decide when researchers need to translate studies

    PubMed Central

    Klitzman, Robert

    2013-01-01

    Informed consent is crucial in research, but potential participants may not all speak the same language, posing questions that have not been examined concerning decisions by institutional review boards (IRBs) and research ethics committees’ (RECs) about the need for researchers to translate consent forms and other study materials. Sixty US IRBs (every fourth one in the list of the top 240 institutions by The National Institutes of Health funding) were contacted, and leaders (eg, chairs) from 34 (response rate=57%) and an additional 12 members and administrators were interviewed. IRBs face a range of problems about translation of informed consent documents, questionnaires and manuals—what, when and how to translate (eg, for how many or what proportion of potential subjects), why to do so and how to decide. Difficulties can arise about translation of specific words and of broader cultural concepts regarding processes of informed consent and research, especially in the developing world. In these decisions, IRBs weigh the need for autonomy (through informed consent) and justice (to ensure fair distribution of benefits and burdens of research) against practical concerns about costs to researchers. At times IRBs may have to compromise between these competing goals. These data, the first to examine when and how IRBs/RECs require researchers to translate materials, thus highlight a range of problems with which these committees struggle, suggesting a need for further normative and empirical investigation of these domains, and consideration of guidelines to help IRBs deal with these tensions. PMID:23475805

  8. How US institutional review boards decide when researchers need to translate studies.

    PubMed

    Klitzman, Robert

    2014-03-01

    Informed consent is crucial in research, but potential participants may not all speak the same language, posing questions that have not been examined concerning decisions by institutional review boards (IRBs) and research ethics committees' (RECs) about the need for researchers to translate consent forms and other study materials. Sixty US IRBs (every fourth one in the list of the top 240 institutions by The National Institutes of Health funding) were contacted, and leaders (eg, chairs) from 34 (response rate=57%) and an additional 12 members and administrators were interviewed. IRBs face a range of problems about translation of informed consent documents, questionnaires and manuals-what, when and how to translate (eg, for how many or what proportion of potential subjects), why to do so and how to decide. Difficulties can arise about translation of specific words and of broader cultural concepts regarding processes of informed consent and research, especially in the developing world. In these decisions, IRBs weigh the need for autonomy (through informed consent) and justice (to ensure fair distribution of benefits and burdens of research) against practical concerns about costs to researchers. At times IRBs may have to compromise between these competing goals. These data, the first to examine when and how IRBs/RECs require researchers to translate materials, thus highlight a range of problems with which these committees struggle, suggesting a need for further normative and empirical investigation of these domains, and consideration of guidelines to help IRBs deal with these tensions.

  9. Suicide patterns in children and adolescents: a review from a pediatric institution in England.

    PubMed

    Zainum, Khairul; Cohen, Marta C

    2017-06-01

    Suicide is a catastrophic event to both families and communities yet it is potentially preventable. This study aims to determine incidence and patterns of suicide in children and young adolescents in our region, raise awareness of this entity as a potentially preventable cause of death in this age group, and identify its possible associated risk factors. We retrospectively reviewed suicide cases presenting as sudden unexpected death in children and adolescents that underwent coronial post-mortems at our institution. This is the largest pathological review of completed suicide in children and young adolescents within a single institution in the United Kingdom. We identified 23 suicide cases during a 12 year period from 2003 to 2015, in which 18 cases (78%) were male and 5 cases (22%) were female. The age range was from 8 to 16 years (mean age 12.82 +/- 2.52 SD). With the exception of one case, all of the victims were Caucasian. The majority, 19 cases (81%), were found dead inside their place of residence, 15 of whom were discovered in their own bedrooms. Twenty-one cases (91%) died from neck compression due to hanging; 6 cases (26%) had used the cord of a dressing gown and 5 (22%) opted to use a belt as the ligature. Two cases (9%) that died from multiple-drug toxicity were female. In 7 cases (30.5%) there was evidence of self-harm and in 3 cases (13%) there was a history of previous suicide attempts. Petechial hemorrhages were found at autopsy in more than half of hanging victims and only three cases (14%) displayed dual distribution of post-mortem hypostasis (back and legs). Seven victims (30.5%) left some form of suicide message to family members and friends, 2 of which wrote the message on their arm. Parental separation, conflict with parents, and depression, were common amongst decedents prior to committing suicide. Substance abuse was uncommon in suicide within our cases. Valuable information is available from thorough review of suicide data in children and

  10. The use of performance standards by AAALAC International to evaluate ethical review in European institutions.

    PubMed

    Guillen, Javier

    2010-02-01

    During the past several decades, society has become increasingly concerned about the welfare of animals used in research. Today, the public asks scientists to justify the use of research animals and to be accountable for their welfare. Research institutions, government bodies and other regulatory authorities have developed mechanisms to ensure that researchers follow the principles of the 3Rs and use and care for research animals in an ethical manner. Additionally, organizations such as the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) have developed voluntary programs that can help researchers to ensure that they are caring for research animals appropriately. The author discusses how AAALAC International uses performance standards to evaluate the ethical review processes of European institutions.

  11. 75 FR 2878 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-19

    ..., Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, 6116... Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute... Ahmad, PhD, Scientific Review Officer, Research Programs Review Branch, Division of Extramural...

  12. Assessing the Employment Experiences of Community College Vocational Program Graduates: A Review of Institutional Follow-Up Studies.

    ERIC Educational Resources Information Center

    Palmer, Jim

    This paper reviews a sample of follow-up studies conducted by community colleges to determine the employment experiences of occupational program graduates. Part I discusses the types of follow-up studies conducted, including institutional follow-up studies of graduates from individual vocational programs, of all vocational graduates, and of…

  13. 76 FR 71047 - National Institutes of Health

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on...., Chief, Extramural Project Review Branch EPRB, NIAAA, National Institutes of Health, 5365 Fishers Lane... Awards., National Institutes of Health, HHS) Dated: November 8, 2011. Jennifer S. Spaeth, Director...

  14. Ethics Regulation in Social Computing Research: Examining the Role of Institutional Review Boards.

    PubMed

    Vitak, Jessica; Proferes, Nicholas; Shilton, Katie; Ashktorab, Zahra

    2017-12-01

    The parallel rise of pervasive data collection platforms and computational methods for collecting, analyzing, and drawing inferences from large quantities of user data has advanced social computing research, investigating digital traces to understand mediated behaviors of individuals, groups, and societies. At the same time, methods employed to access these data have raised questions about ethical research practices. This article provides insights into U.S. institutional review boards' (IRBs) attitudes and practices regulating social computing research. Through descriptive and inferential analysis of survey data from staff at 59 IRBs at research universities, we examine how IRBs evaluate the growing variety of studies using pervasive digital data. Findings unpack the difficulties IRB staff face evaluating increasingly technical research proposals while highlighting the belief in their ability to surmount these difficulties. They also indicate a lack of consensus among IRB staff about what should be reviewed and a willingness to work closely with researchers.

  15. Engaging Institutional Review Boards in Developing a Brief, Community-Responsive Human Subjects Training for Community Partners

    PubMed Central

    Calzo, Jerel P.; Bogart, Laura M.; Francis, Evelyn; Kornetsky, Susan Z.; Winkler, Sabune J.; Kaberry, Julie M.

    2017-01-01

    BACKGROUND Engaging community partners as co-investigators in community-based participatory research (CBPR) requires certification in the rules, ethics, and principles governing research. Despite developments in making human research protection trainings more convenient and standardized (e.g., self-paced Internet modules), time constraints and the structure of the content (which may favor academic audiences) may hinder the training of community partners. OBJECTIVES This paper is motivated by a case example in which academic and community partners, and stakeholders of a community-based organization actively engaged the leadership of a pediatric hospital-based Institutional Review Board (IRB) in implementing a brief, community-responsive human subjects training session. METHODS A two hour, discussion-based human subjects training was developed via collaborations between the IRB and the community and academic partners. Interviews with trainees and facilitators after the training were used to evaluate its acceptability and possible future applications. CONCLUSIONS Local Institutional Review Boards have the potential to assist community partners in building sufficient knowledge of human subjects research protections to engage in specific projects, thereby expediting the progress of vital research to address community needs. We propose the need for developing truncated human subjects education materials to train and certify community partners, and creating formally organized entities within academic and medical institutions that specialize in community-based research to guide the development and implementation of alternative human subjects training certification opportunities for community partners. PMID:28230554

  16. Variations in institutional infrastructure, physician specialization and experience, and outcome in ovarian cancer: a systematic review.

    PubMed

    du Bois, Andreas; Rochon, Justine; Pfisterer, Jacobus; Hoskins, William J

    2009-02-01

    Ovarian cancer outcome varies among different institutions, regions, and countries. This systematic review summarizes the available data evaluating the impact of different physician and hospital characteristics on outcome in ovarian cancer patients. A MEDLINE database search for pertinent publications was conducted and reference lists of each relevant article were screened. Experts in the field were contacted. Selected studies assessed the relationship between physician and/or hospital specialty or volume and at least one of the outcomes of interest. The primary outcome was survival. Additional parameters included surgical outcome (debulking), completeness of staging, and quality of chemotherapy. The authors independently reviewed each article and applied the inclusion/exclusion criteria. The quality of each study was assessed by focusing on strategies to control for important prognostic factors. Forty-four articles met inclusion criteria. Discipline and sub-specialization of the primary treating physician were identified as the most important variable associated with superior outcome. Evidence showing a beneficial impact of institutional factors was weaker, but followed the same trend. Hospital volume was hardly related to any outcome parameter. The limited evidence available showed considerable heterogeneity and has to be interpreted cautiously. Better utilization of knowledge about institutional factors and well-established board certifications may improve outcome in ovarian cancer. Patients and primary-care physicians should select gynecologic oncologists for primary treatment in countries with established sub-specialty training. Policymakers, insurance companies, and lay organizations should support development of respective programs.

  17. The Impacts of State Performance Funding Systems on Higher Education Institutions: Research Literature Review and Policy Recommendations. CCRC Working Paper No. 37

    ERIC Educational Resources Information Center

    Dougherty, Kevin J.; Reddy, Vikash

    2011-01-01

    Over the past three decades policymakers have been seeking new ways to secure improved performance from higher education institutions. One popular approach has been performance funding, which involves use of a formula to tie funding to institutional performance on specified indicators. This report reviews findings from studies on performance…

  18. 78 FR 8156 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; Companion... Review Officer, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer...

  19. Recent Trends in National Institutes of Health Funding of Surgical Research

    PubMed Central

    Rangel, Shawn J.; Efron, Bradley; Moss, R. Lawrence

    2002-01-01

    Objective To compare the amount of National Institutes of Health (NIH) funding provided to departments of surgery with that provided to other major clinical departments, to examine the relationship between peer-review activity and funding success, and to compare trends in participation in the peer-review process between surgeons and representatives from other clinical departments. Summary Background Data Surgical research has made enormous contributions to human health. This work is fundamentally dependent on fair and unbiased distribution of extramural research funds from the NIH. To date, no published report has examined the relative distribution of extramural support between departments of surgery and other major clinical departments. Methods Data regarding funding trends and peer-review activity were obtained from the NIH and compared between departments of surgery and four nonsurgical departments (medicine, psychiatry, pediatrics, neurology). Award data were examined during 1996 to 2001. Participation trends were examined during 1998 to 2000. Results Success rates of surgical proposals were significantly lower than nonsurgical proposals. Differentials in success rates were greatest for proposals assigned to the National Cancer Institute, although relative underfunding for surgical research spanned all major institutes. Awards for surgical grants averaged 5% to 27% less than nonsurgical grants). Surgeons exhibited 35% to 65% less peer-review activity relative to nonsurgeons when normalized to grant submission activity. Overall, surgeons participated on sections where they made up a relatively smaller proportion of total review members compared to nonsurgeons. Conclusions Surgical grant proposals are less likely to be funded and carry significantly smaller awards compared to nonsurgical proposals. Relatively fewer surgeons participate in the review process, and those who do are more likely to be in the minority within study sections. Multiple strategies are

  20. Neutral atom analyzers for diagnosing hot plasmas: A review of research at the ioffe physicotechnical institute

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kislyakov, A. I.; Petrov, M. P.

    2009-07-15

    Research on neutral particle diagnostics of thermonuclear plasmas that has been carried out in recent years at the Ioffe Physicotechnical Institute of the Russian Academy of Sciences (St. Petersburg, Russia) is reviewed. Work on the creation and improvement of neutral atom analyzers was done in two directions: for potential applications (in particular, on the International Thermonuclear Experimental Reactor, which is now under construction at Cadarache in France) and for investigation of the ion plasma component in various devices (in particular, in the largest tokamaks, such as JET, TFTR, and JT-60). Neutral atom analyzers are the main tool for studying themore » behavior of hydrogen ions and isotopes in magnetic confinement systems. They make it possible to determine energy spectra, to perform the isotope analysis of atom fluxes from the plasma, to measure the absolute intensity of the fluxes, and to record how these parameters vary with time. A comparative description of the analyzers developed in recent years at the Ioffe Institute is given. These are ACORD-12/24 analyzers for recording 0.2-100-keV hydrogen and deuterium atoms with a tunable range of simultaneously measured energies, CNPA compact analyzers for a fixed energy gain in the ranges 80-1000 eV and 0.8-100 keV, an ISEP analyzer for simultaneously recording the atoms of all the three hydrogen isotopes (H, D, and T) in the energy range 5-700 keV, and GEMMA analyzers for recording atom fluxes of hydrogen and helium isotopes in the range 0.1-4 MeV. The scintillating detectors of the ISEP and GEMMA analyzers have a lowered sensitivity to neutrons and thus can operate without additional shielding in neutron fields of up to 10{sup 9} n/(cm{sup 2} s). These two types of analyzers, intended to operate under deuterium-tritium plasma conditions, are prototypes of atom analyzers created at the Ioffe Institute for use in the International Thermonuclear Experimental Reactor. With these analyzers, a number of new

  1. Universitywide Program Review: Evolving a Process for Program Improvement and Institutional Planning. Professional File. Number 128, Winter 2012

    ERIC Educational Resources Information Center

    Nelson, Kristi A.; Nicholas, Mark C.

    2012-01-01

    The President of the University of Cincinnati charged the Academic Coordinating Committee (ACC), a universitywide governance body, to conduct a comprehensive review of degree programs by designing a process with multiple outcomes: building an academically stronger university; ensuring consistency with the institution's capacity and academic…

  2. 78 FR 51195 - National Institute on Aging; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging... personal privacy. Name of Committee: National Institute on Aging Initial Review Group; Biological Aging... 20814. Contact Person: Bita Nakhai, Ph.D., Scientific Review Branch, National Institute On Aging...

  3. 75 FR 11188 - National Institute on Aging; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging... personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel; Beeson Meeting...: William Cruce, PhD, Scientific Review Officer, National Institute on Aging, Scientific Review Branch...

  4. 76 FR 57064 - National Institute on Aging; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-15

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging... personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel, AD Genetics... Person: William Cruce, PhD, Scientific Review Officer, National Institute on Aging, Scientific Review...

  5. 78 FR 52552 - National Institute on Aging Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging... personal privacy. Name of Committee: National Institute on Aging Initial Review Group, Neuroscience of Aging Review Committee. Date: October 10-11, 2013. Time: 4:00 p.m. to 2:00 p.m. Agenda: To review and...

  6. 77 FR 51787 - Notice of Submission for OMB Review; Institute of Education Sciences; 2012-13 Teacher Follow-Up...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

    ... DEPARTMENT OF EDUCATION Notice of Submission for OMB Review; Institute of Education Sciences; 2012... Staffing Survey (SASS) SUMMARY: This request from the National Center for Education Statistics (NCES), of the U.S. Department of Education (ED), is for clearance for the full scale data collection for the...

  7. [Burden of relatives and their expectations towards psychiatric institutions. A review of the literature and own results].

    PubMed

    Schmid, R; Spiessl, H; Vukovich, A; Cording, C

    2003-03-01

    This article aimed to provide an overview regarding the burden of relatives of mentally ill patients and their expectations towards psychiatric institutions. The literature was selected from Medline covering the years 1996 - 2002. 342 articles were reviewed, 145 of which were described in this review. The burden of relatives are manifold and can be classified into the following categories: time spent on caring, financial difficulties, occupational restrictions, detrimental effects on relatives own physical and psychological well-being, reduction in leisure activities, negative effects on social relationships, experiences of discrimination and refusal, deficiencies in information about illness, feelings of not being taken seriously, insufficient service support, long distance to mental health service, emotional burdens of caregivers and difficulties with the patients behaviour. The expectations of the relatives mainly refer to the categories "relationship between staff and relatives", "information about illness" and "establishing of institutions required". The various burdens of relatives and their expectations towards psychiatric services point to necessary improvements of mental health services in the sense of a consumer-oriented psychiatric care.

