A Conference to Revise the Declaration of Helsinki

In December, 2012, the World Medical Association conducted a meeting in Cape Town, South Africa to review the Declaration of Helsinki (DoH) of 2008. Representatives from South African, American, Brazilian, Danish and World Medical Associations attended the meeting.  In addition, experts from Germany, Switzerland, Uruguay, Iceland, Malawi  and USA gave presentations. The main topics discussed were vulnerable populations, biobanks, post study arrangements, enhancement, ethics committees and the position of international organizations.

To access the presentations visit Expert Conference on the Revision of the Declaration of Helsinki – Cape Town, 5-7 December 2012 or click for the pdf versions below:

1- Revising the Declaration of Helsinki: Challenges and limitations 

2- The Eight Revision of DoH: What Should be Done?

3- Revision of DoH

Vulnerable Populations

4- Vulnerable Groups

5- Vulnerability

6- Protecting Vulnerable Subjects 

Biobanks 

7- Biobanks

8- Biobanks with Particular Emphasis on Human Research Materials

Post Study Arrangements 

9- Post Study Arrangements 

10- Post Study Access or What Happens Once Research is Over?

11- Post Trial Access to Beneficial Products of Research- An Ethical Obligation

12- Post Trial Obligations to Host Communities

Ethics Committees

13- Ethics Committees

14– Revisions on Declaration of Helsinki

Enhancement 

15- Research on Enhancement – An Issue for the DoH?

Positions of  International Organizations

16- CIOMS Ethical Guidelines for Biomedical Research: Some Issues for the Revision

17- Strengthening Ethics Review Systems -WHO

18- U.S. Department of Health and Human Services Perspectives on the Revision of the Declaration of Helsinki 

19- European Medicines Agency Perspective 

20- Revising the Declaration of Helsinki Points to Consider, TRREE – FMH 

21-  UNESCO and DoH

22- Selected Ethical Aspects of International Clinical Trials Federal Institute for Drugs and Medical Devices, Germany

23-  Post Trial Access in Clinical Trials – Medicine Control Council, South Africa

24- International Federation of Pharmaceutical Manufacturers & Associations

25- European Clinical Research Infrastructure Network Proposals for Amendments to the Declaration of Helsinki: Placebo, Informed Consent, Transparency

Conclusions

26- Consensus building/Summing Up

27- Sentences We Did Not Hear on This Conference