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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
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]
NOTES