Sample records for obtaining irb approval

  1. 21 CFR 812.42 - FDA and IRB approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

  2. 21 CFR 812.42 - FDA and IRB approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

  3. 21 CFR 812.42 - FDA and IRB approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

  4. 21 CFR 812.42 - FDA and IRB approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

  5. 21 CFR 812.42 - FDA and IRB approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

  6. 7 CFR 1c.111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... long-range effects of applying knowledge gained in the research (for example, the possible effects of... 7 Agriculture 1 2010-01-01 2010-01-01 false Criteria for IRB approval of research. 1c.111 Section... Criteria for IRB approval of research. (a) In order to approve research covered by this policy the IRB...

  7. 14 CFR 1230.111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... consider possible long-range effects of applying knowledge gained in the research (for example, the... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Criteria for IRB approval of research. 1230... HUMAN SUBJECTS § 1230.111 Criteria for IRB approval of research. (a) In order to approve research...

  8. 16 CFR 1028.111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... consider possible long-range effects of applying knowledge gained in the research (for example, the... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Criteria for IRB approval of research. 1028... HUMAN SUBJECTS § 1028.111 Criteria for IRB approval of research. (a) In order to approve research...

  9. 7 CFR 1c.113 - Suspension or termination of IRB approval of research.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 1 2011-01-01 2011-01-01 false Suspension or termination of IRB approval of research... § 1c.113 Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's...

  10. 49 CFR 11.111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... long-range effects of applying knowledge gained in the research (for example, the possible effects of... 49 Transportation 1 2010-10-01 2010-10-01 false Criteria for IRB approval of research. 11.111....111 Criteria for IRB approval of research. (a) In order to approve research covered by this policy the...

  11. 15 CFR 27.111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... consider possible long-range effects of applying knowledge gained in the research (for example, the... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false Criteria for IRB approval of research... HUMAN SUBJECTS § 27.111 Criteria for IRB approval of research. (a) In order to approve research covered...

  12. 28 CFR 46.111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... possible long-range effects of applying knowledge gained in the research (for example, the possible effects... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Criteria for IRB approval of research. 46... SUBJECTS § 46.111 Criteria for IRB approval of research. (a) In order to approve research covered by this...

  13. 22 CFR 225.111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... long-range effects of applying knowledge gained in the research (for example, the possible effects of... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Criteria for IRB approval of research. 225.111....111 Criteria for IRB approval of research. (a) In order to approve research covered by this policy the...

  14. 21 CFR 56.113 - Suspension or termination of IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Suspension or termination of IRB approval of research. 56.113 Section 56.113 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of...

  15. 32 CFR 219.111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 2 2014-07-01 2014-07-01 false Criteria for IRB approval of research. 219.111 Section 219.111 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.111 Criteria for IRB approval of research. (a...

  16. 16 CFR 1028.113 - Suspension or termination of IRB approval of research.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... research. 1028.113 Section 1028.113 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.113 Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance...

  17. 45 CFR 690.113 - Suspension or termination of IRB approval of research.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... research. 690.113 Section 690.113 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.113 Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not...

  18. 40 CFR 26.113 - Suspension or termination of IRB approval of research.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... approval of research. 26.113 Section 26.113 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26.113 Suspension or termination of IRB approval of research. An IRB shall...

  19. 49 CFR 11.113 - Suspension or termination of IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... research. 11.113 Section 11.113 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.113 Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the...

  20. 40 CFR 26.113 - Suspension or termination of IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... approval of research. 26.113 Section 26.113 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26.113 Suspension or termination of IRB approval of research. An IRB shall...

  1. The Myth, the Truth, the NASA IRB

    NASA Technical Reports Server (NTRS)

    Covington, M. D.; Flores, M. P.; Neutzler, V. P.; Schlegel, T. T.; Platts, S. H.; Lioyd, C. W.

    2017-01-01

    The purpose of the NASA Institutional Review Board (IRB) is to review research activities involving human subjects to ensure that ethical standards for the care and protection of human subjects have been met and research activities are in compliance with all pertinent federal, state and local regulations as well as NASA policies. NASA IRB's primary role is the protection of human subjects in research studies. Protection of human subjects is the shared responsibility of NASA, the IRB, and the scientific investigators. Science investigators who plan to conduct NASA-funded human research involving NASA investigators, facilities, or funds must submit and coordinate their research studies for review and approval by the NASA IRB prior to initiation. The IRB has the authority to approve, require changes in, or disapprove research involving human subjects. Better knowledge of the NASA IRB policies, procedures and guidelines should help facilitate research protocol applications and approvals. In this presentation, the myths and truths of NASA IRB policies and procedures will be discussed. We will focus on the policies that guide a protocol through the NASA IRB and the procedures that principal investigators must take to obtain required IRB approvals for their research studies. In addition, tips to help ensure a more efficient IRB review will be provided. By understanding the requirements and processes, investigators will be able to more efficiently prepare their protocols and obtain the required NASA IRB approval in a timely manner.

  2. 16 CFR 1028.113 - Suspension or termination of IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... research. 1028.113 Section 1028.113 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.113 Suspension or termination of IRB approval of research. An IRB shall... with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any...

  3. 14 CFR 1230.111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Criteria for IRB approval of research. 1230.111 Section 1230.111 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF... knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should...

  4. 40 CFR 26.1111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Criteria for IRB approval of research...

  5. 45 CFR 46.111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... applying knowledge gained in the research (for example, the possible effects of the research on public... 45 Public Welfare 1 2010-10-01 2010-10-01 false Criteria for IRB approval of research. 46.111... HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.111 Criteria for IRB...

  6. 10 CFR 745.111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among... 10 Energy 4 2010-01-01 2010-01-01 false Criteria for IRB approval of research. 745.111 Section 745...

  7. 32 CFR 219.111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks... 32 National Defense 2 2010-07-01 2010-07-01 false Criteria for IRB approval of research. 219.111...

  8. 45 CFR 690.111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that... 45 Public Welfare 3 2010-10-01 2010-10-01 false Criteria for IRB approval of research. 690.111...

  9. 45 CFR 46.113 - Suspension or termination of IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... research. 46.113 Section 46.113 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.113 Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate...

  10. 45 CFR 46.113 - Suspension or termination of IRB approval of research.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... research. 46.113 Section 46.113 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.113 Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate...

  11. The Real-Time IRB: A Collaborative Innovation to Decrease IRB Review Time.

    PubMed

    Spellecy, Ryan; Eve, Ann Marie; Connors, Emily R; Shaker, Reza; Clark, David C

    2018-06-01

    Lengthy review times for institutional review boards (IRBs) are a well-known barrier to research. In response to numerous calls to reduce review times, we devised "Real-Time IRB," a process that drastically reduces IRB review time. In this, investigators and study staff attend the IRB meeting and make changes to the protocol while the IRB continues its meeting, so that final approval can be issued at the meeting. This achieved an overall reduction in time from submission to the IRB to final approval of 40%. While this process is time and resource intensive, and cannot address all delays in research, it shows great promise for increasing the pace by which research is translated to patient care.

  12. 40 CFR 26.1111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Criteria for IRB approval of research. 26.1111 Section 26.1111 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving...

  13. 40 CFR 26.1111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Criteria for IRB approval of research. 26.1111 Section 26.1111 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving...

  14. 40 CFR 26.1111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Criteria for IRB approval of research. 26.1111 Section 26.1111 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving...

  15. 40 CFR 26.1111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Criteria for IRB approval of research. 26.1111 Section 26.1111 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving...

  16. 34 CFR 97.111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... possible long-range effects of applying knowledge gained in the research (for example, the possible effects... 34 Education 1 2010-07-01 2010-07-01 false Criteria for IRB approval of research. 97.111 Section... Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research...

  17. 40 CFR 26.111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... possible long-range effects of applying knowledge gained in the research (for example, the possible effects... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Criteria for IRB approval of research... HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by...

  18. 21 CFR 56.111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among... included in the study to protect the rights and welfare of these subjects. (c) In order to approve research...

  19. 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

  20. 40 CFR 26.1113 - Suspension or termination of IRB approval of research.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Suspension or termination of IRB approval of research. 26.1113 Section 26.1113 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for...

  1. 40 CFR 26.1113 - Suspension or termination of IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Suspension or termination of IRB approval of research. 26.1113 Section 26.1113 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for...

  2. 40 CFR 26.1113 - Suspension or termination of IRB approval of research.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Suspension or termination of IRB approval of research. 26.1113 Section 26.1113 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for...

  3. 40 CFR 26.1113 - Suspension or termination of IRB approval of research.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Suspension or termination of IRB approval of research. 26.1113 Section 26.1113 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for...

  4. 40 CFR 26.1113 - Suspension or termination of IRB approval of research.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Suspension or termination of IRB approval of research. 26.1113 Section 26.1113 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for...

  5. 28 CFR 46.109 - IRB review of research.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false IRB review of research. 46.109 Section 46... IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB...

  6. 28 CFR 46.109 - IRB review of research.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false IRB review of research. 46.109 Section 46... IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB...

  7. 28 CFR 46.109 - IRB review of research.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false IRB review of research. 46.109 Section 46... IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB...

  8. 28 CFR 46.109 - IRB review of research.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false IRB review of research. 46.109 Section 46... IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB...

  9. 32 CFR 219.113 - Suspension or termination of IRB approval of research.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 2 2014-07-01 2014-07-01 false Suspension or termination of IRB approval of research. 219.113 Section 219.113 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.113 Suspension or...

  10. Biometrics IRB best practices and data protection

    NASA Astrophysics Data System (ADS)

    Boehnen, Christopher; Bolme, David; Flynn, Patrick

    2015-05-01

    The collection of data from human subjects for biometrics research in the United States requires the development of a data collection protocol that is reviewed by a Human Subjects Institutional Review Board (IRB). The IRB reviews the protocol for risks and approves it if it meets the criteria for approval specified in the relevant Federal regulations (45 CFR 46). Many other countries operate similar mechanisms for the protection of human subjects. IRBs review protocols for safety, confidentiality, and for minimization of risk associated with identity disclosure. Since biometric measurements are potentially identifying, IRB scrutiny of biometrics data collection protocols can be expected to be thorough. This paper discusses the intricacies of IRB best practices within the worldwide biometrics community. This is important because research decisions involving human subjects are made at a local level and do not set a precedent for decisions made by another IRB board. In many cases, what one board approves is not approved by another board, resulting in significant inconsistencies that prove detrimental to both researchers and human subjects. Furthermore, the level of biometrics expertise may be low on IRBs, which can contribute to the unevenness of reviews. This publication will suggest possible best practices for designing and seeking IRB approval for human subjects research involving biometrics measurements. The views expressed are the opinions of the authors.

  11. 16 CFR 1028.109 - IRB review of research.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false IRB review of research. 1028.109 Section... § 1028.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB...

  12. 16 CFR 1028.109 - IRB review of research.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false IRB review of research. 1028.109 Section... § 1028.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB...

  13. 16 CFR 1028.109 - IRB review of research.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false IRB review of research. 1028.109 Section... § 1028.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB...

  14. 21 CFR 56.109 - IRB review of research.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false IRB review of research. 56.109 Section 56.109 Food... REVIEW BOARDS IRB Functions and Operations § 56.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research...

  15. 15 CFR 27.109 - IRB review of research.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 15 Commerce and Foreign Trade 1 2011-01-01 2011-01-01 false IRB review of research. 27.109 Section... § 27.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB...

  16. 14 CFR 1230.109 - IRB review of research.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false IRB review of research. 1230.109 Section... SUBJECTS § 1230.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB...

  17. 15 CFR 27.109 - IRB review of research.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 15 Commerce and Foreign Trade 1 2012-01-01 2012-01-01 false IRB review of research. 27.109 Section... § 27.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB...

  18. 21 CFR 56.109 - IRB review of research.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false IRB review of research. 56.109 Section 56.109 Food... REVIEW BOARDS IRB Functions and Operations § 56.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research...

  19. 15 CFR 27.109 - IRB review of research.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 15 Commerce and Foreign Trade 1 2013-01-01 2013-01-01 false IRB review of research. 27.109 Section... § 27.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB...

  20. 34 CFR 97.113 - Suspension or termination of IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Suspension or termination of IRB approval of research. 97.113 Section 97.113 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...

  1. Navigating the IRB: The Ethics of SoTL

    ERIC Educational Resources Information Center

    Martin, Ryan C.

    2013-01-01

    This chapter discusses Institutional Review Boards (IRBs) as they apply to the SoTL. Specifically, it describes when SoTL projects must receive IRB approval, why they must get IRB approval, the review process, and some special issues of concern with regard to SoTL.

  2. 34 CFR 97.403 - IRB duties.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Children Who Are Subjects in Research § 97.403 IRB duties. In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered by this subpart and approve only...

  3. 16 CFR § 1028.109 - IRB review of research.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false IRB review of research. § 1028.109 Section... SUBJECTS § 1028.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB...

  4. 49 CFR 11.109 - IRB review of research.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 1 2012-10-01 2012-10-01 false IRB review of research. 11.109 Section 11.109... research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB shall require that...

  5. 49 CFR 11.109 - IRB review of research.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 1 2014-10-01 2014-10-01 false IRB review of research. 11.109 Section 11.109... research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB shall require that...

  6. 49 CFR 11.109 - IRB review of research.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false IRB review of research. 11.109 Section 11.109... research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB shall require that...

  7. 49 CFR 11.109 - IRB review of research.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 1 2011-10-01 2011-10-01 false IRB review of research. 11.109 Section 11.109... research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB shall require that...

  8. 32 CFR 219.109 - IRB review of research.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 2 2012-07-01 2012-07-01 false IRB review of research. 219.109 Section 219.109...) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities...

  9. 45 CFR 690.109 - IRB review of research.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 3 2011-10-01 2011-10-01 false IRB review of research. 690.109 Section 690.109... OF HUMAN SUBJECTS § 690.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by...

  10. 32 CFR 219.109 - IRB review of research.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 2 2014-07-01 2014-07-01 false IRB review of research. 219.109 Section 219.109...) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities...

  11. 22 CFR 225.109 - IRB Review of Research.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false IRB Review of Research. 225.109 Section 225.109... of Research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB shall require...

  12. 45 CFR 46.403 - IRB duties.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Protections for Children Involved as Subjects in Research § 46.403 IRB duties. In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered by this subpart and approve only research which satisfies the conditions of all applicable sections of this subpart. ...

  13. 7 CFR 1c.109 - IRB review of research.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 1 2011-01-01 2011-01-01 false IRB review of research. 1c.109 Section 1c.109... research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB shall require that...

  14. 7 CFR 1c.109 - IRB review of research.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 1 2012-01-01 2012-01-01 false IRB review of research. 1c.109 Section 1c.109... research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (b) An IRB shall require that...

  15. 45 CFR 690.115 - IRB records.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 3 2014-10-01 2014-10-01 false IRB records. 690.115 Section 690.115 Public... SUBJECTS § 690.115 IRB records. (a) An institution, or when appropriate an IRB, shall prepare and maintain... reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents...

  16. 45 CFR 690.115 - IRB records.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 3 2012-10-01 2012-10-01 false IRB records. 690.115 Section 690.115 Public... SUBJECTS § 690.115 IRB records. (a) An institution, or when appropriate an IRB, shall prepare and maintain... reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents...

  17. 21 CFR 56.115 - IRB records.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false IRB records. 56.115 Section 56.115 Food and Drugs... BOARDS Records and Reports § 56.115 IRB records. (a) An institution, or where appropriate an IRB, shall... research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample...

  18. 14 CFR § 1230.109 - IRB review of research.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 5 2014-01-01 2014-01-01 false IRB review of research. § 1230.109 Section... SUBJECTS (Eff. until 2-14-14) § 1230.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities...

  19. 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.

  20. 14 CFR § 1230.115 - IRB records.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 5 2014-01-01 2014-01-01 false IRB records. § 1230.115 Section § 1230... (Eff. until 2-14-14) § 1230.115 IRB records. (a) An institution, or when appropriate an IRB, shall... research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample...

  1. [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.

  2. 14 CFR 1230.115 - IRB records.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true IRB records. 1230.115 Section 1230.115... documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress...

  3. 14 CFR 1230.115 - IRB records.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false IRB records. 1230.115 Section 1230.115... documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress...

  4. 16 CFR 1028.115 - IRB records.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false IRB records. 1028.115 Section 1028.115 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.115 IRB... evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports...

  5. 34 CFR 97.109 - IRB review of research.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 1 2011-07-01 2011-07-01 false IRB review of research. 97.109 Section 97.109 Education... Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to...

  6. 34 CFR 97.109 - IRB review of research.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 1 2013-07-01 2013-07-01 false IRB review of research. 97.109 Section 97.109 Education... Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to...

  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. IRB Process Improvements: A Machine Learning Analysis.

    PubMed

    Shoenbill, Kimberly; Song, Yiqiang; Cobb, Nichelle L; Drezner, Marc K; Mendonca, Eneida A

    2017-06-01

    Clinical research involving humans is critically important, but it is a lengthy and expensive process. Most studies require institutional review board (IRB) approval. Our objective is to identify predictors of delays or accelerations in the IRB review process and apply this knowledge to inform process change in an effort to improve IRB efficiency, transparency, consistency and communication. We analyzed timelines of protocol submissions to determine protocol or IRB characteristics associated with different processing times. Our evaluation included single variable analysis to identify significant predictors of IRB processing time and machine learning methods to predict processing times through the IRB review system. Based on initial identified predictors, changes to IRB workflow and staffing procedures were instituted and we repeated our analysis. Our analysis identified several predictors of delays in the IRB review process including type of IRB review to be conducted, whether a protocol falls under Veteran's Administration purview and specific staff in charge of a protocol's review. We have identified several predictors of delays in IRB protocol review processing times using statistical and machine learning methods. Application of this knowledge to process improvement efforts in two IRBs has led to increased efficiency in protocol review. The workflow and system enhancements that are being made support our four-part goal of improving IRB efficiency, consistency, transparency, and communication.

  9. 21 CFR 312.66 - Assurance of IRB review.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... proposed clinical study. The investigator shall also assure that he or she will promptly report to the IRB all changes in the research activity and all unanticipated problems involving risk to human subjects or others, and that he or she will not make any changes in the research without IRB approval, except...

  10. 40 CFR 26.403 - IRB duties.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., each IRB shall review observational research covered by this subpart and approve only research that... Research: Additional Protections for Children Involved as Subjects in Observational Research Conducted or...

  11. 21 CFR 50.50 - IRB duties.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... review clinical investigations involving children as subjects covered by this subpart D and approve only... SUBJECTS Additional Safeguards for Children in Clinical Investigations § 50.50 IRB duties. In addition to...

  12. Qualitative Research in Question: A Narrative of Disciplinary Power with/in the IRB

    ERIC Educational Resources Information Center

    Johnson, Tara Star

    2008-01-01

    This article narrates the author's experience of obtaining institutional review board (IRB) approval for her dissertation study. Although her research topic was particularly sensitive, this case is illustrative of the increasing level of difficulty qualitative researchers are facing in conducting not only risky research but also work that is not…

  13. 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.

  14. 38 CFR 16.115 - IRB records.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... adequate documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents... basis for requiring changes in or disapproving research; and a written summary of the discussion of...

  15. 38 CFR 16.115 - IRB records.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... adequate documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents... basis for requiring changes in or disapproving research; and a written summary of the discussion of...

  16. 45 CFR 690.115 - IRB records.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... adequate documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents... basis for requiring changes in or disapproving research; and a written summary of the discussion of...

  17. 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.

  18. IRB Problems and Solutions in Health Communication Research.

    PubMed

    King, Carie S Tucker; Bivens, Kristin Marie; Pumroy, Erin; Rauch, Susan; Koerber, Amy

    2018-07-01

    In this article, we contribute to the current literature on the difficulties that social scientists encounter with IRBs, but with a focus on the distinct challenges that health communication scholars face in dealing with IRBs at their own institutions and elsewhere. Although health communication researchers, like other communication researchers, can expect to face many of the same challenges that their social science colleagues face during the IRB process, the researcher narratives we present in this article suggest that health communication research presents some distinct challenges because the communication interactions that we investigate occur in highly protected, private spaces, including the medical exam room, online patient forums, and electronic health records. To that end, we present a series of examples in which health communication researchers were able to find solutions or workarounds to the challenges they faced in gaining IRB approval for their research. In every case that we present, the researcher had to revise her initial study design to get around the constraints imposed by IRB requirements, and in every case, the researcher reports having experienced points of incommensurability similar to those reported by many other social scientists. In some situations, investigators even express frustration that the IRB's needs and demands superseded those of healthcare professionals and the patients whom they serve. Additionally, in some situations, investigators' understandings of human subjects' protection actually go further to protect patients' privacy and confidentiality than the IRB required. But, in all four cases that we present, the health communication research was ultimately successful.

  19. A Student's Guide to Navigating the IRB: How to Successfully Navigate a Potentially Overwhelming Process

    ERIC Educational Resources Information Center

    Murphy, Corinne M.; Verden, Claire

    2011-01-01

    Graduate students must complete a research project to receive their degree. In addition to this basic requirement, the student may be required to submit a research proposal and application to the governing Institutional Review Board (IRB) for approval prior to beginning the research project. This article describes the IRB process and offers tips…

  20. US IRBs confronting research in the developing world

    PubMed Central

    Klitzman, Robert L.

