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Presentation at the Workshop on Data Management
held at King Saud University Riyadd 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
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.
·
Confidentiality (use of certificates of confidentiality[24])
and security of the data
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
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]
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