40 CFR 26.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-07-01

... intention of involving human subjects. 26.119 Section 26.119 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human... human subjects. In the event research is undertaken without the intention of involving human subjects...

40 CFR 26.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2014 CFR

2014-07-01

... intention of involving human subjects. 26.119 Section 26.119 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human... human subjects. In the event research is undertaken without the intention of involving human subjects...

49 CFR 11.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... involving human subjects. 11.119 Section 11.119 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is...

49 CFR 11.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... involving human subjects. 11.119 Section 11.119 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is...

49 CFR 11.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... involving human subjects. 11.119 Section 11.119 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is...

45 CFR 46.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... involving human subjects. 46.119 Section 46.119 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.119 Research undertaken without the intention of involving human subjects. In the event...

45 CFR 46.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... involving human subjects. 46.119 Section 46.119 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.119 Research undertaken without the intention of involving human subjects. In the event...

45 CFR 46.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-10-01

... involving human subjects. 46.119 Section 46.119 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.119 Research undertaken without the intention of involving human subjects. In the event...

45 CFR 46.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... involving human subjects. 46.119 Section 46.119 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.119 Research undertaken without the intention of involving human subjects. In the event...

15 CFR 27.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-01-01

... intention of involving human subjects. 27.119 Section 27.119 Commerce and Foreign Trade Office of the Secretary of Commerce PROTECTION OF HUMAN SUBJECTS § 27.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human...

16 CFR § 1028.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-01-01

... involving human subjects. § 1028.119 Section § 1028.119 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human...

15 CFR 27.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-01-01

... intention of involving human subjects. 27.119 Section 27.119 Commerce and Foreign Trade Office of the Secretary of Commerce PROTECTION OF HUMAN SUBJECTS § 27.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human...

15 CFR 27.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2011 CFR

2011-01-01

... intention of involving human subjects. 27.119 Section 27.119 Commerce and Foreign Trade Office of the Secretary of Commerce PROTECTION OF HUMAN SUBJECTS § 27.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human...

14 CFR 1230.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2012 CFR

2012-01-01

... of involving human subjects. 1230.119 Section 1230.119 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving...

14 CFR 1230.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-01-01

... of involving human subjects. 1230.119 Section 1230.119 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving...

14 CFR 1230.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-01-01

... of involving human subjects. 1230.119 Section 1230.119 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving...

7 CFR 1c.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-01-01

... human subjects. 1c.119 Section 1c.119 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is later proposed...

7 CFR 1c.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-01-01

... human subjects. 1c.119 Section 1c.119 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is later proposed...

45 CFR 690.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... involving human subjects. 690.119 Section 690.119 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention...

45 CFR 690.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... involving human subjects. 690.119 Section 690.119 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention...

32 CFR 219.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-07-01

... involving human subjects. 219.119 Section 219.119 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the...

38 CFR 16.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2012 CFR

2012-07-01

... without the intention of involving human subjects. 16.119 Section 16.119 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention...

38 CFR 16.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2014 CFR

2014-07-01

... without the intention of involving human subjects. 16.119 Section 16.119 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention...

32 CFR 219.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2011 CFR

2011-07-01

... involving human subjects. 219.119 Section 219.119 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the...

38 CFR 16.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-07-01

... without the intention of involving human subjects. 16.119 Section 16.119 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention...

32 CFR 219.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-07-01

... involving human subjects. 219.119 Section 219.119 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the...

34 CFR 97.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2011 CFR

2011-07-01

... human subjects. 97.119 Section 97.119 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.119 Research undertaken without the intention of involving human...

34 CFR 97.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2013 CFR

2013-07-01

... human subjects. 97.119 Section 97.119 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.119 Research undertaken without the intention of involving human...

34 CFR 97.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-07-01

... human subjects. 97.119 Section 97.119 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.119 Research undertaken without the intention of involving human...

34 CFR 97.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2014 CFR

2014-07-01

... human subjects. 97.119 Section 97.119 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.119 Research undertaken without the intention of involving human...

14 CFR § 1230.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2014 CFR

2014-01-01

... of involving human subjects. § 1230.119 Section § 1230.119 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS (Eff. until 2-14-14) § 1230.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the...

45 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 1 2014-10-01 2014-10-01 false Applications and proposals lacking definite plans for involvement of human subjects. 46.118 Section 46.118 Public Welfare Department of Health and Human... Research Subjects § 46.118 Applications and proposals lacking definite plans for involvement of human...

45 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 1 2011-10-01 2011-10-01 false Applications and proposals lacking definite plans for involvement of human subjects. 46.118 Section 46.118 Public Welfare DEPARTMENT OF HEALTH AND HUMAN... Research Subjects § 46.118 Applications and proposals lacking definite plans for involvement of human...

45 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 1 2012-10-01 2012-10-01 false Applications and proposals lacking definite plans for involvement of human subjects. 46.118 Section 46.118 Public Welfare DEPARTMENT OF HEALTH AND HUMAN... Research Subjects § 46.118 Applications and proposals lacking definite plans for involvement of human...

45 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 1 2013-10-01 2013-10-01 false Applications and proposals lacking definite plans for involvement of human subjects. 46.118 Section 46.118 Public Welfare DEPARTMENT OF HEALTH AND HUMAN... Research Subjects § 46.118 Applications and proposals lacking definite plans for involvement of human...

16 CFR 1702.10 - Human experimental data involving the testing of human subjects.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Human experimental data involving the testing of human subjects. 1702.10 Section 1702.10 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION... PACKAGING ACT REQUIREMENTS; PETITION PROCEDURES AND REQUIREMENTS § 1702.10 Human experimental data involving...

16 CFR 1702.10 - Human experimental data involving the testing of human subjects.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Human experimental data involving the testing of human subjects. 1702.10 Section 1702.10 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION... PACKAGING ACT REQUIREMENTS; PETITION PROCEDURES AND REQUIREMENTS § 1702.10 Human experimental data involving...

16 CFR 1702.10 - Human experimental data involving the testing of human subjects.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Human experimental data involving the testing of human subjects. 1702.10 Section 1702.10 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION... PACKAGING ACT REQUIREMENTS; PETITION PROCEDURES AND REQUIREMENTS § 1702.10 Human experimental data involving...

16 CFR 1702.10 - Human experimental data involving the testing of human subjects.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Human experimental data involving the testing of human subjects. 1702.10 Section 1702.10 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION... PACKAGING ACT REQUIREMENTS; PETITION PROCEDURES AND REQUIREMENTS § 1702.10 Human experimental data involving...

34 CFR 97.101 - To what does this policy apply?

Code of Federal Regulations, 2014 CFR

2014-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.101... applies to all research involving human subjects conducted, supported or otherwise subject to regulation...

34 CFR 97.101 - To what does this policy apply?

Code of Federal Regulations, 2010 CFR

2010-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.101... applies to all research involving human subjects conducted, supported or otherwise subject to regulation...

34 CFR 97.101 - To what does this policy apply?

Code of Federal Regulations, 2012 CFR

2012-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.101... applies to all research involving human subjects conducted, supported or otherwise subject to regulation...

34 CFR 97.101 - To what does this policy apply?

Code of Federal Regulations, 2011 CFR

2011-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.101... applies to all research involving human subjects conducted, supported or otherwise subject to regulation...

34 CFR 97.101 - To what does this policy apply?

Code of Federal Regulations, 2013 CFR

2013-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.101... applies to all research involving human subjects conducted, supported or otherwise subject to regulation...

45 CFR 46.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 1 2012-10-01 2012-10-01 false Research undertaken without the intention of involving human subjects. 46.119 Section 46.119 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research...

78 FR 10538 - Protections for Subjects in Human Research Involving Pesticides

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-14

... the basis of animal data or human observational research. (2) Whether the proposed research is... Protections for Subjects in Human Research Involving Pesticides AGENCY: Environmental Protection Agency (EPA... for the protection of human subjects of research applying to third parties who conduct or support...

45 CFR 46.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human... departments or agencies with the knowledge that subjects may be involved within the period of support, but...

40 CFR 26.1101 - To what does this subpart apply?

Code of Federal Regulations, 2013 CFR

2013-07-01

... HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving... after April 15, 2013 involving intentional exposure of a human subject to: (1) Any substance if, at any... regulations which provide additional protections for human subjects. (f) This subpart does not affect any...

40 CFR 26.1101 - To what does this subpart apply?

Code of Federal Regulations, 2012 CFR

2012-07-01

... HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving... initiated after April 7, 2006 involving intentional exposure of a human subject if, at any time prior to... additional protections for human subjects. (e) This subpart does not affect any State or local laws or...

40 CFR 26.1101 - To what does this subpart apply?

Code of Federal Regulations, 2014 CFR

2014-07-01

... HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving... after April 15, 2013 involving intentional exposure of a human subject to: (1) Any substance if, at any... regulations which provide additional protections for human subjects. (f) This subpart does not affect any...

40 CFR 26.1101 - To what does this subpart apply?

Code of Federal Regulations, 2011 CFR

2011-07-01

... HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving... initiated after April 7, 2006 involving intentional exposure of a human subject if, at any time prior to... additional protections for human subjects. (e) This subpart does not affect any State or local laws or...

40 CFR 26.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Applications and proposals lacking definite plans for involvement of human subjects. 26.118 Section 26.118 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects...

45 CFR 690.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 3 2014-10-01 2014-10-01 false Research undertaken without the intention of involving human subjects. 690.119 Section 690.119 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.119 Research undertaken without...

45 CFR 690.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention... 45 Public Welfare 3 2011-10-01 2011-10-01 false Research undertaken without the intention of...

45 CFR 690.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2010 CFR

2010-10-01

... (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention... 45 Public Welfare 3 2010-10-01 2010-10-01 false Research undertaken without the intention of...

45 CFR 690.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.118... subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of...

45 CFR 690.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.118... subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of...

45 CFR 690.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.118... subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of...

45 CFR 690.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.118... subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of...

45 CFR 690.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.118... subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of...

32 CFR 219.119 - Research undertaken without the intention of involving human subjects.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 2 2014-07-01 2014-07-01 false Research undertaken without the intention of involving human subjects. 219.119 Section 219.119 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.119 Research...

32 CFR 219.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 2 2014-07-01 2014-07-01 false Applications and proposals lacking definite plans for involvement of human subjects. 219.118 Section 219.118 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219...

14 CFR 1230.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Applications and proposals lacking definite plans for involvement of human subjects. 1230.118 Section 1230.118 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.118 Applications and proposals...

14 CFR 1230.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Applications and proposals lacking definite plans for involvement of human subjects. 1230.118 Section 1230.118 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.118 Applications and proposals...

76 FR 5735 - Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-02

... pregnant women and for children who are the subjects of observational research conducted or supported by... whether human testing is necessary given other methods of research. E. Settlement of the Litigation After... Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides AGENCY...

40 CFR 26.101 - To what does this policy apply?

Code of Federal Regulations, 2011 CFR

2011-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26... policy applies to all research involving human subjects conducted, supported or otherwise subject to...

40 CFR 26.101 - To what does this policy apply?

Code of Federal Regulations, 2010 CFR

2010-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26... policy applies to all research involving human subjects conducted, supported or otherwise subject to...

40 CFR 26.101 - To what does this policy apply?

Code of Federal Regulations, 2013 CFR

2013-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26... policy applies to all research involving human subjects conducted, supported or otherwise subject to...

40 CFR 26.101 - To what does this policy apply?

Code of Federal Regulations, 2014 CFR

2014-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26... policy applies to all research involving human subjects conducted, supported or otherwise subject to...

40 CFR 26.101 - To what does this policy apply?

Code of Federal Regulations, 2012 CFR

2012-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26... policy applies to all research involving human subjects conducted, supported or otherwise subject to...

16 CFR § 1702.10 - Human experimental data involving the testing of human subjects.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Human experimental data involving the testing of human subjects. § 1702.10 Section § 1702.10 Commercial Practices CONSUMER PRODUCT SAFETY... PREVENTION PACKAGING ACT REQUIREMENTS; PETITION PROCEDURES AND REQUIREMENTS § 1702.10 Human experimental data...

Protecting the Teaching and Learning Environment: A Hybrid Model for Human Subject Research Public Policy Implementation

ERIC Educational Resources Information Center

Hottenstein, Kristi N.

2017-01-01

Regulations for research involving human subjects have long been a critical issue in higher education. Federal public policy for research involving human subjects impacts institutions of higher education by requiring all federally funded research to be passed by an Institutional Review Board (IRB). Undergraduate research is no exception. Given the…

76 FR 76399 - Agency Information Collection Activities; Proposed Renewal of Several Currently Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-07

... Research Involving Human Subjects. ICR number: EPA ICR No. 2195.04. OMB control number: OMB Control No... for environmental research involving human subjects under FIFRA and/or FFDCA. Although EPA has only... issued a final rule to amend the Federal Policy for the Protection of Human Subjects (also known as the...

16 CFR 1028.116 - General requirements for informed consent.

Code of Federal Regulations, 2011 CFR

2011-01-01

... HUMAN SUBJECTS § 1028.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy... involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which...

15 CFR 27.116 - General requirements for informed consent.

Code of Federal Regulations, 2011 CFR

2011-01-01

... OF HUMAN SUBJECTS § 27.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy... involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which...

38 CFR 16.116 - General requirements for informed consent.

Code of Federal Regulations, 2011 CFR

2011-07-01

... AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research... involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which...

48 CFR 1552.223-70 - Protection of human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Protection of human... 1552.223-70 Protection of human subjects. As prescribed in 1523.303-70, insert the following contract clause when the contract involves human test subjects. Protection of Human Subjects (APR 1984) (a) The...

48 CFR 1552.223-70 - Protection of human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Protection of human... 1552.223-70 Protection of human subjects. As prescribed in 1523.303-70, insert the following contract clause when the contract involves human test subjects. Protection of Human Subjects (APR 1984) (a) The...

48 CFR 1552.223-70 - Protection of human subjects.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Protection of human... 1552.223-70 Protection of human subjects. As prescribed in 1523.303-70, insert the following contract clause when the contract involves human test subjects. Protection of Human Subjects (APR 1984) (a) The...

48 CFR 1552.223-70 - Protection of human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false Protection of human... 1552.223-70 Protection of human subjects. As prescribed in 1523.303-70, insert the following contract clause when the contract involves human test subjects. Protection of Human Subjects (APR 1984) (a) The...

48 CFR 1552.223-70 - Protection of human subjects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Protection of human... 1552.223-70 Protection of human subjects. As prescribed in 1523.303-70, insert the following contract clause when the contract involves human test subjects. Protection of Human Subjects (APR 1984) (a) The...

34 CFR 97.118 - Applications and proposals lacking definite plans for involvement of human subjects.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.118 Applications and proposals lacking definite plans..., or contracts are submitted to departments or agencies with the knowledge that subjects may be...

48 CFR 1352.235-73 - Research involving human subjects-after initial contract award.

Code of Federal Regulations, 2012 CFR

2012-10-01

... the United States Department of Health and Human Services' Office for Human Research Protections... documentation may include: (1) Copies of the human subjects research protocol, advertisements, recruitment... human subjects research protocol, advertisements, recruitment material, and informed consent forms by...

10 CFR 745.116 - General requirements for informed consent.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 745.116 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as... particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject...

32 CFR 219.116 - General requirements for informed consent.

Code of Federal Regulations, 2011 CFR

2011-07-01

... DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a... involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which...

10 CFR 35.6 - Provisions for the protection of human research subjects.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Provisions for the protection of human research subjects... Information § 35.6 Provisions for the protection of human research subjects. (a) A licensee may conduct research involving human research subjects only if it uses the byproduct materials specified on its license...

10 CFR 35.6 - Provisions for the protection of human research subjects.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Provisions for the protection of human research subjects... Information § 35.6 Provisions for the protection of human research subjects. (a) A licensee may conduct research involving human research subjects only if it uses the byproduct materials specified on its license...

10 CFR 35.6 - Provisions for the protection of human research subjects.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Provisions for the protection of human research subjects... Information § 35.6 Provisions for the protection of human research subjects. (a) A licensee may conduct research involving human research subjects only if it uses the byproduct materials specified on its license...

Committees for Ethics in Research involving human subjects.

PubMed

Hossne, William Saad; Vieira, Sonia; De Freitas, Corina Bontempo Duca

2008-01-01

In Brazil since October 1996 there have been guidelines for research involving human subjects. Now human subjects know when their treatment is part of research. Deceit is no longer tolerated. But is not enough to say we offer an explanation to the potential subject and we offer a choice before he or she is confronted with an informed consent form. As in all professional activity, scientific investigation needs social controls. In Brazil, the ultimate responsibility of an investigation lies on the investigator, but in every institution where research is carried out there is a Committee for Ethics in Research. All Committees are subordinated to the National Commission of Ethics in Research, which is submitted to the Brazilian Institute of Health. During 2005 around 17,000 protocols involving 700,000 human subjects were revised by 475 Committees distributed all over the country. Approximately 7,000 people are now working in these Committees.

40 CFR 26.116 - General requirements for informed consent.

Code of Federal Regulations, 2011 CFR

2011-07-01

... PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or... policy, no investigator may involve a human being as a subject in research covered by this policy unless... subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently...

48 CFR 352.270-4 - Protection of human subjects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... regulatory requirements or ethical issues pertaining to research involving human subjects. (End of provision... 48 Federal Acquisition Regulations System 4 2014-10-01 2014-10-01 false Protection of human subjects. 352.270-4 Section 352.270-4 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES...

48 CFR 352.270-4 - Protection of human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... regulatory requirements or ethical issues pertaining to research involving human subjects. (End of provision... 48 Federal Acquisition Regulations System 4 2013-10-01 2013-10-01 false Protection of human subjects. 352.270-4 Section 352.270-4 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES...

48 CFR 352.270-4 - Protection of human subjects.

Code of Federal Regulations, 2010 CFR

2010-10-01

... regulatory requirements or ethical issues pertaining to research involving human subjects. (End of provision... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Protection of human subjects. 352.270-4 Section 352.270-4 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES...

48 CFR 352.270-4 - Protection of human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... regulatory requirements or ethical issues pertaining to research involving human subjects. (End of provision... 48 Federal Acquisition Regulations System 4 2011-10-01 2011-10-01 false Protection of human subjects. 352.270-4 Section 352.270-4 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES...

48 CFR 352.270-4 - Protection of human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... regulatory requirements or ethical issues pertaining to research involving human subjects. (End of provision... 48 Federal Acquisition Regulations System 4 2012-10-01 2012-10-01 false Protection of human subjects. 352.270-4 Section 352.270-4 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES...

Human subjects research handbook: Protecting human research subjects. Second edition

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

NONE

1996-01-30

This handbook serves as a guide to understanding and implementing the Federal regulations and US DOE Orders established to protect human research subjects. Material in this handbook is directed towards new and continuing institutional review board (IRB) members, researchers, institutional administrators, DOE officials, and others who may be involved or interested in human subjects research. It offers comprehensive overview of the various requirements, procedures, and issues relating to human subject research today.

48 CFR 1352.235-73 - Research involving human subjects-after initial contract award.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false Research involving human... Provisions and Clauses 1352.235-73 Research involving human subjects—after initial contract award. As prescribed in 48 CFR 1335.006(d), insert the following clause: Research Involving Human Subjects—After...

48 CFR 1352.235-73 - Research involving human subjects-after initial contract award.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 5 2013-10-01 2013-10-01 false Research involving human... Provisions and Clauses 1352.235-73 Research involving human subjects—after initial contract award. As prescribed in 48 CFR 1335.006(d), insert the following clause: Research Involving Human Subjects—After...

48 CFR 1352.235-73 - Research involving human subjects-after initial contract award.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 5 2014-10-01 2014-10-01 false Research involving human... Provisions and Clauses 1352.235-73 Research involving human subjects—after initial contract award. As prescribed in 48 CFR 1335.006(d), insert the following clause: Research Involving Human Subjects—After...

34 CFR 97.116 - General requirements for informed consent.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Section 97.116 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research..., no investigator may involve a human being as a subject in research covered by this policy unless the...

48 CFR 3424.170 - Protection of human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 7 2013-10-01 2012-10-01 true Protection of human... Individual Privacy 3424.170 Protection of human subjects. In this subsection, “Research” means a systematic... generalizable knowledge. (34 CFR 97.102(d)) Research is considered to involve human subjects when a researcher...

48 CFR 1523.303-70 - Protection of human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Protection of human... Hazardous Material and Material Safety Data 1523.303-70 Protection of human subjects. Contracting Officers shall insert the contract clause at 1552.223-70 when the contract involves human test subjects. ...

48 CFR 3424.170 - Protection of human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 7 2012-10-01 2012-10-01 false Protection of human... Individual Privacy 3424.170 Protection of human subjects. In this subsection, “Research” means a systematic... generalizable knowledge. (34 CFR 97.102(d)) Research is considered to involve human subjects when a researcher...

48 CFR 1523.303-70 - Protection of human subjects.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Protection of human... Hazardous Material and Material Safety Data 1523.303-70 Protection of human subjects. Contracting Officers shall insert the contract clause at 1552.223-70 when the contract involves human test subjects. ...

48 CFR 3424.170 - Protection of human subjects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 7 2014-10-01 2014-10-01 false Protection of human... Individual Privacy 3424.170 Protection of human subjects. In this subsection, “Research” means a systematic... generalizable knowledge. (34 CFR 97.102(d)) Research is considered to involve human subjects when a researcher...

48 CFR 1523.303-70 - Protection of human subjects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Protection of human... Hazardous Material and Material Safety Data 1523.303-70 Protection of human subjects. Contracting Officers shall insert the contract clause at 1552.223-70 when the contract involves human test subjects. ...

