Home 
Contact 
Profile 
Videos 
Presentation
at the Workshop on Grant Writing Faculty of Medicine King Fahad Medical City,
Riyadh February 24, 2014 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
THE NEED FOR REC
·
National and local laws require REC
approval of research; big institutions have their own committee smaller ones
rely on others
·
Journals increasingly ask for REC
approvals[1]
·
RECs have been encouraged in
developing countries[2]
and their problems and challenges have been studied in Egypt, Thailand[3],
India[4],
Baltics[5],
Poland[6],
ElSalvador[7],
African countries[8]
·
RECs’ role has grown from being
advisory to approval and finally to regulation of research[9].
The call to limit the scope of RECs[10],
to have disease-specific RECs[11]
·
RECs roles may conflict: protecting
the research subject vs protecting the researcher and the institution[12].
Institution / researcher best protected by preventing them from errors (ansur
akhaaka dhaaliman aw madluuman)
·
RECs processes delayed research
projects[13]
and hampered participation in national research[14].
Frustrated researchers opting for animal models[15].
Reseachers who know IRB rules and procedures will navigate the approval process
better[16]
[17]
FUNCTIONS OF REC
·
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. Above these regulations REC must ensure the highest
ethical standards in any research.
·
Follow up
evaluation and approval of
matters arising in the course of the research: protocol amendments, study
termination / completion.
·
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, completeness and quality of AE reporting[18],
and any ethical violations / protocol deviations,
MEMBERSHIP OF IRB 1
·
Membership of the REC must have a
diversity of medical professional competencies (clinical and non-clinical) to
make sure that for every project reviewed there is a member from the relevant
discipline and not necessarily the sub-discipline. Physicians tend to dominate
RECs[19]
·
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.
·
At least one of the members must be
a normal community representative with no affiliation to the institution. This
member should not have any connection with medical work.
MEMBERSHIP OF IRB 2
·
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 department,
unit, 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. Staggered renewal
of membership. A member should serve 2-3 terms
SCOPE OF RESEARCH REVIEW BY REC
·
The committee assesses research
proposals and protocols that have ethical implications: (a) research on patients,
volunteers, the recently dead, fetal or embryological tissues (b) research with
potential to breach confidentiality.
·
All research however must be
submitted to the REC Chairman because the researcher cannot be trusted to
determine the classification.
·
The Chairman will determine which
proposals are exempt (no risk no ethical issues) and which are expedited
(minimal risk) and approve them immediately
·
The chairman will determine and approve
expedited proposals (minimal patient risk) and if need be can consult one or
more members of the committee.
·
Full review is done for research
with human intervention.
DOCUMENTS SUBMITTED FOR REC REVIEW
·
Exempt proposals submitted on a
special form with the proposal attached. The form must be signed by the PI and
HOD
·
Full and expedited: Protocols,
investigator brochures, and consent documents of proposals with potentially
significant patient risk are sent to all REC members at least 2 weeks in
advance for review with those from the relevant disciplines being asked to make
a more detailed analysis and make a presentation to the REC.
·
The CVs of investigators and
certification of GCP must be attached
REC MEETING
·
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 and may/may not vote
·
The committee meets in private to
preserve confidentiality. Others argue that they should meet in public for more
transparency[20]
·
If the issues are complicated the
investigator may be invited to the meeting to explain
·
Any member of the committee involved
in a project will recluse himself when that project comes up for discussion.
CRITERIA OF REC APPROVAL 1
·
The two main considerations in REC
decisions are: informed consent and patient safety
·
Informed
and voluntary consent following full disclosure of
objectives, risks and benefits of the research, the right to abstain or
withdraw from the study. Special scrutiny of proxy consent for the vulnerable
will be made to ensure there is no abuse[21],[22],[23].
The investigator must submit reasons in writing in cases in which full
disclosure is deemed inappropriate.
·
Patient
safety based on careful weighing of
benefits and risks.
CRITERIA OF REC APPROVAL 2
·
Scientific
merit: objectives clearly states and
attainable, research design and statistical methods are adequate to produce
clinically and scientifically useful results. Outside experts may be consulted.
The committee will compare the
scientific merit and benefit of the research against risks and costs to
patients. Decision making procedures may improve the risk-benefit discourse[25].
