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

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  • Retha Britz Copyright 2013 All rights reserved for this presentation*Establishment and functioning of a RECRetha 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).*

  • Requirement for RECs: (continue)Act No. 61 of 2003 National Health ActSection 73 (2) A health research ethics committee must - Review research proposals and protocols 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*

  • 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*

  • RECs as per SA GCP (see pages 58 to 63)ResponsibilitiesEthics and legislationComposition (also see ICH GCP 3.2)Appointment of membersProceduresAdvocacy role and interpretersExpedited reviews for maximal public benefitRecords*

  • RECs as per SA GCP (continue)9. Monitoring10. Complaints11. Suspension or discontinuation of research12. Disclosure of potential conflicts of interest*

  • RECs as per the Blue BookAn established REC must review and approve all research proposals involving human participantsREC function (p. 15):Protect the rights and welfare of research ptsEnsure adequate resources to establish and maintain a RECTerms 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)*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:CompositionAppointment of membersProceduresAdvocacy Role InterpretersExpedited Reviews for maximal public benefitMonitoring ComplaintsSuspension/Discontinuation of research*

  • What is different in the Blue Book?Recording of DecisionsCompliance Reports to the NHREC

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  • Recording of DecisionsREC 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 protocol

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  • 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 making

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  • Compliance Reports to the NHRECAll REC to be registered with the NHRECNHREC auditing activities of RECs to ensure compliance with Blue Book requirementsRequired information for audit purposes:Membership and membership changesNumber of meetings heldConfirmation of participation by required categories of membersNr of protocols presented, approved and rejectedMonitoring and related problemsComplaints procedures and nr of complaints received and handled*

  • Other considerationsSecretariat (one full time administrative officer) and physical officeStandard Operating Procedures (SOPs)(See p 16 of Blue Book for required SOPs)WebsiteApplication FormNew research studyAmendment to already approved research protocolAnnual review / progress report*

  • Other considerations(continue)Informed Consent TemplatesMain study Information Leaflet and Consent FormSub-study Information Leaflet and Consent FormHelpful toolsChecklist of required/submitted documentsSchedule of submission dates and REC meeting datesGuidelines for researchers*

  • Other considerations(continue)Training and Continuous Education of MembersBlue Book & SA GCP requires all members to have initial and continued education in research ethics, GCP and scienceChairperson and at least one other member to have in-depth training in research ethicsProof 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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  • ReferencesSOUTH 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.)