    2012-01-01

    Increasingly, US-sponsored research is carried out in developing countries, but how US Institutional Review Boards (IRBs) approach the challenges they then face is unclear. METHODS I conducted in-depth interviews of 2 hours each, with 46 IRB chairs, directors, administrators and members. I contacted the leadership of 60 IRBs in the United States (US) (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding), and interviewed IRB leaders from 34 (55%). RESULTS US IRBs face ethical and logistical challenges in interpreting and applying principles and regulations in developing countries, given economic and health disparities, and limited contextual knowledge. These IRBs perceive wide variations in developing world IRBs/RECs’ quality, resources and training; and health systems in some countries may have long-standing practices of corruption. These IRBs often know little of local contexts, regulations and standards of care, and struggle with understandings of other cultures’ differing views of autonomy, and risks and benefits of daily life. US IRBs thus face difficult decisions, including how to interpret principles, how much to pay subjects and how much sustainability to require from researchers. IRB responses and solutions include trying to maintain higher standards for developing world research, obtain cultural expertise, build IRB infrastructure abroad, communicate with foreign IRBs, ‘negotiate’ for maximum benefits for participants and fearing ‘worst-case scenarios’. CONCLUSIONS US IRBs confront a series of tensions and dilemmas in reviewing developing world research. These data have important implications for increased education of IRBs/RECs and researchers in the US and abroad, and for research and practice. PMID:22515423

  1. US IRBs confronting research in the developing world.

    PubMed

    Klitzman, Robert L

    2012-08-01

    Increasingly, US-sponsored research is carried out in developing countries, but how US Institutional Review Boards (IRBs) approach the challenges they then face is unclear. I conducted in-depth interviews of about 2 hours each, with 46 IRB chairs, directors, administrators and members. I contacted the leadership of 60 IRBs in the United States (US) (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding), and interviewed IRB leaders from 34 (55%). US IRBs face ethical and logistical challenges in interpreting and applying principles and regulations in developing countries, given economic and health disparities, and limited contextual knowledge. These IRBs perceive wide variations in developing world IRBs/RECs' quality, resources and training; and health systems in some countries may have long-standing practices of corruption. These US IRBs often know little of local contexts, regulations and standards of care, and struggle with understandings of other cultures' differing views of autonomy, and risks and benefits of daily life. US IRBs thus face difficult decisions, including how to interpret principles, how much to pay subjects and how much sustainability to require from researchers. IRB responses and solutions include trying to maintain higher standards for developing world research, obtain cultural expertise, build IRB infrastructure abroad, communicate with foreign IRBs, and 'negotiate' for maximum benefits for participants and fearing 'worst-case scenarios'. US and foreign IRBs confront a series of tensions and dilemmas in reviewing developing world research. These data have important implications for increased education of IRBs/RECs and researchers in the US and abroad, and for research and practice. © 2012 Blackwell Publishing Ltd.

  2. 38 CFR 16.111 - Criteria for IRB approval of research.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that... of research. 16.111 Section 16.111 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS...

  3. 45 CFR 46.501 - What IRBs must be registered?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false What IRBs must be registered? 46.501 Section 46.501 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN... is designated by an institution under an assurance of compliance approved for federalwide use by the...

  4. 45 CFR 46.501 - What IRBs must be registered?

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 1 2012-10-01 2012-10-01 false What IRBs must be registered? 46.501 Section 46.501 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN... is designated by an institution under an assurance of compliance approved for federalwide use by the...

  5. 45 CFR 46.501 - What IRBs must be registered?

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 1 2014-10-01 2014-10-01 false What IRBs must be registered? 46.501 Section 46.501 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION PROTECTION OF HUMAN... is designated by an institution under an assurance of compliance approved for federalwide use by the...

  6. 45 CFR 46.501 - What IRBs must be registered?

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 1 2011-10-01 2011-10-01 false What IRBs must be registered? 46.501 Section 46.501 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN... is designated by an institution under an assurance of compliance approved for federalwide use by the...

  7. 45 CFR 46.501 - What IRBs must be registered?

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 1 2013-10-01 2013-10-01 false What IRBs must be registered? 46.501 Section 46.501 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN... is designated by an institution under an assurance of compliance approved for federalwide use by the...

  8. 77 FR 69631 - Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ...://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances...] Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the... IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of...

  9. High temperature Ir segregation in Ir-B ceramics: Effect of oxygen presence on stability of IrB 2 and other Ir-B phases

    DOE PAGES

    Xie, Zhilin; Terracciano, Anthony C.; Cullen, David A.; ...

    2015-05-13

    The formation of IrB 2, IrB 1.35, IrB 1.1 and IrB monoboride phases in the Ir–B ceramic nanopowder was confirmed during mechanochemical reaction between metallic Ir and elemental B powders. The Ir–B phases were analysed after 90 h of high energy ball milling and after annealing of the powder for 72 h at 1050°C in vacuo. The iridium monoboride (IrB) orthorhombic phase was synthesised experimentally for the first time and identified by powder X-ray diffraction. Additionally, the ReB 2 type IrB 2 hexagonal phase was also produced for the first time and identified by high resolution transmission electron microscope. Irmore » segregation along disordered domains of the boron lattice was found to occur during high temperature annealing. Furthermore, these nanodomains may have useful catalytic properties.« less

  10. 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...

  11. Variation in standards of research compensation and child assent practices: a comparison of 69 institutional review board-approved informed permission and assent forms for 3 multicenter pediatric clinical trials.

    PubMed

    Kimberly, Michael B; Hoehn, K Sarah; Feudtner, Chris; Nelson, Robert M; Schreiner, Mark

    2006-05-01

    To systematically compare standards for compensation and child participant assent in informed permission, assent, and consent forms (IP-A-CFs) approved by 55 local institutional review boards (IRBs) reviewing 3 standardized multicenter research protocols. Sixty-nine principal investigators participating in any of 3 national, multicenter clinical trials submitted standardized research protocols for their trials to their local IRBs for approval. Copies of the subsequently IRB-approved IP-A-CFs were then forwarded to an academic clinical research organization. This collection of IRB-approved forms allowed for a quasiexperimental retrospective evaluation of the variation in informed permission, assent, and consent standards operationalized by the local IRBs. Standards for compensation and child participant assent varied substantially across 69 IRB-approved IP-A-CFs. Among the 48 IP-A-CFs offering compensation, monetary compensation was offered by 33 as reimbursement for travel, parking, or food expenses, whereas monetary or material compensation was offered by 22 for subject inconvenience and by 13 for subject time. Compensation ranged widely within and across studies (study 1, $180-1425; study 2, $0-500; and study 3, $0-100). Regarding child participant assent, among the 57 IP-A-CFs that included a form of assent documentation, 33 included a line for assent on the informed permission or consent form, whereas 35 included a separate form written in simplified language. Of the IP-A-CFs that stipulated the documentation of assent, 31 specified > or =1 age ranges for obtaining assent. Informed permission or consent forms were addressed either to parents or child participants. In response to identical clinical trial protocols, local IRBs generate IP-A-CFs that vary considerably regarding compensation and child participant assent.

  12. The Harvard Catalyst Common Reciprocal IRB Reliance Agreement: An Innovative Approach to Multisite IRB Review and Oversight

    PubMed Central

    Winkler, Sabune J.; Witte, Elizabeth

    2014-01-01

    Abstract Reduction of duplicative Institutional Review Board (IRB) review for multiinstitutional studies is a desirable goal to improve IRB efficiency while enhancing human subject protections. Here we describe the Harvard Catalyst Master Reciprocal Common IRB Reliance Agreement (MRA), a system that provides a legal framework for IRB reliance, with the potential to streamline IRB review processes and reduce administrative burden and barriers to collaborative, multiinstitutional research. The MRA respects the legal autonomy of the signatory institutions while offering a pathway to eliminate duplicative IRB review when appropriate. The Harvard Catalyst MRA provides a robust and flexible model for reciprocal reliance that is both adaptable and scalable. PMID:25196592

  13. The Harvard Catalyst Common Reciprocal IRB Reliance Agreement: an innovative approach to multisite IRB review and oversight.

    PubMed

    Winkler, Sabune J; Witte, Elizabeth; Bierer, Barbara E

    2015-02-01

    Reduction of duplicative Institutional Review Board (IRB) review for multiinstitutional studies is a desirable goal to improve IRB efficiency while enhancing human subject protections. Here we describe the Harvard Catalyst Master Reciprocal Common IRB Reliance Agreement (MRA), a system that provides a legal framework for IRB reliance, with the potential to streamline IRB review processes and reduce administrative burden and barriers to collaborative, multiinstitutional research. The MRA respects the legal autonomy of the signatory institutions while offering a pathway to eliminate duplicative IRB review when appropriate. The Harvard Catalyst MRA provides a robust and flexible model for reciprocal reliance that is both adaptable and scalable. © 2014 Wiley Periodicals, Inc.

  14. 14 CFR 1230.107 - IRB membership.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  15. 40 CFR 26.1107 - IRB membership.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... the diversity of the members, including consideration of race, gender, and cultural backgrounds and... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  16. 40 CFR 26.1107 - IRB membership.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... the diversity of the members, including consideration of race, gender, and cultural backgrounds and... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  17. 14 CFR 1230.107 - IRB membership.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  18. 40 CFR 26.1107 - IRB membership.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... the diversity of the members, including consideration of race, gender, and cultural backgrounds and... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  19. 34 CFR 97.107 - IRB membership.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  20. 22 CFR 225.107 - IRB membership.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  1. 28 CFR 46.107 - IRB membership.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  2. 40 CFR 26.107 - IRB membership.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  3. 15 CFR 27.107 - IRB membership.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  4. 49 CFR 11.107 - IRB membership.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  5. 49 CFR 11.107 - IRB membership.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  6. 28 CFR 46.107 - IRB membership.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  7. 34 CFR 97.107 - IRB membership.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  8. 15 CFR 27.107 - IRB membership.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  9. 22 CFR 225.107 - IRB membership.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  10. 16 CFR 1028.107 - IRB membership.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  11. 40 CFR 26.107 - IRB membership.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  12. 22 CFR 225.107 - IRB membership.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  13. 15 CFR 27.107 - IRB membership.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  14. Is Your Ethics Committee Efficient? Using “IRB Metrics” as a Self-Assessment Tool for Continuous Improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand

    PubMed Central

    Adams, Pornpimon; Kaewkungwal, Jaranit; Limphattharacharoen, Chanthima; Prakobtham, Sukanya; Pengsaa, Krisana; Khusmith, Srisin

    2014-01-01

    Tensions between researchers and ethics committees have been reported in several institutions. Some reports suggest researchers lack confidence in the quality of institutional review board (IRB) reviews, and that emphasis on strict procedural compliance and ethical issues raised by the IRB might unintentionally lead to delays in correspondence between researchers and ethics committees, and/or even encourage prevarication/equivocation, if researchers perceive committee concerns and criticisms unjust. This study systematically analyzed the efficiency of different IRB functions, and the relationship between efficiency and perceived quality of the decision-making process. The major purposes of this study were thus (1) to use the IRB Metrics developed by the Faculty of Tropical Medicine, Mahidol University, Thailand (FTM-EC) to assess the operational efficiency and perceived effectiveness of its ethics committees, and (2) to determine ethical issues that may cause the duration of approval process to be above the target limit of 60 days. Based on a literature review of definitions and methods used and proposed for use, in assessing aspects of IRB quality, an “IRB Metrics” was developed to assess IRB processes using a structure-process-outcome measurement model. To observe trends in the indicators evaluated, data related to all protocols submitted to the two panels of the FTM-EC (clinical and non-clinical), between January 2010–September 2013, were extracted and analyzed. Quantitative information based on IRB Metrics structure-process-outcome illuminates different areas for internal-process improvement. Ethical issues raised with researchers by the IRB, which were associated with the duration of the approval process in protocol review, could be considered root causes of tensions between the parties. The assessment of IRB structure-process-outcome thus provides a valuable opportunity to strengthen relationships and reduce conflicts between IRBs and researchers, with

  15. 28 CFR 46.115 - IRB records.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false IRB records. 46.115 Section 46.115 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.115 IRB records... IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific...

  16. 28 CFR 46.115 - IRB records.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false IRB records. 46.115 Section 46.115 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.115 IRB records... IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific...

  17. 16 CFR 1028.115 - IRB records.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false IRB records. 1028.115 Section 1028.115... records. (a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific...

  18. 16 CFR 1028.115 - IRB records.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false IRB records. 1028.115 Section 1028.115... records. (a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific...

  19. 28 CFR 46.115 - IRB records.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false IRB records. 46.115 Section 46.115 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.115 IRB records... IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific...

  20. 15 CFR 27.115 - IRB records.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 15 Commerce and Foreign Trade 1 2013-01-01 2013-01-01 false IRB records. 27.115 Section 27.115... records. (a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific...

  1. 32 CFR 219.107 - IRB membership.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 2 2014-07-01 2014-07-01 false IRB membership. 219.107 Section 219.107 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.107 IRB membership. (a) Each IRB shall have at least five members, with...

  2. 45 CFR 690.115 - IRB records.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 3 2013-10-01 2013-10-01 false IRB records. 690.115 Section 690.115 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.115 IRB records. (a) An institution, or when appropriate an IRB, shall prepare and maintain...

  3. 16 CFR 1028.115 - IRB records.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific... changes in or disapproving research; and a written summary of the discussion of controverted issues and... the IRB and the investigators. (5) A list of IRB members in the same detail as described is § 1028.103...

  4. 28 CFR 46.115 - IRB records.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific... changes in or disapproving research; and a written summary of the discussion of controverted issues and... the IRB and the investigators. (5) A list of IRB members in the same detail as described is § 46.103(b...

  5. 28 CFR 46.115 - IRB records.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific... changes in or disapproving research; and a written summary of the discussion of controverted issues and... the IRB and the investigators. (5) A list of IRB members in the same detail as described is § 46.103(b...

  6. 40 CFR 26.1107 - IRB membership.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... the diversity of the members, including consideration of race, gender, and cultural backgrounds and... the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  7. 40 CFR 26.1107 - IRB membership.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... the diversity of the members, including consideration of race, gender, and cultural backgrounds and... the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  8. 14 CFR 1230.107 - IRB membership.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as... the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  9. 14 CFR 1230.107 - IRB membership.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as... the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  10. 10 CFR 745.115 - IRB records.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false IRB records. 745.115 Section 745.115 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.115 IRB records. (a) An institution, or when appropriate an IRB... of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals...

  11. 34 CFR 97.115 - IRB records.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 1 2011-07-01 2011-07-01 false IRB records. 97.115 Section 97.115 Education Office of... of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.115 IRB records... IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific...

  12. 40 CFR 26.115 - IRB records.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 1 2013-07-01 2013-07-01 false IRB records. 26.115 Section 26.115... Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26.115 IRB records... IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific...

  13. 10 CFR 745.115 - IRB records.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false IRB records. 745.115 Section 745.115 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.115 IRB records. (a) An institution, or when appropriate an IRB... of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals...

  14. 40 CFR 26.115 - IRB records.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 1 2012-07-01 2012-07-01 false IRB records. 26.115 Section 26.115... Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26.115 IRB records... IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific...

  15. 34 CFR 97.115 - IRB records.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 1 2012-07-01 2012-07-01 false IRB records. 97.115 Section 97.115 Education Office of... of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.115 IRB records... IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific...

  16. 15 CFR 27.115 - IRB records.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific... changes in or disapproving research; and a written summary of the discussion of controverted issues and... the IRB and the investigators. (5) A list of IRB members in the same detail as described is § 27.103(b...

  17. 22 CFR 225.107 - IRB membership.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  18. 49 CFR 11.107 - IRB membership.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  19. 49 CFR 11.107 - IRB membership.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  20. 40 CFR 26.107 - IRB membership.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  1. 22 CFR 225.107 - IRB membership.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  2. 16 CFR 1028.107 - IRB membership.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  3. 16 CFR 1028.107 - IRB membership.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  4. 40 CFR 26.107 - IRB membership.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  5. 34 CFR 97.107 - IRB membership.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  6. 15 CFR 27.107 - IRB membership.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  7. 34 CFR 97.107 - IRB membership.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  8. 15 CFR 27.107 - IRB membership.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  9. 28 CFR 46.107 - IRB membership.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  10. 28 CFR 46.107 - IRB membership.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes... the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB...

  11. 45 CFR 46.107 - IRB membership.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote... consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB shall include at least one...

  12. 45 CFR 46.107 - IRB membership.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ..., gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote... consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB shall include at least one...

  13. 10 CFR 745.109 - IRB review of research.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false IRB review of research. 745.109 Section 745.109 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.109 IRB review of research. (a) An IRB shall review... research activities covered by this policy. (b) An IRB shall require that information given to subjects as...

  14. 10 CFR 745.109 - IRB review of research.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false IRB review of research. 745.109 Section 745.109 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.109 IRB review of research. (a) An IRB shall review... research activities covered by this policy. (b) An IRB shall require that information given to subjects as...

  15. How IRBs View and Make Decisions About Consent Forms

    PubMed Central

    Klitzman, Robert L.

    2013-01-01

    IRBs have been criticized for long and complicated consent forms, but how IRBs make decisions about these issues hasn’t been examined. I contacted leaders of 60 IRBs, and interviewed IRB leaders from 34 (response rate = 55%), and 13 members and administrators. IRBs confront challenges and dilemmas regarding these documents: what and how much these forms should include (e.g., how “perfect” forms should be). While IRBs generally seek to decrease the length and complexity, institutions and industry funders often want these forms to be legal documents. IRBs may also “nitpick” these documents without realizing the costs. This study, the first to explore how IRBs view and make decisions about consent forms, suggests underlying tensions, ambiguities, and subjectivities that have important implications for future policy, practice, education, and research. PMID:23485667

  16. 16 CFR § 1028.115 - IRB records.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false IRB records. § 1028.115 Section § 1028.115... records. (a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific...

  17. 12 CFR 550.80 - How do I obtain OTS approval?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 5 2011-01-01 2011-01-01 false How do I obtain OTS approval? 550.80 Section 550.80 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY FIDUCIARY POWERS OF SAVINGS ASSOCIATIONS Obtaining Fiduciary Powers § 550.80 How do I obtain OTS approval? You must file an...

  18. 12 CFR 550.80 - How do I obtain OTS approval?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 5 2010-01-01 2010-01-01 false How do I obtain OTS approval? 550.80 Section 550.80 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY FIDUCIARY POWERS OF SAVINGS ASSOCIATIONS Obtaining Fiduciary Powers § 550.80 How do I obtain OTS approval? You must file an...

  19. 7 CFR 1c.107 - IRB membership.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to... consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB shall include at least one...

  20. 7 CFR 1c.107 - IRB membership.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to... consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB shall include at least one...

  1. 45 CFR 46.107 - IRB membership.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ..., gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote... gender. No IRB may consist entirely of members of one profession. (c) Each IRB shall include at least one...

  2. 45 CFR 46.107 - IRB membership.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ..., gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote... gender. No IRB may consist entirely of members of one profession. (c) Each IRB shall include at least one...

  3. Public health practice vs research: implications for preparedness and disaster research review by State Health Department IRBs.

    PubMed

    Perlman, David

    2008-10-01

    Under the current US Department of Health and Human Services regulatory and ethical system for research involving human subjects, research is defined in terms of several key concepts: intent, systematic investigation, and generalizability. If an investigator engages in a systematic investigation designed or intended to contribute to generalizable knowledge, then he or she is engaged in research. If that research involves living individuals and the investigator will either interact or intervene with people or obtain their identifiable personal information, then the research must be prospectively reviewed by an institutional review board (IRB), a federally mandated committee that ensures the ethical and regulatory appropriateness of proposed research. In public health institutions, and especially at state departments of health, this definition of research may prove vexing for determining when particular public health activities must be reviewed by IRBs. This article outlines several reasons for such vexation and 2 key responses from major public health stakeholders. In the current climate of public health preparedness initiatives at state health departments for disasters and bioterrorism, how research is defined vis-à-vis public health interventions may add even more confusion to preparedness initiatives and pose difficulties in determining when IRB review and the added protections it affords are appropriate. This article suggests several practical ways to avoid confusion and attempts to strike a balance between the need for expeditious approvals of research-based responses to public health disasters and to ensure proper protections for human subjects at state health departments. It is hoped that these suggestions can assist not only state health departments but also academically based researchers who either collaborate with those departments or whose research will need to be reviewed by their IRBs.

  4. 21 CFR 56.107 - IRB membership.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... of its members, and the diversity of the members, including consideration of race, gender, cultural... gender. No IRB may consist entirely of members of one profession. (c) Each IRB shall include at least one...

  5. 45 CFR 690.107 - IRB membership.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity... no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one...

  6. 45 CFR 690.107 - IRB membership.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity... no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one...

  7. 38 CFR 16.107 - IRB membership.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity... no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one...

  8. 38 CFR 16.107 - IRB membership.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity... no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one...

  9. 38 CFR 16.107 - IRB membership.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity... no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one...

  10. 10 CFR 745.107 - IRB membership.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons... qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB...

  11. Local IRBs vs. federal agencies: shifting dynamics, systems, and relationships.

    PubMed

    Klitzman, Robert L

    2012-07-01

    How IRBs relate to federal agencies, and the implications of these relationships, have received little, if any, systematic study. I interviewed 46 IRB chairs, directors, administrators, and members, contacting the leadership of 60 U.S. IRBs (every fourth one in the list of the top 240 institutions by NIH funding), interviewing IRB leaders from 34 (response rate=55%). IRBs describe complex direct and indirect relationships with federal agencies that affect IRBs through audits, guidance documents, and other communications, and can generate problems and challenges. Researchers often blame IRBs for frustrations, but IRBs often serve as the "local face" of federal regulations and agencies and are "stuck in the middle." These data have critical implications for policy, practice, and research.

  12. 32 CFR 219.107 - IRB membership.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... members, and the diversity of the members, including consideration of race, gender, and cultural... qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB...

  13. 32 CFR 219.107 - IRB membership.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... members, and the diversity of the members, including consideration of race, gender, and cultural... qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB...

  14. 32 CFR 219.107 - IRB membership.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB... members, and the diversity of the members, including consideration of race, gender, and cultural...

  15. 32 CFR 219.107 - IRB membership.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB... members, and the diversity of the members, including consideration of race, gender, and cultural...

  16. Development of a Device for Objective Assessment of Tinnitus in Humans

    DTIC Science & Technology

    2017-10-01

    develop and refine the Gap Device and testing methodology . In the third year of the grant, we began to conduct a multisite research study to...in the last quarter of 2016. Secured IRB approvals for all study sites (SIU, Portland VA, Madigan Army Medical Center). HRPO approvals obtained for all... study sites. IRB Continuing Review (CR) and HRPO CR approvals also obtained for SIU and PVA. MAMC IRB CR and HRPO CR approvals are not due until

  17. 21 CFR 56.107 - IRB membership.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... of its members, and the diversity of the members, including consideration of race, gender, cultural... qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB...

