Ethics review and Ethics review and oversight for better oversight for better

governance of health governance of health researchresearch

Amar JesaniAmar JesaniIndian Journal of Medical EthicsIndian Journal of Medical Ethics

Centre for Studies in Ethics and RightsCentre for Studies in Ethics and Rights

Mumbai, IndiaMumbai, India

Overview of presentationOverview of presentation

1. Need for ethics review and 1. Need for ethics review and oversight in health researchoversight in health research

2. What kind of ethics review and 2. What kind of ethics review and oversight are necessary?oversight are necessary?

3. Increase in commercial research3. Increase in commercial research 4. Ethics and governance of research4. Ethics and governance of research 5. Role of civil society organisations5. Role of civil society organisations

Need for ethics review and Need for ethics review and oversightoversight

Generally more acceptable now than Generally more acceptable now than a decade back due to demand made a decade back due to demand made by donors and publishersby donors and publishers

However, at ground level, However, at ground level, researchers are more ready for researchers are more ready for scientific peer review than ethical scientific peer review than ethical review. review.

Scientists are often at loggerhead Scientists are often at loggerhead with those who sit on the ethics with those who sit on the ethics committeescommittees

Need for ethics review and Need for ethics review and oversightoversight

Protection of participants is clearly the Protection of participants is clearly the most important issue in ethics reviewmost important issue in ethics review

Often less recognition of role of ethics Often less recognition of role of ethics review in improving science, & review in improving science, & bringing its method in tune with bringing its method in tune with human rights standardshuman rights standards

In the donor, sponsor and collaborator In the donor, sponsor and collaborator dominated world of research, ethics dominated world of research, ethics review also provides some protection review also provides some protection to researchers in developing countriesto researchers in developing countries

What kind of ethics review What kind of ethics review and oversight?and oversight?

Three levels: Three levels: a. What kind of research to undertake? a. What kind of research to undertake?

Social relevance of research for the Social relevance of research for the communitycommunity

b. The process of research / data collectionb. The process of research / data collection c. Interpretation of findings and utility of c. Interpretation of findings and utility of

outcome of researchoutcome of research So far, guidelines have dealt with So far, guidelines have dealt with

practical issues in “b” more than “a” practical issues in “b” more than “a” and “c”and “c”

Massive increase in Massive increase in commercial researchcommercial research

Research for developing new marketable Research for developing new marketable technologies dominate the research scenetechnologies dominate the research scene

Even in health system and evaluation Even in health system and evaluation research, increasing domination of research, increasing domination of marketing research orgnmarketing research orgn

Example of Clinical Trials in IndiaExample of Clinical Trials in India No. of CROs – from few in 1995, to over 70 in No. of CROs – from few in 1995, to over 70 in

2005 and increasing2005 and increasing In last five years the CT business increased from 5 In last five years the CT business increased from 5

to 120 millions US $, projected to increase ten-to 120 millions US $, projected to increase ten-fold in few yearsfold in few years

Projection by 2020-25: 30% of world’s CTs in IndiaProjection by 2020-25: 30% of world’s CTs in India

Why is India a destination of Why is India a destination of so many clinical trials?so many clinical trials?

Low cost – lower by 50% or moreLow cost – lower by 50% or more Patient pool: Patient pool:

Large numbersLarge numbers Patients with all kind of diseasesPatients with all kind of diseases Availability of treatment naive patientsAvailability of treatment naive patients

Availability of scientific human Availability of scientific human power and large urban hospital power and large urban hospital infrastructureinfrastructure

Lax regulationsLax regulations Availability of business partnersAvailability of business partners

Governance of ResearchGovernance of Research

Governance of ethics review and Governance of ethics review and oversight of research basically oversight of research basically involve three elementsinvolve three elements Standard setting through ethical Standard setting through ethical

guidelinesguidelines Structures established for ethics Structures established for ethics

review and oversightreview and oversight Processes – how these structures Processes – how these structures

function in implementing ethical function in implementing ethical standardsstandards

Guidelines and standardsGuidelines and standards

Internationally more work done to Internationally more work done to develop guidelines and standardsdevelop guidelines and standards

How do national guidelines translate How do national guidelines translate basic ethical principles into national basic ethical principles into national standards?standards?

Importance of national priority Importance of national priority setting for having standards for setting for having standards for social relevance and utility of social relevance and utility of researchresearch

Practical Guidance needed for Practical Guidance needed for compensation for research injuriescompensation for research injuries

StructuresStructures

Ethics Review Committees dominant Ethics Review Committees dominant structuresstructures

Many countries have “decentralised” Many countries have “decentralised” structures to such an extent that structures to such an extent that governments have off-loaded governments have off-loaded responsibilityresponsibility

Institutions sole determinant for Institutions sole determinant for appointing and replacing members, appointing and replacing members, and providing or not providing and providing or not providing resources to committeesresources to committees

StructuresStructures

Members of the ethics committee have Members of the ethics committee have often no training in ethics review and often no training in ethics review and monitoringmonitoring

In the context of no ethics education In the context of no ethics education in medical and public health schools, in medical and public health schools, often researchers and members often researchers and members unaware of ethical standards in unaware of ethical standards in practice as well as researchpractice as well as research

No mechanism for monitoring – left to No mechanism for monitoring – left to ethics auditors appointed by sponsorsethics auditors appointed by sponsors

ProcessesProcesses

Absolutely essential that legal Absolutely essential that legal regulatory authority for research is regulatory authority for research is integrated with the ethics review integrated with the ethics review committees through a legislationcommittees through a legislation

Policies and legislations must Policies and legislations must provide real power and resources to provide real power and resources to ethics review committeesethics review committees

Need to ensure independence from Need to ensure independence from research institutions in order to have research institutions in order to have genuine oversightgenuine oversight

ProcessesProcesses

Need to bring independent – private- Need to bring independent – private- commercial ethics committees and commercial ethics committees and marketing research organisations under the marketing research organisations under the governance mechanismgovernance mechanism

Accreditation mechanism needed for Accreditation mechanism needed for bringing high uniform standardsbringing high uniform standards

Regulation of regulators possible by making Regulation of regulators possible by making functioning of ethics committees functioning of ethics committees transparent and accountabletransparent and accountable Regular reports of their work available in public Regular reports of their work available in public

domaindomain Auditing of functioning of ethics committees as Auditing of functioning of ethics committees as

a part of accreditation mechanisma part of accreditation mechanism

Role of civil societyRole of civil society

Encouragement to research on Encouragement to research on ethical conduct of researchethical conduct of research

Civil society organisations need to Civil society organisations need to get involved in ethics committeesget involved in ethics committees

Providing avenues for participants Providing avenues for participants to consult and complainto consult and complain

Monitoring of clinical trials – in Monitoring of clinical trials – in some countries, need to establish some countries, need to establish Clinical Trials WatchClinical Trials Watch

Responsibilities of developed Responsibilities of developed countriescountries

Regulators of developed countries Regulators of developed countries must examine rigorously proof of must examine rigorously proof of ethical conduct of clinical trials in ethical conduct of clinical trials in developing countriesdeveloping countries

How do pharmaceutical companies How do pharmaceutical companies get marketing clearance without get marketing clearance without providing proof of post trial benefits providing proof of post trial benefits to participants and the communities?to participants and the communities?

Thanks youThanks you