48 CFR 1523.303-70 - Protection of human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Protection of human... Hazardous Material and Material Safety Data 1523.303-70 Protection of human subjects. Contracting Officers shall insert the contract clause at 1552.223-70 when the contract involves human test subjects. ...

48 CFR 1523.303-70 - Protection of human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false Protection of human... Hazardous Material and Material Safety Data 1523.303-70 Protection of human subjects. Contracting Officers shall insert the contract clause at 1552.223-70 when the contract involves human test subjects. ...

48 CFR 3424.170 - Protection of human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 7 2011-10-01 2011-10-01 false Protection of human... Individual Privacy 3424.170 Protection of human subjects. In this subsection, “Research” means a systematic... generalizable knowledge. (34 CFR 97.102(d)) Research is considered to involve human subjects when a researcher...

34 CFR 97.116 - General requirements for informed consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Section 97.116 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research..., no investigator may involve a human being as a subject in research covered by this policy unless the...

34 CFR 97.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2010 CFR

2010-07-01

... research involving no more than minimal risk, and for minor changes in approved research. 97.110 Section 97... Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.110 Expedited review procedures for certain kinds of research involving no more than minimal risk...

40 CFR 26.301 - To what does this subpart apply?

Code of Federal Regulations, 2010 CFR

2010-07-01

... SUBJECTS Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects... involving human subjects who are pregnant women (and therefore their fetuses) conducted or supported by the...

40 CFR 26.301 - To what does this subpart apply?

Code of Federal Regulations, 2013 CFR

2013-07-01

... SUBJECTS Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects... involving human subjects who are pregnant women (and therefore their fetuses) conducted or supported by the...

40 CFR 26.301 - To what does this subpart apply?

Code of Federal Regulations, 2011 CFR

2011-07-01

... SUBJECTS Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects... involving human subjects who are pregnant women (and therefore their fetuses) conducted or supported by the...

40 CFR 26.301 - To what does this subpart apply?

Code of Federal Regulations, 2012 CFR

2012-07-01

... SUBJECTS Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects... involving human subjects who are pregnant women (and therefore their fetuses) conducted or supported by the...

40 CFR 26.301 - To what does this subpart apply?

Code of Federal Regulations, 2014 CFR

2014-07-01

... SUBJECTS Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects... involving human subjects who are pregnant women (and therefore their fetuses) conducted or supported by the...

Motion based parsing for video from observational psychology

NASA Astrophysics Data System (ADS)

Kokaram, Anil; Doyle, Erika; Lennon, Daire; Joyeux, Laurent; Fuller, Ray

2006-01-01

In Psychology it is common to conduct studies involving the observation of humans undertaking some task. The sessions are typically recorded on video and used for subjective visual analysis. The subjective analysis is tedious and time consuming, not only because much useless video material is recorded but also because subjective measures of human behaviour are not necessarily repeatable. This paper presents tools using content based video analysis that allow automated parsing of video from one such study involving Dyslexia. The tools rely on implicit measures of human motion that can be generalised to other applications in the domain of human observation. Results comparing quantitative assessment of human motion with subjective assessment are also presented, illustrating that the system is a useful scientific tool.

40 CFR 26.116 - General requirements for informed consent.

Code of Federal Regulations, 2014 CFR

2014-07-01

... welfare of the subjects; (3) The research could not practicably be carried out without the waiver or... PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or... policy, no investigator may involve a human being as a subject in research covered by this policy unless...

40 CFR 26.116 - General requirements for informed consent.

Code of Federal Regulations, 2013 CFR

2013-07-01

... welfare of the subjects; (3) The research could not practicably be carried out without the waiver or... PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or... policy, no investigator may involve a human being as a subject in research covered by this policy unless...

40 CFR 26.1701 - To what does this subpart apply?

Code of Federal Regulations, 2010 CFR

2010-07-01

... HUMAN SUBJECTS Ethical Standards for Assessing Whether To Rely on the Results of Human Research in EPA... valid and relevant data from research involving intentional exposure of human subjects. ...

40 CFR 26.1701 - To what does this subpart apply?

Code of Federal Regulations, 2011 CFR

2011-07-01

... HUMAN SUBJECTS Ethical Standards for Assessing Whether To Rely on the Results of Human Research in EPA... valid and relevant data from research involving intentional exposure of human subjects. ...

40 CFR 26.1701 - To what does this subpart apply?

Code of Federal Regulations, 2012 CFR

2012-07-01

... HUMAN SUBJECTS Ethical Standards for Assessing Whether To Rely on the Results of Human Research in EPA... valid and relevant data from research involving intentional exposure of human subjects. ...

45 CFR 46.401 - To what do these regulations apply?

Code of Federal Regulations, 2014 CFR

2014-10-01

... this subpart. However, the exemption at § 46.101(b)(2) for research involving survey or interview... HUMAN SUBJECTS Additional Protections for Children Involved as Subjects in Research § 46.401 To what do these regulations apply? (a) This subpart applies to all research involving children as subjects...

45 CFR 46.401 - To what do these regulations apply?

Code of Federal Regulations, 2010 CFR

2010-10-01

... this subpart. However, the exemption at § 46.101(b)(2) for research involving survey or interview... HUMAN SUBJECTS Additional Protections for Children Involved as Subjects in Research § 46.401 To what do these regulations apply? (a) This subpart applies to all research involving children as subjects...

45 CFR 46.401 - To what do these regulations apply?

Code of Federal Regulations, 2013 CFR

2013-10-01

... this subpart. However, the exemption at § 46.101(b)(2) for research involving survey or interview... HUMAN SUBJECTS Additional Protections for Children Involved as Subjects in Research § 46.401 To what do these regulations apply? (a) This subpart applies to all research involving children as subjects...

45 CFR 46.401 - To what do these regulations apply?

Code of Federal Regulations, 2012 CFR

2012-10-01

... this subpart. However, the exemption at § 46.101(b)(2) for research involving survey or interview... HUMAN SUBJECTS Additional Protections for Children Involved as Subjects in Research § 46.401 To what do these regulations apply? (a) This subpart applies to all research involving children as subjects...

45 CFR 46.401 - To what do these regulations apply?

Code of Federal Regulations, 2011 CFR

2011-10-01

... this subpart. However, the exemption at § 46.101(b)(2) for research involving survey or interview... HUMAN SUBJECTS Additional Protections for Children Involved as Subjects in Research § 46.401 To what do these regulations apply? (a) This subpart applies to all research involving children as subjects...

45 CFR 46.201 - To what do these regulations apply?

Code of Federal Regulations, 2010 CFR

2010-10-01

... HUMAN SUBJECTS Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in... section, this subpart applies to all research involving pregnant women, human fetuses, neonates of...

45 CFR 46.201 - To what do these regulations apply?

Code of Federal Regulations, 2012 CFR

2012-10-01

... HUMAN SUBJECTS Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in... section, this subpart applies to all research involving pregnant women, human fetuses, neonates of...

45 CFR 46.201 - To what do these regulations apply?

Code of Federal Regulations, 2013 CFR

2013-10-01

... HUMAN SUBJECTS Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in... section, this subpart applies to all research involving pregnant women, human fetuses, neonates of...

45 CFR 46.201 - To what do these regulations apply?

Code of Federal Regulations, 2014 CFR

2014-10-01

... HUMAN SUBJECTS Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in... section, this subpart applies to all research involving pregnant women, human fetuses, neonates of...

45 CFR 46.201 - To what do these regulations apply?

Code of Federal Regulations, 2011 CFR

2011-10-01

... HUMAN SUBJECTS Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in... section, this subpart applies to all research involving pregnant women, human fetuses, neonates of...

40 CFR 26.1116 - General requirements for informed consent.

Code of Federal Regulations, 2013 CFR

2013-07-01

... PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides... informed consent. No investigator may involve a human being as a subject in research covered by this...

40 CFR 26.1116 - General requirements for informed consent.

Code of Federal Regulations, 2014 CFR

2014-07-01

... PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides... informed consent. No investigator may involve a human being as a subject in research covered by this...

40 CFR 26.1116 - General requirements for informed consent.

Code of Federal Regulations, 2012 CFR

2012-07-01

... PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides... informed consent. No investigator may involve a human being as a subject in research covered by this...

40 CFR 26.1116 - General requirements for informed consent.

Code of Federal Regulations, 2011 CFR

2011-07-01

... PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides... informed consent. No investigator may involve a human being as a subject in research covered by this...

40 CFR 26.1116 - General requirements for informed consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides... informed consent. No investigator may involve a human being as a subject in research covered by this...

45 CFR 46.306 - Permitted research involving prisoners.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 1 2014-10-01 2014-10-01 false Permitted research involving prisoners. 46.306... HUMAN SUBJECTS Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects § 46.306 Permitted research involving prisoners. (a) Biomedical or behavioral research...

21 CFR 50.25 - Elements of informed consent.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic... the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if...

40 CFR 26.116 - General requirements for informed consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or... policy, no investigator may involve a human being as a subject in research covered by this policy unless... rights, or releases or appears to release the investigator, the sponsor, the institution or its agents...

48 CFR 1335.001 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 1335.001 Definitions. Human subject means a living individual... includes communication or interpersonal contact between investigator and subject. “Private information...) in order for obtaining the information to constitute research involving human subjects. Research...

45 CFR 46.205 - Research involving neonates.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 1 2013-10-01 2013-10-01 false Research involving neonates. 46.205 Section 46.205 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research § 46...

45 CFR 46.205 - Research involving neonates.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 1 2011-10-01 2011-10-01 false Research involving neonates. 46.205 Section 46.205 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research § 46...

45 CFR 46.205 - Research involving neonates.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 1 2010-10-01 2010-10-01 false Research involving neonates. 46.205 Section 46.205 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research § 46...

45 CFR 46.205 - Research involving neonates.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 1 2012-10-01 2012-10-01 false Research involving neonates. 46.205 Section 46.205 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research § 46...

Human subject research: reporting ethics approval and informed consent in 3 chiropractic journals.

PubMed

Lawrence, Dana J

2011-11-01

To date, there have been no reports of ethics board approval or informed consent within the chiropractic literature or within chiropractic research. The purpose of this study was to assess the reporting of ethics approval and informed consent in articles published during the 2008 volume year of 3 chiropractic research journals included in PubMed. A quantitative assessment of the articles published in each journal for the 2008 volume year was performed. Information collected included if the article involved human subject research, if it reported ethics board approval, and if informed consent was given to subjects. Data were collected as descriptive statistics (frequency counts and percentages). In aggregate, 50 articles of a total of 143 published involved human subject research (35%). 44 reported ethics board approval (88%), and 28 reported that informed consent had been obtained (56%). Forty-five percent of articles published in the Journal of Manipulative and Physiological Therapeutics involved human subject research (39/87), of which 95% reported ethics board approval (37/39) and 64% reported informed consent (25/39); 12.5% of articles from the Journal of the Canadian Chiropractic Association involved human subject research (5/40), of which 80% reported ethics board approval (4/5) and 40% reported informed consent (2/5); and 37.5% of articles published in Chiropractic and Osteopathy involved human subject research (6/16), of which 50% reported ethics board approval (3/6) and 17% reported informed consent (1/6). Overall, most articles reported ethics approval, and more than half reported consent. This was harmonious with research on this topic from other disciplines. This situation indicates a need for continued quality improvement and for better instruction and dissemination of information on these issues to researchers, to manuscript reviewers, to journal editors, and to the readers. Copyright © 2011 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

34 CFR 97.116 - General requirements for informed consent.

Code of Federal Regulations, 2014 CFR

2014-07-01

... welfare of the subjects; (3) The research could not practicably be carried out without the waiver or... Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research..., no investigator may involve a human being as a subject in research covered by this policy unless the...

34 CFR 97.116 - General requirements for informed consent.

Code of Federal Regulations, 2013 CFR

2013-07-01

... welfare of the subjects; (3) The research could not practicably be carried out without the waiver or... Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research..., no investigator may involve a human being as a subject in research covered by this policy unless the...

40 CFR 26.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2011 CFR

2011-07-01

... of research proposals which have been approved under the procedure. (d) The department or agency head... kinds of research involving no more than minimal risk, and for minor changes in approved research. 26... HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by...

Human Subjects Research and the Physics Classroom

NASA Astrophysics Data System (ADS)

Kubitskey, Beth W.; Thomsen, Marshall

2012-09-01

Physics Education Research is a form of social science research in that it uses human subjects. As physicists we need to be aware of the ethical and legal ramifications of performing this research, taking into account the fundamental differences between working with substances and working with people. For several decades, the federal government has regulated research involving human subjects. With current procedures, a proposal soliciting federal funds for a research project involving human subjects will be flagged by the applicants institution and checked for compliance with appropriate regulations. However, there is a large body of Physics Education Research that is not federally funded and thus may not be flagged. Nevertheless, there are ethical standards that apply to this research. This paper outlines the preliminary considerations for conducting such research.

40 CFR 26.1102 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 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... service programs may include research activities. (e) Human subject means a living individual about whom...

7 CFR 550.18 - Assurances/certifications.

Code of Federal Regulations, 2010 CFR

2010-01-01

... the rights and welfare of human subjects: (1) The Cooperator is responsible for safeguarding the rights and welfare of any human subjects involved in research, development, and related activities... disability, be excluded from participation in, be denied the benefits of, or be otherwise subjected to...

45 CFR 46.116 - General requirements for informed consent.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Section 46.116 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human...

45 CFR 46.116 - General requirements for informed consent.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Section 46.116 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human...

34 CFR 97.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2011 CFR

2011-07-01

... of research proposals which have been approved under the procedure. (d) The department or agency head... research involving no more than minimal risk, and for minor changes in approved research. 97.110 Section 97... Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects...

49 CFR 11.116 - General requirements for informed consent.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Section 11.116 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11... investigator may involve a human being as a subject in research covered by this policy unless the investigator... subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently...

49 CFR 11.116 - General requirements for informed consent.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Section 11.116 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11... investigator may involve a human being as a subject in research covered by this policy unless the investigator... subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently...

45 CFR 46.204 - Research involving pregnant women or fetuses.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 1 2010-10-01 2010-10-01 false Research involving pregnant women or fetuses. 46... PROTECTION OF HUMAN SUBJECTS Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research § 46.204 Research involving pregnant women or fetuses. Pregnant women or fetuses may be...

45 CFR 46.204 - Research involving pregnant women or fetuses.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 1 2014-10-01 2014-10-01 false Research involving pregnant women or fetuses. 46... PROTECTION OF HUMAN SUBJECTS Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research § 46.204 Research involving pregnant women or fetuses. Pregnant women or fetuses may be...

45 CFR 46.204 - Research involving pregnant women or fetuses.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 1 2012-10-01 2012-10-01 false Research involving pregnant women or fetuses. 46... PROTECTION OF HUMAN SUBJECTS Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research § 46.204 Research involving pregnant women or fetuses. Pregnant women or fetuses may be...

45 CFR 46.204 - Research involving pregnant women or fetuses.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 1 2011-10-01 2011-10-01 false Research involving pregnant women or fetuses. 46... PROTECTION OF HUMAN SUBJECTS Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research § 46.204 Research involving pregnant women or fetuses. Pregnant women or fetuses may be...

45 CFR 46.204 - Research involving pregnant women or fetuses.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 1 2013-10-01 2013-10-01 false Research involving pregnant women or fetuses. 46... PROTECTION OF HUMAN SUBJECTS Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research § 46.204 Research involving pregnant women or fetuses. Pregnant women or fetuses may be...

40 CFR 26.1110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2013 CFR

2013-07-01

... HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving... for Human Research Protections, HHS, or any successor office. (b)(1) An IRB may use the expedited...

40 CFR 26.1110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2011 CFR

2011-07-01

... HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving... for Human Research Protections, HHS, or any successor office. (b)(1) An IRB may use the expedited...

40 CFR 26.1110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2014 CFR

2014-07-01

... HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving... for Human Research Protections, HHS, or any successor office. (b)(1) An IRB may use the expedited...

40 CFR 26.1110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2012 CFR

2012-07-01

... HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving... for Human Research Protections, HHS, or any successor office. (b)(1) An IRB may use the expedited...

40 CFR 26.1203 - Prohibition of research involving intentional exposure of any human subject who is a pregnant...

Code of Federal Regulations, 2012 CFR

2012-07-01

... intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman... Exposure of Human Subjects who are Children or Pregnant or Nursing Women § 26.1203 Prohibition of research... nursing woman, or a child. Notwithstanding any other provision of this part, under no circumstances shall...

40 CFR 26.1203 - Prohibition of research involving intentional exposure of any human subject who is a pregnant...

Code of Federal Regulations, 2010 CFR

2010-07-01

... intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman... Exposure of Human Subjects who are Children or Pregnant or Nursing Women § 26.1203 Prohibition of research... nursing woman, or a child. Notwithstanding any other provision of this part, under no circumstances shall...

40 CFR 26.1203 - Prohibition of research involving intentional exposure of any human subject who is a pregnant...

Code of Federal Regulations, 2011 CFR

2011-07-01

... intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman... Exposure of Human Subjects who are Children or Pregnant or Nursing Women § 26.1203 Prohibition of research... nursing woman, or a child. Notwithstanding any other provision of this part, under no circumstances shall...

40 CFR 26.1203 - Prohibition of research involving intentional exposure of any human subject who is a pregnant...

Code of Federal Regulations, 2013 CFR

2013-07-01

... intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman... Pesticide of Human Subjects who are Children or Pregnant or Nursing Women § 26.1203 Prohibition of research... nursing woman, or a child. Notwithstanding any other provision of this part, under no circumstances shall...

40 CFR 26.1203 - Prohibition of research involving intentional exposure of any human subject who is a pregnant...

Code of Federal Regulations, 2014 CFR

2014-07-01

... intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman... Pesticide of Human Subjects who are Children or Pregnant or Nursing Women § 26.1203 Prohibition of research... nursing woman, or a child. Notwithstanding any other provision of this part, under no circumstances shall...

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.

21 CFR 71.1 - Petitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... for use in or on any food, drug, or cosmetic or for coloring the human body. Such proposal shall be... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVE PETITIONS...) If clinical investigations involving human subjects are involved, petitions filed with the...

7 CFR 1c.116 - General requirements for informed consent.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Section 1c.116 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.116... may involve a human being as a subject in research covered by this policy unless the investigator has... subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently...

40 CFR 26.405 - Observational research involving greater than minimal risk but presenting the prospect of direct...

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Observational research involving... Section 26.405 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Observational Research: Additional Protections for Children Involved as Subjects in Observational...

40 CFR 26.1703 - Prohibitions applying to all research subject to this subpart.

Code of Federal Regulations, 2013 CFR

2013-07-01

... human subjects who are pregnant women (and therefore their fetuses), nursing women, or children. Except... involving intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or a child. [78 FR 10545, Feb. 14, 2013] ...

40 CFR 26.1703 - Prohibitions applying to all research subject to this subpart.

Code of Federal Regulations, 2014 CFR

2014-07-01

... human subjects who are pregnant women (and therefore their fetuses), nursing women, or children. Except... involving intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or a child. [78 FR 10545, Feb. 14, 2013] ...

22 CFR 225.116 - General requirements for informed consent.

Code of Federal Regulations, 2011 CFR

2011-04-01

....116 Section 225.116 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF HUMAN..., no investigator may involve a human being as a subject in research covered by this policy unless the... subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently...

28 CFR 46.116 - General requirements for informed consent.

Code of Federal Regulations, 2011 CFR

2011-07-01

.... 46.116 Section 46.116 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN..., no investigator may involve a human being as a subject in research covered by this policy unless the... subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently...

16 CFR 1028.116 - General requirements for informed consent.

Code of Federal Regulations, 2010 CFR

2010-01-01

... HUMAN SUBJECTS § 1028.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy... subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution...

14 CFR 1230.116 - General requirements for informed consent.

Code of Federal Regulations, 2010 CFR

2010-01-01

... PROTECTION OF HUMAN SUBJECTS § 1230.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this... subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution...

38 CFR 16.116 - General requirements for informed consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research... of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the...

45 CFR 690.116 - General requirements for informed consent.

Code of Federal Regulations, 2010 CFR

2010-10-01

... FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research... of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the...

15 CFR 27.116 - General requirements for informed consent.

Code of Federal Regulations, 2010 CFR

2010-01-01

... OF HUMAN SUBJECTS § 27.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy... subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution...

Subject Retrieval from Full-Text Databases in the Humanities

ERIC Educational Resources Information Center

East, John W.

2007-01-01

This paper examines the problems involved in subject retrieval from full-text databases of secondary materials in the humanities. Ten such databases were studied and their search functionality evaluated, focusing on factors such as Boolean operators, document surrogates, limiting by subject area, proximity operators, phrase searching, wildcards,…

21 CFR 50.51 - Clinical investigations not involving greater than minimal risk.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Clinical investigations not involving greater than... HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Additional Safeguards for Children in Clinical Investigations § 50.51 Clinical investigations not involving greater than minimal risk. Any clinical...

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.

34 CFR 97.406 - Research involving greater than minimal risk and no prospect of direct benefit to individual...

Code of Federal Regulations, 2010 CFR

2010-07-01

... subject's disorder or condition. 97.406 Section 97.406 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Additional ED Protections for Children Who Are Subjects in Research... 34 Education 1 2010-07-01 2010-07-01 false Research involving greater than minimal risk and no...

48 CFR 370.301 - Policy.

Code of Federal Regulations, 2010 CFR

2010-10-01

... contract due to inadequate assurance or breach of assurance for protection of human subjects. ... the Contracting Officer shall not award a contract involving human subjects until a prospective....103. The Contracting Officer shall require an applicable Federal-wide assurance (FWA), approved by the...

