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Presentation
at the Workshop on Research Ethics held at Jazan University 14-15th May 2012 by Professor Omar Hasan Kasule Sr.
MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Chairman Institutional Review Board
and Department of Bioethics King Fahad
Medical City Riyadh EM: omarkasule@yahoo.com
1.0 FUNCTIONS OF AN IRB
·
A big institution undertaking several research
projects should have its own committee on medical research ethics. Smaller
institutions can use a committee in the region serving several institutions.
·
The committee assesses research proposals and
protocols that have ethical implications: (a) research on patients, volunteers,
the recently dead, fetal or embryological tissues. (b) any research involving
access to medical records with a potential to breach confidentiality.
·
It is the duty of the committee to ensure the
highest ethical standards in any research.
·
It has to protect the research subjects’
physical and mental well being as stipulated in the Helsinki declaration.
·
It also has the duty to protect the researchers
and the institution in which they work by advising them about ethical conduct
so that they do not commit mistakes that will lead to criminal prosecution.
·
The committee’s role does not end with the
approval of the research. It has to continue monitoring the conduct of the
study to detect any ethical violations.
2.0 MEMBERSHIP OF IRB
·
Membership of the ethics committee is designed
in such a way that all professional and technical competences needed for proper
evaluation of a research proposal are included.
·
Membership should comprise representatives of
the major medical and surgical specializations practiced in the hospital or
region, hospital physicians, hospital nursing staff, general practitioners,
pharmacists, statisticians, ethicists, and lay persons from the community.
·
The lay members should not have any connection
with medical work.
·
In selecting members attempts should be made to
make sure that all genders and age groups are well represented.
·
Members should be selected on their own personal
merit as people with knowledge, skills, and sound judgment. They should discuss
the proposals as individuals and not representatives of any organization or
profession.
·
Members are appointed by the hospital, the
health authority in the region or the government.
·
The period of service on the committee is usually
three years.
·
Membership may be renewed.
3.0 PROCEDURES OF IRB
·
The committee must be provided with adequate
secretarial and logistic assistance to carry out its functions well.
·
A quorum of at least half of the members will be
necessary for holding a meeting. Members who cannot attend can send written
comments.
·
The proposals, protocols, and reports to be
tabled must be send to the members in advance so that they have a chance to
study them.
·
The committee meets in private to preserve
confidentiality.
·
Any member of the committee involved in a
project will recluse himself when that project comes up for discussion.
·
The committee should normally decide by
consensus but where this is not possible decision is based on a 50% vote. Minority
views should be recorded.
·
The decision of the committee may be full
approval, conditional approval, deferment, or rejection.
·
Reasons should be provided for projects approved
conditionally or those that are rejected.
·
The chairperson may approve projects that had
conditional approval if he is satisfied that the conditions were fulfilled.
·
Any amendments to the protocol must be submitted
for committee approval before they are implemented.
4.0 CRITERIA OF ASSESSING RESEARCH
·
The committee will look to see whether the research
subjects were informed of the objectives of the study and of their rights to
participate, abstain, or withdraw from the study.
·
Special scrutiny of proxy consent will be made
to ensure there is no abuse.
·
The investigator must submit reasons in writing in
cases in which full disclosure is deemed inappropriate.
·
The committee will look to make sure that the
objectives are clearly stated and are attainable.
·
The research design and statistical methods must
be judged adequate to produce clinically and scientifically useful results.
·
The committee will compare the scientific merit
and benefit of the research against risks and costs to patients.
·
The submission must have detailed resumes of the
investigators to enable the committee assess their competence to undertake the
research successfully.
·
The adequacy of research facilities is also
assessed.
·
The proposal must provide details on how
confidentiality and security of the data will be assured.
5.0 FOLLOW-UP OF RESEARCH
·
The committee must monitor progress of the
research project and must receive reports of all adverse reactions whether
related to the drug tested or not.
·
Members of the committee can make on-site
inspections to make sure that the approved protocol is adhered to and to
inspect research documents and records.
·
Regular monitoring meetings are held to review
the following: progress of recruitment of research subjects, changes to the
protocol, adverse reactions, the process of informed consent, refusals and
withdrawals, and case record forms.
·
The committee keeps full records of all its
actions.
·
It submits an annual report listing all
proposals considered in the past year, the number approved, and any matters
that deserve attention from higher authorities.