Sustaining public trust: Falling short in the protection of human research participants

Hastings Center Report

Volumn 38, Issue 3, 2008, Pages 8-9

  Mastroianni, Anna C ^a,b  

^a UNIVERSITY OF WASHINGTON   (United States)

^b Landstuhl Regional Medical Center   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COMPENSATION; DRUG APPROVAL; ETHICS; FOOD AND DRUG ADMINISTRATION; HUMAN; HUMAN EXPERIMENT; LEGAL ASPECT; PUBLIC OPINION; RESEARCH ETHICS; RESEARCH SUBJECT; SAFETY; SHORT SURVEY; TRUST; UNITED STATES;

COMPENSATION AND REDRESS; DEVICE APPROVAL; DRUG APPROVAL; ETHICS, RESEARCH; HUMAN EXPERIMENTATION; HUMANS; PUBLIC OPINION; RESEARCH SUBJECTS; TRUST; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 44849115985     PISSN: 00930334     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Short Survey

References (17)

1. USA Today/Kaiser Family Foundation/Harvard School of Public Health, "The Public on Prescription Drugs and Pharmaceutical Companies," March 2008, at 22; http://www.kff.org/kaiserpolls/ pomr030408pkg.cfm.
2. Ibid., at 13.
3. Association for the Accreditation of Human Research Protection Programs, "Accredited Organizations," http://www.aahrpp.org/www.aspx?PageID= 11$1$100, accessed March 18, 2008.
4. M. Mello et al., "The Rise of Litigation in Human Subjects Research," Annals of Internal Medicine 139 (2003): 40-45.
5. See D. Federman et al., eds., Responsible Research: A Systems Approach to Protecting Research Subjects (Washington, D.C.: National Academy Press, 2002);
6. Advisory Committee on Human Radiation Experiments, The Human Radiation Experiments: Final Report of the President's Advisory Committee (New York: Oxford University Press, 1996);
7. A. Mastroianni et al., eds., Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies (Washington, D.C.: National Academy Press, 1994).
8. R. Steinbrook, "Compensation for Injured Research Subjects," New England Journal of Medicine 354 (2006): 1871-73. The Veteran's Administration must provide medical treatment for research injuries under specified circumstances (38 Code of Federal Regulations 17.85).
9. G. Harris, "Tainted Drugs Put Focus on the FDA," New York Times, March 17, 2008.
10. Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008).
11. See, for example, J. Kahn et al., Beyond Consent: Seeking Justice in Research (New York: Oxford University Press, 1998);
12. Mastroianni et al., eds., Women and Health Research;
13. J. Kahn and A. Mastroianni, "Swinging on the Pendulum: Shifting Views of Justice in Human Subject Research," Hastings Center Report 31 (2001): 21-28.
14. E. Turner et al., "Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy," New England Journal of Medicine 358 (2008): 252-60.
15. N. Fost and R. Levine, "The Dysregulation of Human Subjects Research," Journal of the American Medical Association 298 (2007): 2196-98, at 2196.
16. See for example, C. Citro et al., Protecting Participants and Facilitating Social and Behavioral Sciences Research (Washington, D.C.: National Academy Press, 2003);
17. A. Gawande, "A Lifesaving Checklist," The New York Times, December 30, 2007.