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

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

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

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.

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.

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

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

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

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

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

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

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.

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.

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

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.

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 2014 ( 1 week long/system wide) visit and interview (about 70 persons): Official-Dean, Vice-Deans Administrators Staffs IRB members Researchers, research assistants (nurses)

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)

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