The subject-researcher relationship: In defense of contracting around default rules

American Journal of Bioethics

Volumn 11, Issue 4, 2011, Pages 27-30

  Meyer, Michelle N ^a  

^a HARVARD LAW SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BEHAVIOR; CLINICAL TRIAL (TOPIC); CONFLICT OF INTEREST; CONTRACT; DOCTOR PATIENT RELATION; ETHICS; HUMAN; HUMAN RELATION; LEGAL ASPECT; PATIENT; PATIENT RIGHT; PERSONNEL; RESEARCH SUBJECT; TRUST;

CLINICAL TRIALS AS TOPIC; CONFLICT OF INTEREST; CONTRACTS; HUMANS; PATIENT DROPOUTS; PATIENT RIGHTS; PHYSICIAN-PATIENT RELATIONS; POWER (PSYCHOLOGY); RESEARCH PERSONNEL; RESEARCH SUBJECTS; RESEARCHER-SUBJECT RELATIONS; TRUST;

EID: 79953883488     PISSN: 15265161     EISSN: 15360075     Source Type: Journal    
DOI: 10.1080/15265161.2011.560535     Document Type: Article

References (13)

1. Abney v. Amgen, Inc., 443 F.3d 540 (6th Cir. 2006).
2. Dahl v. HEM Pharmaceuticals Corp., 7 F.3d 1399 (9th Cir. 1993), aff'd, 76 F.3d 385 (9th Cir. 1996).
3. Department of Health and Human Services. 2009. 45 CFR Part 46, Subpart A. Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
4. Department of Health and Human Services. 2010. 21 CFR Part 50, Subpart B. Available at: http://www.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50.
5. De Ville, K. 2011. The case against contract: Participant and investigator duty in clinical trials. American Journal of Bioethics 11(4): 16-18.
6. Edwards, S. J. L. 2011. Assessing the remedy: The case for contracts in clinical trials. American Journal of Bioethics 11(4): 3-12.
7. Kraemer-Katz v. U.S. Public Health Service, 872 F. Supp. 1235 (S.D.N.Y. 1994)
8. Mello,M.M., and S. Joffe. 2007. Compact versus contract-Industry sponsors' obligations to their research subjects. New England Journal of Medicine 356(26): 2737-2743.
9. Meyer, M. N. 2006. The plaintiff as person: Cause lawyering, human subject research, and the secret agent problem. Harvard Law Review 119: 1510-1531.
10. Meyer, M. N. 2008. The kindness of strangers: The donative contract between subjects and researchers and the non-obligation to return individual results of genetic research. American Journal of Bioethics 8(11): 44-46.
11. Meyer, M. N. 2010. Against one-size fits all research ethics. Hastings Center Report 40(Sept.-Oct.): 10-11.
12. Morreim, E. H. 2005. The clinical investigator as fiduciary: Discarding a misguided idea. Journal of Law, Medicine & Ethics 33: 586-598.
13. Skloot, R. 2006. Taking the least of you: The tissue-industrial complex. New York Times Magazine, April 16. Available at: http://www.nytimes.com/2006/04/16/magazine/16tissue.html?pagewanted=1&r=3