  18. 21 CFR 56.107 - IRB membership.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB... of its members, and the diversity of the members, including consideration of race, gender, cultural...

  19. 21 CFR 56.107 - IRB membership.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB... of its members, and the diversity of the members, including consideration of race, gender, cultural...

  20. 10 CFR 745.107 - IRB membership.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... expertise of its members, and the diversity of the members, including consideration of race, gender, and... qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB...

  1. 10 CFR 745.107 - IRB membership.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... expertise of its members, and the diversity of the members, including consideration of race, gender, and... qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB...

  2. 10 CFR 745.107 - IRB membership.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB... expertise of its members, and the diversity of the members, including consideration of race, gender, and...

  3. 10 CFR 745.107 - IRB membership.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB... expertise of its members, and the diversity of the members, including consideration of race, gender, and...

  4. 21 CFR 56.104 - Exemptions from IRB requirement.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... INSTITUTIONAL REVIEW BOARDS General Provisions § 56.104 Exemptions from IRB requirement. The following categories of clinical investigations are exempt from the requirements of this part for IRB review: (a) Any investigation which commenced before July 27, 1981 and was subject to requirements for IRB review under FDA...

  5. 21 CFR 56.104 - Exemptions from IRB requirement.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... INSTITUTIONAL REVIEW BOARDS General Provisions § 56.104 Exemptions from IRB requirement. The following categories of clinical investigations are exempt from the requirements of this part for IRB review: (a) Any investigation which commenced before July 27, 1981 and was subject to requirements for IRB review under FDA...

  6. 21 CFR 56.104 - Exemptions from IRB requirement.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... INSTITUTIONAL REVIEW BOARDS General Provisions § 56.104 Exemptions from IRB requirement. The following categories of clinical investigations are exempt from the requirements of this part for IRB review: (a) Any investigation which commenced before July 27, 1981 and was subject to requirements for IRB review under FDA...

  7. 21 CFR 56.104 - Exemptions from IRB requirement.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... INSTITUTIONAL REVIEW BOARDS General Provisions § 56.104 Exemptions from IRB requirement. The following categories of clinical investigations are exempt from the requirements of this part for IRB review: (a) Any investigation which commenced before July 27, 1981 and was subject to requirements for IRB review under FDA...

  8. 34 CFR 97.108 - IRB functions and operations.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false IRB functions and operations. 97.108 Section 97.108 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for... IRB functions and operations. In order to fulfill the requirements of this policy each IRB shall: (a...

  9. 45 CFR 690.109 - IRB review of research.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 3 2013-10-01 2013-10-01 false IRB review of research. 690.109 Section 690.109 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.109 IRB review of research. (a) An IRB shall review and have authority to...

  10. 45 CFR 690.109 - IRB review of research.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 3 2014-10-01 2014-10-01 false IRB review of research. 690.109 Section 690.109 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.109 IRB review of research. (a) An IRB shall review and have authority to...

  11. 45 CFR 690.109 - IRB review of research.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 3 2012-10-01 2012-10-01 false IRB review of research. 690.109 Section 690.109 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.109 IRB review of research. (a) An IRB shall review and have authority to...

  12. 45 CFR 690.109 - IRB review of research.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 3 2010-10-01 2010-10-01 false IRB review of research. 690.109 Section 690.109 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.109 IRB review of research. (a) An IRB shall review and have authority to...

  13. 40 CFR 26.1108 - IRB functions and operations.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Exposure of Non-pregnant, Non-nursing Adults § 26.1108 IRB functions and operations. In order to fulfill... 40 Protection of Environment 1 2013-07-01 2013-07-01 false IRB functions and operations. 26.1108... members of the IRB are present, including at least one member whose primary concerns are in nonscientific...

  14. 40 CFR 26.1108 - IRB functions and operations.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Exposure of Non-pregnant, Non-nursing Adults § 26.1108 IRB functions and operations. In order to fulfill... 40 Protection of Environment 1 2012-07-01 2012-07-01 false IRB functions and operations. 26.1108... members of the IRB are present, including at least one member whose primary concerns are in nonscientific...

  15. 40 CFR 26.1108 - IRB functions and operations.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Exposure of Non-pregnant, Non-nursing Adults § 26.1108 IRB functions and operations. In order to fulfill... 40 Protection of Environment 1 2011-07-01 2011-07-01 false IRB functions and operations. 26.1108... members of the IRB are present, including at least one member whose primary concerns are in nonscientific...

  16. 40 CFR 26.1108 - IRB functions and operations.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Exposure of Non-pregnant, Non-nursing Adults § 26.1108 IRB functions and operations. In order to fulfill... 40 Protection of Environment 1 2010-07-01 2010-07-01 false IRB functions and operations. 26.1108... members of the IRB are present, including at least one member whose primary concerns are in nonscientific...

  17. 40 CFR 26.1108 - IRB functions and operations.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Exposure of Non-pregnant, Non-nursing Adults § 26.1108 IRB functions and operations. In order to fulfill... 40 Protection of Environment 1 2014-07-01 2014-07-01 false IRB functions and operations. 26.1108... members of the IRB are present, including at least one member whose primary concerns are in nonscientific...

  18. 40 CFR 26.115 - IRB records.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific... Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26.115 IRB records... changes in or disapproving research; and a written summary of the discussion of controverted issues and...

  19. 10 CFR 745.115 - IRB records.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals..., against, and abstaining; the basis for requiring changes in or disapproving research; and a written... activities. (4) Copies of all correspondence between the IRB and the investigators. (5) A list of IRB members...

  20. 10 CFR 745.115 - IRB records.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals..., against, and abstaining; the basis for requiring changes in or disapproving research; and a written... activities. (4) Copies of all correspondence between the IRB and the investigators. (5) A list of IRB members...

  1. 40 CFR 26.115 - IRB records.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific... Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26.115 IRB records... changes in or disapproving research; and a written summary of the discussion of controverted issues and...

  2. 34 CFR 97.115 - IRB records.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 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) § 97.115 IRB records... in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these...

  3. 45 CFR 46.109 - IRB review of research.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 1 2014-10-01 2014-10-01 false IRB review of research. 46.109 Section 46.109... SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.109 IRB review of research. (a) An... disapprove all research activities covered by this policy. (b) An IRB shall require that information given to...

  4. 45 CFR 46.115 - IRB records.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 1 2011-10-01 2011-10-01 false IRB records. 46.115 Section 46.115 Public Welfare... for Protection of Human Research Subjects § 46.115 IRB records. (a) An institution, or when... following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the...

  5. 38 CFR 16.107 - IRB membership.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity... entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one...

  6. 45 CFR 690.107 - IRB membership.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity... entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one...

  7. 45 CFR 690.107 - IRB membership.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity... entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one...

  8. 38 CFR 16.107 - IRB membership.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity... entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one...

  9. 49 CFR 11.115 - IRB records.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 1 2012-10-01 2012-10-01 false IRB records. 11.115 Section 11.115 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.115 IRB records. (a) An..., including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that...

  10. 45 CFR 46.115 - IRB records.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 1 2012-10-01 2012-10-01 false IRB records. 46.115 Section 46.115 Public Welfare... for Protection of Human Research Subjects § 46.115 IRB records. (a) An institution, or when... following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the...

  11. 45 CFR 46.115 - IRB records.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 1 2013-10-01 2013-10-01 false IRB records. 46.115 Section 46.115 Public Welfare... for Protection of Human Research Subjects § 46.115 IRB records. (a) An institution, or when... following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the...

  12. 45 CFR 46.115 - IRB records.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 1 2014-10-01 2014-10-01 false IRB records. 46.115 Section 46.115 Public Welfare... for Protection of Human Research Subjects § 46.115 IRB records. (a) An institution, or when... following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the...

  13. 49 CFR 11.115 - IRB records.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 1 2013-10-01 2013-10-01 false IRB records. 11.115 Section 11.115 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.115 IRB records. (a) An..., including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that...

  14. 7 CFR 1c.107 - IRB membership.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to... gender. No IRB may consist entirely of members of one profession. (c) Each IRB shall include at least one...

  15. 7 CFR 1c.107 - IRB membership.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to... gender. No IRB may consist entirely of members of one profession. (c) Each IRB shall include at least one...

  16. 7 CFR 1c.107 - IRB membership.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to... gender. No IRB may consist entirely of members of one profession. (c) Each IRB shall include at least one...

  17. 16 CFR § 1028.107 - IRB membership.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to... no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one...

  18. 14 CFR § 1230.107 - IRB membership.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... members, and the diversity of the members, including consideration of race, gender, and cultural... qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB...

  19. 10 CFR 20.2002 - Method for obtaining approval of proposed disposal procedures.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Method for obtaining approval of proposed disposal procedures. 20.2002 Section 20.2002 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2002 Method for obtaining approval of proposed disposal procedures. A licensee...

  20. 10 CFR 20.2002 - Method for obtaining approval of proposed disposal procedures.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Method for obtaining approval of proposed disposal procedures. 20.2002 Section 20.2002 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2002 Method for obtaining approval of proposed disposal procedures. A licensee...

  1. 10 CFR 20.2002 - Method for obtaining approval of proposed disposal procedures.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Method for obtaining approval of proposed disposal procedures. 20.2002 Section 20.2002 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2002 Method for obtaining approval of proposed disposal procedures. A licensee...

  2. 10 CFR 20.2002 - Method for obtaining approval of proposed disposal procedures.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Method for obtaining approval of proposed disposal procedures. 20.2002 Section 20.2002 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2002 Method for obtaining approval of proposed disposal procedures. A licensee...

  3. 10 CFR 20.2002 - Method for obtaining approval of proposed disposal procedures.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Method for obtaining approval of proposed disposal procedures. 20.2002 Section 20.2002 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2002 Method for obtaining approval of proposed disposal procedures. A licensee...

  4. 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.

  5. 7 CFR 1c.115 - IRB records.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 1 2013-01-01 2013-01-01 false IRB records. 1c.115 Section 1c.115 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.115 IRB records. (a) An institution..., including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that...

  6. 30 CFR 20.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.0 Compliance with the requirements necessary for obtaining approval. To receive approval of MSHA for any electric mine lamps other than standard cap lamps a manufacturer must comply with the...

  7. 30 CFR 20.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.0 Compliance with the requirements necessary for obtaining approval. To receive approval of MSHA for any electric mine lamps other than standard cap lamps a manufacturer must comply with the...

  8. 30 CFR 20.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.0 Compliance with the requirements necessary for obtaining approval. To receive approval of MSHA for any electric mine lamps other than standard cap lamps a manufacturer must comply with the...

  9. 30 CFR 20.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.0 Compliance with the requirements necessary for obtaining approval. To receive approval of MSHA for any electric mine lamps other than standard cap lamps a manufacturer must comply with the...

  10. Leveraging Semantic Knowledge in IRB Databases to Improve Translation Science

    PubMed Central

    Hurdle, John F.; Botkin, Jeffery; Rindflesch, Thomas C.

    2007-01-01

    We introduce the notion that research administrative databases (RADs), such as those increasingly used to manage information flow in the Institutional Review Board (IRB), offer a novel, useful, and mine-able data source overlooked by informaticists. As a proof of concept, using an IRB database we extracted all titles and abstracts from system startup through January 2007 (n=1,876); formatted these in a pseudo-MEDLINE format; and processed them through the SemRep semantic knowledge extraction system. Even though SemRep is tuned to find semantic relations in MEDLINE citations, we found that it performed comparably well on the IRB texts. When adjusted to eliminate non-healthcare IRB submissions (e.g., economic and education studies), SemRep extracted an average of 7.3 semantic relations per IRB abstract (compared to an average of 11.1 for MEDLINE citations) with a precision of 70% (compared to 78% for MEDLINE). We conclude that RADs, as represented by IRB data, are mine-able with existing tools, but that performance will improve as these tools are tuned for RAD structures. PMID:18693856

  11. 30 CFR 250.410 - How do I obtain approval to drill a well?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations Applying for A Permit to Drill § 250.410 How do I obtain approval to drill a well? You must obtain written... 30 Mineral Resources 2 2010-07-01 2010-07-01 false How do I obtain approval to drill a well? 250...

  12. From anonymity to "open doors": IRB responses to tensions with researchers.

    PubMed

    Klitzman, Robert

    2012-07-03

    Tensions between IRBs and researchers in the US and elsewhere have increased, and may affect whether, how, and to what degree researchers comply with ethical guidelines. Yet whether, how, when, and why IRBs respond to these conflicts have received little systematic attention. I contacted 60 US IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed leaders from 34 (response rate = 55%) and an additional 12 members and administrators. IRBs often try to respond to tensions with researchers and improve relationships in several ways, but range widely in how, when, and to what degree (e.g., in formal and informal structure, content, and tone of interactions). IRBs varied from open and accessible to more distant and anonymous, and in the amount and type of "PR work" and outreach they do. Many boards seek to improve the quantity, quality, and helpfulness of communication with PIs, but differ in how. IRBs range in meetings from open to closed, and may have clinics and newsletters. Memos can vary in helpfulness and tone (e.g., using "charm"). IRBs range considerably, too, in the degrees to which they seek to educate PIs, showing them the underlying ethical principles. But these efforts take time and resources, and IRBs thus vary in degrees of responses to PI complaints. This study, the first to explore the mechanisms through which IRBs respond to tensions and interactions with PIs, suggests that these committees seek to respond to conflicts with PIs in varying ways - both formal and informal, involving both the form and content of communications. This study has important implications for future practice, research, and policy, suggesting needs for increased attention to not only what IRBs communicate to PIs, but how (i.e., the tone and the nature of interactions). IRBs can potentially improve relationships with PIs in several ways: using more "open doors" rather than anonymity, engaging in outreach (e.g., through clinics), enhancing

  13. 32 CFR 219.108 - IRB functions and operations.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 2 2014-07-01 2014-07-01 false IRB functions and operations. 219.108 Section 219.108 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.108 IRB functions and operations. In order to...

  14. 32 CFR 219.108 - IRB functions and operations.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 2 2010-07-01 2010-07-01 false IRB functions and operations. 219.108 Section 219.108 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.108 IRB functions and operations. In order to...

  15. 45 CFR 690.108 - IRB functions and operations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 3 2010-10-01 2010-10-01 false IRB functions and operations. 690.108 Section 690.108 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.108 IRB functions and operations. In order to fulfill the requirements of...

  16. 40 CFR 26.109 - IRB review of research.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 26.109 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26.109 IRB... subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights...

  17. 34 CFR 97.109 - IRB review of research.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 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) § 97.109 IRB review... subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights...

  18. 45 CFR 46.109 - IRB review of research.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 1 2013-10-01 2013-10-01 false IRB review of research. 46.109 Section 46.109 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.109 IRB review of research. (a) An...

  19. 45 CFR 46.109 - IRB review of research.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 1 2012-10-01 2012-10-01 false IRB review of research. 46.109 Section 46.109 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.109 IRB review of research. (a) An...

  20. 45 CFR 46.109 - IRB review of research.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 1 2011-10-01 2011-10-01 false IRB review of research. 46.109 Section 46.109 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.109 IRB review of research. (a) An...

  1. 21 CFR 56.104 - Exemptions from IRB requirement.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Exemptions from IRB requirement. 56.104 Section 56.104 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... categories of clinical investigations are exempt from the requirements of this part for IRB review: (a) Any...

  2. The Myth of Community Differences as the Cause of Variations Among IRBs

    PubMed Central

    Klitzman, Robert

    2013-01-01

    Background Although variations among institutional review boards (IRBs) have been documented for 30 years, they continue, raising crucial questions as to why they persist as well as how IRBs view and respond to these variations. Methods In-depth, 2-hour interviews were conducted with 46 IRB chairs, administrators, and members. The leadership of 60 U.S. IRBs were contacted (every fourth one in the list of the top 240 institutions by NIH funding). IRB leaders from 34 of these institutions were interviewed (response rate = 55%). Results The interviewees suggest that differences often persist because IRBs think these are legitimate, and regulations permit variations due to differing “community values.” Yet, these variations frequently appear to stem more from differences in institutional and subjective personality factors, and from “more eyes” examining protocols, trying to foresee all potential future logistical problems, than from the values of the communities from which research participants are drawn. However, IRBs generally appear to defend these variations as reflecting underlying differences in community norms. Conclusions These data pose critical questions for policy and practice. Attitudinal changes and education among IRBs, principal investigators (PIs), policymakers, and others and research concerning these issues are needed. PMID:25285236

  3. How IRBs view and make decisions about coercion and undue influence.

    PubMed

    Klitzman, Robert

    2013-04-01

    Scholars have debated how to define coercion and undue influence, but how institutional review boards (IRBs) view and make decisions about these issues in actual cases has not been explored. I contacted the leadership of 60 US IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health funding), and interviewed 39 IRB leaders or administrators from 34 of these institutions (response rate=55%), and 7 members. IRBs wrestled with defining of 'coercion' and 'undue inducement', most notably in deciding about participant compensation. IRBs often use these terms synonymously and define undue inducement in varying ways, often wrestling with these issues, relying on 'gut feelings', and seeking compromises. Ambiguities arose, partly reflecting underlying tensions: whether subjects should 'get paid' versus 'volunteer' (ie, whether subjects should be motivated by compensation vs altruism), and whether subjects should be paid differently based on income, given possible resultant selection bias. Lack of consistent standards emerged between and even on single IRBs. Questions arose concerning certain aspects and types of studies; for example, how to view and weigh providing free care in research, whether and how recruitment flyers should mention compensation, and how to avoid coercion in paediatric, developing world, or students research. These data, the first to probe qualitatively how IRBs view and approach questions about coercion, undue influence and participant compensation, and to examine how IRBs have reviewed actual cases, reveal several critical ambiguities and dilemmas, and have vital implications for future practice, education, policy and research.

  4. 30 CFR 250.410 - How do I obtain approval to drill a well?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 2 2013-07-01 2013-07-01 false How do I obtain approval to drill a well? 250... THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations Applying for A Permit to Drill § 250.410 How do I obtain approval to drill a well? You...

  5. 30 CFR 250.410 - How do I obtain approval to drill a well?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 2 2014-07-01 2014-07-01 false How do I obtain approval to drill a well? 250... THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations Applying for A Permit to Drill § 250.410 How do I obtain approval to drill a well? You...

  6. 30 CFR 250.410 - How do I obtain approval to drill a well?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 2 2011-07-01 2011-07-01 false How do I obtain approval to drill a well? 250..., DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations Applying for A Permit to Drill § 250.410 How do I obtain approval to drill a...

  7. 30 CFR 250.410 - How do I obtain approval to drill a well?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 2 2012-07-01 2012-07-01 false How do I obtain approval to drill a well? 250... THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations Applying for A Permit to Drill § 250.410 How do I obtain approval to drill a well? You...

  8. 5 CFR 412.301 - Obtaining approval to conduct a Senior Executive Service candidate development program (SESCDP).

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Obtaining approval to conduct a Senior... DEVELOPMENT Senior Executive Service Candidate Development Programs § 412.301 Obtaining approval to conduct a Senior Executive Service candidate development program (SESCDP). (a) An SESCDP is an OPM-approved...

  9. 45 CFR 46.502 - What information must be provided when registering an IRB?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...) of the institution or organization operating the IRB(s); and the name, mailing address, phone number..., phone number, facsimile number, and electronic mail address of the contact person providing the... IRB's mailing address, street address (if different from the mailing address), phone number, facsimile...

  10. 45 CFR 46.502 - What information must be provided when registering an IRB?

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...) of the institution or organization operating the IRB(s); and the name, mailing address, phone number..., phone number, facsimile number, and electronic mail address of the contact person providing the... IRB's mailing address, street address (if different from the mailing address), phone number, facsimile...

  11. 45 CFR 46.502 - What information must be provided when registering an IRB?

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...) of the institution or organization operating the IRB(s); and the name, mailing address, phone number..., phone number, facsimile number, and electronic mail address of the contact person providing the... IRB's mailing address, street address (if different from the mailing address), phone number, facsimile...

  12. 45 CFR 46.502 - What information must be provided when registering an IRB?

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...) of the institution or organization operating the IRB(s); and the name, mailing address, phone number..., phone number, facsimile number, and electronic mail address of the contact person providing the... IRB's mailing address, street address (if different from the mailing address), phone number, facsimile...

  13. 45 CFR 46.502 - What information must be provided when registering an IRB?

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...) of the institution or organization operating the IRB(s); and the name, mailing address, phone number..., phone number, facsimile number, and electronic mail address of the contact person providing the... IRB's mailing address, street address (if different from the mailing address), phone number, facsimile...

  14. Ultrasound and the IRB

    ERIC Educational Resources Information Center

    Epstein, Melissa A.

    2005-01-01

    The purpose of this paper is to assist researchers in writing their research protocols and subject consent forms so that both the Institutional Review Board (IRB) and subjects are assured of the minimal risk associated with diagnostic B-scan ultrasound as it is used in speech research. There have been numerous epidemiological studies on fetal…

  15. Should Society Allow Research Ethics Boards to Be Run As For-Profit Enterprises?

    PubMed Central

    Emanuel, Ezekiel J; Lemmens, Trudo; Elliot, Carl

    2006-01-01

    Background to the debate: An important mechanism for protecting human research participants is the prior approval of a clinical study by a research ethics board, known in the United States as an institutional review board (IRB). Traditionally, IRBs have been run by volunteer committees of scientists and clinicians working in the academic medical centers where the studies they review are being carried out. However, for-profit organizations are increasingly being hired to conduct ethics reviews. Proponents of for-profit IRBs argue that these IRBs are just as capable as academic IRBs at providing high-quality ethics reviews. Critics argue that for-profit IRBs have a conflict of interest because they generate their income from clients who have a direct financial interest in obtaining approval. PMID:16848618

  16. Your IRB: Educating Students, Monitoring Student Research, and Safeguarding Students as Research Subjects

    ERIC Educational Resources Information Center

    Scheppler, Judy; Kolar, Christopher

    2008-01-01

    This article informs about the formation of a school's Institutional Review Board (IRB), presents examples of research that IRBs often encounter, elevates awareness of human subjects research concerns for faculty and staff, and discusses how emerging requirements for science competitions may affect schools, staff and students. An IRB is the group…

  17. IRBs, conflict and liability: will we see IRBs in court? Or is it when?

    PubMed

    Icenogle, Daniel L

    2003-01-01

    The entire human research infrastructure is under intense and increasing financial pressure. These pressures may have been responsible for several errors in judgment by those responsible for managing human research and protecting human subjects. The result of these errors has been some terrible accidents, some of which have cost the lives of human research volunteers. This, in turn, is producing both increased liability risk for those who manage the various aspects of human research and increasing scrutiny as to the capability of the human research protection structure as currently constituted. It is the author's contention that the current structure is fully capable of offering sufficient protection for participants in human research-if Institutional Review Board (IRB) staff and members are given sufficient resources and perform their tasks with sufficient responsibility. The status quo alternative is that IRBs and their members will find themselves at great risk of becoming defendants in lawsuits seeking compensation for damages resulting from human experimentation gone awry.