  8. Evaluating Self-Funded Health Insurance for the Lakeshore Technical Institute as a Cost-Containment Measure.

    ERIC Educational Resources Information Center

    Holstein, Karen E.

    In response to the rising costs of health care and large increases in insurance premiums, a study was conducted at Lakeshore Technical Institute (LTI) to investigate the feasibility of using a self-funded health insurance plan at the college. Data were obtained through a literature review; telephone and on-site discussions with a personnel…

  9. Victor Frankenstein's Institutional Review Board Proposal, 1790.

    PubMed

    Harrison, Gary; Gannon, William L

    2015-10-01

    To show how the case of Mary Shelley's Victor Frankenstein brings light to the ethical and moral issues raised in Institutional Review Board (IRB) protocols, we nest an imaginary IRB proposal dated August 1790 by Victor Frankenstein within a discussion of the importance and function of the IRB. Considering the world of science as would have appeared in 1790 when Victor was a student at Ingolstadt, we offer a schematic overview of a fecund moment when advances in comparative anatomy, medical experimentation and theories of life involving animalcules and animal electricity sparked intensive debates about the basic principles of life and the relationship between body and soul. Constructing an IRB application based upon myriad speculations circulating up to 1790, we imagine how Victor would have drawn upon his contemporaries' scientific work to justify the feasibility of his project, as well as how he might have outlined the ethical implications of his plan to animate life from "dead" tissues. In Mary Shelley's Frankenstein, Victor failed to consider his creature's autonomy, vulnerability, and welfare. In this IRB proposal, we show Victor facing those issues of justice and emphasize how the novel can be an important component in courses or workshops on research ethics. Had Victor Frankenstein had to submit an IRB proposal tragedy may have been averted, for he would have been compelled to consider the consequences of his experiment and acknowledge, if not fulfill, his concomitant responsibilities to the creature that he abandoned and left to fend for itself.

  10. Assessment of Institutional Capacities of Flood Management Institution in Pakistan

    NASA Astrophysics Data System (ADS)

    Khan, Noor M.

    2009-03-01

    Pakistan is frequently devastated by floods. The flood impacts can be reduced if the flood management institutional capacities are improved. This paper reviews and assesses the capacities of flood management institution in Pakistan. Citing a number of case studies about the flood management practices in Pakistan, the study estimates the weaknesses and strengths of the institution with respect to various phases of flood management, namely, mitigation, preparedness, response, and rehabilitation and also with respect to various characteristics of institutions, namely, deliberation, coordination, implementation, and evaluation, using an improved capacity assessment framework. It has been found that the performance of the mitigation and rehabilitation phases is not satisfactory and that of preparedness and response is satisfactory. It is concluded that the functions of deliberation need to be improved while the other three characteristics of institution namely, coordination, implementation, and evaluation are performing well. The study will help the policy makers to concentrate on the identified weak capacities.

  11. Rethinking Ethics Review as Institutional Discourse

    ERIC Educational Resources Information Center

    Halse, Christine; Honey, Anne

    2007-01-01

    In this article, the authors trace the emergence of an institutional discourse of ethical research and interrogate its effects in constituting what ethical research is taken to be and how ethical researchers are configured. They illuminate the dissonance between this regime of truth and research practice and the implications for the injunction to…

  12. 77 FR 4052 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-26

    ... Skin Cancers. Date: February 8-9, 2012. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... Cancer Institute Special Emphasis Panel, Review of P01 Grant Applications (SEP One). [[Page 4053

  13. Review on the Impact of World Higher Education Rankings: Institutional Competitive Competence and Institutional Competence

    ERIC Educational Resources Information Center

    Dembereldorj, Zoljargal

    2018-01-01

    This paper discusses the relevant literature on higher education rankings and its impact on higher education institutions across the globe. The literature suggests that global university rankings impact higher education institutions both in advanced economy and developing countries to build competence to race and exist. Universities in an advanced…

  14. Institutional Approaches to Innovation and Change: A Review of the Esman Model of Institution Building.

    ERIC Educational Resources Information Center

    Bhola, H. S.

    The definitional and conceptual structure of the Esman model of institution building is described in great detail, emphasizing its philosophic and process assumptions and its latent dynamics. The author systematically critiques the Esman model in terms of its (1) specificity to the universe of institution building, (2) generalizability across…

  15. 76 FR 16798 - National Institutes of Health

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review.... Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference..., National Institutes of Health, 6701 Rockledge Drive, Room 4136, MSC 7850, Bethesda, MD 20892, (301) 435...

  16. 76 FR 30374 - National Institute on Aging; Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging... unwarranted invasion of personal privacy. Name of Committee: National Institute on Aging Special Emphasis... 90401. Contact Person: Ramesh Vemuri, PhD, Chief, Scientific Review Branch, National Institute on Aging...

  17. [Test Reviews in Child Psychology: Test Users Wish to Obtain Practical Information Relevant to their Respective Field of Work].

    PubMed

    Renner, Gerolf; Irblich, Dieter

    2016-11-01

    Test Reviews in Child Psychology: Test Users Wish to Obtain Practical Information Relevant to their Respective Field of Work This study investigated to what extent diagnosticians use reviews of psychometric tests for children and adolescents, how they evaluate their quality, and what they expect concerning content. Test users (n = 323) from different areas of work (notably social pediatrics, early intervention, special education, speech and language therapy) rated test reviews as one of the most important sources of information. Readers of test reviews value practically oriented descriptions and evaluations of tests that are relevant to their respective field of work. They expect independent reviews that critically discuss opportunities and limits of the tests under scrutiny. The results show that authors of test reviews should not only have a background in test theory but should also be familiar with the practical application of tests in various settings.

  18. 76 FR 21387 - National Heart, Lung, and Blood Institute;

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-15

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood..., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

  19. Blended Learning as Transformational Institutional Learning

    ERIC Educational Resources Information Center

    VanDerLinden, Kim

    2014-01-01

    This chapter reviews institutional approaches to blended learning and the ways in which institutions support faculty in the intentional redesign of courses to produce optimal learning. The chapter positions blended learning as a strategic opportunity to engage in organizational learning.

  20. A Review of Propulsion Industrial Base Studies and an Introduction to the National Institute of Rocket Propulsion Systems

    NASA Technical Reports Server (NTRS)

    Doreswamy, Rajiv; Fry, Emma K.

    2012-01-01

    Over the past decade there have been over 40 studies that have examined the state of the industrial base and infrastructure that supports propulsion systems development in the United States. This paper offers a comprehensive, systematic review of these studies and develops conclusions and recommendations in the areas of budget, policy, sustainment, infrastructure, workforce retention and development and mission/vision and policy. The National Institute for Rocket Propulsion System (NIRPS) is a coordinated, national organization that is responding to the key issues highlighted in these studies. The paper outlines the case for NIRPS and the specific actions that the Institute is taking to address these issues.

  1. 75 FR 69621 - Submission for OMB Review; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-15

    ... DEPARTMENT OF COMMERCE Submission for OMB Review; Comment Request The Department of Commerce will...- for-profit institutions. Frequency: On occasion. Respondent's Obligation: Required to obtain benefits...-0266, Department of Commerce, Room 6616, 14th and Constitution Avenue, NW., Washington, DC 20230 (or...

  2. 15 CFR 285.15 - Obtaining documents.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false Obtaining documents. 285.15 Section 285.15 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE ACCREDITATION AND ASSESSMENT PROGRAMS NATIONAL...

  3. 15 CFR 285.15 - Obtaining documents.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 15 Commerce and Foreign Trade 1 2013-01-01 2013-01-01 false Obtaining documents. 285.15 Section 285.15 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE ACCREDITATION AND ASSESSMENT PROGRAMS NATIONAL...

  4. 15 CFR 285.15 - Obtaining documents.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 15 Commerce and Foreign Trade 1 2011-01-01 2011-01-01 false Obtaining documents. 285.15 Section 285.15 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE ACCREDITATION AND ASSESSMENT PROGRAMS NATIONAL...

  5. 15 CFR 285.15 - Obtaining documents.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 15 Commerce and Foreign Trade 1 2014-01-01 2014-01-01 false Obtaining documents. 285.15 Section 285.15 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE ACCREDITATION AND ASSESSMENT PROGRAMS NATIONAL...

  6. 77 FR 5032 - National Cancer Institute; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-01

    ... Initiatives; RFA and RFP Concept Reviews; and Scientific Presentations. Place: National Institutes of Health... Group(s); and Budget Presentations; Reports of Special Initiatives; RFA and RFP Concept Reviews; and Scientific Presentations. Place: National Institutes of Health, Building 31, 31 Center Drive, 6th Floor, Conf...

  7. HER2-positive male breast cancer with thyroid cancer: an institutional report and review of literature.

    PubMed

    Bardhan, Pooja; Bui, Marilyn M; Minton, Susan; Loftus, Loretta; Carter, W Bradford; Laronga, Christine; Ismail-Khan, Roohi

    2012-01-01

    We report a rare finding of two male breast cancer patients with HER2-positive breast cancer who also developed thyroid cancer. We reviewed 45 male breast cancer patients treated in our institution from 2003 to 2008. Only five male breast cancer patients were HER2-positive. In reviewing the published data, we found no cases of thyroid cancer and concurrent breast cancer in men. However, breast cancer and thyroid cancer have shown close association in women. This finding therefore provokes speculation as to whether we should investigate whether women with HER2-positive breast cancer are at a higher risk for thyroid cancer. Although this observation seems to be clinically prevalent, publications are sparse in clinical research areas linking thyroid cancer to breast cancer.

  8. Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board.

    PubMed

    Gautier, Isabelle; Janiaud, Perrine; Rollet, Nelly; André, Nicolas; Tsimaratos, Michel; Cornu, Catherine; Malik, Salma; Gentile, Stéphanie; Kassaï, Behrouz

    2017-08-23

    There is a great need for high quality clinical research for children. The European Pediatric Regulation aimed to improve the quality of clinical trials in order to increase the availability of treatments for children. The main purpose of this study was to assess the evolution of both the number and the quality of pediatric trial protocols that were submitted to a French Institutional Review Board (IRB00009118) before and after the initiation of the EU Pediatric Regulation. All protocols submitted to the IRB00009118 between 2003 and 2014 and conducting research on subjects under eighteen years of age were eligible. The quality of randomized clinical trials was assessed according to the guidelines developed by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network and ranked using the Jadad score. Out of 622 protocols submitted to the Institutional Review Board (IRB), 21% (133/622) included children. Among these 133 pediatric protocols, the number of submitted pediatric protocols doubled between the two studied periods. From 2003 to 2008, 47 protocols including 21 institutionally sponsored were submitted to the IRB and from 2009 until 2014, 86 protocols including 48 institutionally sponsored were submitted. No significant trend was observed on the quality of RCTs. The overall median score of RCTs on the Jadad scale was high (3.5), 70.0% of protocols had a Jadad score ≥ 3, and 30.0% had a score < 3. Following the EU Pediatric Regulation, the number of pediatric protocols submitted to the IRB00009118 tends to increase, but no change was noticed regarding their quality.

  9. Institutional Debt: An Analysis of Student Institutional Debt at a Midwestern Multi-Campus University between 2011 and 2014

    ERIC Educational Resources Information Center

    Olafsdottir, Kristin

    2017-01-01

    For the institution and its regional campuses under review, the amount of outstanding student liabilities (i.e., monies owed by the student to the institution for educational-related expenditures not satisfied by the end of the term) grew at an alarming rate between 2000 and 2014, with some of the institution's regional campuses experiencing over…

  10. Research Output of Academic Librarians from Irish Higher Education Institutions 2000-2015: Findings from a Review, Analysis, and Survey

    ERIC Educational Resources Information Center

    O'Brien, Terry; Cronin, Kieran

    2016-01-01

    The purpose of this paper is to quantify, review, and analyze published research output of academic librarians from 21 higher education Institutions in Ireland. A mixed approach using an online survey questionnaire, supplemented by content analysis and extensive literature scoping were used for data collection. Factors inhibiting and predicting…

  11. Institutional Staff Training and Management: A Review of the Literature and a Model for Geriatric, Long-Term-Care Facilities.

    ERIC Educational Resources Information Center

    Burgio, Louis D.; Burgio, Kathryn L.

    1990-01-01

    Asserts that, if long-term care is to progress from custodial model to therapeutic model of rehabilitation, role of nursing assistants must be redesigned. Reviews current methods of institutional staff training and management and proposes model for geriatric, long-term care facilities. Discusses organizational resistance and offers suggestions for…

  12. 77 FR 59199 - National Institute of Dental & Craniofacial Research; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and Craniofacial...., Scientific Review Officer, Scientific Review Branch, National Institute of Dental and Craniofacial, Research...

  13. 78 FR 56902 - National Institute of Dental & Craniofacial Research; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and Craniofacial... Review Officer, Scientific Review Branch, National Institute of Dental and Craniofacial Research, One...

  14. 77 FR 59202 - National Institute of Dental & Craniofacial Research; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and... Review Officer, Scientific Review Branch, National Institute of Dental & Craniofacial Research, National...

  15. 76 FR 5184 - National Institute of Dental & Craniofacial Research; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and..., Scientific Review Officer, Scientific Review Branch, National Institute of Dental and Craniofacial Research...

  16. 77 FR 8268 - National Institute of Dental & Craniofacial Research; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and Craniofacial...., Scientific Review Officer, Scientific Review Branch, National Institute of Dental and Craniofacial Research...

  17. 75 FR 58409 - National Institute of Dental & Craniofacial Research; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and..., Scientific Review Officer, Scientific Review Branch, National Institute of Dental and Craniofacial Research...

  18. 77 FR 10539 - National Institute of Dental & Craniofacial Research; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and Craniofacial... Review Officer Scientific Review Branch, National Institute of Dental and Craniofacial, Research, 6701...

  19. 75 FR 39547 - National Institute of Dental & Craniofacial Research; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and Craniofacial..., Scientific Review Officer, Scientific Review Branch, National Institute of Dental and Craniofacial Research...

  20. 78 FR 39740 - National Institute of Dental & Craniofacial Research; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and Craniofacial...., Scientific Review Officer, Scientific Review Branch, National Institute of Dental and Craniofacial Research...

  1. 76 FR 23826 - National Institute on Drug Abuse; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-28

    ...: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center...: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center... applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville...

  2. 77 FR 63846 - National Institute on Drug Abuse; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard.... Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience...: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center...

  3. 75 FR 10492 - National Institute of Mental Health; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-08

    ... evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive... Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience... review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001...

  4. 77 FR 33472 - National Institute on Drug Abuse; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-06

    .... Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience... and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001.... Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience...

  5. 78 FR 67178 - National Institute of Dental & Craniofacial Research; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and...-Hoon, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute of Dental and...

  6. 78 FR 107 - National Human Genome Research Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... evaluate grant applications. Place: National Human Genome Research Institute, 3rd Floor Conference Room....D., Scientific Review Officer, Scientific Review Branch, National Human Genome Research Institute...

  7. Navigating the Institutional Review Board (IRB) Process for Pharmacy-Related Research

    PubMed Central

    Abdelghany, Osama; Johnston, Susan; Rarus, Rachel; Austin-Szwak, Jennifer; Kirkwood, Craig

    2017-01-01

    Pharmacists' specialized training and knowledge qualify them to lead and engage in research pertaining to optimal medication use. Performing research promotes pharmacy professionalism and fosters interdisciplinary collaboration. To conduct research appropriately, one must have thorough knowledge of when institutional review board (IRB) approval is required and how to successfully navigate IRB processes. The overarching mission of the IRB overseeing research at an organization per federal guidelines is to protect the rights and welfare of human subjects participating in research. This article discusses the following general pharmacy practice–based considerations relating to IRB processes: strategies for developing research projects, key distinctions between quality improvement and research, practical considerations for submitting IRB applications and documentation, different categories of IRB submission, informed consent and conditions for waivers or alterations of consent, and principal investigator obligations for approved research. Pharmacists should also account for organization-specific IRB processes when designing, submitting, and implementing research projects. PMID:28321137

  8. SoTL and the Institutional Review Board: Considerations before Navigating the Application Process for Classroom Research in Higher Education

    ERIC Educational Resources Information Center

    Linder, Kathryn E.; Elek, E. Deborah; Calderon, Lucia

    2014-01-01

    One of the more challenging areas of "Scholarship of Teaching and Learning" (SoTL) research can be navigating the components of human subjects research protections implemented by the Institutional Review Board (IRB). The authors of this article, a faculty developer and a current and former research compliance coordinator, discuss the…

  9. 75 FR 19984 - National Human Genome Research Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome..., National Human Genome Research Institute, National Institutes of Health, 5635 Fishers Lane, Suite 4075... Nakamura, PhD, Scientific Review Officer, Scientific Review Branch, National Human Genome Research...

