1. AAHRPP Accreditation Siriraj Institutional Review Board (SIRB)
Faculty of Medicine Siriraj Hospital

2. Accreditation/Recognitation
SIDCER/FERCAP:
Strategic Initiative for Developing Capacity in Ethical Review
Forum for Ethical Review Committees in Asia and Western Pacific
AAHRPP:
Association for the accreditation of human research protection program

4. AAHRPP Non-profit organization founded in 2001
Founding members
Association of American Medical Colleges
Association of American Universities
Association of Public and Land-grant Universities
Consortium of Social Science Associations
Federation of American Societies for Experimental Biology
National Health Council
Public Responsibility in Medicine and Research
Sole accrediting body in the United States
Offer accreditation worldwide

5. Mission of AAHRPP
AAHRPP accredits high-quality human research protection programs in order to promote excellent, ethically sound research. Through partnerships with research organizations, researchers, sponsors, and the public.
AAHRPP encourages effective, efficient, and innovative systems of protection for human research participants.

6. Accredited organizations
As of March 2014, 243 organizations representing nearly 1,100 entities:
Contract research organizations, hospitals, independent IRBs, research institutes, universities and government agencies
Small (fewer than 20 protocols) and large (greater than 6,000 protocols) institutions
Clinical and non-clinical research programs
USA, Canada, China, India, Korea, Mexico, Saudi Arabia, Singapore and Taiwan etc.

7. What are the benefit to be accredited by AAHRPP?
Not only to protect research participants but also advance research more efficiently and effectively
High standards and protection for research participants
An assurance of quality of research program
Improved efficiently, effectiveness of policies and procedures
A competitive edge
Public trust, confidence

8. Human Research Protection Program
Investigators and Research Staff
Education Programs
Conflict
of Interest
Compliance
Oversight
Pharmacy
Services
Organizational
Plan
Research related injury
Biosafety
Contracts
and Grants
Participant
Outreach
IRB or EC

9. The focus of accreditation
Organization
IRB or EC
Researchers and
Research staff
Protecting research participants is a shared responsibility
Human
Research
Protection
Program }

10. Researchers and Research staff
Adhere to ethical principles and standards appropriate for their discipline.
In designing and conducting research studies, protection of the rights and welfare of research participants as a primary concern.
Conducting research with participants and comply with all applicable laws, regulations, codes, and guidance; the Organization’s policies and procedures for protecting research participants; and the IRB’s or EC’s determinations.
Training and oversight are appropriate

11. Conflict of Interest (COI)
Def: A set of condition in which professional judgment concerning a primary interest (patients’ welfare or research validity) is unduly influenced by secondary interest (financial gain)
Financial:
Non financial:
Professional recognition and promotion
Ability to compete for research funding
Interest in patients’ well being (in contrast to community or employer)
Quest for knowledge
Thompson DF. New Engl J Med 1993:329;573-6

12. IRB should oversee the conflict of interest (COI) of researcher
Researcher’s financial support involving the pharmaceutical company or medical device manufacturer who grants the research funding in several patterns
Being consultant to the company
Being a lecturer of the company
Attending national and international scientific conferences

13. Researcher conflict of interest
1. Researchers and team declare the conflicts of interests of themselves and their immediate family members to IRB by using the researcher COI declaration form.
2. The researcher should disclose the conflict of interest in research in the participant information sheet.
3. If the conflict of interest is greater than acceptable, the IRB may ask the researcher to eliminate the conflict, or refuse to approve the protocol.
4. Individuals who have the conflict of interest in research should not be the one to provide the information sheet and consent form to the participant.

14. Research pharmacy
According to the ICH GCP recommendation in research used pharmacy, the organization assigned the HRPU to take responsibility in this regard under the administrative committee in human research ethics.
Provides oversight and direction for use of investigational medications in the Clinical Research Units, Pharmacy Department and throughout the clinic facilities.
Provide expert consultation to investigators on medication-related issues.

15. การบริหารจัดการยาวิจัยทางคลินิก
นโยบาย
1. การบริหารจัดการยาวิจัยทางคลินิกมี 3 แนวทาง
หัวหน้าโครงการวิจัยเป็นผู้รับผิดชอบเอง
ศูนย์วิจัยคลินิกเป็นผู้รับผิดชอบ
หน่วยวิจัยและบริการวิชาการ ฝ่ายเภสัชกรรมเป็นผู้รับผิดชอบ
2. หัวหน้าโครงการวิจัยยาทางคลินิกในโรงพยาบาลศิริราชต้องจัดให้มี
เภสัชกรหรือบุคลากรที่มีหน้าที่รับผิดชอบด้านยาวิจัยเป็นผู้ควบคุม
การเก็บรักษา การระบุฉลาก การจ่ายยา และการทำลายยาวิจัยในมนุษย์

16. Biosafety Biosafety Committee: Under Research Division
Responsibility for safety of research laboratory that involved cooperation, monitor and assess of regulation international standard.
System and measures to monitor laboratory as biological, Chemical, radiological and health.
Consider and permit the research with biolological agents.
Monitoring and supervision of the safety that research grants and/or location using the Siriraj hospital that conduct of research.
Cooperate with Mahidol university safety committee and relevant institutions.

17. Next Steps Fill gap, provide more documents -- Step II submission
Prepare for site visit: Prepare researchers (visit Depts, prepare fellows and residents), prepare IRB members, prepare relevant units (pharmacy, bio-safety, research related injury)
Site visit from AAHRPP : August – October ( 1 week long/system wide) visit and interview (about 70 persons):
Official-Dean, Vice-Deans
Administrators
Staffs
IRB members
Researchers, research assistants (nurses)

18. Interviewees Total interview time
Head of hospital/organization
45 min
IRB members and staff
7 hr (in 10 sessions)
Conflict of interest and tech transfer
40 min
Investigators
170 min (in 5 sessions)
Study nurses and assistants
70 min (in 2 sessions)
Pharmacists
30 min
Clinical trial auditor
QI person
Clinical trial contract
Chair of Biosafety Committee
Chair of Radiation Protection Committee
Document review
11 hr (in 8 sessions)

19. Comments & Questions !