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 5

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 site)

1.1.6. Terms and conditions of appointment, including policy and duration of appointment, disqualification, resignation and replacement procedures

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 staff;

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 functioning.

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 ethical review.

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 and management.

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.
SOPs should include, but not be limited to:

2.4. CONTINUOUS REVIEW OF SOPs

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 SUBMISSION

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 to researchers.

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 professions.

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 participants.

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 amended protocols.

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 APPROVAL REVIEWS

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 MEETING MINUTES

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 to researchers.

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.

5. ARCHIVING

EC systematically archive documents of its activities for a good time period

5.1. EC/IRB DOCUMENTATION AND ARCHIVING

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 study

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

ied with.