  18. 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.

  19. 45 CFR 690.107 - IRB membership.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... IRB regularly reviews research that involves a vulnerable category of subjects, such as children... entirely of women, including the institution's consideration of qualified persons of both sexes, so long as...

  20. An IRB Transformation: Increasing Quality and Efficiency Using Existing Resources

    ERIC Educational Resources Information Center

    Andrews, Joseph E., Jr.; Moore, J. Brian; Means, Paula; Weinberg, Richard

    2012-01-01

    In an effort to increase review-quality and efficiency, research administration at Wake Forest School of Medicine initiated a change in the operational structure of the Institutional Review Board (IRB) via a reconfiguring of the boards and rescheduling of the convened meetings. The number of IRB Panels was doubled and each panel/board began…

  1. Connected Vehicle Pilot Deployment Program Phase 1 : Human Use Approval Summary : New York City

    DOT National Transportation Integrated Search

    2016-08-04

    The New York City (NYC) Connected Vehicle (CV) Pilot Deployment will be the largest deployment of connected vehicle technology to date. The purpose of the human use approval activity is to apply the Institutional Review Board (IRB) process to the NYC...

  2. 21 CFR 56.107 - IRB membership.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled... consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of...

  3. 45 CFR 46.107 - IRB membership.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally... consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of...

  4. 22 CFR 225.115 - IRB records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of... this policy shall be retained for at least 3 years, and records relating to research which is conducted...

  5. 15 CFR 27.115 - IRB records.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these...)(5). (b) The records required by this policy shall be retained for at least 3 years, and records...

  6. An Analysis of Information Technology Adoption by IRBs of Large Academic Medical Centers in the United States.

    PubMed

    He, Shan; Botkin, Jeffrey R; Hurdle, John F

    2015-02-01

    The clinical research landscape has changed dramatically in recent years in terms of both volume and complexity. This poses new challenges for Institutional Review Boards' (IRBs) review efficiency and quality, especially at large academic medical centers. This article discusses the technical facets of IRB modernization. We analyzed the information technology used by IRBs in large academic institutions across the United States. We found that large academic medical centers have a high electronic IRB adoption rate; however, the capabilities of electronic IRB systems vary greatly. We discuss potential use-cases of a fully exploited electronic IRB system that promise to streamline the clinical research work flow. The key to that approach utilizes a structured and standardized information model for the IRB application. © The Author(s) 2014.

  7. Informed consent and genomic incidental findings: IRB chair perspectives.

    PubMed

    Simon, Christian M; Williams, Janet K; Shinkunas, Laura; Brandt, Debra; Daack-Hirsch, Sandra; Driessnack, Martha

    2011-12-01

    It is unclear how genomic incidental finding (GIF) prospects should be addressed in informed consent processes. An exploratory study on this topic was conducted with 34 purposively sampled Chairs of institutional review boards (IRBs) at centers conducting genome-wide association studies. Most Chairs (96%) reported no knowledge of local IRB requirements regarding GIFs and informed consent. Chairs suggested consent processes should address the prospect of, and study disclosure policy on, GIFs; GIF management and follow-up; potential clinical significance of GIFs; potential risks of GIF disclosure; an opportunity for participants to opt out of GIF disclosure; and duration of the researcher's duty to disclose GIFs. Chairs were concerned about participant disclosure preferences changing over time; inherent limitations in determining the scope and accuracy of claims about GIFs; and making consent processes longer and more complex. IRB Chair and other stakeholder perspectives can help advance informed consent efforts to accommodate GIF prospects.

  8. 45 CFR 690.115 - IRB records.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB... by § 690.116(b)(5). (b) The records required by this policy shall be retained for at least 3 years...

  9. Informed Consent and Genomic Incidental Findings: IRB Chair Perspectives

    PubMed Central

    Simon, Christian M.; Williams, Janet K.; Shinkunas, Laura; Brandt, Debra; Daack-Hirsch, Sandra; Driessnack, Martha

    2013-01-01

    It is unclear how genomic incidental finding (GIF) prospects should be addressed in informed consent processes. An exploratory study on this topic was conducted with 34 purposively sampled Chairs of institutional review boards (IRBs) at centers conducting genome-wide association studies. Most Chairs (96%) reported no knowledge of local IRB requirements regarding GIFs and informed consent. Chairs suggested consent processes should address the prospect of, and study disclosure policy on, GIFs; GIF management and follow-up; potential clinical significance of GIFs; potential risks of GIF disclosure; an opportunity for participants to opt out of GIF disclosure; and duration of the researcher's duty to disclose GIFs. Chairs were concerned about participant disclosure preferences changing over time; inherent limitations in determining the scope and accuracy of claims about GIFs; and making consent processes longer and more complex. IRB Chair and other stakeholder perspectives can help advance informed consent efforts to accommodate GIF prospects. PMID:22228060

  10. "Members of the same club": challenges and decisions faced by US IRBs in identifying and managing conflicts of interest.

    PubMed

    Klitzman, Robert

    2011-01-01

    Conflicts of interest (COIs) in research have received increasing attention, but many questions arise about how Institutional Review Boards (IRBs) view and approach these. I conducted in-depth interviews of 2 hours each with 46 US IRB chairs, administrators, and members, exploring COI and other issues related to research integrity. I contacted leaders of 60 IRBs (every fourth one among the top 240 institutions by NIH funding), and interviewed IRB leaders from 34 of these institutions (response rate = 55%). Data were analyzed using standard qualitative methods, informed by Grounded Theory. IRBs confront financial and non-financial COIs of PIs, institutions, and IRBs themselves. IRB members may seek to help, or compete with, principal investigators (PIs). Non-financial COI also often appear to be "indirect financial" conflicts based on gain (or loss) not to oneself, but to one's colleagues or larger institution. IRBs faced challenges identifying and managing these COI, and often felt that they could be more effective. IRBs' management of their own potential COI vary, and conflicted members may observe, participate, and/or vote in discussions. Individual IRB members frequently judge for themselves whether to recuse themselves. Challenges arise in addressing these issues, since institutions and PIs need funding, financial information is considered confidential, and COI can be unconscious. This study, the first to explore qualitatively how IRBs confront COIs and probe how IRBs confront non-financial COIs, suggests that IRBs face several types of financial and non-financial COIs, involving themselves, PIs, and institutions, and respond varyingly. These data have critical implications for practice and policy. Disclosure of indirect and non-financial COIs to subjects may not be feasible, partly since IRBs, not PIs, are conflicted. Needs exist to consider guidelines and clarifications concerning when and how, in protocol reviews, IRB members should recuse themselves

  11. Understanding and Implementing Limited IRB Review

    EPA Science Inventory

    • The Common Rule regulations that govern human subjects research were revised in January 2017, and are currently scheduled to take effect in July 2018. Among the many changes that affect researchers and Institutional Review Boards (IRBs) is a new process for “Limited...

  12. 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…

  13. A Domain Analysis Model for eIRB Systems: Addressing the Weak Link in Clinical Research Informatics

    PubMed Central

    He, Shan; Narus, Scott P.; Facelli, Julio C.; Lau, Lee Min; Botkin, Jefferey R.; Hurdle, John F.

    2014-01-01

    Institutional Review Boards (IRBs) are a critical component of clinical research and can become a significant bottleneck due to the dramatic increase, in both volume and complexity of clinical research. Despite the interest in developing clinical research informatics (CRI) systems and supporting data standards to increase clinical research efficiency and interoperability, informatics research in the IRB domain has not attracted much attention in the scientific community. The lack of standardized and structured application forms across different IRBs causes inefficient and inconsistent proposal reviews and cumbersome workflows. These issues are even more prominent in multi-institutional clinical research that is rapidly becoming the norm. This paper proposes and evaluates a domain analysis model for electronic IRB (eIRB) systems, paving the way for streamlined clinical research workflow via integration with other CRI systems and improved IRB application throughput via computer-assisted decision support. PMID:24929181

  14. 45 CFR 46.115 - IRB records.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the... for Protection of Human Research Subjects § 46.115 IRB records. (a) An institution, or when... voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a...

  15. 49 CFR 11.115 - IRB records.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ..., including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that... members voting for, against, and abstaining; the basis for requiring changes in or disapproving research... continuing review activities. (4) Copies of all correspondence between the IRB and the investigators. (5) A...

  16. 49 CFR 11.115 - IRB records.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that... members voting for, against, and abstaining; the basis for requiring changes in or disapproving research... continuing review activities. (4) Copies of all correspondence between the IRB and the investigators. (5) A...

  17. 40 CFR 26.1115 - IRB records.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false IRB records. 26.1115 Section 26.1115 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-pregnant, Non...

  18. 40 CFR 26.1115 - IRB records.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 1 2014-07-01 2014-07-01 false IRB records. 26.1115 Section 26.1115 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-pregnant, Non...

  19. 40 CFR 26.1115 - IRB records.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 1 2013-07-01 2013-07-01 false IRB records. 26.1115 Section 26.1115 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-pregnant, Non...

  20. 40 CFR 26.1115 - IRB records.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 1 2011-07-01 2011-07-01 false IRB records. 26.1115 Section 26.1115 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-pregnant, Non...

  1. 40 CFR 26.1115 - IRB records.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 1 2012-07-01 2012-07-01 false IRB records. 26.1115 Section 26.1115 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-pregnant, Non...

  2. 32 CFR 219.115 - IRB records.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 2 2012-07-01 2012-07-01 false IRB records. 219.115 Section 219.115 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS... consent documents, progress reports submitted by investigators, and reports of injuries to subjects. (2...

  3. 32 CFR 219.115 - IRB records.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 2 2013-07-01 2013-07-01 false IRB records. 219.115 Section 219.115 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS... consent documents, progress reports submitted by investigators, and reports of injuries to subjects. (2...

  4. 32 CFR 219.115 - IRB records.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 2 2014-07-01 2014-07-01 false IRB records. 219.115 Section 219.115 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS... consent documents, progress reports submitted by investigators, and reports of injuries to subjects. (2...

  5. 32 CFR 219.115 - IRB records.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 2 2010-07-01 2010-07-01 false IRB records. 219.115 Section 219.115 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS... consent documents, progress reports submitted by investigators, and reports of injuries to subjects. (2...

  6. 32 CFR 219.115 - IRB records.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 2 2011-07-01 2011-07-01 false IRB records. 219.115 Section 219.115 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS... consent documents, progress reports submitted by investigators, and reports of injuries to subjects. (2...

  7. 7 CFR 1c.115 - IRB records.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of... policy shall be retained for at least 3 years, and records relating to research which is conducted shall...

  8. “Members of the Same Club”: Challenges and Decisions Faced by US IRBs in Identifying and Managing Conflicts of Interest

    PubMed Central

    Klitzman, Robert

    2011-01-01

    Conflicts of interest (COIs) in research have received increasing attention, but many questions arise about how Institutional Review Boards (IRBs) view and approach these. Methods I conducted in-depth interviews of 2 hours each with 46 US IRB chairs, administrators, and members, exploring COI and other issues related to research integrity. I contacted leaders of 60 IRBs (every fourth one among the top 240 institutions by NIH funding), and interviewed IRB leaders from 34 of these institutions (response rate = 55%). Data were analyzed using standard qualitative methods, informed by Grounded Theory. Results IRBs confront financial and non-financial COIs of PIs, institutions, and IRBs themselves. IRB members may seek to help, or compete with, principal investigators (PIs). Non-financial COI also often appear to be “indirect financial” conflicts based on gain (or loss) not to oneself, but to one's colleagues or larger institution. IRBs faced challenges identifying and managing these COI, and often felt that they could be more effective. IRBs' management of their own potential COI vary, and conflicted members may observe, participate, and/or vote in discussions. Individual IRB members frequently judge for themselves whether to recuse themselves. Challenges arise in addressing these issues, since institutions and PIs need funding, financial information is considered confidential, and COI can be unconscious. Conclusions This study, the first to explore qualitatively how IRBs confront COIs and probe how IRBs confront non-financial COIs, suggests that IRBs face several types of financial and non-financial COIs, involving themselves, PIs, and institutions, and respond varyingly. These data have critical implications for practice and policy. Disclosure of indirect and non-financial COIs to subjects may not be feasible, partly since IRBs, not PIs, are conflicted. Needs exist to consider guidelines and clarifications concerning when and how, in protocol reviews, IRB

  9. An Analysis of Policies and Procedures for Obtaining New Course Approval at Oakton Community College.

    ERIC Educational Resources Information Center

    Woloshin, Phyllis Lerman

    Procedures and policies by which a new course is introduced into the Oakton Community College curriculum were analyzed in order to discover appropriate procedures for attaining course approval from the internal college governance structure, to implement those procedures in obtaining final approval, and to make recommendations for improvement of…

  10. 7 CFR 1751.104 - Obtaining RUS approval of a proposed Modernization Plan.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Obtaining RUS approval of a proposed Modernization Plan. 1751.104 Section 1751.104 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE TELECOMMUNICATIONS SYSTEM PLANNING AND DESIGN...

  11. Public service quality improvements: a case for exemption from IRB review of public administration research.

    PubMed

    Jordan, Sara R

    2014-01-01

    Should the exemption from Institutional Review Board (IRB) evaluations currently in place for quality improvements research be extended to public administration research that addresses questions of improving the quality of public service delivery? As a means to both reduce the level of disdain held by a group of social science researchers for IRBs and to reduce the cost of review for minimal risk studies, I argue here that much of the current public administration research should also be exempted from normal processes of review by IRBs on the basis of their similarity to Quality Improvements (QI) research, a category of studies already granted exemption. This argument dovetails provisions currently in place for studies of public service and public benefit, but reframes these exemptions in the language of "quality improvements," which may be a more comfortable language for IRBs concerned to demonstrate compliance for review of all fields. To expedite this argument into the practices of IRBs, I included a checklist that researchers could use to self-identify their studies as QI, not research as such.

  12. Ethical and regulatory challenges of research using pervasive sensing and other emerging technologies: IRB perspectives.

    PubMed

    Nebeker, Camille; Harlow, John; Espinoza Giacinto, Rebeca; Orozco-Linares, Rubi; Bloss, Cinnamon S; Weibel, Nadir

    2017-01-01

    Vast quantities of personal health information and private identifiable information are being created through mobile apps, wearable sensors, and social networks. While new strategies and tools for obtaining health data have expanded researchers' abilities to design and test personalized and adaptive health interventions, the deployment of pervasive sensing and computational techniques to gather research data is raising ethical challenges for Institutional Review Boards (IRBs) charged with protecting research participants. To explore experiences with, and perceptions about, technology-enabled research, and identify solutions for promoting responsible conduct of this research we conducted focus groups with human research protection program and IRB affiliates. Our findings outline the need for increased collaboration across stakeholders in terms of: (1) shared and dynamic resources that improve awareness of technologies and decrease potential threats to participant privacy and data confidentiality, and (2) development of appropriate and dynamic standards through collaboration with stakeholders in the research ethics community.

  13. 7 CFR 1c.115 - IRB records.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that... members voting for, against, and abstaining; the basis for requiring changes in or disapproving research... continuing review activities. (4) Copies of all correspondence between the IRB and the investigators. (5) A...

  14. "Protecting" or "Policing": Academic Researchers' View of IRBs in an Arab Context.

    PubMed

    Makhoul, Jihad; El-Alti, Leila; Qutteina, Yara; Nasrallah, Catherine; Sakr, Carol; Nakkash, Rima; Alali, Khalid

    2014-12-01

    A recent surge of research universities and human subjects research funding in the Arab world raises concerns about applied research ethics and oversight. In-depth interviews conducted with 52 researchers in Lebanon and Qatar about their research conduct and the problems they face while conducting it indicate that although researchers admit to the added value of institutional review board (IRB) functions, the researchers have several complaints, such as rigid and contextually insensitive requirements, delays, and inadequate resources at IRBs, and a lack of outreach and effective communication with researchers. The study discusses these challenges pointing to the need for socioculturally adaptive regulations and forms and strengthening outreach and communication between IRBs and their users to improve ethical practices. Implications for future research are also presented. © The Author(s) 2014.

  15. 12 CFR 550.70 - Must I obtain OTS approval or file a notice before I exercise fiduciary powers?

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... before I exercise fiduciary powers? 550.70 Section 550.70 Banks and Banking OFFICE OF THRIFT SUPERVISION... I obtain OTS approval or file a notice before I exercise fiduciary powers? You should refer to the following chart to determine if you must obtain OTS approval or file a notice with OTS before you exercise...

  16. 12 CFR 550.70 - Must I obtain OTS approval or file a notice before I exercise fiduciary powers?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... before I exercise fiduciary powers? 550.70 Section 550.70 Banks and Banking OFFICE OF THRIFT SUPERVISION... I obtain OTS approval or file a notice before I exercise fiduciary powers? You should refer to the following chart to determine if you must obtain OTS approval or file a notice with OTS before you exercise...

  17. 12 CFR 550.70 - Must I obtain OTS approval or file a notice before I exercise fiduciary powers?

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... before I exercise fiduciary powers? 550.70 Section 550.70 Banks and Banking OFFICE OF THRIFT SUPERVISION... I obtain OTS approval or file a notice before I exercise fiduciary powers? You should refer to the following chart to determine if you must obtain OTS approval or file a notice with OTS before you exercise...

  18. 12 CFR 550.70 - Must I obtain OTS approval or file a notice before I exercise fiduciary powers?

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... before I exercise fiduciary powers? 550.70 Section 550.70 Banks and Banking OFFICE OF THRIFT SUPERVISION... I obtain OTS approval or file a notice before I exercise fiduciary powers? You should refer to the following chart to determine if you must obtain OTS approval or file a notice with OTS before you exercise...

  19. 12 CFR 550.70 - Must I obtain OTS approval or file a notice before I exercise fiduciary powers?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... before I exercise fiduciary powers? 550.70 Section 550.70 Banks and Banking OFFICE OF THRIFT SUPERVISION... I obtain OTS approval or file a notice before I exercise fiduciary powers? You should refer to the following chart to determine if you must obtain OTS approval or file a notice with OTS before you exercise...

  20. Ethics, Vulnerability, and Speakers of Other Languages: How University IRBs (Do Not) Speak to Research Involving Refugee Participants

    ERIC Educational Resources Information Center

    Perry, Kristen H.

    2011-01-01

    In this study, the author analyzes the websites of 32 universities' Institutional Review Boards (IRBs) to explore two specific issues: (a) how individual IRBs define "vulnerable populations," and (b) the guidelines those IRBs offer with respect to participants who may have limited or no English language proficiency. Analysis indicates wide…

  1. 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.

  2. Journalists, district attorneys and researchers: why IRBs should get in the middle.

    PubMed

    Chodos, Anna H; Lee, Sei J

    2015-03-29

    Federal regulations in the United States have shaped Institutional Review Boards (IRBs) to focus on protecting individual human subjects. Health services research studies focusing on healthcare institutions such as hospitals or clinics do not have individual human subjects. Since U.S. federal regulations are silent on what type of review, if any, these studies require, different IRBs may approach similar studies differently, resulting in undesirable variation in the review of studies focusing on healthcare institutions. Further, although these studies do not focus on individual human subjects, they may pose risks to participating institutions, as well as individuals who work at those institutions, if identifying information becomes public. Using two recent health services research studies conducted in the U.S. as examples, we discuss variations in the level of IRB oversight for studies focusing on institutions rather than individual human subjects. We highlight how lack of IRB guidance poses challenges for researchers who wish to both protect their subjects and work appropriately with the public, journalists or the legal system in the U.S. Competing interests include the public's interest in transparency, the researcher's interest in their science, and the research participants' interests in confidentiality. Potential solutions that may help guide health services researchers to balance these competing interests include: 1) creating consensus guidelines and standard practices that address confidentiality risk to healthcare institutions and their employees; and 2) expanding the IRB role to conduct a streamlined review of health services research studies focusing on healthcare institutions to balance the competing interest of stakeholders on a case-by-case basis. For health services research studies focusing on healthcare institutions, we outline the competing interests of researchers, healthcare institutions and the public. We propose solutions to decrease

  3. Why do we pay? A national survey of investigators and IRB chairpersons

    PubMed Central

    Ripley, Elizabeth; Macrina, Francis; Markowitz, Monika; Gennings, Chris

    2011-01-01

    The principle that payment to participants should not be undue or coercive is the consensus of international and national guidelines and ethical debates; however, what this means in practice is unclear. This study determined the attitudes and practices of IRB chairpersons and investigators regarding participant payment. One thousand six hundred investigators and 1900 IRB chairpersons received an invitation to participate in a web-based survey. Four hundred and fifty-five investigators (28.3%) and 395 IRB chairpersons (18.6%) responded. The survey was designed to gather considerations that govern payment determination and practical application of these considerations in hypothetical case studies. The survey asked best answer, multiple choice, and open text questions. Short hypothetical case scenarios where presented, and participants were asked to rate factors in the study that might impact payment and then determine their recommended payment. A predictive model was developed for each case to determine factors which affected payment. Although compensation was the primary reason given to justify payment by both investigators and IRB chairpersons, the cases suggested that, in practice, payment is often guided by incentive, as shown by the impact of anticipated difficulty recruiting, inconvenience, and risk in determining payment. Payment models varied by type of study. Ranges for recommended payments by both groups for different types of procedures and studies are presented. PMID:20831420

  4. 40 CFR 26.1109 - IRB review of research.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 1 2013-07-01 2013-07-01 false IRB review of research. 26.1109 Section 26.1109 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

  5. 40 CFR 26.1109 - IRB review of research.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 1 2011-07-01 2011-07-01 false IRB review of research. 26.1109 Section 26.1109 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

  6. 40 CFR 26.1109 - IRB review of research.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 1 2014-07-01 2014-07-01 false IRB review of research. 26.1109 Section 26.1109 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

  7. 40 CFR 26.1109 - IRB review of research.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false IRB review of research. 26.1109 Section 26.1109 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

  8. 40 CFR 26.1109 - IRB review of research.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 1 2012-07-01 2012-07-01 false IRB review of research. 26.1109 Section 26.1109 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

  9. 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.

