Retha Britz Copyright 2013 All rights reserved for this presentation 1 Establishment and functioning of a REC Retha Britz.

Retha Britz Copyright 2013 All rights reserved for this presentation1

Establishment and functioning of a REC

Retha Britz

Requirement for RECs:

Act No. 61 of 2003 National Health ActSection 73 (1) “Every institution, health agency

and health establishment at which health research is conducted, must establish or have access to a health research ethics committee registered with the National Health Research

Ethics Council (NHREC).”

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Requirement for RECs: (continue)

Act No. 61 of 2003 National Health ActSection 73 (2) “A health research ethics committee

must - ”

(a)Review research proposals and protocols

(b)“Grant approval for research by the relevant institution, agency or establishment in instances where research proposals and protocol meet the ethical standards of that health research ethics committee”

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Requirement for RECs: (continue)

SA GCP section 8:“Ethics are as important as scientific considerations when reviewing a research project. An independent SA based research ethics committee must review

the ethical and scientific rigour of all clinical trials to be conducted in SA. Institutions/organisations that

undertake research involving human pts should ensure that there are adequate resources to

establish and maintain a REC”

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RECs as per SA GCP (see pages 58 to 63)

1. Responsibilities

2. Ethics and legislation3. Composition (also see ICH GCP 3.2)

4. Appointment of members

5. Procedures

6. Advocacy role and interpreters

7. Expedited reviews for maximal public benefit

8. Records

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RECs as per SA GCP (continue)

9. Monitoring

10. Complaints

11. Suspension or discontinuation of research

12. Disclosure of potential conflicts of interest

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RECs as per the “Blue Book”

“An established REC must review and approve all research proposals involving human participants”

REC function (p. 15):

Protect the rights and welfare of research pts Ensure adequate resources to establish and maintain a

REC Terms of reference set out re the scope of

responsibilities, relationship to non-affiliate researchers, accountability, mechanisms for reporting and remuneration for members (if any)

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RECs as per the “Blue Book” (continue)

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REC function (p. 15):

The institution/organisation must accept legal responsibility for decisions and advice received from the REC and indemnify REC membersResearchers without affiliation to an institution/organisation with a REC must ensure their projects are approved by an established EC

“Blue Book” and SA GCP has the same requirements in terms of:

Composition Appointment of members Procedures Advocacy Role Interpreters Expedited Reviews for maximal public benefit Monitoring Complaints Suspension/Discontinuation of research

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What is different in the “Blue Book”?

Recording of Decisions Compliance Reports to the NHREC

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Recording of Decisions

REC to maintain record of all research protocols received and reviewed including:

Name of responsible institution/organisationProject identification numberPITitle of the projectDate of ethical approval or non-approvalApproval/non-approval of changes to the protocol

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Recording of Decisions (continue)

REC to maintain record of all research protocols received and reviewed including:

Approval/non-approval of changes to PIL and ICFsApproval/non-approval of changes to advertising materials, letters and noticesComplaints from researchers whose protocols were not approvedTs & Cs of approval of any protocol12

Recording of Decisions (continue)

REC to maintain record of all research protocols received and reviewed including:

Whether approval was by expedited reviewWhether the opinion of another EC was consideredAction taken by the EC to monitor the conduct of the research

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Recording of Decisions (continue)

For multi-centred research proposals, the EC shall also record:

Details of other centres involvedThe approval status of the study at each centreDetails of any amendments required at other centres

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Recording of Decisions (continue)

On file should be:Copy of the research protocolApplication submittedInformation sheets, ICFs Relevant correspondence (in the form that it was approved)A list of committee members present during the discussion of the applications and final decision making15

Compliance Reports to the NHREC

All REC to be registered with the NHREC NHREC auditing activities of RECs to ensure

compliance with Blue Book requirements Required information for audit purposes:

Membership and membership changes Number of meetings held Confirmation of participation by required categories of members Nr of protocols presented, approved and rejected Monitoring and related problems Complaints procedures and nr of complaints received and

handled

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Other considerations

Secretariat (one full time administrative officer) and physical office

Standard Operating Procedures (SOPs)(See p 16 of Blue Book for required SOPs)

Website Application Form

New research studyAmendment to already approved research protocolAnnual review / progress report

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Other considerations(continue)

Informed Consent Templates Main study Information Leaflet and Consent Form Sub-study Information Leaflet and Consent Form

Helpful tools Checklist of required/submitted documents Schedule of submission dates and REC meeting

dates Guidelines for researchers

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Other considerations(continue)

Training and Continuous Education of Members Blue Book & SA GCP requires all members to have initial and

continued education in research ethics, GCP and science Chairperson and at least one other member to have in-depth

training in research ethics Proof of training to be available (e.g. certificates)

Sign and submit FWA in case of reviewing clinical research legal agreement between REC & US government that REC will comply with Office for Human Research Protection regulations and standards

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References

SOUTH AFRICA. Department of Health. Directorate: Health Systems, Research, Research

Coordination and Epidemiology. 2004. Ethics in health research: principles, structures and

processes. Research ethics guidelines. Pretoria: Government Printer. 67 p.

SOUTH AFRICA. Department of Health. Directorate: Health Systems, Research, Research

Coordination and Epidemiology. 2006. South African good clinical practice guidelines. 2nd ed.

Pretoria: Government Printer. 96 p.

SOUTH AFRICA. 2005b. National Health Act no. 61 of 2003. Government gazette, 469:1-94, 23 July 2004. (Regulation gazette no. 26595.)