Resource Document for IRB members

Transcription

1 Resource Document for IRB members The purpose of this document is to provide new members and returning members of the Institutional Review Board (IRB) with: (a) An overview of the roles and responsibilities of the IRB, (b) A list of recommended and suggested education/training opportunities on human research subject protections, and (c) Links to additional important documents that may be helpful to members as they serve on the IRB. The IRB is the administrative body at the American University of Beirut (AUB) responsible for ensuring that the rights, safety, and welfare of human research subjects are fully considered and protected in accordance with international, state, and University policies and procedures. Such protections include, for example, subjects physical or psychological well being, right to privacy, or protection of social standing or employment status. Thus, the IRB has the responsibility to review all research studies involving human subjects conducted by members of the Faculty of Medicine, the Medical Center, as well as the AUB community at large. This includes research conducted on University premises, as well as multi-center or collaborative studies conducted with AUB faculty, regardless of the funding source or testing site. The IRB can approve, request modifications in, deny approval or terminate/suspend any prior approval to, any research activity that falls within its jurisdiction. Presently, the IRB holds a Federal Wide Assurance (FWA) with the Office of Human Research Protection (OHRP), U.S. Department of Human Health Services, as a domestic institution, and thus has the obligation to comply with all its regulations 1. Additionally, the IRB complies with the World Health Organization s Guidelines for Good Clinical Research Practices (GCP) and applicable regulatory requirements (e.g., International Conference on Harmonisation (ICH)). According to ICH/GCP section and Code of Federal Regulations (21CFR56.108), the functions and operations of the IRB include: Ascertaining the acceptability of proposed research in terms of institutional commitments and regulations, accreditation requirements, applicable laws and standards of professional conduct and practice; Conducting initial and continuing review of research proposals to ensure compliance with international standards or ethical practice and the approved protocol; Determining which project requires review more often than annually; Ensuring that changes to approved research plans are not implemented without IRB review and approval except when necessary to remove immediate significant hazard and to ensure human safety; Recommending the suspension of an ongoing research activity in case of deviation from the protocol and existing guidelines; Approving research protocols only when a simple majority of those members present agree that the rights, safety, and welfare of human research subjects is protected; and Reviewing and approving proposals that lie under the special circumstances sections such as exempt proposals, expedited review, rapid response and emergency approval by the IRB is the 1 Links to all regulatory and guidance documents are provided in this text or in the Attachment.

2 responsibility of the IRB Chairperson. Members of the IRB will be notified of such decisions during the following IRB meeting. To prepare new and returning IRB members for these responsibilities, as well as to familiarize individuals involved in the conduct of human subject research with a basic understanding of ethical principles as they apply to human subject protections and regulatory requirements, continuing education and training is recommended by the OHRP. Specifically, the FWA (section 12) states: the OHRP strongly recommends that the Institution and the designated IRB(s) establish educational training and oversight mechanisms (appropriate to the nature and volume of its research) to ensure that research investigators, IRB members and staff, and other appropriate personnel maintain continuing knowledge of, and comply with, the following: relevant ethical principles; relevant federal regulations; written IRB procedures; OHRP guidance; other applicable guidance, state and local laws; and institutional policies for the protection of human subjects. Furthermore, OHRP recommends that a) IRB members and staff complete relevant educational training before reviewing human subjects research; and b) research investigators complete appropriate institutional educational training before conducting human subjects research. In accordance with the FWA statement, it is strongly recommended that IRB members review five important documents and complete two on-line courses, as listed below. (1) American University of Beirut Faculty of Medicine Institutional Review Board Principles and Procedures, (2) Department of Health and Human Services (DHHS) Code of Federal Regulations for the Protection of Human Subjects ( The Common Rule ): (3) CFR Code of Federal Regulations Title 21, Part 56 Institutional Review Boards: (4) CFR- Informed Consent of Human Subjects, 21 CFR 50: wfr=1 (5) Terms of the Federal Wide Assurance (RWA): (6) The National Institutes of Health (NIH), Protecting Human Research Participants ( This on-line NIH course contains a total of 7 modules, which takes between 2 and 3 hours to complete. The user will receive a certificate upon successful completion of all modules. (7) The Collaborative Institutional Training Initiative (CITI) Program ( This on-line subscription service provides research ethics education to all members of the research community. The user can choose from courses with a Biomedical Focus (12 modules), Social and Behavioral Focus (11 modules), or General Interest (5 modules). Additionally, refresher courses are available. Upon completion of each course, the user will receive a certificate. This is a requirement for all faculty and staff engaging in clinical research in most academic institutions in the US, with required periodic certification (every 2-3 years). A short description of the CITI modules can be found at:

3 Prior to the first scheduled meeting of the IRB, that will take place in October, it is recommended that IRB members would have carefully reviewed the five documents listed above. Additionally, IRB members should complete the two on-line training courses and submit their NIH and CITI certificates to the IRB officer Ms. May Al Kassar, by Dec 31, Other on-line training opportunities, references, books, as well as links to documents and regulations mentioned in this letter, are provided in the Attachment and will be posted on the IRB website. Prepared by: Kim Smith Abouchacra, Ph.D. IRB member Approved by: Ibrahim Salti, MD, PhD. IRB Chair Ghada El-Hajj Fuleihan, MD, MPH. Associate Dean for Clinical Research September 2009

4 Resources for IRB Members Links to On-line Education and Training: Office for Human Research Protections (OHRP), Human Subjects Assurance Training. This on-line course contains a total of 3 modules. User will receive a certificate of completion upon reading through the modules. ( HIPAA ( The Health Insurance Portability and Accountability Act was enacted by U.S. Congress in HIPAA Training: Each study binder includes a training section and certification page to verify HIPAA compliance ( Links to Important Regulatory and Guidance Documents: Belmont Report: Nuremberg Code: Declaration of Helsinki Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects: World Health Organization, Guidelines for Good Clinical Research Practices Guidance for Implementation: National Institutes of Health, Guidelines for the Conduct of Research Involving Human Subjects: National Institutes of Health, Policy on Required Education in the Protection of Human Research Participants: International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH/GCP section : Frequently Asked Questions on the Requirement for Education for Protection of Human Subjects: Office for Human Research Protections: Food and Drug Administration: Office of Research Integrity: G. National Cancer Institute: List of Textbooks: Bankert, E.A., Robert, J.A. (2007). Institutional Review Board: Member Handbook (2/E). ISBN-13: , ISBN-10: Bankert, E.A., Robert J.A. (2006). Institutional Review Board: Management and Function (2/E). ISBN-13: , ISBN-10:

5 Davis, A., Bankert, E.A., Hansen, K., Kornetsky, S., McGough, H. (2006). Study Guide for Institutional Review Board Management and Function (2/E). ISBN-13: , ISBN-10: Dunn, C.M., & Chadwick, G.L. (2004). Protecting Study Volunteers In Research: A Manual for Investigative Sites (3rd ed.). Boston: CenterWatch, Inc.