  10. 45 CFR 46.109 - IRB review of research.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.109 IRB review of research. (a) An... judgment the information would meaningfully add to the protection of the rights and welfare of subjects. (c...

  11. A new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves.

    PubMed

    Yoganathan, Ajit P; Fogel, Mark; Gamble, Susan; Morton, Michael; Schmidt, Paul; Secunda, Jeff; Vidmar, Sara; Del Nido, Pedro

    2013-10-01

    Congenital heart valve disease is one of the most common abnormalities in children. There are limited technological solutions available for treating children with congenital heart valve diseases. The aim of this study is to provide the details of the consensus reached in terms of pediatric definitions, design approach, in vitro testing, and clinical trials, which may be used as guidance for developing prosthetic heart valves for the pediatric indication. In stark contrast to the various designs of adult-sized replacement valves available in the market, there are no Food and Drug Administration (FDA)-approved prosthetic heart valves available for use in the pediatric population. There is a pressing need for FDA-approved pediatric valve devices in the United States. The pediatric patient population has been typically excluded from replacement heart valve trials for several reasons. In January 2010, heart valve manufacturers and pediatric clinicians collaborated with academicians and FDA staff in a workshop to suggest ways to successfully evaluate pediatric prosthetic valves and conduct pediatric clinical trials to provide acceptable heart valve replacement options for this patient population. Recommendations, derived from ISO 5840:2005 and the 2010 FDA Draft Replacement Heart Valve Guidance, are provided for hydrodynamic, durability, and fatigue testing. The article specifically addresses in vitro and premarket and postmarket approval clinical studies that should be considered by a heart valve manufacturer for obtaining regulatory approval of pediatric sizes of prosthetic heart valve designs that are already approved for adult clinical use. Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  12. 34 CFR 97.108 - IRB functions and operations.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 1 2011-07-01 2011-07-01 false IRB functions and operations. 97.108 Section 97.108 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for... at least one member whose primary concerns are in nonscientific areas. In order for the research to...

  13. 34 CFR 97.108 - IRB functions and operations.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 1 2012-07-01 2012-07-01 false IRB functions and operations. 97.108 Section 97.108 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for... at least one member whose primary concerns are in nonscientific areas. In order for the research to...

  14. 34 CFR 97.108 - IRB functions and operations.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 1 2014-07-01 2014-07-01 false IRB functions and operations. 97.108 Section 97.108 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for... at least one member whose primary concerns are in nonscientific areas. In order for the research to...

  15. 34 CFR 97.108 - IRB functions and operations.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 1 2013-07-01 2013-07-01 false IRB functions and operations. 97.108 Section 97.108 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for... at least one member whose primary concerns are in nonscientific areas. In order for the research to...

  16. 21 CFR 56.105 - Waiver of IRB requirement.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Waiver of IRB requirement. 56.105 Section 56.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... sponsor or sponsor-investigator, the Food and Drug Administration may waive any of the requirements...

  17. In search of the elusive IrB 2: Can mechanochemistry help?

    DOE PAGES

    Xie, Zhilin; Blair, Richard G.; Orlovskaya, Nina; ...

    2015-10-20

    We produced hexagonal ReB 2-type IrB 2 diboride and orthorhombic IrB monoboride phases, that were previously unknown and saw them produced by mechanochemical syntheses. High energy ball milling of elemental Ir and B powder for 30 h, followed by annealing of the powder at 1050 °C for 48 h, resulted in the formation of the desired phases. Both traditional laboratory and high resolution synchrotron X-ray diffraction (XRD) analyses were used for phase identification of the synthesized powder. Additionally, scanning electron microscopy and transmission electron microscopy were employed, along with XRD, to further characterize the microstructure of the phases produced.

  18. In search of the elusive IrB 2: Can mechanochemistry help?

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

    Xie, Zhilin; Blair, Richard G.; Orlovskaya, Nina

    We produced hexagonal ReB 2-type IrB 2 diboride and orthorhombic IrB monoboride phases, that were previously unknown and saw them produced by mechanochemical syntheses. High energy ball milling of elemental Ir and B powder for 30 h, followed by annealing of the powder at 1050 °C for 48 h, resulted in the formation of the desired phases. Both traditional laboratory and high resolution synchrotron X-ray diffraction (XRD) analyses were used for phase identification of the synthesized powder. Additionally, scanning electron microscopy and transmission electron microscopy were employed, along with XRD, to further characterize the microstructure of the phases produced.

  19. Effectiveness of Blended Learning in a Rural Alternative Education School Setting

    ERIC Educational Resources Information Center

    Skelton, Robin Renee' Gossage

    2017-01-01

    The purpose of this non-experimental, causal-comparative study was to examine the impact of a blended learning format on the academic achievement of at-risk 9-12 grade students in a rural Northeast Georgia school system. After obtaining IRB approval and district curriculum director and superintendent approval, data was obtained for evaluation.…

  20. 13 CFR 127.304 - How does a concern obtain certification from an approved certifier?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false How does a concern obtain certification from an approved certifier? 127.304 Section 127.304 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION WOMEN-OWNED SMALL BUSINESS FEDERAL CONTRACT ASSISTANCE PROCEDURES Certification of EDWOSB or WOSB...

  1. Adrift in the Gray Zone: IRB Perspectives on Research in the Learning Health System.

    PubMed

    Lee, Sandra Soo-Jin; Kelley, Maureen; Cho, Mildred K; Kraft, Stephanie Alessi; James, Cyan; Constantine, Melissa; Meyer, Adrienne N; Diekema, Douglas; Capron, Alexander M; Wilfond, Benjamin S; Magnus, David

    2016-01-01

    Human subjects protection in healthcare contexts rests on the premise that a principled boundary distinguishes clinical research and clinical practice. However, growing use of evidence-based clinical practices by health systems makes it increasingly difficult to disentangle research from a wide range of clinical activities that are sometimes called "research on medical practice" (ROMP), including quality improvement activities and comparative effectiveness research. The recent growth of ROMP activities has created an ethical and regulatory gray zone with significant implications for the oversight of human subjects research. We conducted six semi-structured, open-ended focus group discussions with IRB members to understand their experiences and perspectives on ethical oversight of ROMP, including randomization of patients to standard treatments. Our study revealed that IRB members are unclear or divided on the central questions at stake in the current policy debate over ethical oversight of ROMP: IRB members struggle to make a clear distinction between clinical research and medical practice improvement, lack consensus on when ROMP requires IRB review and oversight, and are uncertain about what constitutes incremental risk when patients are randomized to different treatments, any of which may be offered in usual care. They characterized the central challenge as a balancing act, between, on the one hand, making information fully transparent to patients and providing adequate oversight, and on the other hand, avoiding a chilling effect on the research process or harming the physician-patient relationship. Evidence-based guidance that supports IRB members in providing adequate and effective oversight of ROMP without impeding the research process or harming the physician-patient relationship is necessary to realize the full benefits of the learning health system.

  2. 12 CFR 550.580 - When may I conduct fiduciary activities without obtaining OTS approval?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 5 2011-01-01 2011-01-01 false When may I conduct fiduciary activities without obtaining OTS approval? 550.580 Section 550.580 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY FIDUCIARY POWERS OF SAVINGS ASSOCIATIONS Activities Exempt From This Part § 550.580...

  3. 40 CFR 80.1340 - How does a refiner obtain approval as a small refiner?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Provisions § 80.1340 How does a refiner obtain approval as a small refiner? (a) Applications for small refiner status must be submitted to EPA by December 31, 2007. (b) For U.S. Postal delivery, applications... small refiner status application must contain the following information for the company seeking small...

  4. Telephone-Delivered Cognitive Behavioral Therapy for Chronic Pain Following Traumatic Brain Injury

    DTIC Science & Technology

    2015-10-01

    suggestions for reducing this burden to Department of Defense , Washington Headquarters Services, Directorate for Information Operations and Reports...quarterly progress reports to the Department of Defense (DoD). Researchers have obtained continuing IRB approval from both the UW and VAPSHCS IRBs and...should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation. REPORT

  5. 21 CFR 56.109 - IRB review of research.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the research study is in compliance with part 50, subpart D of this chapter, at the time of its initial review of the research. When some or all of the subjects in a study that is ongoing on April 30... 21 Food and Drugs 1 2011-04-01 2011-04-01 false IRB review of research. 56.109 Section 56.109 Food...

  6. Working with the U.S. Food and Drug Administration to obtain approval of products under the Animal Rule.

    PubMed

    Park, Glen D; Mitchel, Jules T

    2016-06-01

    While the development of medical products and approval by the U.S. Food and Drug Administration (FDA) is well known, the development of countermeasures against exposure to toxic levels of radiation, chemicals, and infectious agents requires special consideration, and there has been, to date, little experience in working with the FDA to obtain approval of these products. The FDA has published a regulation entitled "Approval of Biological Products when Human Efficacy Studies are not Ethical or Feasible." This regulation, known simply as the "Animal Rule," was designed to permit approval or licensing of drugs and biologics when efficacy studies in humans are not ethical or feasible. To date, 12 products have been approved under the Animal Rule. It is highly recommended that sponsors of products that are to be developed under the Animal Rule meet with the FDA and other government entities early in the development process to ensure that the efficacy and safety studies that are planned will meet the FDA's requirements for approval of the product. © 2016 New York Academy of Sciences.

  7. 22 CFR 129.6 - Procedures for obtaining approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... brokering activities must be made to the Directorate of Defense Trade Controls, be signed by an empowered... activity in support of the U.S. Government. (c) The empowered official signing the request for approval...

  8. Bond deformation paths and electronic instabilities of ultraincompressible transition metal diborides: Case study of OsB2 and IrB2

    NASA Astrophysics Data System (ADS)

    Zhang, R. F.; Legut, D.; Wen, X. D.; Veprek, S.; Rajan, K.; Lookman, T.; Mao, H. K.; Zhao, Y. S.

    2014-09-01

    The energetically most stable orthorhombic structure of OsB2 and IrB2 is dynamically stable for OsB2 but unstable for IrB2. Both diborides have substantially lower shear strength in their easy slip systems than their metal counterparts. This is attributed to an easy sliding facilitated by out-of-plane weakening of metallic Os-Os bonds in OsB2 and by an in-plane bond splitting instability in IrB2. A much higher shear resistance of Os-B and B-B bonds than Os-Os ones is found, suggesting that the strengthened Os-B and B-B bonds are responsible for hardness enhancement in OsB2. In contrast, an in-plane electronic instability in IrB2 limits its strength. The electronic structure of deformed diborides suggests that the electronic instabilities of 5d orbitals are their origin of different bond deformation paths. Neither IrB2 nor OsB2 can be intrinsically superhard.

  9. Geophysical anomalies associated with Imjin River Belt (IRB) in the middle Korean Peninsula revealed by geomagnetic depth sounding and seismological data

    NASA Astrophysics Data System (ADS)

    Yang, J.; Choi, H.; Noh, M.; Im, C.

    2012-12-01

    Imjin River Belt (IRB), located in the middle of the Korean Peninsula, has been one of long-standing geological issues because it is a very important tectonic link to understand a tectonic evolution of north-eastern Asia including China, Korea and Japan. Although the IRB has been considered as an extension of collision belt between the North China Block (NCB) and South China Block (SCB), there is little geophysical observation or study on this issue. In recent, we compiled a new induction arrow map for the Korean Peninsula, on the basis of long-period magneto-telluric (MT) data and the geomagnetic depth sounding data performed since the late 1990's. This newly compiled map has finer spatial resolution expecially in the middle area of the peninsula, which helps us to present the geophysical evidence that the IRB is the continuation or extension of the collision belt to the peninsula. The overall pattern of induction arrows in the peninsula appears to indicate a northwest-southeast direction, which is well-known 'sea effect' by the surrounding seas. However, the results of observations in the middle of the peninsula distinctly show an anomalous pattern around the IRB, which can not be explained only by the surrounding seas. This anomalous pattern may be attributed to enhanced conductivity associated with tectonic events that Imjin River Belt has experienced. The 3-D electromagnetic modeling results, considering both surrounding seas and enhanced conductivity of the IRB, explain well the anomalous observations around the IRB. Furthermore, recent seismological study demonstrates that focal mechanism around the IRB is mainly normal faulting event, which may be interpreted as the reactivation of paleo structures that are related to the post collisional lithospheric delamination. All the geophysical evidences convince us that the IRB is an extension of the collision belt between the NCB and SCB to the peninsula.

  10. Legal and ethical values in the resolution of research-related disputes: how can IRBS respond to participant complaints?

    PubMed

    Underhill, Kristen

    2014-02-01

    Under US federal regulations, participants providing informed consent must receive information regarding whom to contact in case of a research-related injury or complaint. Although informed consent processes routinely direct participants to contact institutional review boards (IRBs) with questions or concerns, there has been little empirical study of the ways in which IRBs act to resolve participants' research-related complaints. This article explores available literature on participant complaints, considers the responsibilities of IRBs in dispute resolution, and outlines a research agenda. As a case study, this review considers disputes arising from HIV/AIDS research, focusing on novel issues arising from biomedical HIV prevention trials.

  11. Legal and Ethical Values in the Resolution of Research-Related Disputes: How Can IRBs Respond to Participant Complaints?

    PubMed Central

    Underhill, Kristen

    2014-01-01

    Under U.S. federal regulations, participants providing informed consent must receive information regarding whom to contact in case of a research-related injury or complaint. Although informed consent processes routinely direct participants to contact institutional review boards (IRBs) with questions or concerns, there has been little empirical study of the ways in which IRBs act to resolve participants' research-related complaints. This article explores available literature on participant complaints, considers the responsibilities of IRBs in dispute resolution, and outlines a research agenda. As a case study, this review considers disputes arising from HIV/AIDS research, focusing on novel issues arising from biomedical HIV prevention trials. PMID:24572085

  12. Complete Decomposition of Li 2 CO 3 in Li–O 2 Batteries Using Ir/B 4 C as Noncarbon-Based Oxygen Electrode

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

    Song, Shidong; Xu, Wu; Zheng, Jianming

    Incomplete decomposition of Li2CO3 during charge process is a critical barrier for rechargeable Li-O2 batteries. Here we report complete decomposition of Li2CO3 in Li-O2 batteries using ultrafine iridium-decorated boron carbide (Ir/B4C) nanocomposite as oxygen electrode. The systematic investigation on charging the Li2CO3 preloaded Ir/B4C electrode in an ether-based electrolyte demonstrates that Ir/B4C electrode can decompose Li2CO3 with an efficiency close to 100% at below 4.37 V. In contrast, the bare B4C without Ir electrocatalyst can only decompose 4.7% of preloaded Li2CO3. The reaction mechanism of Li2CO3 decomposition in the presence of Ir/B4C electrocatalyst has been further investigated. A Li-O2 batterymore » using Ir/B4C as oxygen electrode material shows highly enhanced cycling stability than that using bare B4C oxygen electrode. These results clearly demonstrate that Ir/B4C is an effecitive oxygen electrode amterial to completely decompose Li2CO3 at relatively low charge voltages and is of significant importance in improving the cycle performanc of aprotic Li-O2 batteries.« less

  13. Transformation impacts of dissolved and solid phase Fe(II) on trichloroethylene (TCE) reduction in an iron-reducing bacteria (IRB) mixed column system: a mathematical model.

    PubMed

    Bae, Yeunook; Kim, Dooil; Cho, Hyun-Hee; Singhal, Naresh; Park, Jae-Woo

    2012-12-01

    In this research, we conducted trichloroethylene (TCE) reduction in a column filled with iron and iron-reducing bacteria (IRB) and developed a mathematical model to investigate the critical reactions between active species in iron/IRB/contaminant systems. The formation of ferrous iron (Fe(II)) in this system with IRB and zero-valent iron (ZVI, Fe(0)) coated with a ferric iron (Fe(III)) crust significantly affected TCE reduction and IRB respiration in various ways. This study presents a new framework for transformation property and reducing ability of both dissolved (Fe(II)(dissolved)) and solid form ferrous iron (Fe(II)(solid)). Results showed that TCE reduction was strongly depressed by Fe(II)(solid) rather than by other inhibitors (e.g., Fe(III) and lactate), suggesting that Fe(II)(solid) might reduce IRB activation due to attachment to IRB cells. Newly exposed Fe(0) from the released Fe(II)(dissolved) was a strong contributor to TCE reduction compared to Fe(II)(solid). In addition, our research confirmed that less Fe(II)(solid) production strongly supported long-term TCE reduction because it may create an easier TCE approach to Fe(0) or increase IRB growth. Our findings will aid the understanding of the contributions of iron media (e.g., Fe(II)(solid), Fe(II)(dissolved), Fe(III), and Fe(0)) to IRB for decontamination in natural groundwater systems. Copyright © 2012 Elsevier Ltd. All rights reserved.

  14. 40 CFR 26.1503 - Disqualification of an IRB or an institution.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., and (2) The noncompliance adversely affects the rights or welfare of the human subjects of research... institution. 26.1503 Section 26.1503 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL... an institution. (a) Whenever the IRB or the institution has failed to take adequate steps to correct...

  15. 40 CFR 26.1503 - Disqualification of an IRB or an institution.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., and (2) The noncompliance adversely affects the rights or welfare of the human subjects of research... institution. 26.1503 Section 26.1503 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL... an institution. (a) Whenever the IRB or the institution has failed to take adequate steps to correct...

  16. 40 CFR 26.1503 - Disqualification of an IRB or an institution.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., and (2) The noncompliance adversely affects the rights or welfare of the human subjects of research... institution. 26.1503 Section 26.1503 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL... an institution. (a) Whenever the IRB or the institution has failed to take adequate steps to correct...

  17. 40 CFR 26.1503 - Disqualification of an IRB or an institution.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., and (2) The noncompliance adversely affects the rights or welfare of the human subjects of research... institution. 26.1503 Section 26.1503 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL... an institution. (a) Whenever the IRB or the institution has failed to take adequate steps to correct...

  18. 40 CFR 26.1503 - Disqualification of an IRB or an institution.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., and (2) The noncompliance adversely affects the rights or welfare of the human subjects of research... institution. 26.1503 Section 26.1503 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL... an institution. (a) Whenever the IRB or the institution has failed to take adequate steps to correct...

  19. Novel Autoantibody Serum and Cerebrospinal Fluid Biomarkesin Veterans with Gulf War Illness

    DTIC Science & Technology

    2016-10-01

    that 25 years after the war, the health of veterans with GWI is not improving and may be getting worse. Such blood-based autoantibodies may prove...Approvals Planned Months Actual Months 1a. Obtain necessary IRB approvals or Exempt status 1-3 1-4 1b. Obtain DOD Human Research Protections...6d: Preparation of manuscripts • Diagnostic CNS Autoantibody Biomarkers of GWI • Biomarkers of OP pesticide and nerve agent exposures in GW

  20. Brain Consequences of Spinal Cord Injury with and without Neuropathic Pain: Translating Animal Models of Neuroinflammation onto Human Neural Networks and Back

    DTIC Science & Technology

    2016-10-01

    During year one , we have: Obtained IRB and HRPO approval for the human studies , obtained IACUC and ACURO approval for the animal studies , refined the...human study protocol and collected PET-MR data on healthy individuals and spinal cord injured subjects, developed the rodent imaging procedures...qualtiative synthesis of the current state of the field, and 6 studies can be included in a quantitative meta-analysis. The studies eligible for inclusion in

  1. Waiver of consent in noninterventional, observational emergency research: the PROMMTT experience.

    PubMed

    Fox, Erin E; Bulger, Eileen M; Dickerson, Aisha S; del Junco, Deborah J; Klotz, Patricia; Podbielski, Jeanette; Matijevic, Nena; Brasel, Karen J; Holcomb, John B; Schreiber, Martin A; Cotton, Bryan A; Phelan, Herb A; Cohen, Mitchell J; Myers, John G; Alarcon, Louis H; Muskat, Peter; Wade, Charles E; Rahbar, Mohammad H

    2013-07-01

    In the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study, waiver of consent was used because previous literature reported low response rates and subsequent bias. The goal of this article was to examine the rationale and tradeoffs of using waiver of consent in PROMMTT. PROMMTT enrolled trauma patients receiving at least 1 U of red blood cells within 6 hours after admission at 10 US Level 1 trauma centers. Local institutional review boards (IRBs) from all sites approved the study. Site 8 was required by their IRB to attempt consent but was allowed to retain data on patients unable to be consented. Of 121 subjects enrolled at Site 8, 55 consents were obtained (46%), and no patient or legally authorized representative refused to give consent. Of the patients, 36 (30%) died, and 6 (5%) were discharged before consent could be attempted. Consent was attempted but not possible among 24 patients (20%). Of the 10 clinical sites, 6 of the local IRBs approved collection of residual blood samples, 1 had previous approval to collect timed blood samples under a separate protocol, and 3 reported that their local IRBs would not approve collection of residual blood under a waiver of consent. Waiver of consent was used in PROMMTT because of the potential adverse impact of consent refusals; however, there were no refusals. If the IRB for Site 8 had required withdrawal of patients unable to consent and destruction of their data, a serious bias would likely have been introduced. Other tradeoffs included a reduction in sites participating in residual blood collection and a smaller than expected amount of residual blood collected among sites operating under a waiver of consent. Noninterventional emergency research studies should consider these potential tradeoffs carefully before deciding whether waiver of consent would best achieve the goals of a study.

  2. Conducting Science in Disasters: Recommendations from the NIEHS Working Group for Special IRB Considerations in the Review of Disaster Related Research.