48 CFR 1335.001 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-10-01

... CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 1335.001 Definitions. Human subject means a living individual...” includes information about behavior that occurs in a context in which an individual can reasonably expect...) in order for obtaining the information to constitute research involving human subjects. Research...

48 CFR 1335.001 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 1335.001 Definitions. Human subject means a living individual...” includes information about behavior that occurs in a context in which an individual can reasonably expect...) in order for obtaining the information to constitute research involving human subjects. Research...

48 CFR 1335.001 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-10-01

... CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 1335.001 Definitions. Human subject means a living individual...” includes information about behavior that occurs in a context in which an individual can reasonably expect...) in order for obtaining the information to constitute research involving human subjects. Research...

48 CFR 1335.001 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 1335.001 Definitions. Human subject means a living individual...” includes information about behavior that occurs in a context in which an individual can reasonably expect...) in order for obtaining the information to constitute research involving human subjects. Research...

Human subjects in dental research: coping with the regulations. Council on Dental Research.

PubMed

Gibson, W A

1985-02-01

The rules and regulations pertaining to human subjects in research have evolved in response to ethical concerns for the protection of the rights and welfare of such subjects. However, investigators quite often are not well informed on what is required of them in the conduct of their clinical studies. Failure to be provided with sufficient information may be part of the problem, but the nature of such rules and regulations and their diversity and complexity certainly are sources of confusion. This article presents an overview of some of the major components and processes involved in the implementation of the federal regulations. It is hoped that this presentation will lead to a better understanding of the roles of the investigator, the institutional review boards, and the institutional and the federal agencies involved in the protection of human research subjects.

7 CFR 1c.116 - General requirements for informed consent.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Section 1c.116 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.116... may involve a human being as a subject in research covered by this policy unless the investigator has... or the representative is made to waive or appear to waive any of the subject's legal rights, or...

Coming of Age of Human Biology: A Study of the Birth and Growth of a Subject in the School Curriculum.

ERIC Educational Resources Information Center

Denny, M.

1983-01-01

Human biology is a school subject whose utilitarian/pedagogical traditions enjoy support at the School Certificate level but whose academic tradition is under threat at the General Certificate of Education level. An interpretation of the issues involved are discussed in terms of the subject's historical background. (JN)

Ethics is for human subjects too: participant perspectives on responsibility in health research.

PubMed

Cox, Susan M; McDonald, Michael

2013-12-01

Despite the significant literature as well as energy devoted to ethical review of research involving human subjects, little attention has been given to understanding the experiences of those who volunteer as human subjects. Why and how do they decide to participate in research? Is research participation viewed as a form of social responsibility or as a way of obtaining individual benefits? What if anything do research subjects feel they are owed for participation? And what do they feel that they owe the researcher? Drawing on in-depth individual interviews conducted in 2006 and 2007 with 41 subjects who participated in a variety of types of health research in Canada, this paper focuses on subject perspectives on responsibility in research. Highlighting the range of ways that subjects describe their involvement in research and commitments to being a 'good' subject, we present a typology of narratives that sheds new light on the diverse meanings of research participation. These narratives are not mutually exclusive or prescriptive but are presented as ideal types typifying a set of circumstances and values. As such, they collectively illuminate a range of motivations expressed by human subjects as well as potential sources of vulnerability. The typology adds a new dimension to the literature in this area and has significant implications for researchers seeking more human-subject centred approaches to research recruitment and retention, as well as research ethics boards trying to better anticipate the perspectives of prospective participants. Copyright © 2013 Elsevier Ltd. All rights reserved.

28 CFR 46.101 - To what does this policy apply?

Code of Federal Regulations, 2014 CFR

2014-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... policy applies to all research involving human subjects conducted, supported or otherwise subject to... policy applicable to such research. This includes research conducted by federal civilian employees or...

22 CFR 225.101 - To what does this policy apply?

Code of Federal Regulations, 2014 CFR

2014-04-01

....101(b)(2), for research involving survey or interview procedures or observation of public behavior... applies to all research involving human subjects conducted, supported or otherwise subject to regulation... applicable to such research. This includes research conducted by federal civilian employees or military...

15 CFR 27.101 - To what does this policy apply?

Code of Federal Regulations, 2012 CFR

2012-01-01

....101(b)(2), for research involving survey or interview procedures or observation of public behavior... policy applies to all research involving human subjects conducted, supported or otherwise subject to... policy applicable to such research. This includes research conducted by federal civilian employees or...

28 CFR 46.101 - To what does this policy apply?

Code of Federal Regulations, 2011 CFR

2011-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... policy applies to all research involving human subjects conducted, supported or otherwise subject to... policy applicable to such research. This includes research conducted by federal civilian employees or...

49 CFR 11.101 - To what does this policy apply?

Code of Federal Regulations, 2012 CFR

2012-10-01

...), for research involving survey or interview procedures or observation of public behavior, does not... applies to all research involving human subjects conducted, supported or otherwise subject to regulation... applicable to such research. This includes research conducted by federal civilian employees or military...

15 CFR 27.101 - To what does this policy apply?

Code of Federal Regulations, 2013 CFR

2013-01-01

....101(b)(2), for research involving survey or interview procedures or observation of public behavior... policy applies to all research involving human subjects conducted, supported or otherwise subject to... policy applicable to such research. This includes research conducted by federal civilian employees or...

22 CFR 225.101 - To what does this policy apply?

Code of Federal Regulations, 2013 CFR

2013-04-01

....101(b)(2), for research involving survey or interview procedures or observation of public behavior... applies to all research involving human subjects conducted, supported or otherwise subject to regulation... applicable to such research. This includes research conducted by federal civilian employees or military...

49 CFR 11.101 - To what does this policy apply?

Code of Federal Regulations, 2011 CFR

2011-10-01

...), for research involving survey or interview procedures or observation of public behavior, does not... applies to all research involving human subjects conducted, supported or otherwise subject to regulation... applicable to such research. This includes research conducted by federal civilian employees or military...

28 CFR 46.101 - To what does this policy apply?

Code of Federal Regulations, 2013 CFR

2013-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... policy applies to all research involving human subjects conducted, supported or otherwise subject to... policy applicable to such research. This includes research conducted by federal civilian employees or...

49 CFR 11.101 - To what does this policy apply?

Code of Federal Regulations, 2013 CFR

2013-10-01

...), for research involving survey or interview procedures or observation of public behavior, does not... applies to all research involving human subjects conducted, supported or otherwise subject to regulation... applicable to such research. This includes research conducted by federal civilian employees or military...

49 CFR 11.101 - To what does this policy apply?

Code of Federal Regulations, 2010 CFR

2010-10-01

...), for research involving survey or interview procedures or observation of public behavior, does not... applies to all research involving human subjects conducted, supported or otherwise subject to regulation... applicable to such research. This includes research conducted by federal civilian employees or military...

28 CFR 46.101 - To what does this policy apply?

Code of Federal Regulations, 2010 CFR

2010-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... policy applies to all research involving human subjects conducted, supported or otherwise subject to... policy applicable to such research. This includes research conducted by federal civilian employees or...

28 CFR 46.101 - To what does this policy apply?

Code of Federal Regulations, 2012 CFR

2012-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not... policy applies to all research involving human subjects conducted, supported or otherwise subject to... policy applicable to such research. This includes research conducted by federal civilian employees or...

22 CFR 225.101 - To what does this policy apply?

Code of Federal Regulations, 2011 CFR

2011-04-01

....101(b)(2), for research involving survey or interview procedures or observation of public behavior... applies to all research involving human subjects conducted, supported or otherwise subject to regulation... applicable to such research. This includes research conducted by federal civilian employees or military...

22 CFR 225.101 - To what does this policy apply?

Code of Federal Regulations, 2012 CFR

2012-04-01

....101(b)(2), for research involving survey or interview procedures or observation of public behavior... applies to all research involving human subjects conducted, supported or otherwise subject to regulation... applicable to such research. This includes research conducted by federal civilian employees or military...

49 CFR 11.101 - To what does this policy apply?

Code of Federal Regulations, 2014 CFR

2014-10-01

...), for research involving survey or interview procedures or observation of public behavior, does not... applies to all research involving human subjects conducted, supported or otherwise subject to regulation... applicable to such research. This includes research conducted by federal civilian employees or military...

15 CFR 27.101 - To what does this policy apply?

Code of Federal Regulations, 2014 CFR

2014-01-01

....101(b)(2), for research involving survey or interview procedures or observation of public behavior... policy applies to all research involving human subjects conducted, supported or otherwise subject to... policy applicable to such research. This includes research conducted by federal civilian employees or...

15 CFR 27.101 - To what does this policy apply?

Code of Federal Regulations, 2011 CFR

2011-01-01

....101(b)(2), for research involving survey or interview procedures or observation of public behavior... policy applies to all research involving human subjects conducted, supported or otherwise subject to... policy applicable to such research. This includes research conducted by federal civilian employees or...

15 CFR 27.101 - To what does this policy apply?

Code of Federal Regulations, 2010 CFR

2010-01-01

....101(b)(2), for research involving survey or interview procedures or observation of public behavior... policy applies to all research involving human subjects conducted, supported or otherwise subject to... policy applicable to such research. This includes research conducted by federal civilian employees or...

22 CFR 225.101 - To what does this policy apply?

Code of Federal Regulations, 2010 CFR

2010-04-01

....101(b)(2), for research involving survey or interview procedures or observation of public behavior... applies to all research involving human subjects conducted, supported or otherwise subject to regulation... applicable to such research. This includes research conducted by federal civilian employees or military...

45 CFR 46.302 - Purpose.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 1 2011-10-01 2011-10-01 false Purpose. 46.302 Section 46.302 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects § 46.302 Purpose...

45 CFR 46.302 - Purpose.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 1 2010-10-01 2010-10-01 false Purpose. 46.302 Section 46.302 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects § 46.302 Purpose...

45 CFR 46.302 - Purpose.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 1 2012-10-01 2012-10-01 false Purpose. 46.302 Section 46.302 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects § 46.302 Purpose...

45 CFR 46.302 - Purpose.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 1 2014-10-01 2014-10-01 false Purpose. 46.302 Section 46.302 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects § 46.302 Purpose...

45 CFR 46.302 - Purpose.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 1 2013-10-01 2013-10-01 false Purpose. 46.302 Section 46.302 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects § 46.302 Purpose...

10 CFR 35.290 - Training for imaging and localization studies.

Code of Federal Regulations, 2013 CFR

2013-01-01

...; (D) Chemistry of byproduct material for medical use; (E) Radiation biology; and (ii) Work experience... human research subject dosages; (D) Using administrative controls to prevent a medical event involving... patients or human research subjects; and (G) Eluting generator systems appropriate for preparation of...

10 CFR 35.290 - Training for imaging and localization studies.

Code of Federal Regulations, 2012 CFR

2012-01-01

...; (D) Chemistry of byproduct material for medical use; (E) Radiation biology; and (ii) Work experience... human research subject dosages; (D) Using administrative controls to prevent a medical event involving... patients or human research subjects; and (G) Eluting generator systems appropriate for preparation of...

10 CFR 35.290 - Training for imaging and localization studies.

Code of Federal Regulations, 2011 CFR

2011-01-01

...; (D) Chemistry of byproduct material for medical use; (E) Radiation biology; and (ii) Work experience... human research subject dosages; (D) Using administrative controls to prevent a medical event involving... patients or human research subjects; and (G) Eluting generator systems appropriate for preparation of...

10 CFR 35.290 - Training for imaging and localization studies.

Code of Federal Regulations, 2014 CFR

2014-01-01

...; (D) Chemistry of byproduct material for medical use; (E) Radiation biology; and (ii) Work experience... human research subject dosages; (D) Using administrative controls to prevent a medical event involving... patients or human research subjects; and (G) Eluting generator systems appropriate for preparation of...

Federal Policy for the Protection of Human Subjects. Final rule.

PubMed

2017-01-19

The departments and agencies listed in this document announce revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight.

Research Experience and Agreement with Selected Ethics Principles from Canada's "Tri-Council Policy Statement--Ethical Conduct for Research Involving Humans"

ERIC Educational Resources Information Center

Fahy, Pat; Spencer, Bob

2004-01-01

An online survey was conducted of students, instructors, and researchers in distance education regarding principles for the ethical treatment of human research subjects. The study used an online questionnaire based on principles drawn from Canada's "Tri-Council Policy Statement, Ethical Conduct for Research Involving Humans" (TCPS,…

45 CFR 690.116 - General requirements for informed consent.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Section 690.116 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE... provided elsewhere in this policy, no investigator may involve a human being as a subject in research... shall be provided to each subject: (1) A statement that the study involves research, an explanation of...

16 CFR 1028.101 - To what does this policy apply?

Code of Federal Regulations, 2012 CFR

2012-01-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or..., this policy applies to all research involving human subjects conducted, supported or otherwise subject... make the policy applicable to such research. This includes research conducted by federal civilian...

7 CFR 1c.101 - To what does this policy apply?

Code of Federal Regulations, 2013 CFR

2013-01-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or... research involving human subjects conducted, supported or otherwise subject to regulation by any federal... research. This includes research conducted by federal civilian employees or military personnel, except that...

7 CFR 1c.101 - To what does this policy apply?

Code of Federal Regulations, 2011 CFR

2011-01-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or... research involving human subjects conducted, supported or otherwise subject to regulation by any federal... research. This includes research conducted by federal civilian employees or military personnel, except that...

14 CFR 1230.101 - To what does this policy apply?

Code of Federal Regulations, 2013 CFR

2013-01-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or..., this policy applies to all research involving human subjects conducted, supported or otherwise subject... make the policy applicable to such research. This includes research conducted by federal civilian...

14 CFR 1230.101 - To what does this policy apply?

Code of Federal Regulations, 2010 CFR

2010-01-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or..., this policy applies to all research involving human subjects conducted, supported or otherwise subject... make the policy applicable to such research. This includes research conducted by federal civilian...

16 CFR § 1028.101 - To what does this policy apply?

Code of Federal Regulations, 2013 CFR

2013-01-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or..., this policy applies to all research involving human subjects conducted, supported or otherwise subject... make the policy applicable to such research. This includes research conducted by federal civilian...

16 CFR 1028.101 - To what does this policy apply?

Code of Federal Regulations, 2011 CFR

2011-01-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or..., this policy applies to all research involving human subjects conducted, supported or otherwise subject... make the policy applicable to such research. This includes research conducted by federal civilian...

16 CFR 1028.101 - To what does this policy apply?

Code of Federal Regulations, 2010 CFR

2010-01-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or..., this policy applies to all research involving human subjects conducted, supported or otherwise subject... make the policy applicable to such research. This includes research conducted by federal civilian...

16 CFR 1028.101 - To what does this policy apply?

Code of Federal Regulations, 2014 CFR

2014-01-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or..., this policy applies to all research involving human subjects conducted, supported or otherwise subject... make the policy applicable to such research. This includes research conducted by federal civilian...

14 CFR 1230.101 - To what does this policy apply?

Code of Federal Regulations, 2011 CFR

2011-01-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or..., this policy applies to all research involving human subjects conducted, supported or otherwise subject... make the policy applicable to such research. This includes research conducted by federal civilian...

7 CFR 1c.101 - To what does this policy apply?

Code of Federal Regulations, 2012 CFR

2012-01-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or... research involving human subjects conducted, supported or otherwise subject to regulation by any federal... research. This includes research conducted by federal civilian employees or military personnel, except that...

7 CFR 1c.101 - To what does this policy apply?

Code of Federal Regulations, 2014 CFR

2014-01-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or... research involving human subjects conducted, supported or otherwise subject to regulation by any federal... research. This includes research conducted by federal civilian employees or military personnel, except that...

14 CFR 1230.101 - To what does this policy apply?

Code of Federal Regulations, 2012 CFR

2012-01-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or..., this policy applies to all research involving human subjects conducted, supported or otherwise subject... make the policy applicable to such research. This includes research conducted by federal civilian...

7 CFR 1c.101 - To what does this policy apply?

Code of Federal Regulations, 2010 CFR

2010-01-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or... research involving human subjects conducted, supported or otherwise subject to regulation by any federal... research. This includes research conducted by federal civilian employees or military personnel, except that...

Metaphysical and ethical perspectives on creating animal-human chimeras.

PubMed

Eberl, Jason T; Ballard, Rebecca A

2009-10-01

This paper addresses several questions related to the nature, production, and use of animal-human (a-h) chimeras. At the heart of the issue is whether certain types of a-h chimeras should be brought into existence, and, if they are, how we should treat such creatures. In our current research environment, we recognize a dichotomy between research involving nonhuman animal subjects and research involving human subjects, and the classification of a research protocol into one of these categories will trigger different ethical standards as to the moral permissibility of the research in question. Are a-h chimeras entitled to the more restrictive and protective ethical standards applied to human research subjects? We elucidate an Aristotelian-Thomistic metaphysical framework in which to argue how such chimeras ought to be defined ontologically. We then examine when the creation of, and experimentation upon, certain types of a-h chimeras may be morally permissible.

34 CFR 97.114 - Cooperative research.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 34 Education 1 2011-07-01 2011-07-01 false Cooperative research. 97.114 Section 97.114 Education... Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.114 Cooperative research. Cooperative research projects are those projects covered by this policy which involve more than...

Reducing the Time for IRB Reviews: A Case Study

ERIC Educational Resources Information Center

Liberale, Andrea Pescina; Kovach, Jamison V.

2017-01-01

Research activities often involve enrolling human subjects as volunteers to participate in research studies. Federal regulations mandate that research institutions are responsible for protecting the ethical rights and welfare of human subjects from research risks. This is usually accomplished by requiring approval of research protocols by an…

34 CFR 97.114 - Cooperative research.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 34 Education 1 2012-07-01 2012-07-01 false Cooperative research. 97.114 Section 97.114 Education... Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.114 Cooperative research. Cooperative research projects are those projects covered by this policy which involve more than...

34 CFR 97.114 - Cooperative research.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 1 2010-07-01 2010-07-01 false Cooperative research. 97.114 Section 97.114 Education... Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.114 Cooperative research. Cooperative research projects are those projects covered by this policy which involve more than...

34 CFR 97.114 - Cooperative research.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 34 Education 1 2013-07-01 2013-07-01 false Cooperative research. 97.114 Section 97.114 Education... Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.114 Cooperative research. Cooperative research projects are those projects covered by this policy which involve more than...

34 CFR 97.114 - Cooperative research.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 34 Education 1 2014-07-01 2014-07-01 false Cooperative research. 97.114 Section 97.114 Education... Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.114 Cooperative research. Cooperative research projects are those projects covered by this policy which involve more than...

Protection of Human Subjects: Proposed Policy.

ERIC Educational Resources Information Center

Federal Register, 1974

1974-01-01

In the Federal Register of May 30, 1974, regulations were published as Part 46 of Title 45 of the Code of Federal Regulations providing generally for the protection of human subjects involved in research, development, or related activities supported by Department of Health, Education, and Welfare grants or contracts. This notice of proposed…

32 CFR 219.116 - General requirements for informed consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a... or appear to waive any of the subject's legal rights, or releases or appears to release the...

28 CFR 46.116 - General requirements for informed consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

.... 46.116 Section 46.116 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN..., no investigator may involve a human being as a subject in research covered by this policy unless the... or the representative is made to waive or appear to waive any of the subject's legal rights, or...

22 CFR 225.116 - General requirements for informed consent.

Code of Federal Regulations, 2010 CFR

2010-04-01

....116 Section 225.116 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF HUMAN..., no investigator may involve a human being as a subject in research covered by this policy unless the... or the representative is made to waive or appear to waive any of the subject's legal rights, or...

Updating Regulations for Human Subjects Research: The New Common Rule Has arrived! What Changes Are Coming?

EPA Science Inventory

The “Common Rule” refers to the federal regulations that govern research involving human subjects. These regulations have been largely unchanged since 1981, while the research they cover has continued to evolve. After a 6-year rulemaking process, the Common Rule was ...

40 CFR 26.1202 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Prohibition of Third-Party Research for Pesticides Involving Intentional Exposure of Human Subjects who are Children or... subpart as well. In addition, the definitions at 45 CFR 46.202(a) through (f) and at 45 CFR 46.202(h) are...

40 CFR 26.202 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Prohibition of Research Conducted or Supported by EPA Involving Intentional Exposure of Human Subjects who are Children or... subpart as well. In addition, the definitions at 45 CFR 46.202(a) through (f) and at 45 CFR 46.202(h) are...

40 CFR 26.202 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Prohibition of Research Conducted or Supported by EPA Involving Intentional Exposure of Human Subjects who are Children or... subpart as well. In addition, the definitions at 45 CFR 46.202(a) through (f) and at 45 CFR 46.202(h) are...

40 CFR 26.1202 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Prohibition of Third-Party Research for Pesticides Involving Intentional Exposure of Human Subjects who are Children or... subpart as well. In addition, the definitions at 45 CFR 46.202(a) through (f) and at 45 CFR 46.202(h) are...

The Public Health Service guidelines. Governing research involving human subjects: An analysis of the policy-making process

NASA Technical Reports Server (NTRS)

Frankel, M. S.

1972-01-01

The policy making process which led to development of the Public Health Service Guidelines governing research involving human subjects is outlined. Part 1 examines the evolution of PHS Guidelines, tracing (1) evolution of thought and legal interpretation regarding research using human subjects; (2) initial involvement of the Federal government; (3) development of the government's research program; (4) the social-political environment in which formal government policy was developed; and (5) various policy statements issued by the government. Part 2 analyzes the process by which PHS Guidelines were developed and examines the values and other underlying factors which contributed to their development. It was concluded that the evolution of the Guidelines is best understood within the context of a mixed-scanning strategy. In such a strategy, policy makers make fundamental decisions regarding the basic direction of policy and subsequent decisions are made incrementally and within the contexts set by the original fundamental decisions.

