Who's winning the irb wars? The struggle for the soul of human research

Perspectives in Biology and Medicine

Volumn 61, Issue 3, 2018, Pages 450-464

  King, Nancy M P ^a  

^a WAKE FOREST SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ETHICS; HUMAN; HUMAN EXPERIMENT; LEGISLATION AND JURISPRUDENCE; LITERATURE; PROFESSIONAL STANDARD; UNITED STATES;

ETHICS COMMITTEES, RESEARCH; HUMAN EXPERIMENTATION; HUMANS; LITERATURE; UNITED STATES;

EID: 85054463474     PISSN: 00315982     EISSN: None     Source Type: Journal    
DOI: 10.1353/pbm.2018.0055     Document Type: Note

References (19)

1. Batt, S. 2017. Health Advocacy, Inc.: How Pharmaceutical Funding Changed the Breast Cancer Movement. Vancouver: UBC Press.
2. BBC News. 2017. “Charlie Gard: The Story of His Parents’ Legal Fight.” BBC News, July 27. http://www.bbc.com/news/health-40554462.
3. Caffrey, J. 2016. “I Nearly Died in a Medical Drug Trial.” BBC News Mag, March 19. http://www.bbc.com/news/magazine-35766627.
4. Dresser, R. 2017. Silent Partners: Human Subjects and Research Ethics. Oxford: Oxford University Press.
5. Elliott, C. 2007. “The Tyranny of Expertise.” In The Ethics of Bioethics: Mapping the Moral Landscape, ed. L. Eckenwiler and F. Cohn, 43–46. Baltimore: Johns Hopkins University Press.
6. Elliott, C. 2017. “Why Research Oversight Bodies Should Interview Research Subjects.” IRB 39 (2): 8–13.
7. Joelving, F. 2017. “What the Gardasil Testing May Have Missed.” Slate, Dec. 17. https://slate.com/health-and-science/2017/12/flaws-in-the-clinical-trials-for-gardasil-made-it-harder-to-properly-assess-safety.html.
8. Jonas, H. 1969. “Philosophical Reflections on Experimenting with Human Subjects.” Daedalus 98: 219–47.
9. Katz, J. 1996. “Statement of Committee Member Jay Katz.” In Final Report of the Advisory Committee on Human Radiation Experiments. Oxford: Oxford University Press.
10. Klitzman, R. 2015. The Ethics Police? The Struggle to Make Human Research Safe. Oxford: Oxford University Press.
11. National Institutes of Health (NIH). 2016. “Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.” Notice no. NOT-OD-16-094, June 21, 2016. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html.
12. Offit, P. 2017. “Hope after Death: Today’s Anti-Cancer Therapies Wouldn’t Exist Without Jesse Gelsinger.” Daily Beast, Nov. 13. https://www.thedailybeast.com/todays-aggres-sive-anti-cancer-therapies-wouldnt-exist-without-jesse-gelsinger.
13. Rothstein, M. 2015. “Ethical Issues in Big Data Health Research.” J Law Med Ethics 43: 425–29.
14. Schneider, C. 2015. The Censor’s Hand: The Misregulation of Human Subject Research. Cambridge: MIT Press.
15. Suntharalingam, G., et al. 2006. “Cytokine Storm in a Phase 1 Trial of the Anti-CD28 Monoclonal Antibody TGN1412.” N Engl J Med 355: 1018–28.
16. U.S. Dept. of Health and Human Services (HHS). 2011. Human Subjects Research Protections, 76 Federal Register 44512-44531.
17. U.S. Dept. of Health and Human Services (HHS). 2015. Federal Policy for the Protection of Human Subjects, 80 Federal Register 53933-54061 (September 8, 2015). Text of proposed rule at 54044-54056.
18. U.S. Dept. of Health and Human Services (HHS). 2017. Federal Policy for the Protection of Human Subjects, 82 Federal Register 7149-7274 (January 19, 2017). Text of final rule at 7259-7269.
19. U.S. Dept. of Health and Human Services (HHS). 2018. Federal Policy for the Protection of Human Subjects, 83 Federal Register 28497-28520 (June 19, 2018).