RESEARCH AND
ETHICS COMMITTEE
INTRODUCTION
Research ethics committees review proposed studies with
human participants to ensure that
• they conform to internationally and locally accepted ethical
guidelines,
• monitor studies once they have begun and, where relevant,
• take part in follow-up action
• surveillance after the end of the research.
Committees have the authority to approve, reject or stop
studies (or) require modifications to research protocols.
They set policies (or) offer opinions for ongoing ethical issues
in research.
REVIEWS REQUIRED BY ETHICS COMMITTEE
• Review by a research ethics committee is required by
international ethical standards governing research involving
human participants, as well as by local law in many
jurisdictions.
• Review is also essential if the researchers intend to publish
the results of their investigation.
• In international cooperative research, review is required
by the laws of the country in which the research is being
sponsored, even if it is not required by the host country’s own
laws.
RESPONSIBILITIES
• To protect potential participants in the research, but it must
also take into account potential risks and benefits for the
community in which the research will be carried out.
GOAL
• To promote high ethical standards in research for health.
STRUCTURE AND FUNCTION OF RESEARCH ETHICS
COMMITTEE
• Operate within research institutions (or) on a regional (or)
national basis
• Committee which operates within the research institution are
known as Institutional Ethics Committee (IEC) or Institutional
Review Board (IRB)
Advantages of ethics committee within research institution
• Familiar with the local conditions
• Can engage in closer monitoring of ongoing studies.
Disadvantages of ethics committee within research institution
• Committee may feel inhibited from rejecting (or) requesting
significant changes to studies, given the institution’s financial
interest in attracting externally funded research projects.
• Regional and national committees are further removed from the site
where the research is conducted, but they may provide greater
consistency and have greater legitimacy in the eyes of the research
community and the public.
Functions
1. Identifying and weighing up the risks and potential benefits of
research.
2. Evaluating the process and materials (printed documents and
other tools) that will be used for seeking participants’
informed consent.
3. Assessing the recruitment process and any incentives that will
be given to participants.
4. Evaluating risks to participants’ confidentiality (and the
related risk of discrimination) and the adequacy of
confidentiality protections .
5. Examining any other issues that may affect the ethical
acceptability of the research.
6. Studies involving medical interventions, research ethics
committees must determine that adequate care and
treatment will be provided for participants.
7. Committees should consider what will happen to
participants who need medical attention during (or) after the
study, either because they suffer injuries as a result of
participation (or) because of the natural progression of a
pre-existing illness.
Membership
• Research ethics committees must include individuals with
scientific and medical expertise.
• Without such expertise, committee will not be in a position to
understand the procedures to be used in the study and their
potential consequences for participants.
• Committees must assess the scientific validity of the study
design to ensure that it is capable of producing reliable
information.
Membership
• A badly designed study that will not result in usable data,
cannot support any level of risk.
• Research ethics committees should not, however, be made up
exclusively of scientific experts. Some types of risks and
benefits may be more easily identified by non scientific
members, particularly those related to social, legal or
cultural considerations .
Membership
• A diversity of backgrounds and qualifications (in medicine as well
as law, social sciences, etc.) can help ensure that these
judgements are not inappropriately dominated by a single
perspective.
• Social diversity and gender balance should also be reflected in the
committee’s composition.
• Committees also need broad community representation to identify
relevant local attitudes or practices about which the researchers
should be sensitive.
• The membership should be designed to minimize the potential
impact of conflicts of interest on the decision-making process.
Independence of RECs and committee members
• RECs must be independent from sponsors, funders,
investigators, and from undue influence (e.g. political,
institutional, professional or commercial). This ensures that
the interest of research participants is paramount.
• Achieving the independence of RECs is a challenge.
• It requires proper accountability (i.e. making sure the right
people are responsible) and balanced membership (i.e.
making sure the right mix of people is involved).
• REC members must be free from, or have properly managed
and declared, conflicts of interest. REC members who have
conflicts of interest may not be able to participate in decisions
concerning a particular study protocol.
• RECs need to ensure that their written procedures comply
with national, local, and/or institutional requirements as well
as to their own standard operating procedures (SOPs).
Guidelines and regulations for some countries specify that REC
operating procedures should cover:
• How meetings will be conducted
• How applications to have proposals reviewed should be made
• How the REC will make its decisions at announced meetings,
including the minimum quorum (i.e. the minimum number of
people required to attend and vote in order to make a
decision)
• Details of the process for ethics review
• A rule that no participant should be enrolled before the REC
has issued its written favourable opinion of study
• The investigator’s duty to promptly report to the REC any
susbstantial protocol amendements (or) safety issues,
including serious and unexpected adverse events.
THANK YOU
