Research Ethics, Research Policy and Public Health

 

Ethics

Documents

TGN1412 trial

(see also BMJ editorials below)

 

Consent Form
Protocol
News Coverage
International Herald Tribune: When drug trials go horribly wrong
Bloomberg: Parexel Misled Subjects

http://images.bloomberg.com/r06/news/bp/goodyear.jpg

Bioedge: Consent Form for Drug Trial Disaster Flawed

 

Papers

Research Ethics Boards

CDHA Research Ethics Board: Governance, Accountability and Conflict of Interest August 2003 (word)

Submissions

 

World Health Organization (pdf)

Commentary on WHO International Clinical Trials Registry Platform. World Health Organization. November 11 2005
Comments on Disclosure Timing. January 25 2006
Closing the Gaps: Moving Closer to a Collaborative Culture. Balancing increased transparency and competitive advantage. March 31 2006
Commentary
Science and Society: WHO Registry of Clinical Trials

 

World Medical Association

"The Primacy of the Golden Rule": Submission to the Sixth Revision of the Declaration of Helsinki 2008 (Word)

Debating Placebos, Bioethics and Clinical Trials: An exercise in futility? 2010 (Word)

 

Presentations

Trials Registration: An ethical perspective. Cochrane Symposium December 2005

Disclosure and Registration: The transparency revolution. Insight Toronto April 2006

Recruitment of healthy volunteers: Research ethics under pressure. Insight Toronto October 2006

 

 

Massachusetts Society for Medical Research (Boston)

Through the Looking Glass: June 2006
http://www.msmr.org/images/MichaelGoodyear4.JPG

 

Bench to Bedside: June 2007



Publications

Editorials

Learning from the TGN1412 trial. BMJ March 25 2006
Further lessons from the TGN1412 tragedy. BMJ August 5 2006

A model clinical trials agreement. BMJ November 25 2006

The Declaration of Helsinki: Mosaic tablet, dynamic document, or dinosaur? BMJ September 29 2007

Fresh thinking about the Declaration of Helsinki: A comprehensive approach to ethical research BMJ October 17 2008

Does the FDA have the authority to trump the Declaration of Helsinki? BMJ April 21 2009

Editor's Response: Rules of Conscience

 

(see also responses)

 

Letters

From Mercky waters to greater transparency. BMJ July 14 2006[1]

Free access to medical information: A moral right? CMAJ Jan 2 2007

Other

Declaration of Helsinki (Wikipedia)

 

Radio Interview

CBC. The Current June 21 2006 Drug Trials
(click on “Listen to The Current: Part 1” – start at 4:50)
News story

Book reviews

Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials. Jill Fisher 2009. JAMA 2009 (pdf)


Links

Clinical Trial Registration

 

http://ottawagroup.ohri.ca/include/images/OG_header.JPG

Sign the Ottawa Statement!

 

PROCTOR: Public Reporting of Clinical Trial Outcome and Results 2008 (pdf) 

 

Selected Ethics Guidelines

 

American Medical Association 1946 (see Shuster 1997*)

 

Nuremberg Code 1947

 

Declaration of Helsinki 1964

Declaration of Helsinki 1964 (Sixth version 2004)

Proposed revisions - November 2007 (Word) [2]

Second draft, May 2008 (Word)

(FDA to replace 1989 Declaration of Helsinki with GCP, October 2008)

Seventh version (sixth revision) October 2008 (Word)

 

CIOMS: International Ethical Guidelines for Biomedical Research 2002

 

ICH

Efficacy Guidelines

 

UNAIDS

Ethical considerations in HIV preventive vaccine research 2000 (pdf)

Ethical considerations in biomedical HIV prevention trials 2007 (pdf)

 

 

Additional protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research CETS 195. 2005 (Council of Europe) 

Ethical aspects of clinical research in developing countries. Discussion document 2002 (European Commission European Group on Ethics) (pdf)   

Opinion No. 17 (2003) (pdf)

 

The President's Council on Bioethics (US)

Belmont Report 1979

Ethical and policy issues in international research: clinical trials in developing countries 2001 (pdf)

 

Nuffield Council on Bioethics (UK) 

The ethics of research related to healthcare in developing countries 2001 

 

Tri-council policy statement: Ethical conduct for research involving humans 1998 (Canada)

National Statement on Ethical Conduct in Human Research 2007 (Australia)

Health Research Council Guidelines on Ethics in Health Research 2005 (New Zealand)

National Health Research Ethics Council 2004-6 (S Africa)

 

British Sociological Association 2002 

Social Research Association 2003

British Psychological Association Code of Ethics 2006

American Sociological Association Code of Ethics

American Psychological Association Code of Ethics 2002

Human Sciences Research Council Code of Ethics 1997 (S Africa)

 

Canadian Association for HIV/AIDS Research: Ethics in International Research (pdf) 

Jacqueline Gahagan: Ethics issues for HIV/AIDS researchers 2008 (abstract)

Commentaries

 

*Shuster E. Fifty years later: The significance of the Nuremburg code. NEJM 1997 (pdf)

 

Reports

 

Nuffield Council

Ethical issues in public health 2007

Training

 

National Institutes of Health (US) On-line course and certification

 

 


 

Research Policy

Manitoba

Manitoba Centre for Health Policy

 

Nova Scotia

Developing linkages between health researchers and decision-makers: The rationale for an Institute for the Study of Health Outcomes, Services and Policy in Nova Scotia. July 2006 (Word)

Health Services Research Task Group (Ackroyd, Allen, Campbell, Goodyear, Kephart, Rathwell, Warner)

 

Health Policy Research Centre

 


 

Public Health

Presentations

 

Healthy Cities Healthy Communities. What we Know - and What we Don't. Heritage Trust October 2007 (Powerpoint)

 

Does Halifax Regional Municipality  Provide a Healthy Environment for its Citizens? Ecology Action Centre May 2010 (Powerpoint)

 


 

Data Sharing

 

Pisani and AbouZahr. Sharing health data: good intentions are not enough. WHO Bulletin 2010

 

 

 

 

 

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Last updated: 9/1/2010 4:38:00 PM

Links checked Sept 25 2007

 

 

Dr Michael Goodyear, Dalhousie University, Nova Scotia, Canada

For any problems, please contact: mgoodyear@dal.ca



[1] Scroll down to letter #10, if not taken there directly