How do we know that research ethics committees are really working? the neglected role of outcomes assessment in research ethics review

BMC Medical Ethics

Volumn 9, Issue , 2008, Pages

  Coleman, Carl H ^a   Bouësseau, Marie Charlotte ^b  

^a Seton Hall Law School ^*  (United States)

^b WORLD HEALTH ORGANIZATION   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ACCREDITATION; ETHICAL DECISION MAKING; HUMAN; MEDICAL DECISION MAKING; MEDICAL ETHICS; MEDICAL PRACTICE; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; QUALITY CONTROL; RESEARCH ETHICS; REVIEW; ARTICLE; CONFLICT OF INTEREST; DEVELOPING COUNTRY; ECONOMICS; ETHICS; HEALTH CARE QUALITY; HUMAN EXPERIMENT; MEDICAL RESEARCH; RESEARCH SUBJECT; STANDARD; WORLD HEALTH ORGANIZATION;

BIOMEDICAL RESEARCH; CONFLICT OF INTEREST; DEVELOPING COUNTRIES; ETHICAL REVIEW; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; HUMAN EXPERIMENTATION; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); QUALITY ASSURANCE, HEALTH CARE; RESEARCH SUBJECTS; WORLD HEALTH ORGANIZATION;

EID: 42549129895     PISSN: None     EISSN: 14726939     Source Type: Journal    
DOI: 10.1186/1472-6939-9-6     Document Type: Review

References (36)

1. Quality assessment of ethics in health care: the accountability revolution. SM Wolf, American Journal of Law & Medicine 1994 20 105 128 at 110. 7801973
2. Moving beyond compliance: measuring ethical quality to enhance the oversight of human subjects research. HA Taylor, IRB: Ethics & Human Research 2007 29 5 9 14
3. Institutional review boards: is this the least worst we can do? DA Hyman, Northwestern University Law Review 2007 101 749 773
4. Ignorance is neither bliss nor ethical. JH Mueller, Northwestern University Law Review 2007 101 809 836
5. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Council for International Organizations of Medical Sciences, Geneva 2002
6. Guideline for Good Clinical Practice. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1996 http://www.ich.org/LOB/media/MEDIA482.pdf
7. Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research. Council of Europe, 2005 http://conventions.coe. int/treaty/en/treaties/html/195.htm
8. Universal Declaration on Bioethics and Human Rights, art. 19. UNESCO, 2005 http://portal.unesco.org/en/ev.php-URL_ID=31058&URL_DO= DO_TOPIC&URL_SECTION=201.html
9. CH Coleman JA Menikoff JA Goldner NN Dubler, The Ethics and Regulation of Research with Human Subjects Newark, NJ: Lexis 2005
10. Ethical review of health research: a perspective from developing country researchers. AA Hyder, Journal of Medical Ethics 2004 30 68 72 10.1136/jme.2002.001933 14872079
11. Establishment of ethical oversight of human research in El Salvador: lessons learned. MA Caniza, The Lancet 2006 7 1027 1033 10.1016/S1470-2045(06) 70977-9
12. 21 C.F.R. § 312.120. 2008
13. The Mexico Statement on Health Research. Ministerial Summit on Health Research, 2004 http://www.who.int/rpc/summit/agenda/en/ mexico_statement_on_health_research.pdf
14. NEBRA Final Report. Networking for Ethics on Biomedical Research in Africa, 2006 http://www.trree.org/site/en_nebra.phtml
15. The structure and function of research ethics committees in Africa: a case study. NE Kass AH Adnan A Ademola J Appiah-Poku N Barsdorf DE Elsayed M Mokhachane B Mupenda P Ndebele G Ndossi G Sikateyo G Tangwa P Tindana, PLoS Medicine 2007 4 1 e3 17253898 10.1371/journal.pmed.0040003
16. African Malaria Trust Network. http://www.amanet-trust.org/ext/news/ HREGrant.htm
17. R Macklin, Double Standards in Medical Research in Developing Countries Cambridge University Press 2004
18. Efforts To Increase Participation Examined. Research Notes - Clinical Trials, American Health Line June 22, 2006
19. Ethical review of research involving human subjects in Nigeria: legal and policy issues. RN Nwabueze, Indiana International and Comparative Law Review 2003 14 87 116
20. Rationalizing risk assessment in human subject research. CH Coleman, Arizona Law Review 2004 46 1 51 16189913
21. The role of institutional review boards in protecting human subjects: are we really ready to fix a broken system? HG Beh, Law & Psychology Review 2002 26 1 46
22. U.S. health researchers review their ethics review boards: a qualitative study. S Burris K Moss, Journal of Empirical Research on Human Research Ethics 2006 1 2 39 58 10.1525/jer.2006.1.2.39
23. Strengthening local review of research in Africa: is the IRB model relevant? CH Coleman MC Bouësseau, Bioethics Forum 2006 http://www.bioethicsforum.org/ethics-review-of-medical-research-in-Africa.asp
24. Regulatory paradox in the protection of human research subjects: a review of OHRP enforcement letters. S Burris J Welsh, Northwestern University Law Review 2007 101 643 685
25. New Zealand Injury Prevention, Rehabilitation, and Compensation Act, § 32(6). http://interim.legislation.govt.nz/libraries/contents/om_isapi. dll?clientID=858250283&infobase=pal_statutes.nfo&jump=a2001-049%2fs. 32&softpage=DOC#JUMPDEST_a2001-049/s.32
26. Accredited Ethics Committees. Health Research Council of New Zealand, 2005 http://www.hrc.govt.nz/root/Ethics/Ethics%20Overview/ Accredited_Ethics_Committees.html
27. Quality Assurance - Accreditation. See, for example, National Patient Safety Agency (United Kingdom), http://www.nres.npsa.nhs.uk/recs/quality/ accreditation.htm
28. Association for the Accreditation of Human Research Protection Programs, Inc. http://www.aahrpp.org/www.aspx
29. SIDCER Recognition Programme. UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), 2005 http://www.sidcer.org/new_web/main/SIDCER_RecPro.doc
30. Certification. Public Responsibility in Medicine and Research, 2007 http://www.primr.org/certification/certification.html
31. Oversight of human participants research: identifying problems to evaluate reform proposals. EJ Emanuel A Wood A Fleischman A Bowen KA Getz C Grady C Levine DE Hammerschmidt R Faden L Eckenwiler CT Muse J Sugarman, Annals of Internal Medicine 2004 141 282 291 15313744
32. Quality assurance of health care in developing countries. Quality Assurance Project, http://www.qaproject.org/pubs/PDFs/DEVCONT.pdf at14.
33. Medical research and intangible harm. RS Saver, University of Cincinnati Law Review 2006 74 941 1012
34. Interventions to improve research participants' understanding in informed consent for research: a systematic review. J Flory E Emanuel, JAMA 2004 292 1593 1601 10.1001/jama.292.13.1593 15467062
35. Why is quality assurance so difficult? A review of issues in quality assurance over the last decade. RW Brown, Internal Medicine Journal 2002 32 331 337 at 332. 10.1046/j.1445-5994.2002.00240.x 12088353
36. Monitoring the quality of primary care. Quality Assurance Project, http://www.qaproject.org/pubs/PDFs/hmngrfinal.pdf at 3.