Center of Ethical Reinforcement for Human Research Mahidol university MU-CERif

Background Originates from “Mahidol University- Institutional Review Board” (MU-IRB) – under Research Management & Development Division, Office of the President Strengthening capacity in Human research subject protection for Mahidol as a “Research Intensive University” Established to be a “management center” on March 16, 2011 Directly report to the Board chaired by the President to avoid conflict of interest and undue influence in management

Duties and responsibilities Human research subject protection – MU-IRB Education and Training IRB members- Board, Staff Researchers and students Research assistants Quality assurance – harmonization between 7 IRBs in the same university Communication & Networking among stakeholders Regulatory authorities Ethics committee/IRB in Thailand and Asia Pacific region Pharmaceutical Research and Manufacturing Association (PReMA) Community Advisory Board – research participants

Ethical Clearance for Human Research MU-IRB responsible for human research oversight in faculties in Salaya campus who have not set up their own IRB Coordinate reviewing process for multicenter study within Mahidol university Share load from heavy duty IRB and help in “for-cause” audit

Education & Training in Research Ethics Group training Post Grad Students & their advisors Elective course 1 credit GRID 521 Research Ethics since 2010 1st semester (August) for Thai students 2nd semester (November) for Thai students Summer semester (March) for Thai and international students Workshop for Advisors at least once/year Workshop of researchers ( I day course)

Education & Training For IRB Board members Research Ethics course: Basic, Advance Research Forum 2-4 times/year for continuing education For IRB Staff –selected topic workshop For research assistants–selected topic workshop

Education & Training For Individual researcher: consultation clinic Preparing participant information sheet, plan for recruitment and informed consent process Modification of research protocol according to IRB comments and guidance to secure approval How to deal with protocol deviation report and design the correction plan MU-CERif will work for the preferred training program to serve need of researcher requirement by distributing questionnaires in the near future

Quality Assurance in Ethical Review Harmonization of 7 IRBs in Mahidol Phyathai Campus Faculty of Medicine Ramathibody Hospital Faculty of Tropical Medicine Faculty of Public Health Faculty of Dentistry & Pharmacy (2010) Bangkoknoi Campus Faculty of Medicine Siriraj Hospital Salaya Campus MU-IRB: - Central panel, Nurse panel (2009) Social Science group (2010)

Harmony in Deversity Internal survey and recognition 1) MU-IRB – 2 panels – Central panel, Nurse Panel – Demonstration Survey 2010-2011 2) Si-IRB – 4 panels – Appreciation visit 2011 3) Trop Med-IRB – Appreciation visit 2011 4) Ra- IRB – internal survey 2012 5) Pub Health- IRB – internal survey 2012 6) Social Science-IRB – internal survey 2013 7) Dent&Pharm- IRB – internal survey 2013

Harmony in diversity IRB Chair Meeting at least 2 times/year To share experience between IRB, develop best practice To establish guidance in specific procedures Brain storming in common problem solving Develop policy for special issue: Tissue& Data Bank, Sensitive type of research: stem cell, phase 1 clinical trial, genetic research

Communication & Networking Between IRBs through Chair meeting IRB Staff Meeting Research Assistants Meeting Between IRB people and researchers through Human Research Ethics Forum Educational Course/Meeting Communicate with outsiders FERCIT, FERCAP Regulatory Authorities: Thai FDA Pharmaceutical Research and Manufacturing Association (PReMA) Community Advisory Board – research participants Communication through IT – MU-CERif Website: web- board, E- learning, FAQ, etc.

Activities Jan –Feb Training Course for IRB members Jan 25 – Feb 25 (Fulbright Senior Specialist Program) March Mar 24 Seminar for young investigators invited by Research Management & Development Division Mar 29-30 GRID 521 Summer course April Apr 29 Workshop for Advisors (Grad Study) May May 12 Human Research Ethics Forum 1/2011 Thai Herb Research June Jun 23 Chair Meeting 1/2011MOU for multicenter Study, responsibility for research-related injury

Activities July Jul 29 GRID 521 1st semester (2011) November August Aug 5 GRID 521 1st semester (2011) September Sep 2 Workshop in Human Research Ethics for researchers Sep 23 Human Research Ethics Forum 2/2011 Tissue & Data Bank October Oct 20 Workshop for IRB Staff “MOU for multicenter study, early phase trial, BioBank”  November Nov 17 Workshop for recruiter – CRC, BioBank - Recruitment and Informed Consent Process December Dec 22 Chair Meeting 2/2011 Guideline for Biobank

Thank you for your attention