  10. 76 FR 58023 - National Human Genome Research Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Initial..., Scientific Review Officer, Office of Scientific Review, National Human Genome Research Institute, National...

  11. 76 FR 17930 - National Human Genome Research Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special... Review Officer, Scientific Review Branch, National Human Genome Research Institute, 5635 Fishers Lane...

  12. 77 FR 71428 - National Eye Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute... personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel; NEI Clinical..., Scientific Review Officer, Division of Extramural Research, National Eye Institute, National Institutes of...

  13. 76 FR 46822 - National Eye Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-03

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute... unwarranted invasion of personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel... Review Officer, Division of Extramural Research, National Eye Institute, National Institutes of Health...

  14. 75 FR 10295 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-05

    ... G. Lovinger, PhD, Scientific Review Administrator, Special Review and Logistics Branch, Division of... Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Boulevard, Room 7142... and Referral Branch, Division of Extramural Activities, National Cancer Institute, NIH, 6116 Executive...

  15. 77 FR 12600 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-01

    ... Extramural Activities, National Cancer Institute, NIH, 6116 Executive Boulevard, Room 8055B, Bethesda, MD..., Division of Extramural Activities, National Cancer Institute, NIH, 6116 Executive Blvd., Room 8101... Review Officer, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer...

  16. 77 FR 2737 - National Institute on Aging; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-19

    ... for Developing Areas of Investigation in the Basic Biology of Aging. Date: February 9, 2012. Time: 8...., Scientific Review Officer, Scientific Review Branch, National Institute on Aging, Gateway Bldg., 2C212, 7201... Officer, Scientific Review Branch, National Institute on Aging, Gateway Building, Suite 2C212, MSC-9205...

  17. 75 FR 33628 - National Eye Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute... unwarranted invasion of personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel... Review Officer, National Eye Institute, National Institutes of Health, 5635 Fishers Lane, Suite 1300, MSC...

  18. 75 FR 8971 - National Eye Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute... personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel, NEI K99 Grant.... Kenshalo, PhD, Scientific Review Officer, National Eye Institute, National Institutes of Health, 5635...

  19. 76 FR 576 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-05

    ..., Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of...: Wlodek Lopaczynski, M.D., PhD, Scientific Review Officer, Research Programs Review Branch, Division of... Institute Special Emphasis Panel; Collaborative Research in Integrative Cancer Biology and the Tumor...

  20. 75 FR 80512 - National Institute on Drug Abuse; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-22

    ... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis...D, Scientific Review Administrator, Office of Extramural Affairs, National Institute on Drug Abuse... limitations imposed by the review and funding cycle. Name of Committee: National Institute on Drug Abuse...

  1. The Issues and Methodologies in Sustainability Assessment Tools for Higher Education Institutions: A Review of Recent Trends and Future Challenges

    ERIC Educational Resources Information Center

    Yarime, Masaru; Tanaka, Yuko

    2012-01-01

    Assessment tools influence incentives to higher education institutions by encouraging them to move towards sustainability. A review of 16 sustainability assessment tools was conducted to examine the recent trends in the issues and methodologies addressed in assessment tools quantitatively and qualitatively. The characteristics of the current…

  2. 78 FR 37557 - National Institute of General Medical Sciences; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-21

    ...: Margaret J. Weidman, Ph.D., Scientific Review Officer, Office of Scientific Review, National Institute of..., Ph.D., Scientific Review Officer, Office of Scientific Review, National Institute of General Medical..., and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88...

  3. 32 CFR Appendix G to Part 275 - Releasing Information Obtained From Financial Institutions

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... FINANCIAL PRIVACY ACT OF 1978 Pt. 275, App. G Appendix G to Part 275—Releasing Information Obtained From... record was obtained pursuant to the Right to Financial Privacy Act of 1978, 12 U.S.C. 3401 et seq., and... transferring law enforcement office, personnel security element, or intelligence organization, or designee...

  4. 75 FR 27562 - National Institute of Mental Health; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental... Emphasis Panel, Brain Bank Resource Review. Date: June 9, 2010. Time: 9 a.m. to 11 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001...

  5. 75 FR 58409 - National Institute of Dental & Craniofacial Research; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and Craniofacial... Kelly, Scientific Review Officer, Scientific Review Branch, [[Page 58410

  6. 76 FR 59413 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Initial Review Group, Subcommittee J... Of Extramural Activities, National Cancer Institute, 6116 Executive Boulevard, Room 8111, Bethesda...

  7. 75 FR 52537 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Initial Review Group; Subcommittee J... of Extramural Activities, National Cancer Institute, 6116 Executive Boulevard, Room 8111, Bethesda...

  8. 77 FR 6812 - National Institute of Dental and Craniofacial Research, Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and... Raman, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute of Dental and...

  9. 78 FR 19275 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel Tumor Immunology...., Chief Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute...

  10. 76 FR 28236 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel, Cancer Prevention... Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive...

  11. 75 FR 71713 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel, Basic and... Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 6116 Executive Blvd...

  12. 76 FR 22407 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Initial Review Group; Subcommittee J..., Division of Extramural Activities, National Cancer Institute, 6116 Executive Boulevard, Room 8111, Bethesda...

  13. 75 FR 993 - National Institute of Dental & Craniofacial Research; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and... Review Officer, Scientific Review Branch, National Inst of Dental & Craniofacial Research, NIH 6701...

  14. 76 FR 28793 - National Institute of Dental & Craniofacial Research; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental..., Scientific Review Officer, Scientific Review Branch, National Inst of Dental & Craniofacial Research....nih.gov . Name of Committee: National Institute of Dental and Craniofacial Research Special Emphasis...

  15. 75 FR 52537 - National Institute of Dental & Craniofacial Research; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and Craniofacial... Kelly, Scientific Review Officer, Scientific Review Branch, National Inst of Dental & Craniofacial...

  16. 77 FR 24727 - National Eye Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute... personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel; NEI Clinical Trials.... Schaffner, Ph.D., Chief, Scientific Review Branch, Division of Extramural Research, National Eye Institute...

  17. 76 FR 66732 - National Eye Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute... personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel, NEI Genomic Research.... Schaffner, PhD, Chief, Scientific Review Officer, Division of Extramural Research, National Eye Institute...

  18. 78 FR 62639 - National Eye Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute... personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel; NEI Clinical and.... Contact Person: Brian Hoshaw, Ph.D., Scientific Review Officer, National Eye Institute, National...

  19. 77 FR 64525 - National Eye Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute... personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel, NEI Career Development... Schaffner, Ph.D., Chief, Scientific Review Officer, Division of Extramural Research, National Eye Institute...

  20. 76 FR 42718 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel, Cancer Therapies..., Rockville, MD 20582. Contact Person: Delia Tang, MD, Scientific Review Officer, National Cancer Institute...

  1. 75 FR 32489 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Initial Review Group; Subcommittee H... Activities, National Cancer Institute, 6116 Executive Boulevard, Room 8103, Bethesda, MD 20892, (301) 594...

  2. 75 FR 48699 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Initial Review Group, Subcommittee I--Career..., Division of Extramural Activities, National Cancer Institute, NIH, 6116 Executive Blvd, Rm 8113, Bethesda...

  3. 76 FR 17930 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Initial Review Group; Subcommittee A--Cancer..., Division of Extramural Activities, National Cancer Institute, 6116 Executive Blvd, Room 8107, MSC 8328...

  4. Analysis of warning letters issued by the US Food and Drug Administration to clinical investigators, institutional review boards and sponsors: a retrospective study.

    PubMed

    Shetty, Yashashri C; Saiyed, Aafreen A

    2015-05-01

    The US Food and Drug Administration (FDA) issues warning letters to all research stakeholders if unacceptable deficiencies are found during site visits. Warning letters issued by the FDA between January 2011 and December 2012 to clinical investigators and institutional review boards (IRBs) were reviewed for various violation themes and compared to similar studies in the past. Warning letters issued to sponsors between January 2005 and December 2012 were analysed for the first time for a specific set of violations using descriptive statistics. Failure to protect subject safety and to report adverse events to IRBs was found to be significant compared to prior studies for clinical investigators, while failure to follow standard operating procedures and maintain documentation was noted as significant in warning letters to IRBs. Failure to maintain minutes of meeting and to follow written procedures for continuing review were new substantial violations in warning letters issued to IRBs. Forty-six warning letters were issued to sponsors, the most common violations being failure to follow a monitoring schedule (58.69%), failure to obtain investigator agreement (34.78%), failure to secure investigators' compliance (30.43%), and failure to maintain data records and ship documents to investigators (30.43%). Appropriate methods for handling clinical trial procedural violations should be developed and implemented worldwide. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  5. 76 FR 65517 - National Institute on Drug Abuse Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-21

    ... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis... Review Officer, Grants Review Branch, Office of Extramural Affairs, National Institute on Drug Abuse, NIH...

  6. 78 FR 30933 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-23

    ... proposals. Place: National Cancer Institute Shady Grove, Shady Grove, 9609 Medical Center Drive, Room 4W032... Review Officer, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, 9609 Medical Center Drive, Room 7W108, Bethesda, Md 20892-9750, 240-276-6378, [email protected

  7. 75 FR 39546 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-09

    ...; Integrative Cancer Biology in the Tumor Microenvironment (U01). Date: July 22, 2010. Time: 8 a.m. to 5 p.m..., Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, 6116... Review and Logistic Branch, Division of Extramural Activities, NCI, National Institutes of Health, 6116...

  8. Evolving Management of Symptomatic Chronic Subdural Hematoma: Experience of a Single Institution and Review of the Literature

    PubMed Central

    Balser, David; Rodgers, Shaun D.; Johnson, Blair; Shi, Chen; Tabak, Esteban; Samadani, Uzma

    2015-01-01

    Objective Chronic subdural hematoma has an increasing incidence and results in high morbidity and mortality. We review here the ten-year experience of a single institution and the literature regarding the treatment and major associations of chronic subdural hematoma (cSDH). Methods We retrospectively reviewed all cSDHs surgically treated from 2000 to 2010 at our institution to evaluate duration from admission to treatment, type of treatment, length of stay in critical care, length of stay in the hospital and recurrence. The literature was reviewed with regards to incidence, associations and treatment of cSDH. Results From 2000–2008, 44 patients were treated with burr holes. From 2008 to 2010, 29 patients were treated with twist drill evacuation (SEPS). 4 patients from each group were readmitted for reoperation (9% vs. 14%; p=.53). The average time to intervention for SEPS (11.2±15.3 hrs) was faster than for burr holes (40.3±69.1 hrs) (p=.02). The total hospital LOS was shorter for SEPS (9.3±6.8 days) versus burr holes (13.4±10.2 days) (p=.04); both were significantly longer than for a brain tumor patient undergoing craniotomy (7.0±0.5 days, n=94, P<.01). Conclusion Despite decreasing lengths of stay over time as treatment for cSDH evolved from burr holes to SEPS, the length of stay for a cSDH is still greater than that of a patient undergoing craniotomy for brain tumor. We noted 11% recurrence in our series of patients, which included individuals who recurred as late as 3 years after initial diagnosis. PMID:23485050

  9. Credit allocation for research institutes

    NASA Astrophysics Data System (ADS)

    Wang, J.-P.; Guo, Q.; Yang, K.; Han, J.-T.; Liu, J.-G.

    2017-05-01

    It is a challenging work to assess research performance of multiple institutes. Considering that it is unfair to average the credit to the institutes which is in the different order from a paper, in this paper, we present a credit allocation method (CAM) with a weighted order coefficient for multiple institutes. The results for the APS dataset with 18987 institutes show that top-ranked institutes obtained by the CAM method correspond to well-known universities or research labs with high reputation in physics. Moreover, we evaluate the performance of the CAM method when citation links are added or rewired randomly quantified by the Kendall's Tau and Jaccard index. The experimental results indicate that the CAM method has better performance in robustness compared with the total number of citations (TC) method and Shen's method. Finally, we give the first 20 Chinese universities in physics obtained by the CAM method. However, this method is valid for any other branch of sciences, not just for physics. The proposed method also provides universities and policy makers an effective tool to quantify and balance the academic performance of university.

  10. 76 FR 79202 - National Institute Of Dental & Craniofacial Research; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute Of Dental... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and.... Krishnaraju, Ph.D., MS, Scientific Review Officer, Scientific Review Branch, National Inst of Dental...

  11. 76 FR 57061 - National Institute of Dental & Craniofacial Research; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-15

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and Craniofacial...). Contact Person: Mary Kelly, Scientific Review Officer, Scientific Review Branch, National Inst of Dental...

  12. 77 FR 24728 - National Heart, Lung, and Blood Institute Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special... Review Officer, Office of Scientific Review/DERA, National, Heart, Lung, and Blood Institute, 6701...

  13. 78 FR 22272 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-15

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special... Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

  14. 76 FR 42720 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Initial Review Group, Subcommittee I--Career... Extramural Activities, National Cancer Institute, NIH, 6116 Executive Blvd, Rm 8113, Bethesda, MD 20892, 301...

  15. 76 FR 20360 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-12

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Initial Review Group; Subcommittee F... Activities, National Cancer Institute, NIH, 6116 Executive Blvd., Room 8105, Bethesda, MD 20892, 301-451-4759...

  16. 76 FR 28238 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Initial Review Group, Subcommittee I--Career... Activities, National Cancer Institute, NIH, 6116 Executive Blvd, Rm 8113, Bethesda, MD 20892, 301-435-5655...

  17. A Review and Analysis of the Ayurvedic Institute's Ayurvedic Studies Program.

    ERIC Educational Resources Information Center

    Rogers, Curtis R.

    The Ayurvedic Institute, which has been licensed as a private institution of higher education in New Mexico since 1994, offers training in the traditional therapy of East Indian Ayurveda, which includes the use of herbs, nutrition, panchakarma cleansing, and accupressure massage. The institute also offers training in the related disciplines of…

  18. 76 FR 55930 - National Institutes of Health

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center For Scientific Review..., National Institutes of Health, 6701 Rockledge Drive, Room 6194, MSC 7804, Bethesda, MD 20892, 301-996-6208... of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Joseph Thomas...

  19. A systematic review of the international published literature relating to quality of institutional care for people with longer term mental health problems

    PubMed Central

    Taylor, Tatiana L; Killaspy, Helen; Wright, Christine; Turton, Penny; White, Sarah; Kallert, Thomas W; Schuster, Mirjam; Cervilla, Jorge A; Brangier, Paulette; Raboch, Jiri; Kališová, Lucie; Onchev, Georgi; Dimitrov, Hristo; Mezzina, Roberto; Wolf, Kinou; Wiersma, Durk; Visser, Ellen; Kiejna, Andrzej; Piotrowski, Patryk; Ploumpidis, Dimitri; Gonidakis, Fragiskos; Caldas-de-Almeida, José; Cardoso, Graça; King, Michael B

    2009-01-01

    Background A proportion of people with mental health problems require longer term care in a psychiatric or social care institution. However, there are no internationally agreed quality standards for institutional care and no method to assess common care standards across countries. We aimed to identify the key components of institutional care for people with longer term mental health problems and the effectiveness of these components. Methods We undertook a systematic review of the literature using comprehensive search terms in 11 electronic databases and identified 12,182 titles. We viewed 550 abstracts, reviewed 223 papers and included 110 of these. A "critical interpretative synthesis" of the evidence was used to identify domains of institutional care that are key to service users' recovery. Results We identified eight domains of institutional care that were key to service users' recovery: living conditions; interventions for schizophrenia; physical health; restraint and seclusion; staff training and support; therapeutic relationship; autonomy and service user involvement; and clinical governance. Evidence was strongest for specific interventions for the treatment of schizophrenia (family psychoeducation, cognitive behavioural therapy (CBT) and vocational rehabilitation). Conclusion Institutions should, ideally, be community based, operate a flexible regime, maintain a low density of residents and maximise residents' privacy. For service users with a diagnosis of schizophrenia, specific interventions (CBT, family interventions involving psychoeducation, and supported employment) should be provided through integrated programmes. Restraint and seclusion should be avoided wherever possible and staff should have adequate training in de-escalation techniques. Regular staff supervision should be provided and this should support service user involvement in decision making and positive therapeutic relationships between staff and service users. There should be clear lines

  20. A systematic review of the international published literature relating to quality of institutional care for people with longer term mental health problems.

