Projects not initiated by investigators: A retrospective analysis of the queries raised by the institutional ethics committees of a teaching hospital

Journal of Postgraduate Medicine

Volumn 60, Issue 1, 2014, Pages 46-50

  Kuyare, S S ^a   Marathe, P A ^a   Shetty, Y C ^a   Kamat, S K ^a   Katkar, J V ^a   Thatte, U M ^a  

^a KEM HOSPITAL   (India)

Author keywords

Ethical issues; informed consent document; institutional ethics committee; standard of care

Indexed keywords

CLINICAL PRACTICE; CLINICAL TRIAL (TOPIC); GOVERNMENT; INFORMED CONSENT; INSTITUTIONAL ETHICS; METHODOLOGY; RESEARCH ETHICS; RETROSPECTIVE STUDY; REVIEW; STATISTICS; TEACHING HOSPITAL; ETHICS; HUMAN; INDIA; PERSONNEL; PROFESSIONAL STANDARD;

CLINICAL TRIALS AS TOPIC; ETHICAL REVIEW; ETHICS COMMITTEES; HOSPITALS, TEACHING; HUMANS; INDIA; INFORMED CONSENT; RESEARCH PERSONNEL; RETROSPECTIVE STUDIES;

EID: 84897513265     PISSN: 00223859     EISSN: 09722823     Source Type: Journal    
DOI: 10.4103/0022-3859.128808     Document Type: Review

References (21)

1. World Medical Association Declaration of Helsinki (1964). Ethical Principles for Medical Research Involving Human Subjects. Available from: Http://irb.wayne.edu/policies/2-3-declaration-of-helsinki.pdf [Last accessed on 2013 Aug 19].
2. Nuremberg Code. Available from: Http://history.nih.gov/research/ downloads/nuremberg.pdf [Last accessed on 2014 Aug 14].
3. ICMR, Ethical guidelines for Biomedical Research on Human Participants, 2006. Available from: Http://www.icmr.nic.in/ethical- guidelines.pdf [Last accessed on 2013 Aug 14].
4. World Medical Association Declaration of Helsinki (2008) - Ethical Principles for Medical Research Involving Human Subjects 2008. Available from: Http://www.wma.net/en/30publications/10policies/ b3/ [Last accessed on 2013 Aug 14].
5. Council for International Organizations of Medical Sciences. International Ethical Guidelines for Biomedical Research involving Human Subjects. Geneva, Switzerland: CIOMS; 2002. Available from: Http://www.cioms.ch/ publications/layout-guide2002.pdf [Last accessed on 2013 Aug 14].
6. Schedule Y (Drugs and Cosmetic Act 1940; amendment 20th January 2005). Available from: Http://cdsco.nic.in/html/ schedule-y%20(amended%20version-2005) %20original.htm [Last accessed on 2013 Aug 14].
7. Standards and Operational guidance for ethics review of Health-Related Research with Human Participants, WHO, 2011. Available from: Http://whqlibdoc.who.int/publications/2011/9789241502948- eng.pdf [Last accessed on 2013 Aug 14].
8. Clinical Trials Registry-India. Available from: Http://www.ctri.nic.in [Last accessed on 2013 Aug 18].
9. Registration of clinical trials. Notification number F.No. 12-01/09-DC-(Pt-32). Available from: Http://www.cdsco.nic.in/clinical-trial.htm [Last accessed on 2013 Oct 25].
10. Boyce M; London multicentre research ethics committee 1997-2000. Observational study of 353 applications to London multicentre research ethics committee 1997-2000. BMJ 2002;325:1081
11. Lynn MR, Nelson DK. Common (mis) perceptions about IRB review of human subjects research. Nurs Sci Q 2005;18:264-70
12. Klitzman R. From anonymity to "open doors": IRB responses to tensions with researchers. BMC Res Notes 2012;5:347
13. Kass NE, Hyder AA, Ajuwon A, Appiah-Poku J, Barsdorf N, Elsayed DE, et al. The structure and function of research ethics committees in Africa: A case study. PLoS Med 2007;4:26-31
14. Pawar DB, Gawde SR, Marathe PA. Awareness about medical research among resident doctors in a tertiary care hospital: A crosssectional survey. Perspect Clin Res 2012;3:57-61
15. Brehaut JC, Carroll K, Elwyn G, Saginur R, Kimmelman J, Shojania K, et al. Informed consent documents do not encourage good-quality decision making. J Clin Epidemiol 2012;65:708-24
16. Castro M. Placebo versus best-Available-Therapy control group in clinical trials for pharmacologic therapies which is better?. Proc Am Thorac Soc 2007;4:570-3
17. Simon R. Are placebo-controlled clinical trials ethical or needed when alternative treatment exists?. Ann Intern Med 2000;133:474-5
18. Menikoff J. The paradoxical problem with multiple-IRB review. N Engl J Med 2010;363:1591-3
19. Lo B, Barnes M. Protecting research participants while reducing regulatory burdens. JAMA 2011;306:2260-1
20. Grady C. Do IRBs Protect Human Research Participants?. JAMA 2010;304:1122-3
21. Goldfarb N. Can You Handle the Truth?. IEC Appeals. J Clin Res Best Pract 2011;7:1-3