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Policy & Guidance

Welcome to the OHRP Policy and Guidance library!

OHRP has published a variety of policy and regulatory guidance materials to assist the research community in conducting ethical research that is in compliance with the HHS regulations. These include guidance documents and frequently asked questions (FAQs) addressing various topics, findings in the form of OHRP letters addressing regulatory issues, and other media including decision tree graphics and educational videos.

To facilitate access to this library, materials are organized into categories that should be intuitive for the research community, and are also listed alphabetically below under Policy Index. Location of a particular item within a category does not suggest that it may not be relevant to other users or under other categories, and in some instances items are cross-referenced. However, in most cases we expect that users should be able to quickly locate items of interest. The following provides a quick guide:

  • Policy Index provides an alphabetical list of all individual documents, as a way to conveniently access policy and guidance material.
  • Informed Consent groups documents that address autonomy and consent issues.
  • Institutional Issues groups documents that will be of particular concern to institutions, such as management of an IRB and conduct of IRB meetings, determination of institutional-level engagement in human subjects research, and institutional reporting requirements.
  • For Investigators groups documents that will be of particular interest to research investigators, such as how to handle subject withdrawal from a protocol, how to assess unanticipated problems and adverse events that may occur during the conduct of research, and the general responsibilities of research investigators.
  • Vulnerable Populations includes guidance addressing vulnerable groups such as children, prisoners, and subjects for whom a certificate of confidentiality may offer appropriate additional protections.
  • Biological Materials & Data groups OHRP's guidance addressing issues such as research using human subjects data and biological samples, and application of the Genetic Information Nondiscrimination Act (GINA) in research.
  • Protocol Review groups information addressing the categories and criteria for approval of human subjects research under the HHS regulations, including guidance on exempt and expedited review determinations and continuing review.
  • Frequently Asked Questions groups all sets of frequently asked questions in one place.  The questions also appear with the category to which they relate.
  • Checklists & Decision Trees groups decision charts and checklists that have been developed for the IRB community.

All documents in the Policy and Guidance section of the OHRP website reflect current regulatory guidance and findings, including older materials published by OHRP's predecessor organization, the Office for Protection from Research Risks (OPRR). Superseded policy and guidance documents, and other historical materials, are located in the OHRP Archive.

Please note that documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®.