This site provides, HHS and NIH requirements and resources for the extramural community involved in human subjects research in their roles as: Applicants/Grantees, Offerors/Contractors, Peer Reviewers, Institutional Officials.
30-day Comment Extension - The comment period for the Notice of Proposed Rulemaking (NPRM) for the Federal Policy for the Protection of Human Subjects (The Common Rule; 45 CFR 46) has been extended to January 6, 2015 by the Office of the Federal Register: https://www.federalregister.gov/articles/2015/09/08/2015-21756/federal-policy-for-the-protection-of-human-subjects. The document is now open for review and comments. Comments can be submitted electronically to www.regulations.gov; search for the docket number HHS–OPHS–2015–0008.
A brief summary of the proposed changes can be accessed at the following HHS website: http://www.hhs.gov/ohrp/humansubjects/regulations/nprm2015summary.html
- Human Subjects Infographic - This one-page infographic is a guide to defining human subjects research at the NIH. It summarizes human subjects research, what you will need for your NIH application and what you will need if you are funded.
- Preparing the Human Subjects Section - Are you working on human subjects research or human specimens or data? Should you submit a Data and Safety Monitoring Plan? This 15-slide presentation simplifies the human subjects scenarios found in the Supplemental Grant Application Instructions for NIH applications (http://grants.nih.gov/grants/funding/424/SupplementalInstructions.pdf). Find the scenario that best describes your research to determine what supplemental information needs to be submitted with your NIH application.