U.S. Department of Health and Human Services, Federal Policy for the Protection of Human Subjects: Notices and Rules, 56 Fed Reg 28,002–28,032 (Rev. Nov. 13, 2001), including 45 CFR pt 46.
2.
National Bioethics Advisory Commission. Ethical and Policy Issues in Research Involving Human Participants: Volume I. Report and Recommendations of the National Bioethics Advisory Commission, Bethesda, MD, August 2001. Bethesda, MD: National Bioethics Advisory Commission, 2001 (ISBN 1-931022-16-X). Available at: http://www.georgetown.edu/research/nrcbl/nbac/human/overvol1.html. Accessed July 11, 2002.
3.
Office for Human Research Protections (OHPR), U.S. Department of Health and Human Services. OHRP/OPRR compliance activities: Determination letters. Available at: http://ohrp.osophs.dhhs.gov/detrm_letrs/lindex.htm. Accessed July 11, 2002.
4.
KalbPE, KoehlerKG.Legal issues in scientific research. JAMA2002;287:85–91.
5.
Office of the Inspector General, U.S. Department of Health and Human Services. Institutional Review Boards: A time for reform (No. OEI-01-97-00193). Washington, DC: U.S. Department of Health and Human Services, 1998.
6.
LoB, WolfLE, BerkeleyA.Conflict-of-interest policies for investigators in clinical trials. N Engl J Med2000;343:1616–1620.
7.
LemonickMD, GoldsteinA.At your own risk: Some patients join clinical trials out of desperation, others to help medicine advance: Who is to blame if they get sick—or even die?Time2002;159(16):46–56.
8.
StolbergSG.The biotech death of Jesse Gelsinger. N Y Times Mag1999Nov28; 136–140, 149–150.
9.
SteinbrookR.Protecting research subjects: The crisis at Johns Hopkins. N Engl J Med2002;346:716–720.
10.
NathanDG.Careers in translational clinical research: Historical perspectives, future challenges. JAMA2002;287:2424–2427.
U.S. General Accounting Office. Scientific research: Continued vigilance critical to protecting human subjects (Letter Report to the Ranking Minority Member, Hon. John Glenn, Committee on Governmental Affairs, U.S. Senate, 03/08/96, GAO/HEHS-96-72). Washington, DC: General Accounting Office, 1996.
13.
ShalalaD.Protecting research subjects: What must be done. N Engl J Med2000;343:808–810.
National Institutes of Health, U.S. Department of Health and Human Services. Human participant protections education for research teams (on-line tutorial). Available at: http://cme.nci.nih.gov/. Accessed July 11, 2002.
16.
GallinJ.Conducting clinical research: Suggestions for improvement. Presented at the meeting of the Institute of Medicine's Clinical Research Roundtable, Washington, DC, June 13, 2002.