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Challenges: Challenges: Regional Regional
Perspectives: Perspectives: AfricaAfrica
Doug WassenaarDoug Wassenaar
http://www.up.ac.za/sareti.htmhttp://www.up.ac.za/sareti.htm
Fogarty International Center, National Institutes of HealthFogarty International Center, National Institutes of HealthGrant Number 2 R25 TW01599-08 Grant Number 2 R25 TW01599-08
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AimsAims
Review research ethics training activitiesReview research ethics training activities
State of research ethics infrastructureState of research ethics infrastructure
Some commentsSome comments
Note: Impossible to speak for 52 countries: Note: Impossible to speak for 52 countries: Variability is a feature & all generalisations must Variability is a feature & all generalisations must be qualified: Capacity in training & infrastructure be qualified: Capacity in training & infrastructure varies from global best to amongst the most varies from global best to amongst the most under-resourced in the worldunder-resourced in the world
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1: Training opportunities1: Training opportunities
Four NIH Fogarty funded intensive postgraduate Four NIH Fogarty funded intensive postgraduate training programmes:training programmes:SARETI RSA – 2SARETI RSA – 2ndnd 4y cycle – 32 trainees 4y cycle – 32 traineesIRENSA RSA – 2IRENSA RSA – 2ndnd 4y cycle – 54 trainees 4y cycle – 54 traineesMalawi (with MSU)Malawi (with MSU)WAB Ibadan, NigeriaWAB Ibadan, NigeriaDRC (with UNC)DRC (with UNC)(Johns Hopkins has Africa Focus)(Johns Hopkins has Africa Focus)Case Western had some African fellowsCase Western had some African fellowsToronto has occasional African fellowsToronto has occasional African fellows
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Training cont’d: WorkshopsTraining cont’d: Workshops
AMANET: Over 300 persons trained in workshops; new web-based AMANET: Over 300 persons trained in workshops; new web-based course: 345 registered; 78 completed.course: 345 registered; 78 completed.
UNAIDS/AAVP ELH – 3 workshopsUNAIDS/AAVP ELH – 3 workshopsNIH Dept Clinical Bioethics – 8 workshopsNIH Dept Clinical Bioethics – 8 workshopsWellcome Trust – supported 9 symposia & about 6 other ethics Wellcome Trust – supported 9 symposia & about 6 other ethics grantsgrantsEDCTP – 4 symposia & support for 5 RECsEDCTP – 4 symposia & support for 5 RECsFHI?FHI?PRIM&R?PRIM&R?PABIN – annual conferences & networking – 324 members in 26 PABIN – annual conferences & networking – 324 members in 26
countries; some collaboration in workshopscountries; some collaboration in workshopsWHO workshops:WHO workshops:TRREE: In development (web-based & CD-ROM)TRREE: In development (web-based & CD-ROM)Integration in undergrad and postgrad curricula: UnknownIntegration in undergrad and postgrad curricula: Unknown
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Training cont’dTraining cont’d
Based on 4 African publicationsBased on 4 African publicationsLocal Guidelines: PromisingLocal Guidelines: PromisingREC Chairs: About 50% have some REC Chairs: About 50% have some trainingtrainingREC members: Less than 40% have some REC members: Less than 40% have some trainingtraining2 independent publications suggest that 2 independent publications suggest that same persons receive repeated training! same persons receive repeated training! Selection criteria NB.Selection criteria NB.
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InfrastructureInfrastructure
Estimated 100+ RECs in Africa: IncreasingEstimated 100+ RECs in Africa: IncreasingEnabling legal framework: No reliable Enabling legal framework: No reliable data: (good in South Africa)data: (good in South Africa)45 countries with current FWA approvals45 countries with current FWA approvalsAbout 64% of African countries have About 64% of African countries have RECsRECsMembership: 1% ethicists; 6% lawyers; Membership: 1% ethicists; 6% lawyers; 7% community reps; nurses 8%; relig 4%; 7% community reps; nurses 8%; relig 4%; remainder (74%) medics and scientistsremainder (74%) medics and scientists
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Infrastructure cont’dInfrastructure cont’d
32% of RECs have some funding sources32% of RECs have some funding sources40% have no dedicated office space40% have no dedicated office space66% have admin support66% have admin supportThose with better physical and financial Those with better physical and financial resources reported themselves as resources reported themselves as ‘independent’ of outside influence on ‘independent’ of outside influence on decisionsdecisionsThreat to independence from: sponsors Threat to independence from: sponsors (28%), politics (13%)(28%), politics (13%)
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Infrastructure cont’dInfrastructure cont’d
Knowledge of relevant legal frameworks: Knowledge of relevant legal frameworks: generally poorgenerally poor
80% reported no capacity to do post-80% reported no capacity to do post-approval monitoringapproval monitoring
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CommentsComments
Training, especially workshops, must be Training, especially workshops, must be more focussed:more focussed: Fogarty graduates should be used to do more Fogarty graduates should be used to do more
local traininglocal training Workshop funding should be driven by need Workshop funding should be driven by need
assessments & not sponsor drivenassessments & not sponsor driven Explicit selection criteriaExplicit selection criteria Outcome and impact evaluationOutcome and impact evaluation Trainee trackingTrainee tracking
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Comments 2Comments 2
Advanced Fogarty programs vulnerable to Advanced Fogarty programs vulnerable to funding renewals – should seek longer-term funding renewals – should seek longer-term multiple support to ensure sustainability and multiple support to ensure sustainability and complement initial Fogarty investmentcomplement initial Fogarty investmentEU might improve West African, Francophone & EU might improve West African, Francophone & Lusophone capacity building where needs were Lusophone capacity building where needs were surveyed as highest.surveyed as highest.Capacity to do empirical research in research Capacity to do empirical research in research ethics should be developedethics should be developedAfrican scholarship in research ethics is African scholarship in research ethics is underdevelopedunderdeveloped
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ReferencesReferencesBenatar, S. (2006) Protection of human subjects research in South Africa. Benatar, S. (2006) Protection of human subjects research in South Africa.