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

Code of Federal Regulations, 2012 CFR

2012-10-01

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

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

Code of Federal Regulations, 2011 CFR

2011-10-01

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

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

Code of Federal Regulations, 2014 CFR

2014-10-01

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

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

Code of Federal Regulations, 2010 CFR

2010-10-01

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

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

Code of Federal Regulations, 2013 CFR

2013-10-01

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

Ethics in published brain-computer interface research

NASA Astrophysics Data System (ADS)

Specker Sullivan, L.; Illes, J.

2018-02-01

Objective. Sophisticated signal processing has opened the doors to more research with human subjects than ever before. The increase in the use of human subjects in research comes with a need for increased human subjects protections. Approach. We quantified the presence or absence of ethics language in published reports of brain-computer interface (BCI) studies that involved human subjects and qualitatively characterized ethics statements. Main results. Reports of BCI studies with human subjects that are published in neural engineering and engineering journals are anchored in the rationale of technological improvement. Ethics language is markedly absent, omitted from 31% of studies published in neural engineering journals and 59% of studies in biomedical engineering journals. Significance. As the integration of technological tools with the capacities of the mind deepens, explicit attention to ethical issues will ensure that broad human benefit is embraced and not eclipsed by technological exclusiveness.

Legal and ethical issues in neuroimaging research: human subjects protection, medical privacy, and the public communication of research results.

PubMed

Kulynych, Jennifer

2002-12-01

Humans subjects research entails significant legal and ethical obligations. Neuroimaging researchers must be familiar with the requirements of human subjects protection, including evolving standards for the protection of privacy and the disclosure of risk in "non-therapeutic" research. Techniques for creating veridical surface renderings from volumetric anatomical imaging data raise new privacy concerns, particularly under the federal medical privacy regulation. Additionally, neuroimaging researchers must consider their obligation to communicate research results responsibly. The emerging field of neuroethics should strive to raise awareness of these issues and to involve neuroimaging researchers in the legal, ethical, and policy debates that currently surround human subjects research.

Contingency learning in human fear conditioning involves the ventral striatum.

PubMed

Klucken, Tim; Tabbert, Katharina; Schweckendiek, Jan; Merz, Christian Josef; Kagerer, Sabine; Vaitl, Dieter; Stark, Rudolf

2009-11-01

The ability to detect and learn contingencies between fearful stimuli and their predictive cues is an important capacity to cope with the environment. Contingency awareness refers to the ability to verbalize the relationships between conditioned and unconditioned stimuli. Although there is a heated debate about the influence of contingency awareness on conditioned fear responses, neural correlates behind the formation process of contingency awareness have gained only little attention in human fear conditioning. Recent animal studies indicate that the ventral striatum (VS) could be involved in this process, but in human studies the VS is mostly associated with positive emotions. To examine this question, we reanalyzed four recently published classical fear conditioning studies (n = 117) with respect to the VS at three distinct levels of contingency awareness: subjects, who did not learn the contingencies (unaware), subjects, who learned the contingencies during the experiment (learned aware) and subjects, who were informed about the contingencies in advance (instructed aware). The results showed significantly increased activations in the left and right VS in learned aware compared to unaware subjects. Interestingly, this activation pattern was only found in learned but not in instructed aware subjects. We assume that the VS is not involved when contingency awareness does not develop during conditioning or when contingency awareness is unambiguously induced already prior to conditioning. VS involvement seems to be important for the transition from a contingency unaware to a contingency aware state. Implications for fear conditioning models as well as for the contingency awareness debate are discussed.

10 CFR 745.116 - General requirements for informed consent.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 745.116 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as... is made to waive or appear to waive any of the subject's legal rights, or releases or appears to...

40 CFR 26.1703 - Prohibition of reliance on research involving intentional exposure of human subjects who are...

Code of Federal Regulations, 2010 CFR

2010-07-01

...), nursing women, or children. 26.1703 Section 26.1703 Protection of Environment ENVIRONMENTAL PROTECTION... intentional exposure of human subjects who are pregnant women (and therefore their fetuses), nursing women, or... therefore her fetus), a nursing woman, or a child. [71 FR 36175, June 23, 2006] ...

40 CFR 26.1703 - Prohibition of reliance on research involving intentional exposure of human subjects who are...

Code of Federal Regulations, 2011 CFR

2011-07-01

...), nursing women, or children. 26.1703 Section 26.1703 Protection of Environment ENVIRONMENTAL PROTECTION... intentional exposure of human subjects who are pregnant women (and therefore their fetuses), nursing women, or... therefore her fetus), a nursing woman, or a child. [71 FR 36175, June 23, 2006] ...

40 CFR 26.1703 - Prohibition of reliance on research involving intentional exposure of human subjects who are...

Code of Federal Regulations, 2012 CFR

2012-07-01

...), nursing women, or children. 26.1703 Section 26.1703 Protection of Environment ENVIRONMENTAL PROTECTION... intentional exposure of human subjects who are pregnant women (and therefore their fetuses), nursing women, or... therefore her fetus), a nursing woman, or a child. [71 FR 36175, June 23, 2006] ...

10 CFR 745.122 - Use of Federal funds.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Use of Federal funds. 745.122 Section 745.122 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.122 Use of Federal funds. Federal funds administered by a department or agency may not be expended for research involving human subjects unless the...

Canadian governance of health research involving human subjects: is anybody minding the store?

PubMed

McDonald, M

2001-01-01

From an ethical perspective, good governance involves the translation of collective moral intentions into effective and accountable institutional actions. With respect to the use of human subjects in Canadian health research, I contend that there have been many good intentions but very little in the way of appropriate governance arrangements. Hence, the question, "who minds the store?" is especially acute with respect to the protection of vulnerable individuals and groups that are typically recruited as subjects for health research in Canada. Beyond diagnosing failures in governance and their causes, I offer suggestions for significant reforms, including evidence-based ethics assessment, independent oversight, and greater participation of research subjects in governance. I will close with some more general reflections on ethics, law, and governance.

5 CFR 5502.107 - Supplemental disclosure of financial interests in substantially affected organizations applicable...

Code of Federal Regulations, 2010 CFR

2010-01-01

... clinical study involving human subjects under a clinical research protocol approved by an institutional review board. (2) Clinical research has the meaning set forth in 42 U.S.C. 284d(b). (3) Institutional... review a clinical research protocol and approve the initiation of biomedical research involving human...

38 CFR 16.120 - Evaluation and disposition of applications and proposals for research to be conducted or...

Code of Federal Regulations, 2011 CFR

2011-07-01

... disposition of applications and proposals for research to be conducted or supported by a Federal Department or... PROTECTION OF HUMAN SUBJECTS § 16.120 Evaluation and disposition of applications and proposals for research... will evaluate all applications and proposals involving human subjects submitted to the department or...

45 CFR 690.120 - Evaluation and disposition of applications and proposals for research to be conducted or...

Code of Federal Regulations, 2011 CFR

2011-10-01

... proposals for research to be conducted or supported by a Federal department or agency. 690.120 Section 690... PROTECTION OF HUMAN SUBJECTS § 690.120 Evaluation and disposition of applications and proposals for research... evaluate all applications and proposals involving human subjects submitted to the department or agency...

7 CFR 3015.205 - General provisions for grants and cooperative agreements with institutions of higher education...

Code of Federal Regulations, 2014 CFR

2014-01-01

... following provisions regarding the rights and welfare of human subjects: (i) The recipient organization is responsible for safeguarding the rights and welfare of any human subjects involved in research, development... appear to waiver, any of his or her legal rights, including any release of the recipient organization or...

45 CFR 46.205 - Research involving neonates.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 1 2014-10-01 2014-10-01 false Research involving neonates. 46.205 Section 46.205... SUBJECTS Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research § 46.205 Research involving neonates. (a) Neonates of uncertain viability and nonviable neonates may be...

40 CFR 26.1602 - EPA review of completed human research.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false EPA review of completed human research... OF HUMAN SUBJECTS Review of Proposed and Completed Human Research § 26.1602 EPA review of completed human research. (a) When considering data under FIFRA or FFDCA from research involving intentional...

40 CFR 26.1602 - EPA review of completed human research.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 1 2012-07-01 2012-07-01 false EPA review of completed human research... OF HUMAN SUBJECTS Review of Proposed and Completed Human Research § 26.1602 EPA review of completed human research. (a) When considering data under FIFRA or FFDCA from research involving intentional...

40 CFR 26.1602 - EPA review of completed human research.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 1 2011-07-01 2011-07-01 false EPA review of completed human research... OF HUMAN SUBJECTS Review of Proposed and Completed Human Research § 26.1602 EPA review of completed human research. (a) When considering data under FIFRA or FFDCA from research involving intentional...

78 FR 59698 - Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-27

... provides advice relating to the responsible conduct of research involving human subjects with particular... Secretary's Advisory Committee on Human Research Protections AGENCY: Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health, Office for Human Research...

Prodromal disease: Immune responses of the host macrophage system to humoral factors

NASA Technical Reports Server (NTRS)

Criswell, B. S.; Knight, V.

1973-01-01

A composite is presented of nine studies, each yielding information contributing toward an understanding of methods designed to detect disease during the prodromal stages. The data further point to new areas of study that might be useful in early diagnoses. Five of the none experiments were done in mice. Four of these involved acute infectious disease states and one involved a chronic autoimmune type disease. Of the numerous perimeters studied of the acute diseases, the uptake of H3- thymidine by peripheral blood lymphocytes appeared to yield the earliest indication of disease. This test was not useful in studying the chronic disease state. Four of the nine studies involved application of diagnostic technics to human disease. A normal baseline for H3-thymidine incorporation by human lymphocytes was determined. A subject with severe combined immunodeficiency disease was studied. A human volunteer study was done using Influenza A live attenuated vaccine. Finally, a human volunteer study of subjects infected with Influenza A was done.

21 CFR 50.52 - Clinical investigations involving greater than minimal risk but presenting the prospect of direct...

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Clinical investigations involving greater than... OF HUMAN SUBJECTS Additional Safeguards for Children in Clinical Investigations § 50.52 Clinical... subjects. Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in...

45 CFR 46.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2010 CFR

2010-10-01

... review procedure shall adopt a method for keeping all members advised of research proposals which have... research involving no more than minimal risk, and for minor changes in approved research. 46.110 Section 46... SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.110 Expedited review procedures...

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.

40 CFR 26.203 - Prohibition of research conducted or supported by EPA involving intentional exposure of any human...

Code of Federal Regulations, 2013 CFR

2013-07-01

... her fetus), a nursing woman, or child. 26.203 Section 26.203 Protection of Environment ENVIRONMENTAL... Involving Intentional Exposure of Human Subjects who are Children or Pregnant or Nursing Women § 26.203... is a pregnant woman (and therefore her fetus), a nursing woman, or child. Notwithstanding any other...

40 CFR 26.203 - Prohibition of research conducted or supported by EPA involving intentional exposure of any human...

Code of Federal Regulations, 2010 CFR

2010-07-01

... her fetus), a nursing woman, or child. 26.203 Section 26.203 Protection of Environment ENVIRONMENTAL... Involving Intentional Exposure of Human Subjects who are Children or Pregnant or Nursing Women § 26.203... is a pregnant woman (and therefore her fetus), a nursing woman, or child. Notwithstanding any other...

40 CFR 26.203 - Prohibition of research conducted or supported by EPA involving intentional exposure of any human...

Code of Federal Regulations, 2012 CFR

2012-07-01

... her fetus), a nursing woman, or child. 26.203 Section 26.203 Protection of Environment ENVIRONMENTAL... Involving Intentional Exposure of Human Subjects who are Children or Pregnant or Nursing Women § 26.203... is a pregnant woman (and therefore her fetus), a nursing woman, or child. Notwithstanding any other...

40 CFR 26.203 - Prohibition of research conducted or supported by EPA involving intentional exposure of any human...

Code of Federal Regulations, 2014 CFR

2014-07-01

... her fetus), a nursing woman, or child. 26.203 Section 26.203 Protection of Environment ENVIRONMENTAL... Involving Intentional Exposure of Human Subjects who are Children or Pregnant or Nursing Women § 26.203... is a pregnant woman (and therefore her fetus), a nursing woman, or child. Notwithstanding any other...

40 CFR 26.203 - Prohibition of research conducted or supported by EPA involving intentional exposure of any human...

Code of Federal Regulations, 2011 CFR

2011-07-01

... her fetus), a nursing woman, or child. 26.203 Section 26.203 Protection of Environment ENVIRONMENTAL... Involving Intentional Exposure of Human Subjects who are Children or Pregnant or Nursing Women § 26.203... is a pregnant woman (and therefore her fetus), a nursing woman, or child. Notwithstanding any other...

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

PubMed

Bhat, S B; Hegde, T T

2006-09-01

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

45 CFR 46.301 - Applicability.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS... research conducted or supported by the Department of Health and Human Services involving prisoners as... is limited or barred by applicable State or local law. (c) The requirements of this subpart are in...

15 CFR 27.116 - General requirements for informed consent.

Code of Federal Regulations, 2012 CFR

2012-01-01

... will not adversely affect the rights and welfare of the subjects; (3) The research could not... this policy, no investigator may involve a human being as a subject in research covered by this policy... subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution...

Open-Air Biowarfare Testing and the Evolution of Values

PubMed Central

2016-01-01

The United States and the United Kingdom ended outdoor biological warfare testing in populated areas nearly half a century ago. Yet, the conduct, health effects, and propriety of those tests remain controversial. The varied views reflect the limits of currently available test information and evolving societal values on research involving human subjects. Western political culture has changed since the early days of the American and British testing programs. People have become less reluctant to question authority, and institutional review boards must now pre-approve research involving human subjects. Further, the heightened stringency of laboratory containment has accentuated the safety gap between a confined test space and one without physical boundaries. All this makes it less likely that masses of people would again be unwittingly subjected to secret open-air biological warfare tests. PMID:27564984

Research Involving Children: Appendix to Report and Recommendations.

ERIC Educational Resources Information Center

Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Washington, DC.

The appendix contains papers, reports, and other materials that were reviewed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research during its deliberations on research involving children. Entries include the following titles and authors: "Research Involving Children" (Survey Research Center); "Law…

Human Perception of Ambiguous Inertial Motion Cues

NASA Technical Reports Server (NTRS)

Zhang, Guan-Lu

2010-01-01

Human daily activities on Earth involve motions that elicit both tilt and translation components of the head (i.e. gazing and locomotion). With otolith cues alone, tilt and translation can be ambiguous since both motions can potentially displace the otolithic membrane by the same magnitude and direction. Transitions between gravity environments (i.e. Earth, microgravity and lunar) have demonstrated to alter the functions of the vestibular system and exacerbate the ambiguity between tilt and translational motion cues. Symptoms of motion sickness and spatial disorientation can impair human performances during critical mission phases. Specifically, Space Shuttle landing records show that particular cases of tilt-translation illusions have impaired the performance of seasoned commanders. This sensorimotor condition is one of many operational risks that may have dire implications on future human space exploration missions. The neural strategy with which the human central nervous system distinguishes ambiguous inertial motion cues remains the subject of intense research. A prevailing theory in the neuroscience field proposes that the human brain is able to formulate a neural internal model of ambiguous motion cues such that tilt and translation components can be perceptually decomposed in order to elicit the appropriate bodily response. The present work uses this theory, known as the GIF resolution hypothesis, as the framework for experimental hypothesis. Specifically, two novel motion paradigms are employed to validate the neural capacity of ambiguous inertial motion decomposition in ground-based human subjects. The experimental setup involves the Tilt-Translation Sled at Neuroscience Laboratory of NASA JSC. This two degree-of-freedom motion system is able to tilt subjects in the pitch plane and translate the subject along the fore-aft axis. Perception data will be gathered through subject verbal reports. Preliminary analysis of perceptual data does not indicate that the GIF resolution hypothesis is completely valid for non-rotational periodic motions. Additionally, human perception of translation is impaired without visual or spatial reference. The performance of ground-base subjects in estimating tilt after brief training is comparable with that of crewmembers without training.

The Role of Intuition in Risk/Benefit Decision-Making in Human Subjects Research

PubMed Central

Resnik, David B.

2016-01-01

One of the key principles of ethical research involving human subjects is that the risks of research to should be acceptable in relation to expected benefits. Institutional review board (IRB) members often rely on intuition to make risk/benefit decisions concerning proposed human studies. Some have objected to using intuition to make these decisions because intuition is unreliable and biased and lacks transparency. In this paper, I examine the role of intuition in IRB risk/benefit decision-making and argue that there are practical and philosophical limits to our ability to reduce our reliance on intuition in this process. The fact that IRB risk/benefit decision-making involves intuition need not imply that it is hopelessly subjective or biased, however, since there are strategies that IRBs can employ to improve their decisions, such as using empirical data to estimate the probability of potential harms and benefits, developing classification systems to guide the evaluation of harms and benefits, and engaging in moral reasoning concerning the acceptability of risks. PMID:27294429

The Role of Intuition in Risk/Benefit Decision-Making in Human Subjects Research.

PubMed

Resnik, David B

2017-01-01

One of the key principles of ethical research involving human subjects is that the risks of research to should be acceptable in relation to expected benefits. Institutional review board (IRB) members often rely on intuition to make risk/benefit decisions concerning proposed human studies. Some have objected to using intuition to make these decisions because intuition is unreliable and biased and lacks transparency. In this article, I examine the role of intuition in IRB risk/benefit decision-making and argue that there are practical and philosophical limits to our ability to reduce our reliance on intuition in this process. The fact that IRB risk/benefit decision-making involves intuition need not imply that it is hopelessly subjective or biased, however, since there are strategies that IRBs can employ to improve their decisions, such as using empirical data to estimate the probability of potential harms and benefits, developing classification systems to guide the evaluation of harms and benefits, and engaging in moral reasoning concerning the acceptability of risks.

40 CFR 26.302 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Definitions. 26.302 Section 26.302 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in Observational...

40 CFR 26.302 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Definitions. 26.302 Section 26.302 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in Observational...

40 CFR 26.302 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Definitions. 26.302 Section 26.302 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in Observational...

40 CFR 26.302 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Definitions. 26.302 Section 26.302 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in Observational...

40 CFR 26.302 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Definitions. 26.302 Section 26.302 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in Observational...

21 CFR 312.3 - Definitions and interpretations.

Code of Federal Regulations, 2013 CFR

2013-04-01

....3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION General Provisions § 312.3 Definitions and... dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is...

21 CFR 312.3 - Definitions and interpretations.

Code of Federal Regulations, 2012 CFR

2012-04-01

....3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION General Provisions § 312.3 Definitions and... dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is...

48 CFR 370.302 - Types of assurances.

Code of Federal Regulations, 2011 CFR

2011-10-01

....302 Section 370.302 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES HHS SUPPLEMENTATIONS SPECIAL PROGRAMS AFFECTING ACQUISITION Acquisitions Involving Human Subjects 370.302 Types of...'s current “List of Registered Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs...

48 CFR 370.302 - Types of assurances.

Code of Federal Regulations, 2012 CFR

2012-10-01

....302 Section 370.302 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES HHS SUPPLEMENTATIONS SPECIAL PROGRAMS AFFECTING ACQUISITION Acquisitions Involving Human Subjects 370.302 Types of...'s current “List of Registered Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs...

48 CFR 370.302 - Types of assurances.

Code of Federal Regulations, 2010 CFR

2010-10-01

....302 Section 370.302 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES HHS SUPPLEMENTATIONS SPECIAL PROGRAMS AFFECTING ACQUISITION Acquisitions Involving Human Subjects 370.302 Types of...'s current “List of Registered Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs...

48 CFR 370.302 - Types of assurances.

Code of Federal Regulations, 2013 CFR

2013-10-01

....302 Section 370.302 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES HHS SUPPLEMENTATIONS SPECIAL PROGRAMS AFFECTING ACQUISITION Acquisitions Involving Human Subjects 370.302 Types of...'s current “List of Registered Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs...

48 CFR 370.302 - Types of assurances.

Code of Federal Regulations, 2014 CFR

2014-10-01

....302 Section 370.302 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES HHS SUPPLEMENTATIONS SPECIAL PROGRAMS AFFECTING ACQUISITION Acquisitions Involving Human Subjects 370.302 Types of...'s current “List of Registered Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs...

How Merit Pay Undermines Education.

ERIC Educational Resources Information Center

Ramirez, Al

2001-01-01

Why cannot teachers be "incentivized" like lawyers and salespeople? The seemingly logical link between employee production and compensation is debatable and highly subjective. Educators' jobs involve more than teaching academic subjects and often extend beyond the measurable. Input/output reward systems ignore basic human-motivation…

Theorising the 'human subject' in biomedical research: international clinical trials and bioethics discourses in contemporary Sri Lanka.

PubMed

Sariola, Salla; Simpson, Bob

2011-08-01

The global spread of clinical trials activity is accompanied by a parallel growth in research governance and human subject protection. In this paper we analyse how dominant ideas of the 'human subject' in clinical trials are played out in countries that are deemed to be scientifically under-developed. Specifically, we show how rhetorics of individualism, rationality and autonomy implicit in international ethical guidelines governing human subject research are operationalised and localised. We give insights into the ways in which new knowledge forms become embedded in practice. Using the recent upsurge in clinical trials in Sri Lanka as a case study, based on interviews with 23 doctors and researchers carried out during ethnographic fieldwork between 2008-2009, this article explores the tensions that arise for doctors involved with the promotion of bioethics and the attempts to bring local research governance up to international standards. The doctors and researchers intercept, interpret and critique the notions of human subject implicit in new forms of research governance. From their accounts we have identified two concerns. The first is a critique of dominant ideas of the 'human subject' that is informed by ideas of patiency rooted in paternalistic notions of the doctor-patient relationship. Second, 'human subjects' are seen as gendered, and located within family relationships. Both of these bring into question the research subjects' ability to give informed consent and compromise the ideal of an autonomous subject. Copyright © 2010 Elsevier Ltd. All rights reserved.

