IRB Committee Member Resources

1. Seminal Documents:
   • The Belmont Report - Provided by the Office for Human Research Protections
   • International Conference on Harmonization
   • The Nuremberg Code - Provided by the Office for Human Research Protections
   • 45 CFR 46 "The Common Rule" - Provided by the Office for Human Research Protections
2. Bioethics Centers:
   • Center for Bioethics at Pennsylvania University
   • Center for Bioethics, University of Minnesota
   • The Hastings Center
   • Kennedy Institute of Ethics, Georgetown University
   • Poynter Center for the Study of Bioethics, Indiana University
   • Tuskegee University National Center for Bioethics
   • University Center for Ethics and the Professions, Harvard University
3. Books:

   Bankert, E.A. and Amdur, R.J., (2006). Institutional Review Board: Management and Function. Jones & Bartlett: Boston.

   Amdur, R.J. and Bankert, E.A. (2004). Institutional Review Board: Committee Handbook. Jones & Bartlett: Boston.

   Regulations and Guidance on the Protection of Human Subjects: Clinical Investigator, IRB, and Sponsor Responsibilities. (2006). Clinical Research Resources, LLC : Philadelphia

4. Governmental Organizations:

   Office for Human Research Protections (OHRP)

   • 45 CFR 46 DHHS Protection of Human Subjects
   • OHRP Decision Charts
   • OHRP Determination Letters
   • OHRP Glossary of Terms
   • IRB Guidebook
   • OHRP Training Module for Assurances

   U.S. Food and Drug Administration (FDA)

   • 21 CFR 50 FDA Protection of Human Subjects
   • 21 CFR 54 FDA Financial Disclosure by Clinical Investigators
   • 21 CFR 56 FDA Institutional Review Boards
   • 21 CFR 312 Investigational New Drug Application
   • 21 CFR 812 Investigational Device Exemptions
   • Center for Drug Evaluation and Research (CDER)
   • FDA Center for Biologics Evaluation and Research (CBER)
   • FDA Information Sheets for Investigators and IRBs
   • FDA - GCP in FDA Regulated Clinical Trials
5. Education and Training:
   • Collaborative IRB Training Initiative (CITI) – COMING SOON - The CITI course provides instruction in human subjects protection. The course is designed to help users understand human subjects protection issues through a web based program. The CITI human subjects research educational program consists of a Basic Course of 17 modules for Investigators and research personnel involved in Biomedical research and 11 modules specifically prepared for Investigators and research personnel involved in Social / Behavioral research. Each module is focused on a different aspect of bio-ethics and human subjects research. Modules are designed to meet the learning needs of all members of the research team. Content is developed by experts in the field of human subjects protection and is reviewed and updated every six months by experts from the international "IRB community".
   • CITI Course in Responsible Conduct of Research - The Collaborative IRB Training Initiative (CITI) course in the Responsible Conduct of Research is available to all members of the Mayo Clinic research community.
   • Investigator 101 – This highly acclaimed instructional DVD, produced by the Office for Human Research Protections (OHRP) provides essential content for Investigators. This high quality full motion video is based on two presentations: Part 1 – The History and Ethics of Human Subject Research with Jeffrey Cooper, M.D.; and Part 2 – The Top 10 Responsibilities of Investigators with Ms. Ada Sue Selwitz. Both talks are divided into short modules.Suggested Audiences: Investigators, study personnel, institutional officials, reviewers, students, IRB Committee Members and IRB staffTo receive a copy (DVD), please email your request to the IRB Service Center or stop by to pick up a copy.
   • Videotape series: Office for Human Research Protection (OHRP) produced a videotape series entitled “Protecting Human Subjects” that consists of three instructional videotapes:
     1. "EVOLVING CONCERN: Protection for Human Subjects" traces the development of today's comprehensive program to protect human subjects of research out of earlier ethical codes and societal concerns. This film selected historic events in behavioral and biomedical research to show why protection is needed and how it came about.
     2. "BALANCING SOCIETY'S MANDATES: Criteria for Protocol Review" depicts an Institutional Review Board (IRB) in action. Dr. Edmund Pellegrino, Director of the Kennedy Institute of Ethics, explains the basis for the criteria that an IRB follows in reviewing research. In commenting on IRB deliberations he points out why the IRB seeks clarification and information from the researcher.
     3. "THE BELMONT REPORT: Basic Ethical Principles and Their Application" describes the basic ethical principles that underlie research involving human subjects; respect for persons, beneficence, and justice. This film illustrates their application in case studies of biomedical and behavioral research and shows the principles at work in the resolution of ethical conflicts.

     Suggested Audiences: Investigators, study personnel, institutional officials, reviewers, students, IRB Committee Members and IRB staff

     To receive a copy (DVD), please email your request to the IRB Service Center or stop by to pick up a copy.

6. Journals and Newsletters:
   • The American Journal of Bioethics
   • Clinical Trials Advisor
   • Clinical Trials Administrator
   • Illuminata, Inc.
   • IRB: Ethics and Human Research
   • IRB Forum
   • Medical Ethics Advisor
7. Literature Searches:
   • PubMed - National Library of Medicine's database of citations to medical journal articles
   • Locator Plus - Books, journals, and audiovisuals in the NLM collections.
   • CancerLit - References to cancer literature published from the 1960s to the present
   • Medline Plus – National Library of Medicine's consumer health Web site
8. Other Online Education and Training Programs:
   • Conflicts of Interest Web-based Seminar, Columbia University (free registration required)
   • Human Participants Protection Education for Research Teams, National Cancer Institute, NIH
   • Protection of Human Subjects in Research, Indiana University (free access, free testing option)
9. Additional Resource Links:
   • Association for the Accreditation of Human Research Protections Programs (AAHRPP)
   • National Cancer Institute
   • National Cancer Institute - Simplification of Informed Consent Documents
   • Office of Research Integrity