research ethics policies and practices in the african region sonali johnson department of public...
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Research ethics policies and practices in the African Region
Sonali JohnsonDepartment of Public Health and Police
London School of Hygiene and Tropical Medicine
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Why is research ethics important?
• Safeguarding the rights, dignity and respect of individuals is enshrined in international law- e.g. Universal Declaration of Human Rights
• All research involving human subjects must be carried out in accordance with fundamental ethical principles of respect, beneficiance and justice (CIOMS 2002)
• Increasing proliferation of medical research involving multiple sites and thousands of participants
• Concerns as to whether these principals are being systematically applied
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Research Ethics in the African Region
• Much less information on research ethics policies and practices from developing countries
• However, a growing number of studies in the region indicate that there are a number of factors that limit implementation of reseach ethics in health research systems
• These particularly relate to absence of legislation, policies, functional ethics committees (ERCs) and lack of capacity to undertake ethics review (human resources, training, funding)
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Data from previous studies
• Regional study by Kirigia and colleagues in 2003, based on data from 28 countries.- 36% (10/28) did not have a national research ethics committee
• Kirigia and Wambebe’s survey (2006) of national research systems of 10 countries in WHO/AFRO- only 1 had legislation protecting the safety and wellbeing of human subjects
• Milford et al’s (2006) study on ERCs reviewing vaccine trials in 15 countries- 70% reported moderate, limited or no capacity to review HIV vaccine protocols (lack of training given as biggest challenge)
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WHO/AFRO research on ethics
• In 2007, two surveys were administered by WHO/AFRO in countries across the region
• Two survey instruments used1) Health Research Systems Analysis modules
- Sent to institutions conducting health research (medical schools, universities, teaching and non teaching hospitals, NGOs, governmental agencies, charities, independent research institutions)
- Research ethics was one of 7 modules
2) Questionnaire sent directly to the Ministry of Health in 46 AFRO member countries
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Results• High response rate to both surveys
- Institutions in 43 (93%) of member countries responded (total= 634 institutions)
- Information received from respondents in 44 Ministries of Health (96%)
- For the purposes of this presentation, data from the MOH is referred to as the ‘national survey’ and the data from the institutions is referred to as the ‘institutional survey’
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National research ethics legislation
• Majority (73% n=32) of countries did not have legislation related to health research
• 7 countries reported having a law on health research, of which 6 included ethical concerns
However,• 67% (n=425) of institutions reported the
presence of national legislation or regulations for establishing ethical standards (inconsistent findings may indicate lack of knowledge, or ethics covered under other legislation e.g. criminal legislation)
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Research ethics policies
• Limited information on national ethics policies and guidelines in the national level questionnaire
• Institutional survey found that- Policies on research ethics- ‘Yes’= 41% (n=
249), ‘No’=40% (n=251), ‘Don’t know’= 6% (n= 38), No information= 14% (n=86)
- Informed consent- ‘Yes’- 44% (n=281), ‘No’=
32% (n= 206), ‘Don’t know’= 8% (n=48), Noinformation=16% (n=99)
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Question
Low research
Activity (n= 161)
Medium research activity (n=194)
High research activity (n=279)
Does the institution have written policies requiring that researchers obtain the informed consent
of participants?
Yes- 29%
(n= 47)
No- 43%
(n=70)
Don’t know- 12%
(n= 19)
Yes- 49%
(n= 96)
No- 26%
(n= 50)
Don’t know- 9%
(n= 17)
Yes- 49%
(n= 138)
No- 31%
(n= 86)
Don’t know - 8%
(n= 22)
Is there a written policy on ethical review for ALL research involving human subjects within this institution by staff (faculty, researchers or others?)
Yes- 25%
(n= 40)
No- 47%
(n= 76)
Don’t know - 6%
(n= 9)
Yes- 34%
(n= 66)
No- 34%
(n= 65)
Don’t know - 11%
(n= 22)
Yes- 46%
(n= 128)
No- 30%
(n= 84)
Don’t know - 10%
(n= 27)
Is ethical review required for ALL research involving human subjects conducted anywhere in which researchers with this institution participate?
