Presentation on theme: "Siriraj Institutional Review Board (SIRB) Faculty of Medicine Siriraj Hospital."— Presentation transcript:
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
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 AAHRPP
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 Education Programs Conflict of Interest Pharmacy Services Contracts and Grants IRB or EC Participant Outreach Compliance Oversight Investigators and Research Staff Organizational Plan Biosafety Research related injury
The focus of accreditation Organization IRB or EC Researchers and Research staff Protecting research participants is a shared responsibility Human Research Protection Program }
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 Researchers and Research staff
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
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. Researcher conflict of interest
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. Research pharmacy
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.
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) Next Steps
IntervieweesTotal interview time Head of hospital/organization45 min IRB members and staff7 hr (in 10 sessions) Conflict of interest and tech transfer40 min Investigators170 min (in 5 sessions) Study nurses and assistants70 min (in 2 sessions) Pharmacists30 min Clinical trial auditor40 min QI person30 min Clinical trial contract40 min Chair of Biosafety Committee30 min Chair of Radiation Protection Committee30 min Document review11 hr (in 8 sessions)