·
Qualification
of the researchers based on study of their detailed
resumes
·
Adequacy
of research facilities
·
No conflicts
of interest.
DECISIONS OF IRB
·
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. 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. If the
investigator fulfills the missing information the chairman may approve a
conditional approval without returning to the full committee.
TABLE #1: OUTCOME OF PROPOSALS
SUBMITTED TO KFMC IRB
|
Year
|
Exempt
|
Expedited
|
Full
|
Approved
|
Rejected
|
Others
|
Total
|
|
2007
|
|
|
|
|
|
|
|
|
2008
|
|
|
|
|
|
|
|
|
2009
|
|
|
|
|
|
|
|
|
2010
|
|
|
|
|
|
|
|
|
2011
|
|
|
|
|
|
|
|
|
2012
|
|
|
|
|
|
|
|
|
2013
|
|
|
|
|
|
|
|
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. AE reports from all sites of
multi-center trials must be submitted
·
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.
·
Warning letters[26]
·
Audits
OVERSIGHT
OF IRB
·
The committee keeps full records of
all its actions. Records are not priviledged if a suit arises
·
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.
·
The Chairman of IRB reports to the
highest official in the institution
·
Tool for REC self-assessment[27]
·
Researchers have a right of appeal
PROBLEMS
OF IRB 1: HUMAN AND MATERIAL RESOURCES
·
Not enough resources (financial,
secretarial, office space) for their work.
·
Chairman has a lot of administrative
duties because of fulfilling research regulations and legal documents needed by
international sponsors.
·
Work of RECs moving from ethics to
research governance[28]
·
IRBs struggle to catch up with new
clinical research regulations[29]
PROBLEMS OF IRB 3: MEMBERS
·
Members’ training needs often not
fulfilled: lack of time & changing regulations. A specific curriculum is
needed covering: committee working; scientific method; ethical analysis and the
regulatory framework [30]
·
Community member participation is
limited[31].
Confusion about the roles of nonaffiliated and non-scientific members.[32]
Varying ways of using community members[33]
·
Conflicts of interest within REC[34]:
the obvious and the non-obvious
REC
PROBLEMS: SUBMISSIONS
·
Poorly designed and written research
proposals. Many procedural errors[35];
REC normally gives researchers advice on improving their proposals instead of
rejecting them outright.
·
Sponsored research is
over-documented and the sponsors expect REC to review and approve many
documents that have no direct relation to research ethics.
·
What projects to review: Determination
of minimal risk is not easy for example is trauma and sex survey minimal risk?[36]
Is Medical education research under REC review?[37]
[38]
Are quality improvement projects research?[39].
Chart reviews, case reports, observational studies part of IRB?[40]
IRBs have problems dealing with community-based research[41]
·
Retrospective approvals to enable
publications
·
Problem of dealing with incidental
findings[42]
REC
PROBLEMS: GUIDELINES?
·
Inconsistencies among RECs[43]
and difficulty of setting standards[44].
No homogenous code, improper application of standards, lack of auditing
capabilities[45].
·
Different RECs emphasize different
criteria[46].
RECs do not uniformly follow the common rule[47].
Common guidelines reduce the variability[48]
·
Varying decisions of IRBs for multicenter
proposals[49],[50],[51],[52],[53],[54].
Centralized IRBs have been suggested to standardize but they also have their
problems[55],[56].
Cost-benefit considerations[57].
Centralized RECs are remote from researchers and the site of research? Wring
decisions
·
Should IRBs follow centralized
guidelines or should add their own local ones?[58]
Should RECs consider community values?[59]
REC PROBLEMS: DIFFICULT DECISIONS
·
Problems in making decisions on re-use
without informed consent that involves stored tissue[60]
for the same research or different research
·
Deciding on research genetic research
(confidentiality and sending material overseas. Researcher and IRB Chair
perspective on genomic research were different[61].
·
Hot protocols: facial transplants
require different approaches[62]
·
Issues of consent: Online survey
tools may not fulfill consent rules[63].
Waiver of consent for emergency research[64],
long consent forms / Arabic translations
·
Is REC a rubberstamp function: Most
research projects submitted are approved[65].
The majority of RECs are satisfied with submissions by sponsors[66]
REFERENCES
Available upon request