    PubMed

    Taylor, Tatiana L; Killaspy, Helen; Wright, Christine; Turton, Penny; White, Sarah; Kallert, Thomas W; Schuster, Mirjam; Cervilla, Jorge A; Brangier, Paulette; Raboch, Jiri; Kalisová, Lucie; Onchev, Georgi; Dimitrov, Hristo; Mezzina, Roberto; Wolf, Kinou; Wiersma, Durk; Visser, Ellen; Kiejna, Andrzej; Piotrowski, Patryk; Ploumpidis, Dimitri; Gonidakis, Fragiskos; Caldas-de-Almeida, José; Cardoso, Graça; King, Michael B

    2009-09-07

    A proportion of people with mental health problems require longer term care in a psychiatric or social care institution. However, there are no internationally agreed quality standards for institutional care and no method to assess common care standards across countries. We aimed to identify the key components of institutional care for people with longer term mental health problems and the effectiveness of these components. We undertook a systematic review of the literature using comprehensive search terms in 11 electronic databases and identified 12,182 titles. We viewed 550 abstracts, reviewed 223 papers and included 110 of these. A "critical interpretative synthesis" of the evidence was used to identify domains of institutional care that are key to service users' recovery. We identified eight domains of institutional care that were key to service users' recovery: living conditions; interventions for schizophrenia; physical health; restraint and seclusion; staff training and support; therapeutic relationship; autonomy and service user involvement; and clinical governance. Evidence was strongest for specific interventions for the treatment of schizophrenia (family psychoeducation, cognitive behavioural therapy (CBT) and vocational rehabilitation). Institutions should, ideally, be community based, operate a flexible regime, maintain a low density of residents and maximise residents' privacy. For service users with a diagnosis of schizophrenia, specific interventions (CBT, family interventions involving psychoeducation, and supported employment) should be provided through integrated programmes. Restraint and seclusion should be avoided wherever possible and staff should have adequate training in de-escalation techniques. Regular staff supervision should be provided and this should support service user involvement in decision making and positive therapeutic relationships between staff and service users. There should be clear lines of clinical governance that ensure

  1. Ethical dilemmas in community-based participatory research: recommendations for institutional review boards.

    PubMed

    Flicker, Sarah; Travers, Robb; Guta, Adrian; McDonald, Sean; Meagher, Aileen

    2007-07-01

    National and international codes of research conduct have been established in most industrialized nations to ensure greater adherence to ethical research practices. Despite these safeguards, however, traditional research approaches often continue to stigmatize marginalized and vulnerable communities. Community-based participatory research (CBPR) has evolved as an effective new research paradigm that attempts to make research a more inclusive and democratic process by fostering the development of partnerships between communities and academics to address community-relevant research priorities. As such, it attempts to redress ethical concerns that have emerged out of more traditional paradigms. Nevertheless, new and emerging ethical dilemmas are commonly associated with CBPR and are rarely addressed in traditional ethical reviews. We conducted a content analysis of forms and guidelines commonly used by institutional review boards (IRBs) in the USA and research ethics boards (REBs) in Canada. Our intent was to see if the forms used by boards reflected common CBPR experience. We drew our sample from affiliated members of the US-based Association of Schools of Public Health and from Canadian universities that offered graduate public health training. This convenience sample (n = 30) was garnered from programs where application forms were available online for download between July and August, 2004. Results show that ethical review forms and guidelines overwhelmingly operate within a biomedical framework that rarely takes into account common CBPR experience. They are primarily focused on the principle of assessing risk to individuals and not to communities and continue to perpetuate the notion that the domain of "knowledge production" is the sole right of academic researchers. Consequently, IRBs and REBs may be unintentionally placing communities at risk by continuing to use procedures inappropriate or unsuitable for CBPR. IRB/REB procedures require a new framework more

  2. 78 FR 69432 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special...., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

  3. 78 FR 20670 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special...., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

  4. 77 FR 63844 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special...., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

  5. 78 FR 60299 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special...., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

  6. 75 FR 65498 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special... Johnson, PhD, Scientific Review Officer, Review Branch/DERA, National Heart, Lung, and Blood Institute...

  7. 77 FR 6809 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special...., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

  8. 78 FR 13689 - National Institute of General Medical Sciences; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

    ... Person: Brian R. Pike, Ph.D., Scientific Review Officer, Office of Scientific Review, National Institute... R. Pike, Ph.D., Scientific Review Officer, National Institute of General Medical Sciences, National..., Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry...

  9. 75 FR 79010 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... Cancer Institute Special Emphasis Panel Education. Date: January 25, 2011. Time: 3 p.m. to 4:30 p.m..., Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, 6116...

  10. Legal, Institutional, and Economic Indicators of Forest Conservation and Sustainable Management: Review of Information Available for the United States

    Treesearch

    Paul V. Ellefson; Calder M. Hibbard; Michael A. Kilgore; James E. Granskog

    2005-01-01

    This review looks at the Nation’s legal, institutional, and economic capacity to promote forest conservation and sustainable resource management. It focuses on 20 indicators of Criterion Seven of the so-called Montreal Process and involves an extensive search and synthesis of information from a variety of sources. It identifies ways to fill information gaps and improve...

  11. 76 FR 60058 - National Institute on Aging; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging... unwarranted invasion of personal privacy. Name of Committee: National Institute on Aging Special Emphasis...: Ramesh Vemuri, PhD, Chief, Scientific Review Branch, National Institute On Aging, National Institutes of...

  12. Predicting Discharge to Institutional Long-Term Care After Stroke: A Systematic Review and Metaanalysis.

    PubMed

    Burton, Jennifer K; Ferguson, Eilidh E C; Barugh, Amanda J; Walesby, Katherine E; MacLullich, Alasdair M J; Shenkin, Susan D; Quinn, Terry J

    2018-01-01

    Stroke is a leading cause of disability worldwide, and a significant proportion of stroke survivors require long-term institutional care. Understanding who cannot be discharged home is important for health and social care planning. Our aim was to establish predictive factors for discharge to institutional care after hospitalization for stroke. We registered and conducted a systematic review and meta-analysis (PROSPERO: CRD42015023497) of observational studies. We searched MEDLINE, EMBASE, and CINAHL Plus to February 2017. Quantitative synthesis was performed where data allowed. Acute and rehabilitation hospitals. Adults hospitalized for stroke who were newly admitted directly to long-term institutional care at the time of hospital discharge. Factors associated with new institutionalization. From 10,420 records, we included 18 studies (n = 32,139 participants). The studies were heterogeneous and conducted in Europe, North America, and East Asia. Eight studies were at high risk of selection bias. The proportion of those surviving to discharge who were newly discharged to long-term care varied from 7% to 39% (median 17%, interquartile range 12%), and the model of care received in the long-term care setting was not defined. Older age and greater stroke severity had a consistently positive association with the need for long-term care admission. Individuals who had a severe stroke were 26 times as likely to be admitted to long-term care than those who had a minor stroke. Individuals aged 65 and older had a risk of stroke that was three times as great as that of younger individuals. Potentially modifiable factors were rarely examined. Age and stroke severity are important predictors of institutional long-term care admission directly from the hospital after an acute stroke. Potentially modifiable factors should be the target of future research. Stroke outcome studies should report discharge destination, defining the model of care provided in the long-term care setting.

  13. 75 FR 54642 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-08

    ... Blood Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee... unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special.... Johnson, PhD, Scientific Review Officer, Review Branch/DERA, National Heart, Lung, and Blood Institute...

  14. 45 CFR 1150.6 - What opportunity do I have to obtain a review of my debt within the Endowment?

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 3 2011-10-01 2011-10-01 false What opportunity do I have to obtain a review of my debt within the Endowment? 1150.6 Section 1150.6 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES NATIONAL ENDOWMENT FOR THE ARTS...

  15. 45 CFR 1150.6 - What opportunity do I have to obtain a review of my debt within the Endowment?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 3 2010-10-01 2010-10-01 false What opportunity do I have to obtain a review of my debt within the Endowment? 1150.6 Section 1150.6 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES NATIONAL ENDOWMENT FOR THE ARTS...

  16. 76 FR 6628 - National Institute on Aging; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging... personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel; Sex Differences in.... Johnson, PhD, Scientific Review Officer, National Institutes on Aging, National Institutes of Health, 7201...

  17. Referrals between Public Sector Health Institutions for Women with Obstetric High Risk, Complications, or Emergencies in India – A Systematic Review

    PubMed Central

    Singh, Samiksha; Doyle, Pat; Campbell, Oona M.; Mathew, Manu; Murthy, G. V. S.

    2016-01-01

    Emergency obstetric care (EmOC) within primary health care systems requires a linked referral system to be effective in reducing maternal death. This systematic review aimed to summarize evidence on the proportion of referrals between institutions during pregnancy and delivery, and the factors affecting referrals, in India. We searched 6 electronic databases, reviewed four regional databases and repositories, and relevant program reports from India published between 1994 and 2013. All types of study or reports (except editorials, comments and letters) which reported on institution-referrals (out-referral or in-referral) for obstetric care were included. Results were synthesized on the proportion and the reasons for referral, and factors affecting referrals. Of the 11,346 articles identified by the search, we included 232 articles in the full text review and extracted data from 16 studies that met our inclusion criteria Of the 16, one was RCT, seven intervention cohort (without controls), six cross-sectional, and three qualitative studies. Bias and quality of studies were reported. Between 25% and 52% of all pregnancies were referred from Sub-centres for antenatal high-risk, 14% to 36% from nurse run delivery or basic EmOC centres for complications or emergencies, and 2 to 7% were referred from doctor run basic EmOC centres for specialist care at comprehensive EmOC centres. Problems identified with referrals from peripheral health centres included low skills and confidence of staff, reluctance to induce labour, confusion over the clinical criteria for referral, non-uniform standards of care at referral institutions, a tendency to by-pass middle level institutions, a lack of referral communication and supervision, and poor compliance. The high proportion of referrals from peripheral health centers reflects the lack of appropriate clinical guidelines, processes, and skills for obstetric care and referral in India. This, combined with inadequate referral communication

  18. 76 FR 54238 - National Institute on Aging; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-31

    ... personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel, Work Levels..., Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Rebecca J. Ferrell, PhD, Scientific Review... Person: Rebecca J. Ferrell, PhD, Scientific Review Officer, National Institute on Aging, Gateway Building...

  19. [Blood amylase: a biological marker in irradiation accidents? Preliminary results obtained at the Gustave-Roussy Institut (GRI) and a literature review].

    PubMed

    Hennequin, C; Cosset, J M; Cailleux, P E; Girinsky, T; Ganem, G; Hubert, D; Comoy, E; Dutreix, J

    1989-01-01

    The retrospective evaluation of the dose after an irradiation accident is of paramount importance; it allows an adequate selection of patients and the most appropriate treatment can then be proposed. Classical physical dosimetry often lacks precision for dose assessment in such accidents. Cytogenetics, usually more reliable, is not 100% accurate and cannot be used in some particular instances. At the Institut Gustave-Roussy, we studied amylasemia in 15 patients who received a total body irradiation (TBI) for bone marrow grafting, at various dose levels (10, 2 and 1.35 Gy). Hyperamylasemia was found to be constant and dose-dependent. Ten additional patients given a localized irradiation of 2 Gy in the Waldeyer ring had a similar rise in amylasemia as did TBI patients who had received the same dose. In contrast, 13 patients given a pancreatic irradiation (as part of a localized abdominal irradiation) did not show any increase in amylasemia. This study seems to confirm reported data, which suggested that post-TBI hyperamylasemia is almost only related to salivary gland irradiation. Amylasemia could possibly be used as a "biological dosimeter"; however, the dose-effect relationship should be more precisely defined, as well as individual variations. Moreover, the definition of a "threshold-dose" below which hyperamylasemia can never be detected, would be of interest for radioprotection.

  20. Institutional Biosafety Committees and the Inadequacies of Risk Regulation.

    ERIC Educational Resources Information Center

    Bereano, Philip L.

    1984-01-01

    Discusses institutional biosafety committees (IBC) which provide quasi-independent reviews of recombinant DNA work done at an institution. Considers the nature of IBC operation, the National Institutes of Health "Guidelines for Recombinant DNA Research," the composition of IBCs, the intellectual content of IBC deliberations, and issues…

  1. 75 FR 2150 - National Institute of Dental & Craniofacial Research; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... Dental and Craniofacial Research Special Emphasis Panel; Review R13. Date: February 19, 2010. Time: 2 p.m...: Mary Kelly, Scientific Review Officer, Scientific Review Branch, National Inst. of Dental...

  2. 77 FR 31863 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... unwarranted invasion of personal privacy. Name of Committee: Heart, Lung, and Blood Initial Review Group...., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

  3. 78 FR 41941 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-12

    ... evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy...., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 759, 6707 Democracy... review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707...

  4. Concordant, non-atypical breast papillomas do not require surgical excision: A 10-year multi-institution study and review of the literature.

    PubMed

    Grimm, Lars J; Bookhout, Christine E; Bentley, Rex C; Jordan, Sheryl G; Lawton, Thomas J

    2018-05-01

    Non-atypical papillomas (NAPs) diagnosed on core needle biopsy (CNB) frequently undergo surgical excision due to highly variable upstaging rates. The purpose of this study is to document our dual-institution upgrade rates of NAPs diagnosed on core needle biopsy and review the upgrade rates reported in the literature. Following IRB approval, CNB results from Duke University (7/1/2004-6/30/2014) and the University of North Carolina Chapel Hill (1/1/04-6/30/2013) were reviewed to identify non-atypical papillomas. All cases with surgical excision or 2 years of imaging follow up were included. In addition, a literature review identified 60 published studies on upgrades of NAPs diagnosed at CNB. Cases in our cohort and the published literature were reviewed for confounding factors: [1] missing radiologic-pathologic concordance and/or discordance, [2] papillomas included with high-risk lesions, [3] high risk lesions counted as upgrades, [4] review by a nonspecialized breast pathologist, and [5] cancer incidentally detected. Of the 388 CNBs in our dual-institution cohort, 136 (35%) patients underwent surgical excision and 252 (65%) patients had imaging follow up. After controlling for confounders, no cancers (0/388) were found at surgical excision or during follow up imaging. The literature review upstaging rate was 4.0% (166/4157) but 1.8% (4/227) after excluding studies with confounders. The combined upstaging rate from the literature and this study was 0.6% (4/615). The upstaging rate for CNB diagnosed NAPs was 0% in our cohort and 0.6% overall after adjusting for confounders. This low rate does not warrant reflexive surgical excision and diagnostic imaging follow up should be discretionary. Copyright © 2018 Elsevier Inc. All rights reserved.

  5. 77 FR 59933 - National Human Genome Research Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research....D., Scientific Review Officer, Scientific Review Branch, National Human Genome Research Institute...

  6. The American University as a Civic Institution.

    ERIC Educational Resources Information Center

    Stanley, Manfred; And Others

    1989-01-01

    This Civic Arts Review issue contains an essay by Stanley Manfred titled "The American University as a Civic Institution" which identifies some of the features which have made the contemporary American university a civic institution with important civic functions, and identifies some of the societal contradictions which impede recognition and…

  7. 10 CFR 708.35 - How can a party obtain review by the Secretary of Energy of an appeal decision?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false How can a party obtain review by the Secretary of Energy of an appeal decision? 708.35 Section 708.35 Energy DEPARTMENT OF ENERGY DOE CONTRACTOR EMPLOYEE... Secretary of Energy of an appeal decision? (a) By the 30th day after receiving an appeal decision from the...

  8. 77 FR 47654 - National Institute on Drug Abuse; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-09

    ..., Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person.... Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience... review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001...

  9. Institution Morphisms

    NASA Technical Reports Server (NTRS)

    Goguen, Joseph; Rosu, Grigore; Norvig, Peter (Technical Monitor)

    2001-01-01

    Institutions formalize the intuitive notion of logical system, including both syntax and semantics. A surprising number of different notions of morphisim have been suggested for forming categories with institutions as objects, and a surprising variety of names have been proposed for them. One goal of this paper is to suggest a terminology that is both uniform and informative to replace the current rather chaotic nomenclature. Another goal is to investigate the properties and interrelations of these notions. Following brief expositions of indexed categories, twisted relations, and Kan extensions, we demonstrate and then exploit the duality between institution morphisms in the original sense of Goguen and Burstall, and the 'plain maps' of Meseguer, obtaining simple uniform proofs of completeness and cocompleteness for both resulting categories; because of this duality, we prefer the name 'comorphism' over 'plain map.' We next consider 'theoroidal' morphisms and comorphisims, which generalize signatures to theories, finding that the 'maps' of Meseguer are theoroidal comorphisms, while theoroidal morphisms are a new concept. We then introduce 'forward' and 'semi-natural' morphisms, and appendices discuss institutions for hidden algebra, universal algebra, partial equational logic, and a variant of order sorted algebra supporting partiality.

  10. 75 FR 14173 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-24

    ... and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Initial Review Group, Subcommittee J...

  11. 75 FR 71134 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-22

    ... and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Initial Review Group, Subcommittee J...

  12. 76 FR 17929 - National Institute on Aging; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging... unwarranted invasion of personal privacy. Name of Committee: National Institute on Aging Special Emphasis...: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201...

