EC/IRB Recognition Requirements
Generally an EC/IRB will be recognized based on the quality of the EC/IRB, its adherence to specific policies for ethical review, the completeness of its review process, the after review process and documentation.
This document is to be used in conjunction with the SIDCER Self-Assessment Tool, SIDCER Recognition Requirements, and the standards described in the WHO Operational Guidelines for Ethics Committees That Review Biomedical Research, and the WHO complementary guideline Surveying and Evaluating Ethical Review Practices, and the ICH-GCP ICH Harmonised Tripartite Guideline-Guideline for GCP E6(R1).
1. STRUCTURE AND COMPOSITION
The structure, composition and skills (expertise) of the EC/IRB and staff are appropriate to the amount and nature of research reviewed.
1.1. MEMBERSHIP REQUIREMENTS
1.1.1. Members: at least
1.1.2. Gender: Balance
1.1.3. Experience and knowledge: balance in ethics, science
and social science (alternatives to cover the topic of review
should be in place)
1.1.4. Non-scientific or lay person
1.1.5. Non-affiliated person (independent of the institution/research
1.1.6. Terms and conditions of appointment, including policy
and duration of appointment, disqualification, resignation and
1.2. ADMINISTRATIVE REQUIREMENTS
The EC/IRB should have:
1.2.1. Administrators that
oversee the day-to-day activity of the EC/IRB;
1.2.2. Documentation of the functions and activities of the
1.2.3. The Adequate number of administrative staff; and
1.2.4. Terms and conditions of appointments of members.
1.3. MEMBERSHIP INITIAL
AND CONTINUOUS TRAINING
The provisions available
for EC/IRB members to receive introductory as well as continuous
education need to be stated and observed.
1.4. EC/IRB OFFICE
The EC/IRB should have
an office space with necessary equipments and staff for good
1.5. MANAGEMENT OF CONFLICTS
EC/IRB should have a policy
to address conflicts of interest and obligations.
2. ADHERENCE TO SPECIFIC POLICIES
Appropriate management and
operational procedures for optimal and systematic conduct of
2.1. MANAGEMENT OF EC/IRB
The EC/IRB should document
and make publicly available a term of reference, which should
include its purpose, scope, objectives, activities, organization
2.2. AVAILABILITY OF STANDARD
OPERATING PROCEDURES (SOPs)
The EC/IRB should have
a written SOP with which they comply. The reasons for any non-compliance should be stated.
2.3. AREAS AND FUNCTIONS
COVERED BY THE SOPs
The areas of review conducted
by the EC/IRB should be covered by the SOPs.
should include, but not be limited to:
Normal review process,
Review of resubmitted,
Continuous protocol review
Informed consent review, and.
2.4. CONTINUOUS REVIEW OF
The SOPs should be reviewed
at least every three years and revised as necessary. EC/IRB
should indicate how often this is done and also document and
archive copies of the previous versions.
2.5. GUIDELINE FOR PROTOCOL
The EC/IRB should have
a guideline aiding investigators on protocol submission. The
guideline should include the requirements of the EC/IRB for
the review of the different kinds of protocols. An informed
consent document guideline/template should be made available.
2.6. SUBMISSION PROCESS
EC/IRB should indicate
to investigators when to submit a protocol so as to meet meeting
deadlines. Applications by investigators for ethical approval
should be made on standard application forms; EC/IRB should
also have and make available these different application forms
2.7. MEETING REQUIREMENTS
The EC/IRB should have
documented meeting requirements with which they comply. Included
in this is the minimum number of members required per meeting,
the professional requirements, and the distribution of the various
3. COMPLETENESS OF ITS REVIEW PROCESS
EC review protocols and
its supporting documents thoroughly in a timely fashion according
to an established procedure to protect the interest of research
3.1. COMPLETENESS OF PROTOCOL
SUBMITTED FOR REVIEW
EC/IRB should ensure the
completeness of each protocol reviewed.
3.2. REVIEW PROCESS
Reviewers should be given
enough time to review protocols and make comments. EC/IRB should
have a documented and detailed review process with which they
comply, for full committee and expedited reviews. They should
also have and follow a process of establishing independent consultants
that may provide special expertise on research protocols. EC/IRB
should have a process to determine which protocols are exempt,
reviewed expedited and what happens after expedited review and
reviewed by a full board.
3.3. CONTINUOUS AND PROTOCOL AMENDMENT REVIEW
EC/IRB should have a process
of continuous review of projects based on its degree of risks
(at least once per year). A list of documents including project
report required for continuous review should also be made available
for researchers. EC/IRB should specify the researcher is expected
to submit reports and documents for continuous review and indicate
in their SOP how such review should be conducted. The EC/IRB
should also indicate to researchers that any amendment made
on the protocol should not be implemented till it gets the EC/IRB
approval; the EC/IRB should also have a process of reviewing
3.4. ELEMENTS OF REVIEW
The process and functions
of members and staff in this process should be clearly indicated.
EC/IRB should state clearly what elements they review in a
protocol. Review element should include: value of research,
scientific design and conduct,
ethics (risk, benefit, informed consent documents and processes,
care and selection of participants etc.).
3.5. OTHER AFTER-PROTOCOL
EC/IRB should document
and follow procedures for reviewing other after-protocol approval
reviews, such as site visit reports, Data Safety Monitoring
Board progress reports, serious adverse event reports, termination
of study reports, and end of study reports.
3.6. COMPLETENESS EC/IRB
Minutes should be a complete
record of all aspects of the meeting; including time allocated
for review is important as this will reveal, among other things,
how the EC/IRB functions, and its adherence to its stated procedures.
Minutes should accurately reflect actions taken during the meeting
and should also indicate which members were present when the
actions were taken.
3.7. DECISION MAKING PROCESS
In other for the EC/IRB
to function fully they should have a procedure for decision-making
and members should be free to participate fully in discussion,
debate and voting where the need arises.
4. AFTER REVIEW PROCESS
After making a decision
the EC adequately and effectively communicates its decision
4.1. COMMUNICATING DECISION
EC/IRB should have an effective
and timely way of communicating a decision. Where protocol approval
was denied by the EC/IRB, reasons should be clearly stated.
If provisional approval is given areas that need be re-worked
should be clearly stated. EC/IRB should have and issue approval/disapproval
letters with the conditions of approval or reasons for disapproval
clearly stated. The IRB should have and issue suspension/termination
letters with the conditions of lifting suspension and the reasons
for suspension or termination clearly stated.
EC systematically archive
documents of its activities for a good time period
5.1. EC/IRB DOCUMENTATION
All protocols with a complete
set of its supporting materials are maintained by the EC in
a file or database till at least 3 years after the end of the
All documentations on pertinent
discussions and decisions on protocols and communication of
the EC/IRB should be properly filed and archived for easy access.
All documents pertinent
to effective function of the EC including its SOPs, constitutions,
regular annual reports, national and international guidelines
etc. should be properly kept.
A retrieval procedure should
be indicated and complied with. The minimum period of archive
should also be stated and compl