TeleconferenceTeleconference with OHRP Sept 2006. with OHRP Sept 2006.de Oliveira, V. (2007). de Oliveira, V. (2007). EDCTP supported ethics activitiesEDCTP supported ethics activities. Presented at EDCTP . Presented at EDCTP
consultation on Research Ethics in Africa, Geneva, June 2007. 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. 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 (2004). Ethical review of health research: A perspective from developing country researchers. country researchers. Journal of Medical Ethics, 30, Journal of Medical Ethics, 30, 68-72. 68-72.
Kilama, W. (2007). Kilama, W. (2007). AMANETAMANET strengthens health research ethics in Africa.strengthens health research ethics in Africa. Presented at EDCTP consultation on Research Ethics in Africa, Geneva, Presented at EDCTP consultation on Research Ethics in Africa, Geneva, June 2007. June 2007.
Kirigia, J.M., Wambebe, C., & Baba-Moussa, A. (2005). Status of national Kirigia, J.M., Wambebe, C., & Baba-Moussa, A. (2005). Status of national research bioethics committees in the WHO African region. research bioethics committees in the WHO African region. BioMed Central BioMed Central Medical Ethics, 6, Medical Ethics, 6, doi: I0.II86/1472-6030-6-I0, available from: doi: I0.II86/1472-6030-6-I0, available from: http://www.biomedcentral.com/I472-6939/6/I0http://www.biomedcentral.com/I472-6939/6/I0
Milford, C., Wassenaar, D., & Slack, C. (2006). Milford, C., Wassenaar, D., & Slack, C. (2006). Resources and needs of Resources and needs of research ethics committees in Africa. research ethics committees in Africa. IRB Ethics & Human Research, 28, IRB Ethics & Human Research, 28, 1-1-9.9.
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References cont’dReferences cont’d
Moodley, K., & Myer, L. (2007). Health research ethics committees in Moodley, K., & Myer, L. (2007). Health research ethics committees in South Africa 12 years into democracy. South Africa 12 years into democracy. BioMed Central Medical BioMed Central Medical Ethics, 8, Ethics, 8, doi:doi: I0.II86/I472-6939-8-I, available from:I0.II86/I472-6939-8-I, available from:http://www.biomedcentral.com/I472-6938/8/I http://www.biomedcentral.com/I472-6938/8/I
Ogundiran, T.O. (2004). Enhancing the African bioethics initiative. Ogundiran, T.O. (2004). Enhancing the African bioethics initiative. BioMed Central Medical Education, 4, BioMed Central Medical Education, 4, doi: I0.II86/I472-6920-4-2I, doi: I0.II86/I472-6920-4-2I, available from: available from: http://www.biomedcentral.com/I472-6920/4/2Ihttp://www.biomedcentral.com/I472-6920/4/2I
Pan African Bioethics Initiative (2007). Pan African Bioethics Initiative (2007). Pan African Bioethics Initiative Pan African Bioethics Initiative (PABIN).(PABIN). Presented at EDCTP consultation on Research Ethics in Presented at EDCTP consultation on Research Ethics in Africa, Geneva, June 2007. Africa, Geneva, June 2007.
Roberts, L. (2006). Roberts, L. (2006). Extended executive summary: Current practice in Extended executive summary: Current practice in research ethics. Global trends and new opportunities for African research ethics. Global trends and new opportunities for African universities.universities. London: Association of Commonwealth Universities. London: Association of Commonwealth Universities.
World Health Organization (2007World Health Organization (2007). WHO Ethics and Health Initiative ). WHO Ethics and Health Initiative ongoing activities on research ethics in Africa. ongoing activities on research ethics in Africa. Presented at EDCTP Presented at EDCTP consultation on Research Ethics in Africa, Geneva, June 2007. consultation on Research Ethics in Africa, Geneva, June 2007.