  13. 77 FR 1941 - National Institute on Aging; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-12

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging... personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel; GEMSSTAR. Date...: Rebecca J. Ferrell, Ph.D., Scientific Review Officer, National Institute on Aging, Gateway Building, Rm...

  14. 76 FR 3148 - National Institute on Aging; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging... personal privacy. Name of Committee: National Institute on Aging Initial Review Group; Biological Aging... applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212...

  15. 76 FR 57064 - National Institute on Aging; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-15

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging... personal privacy. Name of Committee: National Institute on Aging Initial Review Group, Clinical Aging... applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212...

  16. 77 FR 2737 - National Institute on Aging; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging... personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel; Development and....m. Agenda: To review and evaluate contract proposals. Place: National Institute on Aging, Gateway...

  17. 76 FR 5391 - National Institute on Aging; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging... personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel; Pepper Centers.... Markowska, PhD, DSC, Scientific Review Branch, National Institute on Aging, 7201 Wisconsin Avenue, Suite...

  18. 76 FR 9586 - National Institute of Mental Health; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-18

    ... review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001... Health, NIH, Neuroscience Center/Room 6138/MSC 9608, 6001 Executive Boulevard, Bethesda, MD 20892-9608.... Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience...

  19. 76 FR 34717 - National Institute of Mental Health; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-14

    ...: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center... Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6148, MSC 9609, Rockville, MD 20852-9609... review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001...

  20. 78 FR 9404 - National Institute of Mental Health; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-08

    .... Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience... of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6153, MSC 9608, Bethesda, MD.... Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience...

  1. 75 FR 63845 - National Institute of Mental Health; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-18

    .... Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience... of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6142, MSC 9606, Bethesda, MD... review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001...

  2. 78 FR 34662 - National Institute of Mental Health; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-10

    ... review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001... Health, NIH Neuroscience Center, 6001 Executive Boulevard, Room 6153, MSC 9606, Bethesda, MD 20892, 301.... Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience...

  3. 77 FR 60706 - National Human Genome Research Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special.... Nakamura, Ph.D., Scientific Review Officer, Scientific Review Branch, National Human Genome Research...

  4. 76 FR 65204 - National Human Genome Research Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome... Review Officer, Scientific Review Branch, National Human Genome Research Institute, 5635 Fishers Lane...

  5. 76 FR 2401 - National Institute of Mental Health; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-13

    .... Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience... Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6148, MSC 9609, Rockville, MD 20852-9609.... Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience...

  6. Digitizing dissertations for an institutional repository: a process and cost analysis.

    PubMed

    Piorun, Mary; Palmer, Lisa A

    2008-07-01

    This paper describes the Lamar Soutter Library's process and costs associated with digitizing 300 doctoral dissertations for a newly implemented institutional repository at the University of Massachusetts Medical School. Project tasks included identifying metadata elements, obtaining and tracking permissions, converting the dissertations to an electronic format, and coordinating workflow between library departments. Each dissertation was scanned, reviewed for quality control, enhanced with a table of contents, processed through an optical character recognition function, and added to the institutional repository. Three hundred and twenty dissertations were digitized and added to the repository for a cost of $23,562, or $0.28 per page. Seventy-four percent of the authors who were contacted (n = 282) granted permission to digitize their dissertations. Processing time per title was 170 minutes, for a total processing time of 906 hours. In the first 17 months, full-text dissertations in the collection were downloaded 17,555 times. Locally digitizing dissertations or other scholarly works for inclusion in institutional repositories can be cost effective, especially if small, defined projects are chosen. A successful project serves as an excellent recruitment strategy for the institutional repository and helps libraries build new relationships. Challenges include workflow, cost, policy development, and copyright permissions.

  7. Digitizing Dissertations for an Institutional Repository: A Process and Cost Analysis*

    PubMed Central

    Piorun, Mary; Palmer, Lisa A.

    2008-01-01

    Objective: This paper describes the Lamar Soutter Library's process and costs associated with digitizing 300 doctoral dissertations for a newly implemented institutional repository at the University of Massachusetts Medical School. Methodology: Project tasks included identifying metadata elements, obtaining and tracking permissions, converting the dissertations to an electronic format, and coordinating workflow between library departments. Each dissertation was scanned, reviewed for quality control, enhanced with a table of contents, processed through an optical character recognition function, and added to the institutional repository. Results: Three hundred and twenty dissertations were digitized and added to the repository for a cost of $23,562, or $0.28 per page. Seventy-four percent of the authors who were contacted (n = 282) granted permission to digitize their dissertations. Processing time per title was 170 minutes, for a total processing time of 906 hours. In the first 17 months, full-text dissertations in the collection were downloaded 17,555 times. Conclusion: Locally digitizing dissertations or other scholarly works for inclusion in institutional repositories can be cost effective, especially if small, defined projects are chosen. A successful project serves as an excellent recruitment strategy for the institutional repository and helps libraries build new relationships. Challenges include workflow, cost, policy development, and copyright permissions. PMID:18654648

  8. 77 FR 74675 - National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-17

    ... Person: Ruth Grossman, DDS, Scientific Review Officer, National Institute of Biomedical Imaging and... Person: Ruth Grossman, DDS, Scientific Review Officer, National Institute of Biomedical Imaging and...

  9. 77 FR 40367 - National Eye Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute... unwarranted invasion of personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel..., Washington, DC 20015. Contact Person: Daniel R. Kenshalo, Ph.D., Scientific Review Officer, National Eye...

  10. 76 FR 41273 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-13

    ... Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Commitee: National Cancer Institute Initial Review Group, Subcommittee A--Cancer...

  11. 75 FR 14172 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-24

    ... Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Initial Review Group...

  12. 75 FR 42449 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-21

    ... Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Initial Review Group; Subcommittee A--Cancer...

  13. 77 FR 53207 - National Institute on Aging; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging... personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel, Pepper Centers....D., DSC, Scientific Review Branch, National Institute on Aging, 7201 Wisconsin Avenue, Suite 2c212...

  14. 75 FR 35821 - National Institute On Aging; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute On Aging... personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel Member Conflict SEP...). Contact Person: Ramesh Vemuri, PhD, Chief, Scientific Review Branch, National Institute on Aging, National...

  15. 76 FR 35223 - National Human Genome Research Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special... Person: Rudy O. Pozzatti, PhD, Scientific Review Officer, Scientific Review Branch, National Human Genome...

  16. 78 FR 72093 - National Institute of Mental Health; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-02

    ... review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001... Neuroscience Center, 6001 Executive Blvd., Room 6140, MSC 9608, Bethesda, MD 20892-9608, 301-443-9734, millerda.... Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience...

  17. 76 FR 3148 - National Institute of Mental Health; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-19

    ... review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001... Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6142, MSC 9606, Bethesda, MD 20892-9606, 301.... Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience...

  18. 77 FR 59199 - National Institute of Nursing Research; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-26

    ... Nursing Research; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Nursing...: Mario Rinaudo, MD, Scientific Review Officer, Office of Review, National Institute of Nursing Research...

  19. 75 FR 52538 - National Human Genome Research Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special... Person: Ken D. Nakamura, PhD, Scientific Review Officer, Scientific Review Branch, National Human Genome...

  20. Laboratory productivity and the rate of manual peripheral blood smear review: a College of American Pathologists Q-Probes study of 95,141 complete blood count determinations performed in 263 institutions.

    PubMed

    Novis, David A; Walsh, Molly; Wilkinson, David; St Louis, Mary; Ben-Ezra, Jonathon

    2006-05-01

    Automated laboratory hematology analyzers are capable of performing differential counts on peripheral blood smears with greater precision and more accurate detection of distributional and morphologic abnormalities than those performed by manual examinations of blood smears. Manual determinations of blood morphology and leukocyte differential counts are time-consuming, expensive, and may not always be necessary. The frequency with which hematology laboratory workers perform manual screens despite the availability of labor-saving features of automated analyzers is unknown. To determine the normative rates with which manual peripheral blood smears were performed in clinical laboratories, to examine laboratory practices associated with higher or lower manual review rates, and to measure the effects of manual smear review on the efficiency of generating complete blood count (CBC) determinations. From each of 3 traditional shifts per day, participants were asked to select serially, 10 automated CBC specimens, and to indicate whether manual scans and/or reviews with complete differential counts were performed on blood smears prepared from those specimens. Sampling continued until a total of 60 peripheral smears were reviewed manually. For each specimen on which a manual review was performed, participants indicated the patient's age, hemoglobin value, white blood cell count, platelet count, and the primary reason why the manual review was performed. Participants also submitted data concerning their institutions' demographic profiles and their laboratories' staffing, work volume, and practices regarding CBC determinations. The rates of manual reviews and estimations of efficiency in performing CBC determinations were obtained from the data. A total of 263 hospitals and independent laboratories, predominantly located in the United States, participating in the College of American Pathologists Q-Probes Program. There were 95,141 CBC determinations examined in this study

  1. 75 FR 57965 - National Institute on Aging; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

    ...; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5... Vemuri, PhD, Chief, Scientific Review Branch, National Institute on Aging, National Institutes of Health..., Autophagy, Inflammaging and Immunosenescence. Date: October 14, 2010. Time: 1 p.m. to 5 p.m. Agen To review...

  2. 75 FR 42451 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-21

    ... Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory... and Alcoholism, Initial Review Group, Neuroscience Review Subcommittee. Date: November 2-3, 2010. Time..., Scientific Review Officer, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health...

  3. Research data management in academic institutions: A scoping review.

    PubMed

    Perrier, Laure; Blondal, Erik; Ayala, A Patricia; Dearborn, Dylanne; Kenny, Tim; Lightfoot, David; Reka, Roger; Thuna, Mindy; Trimble, Leanne; MacDonald, Heather

    2017-01-01

    The purpose of this study is to describe the volume, topics, and methodological nature of the existing research literature on research data management in academic institutions. We conducted a scoping review by searching forty literature databases encompassing a broad range of disciplines from inception to April 2016. We included all study types and data extracted on study design, discipline, data collection tools, and phase of the research data lifecycle. We included 301 articles plus 10 companion reports after screening 13,002 titles and abstracts and 654 full-text articles. Most articles (85%) were published from 2010 onwards and conducted within the sciences (86%). More than three-quarters of the articles (78%) reported methods that included interviews, cross-sectional, or case studies. Most articles (68%) included the Giving Access to Data phase of the UK Data Archive Research Data Lifecycle that examines activities such as sharing data. When studies were grouped into five dominant groupings (Stakeholder, Data, Library, Tool/Device, and Publication), data quality emerged as an integral element. Most studies relied on self-reports (interviews, surveys) or accounts from an observer (case studies) and we found few studies that collected empirical evidence on activities amongst data producers, particularly those examining the impact of research data management interventions. As well, fewer studies examined research data management at the early phases of research projects. The quality of all research outputs needs attention, from the application of best practices in research data management studies, to data producers depositing data in repositories for long-term use.

  4. Research data management in academic institutions: A scoping review

    PubMed Central

    Ayala, A. Patricia; Dearborn, Dylanne; Kenny, Tim; Lightfoot, David; Reka, Roger; Thuna, Mindy; Trimble, Leanne

    2017-01-01

    Objective The purpose of this study is to describe the volume, topics, and methodological nature of the existing research literature on research data management in academic institutions. Materials and methods We conducted a scoping review by searching forty literature databases encompassing a broad range of disciplines from inception to April 2016. We included all study types and data extracted on study design, discipline, data collection tools, and phase of the research data lifecycle. Results We included 301 articles plus 10 companion reports after screening 13,002 titles and abstracts and 654 full-text articles. Most articles (85%) were published from 2010 onwards and conducted within the sciences (86%). More than three-quarters of the articles (78%) reported methods that included interviews, cross-sectional, or case studies. Most articles (68%) included the Giving Access to Data phase of the UK Data Archive Research Data Lifecycle that examines activities such as sharing data. When studies were grouped into five dominant groupings (Stakeholder, Data, Library, Tool/Device, and Publication), data quality emerged as an integral element. Conclusion Most studies relied on self-reports (interviews, surveys) or accounts from an observer (case studies) and we found few studies that collected empirical evidence on activities amongst data producers, particularly those examining the impact of research data management interventions. As well, fewer studies examined research data management at the early phases of research projects. The quality of all research outputs needs attention, from the application of best practices in research data management studies, to data producers depositing data in repositories for long-term use. PMID:28542450

  5. 75 FR 14172 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-24

    ... Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI-CNP (U54) Review...

  6. Orbital exenteration: Institutional review of evolving trends in indications and rehabilitation techniques.

    PubMed

    Kiratli, Hayyam; Koç, İrem

    2018-06-01

    To determine the changes in indications for orbital exenteration over 20 years and to assess its impact on patient survival. Evolving techniques of rehabilitation of the orbit in our institution were also evaluated. This was a retrospective review of hospital records of patients who underwent orbital exenteration from 1995 to 2015 in a tertiary care center. Data extracted included primary location of the tumor, preoperative treatments, interval between initial diagnosis and exenteration, status of surgical margins, presence of metastatic disease, and postoperative survival. The types of prosthesis utilized over the years were also reviewed. Cox regression analysis was performed for categorical variables. Kaplan-Meier analysis was used to estimate post-exenteration survival. Over a 20-year period, orbital exenteration was performed on 100 orbits of 100 patients. The mean age was 39.4 years (range: 2 months to 90 years). The most common indications among 98 malignant causes were retinoblastoma, squamous cell carcinoma, basal cell carcinoma, extraocular extension of uveal melanoma, and conjunctival melanoma. Postoperative survival was significantly related to age and tumor location but independent from gender, surgical margin, histopathological diagnosis, previous treatment modality, and preoperative interval. In the whole cohort, 1-year and 5-year survival rates were 97% and 84%, respectively. Exenteration appears to be life-saving in children with orbital extension of retinoblastoma. While patients exenterated for malignant eyelid tumors have the best chance of survival, those with orbital extension of uveal melanoma and adenoid cystic carcinoma of the lacrimal gland have the worst prognosis.

  7. 75 FR 26968 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-13

    ...: Gerald G. Lovinger, PhD, Scientific Review Officer, Special Review and Logistics Branch, Division of...: To review and evaluate grant applications. Place: Legacy Hotel and Meeting Center, 1775 Rockville..., Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH...

  8. 78 FR 55750 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

    ..., Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of.... Contact Person: Caterina Bianco, MD, Ph.D., Scientific Review Officer, Research Programs Review Branch...: David G. Ransom, Ph.D., Scientific Review Officer, Research Programs Review Branch, Division of...

  9. Genealogical databases as a tool for extending follow-up in clinical reviews.

    PubMed

    Ho, Thuy-Van; Chowdhury, Naweed; Kandl, Christopher; Hoover, Cindy; Robinson, Ann; Hoover, Larry

    2016-08-01

    Long-term follow-up in clinical reviews often presents significant difficulty with conventional medical records alone. Publicly accessible genealogical databases such as Ancestry.com provide another avenue for obtaining extended follow-up and added outcome information. No previous studies have described the use of genealogical databases in the follow-up of individual patients. Ancestry.com, the largest genealogical database in the United States, houses extensive demographic data on an increasing number of Americans. In a recent retrospective review of esthesioneuroblastoma patients treated at our institution, we used this resource to ascertain the outcomes of patients otherwise lost to follow-up. Additional information such as quality of life and supplemental treatments the patient may have received at home was obtained through direct contact with living relatives. The use of Ancestry.com resulted in a 25% increase (20 months) in follow-up duration as well as incorporation of an additional 7 patients in our study (18%) who would otherwise not have had adequate hospital chart data for inclusion. Many patients within this subset had more advanced disease or were remotely located from our institution. As such, exclusion of these outliers can impact the quality of subsequent outcome analysis. Online genealogical databases provide a unique resource of public information that is acceptable to institutional review boards for patient follow-up in clinical reviews. Utilization of Ancestry.com data led to significant improvement in follow-up duration and increased the number of patients with sufficient data that could be included in our retrospective study. © 2016 ARS-AAOA, LLC.

