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

การบร�หารจั�ดการยาวิ�จั�ยทางคลิ�นิ�ก นิโยบาย1. การบร�หารจั�ดการยาวิ�จั�ยทางคลิ�นิ�กมี� 3แนิวิทาง

• หั�วหัน้�าโครงการว�จั�ยเป็�น้ผู้��ร �บผู้�ดชอบเอง• ศู�น้ย�ว�จั�ยคลิ�น้�กเป็�น้ผู้��ร �บผู้�ดชอบ• หัน้�วยว�จั�ยแลิะบร�การว�ชาการ ฝ่ ายเภสั�ชกรรมเป็�น้ผู้��ร �บผู้�ดชอบ

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-

นิโยบาย1. การบร�หารจั�ดการยาวิ�จั�ยทางคลิ�นิ�กมี� 3แนิวิทาง

• หั�วหัน้�าโครงการว�จั�ยเป็�น้ผู้��ร �บผู้�ดชอบเอง• ศู�น้ย�ว�จั�ยคลิ�น้�กเป็�น้ผู้��ร �บผู้�ดชอบ• หัน้�วยว�จั�ยแลิะบร�การว�ชาการ ฝ่ ายเภสั�ชกรรมเป็�น้ผู้��ร �บผู้�ดชอบ

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)