    PubMed

    Packenham, Joan P; Rosselli, Richard T; Ramsey, Steve K; Taylor, Holly A; Fothergill, Alice; Slutsman, Julia; Miller, Aubrey

    2017-09-25

    Research involving human subjects after public health emergencies and disasters may pose ethical challenges. These challenges may include concerns about the vulnerability of prospective disaster research participants, increased research burden among disaster survivors approached by multiple research teams, and potentially reduced standards in the ethical review of research by institutional review boards (IRBs) due to the rush to enter the disaster field. The NIEHS Best Practices Working Group for Special IRB Considerations in the Review of Disaster Related Research was formed to identify and address ethical and regulatory challenges associated with the review of disaster research. The working group consists of a diverse collection of disaster research stakeholders across a broad spectrum of disciplines. The working group convened in July 2016 to identify recommendations that are instrumental in preparing IRBs to review protocols related to public health emergencies and disasters. The meeting included formative didactic presentations and facilitated breakout discussions using disaster-related case studies. Major thematic elements from these discussions were collected and documented into 15 working group recommendations, summarized in this article, that address topics such as IRB disaster preparedness activities, informed consent, vulnerable populations, confidentiality, participant burden, disaster research response integration and training, IRB roles/responsibilities, community engagement, and dissemination of disaster research results. https://doi.org/10.1289/EHP2378.

  3. What English Language Learners Have to Say about NCLB Testing

    ERIC Educational Resources Information Center

    Yee, Mary

    2015-01-01

    This study constitutes the secondary analysis of data collected as part of classroom instruction in a prior practitioner inquiry study. Consequently, IRB approval, parental consent, and participant assent for the present study were obtained after the conclusion of the original study.

  4. Discovery of Novel Gene Elements Associated with Prostate Cancer Progression

    DTIC Science & Technology

    2014-12-01

    consent under an Institutional Review Board (IRB) approved protocol at the University of Michigan [SPORE in Prostate Cancer (Tissue/Serum/Urine) Bank IRB...1994-0481]. For the Weill Cornell Medical College patient samples, prostate tissues were collected as part of an IRB- approved protocol at Weill...PCAT-1 or nontargeting short hairpin RNA (shRNA) lentiviral constructs for 48 hours. GFPþ cells were drug -selected using 1 mg/mL puromycin. PCAT-1

  5. A single center analysis of factors influencing study start-up timeline in clinical trials.

    PubMed

    Krafcik, Brianna M; Doros, Gheorghe; Malikova, Marina A

    2017-11-01

    Efficient start-up phase in clinical trials is crucial to execution. The goal was to determine factors contributing to delays. The start-up milestones were assessed for 38 studies and analyzed. Total start-up time was shorter for following studies: device trials, no outsourcing, fewer ancillary services used and in interventional versus observational designs. The use of a centralized Institutional Review Board (IRB) versus a local IRB reduced time to approval. Studies that never enrolled took longer on average to finalize their budget/contract, and obtain IRB than ones that did enroll. Different features of clinical trials can affect timeline of start-up process. An understanding of the impact of each feature allows for optimization.

  6. Conducting Science in Disasters: Recommendations from the NIEHS Working Group for Special IRB Considerations in the Review of Disaster Related Research

    PubMed Central

    Rosselli, Richard T.; Ramsey, Steve K.; Taylor, Holly A.; Fothergill, Alice; Slutsman, Julia; Miller, Aubrey

    2017-01-01

    Summary: Research involving human subjects after public health emergencies and disasters may pose ethical challenges. These challenges may include concerns about the vulnerability of prospective disaster research participants, increased research burden among disaster survivors approached by multiple research teams, and potentially reduced standards in the ethical review of research by institutional review boards (IRBs) due to the rush to enter the disaster field. The NIEHS Best Practices Working Group for Special IRB Considerations in the Review of Disaster Related Research was formed to identify and address ethical and regulatory challenges associated with the review of disaster research. The working group consists of a diverse collection of disaster research stakeholders across a broad spectrum of disciplines. The working group convened in July 2016 to identify recommendations that are instrumental in preparing IRBs to review protocols related to public health emergencies and disasters. The meeting included formative didactic presentations and facilitated breakout discussions using disaster-related case studies. Major thematic elements from these discussions were collected and documented into 15 working group recommendations, summarized in this article, that address topics such as IRB disaster preparedness activities, informed consent, vulnerable populations, confidentiality, participant burden, disaster research response integration and training, IRB roles/responsibilities, community engagement, and dissemination of disaster research results. https://doi.org/10.1289/EHP2378 PMID:28949918

  7. 42 CFR 433.113 - Reduction of FFP for failure to operate a system and obtain initial approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Reduction of FFP for failure to operate a system... ADMINISTRATION Mechanized Claims Processing and Information Retrieval Systems § 433.113 Reduction of FFP for failure to operate a system and obtain initial approval. (a) Except as waived under § 433.130 or 433.131...

  8. Pathogenesis and Prediction of Future Rheumatoid Arthritis

    DTIC Science & Technology

    2014-10-01

    characterized by abnormalities of the immune system prior to the onset of the clinically apparent inflammatory joint disease that currently defines RA. The...the clinically apparent inflammatory joint disease that currently defines RA. The primary goal of this project is to investigate this preclinical...environmental exposures such as smoking, periodontal disease were ascertained. Goal 2. Local and governmental IRB approvals, and HRPO approval, were obtained

  9. 30 CFR 250.906 - What must I do to obtain approval for the proposed site of my platform?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... geological survey relevant to the design and siting of your platform. Your geological survey must assess: (1..., the possibility and effects of seafloor subsidence. (c) Subsurface surveys. Depending upon the design... obtain approval for the proposed site of my platform? (a) Shallow hazards surveys. You must perform a...

  10. Honest broker protocol streamlines research access to data while safeguarding patient privacy.

    PubMed

    Silvey, Scott A; Silvey, Scott Andrew; Schulte, Janet; Smaltz, Detlev H; Smaltz, Detlev Herb; Kamal, Jyoti

    2008-11-06

    At Ohio State University Medical Center, The Honest Broker Protocol provides a streamlined mechanism whereby investigators can obtain de-identified clinical data for non-FDA research without having to invest the significant time and effort necessary to craft a formalized protocol for IRB approval.

  11. 12 CFR 150.70 - Must I obtain OCC approval or file a notice before I exercise fiduciary powers?

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... before I exercise fiduciary powers? 150.70 Section 150.70 Banks and Banking COMPTROLLER OF THE CURRENCY....70 Must I obtain OCC approval or file a notice before I exercise fiduciary powers? You should refer... before you exercise fiduciary powers. This chart does not apply to activities that are exempt under...

  12. 12 CFR 150.70 - Must I obtain OCC approval or file a notice before I exercise fiduciary powers?

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... before I exercise fiduciary powers? 150.70 Section 150.70 Banks and Banking COMPTROLLER OF THE CURRENCY....70 Must I obtain OCC approval or file a notice before I exercise fiduciary powers? You should refer... before you exercise fiduciary powers. This chart does not apply to activities that are exempt under...

  13. 12 CFR 150.70 - Must I obtain OCC approval or file a notice before I exercise fiduciary powers?

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... before I exercise fiduciary powers? 150.70 Section 150.70 Banks and Banking COMPTROLLER OF THE CURRENCY....70 Must I obtain OCC approval or file a notice before I exercise fiduciary powers? You should refer... before you exercise fiduciary powers. This chart does not apply to activities that are exempt under...

  14. IRBS and Social Work: A Survey of Program Directors' Knowledge and Attitudes

    ERIC Educational Resources Information Center

    Valutis, Stephanie; Rubin, Deborah

    2010-01-01

    The philosophical basis for the federal human subject protection policy is congruent with the values of the social work profession. The pragmatics are more complicated. The purpose of this study was to explore the attitudes toward, knowledge about, and practices of institutional review boards (IRBs) across colleges and universities as reported by…

  15. Dr. John H. Hopps Jr. Research Scholars Program

    DTIC Science & Technology

    2014-10-20

    Program staff, alumni and existing participants. Over the course of the last five months, SageFox has successfully obtained IRB approval for all...and awards. Progress made in development of the HoppsNet system included design and implementation of a relational database in MySQL , development of

  16. Waiver of consent in non-interventional, observational emergency research: the PROMMTT experience

    PubMed Central

    Fox, Erin E.; Bulger, Eileen M.; Dickerson, Aisha S.; del Junco, Deborah J.; Klotz, Patricia; Podbielski, Jeanette; Matijevic, Nena; Brasel, Karen J.; Holcomb, John B.; Schreiber, Martin A.; Cotton, Bryan A.; Phelan, Herb A.; Cohen, Mitchell J.; Myers, John G.; Alarcon, Louis H.; Muskat, Peter; Wade, Charles E.; Rahbar, Mohammad H.

    2013-01-01

    Background In the PRospective Observational Multi-center Major Trauma Transfusion (PROMMTT) study, waiver of consent was utilized because previous literature reported low response rates and subsequent bias. The goal of this manuscript is to examine the rationale and tradeoffs of using waiver of consent in PROMMTT. Methods PROMMTT enrolled trauma patients receiving at least one unit of red blood cells within 6 hours after admission at ten US Level 1 Trauma Centers. Local Institutional Review Boards (IRBs) from all sites approved the study. Site 8 was required by their IRB to attempt consent, but was allowed to retain data on patients unable to be consented. Results Of 121 subjects enrolled at Site 8, 55 consents were obtained (46%) and no patient or legally-authorized representative refused to give consent. Thirty-six (30%) patients died and 6 (5%) were discharged before consent could be attempted. Consent was attempted but not possible among 24 patients (20%). Of the 10 clinical sites, six of the local IRBs approved collection of residual blood samples, one had prior approval to collect timed blood samples under a separate protocol, and three reported that their local IRBs would not approve collection of residual blood under a waiver of consent. Conclusions Waiver of consent was used in PROMMTT because of the potential adverse impact of consent refusals; however, there were no refusals. If Site 8’s IRB had required withdrawal of patients unable to consent and destruction of their data, a serious bias would likely have been introduced. Other tradeoffs included a reduction in sites participating in residual blood collection, and a smaller than expected amount of residual blood collected among sites operating under a waiver of consent. Non-interventional emergency research studies should consider these potential tradeoffs carefully before deciding whether waiver of consent would best achieve the goals of a study. Level of Evidence Prospective, Level II PMID:23778508

  17. 45 CFR 46.505 - When must IRB registration information be renewed or updated?

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 1 2013-10-01 2013-10-01 false When must IRB registration information be renewed or updated? 46.505 Section 46.505 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... accepted by, OHRP begins a new 3-year effective period. (d) An institution's or organization's decision to...

  18. 45 CFR 46.505 - When must IRB registration information be renewed or updated?

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 1 2011-10-01 2011-10-01 false When must IRB registration information be renewed or updated? 46.505 Section 46.505 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... accepted by, OHRP begins a new 3-year effective period. (d) An institution's or organization's decision to...

  19. 45 CFR 46.505 - When must IRB registration information be renewed or updated?

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 1 2014-10-01 2014-10-01 false When must IRB registration information be renewed or updated? 46.505 Section 46.505 Public Welfare Department of Health and Human Services GENERAL... accepted by, OHRP begins a new 3-year effective period. (d) An institution's or organization's decision to...

  20. 45 CFR 46.505 - When must IRB registration information be renewed or updated?

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 1 2012-10-01 2012-10-01 false When must IRB registration information be renewed or updated? 46.505 Section 46.505 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... accepted by, OHRP begins a new 3-year effective period. (d) An institution's or organization's decision to...

  1. 45 CFR 46.505 - When must IRB registration information be renewed or updated?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false When must IRB registration information be renewed or updated? 46.505 Section 46.505 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... accepted by, OHRP begins a new 3-year effective period. (d) An institution's or organization's decision to...

  2. Quick Reference Guide for IRB submission at Air Command and Staff College

    DTIC Science & Technology

    2009-04-01

    ACSC/THARP/2009 AIR COMMAND AND STAFF COLLEGE AIR UNIVERSITY ACSC EEG BASELINE ASSESSMENT by David F. Tharp, Maj, USAFR A Research Report...ACSC EEG Baseline Assessment Principal Investigator: Maj (Dr.) David F. Tharp Requirement Completed Notes Division cover letter From the sponsoring...FOR 711 HPW/IR (AFRL IRB) FROM: AFRL/DIRECTORATE OR OTHER ORGANIZATION SUBJECT: ACSC EEG Baseline Assessment 1. The undersigned have reviewed the

  3. 43 CFR 3271.13 - How do I obtain approval to build pipelines and facilities connecting the well field to...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false How do I obtain approval to build pipelines and facilities connecting the well field to utilization facilities not located on Federal lands leased for geothermal resources? 3271.13 Section 3271.13 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND...

  4. 43 CFR 3271.13 - How do I obtain approval to build pipelines and facilities connecting the well field to...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false How do I obtain approval to build pipelines and facilities connecting the well field to utilization facilities not located on Federal lands leased for geothermal resources? 3271.13 Section 3271.13 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND...

  5. 43 CFR 3271.13 - How do I obtain approval to build pipelines and facilities connecting the well field to...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false How do I obtain approval to build pipelines and facilities connecting the well field to utilization facilities not located on Federal lands leased for geothermal resources? 3271.13 Section 3271.13 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND...

  6. 43 CFR 3271.13 - How do I obtain approval to build pipelines and facilities connecting the well field to...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false How do I obtain approval to build pipelines and facilities connecting the well field to utilization facilities not located on Federal lands leased for geothermal resources? 3271.13 Section 3271.13 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND...

  7. The Technologies of Normalization and Self: Thinking about IRBs and Extrinsic Research Ethics with Foucault

    ERIC Educational Resources Information Center

    Koro-Ljungberg, Mirka; Gemignani, Marco; Brodeur, Cheri Winton; Kmiec, Cheryl

    2007-01-01

    In this article, the authors discuss the technologies of normalization and self in relation to ethics and the problematization of extrinsic research ethics. They argue that institutional review boards (IRBs) and other similar institutional mechanisms promote extrinsic forms of ethics that are exemplified through institutionalized structures such…

  8. 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

  9. Phase I Trial of Intratumoral Administration of NIS Expressing Strain of Measles Virus in Unresectable or Recurrent Malignant Peripheral Nerve Sheath Tumor

    DTIC Science & Technology

    2016-10-01

    Release; Distribution Unlimited 13. SUPPLEMENTARY NOTES 14. ABSTRACT Study approved by Mayo IRB on April 18 , 2016, and by USAMRMC/ORP/HRPO on May 6...MV-NIS, Oncolytic Virus, Measles Virus 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18 . NUMBER OF PPAGES 19a. NAME OF...1. Received Mayo IRB approval on 04/ 18 /2016 2. The US Army Medical Research and Materiel Command (USAMRMC), Office of Research Protections (ORP

  10. 30 CFR 22.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.0 Compliance... methane detectors a manufacturer must comply with the requirements specified in this part. ...

  11. 30 CFR 22.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.0 Compliance... methane detectors a manufacturer must comply with the requirements specified in this part. ...

  12. 30 CFR 22.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.0 Compliance... methane detectors a manufacturer must comply with the requirements specified in this part. ...

  13. 30 CFR 22.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.0 Compliance... methane detectors a manufacturer must comply with the requirements specified in this part. ...

  14. 30 CFR 22.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.0 Compliance... methane detectors a manufacturer must comply with the requirements specified in this part. ...

  15. Internet-based crowdsourcing and research ethics: the case for IRB review.

    PubMed

    Graber, Mark A; Graber, Abraham

    2013-02-01

    The recent success of Foldit in determining the structure of the Mason-Pfizer monkey virus (M-PMV) retroviral protease is suggestive of the power-solving potential of internet-facilitated game-like crowdsourcing. This research model is highly novel, however, and thus, deserves careful consideration of potential ethical issues. In this paper, we will demonstrate that the crowdsourcing model of research has the potential to cause harm to participants, manipulates the participant into continued participation, and uses participants as experimental subjects. We conclude that protocols relying on this model require institutional review board (IRB) scrutiny.

  16. 24 CFR 1000.108 - How is HUD approval obtained by a recipient for housing for non low-income Indian families and...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... recipient for housing for non low-income Indian families and model activities? 1000.108 Section 1000.108... AMERICAN HOUSING ACTIVITIES Affordable Housing Activities § 1000.108 How is HUD approval obtained by a.... Assistance to non low-income Indian families must be in accordance with § 1000.110. Proposals may be...

  17. Complete Decomposition of Li2CO3 in Li-O2 Batteries Using Ir/B4C as Noncarbon-Based Oxygen Electrode.

    PubMed

    Song, Shidong; Xu, Wu; Zheng, Jianming; Luo, Langli; Engelhard, Mark H; Bowden, Mark E; Liu, Bin; Wang, Chong-Min; Zhang, Ji-Guang

    2017-03-08

    Instability of carbon-based oxygen electrodes and incomplete decomposition of Li 2 CO 3 during charge process are critical barriers for rechargeable Li-O 2 batteries. Here we report the complete decomposition of Li 2 CO 3 in Li-O 2 batteries using the ultrafine iridium-decorated boron carbide (Ir/B 4 C) nanocomposite as a noncarbon based oxygen electrode. The systematic investigation on charging the Li 2 CO 3 preloaded Ir/B 4 C electrode in an ether-based electrolyte demonstrates that the Ir/B 4 C electrode can decompose Li 2 CO 3 with an efficiency close to 100% at a voltage below 4.37 V. In contrast, the bare B 4 C without Ir electrocatalyst can only decompose 4.7% of the preloaded Li 2 CO 3 . Theoretical analysis indicates that the high efficiency decomposition of Li 2 CO 3 can be attributed to the synergistic effects of Ir and B 4 C. Ir has a high affinity for oxygen species, which could lower the energy barrier for electrochemical oxidation of Li 2 CO 3 . B 4 C exhibits much higher chemical and electrochemical stability than carbon-based electrodes and high catalytic activity for Li-O 2 reactions. A Li-O 2 battery using Ir/B 4 C as the oxygen electrode material shows highly enhanced cycling stability than those using the bare B 4 C oxygen electrode. Further development of these stable oxygen-electrodes could accelerate practical applications of Li-O 2 batteries.

  18. Ethical Issues and Practical Challenges in Suicide Research.

    PubMed

    Hom, Melanie A; Podlogar, Matthew C; Stanley, Ian H; Joiner, Thomas E

    2017-03-01

    Research with human subjects represents a critical avenue for suicide prevention efforts; however, such research is not without its ethical and practical challenges. Specifically, given the nature of research with individuals at elevated risk for suicide (e.g., increased concerns regarding participant safety, adverse events, liability, difficulties often arise during the institutional review board (IRB) evaluation and approval process. This paper aims to discuss IRB-related issues associated with suicide prevention research, including researcher and IRB panel member responsibilities, suicide risk assessment and management ethics and procedures, informed consent considerations, preparation of study protocols, and education and training. Points to consider and components to potentially include in an IRB application for suicide-related research are additionally provided. Literature relevant to ethics in suicide research and suicide risk assessment and management was reviewed and synthesized. Suicide research can be conducted in accordance with ethical principles while also furthering the science of suicide prevention. Despite the challenging nature of suicide prevention research, empirically informed solutions exist to address difficulties that may emerge in interfacing with IRBs. There remain areas for improvement in the IRB approval process that warrant further investigation and work.

  19. 30 CFR 20.0 - Compliance with the requirements necessary for obtaining approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP... MSHA for any electric mine lamps other than standard cap lamps a manufacturer must comply with the...

  20. USASOC Injury Prevention/Performance Optimization Musculoskeletal Screening Initiative

    DTIC Science & Technology

    2016-10-29

    Initiative " PRINCIPAL INVESTIGATOR: Kim Beals RECIPIENT: Dr. Christie Vu REPORT DATE: October 2016 TYPE OF REPORT: Annual PREPARED FOR: U.S...Injury Prevention/Performance Optimization Musculoskeletal Screening Initiative 5a. CONTRACT NUMBER W81XWH-15-C-0179 " 5b. GRANT NUMBER 5c... initiate work on the Phase 3 and 4 research aims b) IRB & DoD Regulatory Approvals i) University of Pittsburgh IRB approved May 23, 2016 ii) HRPO USAMRMC

  1. Phase I Trial of Intratumoral Administration of NIS-Expressing Strain of Measles Virus in Unresectable or Recurrent Malignant Peripheral Nerve Sheath Tumor

    DTIC Science & Technology

    2017-10-01

    Distribution Unlimited 13. SUPPLEMENTARY NOTES 14. ABSTRACT Study approved by Mayo IRB on April 18 , 2016, and by USAMRMC/ORP/HRPO on May 6, 2016. All...Sheath Tumor(MPNST), MV-NIS, Oncolytic Virus, Measles Virus 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18 . NUMBER OF PPAGES 19a. NAME...virus incorporation and persistence in MPNST after injection Subtask 2: Assess viremia and viral shedding 1. Received Mayo IRB approval on 04/ 18 /2016

  2. From the Form to the Face to Face: IRBs, Ethnographic Researchers, and Human Subjects Translate Consent

    ERIC Educational Resources Information Center

    Metro, Rosalie

    2014-01-01

    Based on my fieldwork with Burmese teachers in Thailand, I describe the drawbacks of using IRB-mandated written consent procedures in my cross-cultural collaborative ethnographic research on education. Drawing on theories of intersubjectivity (Mikhail Bakhtin), ethics (Emmanuel Levinas), and translation (Naoki Sakai), I describe face-to-face…

  3. Novel Autoantibody Serum and Cerebrospinal Fluid Biomarkers in Veterans with Gulf War Illness

    DTIC Science & Technology

    2017-10-01

    autoantibodies against neuronal and glial cells in these veterans and are in agreement with recent reports indicating that 25 years after the war, the health of...Planned Months Actual Months 1a. Obtain necessary IRB approvals or Exempt status 1-3 1-4 1b. Obtain DOD Human Research Protections Office...Gulf War patients with chronic fatigue syndrome (CFS) and others with Irritable Bowel Syndrome (IBS), OP pesticide and nerve agent exposures in GW

  4. Researcher liability for negligence in human subject research: informed consent and researcher malpractice actions.

    PubMed

    Jansson, Roger L

    2003-02-01

    Two sets of federal regulations, the "Common Rule" and Food and Drug Administration (FDA) regulations, govern human subject research that is either federally-funded or involves FDA regulated products. These regulations require, inter alia, that: (1) researchers obtain informed consent from human subjects, and (2) that an Institutional Review Board (IRB) independently review and approve the research protocol. Although the federal regulations do not provide an express cause of action against researchers, research subjects should be able to bring informed consent and malpractice actions against researchers by establishing a duty of care and standard of care. Researchers owe human subjects a duty of care analogous to the special relationship between physicians and patients. The federal regulations should provide the minimum standard of care for informed consent in human subject research, and complying with them should be a partial defense. In contrast, expert testimony should establish the standard of care for researcher malpractice, and IRB approval should be a partial defense.