  10. Ethical Dilemmas in Community-Based Participatory Research: Recommendations for Institutional Review Boards

    PubMed Central

    Travers, Robb; Guta, Adrian; McDonald, Sean; Meagher, Aileen

    2007-01-01

    National and international codes of research conduct have been established in most industrialized nations to ensure greater adherence to ethical research practices. Despite these safeguards, however, traditional research approaches often continue to stigmatize marginalized and vulnerable communities. Community-based participatory research (CBPR) has evolved as an effective new research paradigm that attempts to make research a more inclusive and democratic process by fostering the development of partnerships between communities and academics to address community-relevant research priorities. As such, it attempts to redress ethical concerns that have emerged out of more traditional paradigms. Nevertheless, new and emerging ethical dilemmas are commonly associated with CBPR and are rarely addressed in traditional ethical reviews. We conducted a content analysis of forms and guidelines commonly used by institutional review boards (IRBs) in the USA and research ethics boards (REBs) in Canada. Our intent was to see if the forms used by boards reflected common CBPR experience. We drew our sample from affiliated members of the US-based Association of Schools of Public Health and from Canadian universities that offered graduate public health training. This convenience sample (n = 30) was garnered from programs where application forms were available online for download between July and August, 2004. Results show that ethical review forms and guidelines overwhelmingly operate within a biomedical framework that rarely takes into account common CBPR experience. They are primarily focused on the principle of assessing risk to individuals and not to communities and continue to perpetuate the notion that the domain of “knowledge production” is the sole right of academic researchers. Consequently, IRBs and REBs may be unintentionally placing communities at risk by continuing to use procedures inappropriate or unsuitable for CBPR. IRB/REB procedures require a new framework

  11. The Design of Video Games in the Implementation of Malay Language Learning among Foreign Students in an Institution of Higher Learning

    ERIC Educational Resources Information Center

    Rosman, Fuziah; Alias, Norlidah; Rahman, Mohd Nazri Abdul; Dewitt, Dorothy

    2015-01-01

    This study aims at reviewing the curriculum design by including video games in the implementation of the Malay language course at an Institute of Higher Learning. The objective of this study is to obtain expert opinion on the expected manner of implementation of video games in learning the Malay language. The Fuzzy Delphi technique (FDM) is used…

  12. 75 FR 71711 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-24

    ... Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory... Alcohol Abuse and Alcoholism Initial Review Group; Neuroscience Review Subcommittee. Date: March 8-9, 2011..., Scientific Review Officer, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health...

  13. The Proposal Auto-Categorizer and Manager for Time Allocation Review at the Space Telescope Science Institute

    NASA Astrophysics Data System (ADS)

    Strolger, Louis-Gregory; Porter, Sophia; Lagerstrom, Jill; Weissman, Sarah; Reid, I. Neill; Garcia, Michael

    2017-04-01

    The Proposal Auto-Categorizer and Manager (PACMan) tool was written to respond to concerns about subjective flaws and potential biases in some aspects of the proposal review process for time allocation for the Hubble Space Telescope (HST), and to partially alleviate some of the anticipated additional workload from the James Webb Space Telescope (JWST) proposal review. PACMan is essentially a mixed-method Naive Bayesian spam filtering routine, with multiple pools representing scientific categories, that utilizes the Robinson method for combining token (or word) probabilities. PACMan was trained to make similar programmatic decisions in science category sorting, panelist selection, and proposal-to-panelists assignments to those made by individuals and committees in the Science Policies Group (SPG) at the Space Telescope Science Institute. Based on training from the previous cycle’s proposals, at an average of 87%, PACMan made the same science category assignments for proposals in Cycle 24 as the SPG. Tests for similar science categorizations, based on training using proposals from additional cycles, show that this accuracy can be further improved, to the > 95 % level. This tool will be used to augment or replace key functions in the Time Allocation Committee review processes in future HST and JWST cycles.

  14. 75 FR 44274 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... Cancer Institute Special Emphasis Panel, Nanotechnology Imaging and Sensing Platforms for Improved Diagnosis of Cancer. Date: August 31, 2010. Time: 12 p.m. to 1:30 p.m. Agenda: To review and evaluate...

  15. 76 FR 577 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; Therapeutic Strategies for Cancer. Date: February 2-4, 2011. Time: 3 p.m. to 5 p.m. Agenda: To review and evaluate grant...

  16. FACULTY PUBLICATIONS OF THE INSTITUTE FOR RESEARCH ON EXCEPTIONAL CHILDREN.

    ERIC Educational Resources Information Center

    Illinois Univ., Urbana. Inst. of Research for Exceptional Children.

    THE PUBLICATIONS OF EACH OF 14 FACULTY MEMBERS OF THE INSTITUTE FOR RESEARCH ON EXCEPTIONAL CHILDREN ARE LISTED BY TYPE OF PUBLICATION, THAT IS, JOURNAL ARTICLES, BOOK REVIEWS, BOOKS, AND MONOGRAPHS. ALSO INCLUDED ARE OTHER PUBLICATIONS OF THE INSTITUTE AND DOCTORAL DISSERTATIONS SUPPORTED BY THE INSTITUTE. (CG)

  17. 77 FR 12599 - National Institute of Nursing Research; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-01

    ... Nursing Research; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act... unwarranted invasion of personal privacy. Name of Committee: National Institute of Nursing Research Special... Review Officer, Office of Review, National Inst of Nursing Research, National Institutes of Health, 6701...

  18. The impact of Cochrane Systematic Reviews: a mixed method evaluation of outputs from Cochrane Review Groups supported by the UK National Institute for Health Research.

    PubMed

    Bunn, Frances; Trivedi, Daksha; Alderson, Phil; Hamilton, Laura; Martin, Alice; Iliffe, Steve

    2014-10-27

    There has been a growing emphasis on evidence-informed decision-making in health care. Systematic reviews, such as those produced by the Cochrane Collaboration, have been a key component of this movement. The UK National Institute for Health Research (NIHR) Systematic Review Programme currently supports 20 Cochrane Review Groups (CRGs). The aim of this study was to identify the impacts of Cochrane reviews published by NIHR-funded CRGs during the years 2007-2011. We sent questionnaires to CRGs and review authors, interviewed guideline developers and used bibliometrics and documentary review to get an overview of CRG impact and to evaluate the impact of a sample of 60 Cochrane reviews. We used a framework with four categories (knowledge production, research targeting, informing policy development and impact on practice/services). A total of 1,502 new and updated reviews were produced by the 20 NIHR-funded CRGs between 2007 and 2011. The clearest impacts were on policy with a total of 483 systematic reviews cited in 247 sets of guidance: 62 were international, 175 national (87 from the UK) and 10 local. Review authors and CRGs provided some examples of impact on practice or services, for example, safer use of medication, the identification of new effective drugs or treatments and potential economic benefits through the reduction in the use of unproven or unnecessary procedures. However, such impacts are difficult to objectively document, and the majority of reviewers were unsure if their review had produced specific impacts. Qualitative data suggested that Cochrane reviews often play an instrumental role in informing guidance, although a poor fit with guideline scope or methods, reviews being out of date and a lack of communication between CRGs and guideline developers were barriers to their use. Health and economic impacts of research are generally difficult to measure. We found that to be the case with this evaluation. Impacts on knowledge production and clinical

  19. Institutional Elderly Care Services and Moroccan and Turkish Migrants in Belgium: A Literature Review.

    PubMed

    Ahaddour, Chaïma; van den Branden, Stef; Broeckaert, Bert

    2016-10-01

    In several European countries, including Belgium, the rapid ageing of the migrant population has emerged only recently on the political agenda. The aim of this literature review is threefold. Firstly, it provides a review of the available studies on the accessibility and use of institutional care services by Moroccan and Turkish migrants in the Flemish part of Belgium including Flanders and Brussels. Secondly, it identifies their specific needs regarding elderly care services. Finally, it provides an overview of the way in which Belgian policy has dealt with the issue of migration and elderly care. Literature published between 1965 and 2014 and relevant to the Belgian context has been included. This search yielded 21 references, of which 8 empirical studies, 5 policy literature, 3 theoretical studies, 3 news articles and 2 popularized reports. Mainstream elderly care remains relatively inaccessible for these migrants due to the language and a series of cultural and religious barriers, a low level of education, financial constraints, a lack of knowledge of health care systems, and the so-called return and care dilemmas. Their religious and cultural needs are currently not met by elderly care services. The inclusive and neutral Belgian policy seems to pay insufficient attention to these issues.

  20. Reuse of samples: ethical issues encountered by two institutional ethics review committees in Kenya.

    PubMed

    Langat, Simon K

    2005-10-01

    There is growing concern about the reuse and exploitation of biological materials (human tissues) for use in research worldwide. Most discussions about samples have taken place in developed countries, where genetic manipulation techniques have greatly advanced in recent years. There is very little discussion in developing countries, although collaborative research with institutions from developed countries is on the increase. The study sought to identify and describe ethical issues arising in the storage, reuse and exportation of samples in a developing country. Research protocols presented to two Ethics Review Committees in Kenya during a period of two years were reviewed. A record was made of the protocol title, sample collected, request for storage, reuse or exportation and whether or not subject consent was sought. The findings indicated that about 25% out of the 388 protocols sought permission for reuse and only half of those actually informed subjects of the contemplated re-use. Less than 20% requested storage and again, about half of them sought consent from subjects. There is an indication that investigators do not see the need to seek consent for storage, reuse and exportation of samples. It is proposed that these issues should be addressed through policy interventions at both the national and global levels.

  1. 75 FR 22411 - National Institute of Mental Health; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-28

    ... Committee: National Institute of Mental Health Initial Review Group; Interventions Committee for Disorders... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Mental Health...

  2. 76 FR 23826 - National Institute of Mental Health; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-28

    ... Committee: National Institute of Mental Health Initial Review Group; Interventions Committee for Disorders... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental... unwarranted invasion of personal privacy. Name of Committee: National Institute of Mental Health Initial...

  3. 78 FR 28599 - National Institute of Mental Health; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-15

    ... Institute of Mental Health Initial Review Group; Interventions Committee for Disorders Involving Children... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental... unwarranted invasion of personal privacy. Name of Committee: National Institute of Mental Health Initial...

  4. 75 FR 53703 - National Human Genome Research Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome..., Scientific Review Branch, National Human Genome Research Institute, National Institutes of Health, 5635.... (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of...

  5. 77 FR 71604 - National Human Genome Research Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-03

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special..., Scientific Review Branch, National Human Genome Research Institute, National Institutes of Health, 5635...

  6. 76 FR 11799 - National Institute of Mental Health; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-03

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Mental Health..., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH...

  7. 75 FR 68612 - National Institute of Mental Health; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental... unwarranted invasion of personal privacy. Name of Committee: National Institute of Mental Health Special... Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience...

  8. 78 FR 45933 - National Institute of Mental Health; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Mental Health...., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH...

  9. 75 FR 12243 - National Institute of Mental Health; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-15

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental... unwarranted invasion of personal privacy. Name of Committee: National Institute of Mental Health Special... Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience...

  10. 77 FR 11139 - National Institute of Mental Health Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental... unwarranted invasion of personal privacy. Name of Committee: National Institute of Mental Health Special...., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH...

  11. 75 FR 8372 - National Institute of Mental Health; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental... unwarranted invasion of personal privacy. Name of Committee: National Institute of Mental Health Special... Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience...

  12. 78 FR 54477 - National Institute of Mental Health; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental... unwarranted invasion of personal privacy. Name of Committee: National Institute of Mental Health Initial...., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health National...

  13. 76 FR 16798 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-25

    ... Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory... Alcoholism Initial Review Group; Neuroscience Review Subcommittee. Date: June 9-10, 2011. Time: 8:30 a.m. to..., Scientific Review Officer, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health...

  14. Factors associated with institutional delivery service utilization in Ethiopia.

    PubMed

    Kebede, Alemi; Hassen, Kalkidan; Nigussie Teklehaymanot, Aderajew

    2016-01-01

    Most obstetric complications occur unpredictably during the time of delivery, but they can be prevented with proper medical care in the health facilities. Despite the Ethiopian government's efforts to expand health service facilities and promote health institution-based delivery service in the country, an estimated 85% of births still take place at home. The review was conducted with the aim of generating the best evidence on the determinants of institutional delivery service utilization in Ethiopia. The reviewed studies were accessed through electronic web-based search strategy from PubMed, HINARI, Mendeley reference manager, Cochrane Library for Systematic Reviews, and Google Scholar. Review Manager V5.3 software was used for meta-analysis. Mantel-Haenszel odds ratios (ORs) and their 95% confidence intervals (CIs) were calculated. Heterogeneity of the study was assessed using I (2) test. People living in urban areas (OR =13.16, CI =1.24, 3.68), with primary and above educational level of the mother and husband (OR =4.95, CI =2.3, 4. 8, and OR =4.43, CI =1.14, 3.36, respectively), who encountered problems during pregnancy (OR =2.83, CI =4.54, 7.39), and living at a distance <5 km from nearby health facility (OR =2.6, CI =3.33, 6.57) showed significant association with institutional delivery service utilization. Women's autonomy was not significantly associated with institutional delivery service utilization. Distance to health facility and problems during pregnancy were factors positively and significantly associated with institutional delivery service utilization. Promoting couples education beyond primary education regarding the danger signs of pregnancy and benefits of institutional delivery through available communication networks such as health development army and promotion of antenatal care visits and completion of four standard visits by pregnant women were recommended.

  15. Factors associated with institutional delivery service utilization in Ethiopia

    PubMed Central

    Kebede, Alemi; Hassen, Kalkidan; Nigussie Teklehaymanot, Aderajew

    2016-01-01

    Background Most obstetric complications occur unpredictably during the time of delivery, but they can be prevented with proper medical care in the health facilities. Despite the Ethiopian government’s efforts to expand health service facilities and promote health institution-based delivery service in the country, an estimated 85% of births still take place at home. Objective The review was conducted with the aim of generating the best evidence on the determinants of institutional delivery service utilization in Ethiopia. Methods The reviewed studies were accessed through electronic web-based search strategy from PubMed, HINARI, Mendeley reference manager, Cochrane Library for Systematic Reviews, and Google Scholar. Review Manager V5.3 software was used for meta-analysis. Mantel–Haenszel odds ratios (ORs) and their 95% confidence intervals (CIs) were calculated. Heterogeneity of the study was assessed using I2 test. Results People living in urban areas (OR =13.16, CI =1.24, 3.68), with primary and above educational level of the mother and husband (OR =4.95, CI =2.3, 4. 8, and OR =4.43, CI =1.14, 3.36, respectively), who encountered problems during pregnancy (OR =2.83, CI =4.54, 7.39), and living at a distance <5 km from nearby health facility (OR =2.6, CI =3.33, 6.57) showed significant association with institutional delivery service utilization. Women’s autonomy was not significantly associated with institutional delivery service utilization. Conclusion and recommendation Distance to health facility and problems during pregnancy were factors positively and significantly associated with institutional delivery service utilization. Promoting couples education beyond primary education regarding the danger signs of pregnancy and benefits of institutional delivery through available communication networks such as health development army and promotion of antenatal care visits and completion of four standard visits by pregnant women were recommended. PMID:27672342

  16. Literature review on production process to obtain extra virgin olive oil enriched in bioactive compounds. Potential use of byproducts as alternative sources of polyphenols.

    PubMed

    Frankel, Edwin; Bakhouche, Abdelhakim; Lozano-Sánchez, Jesús; Segura-Carretero, Antonio; Fernández-Gutiérrez, Alberto

    2013-06-05

    This review describes the olive oil production process to obtain extra virgin olive oil (EVOO) enriched in polyphenol and byproducts generated as sources of antioxidants. EVOO is obtained exclusively by mechanical and physical processes including collecting, washing, and crushing of olives, malaxation of olive paste, centrifugation, storage, and filtration. The effect of each step is discussed to minimize losses of polyphenols from large quantities of wastes. Phenolic compounds including phenolic acids, alcohols, secoiridoids, lignans, and flavonoids are characterized in olive oil mill wastewater, olive pomace, storage byproducts, and filter cake. Different industrial pilot plant processes are developed to recover phenolic compounds from olive oil byproducts with antioxidant and bioactive properties. The technological information compiled in this review will help olive oil producers to improve EVOO quality and establish new processes to obtain valuable extracts enriched in polyphenols from byproducts with food ingredient applications.

  17. Accrediting osteopathic postdoctoral training institutions.

    PubMed

    Duffy, Thomas

    2011-04-01

    All postdoctoral training programs approved by the American Osteopathic Association are required to be part of an Osteopathic Postdoctoral Training Institution (OPTI) consortium. The author reviews recent activities related to OPTI operations, including the transfer the OPTI Annual Report to an electronic database, revisions to the OPTI Accreditation Handbook, training at the 2010 OPTI Workshop, and new requirements of the American Osteopathic Association Commission on Osteopathic College Accreditation. The author also reviews the OPTI accreditation process, cites common commendations and deficiencies for reviews completed from 2008 to 2010, and provides an overview of plans for future improvements.

  18. 78 FR 28235 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

    ... Basal- like Breast Cancer. Date: June 13, 2013. Time: 12:00 p.m. to 1:00 p.m. Agenda: To review and... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel, Novel Imaging Agents...

  19. 77 FR 12318 - National Eye Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute... unwarranted invasion of personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel; NEI Anterior Eye Disease. Date: March 19, 2012. Time: 1 p.m. to 2:30 p.m. Agenda: To review and...

  20. 75 FR 20853 - National Eye Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute... unwarranted invasion of personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel, Immunosuppression for Eye Diseases. Date: April 20, 2010. Time: 3 p.m. to 4 p.m. Agenda: To review and evaluate...