Nursing research in the United States: the protection of human subjects.

PubMed

Oddi, L F; Cassidy, V R

1990-01-01

In the United States the protection of the rights of human subjects in experimentation has evolved at three levels: professional, public, and private. At the professional level, codes, guidelines and the Patient's Bill of Rights address the issues of protecting the dignity, privacy and autonomy of individuals who serve as research subjects. At the public level, regulations promulgated by the Food and Drug Administration and the Department of Health and Human Services have become the standard for protecting human subjects. At the private level, United States common law regulates the conduct of individual researchers by requiring them to act in a manner consistent with generally accepted standards of care. As professionals, nurses must be actively involved in the formation of public policy regarding the conduct of research and strive to formulate a research agenda that will ensure that the ethics of research in nursing is above question.

48 CFR 370.304 - Contract clauses.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 4 2011-10-01 2011-10-01 false Contract clauses. 370.304 Section 370.304 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES HHS SUPPLEMENTATIONS SPECIAL PROGRAMS AFFECTING ACQUISITION Acquisitions Involving Human Subjects 370.304 Contract clauses. (a...

DNA Damage Response and Radiosensitivity of Immune Cells from Subjects Undergoing Confinement in the NASA Human Exploration Research Analog

NASA Technical Reports Server (NTRS)

Moreno-Villanueva, Maria

2017-01-01

The Human Exploration Research Analog (HERA) represents an analog for simulation of isolation, confinement and remote conditions of mission exploration scenarios. HERA aims at investigating team performance and cooperation, reaction to stress, signs of early depression, anxiety and anger and their impact on human health. HERA is a collaborative project involving experts in different fields. Not only psychological but also clinical biomarkers of stress, e.g. adrenaline has been measured. It is known that stress hormones induce DNA strand breaks thus, within this project, my tasks was to determine the level of DNA strand breaks as well as expression of genes involved in DNA damage response in immune cells obtained from HERA subjects. Furthermore, the sensitivity of the cells to ex vivo radiation was also assessed.

40 CFR 26.1102 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... life or during the performance of routine physical or psychological examinations or tests. (i) Research... Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-pregnant, Non... subject's participation in the procedure(s) involved in the research. (d) Research means a systematic...

40 CFR 26.1102 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... life or during the performance of routine physical or psychological examinations or tests. (i) Research... Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-pregnant, Non... subject's participation in the procedure(s) involved in the research. (d) Research means a systematic...

40 CFR 26.1124 - [Reserved

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 1 2014-07-01 2014-07-01 false [Reserved] 26.1124 Section 26.1124 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...

40 CFR 26.1112 - Review by institution.

Code of Federal Regulations, 2011 CFR

2011-07-01

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

40 CFR 26.1112 - Review by institution.

Code of Federal Regulations, 2012 CFR

2012-07-01

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

40 CFR 26.1124 - [Reserved

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 1 2011-07-01 2011-07-01 false [Reserved] 26.1124 Section 26.1124 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...

40 CFR 26.1117 - Documentation of informed consent.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving...

40 CFR 26.1124 - [Reserved

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 1 2012-07-01 2012-07-01 false [Reserved] 26.1124 Section 26.1124 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...

40 CFR 26.1117 - Documentation of informed consent.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving...

40 CFR 26.1112 - Review by institution.

Code of Federal Regulations, 2013 CFR

2013-07-01

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

40 CFR 26.1112 - Review by institution.

Code of Federal Regulations, 2014 CFR

2014-07-01

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

40 CFR 26.1124 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false [Reserved] 26.1124 Section 26.1124 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...

40 CFR 26.1124 - [Reserved

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 1 2013-07-01 2013-07-01 false [Reserved] 26.1124 Section 26.1124 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...

40 CFR 26.1117 - Documentation of informed consent.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving...

40 CFR 26.1112 - Review by institution.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

40 CFR 26.1117 - Documentation of informed consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving...

40 CFR 26.1117 - Documentation of informed consent.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving...

The Ethics of Biosafety Considerations in Gain-of-Function Research Resulting in the Creation of Potential Pandemic Pathogens

PubMed Central

Lipsitch, Marc; Levinson, Meira

2015-01-01

This paper proposes an ethical framework for evaluating biosafety risks of gain-of-function (GOF) experiments that create novel strains of influenza expected to be virulent and transmissible in humans, so-called potential pandemic pathogens (PPP). Such research raises ethical concerns because of the risk that accidental release from a laboratory could lead to extensive or even global spread of a virulent pathogen. Biomedical research ethics has focused largely on human subjects research, while biosafety concerns about accidental infections, seen largely as a problem of occupational health, have been ignored. GOF/PPP research is an example of a small but important class of research where biosafety risks threaten public health, well beyond the small number of persons conducting the research. We argue that bioethical principles that ordinarily apply only to human subjects research should also apply to research that threatens public health, even if, as in GOF/PPP studies, the research involves no human subjects. Specifically we highlight the Nuremberg Code’s requirements of “fruitful results for the good of society, unprocurable by other methods,” and proportionality of risk and humanitarian benefit, as broad ethical principles that recur in later documents on research ethics and should also apply to certain types of research not involving human subjects. We address several potential objections to this view, and conclude with recommendations for bringing these ethical considerations into policy development. PMID:26320212

16 CFR 1028.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2010 CFR

2010-01-01

... kinds of research involving no more than minimal risk, and for minor changes in approved research. 1028... HUMAN SUBJECTS § 1028.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. (a) The Secretary, HHS, has established...

14 CFR 1230.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2010 CFR

2010-01-01

... kinds of research involving no more than minimal risk, and for minor changes in approved research. 1230... HUMAN SUBJECTS § 1230.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. (a) The Secretary, HHS, has established...

16 CFR 1028.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2011 CFR

2011-01-01

... of research proposals which have been approved under the procedure. (d) The department or agency head... kinds of research involving no more than minimal risk, and for minor changes in approved research. 1028... HUMAN SUBJECTS § 1028.110 Expedited review procedures for certain kinds of research involving no more...

14 CFR 1230.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2011 CFR

2011-01-01

... of research proposals which have been approved under the procedure. (d) The department or agency head... kinds of research involving no more than minimal risk, and for minor changes in approved research. 1230... HUMAN SUBJECTS § 1230.110 Expedited review procedures for certain kinds of research involving no more...

45 CFR 690.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2011 CFR

2011-10-01

... research involving no more than minimal risk, and for minor changes in approved research. 690.110 Section 690.110 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.110 Expedited review procedures for certain kinds of research involving no...

"The only feasible means." The Pentagon's ambivalent relationship with the Nuremberg Code.

PubMed

Moreno, J D

1996-01-01

Convinced that armed conflict with the Soviet Union was all but inevitable, that such conflict would involve unconventional atomic, biological, and chemical warfare, and that research with human subjects was essential to respond to the threat, in the early 1950s the U.S. Department of Defense promulgated a policy governing human experimentation based on the Nuremberg Code. Yet the policymaking process focused on the abstract issue of whether human experiments should go forward at all, ignoring the reality of humans subjects research already under way and leaving unanswered ethical questions about how to conduct such research. Documents newly released to the Advisory Committee on Human Radiation Experiments tell the story of the Pentagon policy.

40 CFR 26.1123 - Early termination of research.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Early termination of research. 26.1123 Section 26.1123 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

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...

40 CFR 26.1123 - Early termination of research.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Early termination of research. 26.1123 Section 26.1123 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

40 CFR 26.1118-26.1122 - [Reserved

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 1 2012-07-01 2012-07-01 false [Reserved] 26.1118-26.1122 Section 26.1118-26.1122 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

40 CFR 26.1103-26.1106 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false [Reserved] 26.1103-26.1106 Section 26.1103-26.1106 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

40 CFR 26.1118-26.1122 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false [Reserved] 26.1118-26.1122 Section 26.1118-26.1122 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

40 CFR 26.1103-26.1106 - [Reserved

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 1 2014-07-01 2014-07-01 false [Reserved] 26.1103-26.1106 Section 26.1103-26.1106 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

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...

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...

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...

40 CFR 26.1118-26.1122 - [Reserved

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 1 2013-07-01 2013-07-01 false [Reserved] 26.1118-26.1122 Section 26.1118-26.1122 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

40 CFR 26.1118-26.1122 - [Reserved

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 1 2014-07-01 2014-07-01 false [Reserved] 26.1118-26.1122 Section 26.1118-26.1122 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

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...

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...

40 CFR 26.1123 - Early termination of research.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Early termination of research. 26.1123 Section 26.1123 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

40 CFR 26.1103-26.1106 - [Reserved

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 1 2012-07-01 2012-07-01 false [Reserved] 26.1103-26.1106 Section 26.1103-26.1106 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

40 CFR 26.1123 - Early termination of research.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Early termination of research. 26.1123 Section 26.1123 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

40 CFR 26.1123 - Early termination of research.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Early termination of research. 26.1123 Section 26.1123 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

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...

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...

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...

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...

40 CFR 26.1118-26.1122 - [Reserved

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 1 2011-07-01 2011-07-01 false [Reserved] 26.1118-26.1122 Section 26.1118-26.1122 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

40 CFR 26.1103-26.1106 - [Reserved

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 1 2013-07-01 2013-07-01 false [Reserved] 26.1103-26.1106 Section 26.1103-26.1106 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

40 CFR 26.1103-26.1106 - [Reserved

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 1 2011-07-01 2011-07-01 false [Reserved] 26.1103-26.1106 Section 26.1103-26.1106 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional...

Online Resources for Teaching Units on: Ecological Footprint of Human Food

ERIC Educational Resources Information Center

Marrocco, Aldo T.

2011-01-01

The modern food system involves high consumption of natural resources and other forms of environmental degradation. This paper is a presentation of internet resources such as scientific contributions, graphics, tables, images, animations and interactive atlases that can help to teach this subject. The discussion contains some subjects considered…

Explanations, Education, and Electromagnetic Fields.

ERIC Educational Resources Information Center

Friedman, Sharon M.

Explaining complex scientific and environmental subjects in the mass media is difficult to do, particularly under such constraints as short deadlines and lack of space or time. When a scientific controversy and human health risk are involved, this becomes an even harder task to accomplish. The subject of electromagnetic fields (EMF) involves…

Dimensions of Human-Work Domain Interaction: A Preliminary Analysis for the Design of a Corporate Digital Library.

ERIC Educational Resources Information Center

Xie, Hong

2003-01-01

Applies the cognitive system engineering approach to investigate human-work interaction at a corporate setting. Reports preliminary analysis of data collected from diary analysis and interview of 20 subjects. Results identify three dimensions for each of four interactive activities involved in human-work interaction and their relationships.…

38 CFR 16.101 - To what does this policy apply?

Code of Federal Regulations, 2013 CFR

2013-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not...) of this section, this policy applies to all research involving human subjects conducted, supported or... action to make the policy applicable to such research. This includes research conducted by federal...

38 CFR 16.101 - To what does this policy apply?

Code of Federal Regulations, 2012 CFR

2012-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not...) of this section, this policy applies to all research involving human subjects conducted, supported or... action to make the policy applicable to such research. This includes research conducted by federal...

38 CFR 16.101 - To what does this policy apply?

Code of Federal Regulations, 2010 CFR

2010-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not...) of this section, this policy applies to all research involving human subjects conducted, supported or... action to make the policy applicable to such research. This includes research conducted by federal...

38 CFR 16.101 - To what does this policy apply?

Code of Federal Regulations, 2014 CFR

2014-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not...) of this section, this policy applies to all research involving human subjects conducted, supported or... action to make the policy applicable to such research. This includes research conducted by federal...

38 CFR 16.101 - To what does this policy apply?

Code of Federal Regulations, 2011 CFR

2011-07-01

...), for research involving survey or interview procedures or observation of public behavior, does not...) of this section, this policy applies to all research involving human subjects conducted, supported or... action to make the policy applicable to such research. This includes research conducted by federal...

The measurement and facilitation of cooperative task performance. [reactions of humans to stress exposure

NASA Technical Reports Server (NTRS)

Hutchinson, R. R.

1975-01-01

Experiments were conducted to determine under what conditions jaw clenching will occur in humans as a response to stress exposure. The method for measuring reactions to stress involves a series of electrical recordings of the masseter and temporalis muscles. A high fixed-ratio response requirement in the first series of experiments shows that jaw clenching in humans occurs in situations analogous to those which produce biting in infrahuman subjects. In the second series, reduction in the amounts of money recieved by subjects is shown to cause increases in the jaw clench response and other negative effect motor behaviors. The third series demonstrates that perception of more favorable conditions existing for another person can increase anger and hostility in the subject.

[About the genesis of the first Polish local research ethics committee].

PubMed

Paprocka-Lipinska, Anna

2014-12-01

From the moment in which the development of medicine became necessary experimental research involving human subjects, the question arose about the ethical limits and limitations of the experiment. The turning point was the year 1947. The Nuremberg Code was formulated after the disclosure of pseudo-medical experiments involving human subjects during the Second World War. In 1964, the medical world accepted the Declaration of Helsinki, which, however, did not prevent abuses and it became necessary to appoint independent ethics committees supervising and enforcing the application of ethics in biomedical experiments. In Poland in the 60's and 70's started a discussion on the ethical rules related to conduct of research involving humans. The initiators of the appointment of bioethics committees were professors of medicine, inspiring experiences of their Western colleagues. It was difficult for reasons of political ideologies to convince the authorities to use the best of western solutions. This paper attempts to describe the circumstances connected with the appointment in 1979 at the Medical University of Gdansk, the first Polish bioethics committee.

Measurement of visual contrast sensitivity

NASA Astrophysics Data System (ADS)

Vongierke, H. E.; Marko, A. R.

1985-04-01

This invention involves measurement of the visual contrast sensitivity (modulation transfer) function of a human subject by means of linear or circular spatial frequency pattern on a cathode ray tube whose contrast is automatically decreasing or increasing depending on the subject pressing or releasing a hand-switch button. The threshold of detection of the pattern modulation is found by the subject by adjusting the contrast to values which vary about the subject's threshold thereby determining the threshold and also providing by the magnitude of the contrast fluctuations between reversals some estimate of the variability of the subject's absolute threshold. The invention also involves the slow automatic sweeping of the spatial frequency of the pattern over the spatial frequencies after preset time intervals or after threshold has been defined at each frequency by a selected number of subject-determined threshold crossings; i.e., contrast reversals.

Are decisions under risk malleable?

PubMed

Fong, C; McCabe, K

1999-09-14

Human decision making under risk and uncertainty may depend on individual involvement in the outcome-generating process. Expected utility theory is silent on this issue. Prospect theory in its current form offers little, if any, prediction of how or why involvement in a process should matter, although it may offer ex post interpretations of empirical findings. Well-known findings in psychology demonstrate that when subjects exercise more involvement or choice in lottery procedures, they value their lottery tickets more highly. This often is interpreted as an "illusion of control," meaning that when subjects are more involved in a lottery, they may believe they are more likely to win, perhaps because they perceive that they have more control over the outcome. Our experimental design eliminates several possible alternative explanations for the results of previous studies in an experiment that varies the degree and type of involvement in lottery procedures. We find that in treatments with more involvement subjects on average place less rather than more value on their lottery tickets. One possible explanation for this is that involvement interacts with loss aversion by causing subjects to weigh losses more heavily than they would otherwise. One implication of our study is that involvement, either independently or in interaction with myopic loss aversion, may help explain the extreme risk aversion of bond investors.

Erotic and disgust-inducing pictures--differences in the hemodynamic responses of the brain.

PubMed

Stark, Rudolf; Schienle, Anne; Girod, Cornelia; Walter, Bertram; Kirsch, Peter; Blecker, Carlo; Ott, Ulrich; Schäfer, Axel; Sammer, Gebhard; Zimmermann, Mark; Vaitl, Dieter

2005-09-01

The aim of this fMRI study was to explore brain structures that are involved in the processing of erotic and disgust-inducing pictures. The stimuli were chosen to trigger approach and withdrawal tendencies, respectively. By adding sadomasochistic (SM) scenes to the design and examining 12 subjects with and 12 subjects without sadomasochistic preferences, we introduced a picture category that induced erotic pleasure in one sample and disgust in the other sample. Since we also presented neutral pictures, all subjects viewed pictures of four different categories: neutral, disgust-inducing, erotic, and SM erotic pictures. The analysis indicated that several brain structures are commonly involved in the processing of disgust-inducing and erotic pictures (occipital cortex, hippocampus, thalamus, and the amygdala). The ventral striatum was specifically activated when subjects saw highly sexually arousing pictures. This indicates the involvement of the human reward system during the processing of visual erotica.

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...

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...

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...

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...

15 CFR 27.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2010 CFR

2010-01-01

... certain kinds of research involving no more than minimal risk, and for minor changes in approved research... HUMAN SUBJECTS § 27.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. (a) The Secretary, HHS, has established, and...

45 CFR 690.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2010 CFR

2010-10-01

... research involving no more than minimal risk, and for minor changes in approved research. 690.110 Section... PROTECTION OF HUMAN SUBJECTS § 690.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. (a) The Secretary, HHS, has...

15 CFR 27.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2011 CFR

2011-01-01

... of research proposals which have been approved under the procedure. (d) The department or agency head... certain kinds of research involving no more than minimal risk, and for minor changes in approved research... HUMAN SUBJECTS § 27.110 Expedited review procedures for certain kinds of research involving no more than...

45 CFR 690.101 - To what does this policy apply?

Code of Federal Regulations, 2014 CFR

2014-10-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or...) of this section, this policy applies to all research involving human subjects conducted, supported or... action to make the policy applicable to such research. This includes research conducted by federal...

45 CFR 690.101 - To what does this policy apply?

Code of Federal Regulations, 2013 CFR

2013-10-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or...) of this section, this policy applies to all research involving human subjects conducted, supported or... action to make the policy applicable to such research. This includes research conducted by federal...

45 CFR 690.101 - To what does this policy apply?

Code of Federal Regulations, 2011 CFR

2011-10-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or...) of this section, this policy applies to all research involving human subjects conducted, supported or... action to make the policy applicable to such research. This includes research conducted by federal...

45 CFR 690.101 - To what does this policy apply?

Code of Federal Regulations, 2012 CFR

2012-10-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or...) of this section, this policy applies to all research involving human subjects conducted, supported or... action to make the policy applicable to such research. This includes research conducted by federal...

45 CFR 690.101 - To what does this policy apply?

Code of Federal Regulations, 2010 CFR

2010-10-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or...) of this section, this policy applies to all research involving human subjects conducted, supported or... action to make the policy applicable to such research. This includes research conducted by federal...

40 CFR 26.402 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... child's affirmative agreement to participate in research. Mere failure to object should not, absent... research with human subjects that does not meet the definition of research involving intentional exposure...

Age-related changes in human posture control: Sensory organization tests

NASA Technical Reports Server (NTRS)

Peterka, R. J.; Black, F. O.

1989-01-01

Postural control was measured in 214 human subjects ranging in age from 7 to 81 years. Sensory organization tests measured the magnitude of anterior-posterior body sway during six 21 s trials in which visual and somatosensory orientation cues were altered (by rotating the visual surround and support surface in proportion to the subject's sway) or vision eliminated (eyes closed) in various combinations. No age-related increase in postural sway was found for subjects standing on a fixed support surface with eyes open or closed. However, age-related increases in sway were found for conditions involving altered visual or somatosensory cues. Subjects older than about 55 years showed the largest sway increases. Subjects younger than about 15 years were also sensitive to alteration of sensory cues. On average, the older subjects were more affected by altered visual cues whereas younger subjects had more difficulty with altered somatosensory cues.

The ethics of biosafety considerations in gain-of-function research resulting in the creation of potential pandemic pathogens.

PubMed

Evans, Nicholas Greig; Lipsitch, Marc; Levinson, Meira

2015-11-01

This paper proposes an ethical framework for evaluating biosafety risks of gain-of-function (GOF) experiments that create novel strains of influenza expected to be virulent and transmissible in humans, so-called potential pandemic pathogens (PPPs). Such research raises ethical concerns because of the risk that accidental release from a laboratory could lead to extensive or even global spread of a virulent pathogen. Biomedical research ethics has focused largely on human subjects research, while biosafety concerns about accidental infections, seen largely as a problem of occupational health, have been ignored. GOF/PPP research is an example of a small but important class of research where biosafety risks threaten public health, well beyond the small number of persons conducting the research.We argue that bioethical principles that ordinarily apply only to human subjects research should also apply to research that threatens public health, even if, as in GOF/PPP studies, the research involves no human subjects. Specifically we highlight the Nuremberg Code's requirements of 'fruitful results for the good of society, unprocurable by other methods', and proportionality of risk and humanitarian benefit, as broad ethical principles that recur in later documents on research ethics and should also apply to certain types of research not involving human subjects. We address several potential objections to this view, and conclude with recommendations for bringing these ethical considerations into policy development. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

A complex selection signature at the human AVPR1B gene.

