Aligning regulations and ethics in human research

Science

Volumn 337, Issue 6094, 2012, Pages 527-528

  Dresser, Rebecca ^a  

^a WASHINGTON UNIVERSITY SCHOOL OF LAW   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ETHICS; INJURY; REGULATORY FRAMEWORK; RESEARCH WORK;

GOVERNMENT; HUMAN; LAW; LAW SUIT; PRIORITY JOURNAL; RESEARCH ETHICS; REVIEW; UNITED STATES; ARTICLE; ETHICS; HUMAN EXPERIMENT; INFORMED CONSENT; PRACTICE GUIDELINE; STANDARD; STATISTICS;

UNITED STATES;

CONSENT FORMS; GUIDELINES AS TOPIC; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; UNITED STATES; UNITED STATES GOVERNMENT AGENCIES;

EID: 84864780304     PISSN: 00368075     EISSN: 10959203     Source Type: Journal    
DOI: 10.1126/science.1218323     Document Type: Review

References (19)

1. Department of Health and Human Services, Fed. Regist. 76, 44512 (2011); www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18792.htm.
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12. National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants (NBAC, Washington, DC, 2001), p. 123.
13. Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Participants in Human Subjects Research (Commission, Washington, DC, 2011), pp. 56-70.
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15. E. R. Pike, Am. J. Law Med. 38, 7 (2012).
16. It is not clear why this issue was not addressed in the ANPRM. Officials may have wanted to wait for the Presidential Commission Report (13), which was issued several months after the ANPRM. It is possible that compensation will be considered in the next set of Common Rule proposals, or officials could address the issue separately, e.g., by setting up a project to collect necessary data. Noting the persistent lack of a government response to previous advisory group recommendations, the Presidential Commission called on officials to "publicly release reasons for changing or maintaining the status quo."
17. E. J. Emanuel, D. Wendler, C. Grady, JAMA 283, 2701 (2000).
18. A. J. London, J. Kimmelman, M. E. Emborg, Science 328, 829 (2010).
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