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

2. 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

3. 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

4. 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

5. 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)

6. 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

7. 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

8. 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)

9. Harmony in Deversity Internal survey and recognition
1) MU-IRB – 2 panels – Central panel, Nurse Panel – Demonstration Survey
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

10. 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

11. 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.

12. 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 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

13. 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

14. Thank you for your attention