PubMed

Cagliani, Rachele; Fumagalli, Matteo; Pozzoli, Uberto; Riva, Stefania; Cereda, Matteo; Comi, Giacomo P; Pattini, Linda; Bresolin, Nereo; Sironi, Manuela

2009-06-01

The vasopressin receptor type 1b (AVPR1B) is mainly expressed by pituitary corticotropes and it mediates the stimulatory effects of AVP on ACTH release; common AVPR1B haplotypes have been involved in mood and anxiety disorders in humans, while rodents lacking a functional receptor gene display behavioral defects and altered stress responses. Here we have analyzed the two exons of the gene and the data we present suggest that AVPR1B has been subjected to natural selection in humans. In particular, analysis of exon 2 strongly suggests the action of balancing selection in African populations and Europeans: the region displays high nucleotide diversity, an excess of intermediate-frequency alleles, a higher level of within-species diversity compared to interspecific divergence and a genealogy with common haplotypes separated by deep branches. This relatively unambiguous situation coexists with unusual features across exon 1, raising the possibility that a nonsynonymous variant (Gly191Arg) in this region has been subjected to directional selection. Although the underlying selective pressure(s) remains to be identified, we consider this to be among the first documented examples of a gene involved in mood disorders and subjected to natural selection in humans; this observation might add support to the long-debated idea that depression/low mood might have played an adaptive role during human evolution.

A complex selection signature at the human AVPR1B gene

PubMed Central

Cagliani, Rachele; Fumagalli, Matteo; Pozzoli, Uberto; Riva, Stefania; Cereda, Matteo; Comi, Giacomo P; Pattini, Linda; Bresolin, Nereo; Sironi, Manuela

2009-01-01

Background The vasopressin receptor type 1b (AVPR1B) is mainly expressed by pituitary corticotropes and it mediates the stimulatory effects of AVP on ACTH release; common AVPR1B haplotypes have been involved in mood and anxiety disorders in humans, while rodents lacking a functional receptor gene display behavioral defects and altered stress responses. Results Here we have analyzed the two exons of the gene and the data we present suggest that AVPR1B has been subjected to natural selection in humans. In particular, analysis of exon 2 strongly suggests the action of balancing selection in African populations and Europeans: the region displays high nucleotide diversity, an excess of intermediate-frequency alleles, a higher level of within-species diversity compared to interspecific divergence and a genealogy with common haplotypes separated by deep branches. This relatively unambiguous situation coexists with unusual features across exon 1, raising the possibility that a nonsynonymous variant (Gly191Arg) in this region has been subjected to directional selection. Conclusion Although the underlying selective pressure(s) remains to be identified, we consider this to be among the first documented examples of a gene involved in mood disorders and subjected to natural selection in humans; this observation might add support to the long-debated idea that depression/low mood might have played an adaptive role during human evolution. PMID:19486526

An Information Theoretic Model for the Human Processing of Cognitive Tasks.

ERIC Educational Resources Information Center

Moser, Gene W.

An information-theory model of human memory was tested in thirteen experiments which involved children (six years and older) and graduate students. The subjects conducted science investigations in laboratory and non-laboratory settings, solved problems of electrical circuits, and participated in classroom science lessons. The tasks used involved…

Changes to the Common Rule Regulations and Implications for Human Research

EPA Science Inventory

The regulations that govern research involving human subjects are known as the “Common Rule,” because they are shared in common by 18 federal departments and agencies that conduct and support such research. [The US FDA is not a signatory to the Common Rule.] These reg...

7 CFR 1c.116 - General requirements for informed consent.

Code of Federal Regulations, 2012 CFR

2012-01-01

... welfare of the subjects; (3) The research could not practicably be carried out without the waiver or... may involve a human being as a subject in research covered by this policy unless the investigator has... releases or appears to release the investigator, the sponsor, the institution or its agents from liability...

49 CFR 11.116 - General requirements for informed consent.

Code of Federal Regulations, 2014 CFR

2014-10-01

... welfare of the subjects; (3) The research could not practicably be carried out without the waiver or... investigator may involve a human being as a subject in research covered by this policy unless the investigator... releases or appears to release the investigator, the sponsor, the institution or its agents from liability...

7 CFR 1c.116 - General requirements for informed consent.

Code of Federal Regulations, 2013 CFR

2013-01-01

... welfare of the subjects; (3) The research could not practicably be carried out without the waiver or... may involve a human being as a subject in research covered by this policy unless the investigator has... releases or appears to release the investigator, the sponsor, the institution or its agents from liability...

22 CFR 225.116 - General requirements for informed consent.

Code of Federal Regulations, 2012 CFR

2012-04-01

... welfare of the subjects; (3) The research could not practicably be carried out without the waiver or..., no investigator may involve a human being as a subject in research covered by this policy unless the... releases or appears to release the investigator, the sponsor, the institution or its agents from liability...

49 CFR 11.116 - General requirements for informed consent.

Code of Federal Regulations, 2013 CFR

2013-10-01

... welfare of the subjects; (3) The research could not practicably be carried out without the waiver or... investigator may involve a human being as a subject in research covered by this policy unless the investigator... releases or appears to release the investigator, the sponsor, the institution or its agents from liability...

40 CFR 26.201 - To what does this subpart apply?

Code of Federal Regulations, 2012 CFR

2012-07-01

... Subjects who are Children or Pregnant or Nursing Women § 26.201 To what does this subpart apply? (a) This subpart applies to all research involving intentional exposure of any human subject who is a pregnant woman (and her fetus) or a child conducted or supported by the Environmental Protection Agency (EPA...

40 CFR 26.201 - To what does this subpart apply?

Code of Federal Regulations, 2013 CFR

2013-07-01

... Subjects who are Children or Pregnant or Nursing Women § 26.201 To what does this subpart apply? (a) This subpart applies to all research involving intentional exposure of any human subject who is a pregnant woman (and her fetus) or a child conducted or supported by the Environmental Protection Agency (EPA...

40 CFR 26.201 - To what does this subpart apply?

Code of Federal Regulations, 2011 CFR

2011-07-01

... Subjects who are Children or Pregnant or Nursing Women § 26.201 To what does this subpart apply? (a) This subpart applies to all research involving intentional exposure of any human subject who is a pregnant woman (and her fetus) or a child conducted or supported by the Environmental Protection Agency (EPA...

40 CFR 26.201 - To what does this subpart apply?

Code of Federal Regulations, 2014 CFR

2014-07-01

... Subjects who are Children or Pregnant or Nursing Women § 26.201 To what does this subpart apply? (a) This subpart applies to all research involving intentional exposure of any human subject who is a pregnant woman (and her fetus) or a child conducted or supported by the Environmental Protection Agency (EPA...

40 CFR 26.201 - To what does this subpart apply?

Code of Federal Regulations, 2010 CFR

2010-07-01

... Subjects who are Children or Pregnant or Nursing Women § 26.201 To what does this subpart apply? (a) This subpart applies to all research involving intentional exposure of any human subject who is a pregnant woman (and her fetus) or a child conducted or supported by the Environmental Protection Agency (EPA...

75 FR 47592 - Final Test Guideline; Product Performance of Skin-applied Insect Repellents of Insect and Other...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

... considerations affecting the design and conduct of repellent studies when human subjects are involved. Any... recommendations for the design and execution of studies to evaluate the performance of pesticide products intended... recommends appropriate study designs and methods for selecting subjects, statistical analysis, and reporting...

Individual differences in human annoyance response to noise

NASA Technical Reports Server (NTRS)

Pearson, R. G.; Hart, F. D.; Obrien, J. F.

1975-01-01

Individual variations in annoyance and in susceptibility to noise were studied to establish a finer definition of the ingredients of the human annoyance response. The study involved interactions among a heterogeneous sample of human subjects, various noise stimuli, and different physical environments of exposure. Significant differences in annoyance ratings among the six noise stimuli, all equated for peak sound pressure level, were found.

The FDA's role in medical device clinical studies of human subjects

NASA Astrophysics Data System (ADS)

Saviola, James

2005-03-01

This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.

A Rule Based Approach to ISS Interior Volume Control and Layout

NASA Technical Reports Server (NTRS)

Peacock, Brian; Maida, Jim; Fitts, David; Dory, Jonathan

2001-01-01

Traditional human factors design involves the development of human factors requirements based on a desire to accommodate a certain percentage of the intended user population. As the product is developed human factors evaluation involves comparison between the resulting design and the specifications. Sometimes performance metrics are involved that allow leniency in the design requirements given that the human performance result is satisfactory. Clearly such approaches may work but they give rise to uncertainty and negotiation. An alternative approach is to adopt human factors design rules that articulate a range of each design continuum over which there are varying outcome expectations and interactions with other variables, including time. These rules are based on a consensus of human factors specialists, designers, managers and customers. The International Space Station faces exactly this challenge in interior volume control, which is based on anthropometric, performance and subjective preference criteria. This paper describes the traditional approach and then proposes a rule-based alternative. The proposed rules involve spatial, temporal and importance dimensions. If successful this rule-based concept could be applied to many traditional human factors design variables and could lead to a more effective and efficient contribution of human factors input to the design process.

14 CFR § 1230.101 - To what does this policy apply?

Code of Federal Regulations, 2014 CFR

2014-01-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or... paragraph (b) of this section, this policy applies to all research involving human subjects conducted... administrative action to make the policy applicable to such research. This includes research conducted by federal...

Picturing neuroscience research through a human rights lens: Imaging first-episode schizophrenic treatment-naive individuals

PubMed Central

Eijkholt, Marleen; Anderson, James A.; Illes, Judy

2012-01-01

In this paper we examine imaging research involving first-episode schizophrenic treatment-naive individuals (FESTNIs) through a legal human rights lens; in particular, the lens of the Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research. We identify a number of ethical and legal hot spots highlighted by the Protocol, and offer a series of recommendations designed to ensure the human rights compatibility of this research. Subsequently, we argue that the lack of reporting on design elements related to ethical concerns frustrates commitments at the heart of the human rights approach, namely, transparency and openness to international scrutiny. To redress this problem, we introduce two norms for the first time: ethical transparency, and ethical reproducibility. When concluding, we offer a set of reporting guidelines designed to operationalize these norms in the context of imaging research involving FESTNIs. Though we will not make this case here, we believe that parallel reporting guidelines should be incorporated into other areas of research involving human subjects. PMID:22304987

Hemodynamic and Electrophysiological Relationship Involved in Human Face Processing: Evidence from a Combined fMRI-ERP Study

ERIC Educational Resources Information Center

Iidaka, Tetsuya; Matsumoto, Atsushi; Haneda, Kaoruko; Okada, Tomohisa; Sadato, Norihiro

2006-01-01

Functional magnetic resonance imaging (fMRI) and event-related potential (ERP) experiments were conducted in the same group of subjects and with an identical task paradigm to investigate a possible relationship between hemodynamic and electrophysiological responses within the brain. The subjects were instructed to judge whether visually presented…

16 CFR 1028.120 - Evaluation and disposition of applications and proposals for research to be conducted or...

Code of Federal Regulations, 2011 CFR

2011-01-01

... and proposals for research to be conducted or supported by a Federal Department or Agency. 1028.120... SUBJECTS § 1028.120 Evaluation and disposition of applications and proposals for research to be conducted... applications and proposals involving human subjects submitted to the department or agency through such officers...

45 CFR 46.101 - To what does this policy apply?

Code of Federal Regulations, 2012 CFR

2012-10-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or... SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.101 To what does this policy apply? (a) Except as provided in paragraph (b) of this section, this policy applies to all research...

45 CFR 46.101 - To what does this policy apply?

Code of Federal Regulations, 2011 CFR

2011-10-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or... SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.101 To what does this policy apply? (a) Except as provided in paragraph (b) of this section, this policy applies to all research...

45 CFR 46.101 - To what does this policy apply?

Code of Federal Regulations, 2014 CFR

2014-10-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or... SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.101 To what does this policy apply? (a) Except as provided in paragraph (b) of this section, this policy applies to all research...

45 CFR 46.101 - To what does this policy apply?

Code of Federal Regulations, 2013 CFR

2013-10-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or... SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.101 To what does this policy apply? (a) Except as provided in paragraph (b) of this section, this policy applies to all research...

45 CFR 46.101 - To what does this policy apply?

Code of Federal Regulations, 2010 CFR

2010-10-01

..., subpart C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or... SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.101 To what does this policy apply? (a) Except as provided in paragraph (b) of this section, this policy applies to all research...

A Prediction of Response of the Head and Neck of the U.S. Adult Military Population to Dynamic Impact Acceleration from Selected Dynamic Test Subjects.

DTIC Science & Technology

1976-05-01

to Review Grants for Clinical Research and Investigation Involving Human Beings, Medical School, The University of Michigan. 3 of biomechanical models...human volunteers in dynamic sled tests found no clinically observable effects. due to acceleration on a subject in which the peak mouth angular...minutes cf rest between trials , and the average fo-ce of each set computed. Figure 2.7 shows typi- cal forcc curves and the EMG signal resulting from

ISRUC-Sleep: A comprehensive public dataset for sleep researchers.

PubMed

Khalighi, Sirvan; Sousa, Teresa; Santos, José Moutinho; Nunes, Urbano

2016-02-01

To facilitate the performance comparison of new methods for sleep patterns analysis, datasets with quality content, publicly-available, are very important and useful. We introduce an open-access comprehensive sleep dataset, called ISRUC-Sleep. The data were obtained from human adults, including healthy subjects, subjects with sleep disorders, and subjects under the effect of sleep medication. Each recording was randomly selected between PSG recordings that were acquired by the Sleep Medicine Centre of the Hospital of Coimbra University (CHUC). The dataset comprises three groups of data: (1) data concerning 100 subjects, with one recording session per subject; (2) data gathered from 8 subjects; two recording sessions were performed per subject, and (3) data collected from one recording session related to 10 healthy subjects. The polysomnography (PSG) recordings, associated with each subject, were visually scored by two human experts. Comparing the existing sleep-related public datasets, ISRUC-Sleep provides data of a reasonable number of subjects with different characteristics such as: data useful for studies involving changes in the PSG signals over time; and data of healthy subjects useful for studies involving comparison of healthy subjects with the patients, suffering from sleep disorders. This dataset was created aiming to complement existing datasets by providing easy-to-apply data collection with some characteristics not covered yet. ISRUC-Sleep can be useful for analysis of new contributions: (i) in biomedical signal processing; (ii) in development of ASSC methods; and (iii) on sleep physiology studies. To evaluate and compare new contributions, which use this dataset as a benchmark, results of applying a subject-independent automatic sleep stage classification (ASSC) method on ISRUC-Sleep dataset are presented. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Informed consent in human subject research: a comparison of current international and Nigerian guidelines.

PubMed

Fadare, Joseph O; Porteri, Corinna

2010-03-01

Informed consent is a basic requirement for the conduct of ethical research involving human subjects. Currently, the Helsinki Declaration of the World Medical Association and the International Ethical Guidelines for Biomedical Research of the Council for International Organizations of Medical Sciences (CIOMS) are widely accepted as international codes regulating human subject research and the informed consent sections of these documents are quite important. Debates on the applicability of these guidelines in different socio-cultural settings are ongoing and many workers have advocated the need for national or regional guidelines. Nigeria, a developing country, has recently adopted its national guideline regulating human subject research: the National Health Research Ethics Committee (NHREC) code. A content analysis of the three guidelines was done to see if the Nigerian guidelines confer any additional protection for research subjects. The concept of a Community Advisory Committee in the Nigerian guideline is a novel one that emphasizes research as a community burden and should promote a form of "research friendship" to foster the welfare of research participants. There is also the need for a regular update of the NHREC code so as to address some issues that were not considered in its current version.

38 CFR 16.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2010 CFR

2010-07-01

... procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. 16.110 Section 16.110 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.110 Expedited review procedures for certain kinds of research...

21 CFR 312.3 - Definitions and interpretations.

Code of Federal Regulations, 2014 CFR

2014-04-01

....C. 301-392)). Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is...

You can't drink a word: lexical and individual emotionality affect subjective familiarity judgments.

PubMed

Westbury, Chris

2014-10-01

For almost 30 years, subjective familiarity has been used in psycholinguistics as an explanatory variable, allegedly able to explain many phenomena that have no other obvious explanation (Gernsbacher in J Exp Psychol General 113:256-281, 1984). In this paper, the hypothesis tested is that the subjective familiarity of words is reflecting personal familiarity with or importance of the referents of words. Using an empirically-grounded model of affective force derived from Wundt (Grundriss der Psychologie [Outlines of Psychology]. Engelmann, Leibzig, 1896) and based in a co-occurrence model of semantics (which involves no human judgment), it is shown that affective force can account for the same variance in a large set of human subjective familiarity judgments as other human subjective familiarity judgments, can predict whether people will rate new words of the same objective frequency as more or less familiar, can predict lexical access as well as human subjective familiarity judgments do, and has a predicted relationship to age of acquisition norms. Individuals who have highly affective reactivity [as measured by Carver and White's (J Pers Soc Psychol 67(2):319-333, 1994) Behavioral Inhibition Scale and Behavioral Activation Scales] rate words as significantly more familiar than individuals who have low affective reactivity.

Determining the neural substrates of goal-directed learning in the human brain.

PubMed

Valentin, Vivian V; Dickinson, Anthony; O'Doherty, John P

2007-04-11

Instrumental conditioning is considered to involve at least two distinct learning systems: a goal-directed system that learns associations between responses and the incentive value of outcomes, and a habit system that learns associations between stimuli and responses without any link to the outcome that that response engendered. Lesion studies in rodents suggest that these two distinct components of instrumental conditioning may be mediated by anatomically distinct neural systems. The aim of the present study was to determine the neural substrates of the goal-directed component of instrumental learning in humans. Nineteen human subjects were scanned with functional magnetic resonance imaging while they learned to choose instrumental actions that were associated with the subsequent delivery of different food rewards (tomato juice, chocolate milk, and orange juice). After training, one of these foods was devalued by feeding the subject to satiety on that food. The subjects were then scanned again, while being re-exposed to the instrumental choice procedure (in extinction). We hypothesized that regions of the brain involved in goal-directed learning would show changes in their activity as a function of outcome devaluation. Our results indicate that neural activity in one brain region in particular, the orbitofrontal cortex, showed a strong modulation in its activity during selection of a devalued compared with a nondevalued action. These results suggest an important contribution of orbitofrontal cortex in guiding goal-directed instrumental choices in humans.

Study of the regulation by nutrients of the expression of genes involved in lipogenesis and obesity in humans and animals.

PubMed

Delzenne, N; Ferré, P; Beylot, M; Daubioul, C; Declercq, B; Diraison, F; Dugail, I; Foufelle, F; Foretz, M; Mace, K; Reimer, R; Palmer, G; Rutter, G; Tavare, J; Van Loo, J; Vidal, H

2001-08-01

Dietary digestible carbohydrates are able to modulate lipogenesis, by modifying the expression of genes coding for key lipogenic enzymes, like fatty acid synthase. The overall objective of the Nutrigene project (FAIR-CT97-3011) was to study the efficiency of various carbohydrates to modulate the lipogenic capacity and relevant gene expression in rat and human species (control and obese subjects) and to understand the underlying molecular mechanisms involved in the regulation of lipogenic genes by carbohydrates. Key cellular mediators (namely SREBP-1c and 2, AMP activated protein kinase, cholesterol content) of the regulation of lipogenic gene expression by glucose and/or insulin were identified and constitute new putative targets in the development of plurimetabolic syndrome associated with obesity. In humans, hepatic lipogenesis and triglyceride synthesis, assessed in vivo by the use of stable isotopes, was promoted by a high-carbohydrate diet in non obese subjects, and in non alcoholic steatotic patients, but was not modified in the adipose tissue of obese subjects. Non digestible/fermentable carbohydrates, such as fructans, were shown to decrease hepatic lipogenesis in non obese rats, and to lessen hepatic steatosis and body weight in obese Zucker rats. If confirmed in obese humans, this would allow the development of functional food able to counteract the metabolic disturbances linked to obesity.

Human radiation studies: Remembering the early years. Oral history of biophysicist Cornelius A. Tobias, Ph.D., January 16, 1995

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

NONE

1995-07-01

Dr. Cornelius A. Tobias was interviewed by representatives of US DOE Office of Human Radiation Experiments (OHRE). He was chosen for this interview because of his extensive biophysics and medical physics research activities while he was employed by the University of California, Berkeley and San Francisco and at the Donner Laboratory. He discusses his involvement in wartime studies of effects of high altitude on aviators, carbon monoxide with radioactive tracers, blood studies with radioactive iron, human use committees, heavy-ion research with the Bevatron, boron isotope research, classified research involving human subjects, heavy-particle radiography, heavy- particle beams and medical research, andmore » pituitary irradiation studies,.« less

40 CFR 26.1201 - To what does this subpart apply?

Code of Federal Regulations, 2011 CFR

2011-07-01

... HUMAN SUBJECTS Prohibition of Third-Party Research for Pesticides Involving Intentional Exposure of...? Subpart L applies to any person who, after April 7, 2006, conducts or supports research with a human... section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a); or (2) To be held for later...

40 CFR 26.1201 - To what does this subpart apply?

Code of Federal Regulations, 2010 CFR

2010-07-01

... HUMAN SUBJECTS Prohibition of Third-Party Research for Pesticides Involving Intentional Exposure of...? Subpart L applies to any person who, after April 7, 2006, conducts or supports research with a human... section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a); or (2) To be held for later...

40 CFR 26.1101 - To what does this subpart apply?

Code of Federal Regulations, 2010 CFR

2010-07-01

... the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a); or (2) To hold the results of the research... results of such research to EPA; or (2) The person is a member of a class of people who, or whose products... HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving...

