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Presentation at the Workshop on Data Management held at King
Saud University Riyadh Saudi Arabia on April 29th 2013 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
Abstract
The functions of
IRB are to (a) initial evaluation and approval of research proposals to make
sure they fulfill the requirements of the Saudi regulations on human research
and the international consensus Good Clinical Practice Guidelines (b) follow up
and approval of matters arising in the course of the research: protocol
amendments, protocol deviations, adverse events, and ethical violations (c) monitoring
of study execution by checking on vital issues such as proper consenting
procedures, confidentiality of the data, and complete and up to date
documentation.
Membership of
the REC must have a diversity of medical professional competencies to make sure
that for every project reviewed there is a member from the relevant discipline
and not necessarily the sub-discipline. Membership must also include both
clinical and basic science competencies. At least one of the members must be a
normal community representative with no affiliation to the institution.
All research
however simple it may be must be submitted to the REC Chairman. The Chairman
will determine which proposals are exempt because they have no patient safety
or ethical implications and go ahead to approve them immediately. The chairman
can also approve expedited proposals (minimal patient risk) and if need be can
consult one or more members of the committee. Protocols, investigator
brochures, and consent documents of proposals with potentially significant
patient risk are sent to all REC members for review with those from the
relevant disciplines being asked to make a more detailed analysis and make a
presentation to the REC. Outside experts may be consulted. If the issues are
complicated the investigator may be invited to the meeting to explain.
The two main
considerations in REC decisions are: (a) informed and voluntary consent
following full disclosure of risks and benefits of the research (b) patient
safety based on careful weighing of benefits and risks. Other considerations
are: (a) confidentiality, (c) qualification of the researchers, (c) research
facilities (d) conflicts of interest. REC decisions are best taken by consensus
but if this is not possible the decision will be based on a simple majority of
the members attending if the quorum is assured. The decision can be full
approval, conditional approval, or rejection. If the investigator fulfills the
missing information the chairman may approve a conditional approval without
returning to the full committee.
RECs encounter
several problems in their work. They usually have no enough resources
(financial, secretarial, office space) for their work. The Chairman spends most
time in administrative issues and making and communicating most of the
decisions that are subsequently endorsed by the committee. Delegation of
decision making to the chairman expedites REC work and reduces researcher
frustration. Members busy in their clinical work may not have enough time to
study the proposals in detail. Many research proposals are not well written and
if strict criteria were followed they should be rejected without consideration
but this will discourage research; REC normally gives researchers advice on
improving their proposals. International sponsors of research from the pharma
industry have increased the administrative workload of RECs by requiring so
many documents and certification to conform to research regulations in their
respective countries. Sponsored research is over-documented and the sponsor
expects REC to review and approve many documents that have no direct relation
to research ethics. Because of lack of clear regulations, RECs face problems in
making decisions on research that involves storing tissue and genetic material
as well as sending it for research in collaborating laboratories overseas.