  5. Multimodal Intervention Trial for Cognitive Deficits in Neurofibromatosis Type 1: Efficacy of computerized Cognitive Training and Stimulant Medication

    DTIC Science & Technology

    2016-10-01

    created research database , submitted for and obtained IRB approval for the coordinating site (Children’s National), and enrolled B participants...intellectual quotient, executive functioning, and academic perfonnance In children with NFl over time. Given the high incidence and burdens of...identification and training of study personnel and database initial activities (months 2·6); 3) participant recruitment, therapy, and participant

  6. Salivary Proteomic and microRNA Biomarkers Development for Lung Cancer Detection

    DTIC Science & Technology

    2013-08-01

    an additional arm under an existing approved IRB at the GLA-VA titled “Salivary Biomarker Development for Oral Cancer Detection”. When we were... Oral Cancer in its title and did not include Lung Cancer. This was flagged by our administrative staff at UCLA. We informed and requested the GLA-VA to...flagging the incorrect inclusion of oral cancer in the title of the approved GLA-VA IRB. On April 3, 2013 Dr. Sheila Rowe from USAMRMC contacted us

  7. 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…

  8. 40 CFR 26.303 - Duties of IRBs in connection with observational research involving pregnant women and fetuses.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... observational research involving pregnant women and fetuses. 26.303 Section 26.303 Protection of Environment... Protections for Pregnant Women and Fetuses Involved as Subjects in Observational Research Conducted or Supported by EPA § 26.303 Duties of IRBs in connection with observational research involving pregnant women...

  9. 40 CFR 26.303 - Duties of IRBs in connection with observational research involving pregnant women and fetuses.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... observational research involving pregnant women and fetuses. 26.303 Section 26.303 Protection of Environment... Protections for Pregnant Women and Fetuses Involved as Subjects in Observational Research Conducted or Supported by EPA § 26.303 Duties of IRBs in connection with observational research involving pregnant women...

  10. 40 CFR 26.303 - Duties of IRBs in connection with observational research involving pregnant women and fetuses.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... observational research involving pregnant women and fetuses. 26.303 Section 26.303 Protection of Environment... Protections for Pregnant Women and Fetuses Involved as Subjects in Observational Research Conducted or Supported by EPA § 26.303 Duties of IRBs in connection with observational research involving pregnant women...

  11. 40 CFR 26.303 - Duties of IRBs in connection with observational research involving pregnant women and fetuses.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... observational research involving pregnant women and fetuses. 26.303 Section 26.303 Protection of Environment... Protections for Pregnant Women and Fetuses Involved as Subjects in Observational Research Conducted or Supported by EPA § 26.303 Duties of IRBs in connection with observational research involving pregnant women...

  12. 40 CFR 26.303 - Duties of IRBs in connection with observational research involving pregnant women and fetuses.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... observational research involving pregnant women and fetuses. 26.303 Section 26.303 Protection of Environment... Protections for Pregnant Women and Fetuses Involved as Subjects in Observational Research Conducted or Supported by EPA § 26.303 Duties of IRBs in connection with observational research involving pregnant women...

  13. Exercise to Counteract Loss of Bone and Muscle During Androgen Deprivation Therapy in Men with Prostate Cancer

    DTIC Science & Technology

    2009-08-01

    finishers in the current study on age and body mass index . This will enable us to evaluate BMD and body composition changes in response to exercise in men...support from the Clinical Nutrition Research Unit (CNRU) • prepare data forms • prepare data base • train research staff Final approval of the protocol...the local IRB on 19 Feb 2008. In the past year, the consent form underwent minor changes to update standard language used by the local IRB (approved

  14. 45 CFR 46.203 - Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... involving pregnant women, fetuses, and neonates. 46.203 Section 46.203 Public Welfare DEPARTMENT OF HEALTH... Pregnant Women, Human Fetuses and Neonates Involved in Research § 46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates. In addition to other responsibilities assigned to...

  15. 45 CFR 46.203 - Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... involving pregnant women, fetuses, and neonates. 46.203 Section 46.203 Public Welfare DEPARTMENT OF HEALTH... Pregnant Women, Human Fetuses and Neonates Involved in Research § 46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates. In addition to other responsibilities assigned to...

  16. 45 CFR 46.203 - Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... involving pregnant women, fetuses, and neonates. 46.203 Section 46.203 Public Welfare Department of Health... Pregnant Women, Human Fetuses and Neonates Involved in Research § 46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates. In addition to other responsibilities assigned to...

  17. 45 CFR 46.203 - Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... involving pregnant women, fetuses, and neonates. 46.203 Section 46.203 Public Welfare DEPARTMENT OF HEALTH... Pregnant Women, Human Fetuses and Neonates Involved in Research § 46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates. In addition to other responsibilities assigned to...

  18. 45 CFR 46.203 - Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... involving pregnant women, fetuses, and neonates. 46.203 Section 46.203 Public Welfare DEPARTMENT OF HEALTH... Pregnant Women, Human Fetuses and Neonates Involved in Research § 46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates. In addition to other responsibilities assigned to...

  19. Those Responsible for Approving Research Studies Have Poor Knowledge of Research Study Design: a Knowledge Assessment of Institutional Review Board Members.

    PubMed

    Mhaskar, Rahul; Pathak, Elizabeth Barnett; Wieten, Sarah; Guterbock, Thomas M; Kumar, Ambuj; Djulbegovic, Benjamin

    2015-08-01

    Institutional Review Board (IRB) members have a duty to protect the integrity of the research process, but little is known about their basic knowledge of clinical research study designs. A nationwide sample of IRB members from major US research universities completed a web-based questionnaire consisting of 11 questions focusing on basic knowledge about clinical research study designs. It included questions about randomized controlled trials (RCTs) and other observational research study designs. Potential predictors (age, gender, educational attainment, type of IRB, current IRB membership, years of IRB service, clinical research experience, and self-identification as a scientist) of incorrect answers were evaluated using multivariate logistic regression models. 148 individuals from 36 universities participated. The majority of participants, 68.9% (102/148), were holding a medical or doctoral degree. Overall, only 26.5% (39/148) of participants achieved a perfect score of 11. On the six-question subset addressing RCTs, 46.6% (69/148) had a perfect score. Most individual questions, and the summary model of overall quiz score (perfect vs. not perfect), revealed no significant predictors - indicating that knowledge deficits were not limited to specific subgroups of IRB members. For the RCT knowledge score there was one significant predictor: compared with MDs, IRB members without a doctoral degree were three times as likely to answer at least one RCT question incorrectly (Odds Ratio: 3.00, 95% CI 1.10-8.20). However, even among MD IRB members, 34.1% (14/41) did not achieve a perfect score on the six RCT questions. This first nationwide study of IRB member knowledge about clinical research study designs found significant knowledge deficits. Knowledge deficits were not limited to laypersons or community advocate members of IRBs, as previously suggested. Akin to widespread ethical training requirements for clinical researchers, IRB members should undergo systematic

  20. Analysis of Regional Timelines To Set Up a Global Phase III Clinical Trial in Breast Cancer: The Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Experience

    PubMed Central

    de Azambuja, Evandro; Bradbury, Ian; Saini, Kamal S.; Bines, José; Simon, Sergio D.; Dooren, Veerle Van; Aktan, Gursel; Pritchard, Kathleen I.; Wolff, Antonio C.; Smith, Ian; Jackisch, Christian; Lang, Istvan; Untch, Michael; Boyle, Frances; Xu, Binghe; Baselga, Jose; Perez, Edith A.; Piccart-Gebhart, Martine

    2013-01-01

    Purpose. This study measured the time taken for setting up the different facets of Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization (ALTTO), an international phase III study being conducted in 44 participating countries. Methods. Time to regulatory authority (RA) approval, time to ethics committee/institutional review board (EC/IRB) approval, time from study approval by EC/IRB to first randomized patient, and time from first to last randomized patient were prospectively collected in the ALTTO study. Analyses were conducted by grouping countries into either geographic regions or economic classes as per the World Bank's criteria. Results. South America had a significantly longer time to RA approval (median: 236 days, range: 21–257 days) than Europe (median: 52 days, range: 0–151 days), North America (median: 26 days, range: 22–30 days), and Asia-Pacific (median: 62 days, range: 37–75 days). Upper-middle economies had longer times to RA approval (median: 123 days, range: 21–257 days) than high-income (median: 47 days, range: 0–112 days) and lower-middle income economies (median: 57 days, range: 37–62 days). No significant difference was observed for time to EC/IRB approval across the studied regions (median: 59 days, range 0–174 days). Overall, the median time from EC/IRB approval to first recruited patient was 169 days (range: 26–412 days). Conclusion. This study highlights the long time intervals required to activate a global phase III trial. Collaborative research groups, pharmaceutical industry sponsors, and regulatory authorities should analyze the current system and enter into dialogue for optimizing local policies. This would enable faster access of patients to innovative therapies and enhance the efficiency of clinical research. PMID:23359433

  1. Development of a Hybrid Optical Biopsy Probe to Improve Prostate Cancer Diagnosis

    DTIC Science & Technology

    2011-06-01

    integrated needle probe can be developed for guiding needle biopsy for prostate cancer diagnosis. Multi-modal optical measurements to be utilized for... needle probe can be developed for guiding needle biopsy for prostate cancer diagnosis. Multi-modal optical measurements to be utilized for the study...tissue, into a transrectal- ultrasound , needle - biopsy probe. In the development phase, documentation to obtain IRB approval for ex vivo human prostate

  2. The Roles of the Bone Marrow Microenvironment in Controlling Tumor Dormancy

    DTIC Science & Technology

    2015-10-01

    Shiozawa, M.D., Ph.D. CONTRACTING ORGANIZATION: Wake Forest School of Medicine Ann Arbor, MI 48109 REPORT DATE: October 2015 TYPE OF REPORT...PERFORMING ORGANIZATION REPORT NUMBER Wake Forest University Health Sciences Medical Center Blvd. Winston-Salem NC 27157 9. SPONSORING... Wake Forest School of Medicine as of 03/01/15. The PI obtained the necessary institutional approvals (IACUC, IRB, IBC) and submitted the grant

  3. 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

    sites required at least one resubmission, and 15 percent of sites required three or more (up to six) resubmissions. Only 12 percent of sites required any procedural or substantive revision; most resubmissions were editorial changes to the wording of the consent document.Process failures (long turnaround times, lost paperwork, difficulty in obtaining necessary forms, unavailability of key personnel at IRBs). The process required from 52 to 798 (median 286) days to obtain approval at each site. Conclusions Several features of the IRB system as currently configured impose costly burdens of administrative activity and delay on observational health services research studies, and paradoxically decrease protection of human subjects. Central review with local opt-out, cooperative review, or a system of peer review could reduce costs and improve protection of human subjects. PMID:16430608

  4. Ethical standards for medical research in the Israeli military - review of the changes in the last decade.

    PubMed

    Hassidim, Ayal; Kayouf, Raeed; Yavnai, Nirit; Panush, Naomi; Dagan, David; Bader, Tarif; Hartal, Michael

    2016-01-01

    research approval process data similar to those presented here, medical institutions can help build and support a peer-based benchmarking process through which individual IRBs can appraise their own processes and approval rates.

  5. Genetic Variations in SLCO Transporter Genes Contributing to Racial Disparity in Aggressiveness of Prostate Cancer

    DTIC Science & Technology

    2015-10-01

    situ RNA hybridization staining of a TMA set and tissue sections from Roswell Park Cancer Institute (RPCI) and PCaP, respectively; 2) completion of...Facility at Roswell Park Cancer Institute (RPCI). Three Subtasks were proposed: Subtask 1 (months 1-3): Obtain approval for IRB protocol and request...Resource Network (PRN) at Roswell Park Cancer Institute (RPCI). The predominantly expressed SLCO transporters in AA or EA, and the transporters with

  6. 46 CFR 175.800 - Approved equipment and material.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... required by this subchapter to be approved or of an approved type, must have been manufactured and approved... Accepted under Marine Inspection and Navigation Laws” lists approved equipment by type and manufacturer. COMDTINST M16714.3 (Series) may be obtained from New Orders, Superintendent of Documents, P.O. Box 371954...

  7. 46 CFR 175.800 - Approved equipment and material.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... required by this subchapter to be approved or of an approved type, must have been manufactured and approved... Accepted under Marine Inspection and Navigation Laws” lists approved equipment by type and manufacturer. COMDTINST M16714.3 (Series) may be obtained from New Orders, Superintendent of Documents, P.O. Box 371954...

  8. 14 CFR 415.5 - Policy and safety approvals.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 415.5 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH LICENSE General § 415.5 Policy and safety approvals. To obtain a launch license, an applicant must obtain policy and safety approvals from the FAA. Requirements...

  9. 14 CFR 415.5 - Policy and safety approvals.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 415.5 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH LICENSE General § 415.5 Policy and safety approvals. To obtain a launch license, an applicant must obtain policy and safety approvals from the FAA. Requirements...

  10. 14 CFR 431.5 - Policy and safety approvals.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Policy and safety approvals. 431.5 Section 431.5 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... Policy and safety approvals. To obtain either type of RLV mission license, an applicant must obtain...

  11. 14 CFR 431.5 - Policy and safety approvals.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Policy and safety approvals. 431.5 Section 431.5 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... Policy and safety approvals. To obtain either type of RLV mission license, an applicant must obtain...

  12. 14 CFR 431.5 - Policy and safety approvals.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Policy and safety approvals. 431.5 Section 431.5 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... Policy and safety approvals. To obtain either type of RLV mission license, an applicant must obtain...

  13. 14 CFR 431.5 - Policy and safety approvals.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Policy and safety approvals. 431.5 Section 431.5 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... Policy and safety approvals. To obtain either type of RLV mission license, an applicant must obtain...

  14. 14 CFR 431.5 - Policy and safety approvals.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Policy and safety approvals. 431.5 Section 431.5 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION... Policy and safety approvals. To obtain either type of RLV mission license, an applicant must obtain...

  15. 45 CFR 690.108 - IRB functions and operations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ....108 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION... is used (see § 690.110), review proposed research at convened meetings at which a majority of the... areas. In order for the research to be approved, it shall receive the approval of a majority of those...

  16. Obtaining NASA Approval for use of Non-Metallic Materials in Manned Space Flight

    NASA Technical Reports Server (NTRS)

    Davis, Samuel E.; Wise, Harry L.

    2003-01-01

    Material manufacturers and suppliers are often surprised when a material commonly provided to industry is not approved for use on manned spacecraft. Often the reason is a lack of test data in environments that simulate those encountered in space applications, especially oxygen-enriched conditions, which significantly increase both the likelihood of material combustion and the propagation of a fire. This paper introduces the requirements for flight approval of non-metallic materials, focusing on material testing for human-rated space flight programs; it reviews the history of flight materials requirements and provides the rationale for such and introduces specific requirements related to testing and to good material engineering and design practices. After describing the procedure for submitting materials to be tested, the paper outlines options available if a material fails testing. In addition, this treatise introduces the National Aeronautics and Space Administration's (NASA's) Materials and Processes Technical Information System (MAPTIS), a database housing all test data produced in accordance with NASA-STD-6001, Flammability, Odor, Offgassing, and Compatibility Requirements and Test Procedures for Materials in Environments that Support Combustion.

  17. FLT-PET/CT as a Biomarker of Therapeutic Response in Pemetrexed Therapy for Non-Small Cell Lung Cancer

    DTIC Science & Technology

    2015-10-01

    therapy in a human patient. These images are from a 63 y/o male with NSCLC participating in our exploratory clinical trial of FLT- PET “flare”. (a... PET in a human NSCLC patient. Results: In NSCLC cells in vitro, we identified a burst in thymidine salvage pathway activity, assessed by 3H...25 Human PET imaging IRB approval was obtained through the University of Pennsylvania Institutional Review Board for use of FLT- PET /CT

  18. Ultrasound-Based Guidance for Partial Breast Irradiation Therapy

    DTIC Science & Technology

    2011-01-01

    and also are inexpensive. b. Collect US data from patient before the PBI treatment at the same time that CT is collected (months 2-14). We...introduces minimal divergence from the original workflow of PBI treatment. We have an approved institutional review board (IRB) protocol to obtain B...irradiation of only the in- volved area of the breast, partial breast irradiation ( PBI ), is as effective as whole breast irradiation [1]. Benefits of PBI

  19. Multicenter Clinical Trial of Keratin Biomaterials for Peripheral Nerve Regeneration

    DTIC Science & Technology

    2013-10-01

    As soon as the IND is available, our team will be able to obtain final approval for the study protocol from the Copernicus Group, an independent... Copernicus Group, an independent IRB located in Research Triangle Park, North Carolina. Due to the conflict of interest policies at the Wake Forest...School of Medicine, Dr. Li was asked to send the protocol to an independent review board.  October 13, 2010: The Copernicus Group granted conditional

  20. Measurement of Forces and Moments Transmitted to the Residual Limb

    DTIC Science & Technology

    2008-08-01

    leg and residual limb, the condition of your residual limb including touch and pressure sensation, and the type of components used in your prosthesis ...measured by a tri-axial transducer mounted on the pylon of a transtibial prosthesis distal to the socket can be used to estimate the intra-socket...alignment has been developed, and IRB approval has been obtained. 15. SUBJECT TERMS Amputees, prosthesis alignment, socket pressure, gait, force and moment

  1. Applying for ethical approval for research: the main issues.

    PubMed

    Gelling, Leslie

    2016-01-13

    The need to obtain research ethical approval is common to all research involving human participants. This approval must be obtained before research participants can be approached and before data collection can begin. The process of ethical review is one way that research participants can be confident that possible risks have been considered, minimised and deemed acceptable. This article outlines some of the main issues researchers should consider when planning an application for research ethical approval by answering the following six questions: 'Do I need research ethical approval?', 'How many applications will I need to make?', 'Where should I apply for research ethical approval?', 'What do I need to include in my application?', 'What do research ethics committees look for?' and 'What other approvals might I need?' Answering these questions will enable researchers to navigate the ethical review process.

  2. Why should ethics approval be required prior to publication of health promotion research?

    PubMed

    Newson, Ainsley J; Lipworth, Wendy

    2015-12-01

    Most academic journals that publish studies involving human participants require evidence that the research has been approved by a human research ethics committee (HREC). Yet journals continue to receive submissions from authors who have failed to obtain such approval. In this paper, we provide an ethical justification of why journals should not, in general, publish articles describing research that has no ethics approval, with particular attention to the health promotion context. Using theoretical bioethical reasoning and drawing on a case study, we first rebut some potential criticisms of the need for research ethics approval. We then outline four positive claims to justify a presumption that research should, in most instances, be published only if it has been undertaken with HREC approval. We present four justifications for requiring ethics approval before publication: (1) HREC approval adds legitimacy to the research; (2) the process of obtaining HREC approval can improve the quality of an intervention being investigated; (3) obtaining HREC approval can help mitigate harm; and (4) obtaining HREC approval demonstrates respect for persons. This paper provides a systematic and comprehensive assessment of why research ethics approval should generally be obtained before publishing in the health promotion context. So what? Journals such as the Health Promotion Journal of Australia have recently begun to require research ethics approval for publishing research. Health promotion researchers will be interested in learning the ethical justification for this change.

  3. 77 FR 24677 - Notice of Intent To Seek Approval to Revise and Extend a Currently Approved Information Collection

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ... (NASS) to request revision and extension of a currently approved information collection, the Egg...: Title: Egg, Chicken, and Turkey Surveys. OMB Number: 0535-0004. Expiration Date of Approval: October 31.... The Egg, Chicken, and Turkey Surveys obtain basic poultry statistics from voluntary cooperators...

  4. 36 CFR 1228.12 - How do agencies obtain approval to loan permanent or unscheduled records?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Records Programs (NWM), 8601 Adelphi Road, College Park, MD 20740-6001, phone number (301) 837-1738... be submitted or approved by the individual authorized to sign records schedules as described in...

  5. 36 CFR 1228.12 - How do agencies obtain approval to loan permanent or unscheduled records?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Records Programs (NWM), 8601 Adelphi Road, College Park, MD 20740-6001, phone number (301) 837-1738... be submitted or approved by the individual authorized to sign records schedules as described in...

  6. Metamaterial Resonant Absorbers for Terahertz Sensing

    DTIC Science & Technology

    2015-12-01

    Equation Chapter 1 Section 1 NAVAL POSTGRADUATE SCHOOL MONTEREY, CALIFORNIA THESIS Approved for public release; distribution...Co-Advisor Fabio Alves THIS PAGE INTENTIONALLY LEFT BLANK i REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704–0188 Public reporting...Department of Defense or the U.S. government. IRB Protocol number ____N/A____. 12a. DISTRIBUTION / AVAILABILITY STATEMENT Approved for public

  7. High Power Quantum Cascade Laser for Terahertz Imaging

    DTIC Science & Technology

    2012-03-01

    NAVAL POSTGRADUATE SCHOOL MONTEREY, CALIFORNIA THESIS Approved for public release, distribution is unlimited HIGH POWER QUANTUM...Second Reader: Fabio Alves THIS PAGE INTENTIONALLY LEFT BLANK i REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704-0188 Public reporting...Department of Defense or the U.S. Government. IRB Protocol Number: N/A 12a. DISTRIBUTION / AVAILABILITY STATEMENT Approved for public release

  8. Highly Absorbing Metal Nanolaminates for Bi-Material THz Sensors

    DTIC Science & Technology

    2011-09-01

    NAVAL POSTGRADUATE SCHOOL MONTEREY, CALIFORNIA THESIS Approved for public release; distribution is unlimited HIGHLY ABSORBING...Prescribed by ANSI Std. 239-18 REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704-0188 Public reporting burden for this collection of information is...Government. IRB Protocol number: N/A. 12a. DISTRIBUTION / AVAILABILITY STATEMENT Approved for public release; distribution is unlimited 12b

  9. 22 CFR 225.115 - IRB records.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and... members voting for, against, and abstaining; the basis for requiring changes in or disapproving research...