Levels of Antibodies against Human Heat Shock Protein (HSP) 60 in Patients with Glaucoma in Poland

PubMed Central

Grabska-Liberek, Iwona; Skonieczna, Katarzyna; Olesińska, Marzena; Terelak-Borys, Barbara; Kocięcki, Jarosandlstrokaw; Sikora, Mariusz; Jamrozy-Witkowska, Agnieszka; Tesla, Piotr; Czarnocka, Barbara

2015-01-01

Background Although elevated intraocular pressure is a major risk factor for the development of glaucoma, there is increasing evidence that the immune system may be involved in the development of normal-tension glaucoma (NTG). The aim of this study was to determine if NTG is associated with elevated levels of antibodies against human heat shock protein (HSP) 60. Material/Methods The study was conducted in 139 subjects (35 subjects with NTG [Group 1], 34 subjects with primary open-angle glaucoma/POAG/[Group 2], 24 subjects with autoimmune rheumatic diseases [Group 3], and 36 healthy controls [Group 4]). All subjects had complete ophthalmologic examination (visual acuity, slit-lamp examination, tonometry, gonioscopy; visual-field examination, and optical coherence tomography/OCT/of the optic nerve head and the macula). Blood samples were collected for the measurements of serum levels of antibodies against human HSP60. Results The subjects with rheumatic diseases had the highest median serum level of antibodies against HSP60 – 20.49 ng/mL. The values in the subjects with NTG, POAG, and in controls were 18.79 ng/mL, 18.61 ng/mL and 17.61 ng/mL, respectively (p=0.96). Conclusions This study does not confirm the hypothesis that normal-tension glaucoma is associated with elevated blood levels of antibodies against human heat shock protein (HSP) 60. PMID:25786333

US medical researchers, the Nuremberg Doctors Trial, and the Nuremberg Code. A review of findings of the Advisory Committee on Human Radiation Experiments.

PubMed

Faden, R R; Lederer, S E; Moreno, J D

1996-11-27

The Advisory Committee on Human Radiation Experiments (ACHRE), established to review allegations of abuses of human subjects in federally sponsored radiation research, was charged with identifying appropriate standards to evaluate the ethics of cold war radiation experiments. One central question for ACHRE was to determine what role, if any, the Nuremberg Code played in the norms and practices of US medical researchers. Based on the evidence from ACHRE's Ethics Oral History Project and extensive archival research, we conclude that the Code, at the time it was promulgated, had little effect on mainstream medical researchers engaged in human subjects research. Although some clinical investigators raised questions about the conduct of research involving human beings, the medical profession did not pursue this issue until the 1960s.

Attending to emotions is sharing of emotions - A multidisciplinary perspective to social attention and emotional sharing. Comment on Zahavi and Rochat (2015).

PubMed

Bader, Oren

2016-05-01

Attending to bodily expression of emotions plays an important role in the human social world. It provides subjects with valuable information, constructs opportunities to act, and importantly, as Daniel Stern pointed out, it is involved in the constitution of the direct experience of others. Whether mutual or one-sided, these direct experiences, in which the subject can share the perspectives and attitudes of other subjects, always comprise one person's bodily expression of emotions that is available to another person. In this article I suggest that attending to other subjects' expressed emotions involves a special (social) mode of attention and emotional sharing. This suggestion challenges Dan Zahavi's view that confines the sharing of emotions solely to reciprocal experiences. Copyright © 2016 Elsevier Inc. All rights reserved.

Effects of the beta-blocker propranolol on cued and contextual fear conditioning in humans.

PubMed

Grillon, Christian; Cordova, Jeremy; Morgan, Charles Andrew; Charney, Dennis S; Davis, Michael

2004-09-01

Beta-adrenergic receptors are involved in the consolidation of emotional memories. Yet, a number of studies using Pavlovian cued fear conditioning have been unable to demonstrate an effect of beta-adrenergic blockade on acquisition or retention of fear conditioning. Evidence for the involvement of beta-adrenergic receptors in emotional memories comes mostly from studies using fear inhibitory avoidance in rodents. It is possible that fear inhibitory avoidance is more akin to contextual conditioning than to cued fear conditioning, suggesting that context conditioning may be disrupted by beta-adrenergic blockade. This study investigated the effects of the beta-adrenergic blocker propranolol on cued and contextual fear conditioning in humans. Subjects were given either placebo (n=15) or 40 mg propranolol (n=15) prior to differential cued conditioning. A week later, they were tested for retention of context and cued fear conditioning using physiological (startle reflex and electrodermal activity) and subjective measures of emotional arousal. The results were consistent with the hypothesis. The skin conductance level (SCL) and the subjective measure of arousal suggested reduced emotional arousal upon returning to the conditioning context in the propranolol group, compared to the placebo group. The acquisition and retention of cued fear conditioning were not affected by propranolol. These results suggest that beta-adrenergic receptors are involved in contextual fear conditioning.

Improved memory for reward cues following acute buprenorphine administration in humans.

PubMed

Syal, Supriya; Ipser, Jonathan; Terburg, David; Solms, Mark; Panksepp, Jaak; Malcolm-Smith, Susan; Bos, Peter A; Montoya, Estrella R; Stein, Dan J; van Honk, Jack

2015-03-01

In rodents, there is abundant evidence for the involvement of the opioid system in the processing of reward cues, but this system has remained understudied in humans. In humans, the happy facial expression is a pivotal reward cue. Happy facial expressions activate the brain's reward system and are disregarded by subjects scoring high on depressive mood who are low in reward drive. We investigated whether a single 0.2mg administration of the mixed mu-opioid agonist/kappa-antagonist, buprenorphine, would influence short-term memory for happy, angry or fearful expressions relative to neutral faces. Healthy human subjects (n38) participated in a randomized placebo-controlled within-subject design, and performed an emotional face relocation task after administration of buprenorphine and placebo. We show that, compared to placebo, buprenorphine administration results in a significant improvement of memory for happy faces. Our data demonstrate that acute manipulation of the opioid system by buprenorphine increases short-term memory for social reward cues. Copyright © 2015. Published by Elsevier Ltd.

Undergraduate research involving human subjects should not be granted ethical approval unless it is likely to be of publishable quality.

PubMed

Gallagher, Cathal T; McDonald, Lisa J; McCormack, Niamh P

2014-06-01

Small-scale research projects involving human subjects have been identified as being effective in developing critical appraisal skills in undergraduate students. In deciding whether to grant ethical approval to such projects, university research ethics committees must weigh the benefits of the research against the risk of harm or discomfort to the participants. As the learning objectives associated with student research can be met without the need for human subjects, the benefit associated with training new healthcare professionals cannot, in itself, justify such risks. The outputs of research must be shared with the wider scientific community if it is to influence future practice. Our survey of 19 UK universities indicates that undergraduate dissertations associated with the disciplines of medicine, dentistry and pharmacy are not routinely retained in their library catalogues, thus closing a major avenue to the dissemination of their findings. If such research is unlikely to be published in a peer-reviewed journal, presented at a conference, or otherwise made available to other researchers, then the risks of harm, discomfort or inconvenience to participants are unlikely to be offset by societal benefits. Ethics committees should be satisfied that undergraduate research will be funnelled into further research that is likely to inform clinical practice before granting ethical approval.

Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights.

PubMed

Ekmekci, Perihan Elif; Arda, Berna

2017-01-01

Interventions in medicine require multicenter clinical trials on a large rather than limited number of subjects from various genetic and cultural backgrounds. International guidelines to protect the rights and well-being of human subjects involved in clinical trials are criticized for the priority they place on Western cultural values. These discussions become manifest especially with regard to the content and methodology of the informed consent procedure. The ethical dilemma emerges from the argument that there are fundamental differences about the concept of respect for the autonomy of individuals in different cultures and religions. Some communities prioritize the consent of community leaders or the head of family - usually men - over the voluntary and free consent of the individual. The aim of this work is to discuss this ethical dilemma to determine a base for a consensus that satisfies the sensibilities of different cultures without damaging the rights and autonomy of human subjects.

Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights

PubMed Central

Ekmekci, Perihan Elif; Arda, Berna

2018-01-01

Interventions in medicine require multicenter clinical trials on a large rather than limited number of subjects from various genetic and cultural backgrounds. International guidelines to protect the rights and well-being of human subjects involved in clinical trials are criticized for the priority they place on Western cultural values. These discussions become manifest especially with regard to the content and methodology of the informed consent procedure. The ethical dilemma emerges from the argument that there are fundamental differences about the concept of respect for the autonomy of individuals in different cultures and religions. Some communities prioritize the consent of community leaders or the head of family – usually men – over the voluntary and free consent of the individual. The aim of this work is to discuss this ethical dilemma to determine a base for a consensus that satisfies the sensibilities of different cultures without damaging the rights and autonomy of human subjects. PMID:29645014

Military chemical warfare agent human subjects testing: part 1--history of six-decades of military experiments with chemical warfare agents.

PubMed

Brown, Mark

2009-10-01

Military chemical warfare agent testing from World War I to 1975 produced thousands of veterans with concerns of possible long-term health consequences. Clinical and research evaluation of potential long-term health effects has been difficult because the exposures occurred decades ago, the identity of troops exposed and exposure magnitudes are uncertain, and acute effects during experiments poorly documented. In contrast, a companion article describes the large amount of information available about the specific agents tested and their long-term health effects. This short history describes U.S. military chemical-agent experiments with human subjects and identifies tested agents. Finally, the demonstrated need to anticipate future health concerns from military personnel involved in such military testing suggests current and future military researchers should be required, by law and regulation, to fully record the identity of those exposed, relevant exposure magnitude, and complete medical information for all subjects. New study protocols and institutional review board approvals for research involving military personnel should reflect this need.

Institutional review board training for community practices: advice from the Agency for Health Care Research and Quality Practice-Based Research Network listserv.

PubMed

Dolor, Rowena J; Smith, Peter C; Neale, Anne Victoria

2008-01-01

Human subject protection training is required for all research personnel regardless of funding source. This article summarizes recommendations from a discussion about ethics training for community personnel from the practice-based research network (PBRN) listserv sponsored by the Agency for Health Care Research and Quality PBRN Resource Center. PBRN projects can involve community providers and their staff as subjects of the research project or as collaborators with recruitment and data collection. Distinguishing between usual care and research procedures is important for determining if training is required of community-based personnel. The use of research assistants or practice facilitators to collect research-related information is one way of limiting practice involvement to usual care procedures, thereby allowing PBRNs to limit training to dedicated research staff. Key methodologies for human subject protection training of community practice staff include on-site lectures, online modules, videotapes, and paper-based training. Ultimately, a discussion by the PBRN researcher with his or her governing Institutional Review Board is recommended for finding acceptable strategies within a PBRN.

Spontaneous triadic engagement in bonobos (Pan paniscus) and chimpanzees (Pan troglodytes).

PubMed

MacLean, Evan; Hare, Brian

2013-08-01

Humans are believed to have evolved a unique motivation to participate in joint activities that first develops during infancy and supports the development of shared intentionality. We conducted five experiments with bonobos (Pan paniscus) and chimpanzees (Pan troglodytes) (Total n = 119) to assess their motivation to spontaneously participate in joint activities with a conspecific or a human. We found that even the youngest subjects preferred to interact together with a human and a toy rather than engaging in an identical game alone. In addition, we found that subjects could spontaneously interact with a human in a turn-taking game involving passing a ball back and forth and used behaviors to elicit additional interaction when the game was disrupted. However, when paired with a conspecific, subjects preferred to interact with an object individually rather than together. Our results indicate that nonhuman apes are motivated to engage in triadic activities if they occur spontaneously with humans and require a minimum amount of coordination. These findings leave open the question of whether these activities are coordinated through shared intentions.

Default, Cognitive and Affective Brain Networks in Human Tinnitus

DTIC Science & Technology

Tinnitus is a major health problem among those currently and formerly in military service. This project hypothesizes that many of the clinically...significant, non-auditory aspects of the tinnitus condition involve two major brain networks: the cognitive control network (CCN) and the default mode...function can be assessed. Subjects in three groups are being compared: (1) control subjects with clinically-normal hearing thresholds and no tinnitus

[Medical research and vulnerable subjects: unemployed people].

PubMed

Niebrój, Lesław

2006-01-01

Although the importance of medical research for the diagnosis and treatment of human diseases is unquestionable, the use of human subjects, however, still presents a complex ethical problem. Moral difficulties occur in particular when the medical research deals with vulnerable subjects. Vulnerable individuals are defined as those who experience diminished actual autonomy. Among the groups which should be considered as being vulnerable are usually listed the following: children, pregnant women, mentally or emotionally disabled, physically disabled, homeless, and institutionalized people. This study addresses key concerns that gave rise to the question of whether unemployed people had to be recognized as vulnerable subjects. The term "vulnerability" was clarified and it was assumed that the "vulnerability" of medical research subjects' had to be understood as a form of continuum from potential, through the circumstantial, temporal, episodic, permanent to inevitable vulnerability. The conclusion was drawn that unemployed people were, at least, potentially vulnerable subjects. Research involving unemployed people presents important moral challenges to researchers and should be undertaken very carefully, following special ethical guidelines.

Strengthening protections for human subjects: proposed restrictions on the publication of transplant research involving prisoners.

PubMed

Valapour, Maryam; Paulson, Kristin M; Hilde, Alisha

2013-04-01

Publication is one of the primary rewards in the academic research community and is the first step in the dissemination of a new discovery that could lead to recognition and opportunity. Because of this, the publication of research can serve as a tacit endorsement of the methodology behind the science. This becomes a problem when vulnerable populations that are incapable of giving legitimate informed consent, such as prisoners, are used in research. The problem is especially critical in the field of transplant research, in which unverified consent can enable research that exploits the vulnerabilities of prisoners, especially those awaiting execution. Because the doctrine of informed consent is central to the protection of vulnerable populations, we have performed a historical analysis of the standards of informed consent in codes of international human subject protections to form the foundation for our limit and ban recommendations: (1) limit the publication of transplant research involving prisoners in general and (2) ban the publication of transplant research involving executed prisoners in particular. Copyright © 2013 American Association for the Study of Liver Diseases.

Twenty-first Century ethics of medical research involving human subjects: achievements and challenges.

PubMed

Tzamaloukas, Antonios H; Konstantinov, Konstantin N; Agaba, Emmanuel I; Raj, Dominic S C; Murata, Glen H; Glew, Robert H

2008-01-01

The field of ethics in medical research has seen important developments in the last three decades, but it also faces great challenges in the new century. The purposes of this report are to examine the current status of ethics of medical research involving human subjects and the nature of the ethical challenges facing this research, to identify the weakness of the current system of safeguards for ethical research, and to stress the importance of the ethical character of the researcher, which is the safeguard that has the greatest potential for protecting the research subjects. Researchers appreciate the risks of human medical research that create ethical dilemmas and the need for an ethical compromise in order to proceed with the research. The main elements of the compromise, formulated primarily from experiences in the Second World War, include: (1) the dominant position of the ethical principle of autonomy; (2) the demand for a signed informed consent; (3) the likelihood of improving health with the research protocol, which must be approved by a duly appointed supervising committee; and (4) an acceptable risk/benefit ratio. The main weakness of this set of safeguards is the difficulty with obtaining a truly informed consent. The new challenges to ethical medical research stem from certain types of research, such as genetic and stem cell research, and from the increasing involvement of the industry in planning and funding the research studies. Developing medical researchers with an ethical character and knowledge about ethics in medicine may be the most effective safeguard in protecting participants of medical research experiments.

Human Visual System as a Double-Slit Single Photon Interference Sensor: A Comparison between Modellistic and Biophysical Tests

PubMed Central

Pizzi, Rita; Wang, Rui; Rossetti, Danilo

2016-01-01

This paper describes a computational approach to the theoretical problems involved in the Young's single-photon double-slit experiment, focusing on a simulation of this experiment in the absence of measuring devices. Specifically, the human visual system is used in place of a photomultiplier or similar apparatus. Beginning with the assumption that the human eye perceives light in the presence of very few photons, we measure human eye performance as a sensor in a double-slit one-photon-at-a-time experimental setup. To interpret the results, we implement a simulation algorithm and compare its results with those of human subjects under identical experimental conditions. In order to evaluate the perceptive parameters exactly, which vary depending on the light conditions and on the subject’s sensitivity, we first review the existing literature on the biophysics of the human eye in the presence of a dim light source, and then use the known values of the experimental variables to set the parameters of the computational simulation. The results of the simulation and their comparison with the experiment involving human subjects are reported and discussed. It is found that, while the computer simulation indicates that the human eye has the capacity to detect the corpuscular nature of photons under these conditions, this was not observed in practice. The possible reasons for the difference between theoretical prediction and experimental results are discussed. PMID:26816029

Research Ethics in the Era of Personalized Medicine: Updating Science's Contract with Society

PubMed Central

Meslin, Eric M.; Cho, Mildred K.

2010-01-01

With the completed sequence of the human genome has come the prospect of substantially improving the quality of life for millions through personalized medicine approaches. Still, any advances in this direction require research involving human subjects. For decades science and ethics have enjoyed an allegiance reflected in a common set of ethical principles and procedures guiding the conduct of research with human subjects. Some of these principles emphasize avoiding harm over maximizing benefit. In this paper we revisit the priority given to these ethical principles – particularly the principles that support a cautious approach to science – and propose a reframing of the ‘social contract’ between science and society that emphasizes reciprocity and meeting public needs. PMID:20805701

The Nuremberg Code and the Nuremberg Trial. A reappraisal.

PubMed

Katz, J

1996-11-27

The Nuremberg Code includes 10 principles to guide physician-investigators in experiments involving human subjects. These principles, particularly the first principle on "voluntary consent," primarily were based on legal concepts because medical codes of ethics existent at the time of the Nazi atrocities did not address consent and other safeguards for human subjects. The US judges who presided over the proceedings did not intend the Code to apply only to the case before them, to be a response to the atrocities committed by the Nazi physicians, or to be inapplicable to research as it is customarily carried on in medical institutions. Instead, a careful reading of the judgment suggests that they wrote the Code for the practice of human experimentation whenever it is being conducted.

10 CFR 733.3 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... fields of science, engineering, and mathematics, such as research in economics, education, linguistics, medicine, psychology, social sciences, statistics, and research involving human subjects or animals.... Research record means the record of all data or results that embody the facts resulting from scientists...

10 CFR 733.3 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... fields of science, engineering, and mathematics, such as research in economics, education, linguistics, medicine, psychology, social sciences, statistics, and research involving human subjects or animals.... Research record means the record of all data or results that embody the facts resulting from scientists...

10 CFR 733.3 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... fields of science, engineering, and mathematics, such as research in economics, education, linguistics, medicine, psychology, social sciences, statistics, and research involving human subjects or animals.... Research record means the record of all data or results that embody the facts resulting from scientists...

10 CFR 733.3 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... fields of science, engineering, and mathematics, such as research in economics, education, linguistics, medicine, psychology, social sciences, statistics, and research involving human subjects or animals.... Research record means the record of all data or results that embody the facts resulting from scientists...

10 CFR 733.3 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... fields of science, engineering, and mathematics, such as research in economics, education, linguistics, medicine, psychology, social sciences, statistics, and research involving human subjects or animals.... Research record means the record of all data or results that embody the facts resulting from scientists...

Fish as a Predictive Model for Epigenetic Carcinogens

DTIC Science & Technology

1993-12-23

increased fatty acyl-CoA oxidase activity. Studies conducted in vitro also showed that the peroxisome proliferating agents displayed relatively low capacity...of Laboratory Resources, National Research Council ( NIH Publication No. 86-23, Revised 1985). For the protection of human subjects, the investigator(s...to the NIH Guidelines for Research Involving Recombinant DNA Molecules. In the conduct of research involving hazardous organisms, the investigator(s

Simulating Human Cognition in the Domain of Air Traffic Control

NASA Technical Reports Server (NTRS)

Freed, Michael; Johnston, James C.; Null, Cynthia H. (Technical Monitor)

1995-01-01

Experiments intended to assess performance in human-machine interactions are often prohibitively expensive, unethical or otherwise impractical to run. Approximations of experimental results can be obtained, in principle, by simulating the behavior of subjects using computer models of human mental behavior. Computer simulation technology has been developed for this purpose. Our goal is to produce a cognitive model suitable to guide the simulation machinery and enable it to closely approximate a human subject's performance in experimental conditions. The described model is designed to simulate a variety of cognitive behaviors involved in routine air traffic control. As the model is elaborated, our ability to predict the effects of novel circumstances on controller error rates and other performance characteristics should increase. This will enable the system to project the impact of proposed changes to air traffic control procedures and equipment on controller performance.

Health complaints among subjects involved in oil cleanup operations during oil spillage from a Greek tanker "Tasman Spirit".

PubMed

Meo, Sultan Ayoub; Al-Drees, Abdul Majeed; Rasheed, Shahzad; Meo, Imran Mu; Al-Saadi, Muslim M; Ghani, Hamza A; Alkandari, Jasem Ramadan

2009-01-01

Oil spillage in the sea water is a disaster for marine life and humans in the vicinity. The study aimed at investigating health complaints among subjects involved in oil cleanup operations during a spillage from a Greek oil tanker "Tasman Spirit". The project was conducted under the supervision of the Department of Physiology, College of Medicine, King Khalid University Hospital, King Saud University, Riyadh, Saudi Arabia. The study concerned the respiratory and general health complaints in 50 apparently healthy, non-smoking male workers exposed to crude oil during oil cleanup operations. The exposed group was matched with a similar number of male, non-smoking controls. The health complaints were evaluated based on a comprehensive interview. The subjects involved in oil cleanup operations had significantly higher rates of health complaints including cough (38%), runny nose (36%), eye irritation/redness (32%), sore throat (28%), headache (28%), nausea (24%) and general illness (18%), compared to their matched controls. Air pollution due to crude oil spillage into sea water may cause respiratory and general health complaints in workers involved in oil cleanup operations.

How Building Systems Affect Worker Wellness

DTIC Science & Technology

1994-03-01

spatial configuration must strike a balance between the objective needs of the organization and the more subjective human ingredient. Good building...sense, building design for thermal comfort involves a balance between the building’s orientation, its windowing scheme, the use of thermal mass, and the...stated above. An improved quality of worklife and a humanized work environment are psychological incentives that can increase productivity. Worker specific

Technology, expertise and social cognition in human evolution.

