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21CFR56.110 (subpart C: IRB functions and operations)
Last amended June
21CFR56.110 (subpart C: IRB functions and operations). Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. Last amended 1991 June.
Office of Inspector General, Report OEI-01-97-00193. Washington: Department of Health and Human Services; June. 90 p.
Gibbs Brown, J. Institutional review boards: a time for reform. Office of Inspector General, Report OEI-01-97-00193. Washington: Department of Health and Human Services; 1998 June. 90 p. Available: http.//oig.hhs.gov/oei/reports/oei- 01-97-00193.pdf (accessed 2004 Nov 17).
United States Department of Health and Human Services
Domestic IRB Registry. In: OHRP, Web site of the Office for Human Research Protections, United States Department of Health and Human Services. Available: http://ohrp.cit.nih.gov/search/asearch.asp#ASUR (accessed 2004 Aug 10).
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Washington: United States Department of Health and Human Services
Office for Human Research Protections 2004 Determination Letters. Washington: United States Department of Health and Human Services; 2004. Available: www.hhs.gov/ohrp/compliance/letters/index.html (accessed 2004 Oct 6).
A study of warning letters issued to clinical investigators by the United States Food and Drug Administration
Bramstedt KA. A study of warning letters issued to clinical investigators by the United States Food and Drug Administration. Clin Invest Med 2004;27:129-34.
Rockville (MD): FDA; August. The 2004 March revised version
FDA. FDA/ORA regulatory procedures manual. Rockville (MD): FDA; 1997 August. The 2004 March revised version is available: www.fda.gov/ora/ compliance_ref/rpm/default.htm (accessed 2004 Oct 4 and Dec 9, respectively).
Breaking the camel's back: Multicenter clinical trials and local institutional review boards
Burman WJ, Reves RR, Cohn DL, Schooley RT. Breaking the camel's back: multicenter clinical trials and local institutional review boards. Ann Intern Med 2001;134:152-7.
FDA. Warning letters and responses. In: PDA's Electronic Freedom of Information Reading Room (a Web site). Available: www.fda.gov/foi/warning.htm (accessed 2004 Aug 15).
FDA. FDA warning letter to Great Lakes College of Clinical Medicine, 09 March 2000. Available: www.fda .gov/foi/warning_letters/m3492n.pdf (accessed 2004 Aug 12).
FDA. FDA warning letter to Essex Institutional Review Board, 27 August 1998. Available: www.fda.gov/foi/warning_letters/t1989m.pdf (accessed 2004 Aug 12).
Posting warning letter responses on PDA's Web site: Notice of pilot program
FDA. Posting warning letter responses on PDA's Web site: notice of pilot program. Federal Register 2003;68 (120):37162-3. Available: http://a257.g. akamaitech.net /7/257/2422/14mar20010800/edocket.access.gpo.gov /2003/03-15732.htm (accessed 2004 Nov 17).
CFR50.24 (part 50: Protection of human subjects; subpart B: Informed consent of human subjects; section 50.24)
Oct
21CFR50.24 (part 50: Protection of human subjects; subpart B: Informed consent of human subjects; section 50.24). Exception from informed consent requirements for emergency research. 1996 Oct.
Office of Inspector General, Report OEI-01-97-00190. Washington: Department of Health and Human Services; June. 38 pages
Gibbs Brown J. Institutional review boards: their role in reviewing approved research. Office of Inspector General, Report OEI-01-97-00190. Washington: Department of Health and Human Services; 1998 June. 38 pages. Available: http://oig.hhs.gov/oei/reports/oei -01-97-00190.pdf (accessed 2004 Nov 17).
FDA. FDA warning letter to North Texas Institutional Review Board, 14 April 2003. Available: www.fda.gov/foi/warning_letters/g3960d.htm (accessed 2004 Aug 13).
International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH)
ICH topic E6. Ottawa: Health Canada
International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH). Good clinical practice: consolidated guideline. ICH topic E6. Ottawa: Health Canada; 1997 (revised 2002 Feb 2). Available: www .hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/e6_e.pdf (accessed 2004 Nov 17).
Department of Justice Canada, Consolidated Statutes and Regulations: Food and Drug Regulations, C.R.C., c.05 (Division 5). Drugs for clinical trials involving human subjects. Updated 2004 Aug. Available: http://laws.justice.gc. ca/en/F-27/C.R.C.-c.870/128780.html#rid-128853 (accessed 2004 Nov 17).
Central Office for Research Ethics Committees (COREC). Standard operating procedures for research ethics committees. London (UK): COREC; 2004 Feb. Available: www.corec.org.uk/applicants/help/docs/SOPs.doc (accessed 2004 Nov 17).
Department of Health. Governance arrangements for NHS Research Ethics Committees. London (UK): the Department; 2001 July. Available: www.dh.gov.uk /assetRoot/04/05/86/09/04058609.pdf (accessed 2004 Nov 17).
