1. Ethics review and oversight for better governance of health research Amar Jesani Indian Journal of Medical Ethics Centre for Studies in Ethics and Rights Mumbai, India

2. Overview of presentation 1. Need for ethics review and oversight in health research 1. Need for ethics review and oversight in health research 2. What kind of ethics review and oversight are necessary? 2. What kind of ethics review and oversight are necessary? 3. Increase in commercial research 3. Increase in commercial research 4. Ethics and governance of research 4. Ethics and governance of research 5. Role of civil society organisations 5. Role of civil society organisations

3. Need for ethics review and oversight Generally more acceptable now than a decade back due to demand made by donors and publishers Generally more acceptable now than a decade back due to demand made by donors and publishers However, at ground level, researchers are more ready for scientific peer review than ethical review. However, at ground level, researchers are more ready for scientific peer review than ethical review. Scientists are often at loggerhead with those who sit on the ethics committees Scientists are often at loggerhead with those who sit on the ethics committees

4. Need for ethics review and oversight Protection of participants is clearly the most important issue in ethics review Protection of participants is clearly the most important issue in ethics review Often less recognition of role of ethics review in improving science, & bringing its method in tune with human rights standards Often less recognition of role of ethics review in improving science, & bringing its method in tune with human rights standards In the donor, sponsor and collaborator dominated world of research, ethics review also provides some protection to researchers in developing countries In the donor, sponsor and collaborator dominated world of research, ethics review also provides some protection to researchers in developing countries

5. What kind of ethics review and oversight? Three levels: Three levels: a. What kind of research to undertake? Social relevance of research for the community a. What kind of research to undertake? Social relevance of research for the community b. The process of research / data collection b. The process of research / data collection c. Interpretation of findings and utility of outcome of research c. Interpretation of findings and utility of outcome of research So far, guidelines have dealt with practical issues in b more than a and c So far, guidelines have dealt with practical issues in b more than a and c

6. Massive increase in commercial research Research for developing new marketable technologies dominate the research scene Research for developing new marketable technologies dominate the research scene Even in health system and evaluation research, increasing domination of marketing research orgn Even in health system and evaluation research, increasing domination of marketing research orgn Example of Clinical Trials in India Example of Clinical Trials in India No. of CROs – from few in 1995, to over 70 in 2005 and increasing No. of CROs – from few in 1995, to over 70 in 2005 and increasing In last five years the CT business increased from 5 to 120 millions US $, projected to increase ten-fold in few years In last five years the CT business increased from 5 to 120 millions US $, projected to increase ten-fold in few years Projection by 2020-25: 30% of worlds CTs in India Projection by 2020-25: 30% of worlds CTs in India

7. Why is India a destination of so many clinical trials? Low cost – lower by 50% or more Low cost – lower by 50% or more Patient pool: Patient pool: Large numbers Large numbers Patients with all kind of diseases Patients with all kind of diseases Availability of treatment naive patients Availability of treatment naive patients Availability of scientific human power and large urban hospital infrastructure Availability of scientific human power and large urban hospital infrastructure Lax regulations Lax regulations Availability of business partners Availability of business partners

8. Governance of Research Governance of ethics review and oversight of research basically involve three elements Governance of ethics review and oversight of research basically involve three elements Standard setting through ethical guidelines Standard setting through ethical guidelines Structures established for ethics review and oversight Structures established for ethics review and oversight Processes – how these structures function in implementing ethical standards Processes – how these structures function in implementing ethical standards

9. Guidelines and standards Internationally more work done to develop guidelines and standards Internationally more work done to develop guidelines and standards How do national guidelines translate basic ethical principles into national standards? How do national guidelines translate basic ethical principles into national standards? Importance of national priority setting for having standards for social relevance and utility of research Importance of national priority setting for having standards for social relevance and utility of research Practical Guidance needed for compensation for research injuries Practical Guidance needed for compensation for research injuries

10. Structures Ethics Review Committees dominant structures Ethics Review Committees dominant structures Many countries have decentralised structures to such an extent that governments have off-loaded responsibility Many countries have decentralised structures to such an extent that governments have off-loaded responsibility Institutions sole determinant for appointing and replacing members, and providing or not providing resources to committees Institutions sole determinant for appointing and replacing members, and providing or not providing resources to committees

11. Structures Members of the ethics committee have often no training in ethics review and monitoring Members of the ethics committee have often no training in ethics review and monitoring In the context of no ethics education in medical and public health schools, often researchers and members unaware of ethical standards in practice as well as research In the context of no ethics education in medical and public health schools, often researchers and members unaware of ethical standards in practice as well as research No mechanism for monitoring – left to ethics auditors appointed by sponsors No mechanism for monitoring – left to ethics auditors appointed by sponsors

12. Processes Absolutely essential that legal regulatory authority for research is integrated with the ethics review committees through a legislation Absolutely essential that legal regulatory authority for research is integrated with the ethics review committees through a legislation Policies and legislations must provide real power and resources to ethics review committees Policies and legislations must provide real power and resources to ethics review committees Need to ensure independence from research institutions in order to have genuine oversight Need to ensure independence from research institutions in order to have genuine oversight

13. Processes Need to bring independent – private- commercial ethics committees and marketing research organisations under the governance mechanism Need to bring independent – private- commercial ethics committees and marketing research organisations under the governance mechanism Accreditation mechanism needed for bringing high uniform standards Accreditation mechanism needed for bringing high uniform standards Regulation of regulators possible by making functioning of ethics committees transparent and accountable Regulation of regulators possible by making functioning of ethics committees transparent and accountable Regular reports of their work available in public domain Regular reports of their work available in public domain Auditing of functioning of ethics committees as a part of accreditation mechanism Auditing of functioning of ethics committees as a part of accreditation mechanism

14. Role of civil society Encouragement to research on ethical conduct of research Encouragement to research on ethical conduct of research Civil society organisations need to get involved in ethics committees Civil society organisations need to get involved in ethics committees Providing avenues for participants to consult and complain Providing avenues for participants to consult and complain Monitoring of clinical trials – in some countries, need to establish Clinical Trials Watch Monitoring of clinical trials – in some countries, need to establish Clinical Trials Watch

15. Responsibilities of developed countries Regulators of developed countries must examine rigorously proof of ethical conduct of clinical trials in developing countries Regulators of developed countries must examine rigorously proof of ethical conduct of clinical trials in developing countries How do pharmaceutical companies get marketing clearance without providing proof of post trial benefits to participants and the communities? How do pharmaceutical companies get marketing clearance without providing proof of post trial benefits to participants and the communities?

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