PubMed

Stout, Dietrich; Passingham, Richard; Frith, Christopher; Apel, Jan; Chaminade, Thierry

2011-04-01

Paleolithic stone tools provide concrete evidence of major developments in human behavioural and cognitive evolution. Of particular interest are evolving cognitive mechanisms implied by the cultural transmission of increasingly complex prehistoric technologies, hypothetically including motor resonance, causal reasoning and mentalizing. To test the relevance of these mechanisms to specific Paleolithic technologies, we conducted a functional magnetic resonance imaging study of Naïve, Trained and Expert subjects observing two toolmaking methods of differing complexity and antiquity: the simple 'Oldowan' method documented by the earliest tools 2.5 million years ago; and the more complex 'Acheulean' method used to produce refined tools 0.5 million years ago. Subjects observed 20-s video clips of an expert demonstrator, followed by behavioural tasks designed to maintain attention. Results show that observational understanding of Acheulean toolmaking involves increased demands for the recognition of abstract technological intentions. Across subject groups, Acheulean compared with Oldowan toolmaking was associated with activation of left anterior intraparietal and inferior frontal sulci, indicating the relevance of resonance mechanisms. Between groups, Naïve subjects relied on bottom-up kinematic simulation in the premotor cortex to reconstruct unfamiliar intentions, and Experts employed a combination of familiarity-based sensorimotor matching in the posterior parietal cortex and top-down mentalizing involving the medial prefrontal cortex. While no specific differences between toolmaking technologies were found for Trained subjects, both produced frontal activation relative to Control, suggesting focused engagement with toolmaking stimuli. These findings support motor resonance hypotheses for the evolutionary origins of human social cognition and cumulative culture, directly linking these hypotheses with archaeologically observable behaviours in prehistory. © 2011 The Authors. European Journal of Neuroscience © 2011 Federation of European Neuroscience Societies and Blackwell Publishing Ltd.

"Scientific peep show": the human body in contemporary science museums.

PubMed

Canadelli, Elena

2011-01-01

The essay focuses on the discourse about the human body developed by contemporary science museums with educational and instructive purposes directed at the general public. These museums aim mostly at mediating concepts such as health and prevention. The current scenario is linked with two examples of past museums: the popular anatomical museums which emerged during the 19th century and the health museums thrived between 1910 and 1940. On the museological path about the human body self-care we went from the emotionally involving anatomical Venuses to the inexpressive Transparent Man, from anatomical specimens of ill organs and deformed subjects to the mechanical and electronic models of the healthy body. Today the body is made transparent by the new medical diagnostics and by the latest discoveries of endoscopy. The way museums and science centers presently display the human body involves computers, 3D animation, digital technologies, hands-on models of large size human parts.

On the almost inconceivable misunderstandings concerning the subject of value-free social science.

PubMed

Black, Donald

2013-12-01

A value judgment says what is good or bad, and value-free social science simply means social science free of value judgments. Yet many sociologists regard value-free social science as undesirable or impossible and readily make value judgments in the name of sociology. Often they display confusion about such matters as the meaning of value-free social science, value judgments internal and external to social science, value judgments as a subject of social science, the relevance of objectivity for value-free social science, and the difference between the human significance of social science and value-free social science. But why so many sociologists are so value-involved - and generally so unscientific - is sociologically understandable: The closest and most distant subjects attract the least scientific ideas. And during the past century sociologists have become increasingly close to their human subject. The debate about value-free social science is also part of an epistemological counterrevolution of humanists (including many sociologists) against the more scientific social scientists who invaded and threatened to expropriate the human subject during the past century. © London School of Economics and Political Science 2013.

Human subjects protection training for community workers: an example from "Faith Moves Mountains".

PubMed

Hatcher, Jennifer; Schoenberg, Nancy E

2007-01-01

Despite widespread agreement on the necessity of protecting human subjects, questions regarding ethical treatment and protection of human subjects remain and are particularly vexing for community-based participatory research (CBPR). There has been a notable lack of attention paid to what type of training should be provided and how to balance "real-life" concerns with official requirements. The purpose of this article is to demonstrate how, in consultation with the Office of Research Integrity (ORI) at our institution and our community partners, we developed training that overcame concerns related to instruction of community workers on protection of human subjects. We developed a training module written in lay terms and containing only information pertinent to non-key personnel and their role in the CBPR project. We designed and piloted this material in collaboration with our community partners who work with us to recruit and train lay health advisors (LHAs) and oversee the day-to-day operations of the CBPR project. The educational module was presented to the community workers as a part of a day-long training session. The written materials were a part of a notebook of information accompanied by an oral Power Point presentation. Each of the workers was given a written test to evaluate knowledge of the content presented. The test was administered by the project director, a community member herself, and then sent to our institution for grading by personnel not involved in this project. To date, all community workers have passed the written test. The community members, research partners, and the ORI are satisfied with the scope and simplicity of the training program developed. Our team's collaborative approach to community-based human subjects training contributes to advancing a grounded, feasible, and rigorous process of protecting human subjects while implementing CBPR ideals.

Human Factors in the Design of the Crew Exploration Vehicle (CEV)

NASA Technical Reports Server (NTRS)

Whitmore, Mihriban; Byrne, Vicky; Holden, Kritina

2007-01-01

NASA s Space Exploration vision for humans to venture to the moon and beyond provides interesting human factors opportunities and challenges. The Human Engineering group at NASA has been involved in the initial phases of development of the Crew Exploration Vehicle (CEV), Orion. Getting involved at the ground level, Human Factors engineers are beginning to influence design; this involvement is expected to continue throughout the development lifecycle. The information presented here describes what has been done to date, what is currently going on, and what is expected in the future. During Phase 1, prior to the contract award to Lockheed Martin, the Human Engineering group was involved in generating requirements, conducting preliminary task analyses based on interviews with subject matter experts in all vehicle systems areas, and developing preliminary concepts of operations based on the task analysis results. In addition, some early evaluations to look at CEV net habitable volume were also conducted. The program is currently in Phase 2, which is broken down into design cycles, including System Readiness Review, Preliminary Design Review, and Critical Design Review. Currently, there are ongoing Human Engineering Technical Interchange Meetings being held with both NASA and Lockheed Martin in order to establish processes, desired products, and schedules. Multiple design trades and quick-look evaluations (e.g. display device layout and external window size) are also in progress. Future Human Engineering activities include requirement verification assessments and crew/stakeholder evaluations of increasing fidelity. During actual flights of the CEV, the Human Engineering group is expected to be involved in in-situ testing and lessons learned reporting, in order to benefit human space flight beyond the initial CEV program.

The Resurrection of Malthus: space as the final escape from the law of diminishing returns

NASA Astrophysics Data System (ADS)

Sommers, J.; Beldavs, V.

2017-09-01

If there is a self-sustaining space economy, which is the goal of the International Lunar Decade, then it is a subject of economic analysis. The immediate challenge of space economics then is to conceptually demonstrate how a space economy could emerge and work where markets do not exist and few human agents may be involved, in fact where human agents may transact with either human agents or robotic agents or robotic agents may transact with other robotic agents.

SPECT assessment of brain activation induced by caffeine: no effect on areas involved in dependence

PubMed Central

Nehlig, Astrid; Armspach, Jean-Paul; Namer, Izzie J.

2010-01-01

Caffeine is not considered addictive, and in animals it does not trigger metabolic increases or dopamine release in brain areas involved in reinforcement and reward. Our objective was to measure caffeine effects on cerebral perfusion in humans using single photon emission computed tomography, with a specific focus on areas of reinforcement and reward. Two groups of nonsmoking subjects were studied, one with a low (8 subjects) and one with a high (6 subjects) daily coffee consumption. The subjects ingested 3 mg/kg caffeine or placebo in a raspberry-tasting drink, and scans were performed 45 min after ingestion. A control group of 12 healthy volunteers receiving no drink was also studied. Caffeine consumption led to a generalized, statistically nonsignificant perfusion decrease of 6% to 8%, comparable in low and high consumers. Compared with controls, low consumers displayed neuronal activation bilaterally in inferior frontal gyrusanterior insular cortex and uncus, left internal parietal cortex, right lingual gyrus, and cerebellum. In high consumers, brain activation occurred bilaterally only in hypothalamus. Thus, on a background of widespread low-amplitude perfusion decrease, caffeine activates a few regions mainly involved in the control of vigilance, anxiety, and cardiovascular regulation, but does not affect areas involved in reinforcing and reward. PMID:20623930

SPECT assessment of brain activation induced by caffeine: no effect on areas involved in dependence.

PubMed

Nehlig, Astrid; Armspach, Jean-Paul; Namer, Izzie J

2010-01-01

Caffeine is not considered addictive, and in animals it does not trigger metabolic increases or dopamine release in brain areas involved in reinforcement and reward. Our objective was to measure caffeine effects on cerebral perfusion in humans using single photon emission computed tomography with a specific focus on areas of reinforcement and reward. Two groups of nonsmoking subjects were studied, one with a low (8 subjects) and one with a high (6 subjects) daily coffee consumption. The subjects ingested 3 mg/kg caffeine or placebo in a raspberry-tasting drink, and scans were performed 45 min after ingestion. A control group of 12 healthy volunteers receiving no drink was also studied. Caffeine consumption led to a generalized, statistically nonsignificant perfusion decrease of 6% to 8%, comparable in low and high consumers. Compared with controls, low consumers displayed neuronal activation bilaterally in inferior frontal gyrus-anterior insular cortex and uncus, left internal parietal cortex, right lingual gyrus, and cerebellum. In high consumers, brain activation occurred bilaterally only in hypothalamus. Thus, on a background of widespread low-amplitude perfusion decrease, caffeine activates a few regions mainly involved in the control of vigilance, anxiety, and cardiovascular regulation, but does not affect areas involved in reinforcing and reward.

A Comparison of National Policies on Research Involving Human Subjects to Facilitate Review and Approval of Collaborative Research

DTIC Science & Technology

2008-11-26

Exemptions: 1. Routine educational testing 2. Quality assurance studies 3. Strict performance reviews 4. Occupational training 5. Anonymous data...following categories are exempt from this policy: (1) Research conducted in established or commonly accepted educational settings, involving normal... educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the

[Argentina, Brazil and Mexico. Biomedical research and the defense of a single standard of attention in developing countries].

PubMed

Angeles-Llerenas, Angélica; Bello, María Alejandra; Dirce, Guilhem; Salinas, Mario Alberto

2004-01-01

In the Helsinki Declaration, which established the ethical principles for research with human subjects, article 5 states, "...concern about the well-being of human beings should always come before the interests of science and of society..." Research proposals should include this commitment, both in developed and developing countries. In countries like Argentina, Brazil and Mexico, much of the population experience situations of great injustice, including a lack of equal access to health care. In some cases, sectors of the pharmaceutical industry may see these deficiencies as offering opportunities for carrying out research and achieving economic profits, something which carries the risk of perpetuating and even intensifying the unjust situations and violations of human rights--these population groups already suffer from. This situation implies the need for commitment to and ethical reflection upon human rights related to health. Agreements are needed between the actors involved in health research: sources of funding, researchers, public policy makers, and the study subjects themselves, in order to protect the latter's rights, including continuity of medical treatment for research subjects, when necessary.

Learning stochastic reward distributions in a speeded pointing task.

PubMed

Seydell, Anna; McCann, Brian C; Trommershäuser, Julia; Knill, David C

2008-04-23

Recent studies have shown that humans effectively take into account task variance caused by intrinsic motor noise when planning fast hand movements. However, previous evidence suggests that humans have greater difficulty accounting for arbitrary forms of stochasticity in their environment, both in economic decision making and sensorimotor tasks. We hypothesized that humans can learn to optimize movement strategies when environmental randomness can be experienced and thus implicitly learned over several trials, especially if it mimics the kinds of randomness for which subjects might have generative models. We tested the hypothesis using a task in which subjects had to rapidly point at a target region partly covered by three stochastic penalty regions introduced as "defenders." At movement completion, each defender jumped to a new position drawn randomly from fixed probability distributions. Subjects earned points when they hit the target, unblocked by a defender, and lost points otherwise. Results indicate that after approximately 600 trials, subjects approached optimal behavior. We further tested whether subjects simply learned a set of stimulus-contingent motor plans or the statistics of defenders' movements by training subjects with one penalty distribution and then testing them on a new penalty distribution. Subjects immediately changed their strategy to achieve the same average reward as subjects who had trained with the second penalty distribution. These results indicate that subjects learned the parameters of the defenders' jump distributions and used this knowledge to optimally plan their hand movements under conditions involving stochastic rewards and penalties.

The applied importance of research on the matching law

PubMed Central

Pierce, W. David; Epling, W. Frank

1995-01-01

In this essay, we evaluate the applied implications of two articles related to the matching law and published in the Journal of the Experimental Analysis of Behavior, May 1994. Building on Mace's (1994) criteria for increasing the applied relevance of basic research, we evaluate the applied implications of basic research studies. Research by Elsmore and McBride (1994) and Savastano and Fantino (1994) involve an extension of the behavioral model of choice. Elsmore and McBride used rats as subjects, but arranged a multioperant environment that resembles some of the complex contingencies of human behavior. Savastino and Fantino used human subjects and extended the matching law to ratio and interval contingencies. These experiments contribute to a growing body of knowledge on the matching law and its relevance for human behavior. PMID:16795866

21 CFR 1003.31 - Granting the exemption.

Code of Federal Regulations, 2010 CFR

2010-04-01

... applicable Federal standard is such as to create a significant risk of injury, including genetic injury, to... is desirable. Where such evidence includes nonclinical laboratory studies, the data submitted shall... includes clinical investigations involving human subjects, the data submitted shall include, with respect...

Protease-activated receptor 2, a receptor involved in melanosome transfer, is upregulated in human skin by ultraviolet irradiation.

PubMed

Scott, G; Deng, A; Rodriguez-Burford, C; Seiberg, M; Han, R; Babiarz, L; Grizzle, W; Bell, W; Pentland, A

2001-12-01

Previous studies have shown that the protease-activated receptor 2 is involved in skin pigmentation through increased phagocytosis of melanosomes by keratinocytes. Ultraviolet irradiation is a potent stimulus for melanosome transfer. We show that protease-activated receptor 2 expression in human skin is upregulated by ultraviolet irradiation. Subjects with skin type I, II, or III were exposed to two or three minimal erythema doses of irradiation from a solar simulator. Biopsies were taken from nonexposed and irradiated skin 24 and 96 h after irradiation and protease-activated receptor 2 expression was detected using immunohistochemical staining. In nonirradiated skin, protease-activated receptor 2 expression was confined to keratinocytes in the lower one-third of the epidermis. After ultraviolet irradiation protease-activated receptor 2 expression was observed in keratinocytes in the upper two-thirds of the epidermis or the entire epidermis at both time points studied. Subjects with skin type I showed delayed upregulation of protease-activated receptor 2 expression, however, compared with subjects with skin types II and III. Irradiated cultured human keratinocytes showed upregulation in protease-activated receptor 2 expression as determined by immunofluorescence microscopy and Western blotting. Cell culture supernatants from irradiated keratinocytes also exhibited a dose-dependent increase in protease-activated receptor-2 cleavage activity. These results suggest an important role for protease-activated receptor-2 in pigmentation in vivo. Differences in protease-activated receptor 2 regulation in type I skin compared with skin types II and III suggest a potential mechanism for differences in tanning in subjects with different skin types.

On the morality of Guinea-pig recruitment.

PubMed

Valdman, Mikhail

2010-07-01

ABSTRACT Can it be wrong to conduct medical research on human subjects even with their informed consent and even when the transaction between the subjects and researchers is expected to be mutually beneficial? This question is especially pressing today in light of the rise of a semi-professional class of 'guinea pigs'- human research subjects that sell researchers a right of access to their bodies in exchange for money. Can these exchanges be morally problematic even when they are consensual and mutually beneficial? I argue that there are two general kinds of concern one can have about such transactions - concerns about the nature of what is sold and concerns about the conditions in which the selling occurs. The former involves worries about degradation and the possible wrongness of selling a right of access to one's body. These worries, I argue, are not very serious. The latter involves worries about coercion, exploitation, and undue influence - about how, by virtue of their ignorance, impulsiveness, or desperation, guinea pigs can be taken advantage of by medical researchers. These worries are quite serious but I argue that, at least in cases where the exchange between guinea pigs and researchers is consensual and mutually beneficial, they do not raise insurmountable moral problems.

Are You Talking to Me? Dialogue Systems Supporting Mixed Teams of Humans and Robots

NASA Technical Reports Server (NTRS)

Dowding, John; Clancey, William J.; Graham, Jeffrey

2006-01-01

This position paper describes an approach to building spoken dialogue systems for environments containing multiple human speakers and hearers, and multiple robotic speakers and hearers. We address the issue, for robotic hearers, of whether the speech they hear is intended for them, or more likely to be intended for some other hearer. We will describe data collected during a series of experiments involving teams of multiple human and robots (and other software participants), and some preliminary results for distinguishing robot-directed speech from human-directed speech. The domain of these experiments is Mars-analogue planetary exploration. These Mars-analogue field studies involve two subjects in simulated planetary space suits doing geological exploration with the help of 1-2 robots, supporting software agents, a habitat communicator and links to a remote science team. The two subjects are performing a task (geological exploration) which requires them to speak with each other while also speaking with their assistants. The technique used here is to use a probabilistic context-free grammar language model in the speech recognizer that is trained on prior robot-directed speech. Intuitively, the recognizer will give higher confidence to an utterance if it is similar to utterances that have been directed to the robot in the past.

Health information seeking on the Internet: The role of involvement in searching for and assessing online health information.

PubMed

Park, Sun-Young; Go, Eun

2016-01-01

This study focuses on how young people with differing levels of involvement seek and evaluate information about the human papillomavirus online. The results, which are drawn from an experiment and a self-administered survey, suggest that compared to people with a low level of involvement, people with a high level of involvement engage in more information search activity. The results also indicate that those with a high level of involvement in a given subject place a higher value on a website's message features than on its structural features. Implications, limitations, and suggestions for future research are discussed.

Cinnamic Acid Is Partially Involved in Propolis Immunomodulatory Action on Human Monocytes

PubMed Central

Conti, Bruno José; Búfalo, Michelle Cristiane; Golim, Marjorie de Assis; Sforcin, José Maurício

2013-01-01

Propolis is a beehive product used in traditional medicine due to its biological properties. It shows a complex chemical composition including phenolics, such as cinnamic acid (Ci). The mechanisms of action of propolis have been the subject of research recently; however, the involvement of Ci on propolis activity was not investigated on immune cells. Ci effects were evaluated on human monocytes, assessing the expression of Toll-like receptors (TLRs), HLA-DR, and CD80. Cytokine production (TNF-α and IL-10) and the fungicidal activity of monocytes were evaluated as well. Data showed that Ci downregulated TLR-2, HLA-DR, and CD80 and upregulated TLR-4 expression by human monocytes. High concentrations of Ci inhibited both TNF-α and IL-10 production, whereas the same concentrations induced a higher fungicidal activity against Candida albicans. TNF-α and IL-10 production was decreased by blocking TLR-4, while the fungicidal activity of monocytes was not affected by blocking TLRs. These results suggest that Ci modulated antigen receptors, cytokine production, and the fungicidal activity of human monocytes depending on concentration, and TLR-4 may be involved in its mechanism of action. Ci seemed to be partially involved in propolis activities. PMID:23762102

Genetic variants in AKR1B10 associate with human eating behavior.

PubMed

Rohde, Kerstin; Federbusch, Martin; Horstmann, Annette; Keller, Maria; Villringer, Arno; Stumvoll, Michael; Tönjes, Anke; Kovacs, Peter; Böttcher, Yvonne

2015-03-25

The human Aldoketoreductase 1B10 gene (AKR1B10) encodes one of the enzymes belonging to the family of aldoketoreductases and may be involved in detoxification of nutrients during digestion. Further, AKR1B10 mRNA (messenger ribonucleic acid) expression was diminished in brain regions potentially involved in the regulation of eating behavior in rats which are more sensitive to cocaine and alcohol. We hypothesized that the human AKR1B10 gene may also play a role in the regulation of human eating behavior. We investigated the effects of 5 genetic variants of AKR1B10 on human eating behavior among 548 subjects from a German self-contained population, the Sorbs, and in 350 subjects from another independent German cohort. Among the Sorbs, we observed nominal associations with disinhibition at the 5' untranslated region (5' UTR) variant rs10232478 and the intragenic variants rs1834150 and rs782881 (all P ≤ 0.05). Further, we detected a relationship of rs1834150 and rs782881 with waist, smoking consumption (rs782881) and coffee consumption (rs1834150) (all P ≤ 0.05). Albeit non-significant, replication analyses revealed similar effect directions for disinhibition at rs1834150 (combined P = 0.0096). Moreover, in the replication cohort we found rs1834150 related to increased restraint scores with a similar direction as in the Sorbs (combined P = 0.0072). Our data suggest that genetic variants in the AKR1B10 locus may influence human eating behavior.

Ethical and Social Issues in Health Research Involving Incarcerated People.

PubMed

Coughlin, Steven S; Lewis, Sharon R; Smith, Selina A

2016-01-01

The use of inmates in research in the U.S. was restricted by the recommendations of the National Commission and by federal regulations and guidelines that followed. By the 1980s, many health care officials became concerned about the exclusion of inmates from experimental treatments for human immunodeficiency virus infection (HIV). These developments in ethics occurred in the context of racial/ethnic disparities in health. In this article, ethical considerations in clinical and public health research on HIV in prison and jail settings are considered. Ethical considerations in mental health research are summarized as well as issues pertaining to research involving female inmates. Issues related to oversight of research involving incarcerated people are considered along with the ethics of public health research. The ethics of research involving incarcerated people extends beyond traditional issues in human subjects ethics to include issues within the domains of bioethics and public health ethics.