Yes- 27%
(n= 44)
No- 9%
(n= 14)
Don’t know - 9%
(n= 14
Yes- 37%
(n= 72)
No- 8%
(n= 15)
Don’t know - 14%
(n= 27)
Yes- 43%
(n= 120)
No- 12%
(n= 33)
Don’t know - 11%
(n= 30)
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Research ethics policies(cont…)
• 16% (n=102) of institutions reported having a written policy for research involving traditional or complementary medicine
• 14% (n= 87) had a policy requiring special ethical review of research involving issues such as abortion, artificial reproductive technologies etc
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Ethics review committees(ERC)
• Majority of countries report having a functional ethics committee (73%, n=32)
• More than half of all countries (57%, n= 25) reported having a national ERC
• 24% (n= 175) of all institutions reported having a written policy establishing an ERC
• Functions of the national ERCs include ethical review, advice on ethics, some monitoring and follow up, very few offer training.
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Scientific Review Committees (SRC)
• National level survey- only half (50%, n= 22) reported having a scientific review committee
• Less than half of countries reported having both an ERC and SRC (43%, n= 19)
• More countries tend to have an ERC than an SRC
• At the institutional level, 25% that responded to the question (n=91), reported using the SRC in lieu of an ERC and 86 institutions (35%) reported combining ethical review with scientific review.
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Monitoring and regulation of research ethics
• Data mainly from the institutional survey- 22% (n= 142) reported policies in place to
monitor on-going research- Of institutions that responded to a question on
penalties for non-compliance with regulations and decisions of the ERC, 37% reported ‘Yes’, 27% reported ‘No’, and 37% ‘did not know’
- Similarly, available information from other sources indicates that relatively few national ERCs have systematic follow up mechanisms.
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Capacity for ethics review• Very few ERCs (national and institutional) offer training
in research ethics• Only 12% (n=75) of institutions reported providing ethics
training for ERC members, while 41% did not, and 10% (n=61) did not know.
• 31% (n=199) reported links with national and/or regional ethics organizations such as PABIN, FERCAP and so on (unclear if this includes participation in activities)
• Relatively few institutions reported providing administrative support for ethical review (Yes- 13%, n= 85, ‘No’= 24%, n=155, ‘Don’t know’, n=13%, n=80)
• 24% (n=155) reported having a dedicated staff person, while almost half (48%, n= 304) did not.
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Research priorities and ethics review
• The institutional survey contained a question on whether while reviewing collaborative research, the ERC would disapprove of a project that did not have the realistic prospect of serving the health needs of the population (e.g. does the research conform to a formal list of national priorities)
• 51% of institutions responded (n=321), of these‘Yes’= 22% (n=138), ‘No’= 10% (n=61) and ‘Don’t know’= 19% (n= 122)
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Discussion
• Lack of legislation mandating attention to research ethics (concern that ethics procedures can therefore be ‘bypassed’)
• Encouraging that most countries in the Region report having a functional ethics committee
• However, some countries report not having either an ERC or SRC
• ‘Decentralized’ system of ethics review may lead to ‘fragmentation’, inconsistent operating procedures, ‘ethics review ‘shopping’
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• Lack of policies and legislation requiring informed consent is a concern
• Relatively few institutions have mechanisms for conflict of interest (could undermine objectivity and independence)
• Training in ethics is limited and there is a lack of institutional support
• However, there are increasing capacity building initiatives in the region e.g. PABIN, SARETI, IRENSA etc, as well as national workshops on research ethics
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Limitations
• Despite high response rate, there were a number of gaps in responses to questions
• Unclear as to how many other people were consulted in filling out the questionnaires
• Criticism that the institutional instrument was too long
• Analysis here of both surveys is limited to selected questions. Further analysis in relation to other findings in the overall surveys is planned.
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Thank you!