Updated October 27, 2022
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This FDA Manual of Policies and Procedures (MAPP) establishes the policies and procedures that employees in the Center for Drug Evaluation and Research (CDER) must follow when submitting human subject research for review to FDA’s Institutional Review Board (IRB), the Research Involving Human Subjects Committee (RIHSC), in the Office of Science and Health Coordination (OSHC) within the Office of the Commissioner. These procedures must be followed, and written RIHSC approval or exemption obtained, before initiating any research involving human subjects. This MAPP also establishes policies and procedures pertaining to responsibilities for study conduct and oversight.
This MAPP is a revision of an earlier MAPP originally numbered 4112.6. The MAPP’s change in number reflects the establishment of the Office of Translational Sciences (OTS) within CDER.
Additional FDA Resources:
- 45 CFR part 46 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
- "Ethical Principles and Guidelines for the Protection of Human Subjects of Research," the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Office of the Secretary, HHS, April 18, 1979 (the Belmont Report) http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm
- "Federal-wide Assurance of Protection for Human Subjects," OHRP, HHS http://www.hhs.gov/ohrp/assurances/assurances_index.html
- Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule (http://privacyruleandresearch.nih.gov/pr_02.asp)
- Information Sheet Guidances - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
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