1. Steinbrook R. Improving protections for research subjects. N Engl J Med2002; 346: 1425–1430.
2.
2. Emanuel EJ, Wood A, Fleischman A et al. Oversight of human participants research: identifying problems to evaluate reform proposals. Ann Intern Med2004; 141: 282–291.
3.
3. United States Department of Health and Human Services. OHRP Compliance Activities: Common Findings and Guidance – 7/10/2002. http://www.hhs.gov/ohrp/compliance/findings.pdf (accessed 7 October 2004).
4.
4. 45 CFR 46.
5.
5. Human subject protection: FDA's role in a system of safeguards (Publication No. FS 01-11). Rockville, MD: Food and Drug Administration, 2002.
6.
6. Office of Regulatory Affairs, United States Food and Drug Administration. Disqualified/Restricted/Assurances Lists for Clinical Investigators. http://www.fda.gov/ora/compliance_ref/bimo/dis_res_assur.htm (accessed 7 October 2004).
7.
7. Office of Regulatory Affairs, United States Food and Drug Administration. AIP Procedures. http://www.fda.gov/ora/compliance_ref/aip_procedures/ (accessed 7 October 2004).
8.
8. Office of Research Integrity, United States Department of Health & Human Services. Annual Report 2003. Available at: http://ori.dhhs.gov/multimedia/acrobat/ori_annual_report_2003.pdf (accessed 7 October 2004).
9.
9. 45 CFR 50.102
10.
10. Reynolds SM. ORI findings of scientific misconduct in clinical trials and publicly funded research, May 1992–2002. Clin Trials2004; 509–516.
