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 ReviewForum for Ethical Review Committees in Asia and Western PacificAAHRPP:Association for the accreditation of human research protection program
4 AAHRPP Non-profit organization founded in 2001 Founding membersAssociation of American Medical CollegesAssociation of American UniversitiesAssociation of Public and Land-grant UniversitiesConsortium of Social Science AssociationsFederation of American Societies for Experimental BiologyNational Health CouncilPublic Responsibility in Medicine and ResearchSole accrediting body in the United StatesOffer accreditation worldwide
5 Mission of AAHRPPAAHRPP 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 agenciesSmall (fewer than 20 protocols) and large (greater than 6,000 protocols) institutionsClinical and non-clinical research programsUSA, 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 effectivelyHigh standards and protection for research participantsAn assurance of quality of research programImproved efficiently, effectiveness of policies and proceduresA competitive edgePublic trust, confidence
8 Human Research Protection Program Investigators and Research StaffEducation ProgramsConflictof InterestComplianceOversightPharmacyServicesOrganizationalPlanResearch related injuryBiosafetyContractsand GrantsParticipantOutreachIRB or EC
9 The focus of accreditation OrganizationIRB or ECResearchers andResearch staffProtecting research participants is a shared responsibilityHumanResearchProtectionProgram}
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 promotionAbility to compete for research fundingInterest in patients’ well being (in contrast to community or employer)Quest for knowledgeThompson 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 patternsBeing consultant to the companyBeing a lecturer of the companyAttending 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 pharmacyAccording 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.
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-DeansAdministratorsStaffsIRB membersResearchers, research assistants (nurses)
18 Interviewees Total interview time Head of hospital/organization45 minIRB members and staff7 hr (in 10 sessions)Conflict of interest and tech transfer40 minInvestigators170 min (in 5 sessions)Study nurses and assistants70 min (in 2 sessions)Pharmacists30 minClinical trial auditorQI personClinical trial contractChair of Biosafety CommitteeChair of Radiation Protection CommitteeDocument review11 hr (in 8 sessions)