Challenges: Regional Perspectives: Africa

1. Challenges: Regional Perspectives: Africa Doug Wassenaar http://www.up.ac.za/sareti.htm Fogarty International Center, National Institutes of Health Grant Number 2 R25 TW01599-08

2. Aims • Review research ethics training activities • State of research ethics infrastructure • Some comments • Note: Impossible to speak for 52 countries: Variability is a feature & all generalisations must be qualified: Capacity in training & infrastructure varies from global best to amongst the most under-resourced in the world

3. 1: Training opportunities • Four NIH Fogarty funded intensive postgraduate training programmes: • SARETI RSA – 2nd 4y cycle – 32 trainees • IRENSA RSA – 2nd 4y cycle – 54 trainees • Malawi (with MSU) • WAB Ibadan, Nigeria • DRC (with UNC) • (Johns Hopkins has Africa Focus) • Case Western had some African fellows • Toronto has occasional African fellows

4. Training cont’d: Workshops • AMANET: Over 300 persons trained in workshops; new web-based course: 345 registered; 78 completed. • UNAIDS/AAVP ELH – 3 workshops • NIH Dept Clinical Bioethics – 8 workshops • Wellcome Trust – supported 9 symposia & about 6 other ethics grants • EDCTP – 4 symposia & support for 5 RECs • FHI? • PRIM&R? • PABIN – annual conferences & networking – 324 members in 26 countries; some collaboration in workshops • WHO workshops: • TRREE: In development (web-based & CD-ROM) • Integration in undergrad and postgrad curricula: Unknown

5. Training cont’d • Based on 4 African publications • Local Guidelines: Promising • REC Chairs: About 50% have some training • REC members: Less than 40% have some training • 2 independent publications suggest that same persons receive repeated training! Selection criteria NB.

6. Infrastructure Estimated 100+ RECs in Africa: Increasing • Enabling legal framework: No reliable data: (good in South Africa) • 45 countries with current FWA approvals • About 64% of African countries have RECs • Membership: 1% ethicists; 6% lawyers; 7% community reps; nurses 8%; relig 4%; remainder (74%) medics and scientists

7. Infrastructure cont’d • 32% of RECs have some funding sources • 40% have no dedicated office space • 66% have admin support • Those with better physical and financial resources reported themselves as ‘independent’ of outside influence on decisions • Threat to independence from: sponsors (28%), politics (13%)

8. Infrastructure cont’d • Knowledge of relevant legal frameworks: generally poor • 80% reported no capacity to do post-approval monitoring

9. Comments • Training, especially workshops, must be more focussed: • Fogarty graduates should be used to do more local training • Workshop funding should be driven by need assessments & not sponsor driven • Explicit selection criteria • Outcome and impact evaluation • Trainee tracking

10. Comments 2 • Advanced Fogarty programs vulnerable to funding renewals – should seek longer-term multiple support to ensure sustainability and complement initial Fogarty investment • EU might improve West African, Francophone & Lusophone capacity building where needs were surveyed as highest. • Capacity to do empirical research in research ethics should be developed • African scholarship in research ethics is underdeveloped

11. References Benatar, S. (2006) Protection of human subjects research in South Africa. Teleconference with OHRP Sept 2006. de Oliveira, V. (2007). EDCTP supported ethics activities. Presented at EDCTP consultation on Research Ethics in Africa, Geneva, June 2007. Hyder, A.A., Wali, S.A., Khan, A.N., Teoh, N.B., Kass, N.E., & Dawson, L. (2004). Ethical review of health research: A perspective from developing country researchers. Journal of Medical Ethics, 30, 68-72. Kilama, W. (2007). AMANETstrengthens health research ethics in Africa. Presented at EDCTP consultation on Research Ethics in Africa, Geneva, June 2007. Kirigia, J.M., Wambebe, C., & Baba-Moussa, A. (2005). Status of national research bioethics committees in the WHO African region. BioMed Central Medical Ethics, 6, doi: I0.II86/1472-6030-6-I0, available from: http://www.biomedcentral.com/I472-6939/6/I0 Milford, C., Wassenaar, D., & Slack, C. (2006). Resources and needs of research ethics committees in Africa. IRB Ethics & Human Research, 28, 1-9.

12. References cont’d Moodley, K., & Myer, L. (2007). Health research ethics committees in South Africa 12 years into democracy. BioMed Central Medical Ethics, 8, doi:I0.II86/I472-6939-8-I, available from: http://www.biomedcentral.com/I472-6938/8/I Ogundiran, T.O. (2004). Enhancing the African bioethics initiative. BioMed Central Medical Education, 4, doi: I0.II86/I472-6920-4-2I, available from: http://www.biomedcentral.com/I472-6920/4/2I Pan African Bioethics Initiative (2007). Pan African Bioethics Initiative (PABIN). Presented at EDCTP consultation on Research Ethics in Africa, Geneva, June 2007. Roberts, L. (2006). Extended executive summary: Current practice in research ethics. Global trends and new opportunities for African universities. London: Association of Commonwealth Universities. World Health Organization (2007). WHO Ethics and Health Initiative ongoing activities on research ethics in Africa. Presented at EDCTP consultation on Research Ethics in Africa, Geneva, June 2007.