  10. 77 FR 47544 - Approval of Classification Societies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-09

    ...-AB35 Approval of Classification Societies AGENCY: Coast Guard, DHS. ACTION: Final rule. SUMMARY: Federal law requires that classification societies conducting certain work in the United States be... that classification societies must meet in order to obtain approval by the Coast Guard. Through this...

  11. A New Ethical Challenge for Institutional Review Boards (IRBs)/Ethics Committees (ECs) in the Assessment of Pediatric Clinical Trials.

    PubMed

    Rose, Klaus; Kummer, Hans

    2015-05-28

    Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)'s Pediatric Committee (PDCO) may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs)/ethics committees (ECs) and that clinical trials resulting from negotiations with EMA's PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients.

  12. A New Ethical Challenge for Institutional Review Boards (IRBs)/Ethics Committees (ECs) in the Assessment of Pediatric Clinical Trials

    PubMed Central

    Rose, Klaus; Kummer, Hans

    2015-01-01

    Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)’s Pediatric Committee (PDCO) may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs)/ethics committees (ECs) and that clinical trials resulting from negotiations with EMA’s PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients. PMID:27417359

  13. 21 CFR 56.115 - IRB records.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample... abstaining; the basis for requiring changes in or disapproving research; and a written summary of the... this regulation shall be retained for at least 3 years after completion of the research, and the...

  14. 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.

  15. 48 CFR 237.170-2 - Approval requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...-2 Approval requirements. (a) Acquisition of services through a contract or task order that is not performance based. (1) For acquisitions at or below $85.5 million, obtain the approval of the official... the senior procurement executive. (b) Acquisition of services through use of a contract or task order...

  16. 7 CFR 1737.41 - Procedure for obtaining approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... RUS financing. (3) The proposed interim financing presents unacceptable loan security risks to RUS, or..., DEPARTMENT OF AGRICULTURE PRE-LOAN POLICIES AND PROCEDURES COMMON TO INSURED AND GUARANTEED TELECOMMUNICATIONS LOANS Interim Financing of Construction of Telephone Facilities § 1737.41 Procedure for obtaining...

  17. 7 CFR 3300.19 - Application for approval.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... BE USED FOR SUCH CARRIAGE (ATP); INSPECTION, TESTING, AND CERTIFICATION OF SPECIAL EQUIPMENT Approval... the Form, Application for Approval as a U.S. ATP Testing Station, may be obtained by a request to the ATP manager. The following information must be supplied in the application: (a) A statement that the...

  18. 7 CFR 3300.19 - Application for approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... BE USED FOR SUCH CARRIAGE (ATP); INSPECTION, TESTING, AND CERTIFICATION OF SPECIAL EQUIPMENT Approval... the Form, Application for Approval as a U.S. ATP Testing Station, may be obtained by a request to the ATP manager. The following information must be supplied in the application: (a) A statement that the...

  19. 7 CFR 3300.19 - Application for approval.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... BE USED FOR SUCH CARRIAGE (ATP); INSPECTION, TESTING, AND CERTIFICATION OF SPECIAL EQUIPMENT Approval... the Form, Application for Approval as a U.S. ATP Testing Station, may be obtained by a request to the ATP manager. The following information must be supplied in the application: (a) A statement that the...

  20. The Effect of Online Collaborative Learning on Middle School Student Science Literacy and Sense of Community

    ERIC Educational Resources Information Center

    Wendt, Jillian Leigh

    2013-01-01

    This study examines the effects of online collaborative learning on middle school students' science literacy and sense of community. A quantitative, quasi-experimental pretest/posttest control group design was used. Following IRB approval and district superintendent approval, students at a public middle school in central Virginia completed a…

  1. 75 FR 53371 - Liquefied Natural Gas Facilities: Obtaining Approval of Alternative Vapor-Gas Dispersion Models

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-31

    ... factors as the approved models, are validated by experimental test data, and receive the Administrator's... stage of the MEP involves applying the model against a database of experimental test cases including..., particularly the requirement for validation by experimental test data. That guidance is based on the MEP's...

  2. 36 CFR § 1228.12 - How do agencies obtain approval to loan permanent or unscheduled records?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Records Programs (NWM), 8601 Adelphi Road, College Park, MD 20740-6001, phone number (301) 837-1738... be submitted or approved by the individual authorized to sign records schedules as described in...

  3. Mechanisms of CTC Biomarkers in Breast Cancer Brain Metastasis

    DTIC Science & Technology

    2015-10-01

    3. ACCOMPLISHMENTS What were the major goals of the project? Dr. David Hong at MD Anderson was the partnering PI of this protocol . The major...blood (CTC analyses). Peripheral blood samples and tumor tissues will be collected and provided by Dr. David Hong under a MDACC IRB- protocol which has...per IRB-approved protocol ) will be drawn and immediately undergo CTC analyses. Blood may be drawn from the same individual on more than one occasion

  4. The Rockefeller University Navigation Program: A Structured Multidisciplinary Protocol Development and Educational Program to Advance Translational Research

    PubMed Central

    Kost, Rhonda G.; Dowd, Kathleen A.; Hurley, Arlene M.; Rainer, Tyler‐Lauren; Coller, Barry S.

    2014-01-01

    Abstract The development of translational clinical research protocols is complex. To assist investigators, we developed a structured supportive guidance process (Navigation) to expedite protocol development to the standards of good clinical practice (GCP), focusing on research ethics and integrity. Navigation consists of experienced research coordinators leading investigators through a concerted multistep protocol development process from concept initiation to submission of the final protocol. To assess the effectiveness of Navigation, we collect data on the experience of investigators, the intensity of support required for protocol development, IRB review outcomes, and protocol start and completion dates. One hundred forty‐four protocols underwent Navigation and achieved IRB approval since the program began in 2007, including 37 led by trainee investigators, 26 led by MDs, 9 by MD/PhDs, 57 by PhDs, and 12 by investigators with other credentials (e.g., RN, MPH). In every year, more than 50% of Navigated protocols were approved by the IRB within 30 days. For trainees who had more than one protocol navigated, the intensity of Navigation support required decreased over time. Navigation can increase access to translational studies for basic scientists, facilitate GCP training for investigators, and accelerate development and approval of protocols of high ethical and scientific quality. PMID:24405608

  5. 7 CFR 3300.19 - Application for approval.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... and telephone number of the testing station, and name and title of person in charge of the station. (c... of Testing Stations § 3300.19 Application for approval. An application by an officer of the... the Form, Application for Approval as a U.S. ATP Testing Station, may be obtained by a request to the...

  6. 7 CFR 3300.19 - Application for approval.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... and telephone number of the testing station, and name and title of person in charge of the station. (c... of Testing Stations § 3300.19 Application for approval. An application by an officer of the... the Form, Application for Approval as a U.S. ATP Testing Station, may be obtained by a request to the...

  7. Ethical Considerations Related to Return of Results from Genomic Medicine Projects: The eMERGE Network (Phase III) Experience

    PubMed Central

    Fossey, Robyn; Kochan, David; Winkler, Erin; Pacyna, Joel E.; Olson, Janet; Thibodeau, Stephen; Connolly, John J.; Harr, Margaret; Behr, Meckenzie A.; Prows, Cynthia A.; Cobb, Beth; Myers, Melanie F.; Leslie, Nancy D.; Namjou-Khales, Bahram; Milo Rasouly, Hila; Wynn, Julia; Fedotov, Alexander; Chung, Wendy K.; Gharavi, Ali; Williams, Janet L.; Pais, Lynn; Holm, Ingrid; Aufox, Sharon; Smith, Maureen E.; Scrol, Aaron; Leppig, Kathleen; Jarvik, Gail P.; Wiesner, Georgia L.; Li, Rongling; Stroud, Mary; Smoller, Jordan W.; Sharp, Richard R.; Kullo, Iftikhar J.

    2018-01-01

    We examined the Institutional Review Board (IRB) process at 9 academic institutions in the electronic Medical Records and Genomics (eMERGE) Network, for proposed electronic health record-based genomic medicine studies, to identify common questions and concerns. Sequencing of 109 disease related genes and genotyping of 14 actionable variants is being performed in ~28,100 participants from the 9 sites. Pathogenic/likely pathogenic variants in actionable genes are being returned to study participants. We examined each site’s research protocols, informed-consent materials, and interactions with IRB staff. Research staff at each site completed questionnaires regarding their IRB interactions. The time to prepare protocols for IRB submission, number of revisions and time to approval ranged from 10–261 days, 0–11, and 11–90 days, respectively. IRB recommendations related to the readability of informed consent materials, specifying the full range of potential risks, providing options for receiving limited results or withdrawal, sharing of information with family members, and establishing the mechanisms to answer participant questions. IRBs reviewing studies that involve the return of results from genomic sequencing have a diverse array of concerns, and anticipating these concerns can help investigators to more effectively engage IRBs. PMID:29301385

  8. 21 CFR 56.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... research involving no more than minimal risk, and for minor changes in approved research. 56.110 Section 56... of research involving no more than minimal risk, and for minor changes in approved research. (a) The... categories of research that may be reviewed by the IRB through an expedited review procedure. The list will...

  9. Missile Base Deployments: Impact on Military Children

    DTIC Science & Technology

    2017-04-25

    deployments: Impact on military children Background: The effects of a parent’s combat deployment on their children are well studied . Chi ldren seen in...explore parent’s perspective regarding study participation by their children . IRB approval#: UTK-IRB-15-02251-XP Funding source: TSNRP HU0001-15- l-TS12... Children presented at/published to TSNRP Researcb/EBP Dissemination Course, Ellicott City, MD, 25-27 April 2017 in accordance with MDWI 41-108, has

  10. [Local approval procedures act as a brake on RCTs].

    PubMed

    van der Stok, E P; Huiskens, J; Hemmes, B; Grünhagen, D J; van Gulik, T M; Verhoef, C; Punt, C J A

    2016-01-01

    Large multicentre randomised controlled trials (RCTs) in the Netherlands are increasingly being impeded by major differences between local approval procedures. However, no national agenda exists as yet to improve this situation. The existence of major local differences in processing time and documentation required has been reported previously but little is known about the costs incurred and whether or not specific certifications and research contracts are mandatory. The current study evaluated these aspects of local procedures for obtaining approval of two oncological multicentre RCTs. Retrospective, descriptive. All local procedures for obtaining approval of two randomised clinical trials were evaluated: the CAIRO5 and CHARISMA trials initiated by the Dutch Colorectal Cancer Group (DCCG). We objectified time between approval by the Medical Ethics Review Committee (METC) and final approval by the Board of Directors (RvB), the type and number of documents needed, and costs charged. The median time interval between the approval by the Medical Ethics Review Committee and the approval by the Board of Directors was 90 days (range 4-312). The number of documents required per centre ranged from 6-20. The costs charged ranged from € 0-€ 1750, and amounted to € 8575 for all procedures combined. No costs were charged by the majority of the centres. The approval procedures for multicentre clinical trials in the Netherlands demonstrate major differences. Processing times, documentation required and costs are unpredictable; greater uniformity is highly desirable in this context.

  11. Let Archived Paraffin Blocks Be Utilized for Research with Waiver of Informed Consent.

    PubMed

    Kim, Yong-Jin; Park, Jeong Sik; Ko, Karam; Jeong, Chang Rok

    2018-05-01

    Advances in biomedical and genetic research have contributed to more effective public health improvement via bench-to-bed research and the emergence of personalized medicine. This has certainly showcased the importance of archived human tissues, especially paraffin-embedded blocks in pathology. Currently in Korea, undue legislative regulations of the Bioethics and Safety Act suspend and at times discourage studies from taking place. In this paper, the authors underline the value of paraffin blocks in the era of personalized and translational medicine. We discuss detailed clauses regarding the applicability of paraffin blocks from a legal perspective and compare Korea's regulations with those of other countries. The necessity for allowing waived consent and Institutional Review Board (IRB) approval will be argued throughout. The authors suggest that researchers declare the following to obtain IRB approval and waiver of informed consents: research could not be practically carried out without a waiver of consent; the proposed research presents no more than minimal risk of harm to subjects, and the waiver of consent will not adversely affect the rights and welfare of subjects; and research will not utilize a tissue block if only 1 is available for each subject, to allow future clinical use such as re-evaluation or further studies.

  12. Protecting the Navajo People through tribal regulation of research.

    PubMed

    Brugge, Doug; Missaghian, Mariam

    2006-07-01

    This essay explores the process and issues related to community collaborative research that involves Native Americans generally, and specifically examines the Navajo Nation's efforts to regulate research within its jurisdiction. Researchers need to account for both the experience of Native Americans and their own preconceptions about Native Americans when conducting research about Native Americans. The Navajo Nation institutionalized an approach to protecting members of the nation when it took over Institutional Review Board (IRB) responsibilities from the US Indian Health Service (IHS) in 1996. While written regulations for the Navajo Nation IRB are not dissimilar, and in some ways are less detailed than those of the IHS IRB, in practice the Navajo Nation allows less flexibility. Primary examples of this include not allowing expedited review and requiring prepublication review of all manuscripts. Because of its broad mandate, the Navajo Nation IRB may also require review of some projects that would not normally be subject to IRB approval, including investigative journalism and secondary research about Navajo People that does not involve direct data collection from human subjects.

  13. E-facts: business process management in clinical data repositories.

    PubMed

    Wattanasin, Nich; Peng, Zhaoping; Raine, Christine; Mitchell, Mariah; Wang, Charles; Murphy, Shawn N

    2008-11-06

    The Partners Healthcare Research Patient Data Registry (RPDR) is a centralized data repository that gathers clinical data from various hospital systems. The RPDR allows clinical investigators to obtain aggregate numbers of patients with user-defined characteristics such as diagnoses, procedures, medications, and laboratory values. They may then obtain patient identifiers and electronic medical records with prior IRB approval. Moreover, the accurate identification and efficient population of worthwhile and quantifiable facts from doctor's report into the RPDR is a significant process. As part of our ongoing e-Fact project, this work describes a new business process management technology that helps coordinate and simplify this procedure.

  14. Regional Anesthesia and Valproate Sodium for the Prevention of Chronic Post-Amputation Pain

    DTIC Science & Technology

    2013-10-01

    revised documents August Non-perishable Supplies ordered & received DUKE IRB approved study via expedited review September Submitted all revisions...2013 February March April May June July August September October HRPO request for revised, addtn’l docs VA approved protocol...A few candidate gene polymorphisms have been linked to pain susceptibility, including catechol-O-methyltranferase ( COMT ). This gene modulates

  15. Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.

    PubMed

    DiMasi, Joseph A

    2013-06-01

    Much of the literature on trends and factors affecting biopharmaceutical innovation has focused overwhelmingly on the development and approval of never-before approved drugs and biologics. Little attention has been paid to new uses for already-approved compounds, which can be an important form of innovation. This paper aimed to determine and analyze recent trends in the number and type of new or modified US indication approvals for drugs and biologics. We also examine regulatory approval-phase times for new-use efficacy supplements and compare them to approval-phase times for original-use approvals over the same period. We developed a data set of efficacy supplements approved by the US Food and Drug Administration (FDA) from 1998 to 2011 that includes information on the type, approval-phase time (time from submission to the FDA of an application for marketing approval to approval of the application), and FDA therapeutic-significance rating for the approved application, which we obtained from an FDA Web site. This data set was merged with a Tufts Center for the Study of Drug Development (CSDD) data set of US new drug and biologics approvals. We developed descriptive statistics on trends in the number and type of new-use efficacy supplements, on US regulatory approval-phase times for the supplements, and on original new drug and biologics approvals over the study period and for the time from original- to new-use approval. The total number of new-use efficacy-supplement approvals did not exhibit a marked trend, but the number of new pediatric-indication approvals increased substantially. Approval-phase times for new-use supplements varied by therapeutic class and FDA therapeutic-significance rating. Mean approval-phase times were highest for central nervous system compounds (13.8 months) and lowest for antineoplastics (8.9 months). The mean time from original to supplement approval was substantially longer for new pediatric indications than for other new uses. Mean

  16. Fertility Preservation for Children Diagnosed with Cancer

    MedlinePlus Videos and Cool Tools

    ... for Children Diagnosed with Cancer Ask Your Doctor Information for Patients Many adult survivors of childhood cancer ... study approved by an IRB . Resources For more information about infertility risk and fertility preservation options for ...

  17. 33 CFR 66.01-30 - Corps of Engineers' approval.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 33 Navigation and Navigable Waters 1 2014-07-01 2014-07-01 false Corps of Engineers' approval. 66... Corps of Engineers' approval. (a) Before any private aid to navigation consisting of a fixed structure... first be obtained from the District Engineer, U.S. Army Corps of Engineers in whose district the aid...

  18. 33 CFR 66.01-30 - Corps of Engineers' approval.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 33 Navigation and Navigable Waters 1 2012-07-01 2012-07-01 false Corps of Engineers' approval. 66... Corps of Engineers' approval. (a) Before any private aid to navigation consisting of a fixed structure... first be obtained from the District Engineer, U.S. Army Corps of Engineers in whose district the aid...

  19. 33 CFR 66.01-30 - Corps of Engineers' approval.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 33 Navigation and Navigable Waters 1 2013-07-01 2013-07-01 false Corps of Engineers' approval. 66... Corps of Engineers' approval. (a) Before any private aid to navigation consisting of a fixed structure... first be obtained from the District Engineer, U.S. Army Corps of Engineers in whose district the aid...

  20. 33 CFR 66.01-30 - Corps of Engineers' approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Corps of Engineers' approval. 66... Corps of Engineers' approval. (a) Before any private aid to navigation consisting of a fixed structure... first be obtained from the District Engineer, U.S. Army Corps of Engineers in whose district the aid...

  1. 33 CFR 66.01-30 - Corps of Engineers' approval.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 33 Navigation and Navigable Waters 1 2011-07-01 2011-07-01 false Corps of Engineers' approval. 66... Corps of Engineers' approval. (a) Before any private aid to navigation consisting of a fixed structure... first be obtained from the District Engineer, U.S. Army Corps of Engineers in whose district the aid...

  2. 5 CFR 4701.102 - Prior approval for certain outside employment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE FEDERAL ELECTION COMMISSION § 4701.102 Prior approval for... or consultation, which requires advanced knowledge in a field of science or learning customarily... obtain written approval from the Designated Agency Ethics Official before engaging in outside employment...

  3. 5 CFR 4701.102 - Prior approval for certain outside employment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE FEDERAL ELECTION COMMISSION § 4701.102 Prior approval for... or consultation, which requires advanced knowledge in a field of science or learning customarily... obtain written approval from the Designated Agency Ethics Official before engaging in outside employment...

  4. 5 CFR 4701.102 - Prior approval for certain outside employment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE FEDERAL ELECTION COMMISSION § 4701.102 Prior approval for... or consultation, which requires advanced knowledge in a field of science or learning customarily... obtain written approval from the Designated Agency Ethics Official before engaging in outside employment...

  5. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... approval or disapproval of the machine. (a) If the qualified electrical representative recommends field..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or...

  6. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... approval or disapproval of the machine. (a) If the qualified electrical representative recommends field..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or...

  7. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

  8. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

  9. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

  10. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

  11. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

  12. 34 CFR 97.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects... presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the...

  13. 34 CFR 97.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects... presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the...

  14. 34 CFR 97.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects... presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the...

  15. 34 CFR 97.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects... presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the...

  16. Protocol Coordinator | Center for Cancer Research

    Cancer.gov

    diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. KEY ROLES/RESPONSIBILITIES The Protocol Coordinator II: Provides comprehensive clinical and administrative support to the Brain Tumor Trial Collaborative, Neuro-Oncology Branch, NCI, National Institutes of Health Serves as a liaison with Principal Investigators (PIs), the associated study teams and a variety of offices associated with protocol development and approvals Orchestrates meetings with investigators and other key medical staff to identify required support Coordinates the writing and regulatory review processes that occur in tandem, facilitates the bi-directional dialogue and feedback between various teams, and assists investigators and medical writers on the production/revision of clinical research protocols Assists research staff in coordinating/navigating requirements for special circumstances and facilitates access to necessary services Facilitates initiation of intramural research by providing assistance in obtaining required approvals Coordinates with investigators and medical writers to ensure Institutional Review Board (IRB) and Food and Drug Administration (FDA) stipulations are appropriately addressed in a timely manner Provides consultation and assistance for all aspects of the protocol lifecycle including initial Investigational New Drug (IND) submission, IRB submission, continuing review applications, protocol amendments, annual reports, and protocol inactivation with IRB and FDA Tracks a portfolio of protocols through each lifecycle step; processes and tracks appropriate approvals (e.g., IRB, Data and Safety Monitoring Board, Radiation Safety, Office of Protocol Services, etc.) Provides

  17. 14 CFR 21.339 - Special export airworthiness approval for aircraft.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... export airworthiness approval for an aircraft engine, propeller, or article is issued. (c) If the FAA... difference between the aircraft to be exported and its type design. § 21.331 Issuance of export airworthiness approvals for aircraft engines, propellers, and articles. (a) A person may obtain from the FAA an export...

  18. 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

  19. Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka

    PubMed Central

    Sumathipala, Athula; Siribaddana, Sisira; Hewege, Suwin; Lekamwattage, Manura; Athukorale, Manjula; Siriwardhana, Chesmal; Murray, Joanna; Prince, Martin

    2008-01-01

    Background International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka. Methods We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM) library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized. Results Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent. Conclusion Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal. PMID:18267015

  20. 42 CFR 84.30 - Certificates of approval; scope of approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Certificates of approval; scope of approval. 84.30 Section 84.30 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Approval and...

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