3rd Forum – Capetown, South Africa, 21-23 February 2002

Supported by:

• Fogarty International Center & other institutes of The National Institutes of Health
• Centers for Disease Control and Prevention
• The World Health Organisation
• Inserm
• The Wellcome Trust
• PAHO
• The European Forum for Good Clinical Practice
• The Medical Research Council, South Africa

Programme Details

20 February 2002:
Research Bioethics & Public Health

1900 Welcome drinks reception

Forum registration (Please note – Whilst registration will be possible on the morning of Thursday 21 February, delegates attending the welcome reception are encouraged to register during the evening of the 20th)

Venue: The Villa Room (2nd Floor)

21 February 2002: Research Bioethics & Public Health

The Forum will take place in the Stellenbosch and Constantia rooms located on the 2nd Floor. Delegates will be informed of breakout group membership and locations during registration.

8:00 Forum registration (for any delegates who were unable to register during the welcome reception)

8:30 Welcome: Dr Malegapuru Makgoba (*)(MRC South Africa) and Mr Nick Winterton (MRC UK)

8:40 Keynote speech: Professor Sir Kenneth Calman (University of Durham, UK)

Theme 1: Do current guidelines promote or constrain post-trial access to drugs, devices and vaccines?

Session co-chaired by Dr Malegapuru Makgoba (*)(MRC South Africa) and Mr Nick Winterton (MRC UK)

9:10 Plenary introduction: Dr Churchill Lukwiya Onen (Princess Marina Hospital, Gaborone, Botswana)

9:40 Presentation of two relevant case studies: Professor Ruth Macklin (Albert Einstein College of Medicine, USA)
– Case study 1: access to treatment following clinical trials: the case of a pneumococcal -conjugate vaccine trial in The Gambia
– Case study 2: what are researchers’ and institutions’ responsibilities to the study  community?

9:50 Break

10:10 Discussion of case studies in breakout groups

12:10 Report back from breakout groups in plenary session

13:00 Lunch

14:00 Keynote speech: Mr Doug Wassenaar (University of Natal, South Africa)

Theme 2: Creating a national framework for ethical research: what’s needed and how to go about it

Session co-chaired by Dr Godwin Ndossi (Tanzania Food & Nutrition Centre, Tanzania) and Professor Keith McAdam (MRC Laboratories, The Gambia)

14:30 Plenary introduction: Professor Godfrey Tangwa (University of Yaoundé, Cameroon)

15:00 Presentation of two relevant case studies: Professor Zulfiqar Ahmed Bhutta (Aga Khan University, Pakistan)
– Case study 3: obligations to third parties in the face of possible harm
– Case study 4: is community consent authentic and legitimate?

15:10 Break

15:30 Discussion of case studies in breakout groups

17:30 Report back from breakout groups in plenary session

18:20 End of session

20:00 Gala dinner in the hotel

22 February 2002:

8:40 Keynote speech: Dr Peter Singer (University of Toronto, Canada)

Theme 3: Best current methods: balancing standards of care with appropriate trial design

Session co-chaired by Dr Dafna Feinholz-Klip (Instituto Nacional de Perinatalogia, Mexico)

9:10 Plenary introduction: Dr Maarten Schim van der Loeff (MRC Laboratories, The Gambia)

9:40 Presentation of two relevant case studies: Dr James Lavery (Fogarty International Centre, USA)
– Case study 5: evaluating the use of traditional medicines
– Case study 6: the wider implications of preventing mother-to-child transmission of HIV, and subsequent management of women and children, in rural Uganda

9:50 Break

10:10 Discussion of case studies in breakout groups

12:10 Report back from breakout groups in plenary session

13:00 Lunch

Afternoon – Arrangements to be confirmed

Evening – Informal dinner (Arrangements to be advised)

23 February 2002:

9:00 Summing up of proceedings: Dr Malegapuru Makgoba (*)(MRC South Africa) and Mr Nick Winterton (MRC UK)

9:30 Business meeting – purpose and future of Global Forum

11:30 Preview of next meeting

11:45 End of formal proceedings followed by LUNCH at the hotel

Case Studies

• Access to treatment following clinical trials: the case of a pneumococcal conjugate vaccine trial in the Gambia
• What are researchers’ and institutions’ responsibilities to the study community?
• Obligations to Third Parties in the Face of Possible Harm
• Is Community Consent Authentic and Legitimate?
• Evaluating the use of traditional medicines
• The wider implications of preventing mother-to child transmission of HIV, and subsequent management of women and children, in rural Uganda

• Brief summary
• Report 1
• Report 2