Siriraj Institutional Review Board (SIRB) Faculty of Medicine Siriraj Hospital.
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Transcript of Siriraj Institutional Review Board (SIRB) Faculty of Medicine Siriraj Hospital.
Siriraj Institutional Review Board Siriraj Institutional Review Board (SIRB)(SIRB)
Faculty of Medicine Siriraj HospitalFaculty 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
StatesOffer accreditation worldwide
AAHRPPAAHRPP
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 organizationsAs 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
Conflictof Interest
Pharmacy Services
Contracts and Grants
IRB or EC
Participant Outreach
ComplianceOversight
Investigators and Research Staff
Organizational Plan
BiosafetyResearch related injury
The focus of accreditation
Organization IRB or EC Researchers and
Research staff
Protecting research participants is a shared responsibility
Human ResearchProtectionProgram
}
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 knowledgeThompson 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
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.
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
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นิโยบาย1. การบร�หารจั�ดการยาวิ�จั�ยทางคลิ�นิ�กมี� 3แนิวิทาง
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2. ห�วิหนิ�าโครงการวิ�จั�ยยาทางคลิ�นิ�กในิโรงพยาบาลิศิ�ร�ราชต้�องจั�ดให�มี� เภสั�ชกรหร อบ!คลิากรท�"มี�หนิ�าท�"ร�บผิ�ดชอบด�านิยาวิ�จั�ยเป็%นิผิ&�ควิบค!มี การเก'บร�กษา การระบ!ฉลิาก การจั+ายยา แลิะการท,าลิายยาวิ�จั�ยในิมีนิ!ษย-
BiosafetyBiosafety 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
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 40 min
QI person 30 min
Clinical trial contract 40 min
Chair of Biosafety Committee 30 min
Chair of Radiation Protection Committee 30 min
Document review 11 hr (in 8 sessions)