  1. 77 FR 67015 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel NCI Omnibus and Cancer Therapy. Date: November 14-15, 2012. Time: 2:00 p.m. to 5:00 p.m. Agenda: To review and evaluate...

  2. 75 FR 80510 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute... personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; Novel Digital X-ray Sources for Cancer Imaging Applications. Date: January 11, 2011. Time: 11 a.m. to 3 p.m. Agenda: To review...

  3. 75 FR 16816 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-02

    ... personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel, NCI SPORE in Skin and Prostate Cancers. Date: June 15-16, 2010. Time: 4 p.m. to 5 p.m. Agenda: To review and evaluate... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute...

  4. 75 FR 4829 - National Institute on Aging; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-29

    ... Institute on Aging Special Emphasis Panel; Summer Research Training In Aging For Medical Students--NIA T35... review and evaluate contract proposals. Place: National Institute on Aging, Gateway Building, 7201..., Aging Research, National Institutes of Health, HHS) [[Page 4830

  5. 76 FR 28056 - National Human Genome Research Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-13

    ... Research Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee... clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Initial Review Group, Genome Research Review Committee. Date: June 2, 2011. Time: 11:30 a.m. to 3...

  6. Reviewing Institutional Policies for Electronic Management of Assessment

    ERIC Educational Resources Information Center

    Voce, Julie

    2015-01-01

    Electronic assignment submission (e-submission) tools, such as those within course management systems (e.g. Blackboard), or systems such as Turnitin, which enable students to submit coursework online are now one of the main centrally supported institutional tools in Higher Education (HE) in the United Kingdom (UK), however the development of…

  7. 75 FR 67380 - National Human Genome Research Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... Review Branch, National Human Genome Research Institute, National Institutes of Health, 5635 Fishers Lane.... (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of...

  8. Characteristics and determinants of knowledge transfer policies at universities and public institutions in medical research--protocol for a systematic review of the qualitative research literature.

    PubMed

    Jahn, Rosa; Müller, Olaf; Bozorgmehr, Kayvan

    2015-08-19

    Universities, public institutions, and the transfer of knowledge to the private sector play a major role in the development of medical technologies. The decisions of universities and public institutions regarding the transfer of knowledge impact the accessibility of the final product, making it easier or more difficult for consumers to access these products. In the case of medical research, these products are pharmaceuticals, diagnostics, or medical procedures. The ethical dimension of access to these potentially lifesaving products is apparent and distinguishes the transfer of medical knowledge from the transfer of knowledge in other areas. While the general field of technology transfer from academic and public to private actors is attracting an increasing amount of scholarly attention, the specifications of knowledge transfer in the medical field are not as well explored. This review seeks to provide a systematic overview and analysis of the qualitative literature on the characteristics and determinants of knowledge transfer in medical research and development. The review systematically searches the literature for qualitative studies that focus on knowledge transfer characteristics and determinants at medical academic and public research institutions. It aims at identifying and analyzing the literature on the content and context of knowledge transfer policies, decision-making processes, and actors at academic and public institutions. The search strategy includes the databases PubMed, Web of Science, ProQuest, and DiVa. These databases will be searched based on pre-specified search terms. The studies selected for inclusion in the review will be critically assessed for their quality utilizing the Qualitative Research Checklist developed by the Clinical Appraisal Skills Programme. Data extraction and synthesis will be based on the meta-ethnographic approach. This review seeks to further the understanding of the kinds of transfer pathways that exist in medical

  9. Kenya's Harambee Institutes of Technology.

    ERIC Educational Resources Information Center

    Kintzer, Frederick C.

    1989-01-01

    Reviews the history and current status of the Harambee Institutes of Technology in Kenya. Offers a critique of the parallel vocationalized system. Discusses the vocational-technical/general education controversy, diversification among types of schools, financing, and the 8-4-4 Plan. (DMM)

  10. 75 FR 52537 - National Human Genome Research Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-26

    ... Research Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Initial Review Group; Genome Research Review Committee. Date: October 29, 2010. Time: 3 p.m. to 6 p.m. Agenda: To...

  11. 75 FR 2148 - National Human Genome Research Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-14

    ... Research Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Initial Review Group, Genome Research Review Committee. Date: March 4, 2010. Time: 12 p.m. to 5 p.m. Agenda: To...

  12. The Emerging Chinese Institutional Architecture in Higher Education

    ERIC Educational Resources Information Center

    Lo, William Yat Wai

    2014-01-01

    The article reviews the global landscape of higher education with the anticipation of an emerging Chinese institutional architecture in Asia-Pacific higher education. It starts with a theoretical framework for analyzing the functionalities of values and institutions in international higher education by adopting Joseph Nye's concept of soft power.…

  13. Strategies to Promote Sustainability in Higher Education Institutions

    ERIC Educational Resources Information Center

    Berchin, Issa Ibrahim; Grando, Vanessa dos Santos; Marcon, Gabriela Almeida; Corseuil, Louise; Guerra, José Baltazar Salgueirinho Osório de Andrade

    2017-01-01

    Purpose: This paper aims to analyze strategies that promote sustainability in higher education institutions (HEIs), focusing on the case study of a federal institute of higher education in Brazil. Design/methodology/approach: The research was based on a scientific literature review on sustainability in HEIs, to identify the recurrent actions for…

  14. 76 FR 10911 - National Institute of General Medical Sciences; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-28

    ... General Medical Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory... Sciences Special Emphasis Panel; Review of Minority Biomedical Research Support Applications. Date: March... Review, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive...

  15. 77 FR 67827 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-14

    ... Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: William J. Johnson, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701... Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Research Centers at Minority...

  16. 77 FR 12859 - National Institute of Neurological Disorders and Stroke Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of...: A Blueprint for Transforming Prevention, Care, Education, and Research and a review of information... Blueprint for Transforming Prevention, Care, Education, and Research and a review of information gathered on...

  17. 75 FR 4092 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood..., Scientific Review Officer, Review Branch/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge...

  18. 75 FR 5090 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood... Review Officer, Review Branch/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room...

  19. 77 FR 10538 - National Heart, Lung, and Blood Institute Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood...., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

  20. 78 FR 52937 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special... Wohler Sunnarborg, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National, Heart...

  1. 78 FR 42529 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special... Wohler Sunnarborg, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National, Heart...

  2. 77 FR 18252 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood... Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

  3. 77 FR 9670 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood...., Scientific Review Officer, Review Branch/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge...

  4. 76 FR 11253 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood..., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

  5. 77 FR 60705 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood...., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

  6. 77 FR 16843 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood... Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

  7. 78 FR 8155 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-05

    ...; NCI Omnibus Cancer Biology 1. Date: March 11-12, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review..., Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH..., MD, Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities...

  8. 75 FR 21640 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ..., Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, 6116....D., PhD, Scientific Review Officer, Research Programs Review Branch, Division of Extramural... & Tissue Biology P01. Date: May 26-28, 2010. Time: 5 p.m. to 5 p.m. Agenda: To review and evaluate grant...

  9. The impact of Cochrane Reviews: a mixed-methods evaluation of outputs from Cochrane Review Groups supported by the National Institute for Health Research.

    PubMed

    Bunn, Frances; Trivedi, Daksha; Alderson, Phil; Hamilton, Laura; Martin, Alice; Pinkney, Emma; Iliffe, Steve

    2015-04-01

    The last few decades have seen a growing emphasis on evidence-informed decision-making in health care. Systematic reviews, such as those produced by Cochrane, have been a key component of this movement. The National Institute for Health Research (NIHR) Systematic Review Programme currently supports 20 Cochrane Review Groups (CRGs) in the UK and it is important that this funding represents value for money. The overall aim was to identify the impacts and likely impacts on health care, patient outcomes and value for money of Cochrane Reviews published by 20 NIHR-funded CRGs during the years 2007-11. We sent questionnaires to CRGs and review authors, undertook interviews with guideline developers (GDs) and used bibliometrics and documentary review to get an overview of CRG impact and to evaluate the impact of a sample of 60 Cochrane Reviews. The evaluation was guided by a framework with four categories (knowledge production, research targeting, informing policy development and impact on practice/services). A total of 3187 new and updated reviews were published on the Cochrane Database of Systematic Reviews between 2007 and 2011, 1502 (47%) of which were produced by the 20 CRGs funded by the NIHR. We found 40 examples where reviews appeared to have influenced primary research and reviews had contributed to the creation of new knowledge and stimulated debate. Twenty-seven of the 60 reviews had 100 or more citations in Google Scholar™ (Google, CA, USA). Overall, 483 systematic reviews had been cited in 247 sets of guidance. This included 62 sets of international guidance, 175 sets of national guidance (87 from the UK) and 10 examples of local guidance. Evidence from the interviews suggested that Cochrane Reviews often play an instrumental role in informing guidance, although reviews being a poor fit with guideline scope or methods, reviews being out of date and a lack of communication between CRGs and GDs were barriers to their use. Cochrane Reviews appeared to have led

  10. Primary intracranial soft tissue sarcomas in children, adolescents, and young adults: single institution experience and review of the literature.

    PubMed

    Maher, Ossama M; Khatua, Soumen; Mukherjee, Devashis; Olar, Adriana; Lazar, Alexander; Luthra, Raja; Liu, Diane; Wu, Jimin; Ketonen, Leena; Zaky, Wafik

    2016-03-01

    There is a paucity of literature reporting the outcome of intracranial sarcomas (IS) in children, adolescents, and young adults (CAYA). A multimodal therapeutic approach is commonly used, with no well-established treatment consensus. We conducted a retrospective review of CAYA with IS, treated at our institution, to determine their clinical findings, treatments, and outcomes. Immunohistochemistry (PDGFRA and EGFR) and DNA sequencing were performed on 5 tumor samples. A literature review of IS was also conducted. We reviewed 13 patients (median age, 7 years) with a primary diagnosis of IS between 1990 and 2015. Diagnoses included unclassified sarcoma (n = 9), chondrosarcoma (n = 2), and rhabdomyosarcoma (n = 2). Five patients underwent upfront gross total resection (GTR) of the tumor. The 5-drug regimen (vincristine, doxorubicin, cyclophosphamide, etoposide, and ifosfamide) was the most common treatment used. Nine patients died due to progression or recurrence (n = 8) or secondary malignancy (n = 1). The median follow-up period of the 4 surviving patients was 1.69 years (range 1.44-5.17 years). The 5-year progression-free survival and overall survival rates were 21 and 44 %, respectively. BRAF, TP53, KRAS, KIT, ERBB2, MET, RET, ATM, and EGFR mutations were detected in 4 of the 5 tissue samples. All 5 samples were immunopositive for PDGFRA, and only 2 were positive for EGFR. IS remain a therapeutic challenge due to high progression and recurrence rates. Collaborative multi-institutional studies are warranted to delineate a treatment consensus and investigate tumor biology to improve the disease outcome.

  11. The Limits of Institutional Reflexivity in Bulgarian Universities

    ERIC Educational Resources Information Center

    Slantcheva, Snejana

    2004-01-01

    This article focuses on the notion of institutional reflexivity. Its theoretical framework is based on the views of a group of sociologists--Anthony Giddens, Ulrich Beck, Scott Lash--who developed the concept of reflexive modernization. The article applies the notion of institutional reflexivity to the field of higher education and reviews the…

  12. 78 FR 66370 - National Institute of General Medical Sciences; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-05

    ... General Medical Sciences; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory... Sciences Special Emphasis Panel; Peer Review of SCORE Grant Applications. Date: November 15, 2013. Time: 8... Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes...

  13. 77 FR 59200 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-26

    ... Blood Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee... clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood... Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

  14. 75 FR 61507 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... Blood Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee... clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood... Kim, PhD, Scientific Review Officer, Review Branch, DERA, National Heart, Lung, and Blood Institute...

  15. 77 FR 43099 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-23

    ... Blood Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee... clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood...., Scientific Review Officer, Review Branch/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge...

  16. 75 FR 8085 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

    ... Blood Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee... clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood... Johnson, PhD, Scientific Review Officer, Review Branch/DERA, National Heart, Lung, and Blood Institute...

  17. 76 FR 27068 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-10

    ... Blood Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee... clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood... Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

  18. 77 FR 6571 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-08

    ... Blood Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee... clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood... Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

  19. 77 FR 14533 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-12

    ... Blood Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee... clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood... Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

  20. 77 FR 43098 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-23

    ... Blood Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee... clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood... Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701...

  1. 75 FR 26762 - National Institute of Dental & Craniofacial Research; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-12

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... Dental and Craniofacial Research Special Emphasis Panel; RFA (DE-10-003). Date: June 7, 2010. Time: 8:30..., Scientific Review Officer, Scientific Review Branch, National Inst of Dental & Craniofacial Research...

  2. 76 FR 5183 - National Institute of Dental & Craniofacial Research; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental & Craniofacial Research; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act.... Krishnaraju, PhD, MS, Scientific Review Officer, Scientific Review Branch, National Inst. of Dental...

  3. 77 FR 69870 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... unwarranted invasion of personal privacy. Name of Committee: Heart, Lung, and Blood Initial Review Group... Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7196, Bethesda, MD...

  4. 78 FR 66031 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special... Pintucci, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and...

  5. 78 FR 32408 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... unwarranted invasion of personal privacy. Name of Committee: Heart, Lung, and Blood Initial Review Group NHLBI... Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive...

  6. 78 FR 60299 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... unwarranted invasion of personal privacy. Name of Committee: Heart, Lung, and Blood Initial Review Group..., Office of Scientific Review/DERA National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room...

  7. The quality of reports of medical and public health research from Palestinian institutions: a systematic review

    PubMed Central

    Abu-Rmeileh, Niveen ME; Elessi, Khamis; Obeidallah, Mohammad; Bjertness, Espen; Chalmers, Iain

    2017-01-01

    Objective Over the past decade, there has been an increase in reports of health research from Palestine, but no assessment of their quality. We have assessed the quality of reports of Palestinian health research and factors associated with it. Design This is a systematic review. Inclusion criteria We searched Medline and Scopus for reports of original research relevant to human health or healthcare authored by researchers affiliated with Palestinian institutions and published between January 2000 and August 2015 inclusive. Outcomes We used international guidelines to assess report quality, classifying as adequate those with ≥50% of items completely addressed. Results Of 2383 reports identified, 497 met our inclusion criteria. Just over half (264; 55%) of these were published after 2010. 354 (71%) of first authors were affiliated with Palestinian institutions; 261 (53%) reports had coauthors from outside Palestine. The majority of the reports in our study were inadequately reported (342; 69%), and none had adequately reported all items. Of 439 observational studies, 11 (2.5%) reports provided adequate descriptions of eligibility criteria and selection procedures; 35 (8%) reported efforts to address potential sources of bias; 50 (11.4%) reported the basis for the study sample size; and funding sources were mentioned in 74 reports (17%). Higher reporting quality was associated with international affiliation of the first author (prevalence ratio (PR) 1.6 (95% CI 1.2 to 2.1)), international collaboration (PR 2.9 (95% CI 1.7 to 5.0)), international funding (PR 1.9 (95% CI1.5 to 2.5)), publication after 2005 (PR 3.9 (95% CI 1.8 to 8.5)) and four or more coauthors (PR 1.5 (95% CI 1.1 to 2.1)). Conclusion Although the quality of reports of Palestinian research has improved in recent years, it remains well below an acceptable standard. International reporting guidelines should be used to guide research design and improve the quality of reports of research. Trial

  8. The quality of reports of medical and public health research from Palestinian institutions: a systematic review.

    PubMed

    Albarqouni, Loai; Abu-Rmeileh, Niveen Me; Elessi, Khamis; Obeidallah, Mohammad; Bjertness, Espen; Chalmers, Iain

    2017-06-09

    Over the past decade, there has been an increase in reports of health research from Palestine, but no assessment of their quality. We have assessed the quality of reports of Palestinian health research and factors associated with it. This is a systematic review. We searched Medline and Scopus for reports of original research relevant to human health or healthcare authored by researchers affiliated with Palestinian institutions and published between January 2000 and August 2015 inclusive. We used international guidelines to assess report quality, classifying as adequate those with ≥50% of items completely addressed. Of 2383 reports identified, 497 met our inclusion criteria. Just over half (264; 55%) of these were published after 2010. 354 (71%) of first authors were affiliated with Palestinian institutions; 261 (53%) reports had coauthors from outside Palestine. The majority of the reports in our study were inadequately reported (342; 69%), and none had adequately reported all items. Of 439 observational studies, 11 (2.5%) reports provided adequate descriptions of eligibility criteria and selection procedures; 35 (8%) reported efforts to address potential sources of bias; 50 (11.4%) reported the basis for the study sample size; and funding sources were mentioned in 74 reports (17%). Higher reporting quality was associated with international affiliation of the first author (prevalence ratio (PR) 1.6 (95% CI 1.2 to 2.1)), international collaboration (PR 2.9 (95% CI 1.7 to 5.0)), international funding (PR 1.9 (95% CI1.5 to 2.5)), publication after 2005 (PR 3.9 (95% CI 1.8 to 8.5)) and four or more coauthors (PR 1.5 (95% CI 1.1 to 2.1)). Although the quality of reports of Palestinian research has improved in recent years, it remains well below an acceptable standard. International reporting guidelines should be used to guide research design and improve the quality of reports of research. The systematic review protocol was registered in the International Prospective

  9. 76 FR 5594 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-01

    ... National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Initial Review Group, Developmental Biology Subcommittee... Review, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6100...

