Research ethics policies and practices in the African Region

Sonali JohnsonDepartment of Public Health and Police

London School of Hygiene and Tropical Medicine

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

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)

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)

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

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’

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)

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)

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)

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

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.

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.

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.

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.

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)

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’

• 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

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.

Thank you!