Research Ethics Review

Transcription

1 Research Ethics Review Country Experience Philippines Vicente Y. Belizario, Jr. University of the Philippines Manila August 17, 2011

2 National Standards or Guidelines National standards for RECs National Ethical Guidelines for Health Research, 2006 Philippine Health Research Ethics Board, Philippine National Health Research System National guidelines defining research ethics review process Cluster RECs, Institutional RECs Scope: review, approval, postapproval

3 Mandates of the Philippine Health Research Ethics Board (PHREB) Formulation of guidelines: - ethical conduct in health research - establishment and management of ERCs Monitoring performance of ERCs Providing advice related to ethical issues in human health research

4 Scope of the National Ethical Guidelines for Health Research (PNHRS, 2006)

5 Data on REC/IRB Estimated number of RECs/IRB operating in the country Survey of local institutions conducted by the TWG on Ethics showed that only 50%of these institutions have REC/IRB (PNHRS, 2004) 103 RECs/IRBs registered with the PHREB ~50% in the National Capital Region Only 4 are recognized by the Forum for Ethics Review Committees in Asia and Western Pacific (FERCAP) Type of organizations/institutions Academic/research institutions Medical centers/hospitals Department of Health (Central Office, CHDs)

6 SIDCER-FERCAP Recognized RECs/IRBs as of 2010 TOTAL: 72 BHUTAN (1) CHINA (10) INDIA (2) INDONESIA (1) PHILIPPINES (4) SOUTH KOREA (20) SRI LANKA (1) TAIWAN (22) THAILAND (11) SIDCER-FERCAP Tools

7 National systems to monitor RECs National database on REC/IRBs operating in the country Maintained by the PHREB Data collected by initial registration and annual reporting Database used for policy-making and monitoring

8 National systems to monitor RECs Accreditation of REC/IRB operating in the country (upcoming) Responsible agency: PHREB Resources required for training accreditors/ accrediting teams, advocacy, assessment of RECs for accreditation, database Outcomes: Levels 1-3 accreditation, network of accredited RECs Criteria: similar to SIDCER/FERCAP requirements 1. Structure and composition of EC/IRB 2. Adherence to specific policies 3. Completeness of its review process 4. After review process 5. Documentation and archiving

9 Role of RECs beyond initial review Continuing oversight after review process Monitoring progress and final reports, monitoring serious adverse events (SAEs) Registering trials by institution through RECs, national, ideally through FDA/regulatory authority

10 National Efforts to build REC/IRB capacity National (or subnational) programs for training and capacity building of REC/IRBs UPM-NIH Training Center for Health Research Ethics and Good Clinical Practice DOST-PCHRD, DOH Regional Health Research and Development Committees Sponsor-initiated training Institution-initiated training Brief description of the training program Health research ethics, good clinical practice SOPs for REC/IRB members Research methodologies and research ethics (continuing ethics education) REC/IRB strengthening: preparing for accreditation/recognition

11 National Efforts to build REC/IRB capacity Who are targeted for training? REC members Researchers and academics IRB managers/research staff/heads of institutions Policy makers/regulatory authority Sponsor

12 Year UPM-NIH TRAINING CENTER FOR HEALTH RESEARCH ETHICS AND GOOD CLINICAL PRACTICE No. of trainings conducted No. of participants TOTAL 41 1,879 No. of RECs/IRBs represented = Geographic Distribution of REC/IRB represented

13 Challenges and barriers in ensuring good quality ethics review Administrators of academic/research institutions Notion that IRB review is unnecessary extra step Lack of willing and well-trained IRB members, lack of incentives Delayed implementation of accreditation scheme

14 Facilitatory factors in ensuring quality ethics review Guidelines/policies in place (can be stronger?) Continuing capacity building and advocacy leading to higher awareness Clamor: After training, what else?

15 NATIONAL POLICIES DOST AO 001 Series All institutions that conduct health research are urged to establish review committees that shall be in charge of ethical evaluation and monitoring of research involving human participants. The composition and procedures must be in compliance with the guidelines in the 2006 National Ethical Guidelines for Health Research (DOST-PCHRD). 2. All research protocols for the conduct of biomedical and behavioral researches involving human subjects shall be submitted to ethics review committees for coordination, comment, guidance, and approval. CHED Memo 34 Series of 2007 (Endorsement of DOST AO 001, Series 2007 for HEIs) DOST AO 001 Series of 2008 Subject: Registration of all Ethics Committees at the PHREB

16 Overall assessment What is your overall assessment about functioning of RECs and quality of ethics review of ongoing research? Based on registration and self-reporting, it is difficult to estimate the proportion of research that undergoes review and to assess the quality of review Need to implement a national accreditation scheme Need to incorporate research ethics and good clinical practice in academic curriculum

17 REC: Health Research Governance and Management Function Do you think monitoring the activities, training, building capacity should be one of the national health research governance and management function? Yes, to ensure compliance with international and national standards and regulations, raise quality of health research Which organization/institutions in your country do you think can take on this role? PNHRS (DOH, DOST, CHED, UPM)

18 THANK YOU