Useful Links & Resources
of Research Ethics


 
The World Medical Association

World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects

 
Hospital Authority

Managing Liability in Clinical Trials

 
U.S. Department of Health and Human Services

Office for Human Research Protection
Monitor research involving human subject

Office of Research Integrity
Promotes integrity in biomedical and behavioral research

 
U.S. Food & Drug Administration

U.S. FDA Guidance for IRB and Clinical Investigators
The accompanying "Appendix H - Self-evaluation Checklist for IRBs" offers a useful tool for institutions contemplating establishing an ethics committee.

 
U.K. Department of Health

U.K. Research Governance Framework for Health and Social Care
This framework defines the broad principles of research governance for health and social care research.
The document "Governance Arrangements for NHS Research Ethics Committee" sets the standards for reviewing the ethical aspects of proposals for research in the NHS and Social Care.

 
The Journal of the American Medical Association

Clinical trial registration: a statement from the International Committee of Medical Journal Editors
DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. JAMA 2004 Sept; 292(11): 1363-4.

 
FindArticles.com

38 articles on IRB or Ethics Committee
Free article search

 
National Institutes of the Health

Bioethics Resources on the Web

 
Harvard Medical School

Office for Research Subject Protection

 
U.S. Food & Drug Administration

FDA Guidance on Clinical Trial Data Monitoring Committees

 
EthicsWeb.ca

Canadian Ethics Websites

 
EUROPA

European Commission website - Science and Society

 
The Institutional Review Board

Discussion and News Forum

 
Royal College of Nursing

RCN Guidance for Nurses: Research Ethics

 
The World Health Organization

WHO technical consultation on clinical trial registration standards

 
The World Health Organization

Handbook for Good Clinical Research Practice

 
University of Pittsburgh

IRB Guidance on Research Limited to Retrospective Medical Record Reviews

 



Relevant reading:

Committee on Assessing the System for Protecting Human Research Subjects, Board on Health Sciences Policy, Institute of Medicine. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington D.C.: National Academy Press; 2001.

This report provides the committee's response to the tasks of reviewing and considering proposed performance standards, recommending standards for accreditation, adn recommending an approach to monitoring and evaluating the system for the protection of human research participants.

Figure 1 in the "Executive Summary" illustrates the different components of the Human Research Participant Protection Programs (HRPPP) at a glance.

Savulescu J, Chalmers I, Blunt J. Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability. BMJ 1996 Nov 30; 313:1390-3.

Blunt J. Savulescu, Watson AJM. Meeting the challenges facing research ethics committees: some practical suggestions. BMJ 1998 Jan 3; 316: 58-61

Clinical Trials Centre, Faculty of Medicine, The University of Hong Kong. Operating an ethics committee to international standards, 2000 spring; 2(1).

Clinical trials without ethical review under the spotlight. Bulletin of the World Health Organization 2004 April; 82(4): 314.

 


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Last update: 13 November 2007