  10. 77 FR 61418 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-09

    ... National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Initial Review Group Function, Integration, and... Review, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6100...

  11. 78 FR 28234 - National Cancer Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

    ...: Caterina Bianco, MD, Ph.D., Scientific Review Officer, Research Programs Review Branch, Division of... Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute....396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399...

  12. 75 FR 70273 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ... unwarranted invasion of personal privacy. Name of Committee: Heart, Lung, and Blood Initial Review Group... Blood Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee... Officer, Review Branch/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7196...

  13. 75 FR 29356 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-25

    ... unwarranted invasion of personal privacy. Name of Committee: Heart, Lung, and Blood Initial Review Group... Blood Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee... Officer, Review Branch/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7196...

  14. 75 FR 36101 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-24

    ... National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Special Emphasis Panel Slack and Slick Channels. Date: July..., PhD, Scientific Review Administrator, Division of Scientific Review, National Institute of Child...

  15. 75 FR 36100 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-24

    ... National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Special Emphasis Panel National Childrens Study. Date: July..., Scientific Review Administrator, Division of Scientific Review, National Institute of Child Health and Human...

  16. 76 FR 12125 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-04

    ... National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Special Emphasis Panel; Corpus Luteal Contribution to...., Scientific Review Officer, Division of Scientific Review, Eunice Kennedy Shriver National Institute of Child...

  17. 75 FR 26761 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-12

    ... National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Special Emphasis Panel; Asymmetric Robotic Gait Training and... Review Administrator, Division of Scientific Review, National Institute of Child Health and Human...

  18. 75 FR 26761 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-12

    ... National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Special Emphasis Panel; Experimental Research on the Effects..., PhD, Scientific Review Administrator, Division of Scientific Review, National Institute of Child...

  19. 77 FR 34394 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-11

    ... National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Initial Review Group, Obstetrics and Maternal-Fetal Biology... of Scientific Review, Eunice Kennedy Shriver National Institute of Child Health and Human Development...

  20. 77 FR 73036 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-07

    ... National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d... Institute of Child Health and Human Development Special Emphasis Panel. NICHD T32 Teleconference Review... of Scientific Review, Eunice Kennedy Shriver National Institute of Child Health and Human Development...

  1. 76 FR 62082 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-06

    ... Sciences and Epidemiology National Cancer Institute. The meeting will be closed to the public as indicated... Epidemiology, National Cancer Institute. Date: November 14, 2011. Time: 8:30 a.m. to 4 p.m. Agenda: To review...

  2. 76 FR 33321 - National Cancer Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-08

    ... Sciences and Epidemiology National Cancer Institute. The meeting will be closed to the public as indicated... Epidemiology, National Cancer Institute. Date: July 12, 2011. Time: 9 a.m. to 4 p.m. Agenda: To review and...

  3. 75 FR 54348 - National Institute of Mental Health; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-07

    ... evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive... Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience...: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852...

  4. 75 FR 45646 - National Institute of Mental Health; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... evaluate contract proposals. Place: National Institutes of Health, Neuroscience Center, 6001 Executive... Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience... proposals. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville...

  5. 77 FR 71605 - National Institute of Dental & Craniofacial Research; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-03

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and... Officer, Scientific Review Branch, National Institute of Dental and Craniofacial Research, 6701 Democracy...

  6. 76 FR 38193 - National Institute of Dental & Craniofacial Research; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental.... Name of Committee: National Institute of Dental and Craniofacial Research Special Emphasis Panel... Officer, Scientific Review Branch, National Inst of Dental & Craniofacial Research, National Institutes of...

  7. Assessing the Scientific Research Productivity of a Brazilian Healthcare Institution: A Case Study at the Heart Institute of São Paulo, Brazil

    PubMed Central

    Tess, Beatriz Helena; Furuie, Sérgio Shiguemi; Castro, Regina Célia Figueiredo; do Carmo Cavarette Barreto, Maria; Nobre, Moacyr Roberto Cuce

    2009-01-01

    INTRODUCTION: The present study was motivated by the need to systematically assess the research productivity of the Heart Institute (InCor), Medical School of the University of São Paulo, Brazil. OBJECTIVE: To explore methodology for the assessment of institutional scientific research productivity. MATERIALS AND METHODS: Bibliometric indicators based on searches for author affiliation of original scientific articles or reviews published in journals indexed in the databases Web of Science, MEDLINE, EMBASE, LILACS and SciELO from January 2000 to December 2003 were used in this study. The retrieved records were analyzed according to the index parameters of the journals and modes of access. The number of citations was used to calculate the institutional impact factor. RESULTS: Out of 1253 records retrieved from the five databases, 604 original articles and reviews were analyzed; of these, 246 (41%) articles were published in national journals and 221 (90%) of those were in journals with free online access through SciELO or their own websites. Of the 358 articles published in international journals, 333 (93%) had controlled online access and 223 (67%) were available through the Capes Portal of Journals. The average impact of each article for InCor was 2.224 in the period studied. CONCLUSION: A simple and practical methodology to evaluate the scientific production of health research institutions includes searches in the LILACS database for national journals and in MEDLINE and the Web of Science for international journals. The institutional impact factor of articles indexed in the Web of Science may serve as a measure by which to assess and review the scientific productivity of a research institution. PMID:19578662

  8. 76 FR 24890 - National Institute on Aging; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-03

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging... personal privacy. Name of Committee: National Institute on Aging Initial Review Group, Biological Aging... Aging, Gateway Bldg., 2c212, 7201 Wisconsin Avenue, Bethesda, MD 20814, 301-402- 7701, [email protected

  9. 19 CFR 206.15 - Institution of investigation.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... INVESTIGATIONS RELATING TO GLOBAL AND BILATERAL SAFEGUARD ACTIONS, MARKET DISRUPTION, TRADE DIVERSION, AND REVIEW OF RELIEF ACTIONS Investigations Relating to Global Safeguard Actions § 206.15 Institution of...

  10. 19 CFR 206.15 - Institution of investigation.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... INVESTIGATIONS RELATING TO GLOBAL AND BILATERAL SAFEGUARD ACTIONS, MARKET DISRUPTION, TRADE DIVERSION, AND REVIEW OF RELIEF ACTIONS Investigations Relating to Global Safeguard Actions § 206.15 Institution of...

  11. 19 CFR 206.15 - Institution of investigation.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... INVESTIGATIONS RELATING TO GLOBAL AND BILATERAL SAFEGUARD ACTIONS, MARKET DISRUPTION, TRADE DIVERSION, AND REVIEW OF RELIEF ACTIONS Investigations Relating to Global Safeguard Actions § 206.15 Institution of...

  12. 19 CFR 206.15 - Institution of investigation.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... INVESTIGATIONS RELATING TO GLOBAL AND BILATERAL SAFEGUARD ACTIONS, MARKET DISRUPTION, TRADE DIVERSION, AND REVIEW OF RELIEF ACTIONS Investigations Relating to Global Safeguard Actions § 206.15 Institution of...

  13. 78 FR 23772 - National Institute on Drug Abuse; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-22

    .... Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Neuroscience... evaluate contract proposals. Place: National Institutes of Health, Neuroscience Center, 6001 Executive.... Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852...

  14. 75 FR 22816 - National Institute of Mental Health; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

    ... evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive... Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience.... Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852...

  15. 78 FR 13358 - National Institute of Mental Health; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ... applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville... Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center... review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001...

  16. 77 FR 58855 - National Institute on Drug Abuse Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-24

    ...: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852. Contact... evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive.... Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience...

  17. 78 FR 28234 - National Institute of Dental and Craniofacial Research; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and... Review Officer, National Institute of Dental and Craniofacial Research, National Institutes of Health...

  18. Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective.

    PubMed

    Ezzat, Hanna; Ross, Sue; von Dadelszen, Peter; Morris, Tara; Liston, Robert; Magee, Laura A

    2010-07-30

    For ethical approval of a multicentre study in Canada, investigators must apply separately to individual Research Ethics Boards (REBs). In principle, the protection of human research subjects is of utmost importance. However, in practice, the process of multicentre ethics review can be time consuming and costly, requiring duplication of effort for researchers and REBs. We used our experience with ethical review of The Canadian Perinatal Network (CPN), to gain insight into the Canadian system. The applications forms of 16 different REBs were abstracted for a list of standardized items. The application process across sites was compared. Correspondence between the REB and the investigators was documented in order to construct a timeline to approval, identify the specific issues raised by each board, and describe how they were resolved. Each REB had a different application form. Most (n = 9) had a two or three step application process. Overall, it took a median of 31 days (range 2-174 days) to receive an initial response from the REB. Approval took a median of 42 days (range 4-443 days). Privacy and consent were the two major issues raised. Several additional minor or administrative issues were raised which delayed approval. For CPN, the Canadian REB process of ethical review proved challenging. REBs acted independently and without unified application forms or submission procedures. We call for a critical examination of the ethical, privacy and institutional review processes in Canada, to determine the best way to undertake multicentre review.

  19. Ethical review and informed consent in cardiovascular research reports in Argentina.

    PubMed

    Borracci, Raúl A; Calderón, Gustavo; Seoane, Martín R; Perez, Analía C; Doval, Hernán C

    2008-05-01

    Requirements for Institutional Review Board approval and informed consent for research involving human subjects have existed for more than 2 decades. However, evidence of fulfillment of these requirements is sometimes lacking in cardiovascular research reports in Argentina. Since ethical standards vary between committees, there may be some confusion among researchers regarding the need for an ethical review when conducting low risk research. To examine the frequency of obtaining an ethical review and informed consent in cardiovascular research in Argentina. Through a questionnaire, we contacted authors of 100 reports submitted to our annual scientific meeting during 2006. Thirty six per cent of questionnaires were resubmitted with confirmation of ethical review, 34% responded that ethical review was not obtained, 23% reported as being exempt and 7% were never resubmitted. Most articles obtaining ethical review were pharmacological trials or research involving assessment of new devices. On the other hand, most articles reporting lack of or exemption from ethical review come from epidemiological research or studies evaluating non-invasive methods. Sixty percent of phase IV pharmacological trials, research on cellular implantation or assessment of new devices met federal regulations requirements. The rate of ethical review and use of informed consent in cardiovascular reports in Argentina vary among articles. Most research involving prospective observational studies and nearly 50% of protocols including intervention or invasive procedures do not report ethical review. This high proportion of articles lacking ethical review suggests the presence of legal and ethical flaws which should be discussed and overcome.

  20. 75 FR 37818 - National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-30

    ... review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001... Administrator, Scientific Review Branch, Division of Extramural Research, NINDS/NIH/DHHS/Neuroscience Center... Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) Dated...

  1. 75 FR 71134 - National Institute of General Medical Sciences; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-22

    ... General Medical Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory... Sciences Special Emphasis Panel; Conference Grants Review. Date: December 13, 2010. Time: 1 p.m. to 6 p.m..., Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of...

  2. 77 FR 11563 - National Institute on Aging; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    ... personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel; Systems Biology of... Officer, Scientific Review Branch, National Institute on Aging, Gateway Bldg., 2C212, 7201 Wisconsin...

  3. Student Feedback Systems in Higher Education: A Focused Literature Review and Environmental Scan

    ERIC Educational Resources Information Center

    Alderman, Lyn; Towers, Stephen; Bannah, Sylvia

    2012-01-01

    In recent times, higher education institutions have paid increasing attention to the views of students to obtain feedback on their experience of learning and teaching through internal surveys. This article reviews research in the field and reports on practices in other Australian universities. Findings demonstrate that while student feedback is…

  4. 77 FR 5035 - National Human Genome Research Institute; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research... Officer, Scientific Review Branch, National Human Genome Research Institute, National Institutes of Health...

  5. Anaesthesia-related haemodynamic complications in Williams syndrome patients: a review of one institution's experience.

    PubMed

    Olsen, M; Fahy, C J; Costi, D A; Kelly, A J; Burgoyne, L L

    2014-09-01

    Williams syndrome is a genetic disorder associated with cardiac pathology, including supravalvular aortic stenosis and coronary artery stenosis. Sudden cardiac death has been reported in the perioperative period and attributed to cardiovascular pathology. In this retrospective audit, case note and anaesthetic records were reviewed for all confirmed Williams syndrome patients who had received an anaesthetic in our institution between July 1974 and November 2009. There were a total of 108 anaesthetics administered in 29 patients. Twelve of the anaesthetics (11.1%) were associated with cardiac complications including cardiac arrest in two cases (1.85%). Of the two cardiac arrests, one patient died within the first 24 hours postanaesthetic and the other patient survived, giving an overall mortality of 0.9% (3.4%). We conclude that Williams syndrome confers a significant anaesthetic risk, which should be recognised and considered by clinicians planning procedures requiring general anaesthesia.

  6. 77 FR 24973 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special... Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, National Institutes...

  7. 77 FR 2987 - National Institute of Dental & Craniofacial Research; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and....D., Scientific Review Officer, Natl Inst of Dental and Craniofacial Research, National Institutes of...

  8. 75 FR 2146 - National Institute of Dental & Craniofacial Research; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and Craniofacial.... King, PhD, Chief, Scientific Review Branch, National Institute of Dental and Craniofacial Research/NIH...

  9. 76 FR 20693 - National Institute of Dental & Craniofacial Research; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and Craniofacial... Review Branch, National Institute of Dental and Craniofacial Research, One Democracy Plaza, Room 670...

  10. 77 FR 40369 - National Institute of Dental & Craniofacial Research; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Dental and... Review Branch, National Institute of Dental and Craniofacial Research, 6701 Democracy Blvd., Rm. 676...

  11. 78 FR 63995 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and... unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special... Scientific Review/DERA, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701...

  12. 75 FR 67381 - National Institute on Aging; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging... personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel HIV, HAART and AGING. Date: November 23, 2010. Time: 1 p.m. to 5 p.m. Agenda: To review and evaluate grant applications...

  13. 75 FR 39698 - National Institute on Aging; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-12

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging... personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel, Network Infrastructure for Aging Research. Date: July 20, 2010. Time: 12 p.m. to 4 p.m. Agenda: To review and evaluate...

  14. 75 FR 63497 - National Institute on Aging; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-15

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging... personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel; Genetic Determinants of Healthy Aging. Date: November 10, 2010. Time: 1 p.m. to 5 p.m. Agenda: To review and evaluate...

  15. Building Institutions for the Next 50 Years of Creativity Research

    ERIC Educational Resources Information Center

    Silvia, Paul J.

    2017-01-01

    The "Journal of Creative Behavior's" remarkable half-century is a good occasion for reflecting on the role of a scholarly field's institutions in fostering creative work. In creativity studies, some of our institutions are flourishing, particularly our many excellent peer-reviewed journals. But we face some institutional challenges that…

  16. 75 FR 6042 - National Institute on Aging; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-05

    ... personal privacy. Name of Committee: National Institute on Aging Initial Review Group, Behavior and Social Science of Aging Review Committee. Date: March 4-5, 2010. Time: 4 p.m. to 12 p.m. Agenda: To review and...

  17. 75 FR 56119 - National Institute on Aging; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-15

    ... personal privacy. Name of Committee: National Institute on Aging Initial Review Group; Behavior and Social Science of Aging Review Committee. Date: October 7-8, 2010. Time: 4 p.m. to 12 p.m. Agenda: To review and...

  18. 77 FR 24969 - National Institute on Aging; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-26

    ... personal privacy. Name of Committee: National Institute on Aging Initial Review Group; Behavior and Social Science of Aging Review Committee. Date: June 6-7, 2012. Time: 3 p.m. to 12 p.m. Agenda: To review and...

  19. 76 FR 6628 - National Institute on Aging; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... personal privacy. Name of Committee: National Institute on Aging Initial Review Group; Behavior and Social Science of Aging Review Committee. Date: March 3-4, 2011. Time: 5 p.m. to 5 p.m. Agenda: To review and...

  20. 77 FR 6129 - National Institute on Aging Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-07

    ... personal privacy. Name of Committee: National Institute on Aging Initial Review Group; Behavior and Social Science of Aging Review Committee. Date: March 1-2, 2012. Time: 4 p.m. to 12 p.m. Agenda: To review and...