Research Involving Human Subjects
About Peer Review
Learn about the review of human subjects during the peer review process. Applicants can get a better idea of what peer reviewers look for in the application and Protection of Human Subjects section. Peer Reviewers can find guidance for reviewing the human subjects research plan.
The Interim Final Rule to delay revisions to the Common Rule that was put on public display by the Office of the Federal Register last week (see January 17, 2018 listserv announcement about that here: https://www.hhs.gov/ohrp/interim-final-rule-common-rule.html) was published in yesterday’s edition of the Federal Register. To access the IFR Federal Register Notice, go here: https://www.gpo.gov/fdsys/pkg/FR-2018-01-22/pdf/2018-00997.pdf. To be assured consideration, comments on the IFR must be received no later than 11:59 p.m. Eastern Standard Time on March 19, 2018. To submit comments during the open comment period or browse posted comments, go here: https://www.regulations.gov/document?D=HHS-OPHS-2017-0001-0001.
This delay does not impact any NIH-specific policies, such as the implementation of the NIH's Single IRB Policy, which is effective for research applications submitted for due dates on or after January 25, 2018.
A brief summary of the proposed changes can be accessed at the following HHS website: http://www.hhs.gov/ohrp/humansubjects/regulations/nprm2015summary.html
NIH has published a Guide Notice (NOT-OD-15-127) describing the implementation of new research requirements contained in the Newborn Screening Saves Lives Reauthoriztion Act. This legislation designates federally funded research using newborn dried blood spots collected on or acter March 18, 2015 as non-exempt human subjects research for which parental permission must have been obtained.
Implementation questions should be directed to Dr. Tina Urv and NICHD.
New Human Subjects Tools
- Preparing the Human Subjects Section - Have you seen the new PHS Human Subjects and Clinical Trials Information Form? Are you working on human subjects research or human specimens or data? Should you submit a Data and Safety Monitoring Plan? This presentation simplifies the human subjects scenarios used to describe the different options for human subjects in research. Find the scenario that best describes your research to determine what information is needed with your NIH application. This guide has been updated for the new form, additional requirements for clinical trials, and specific information for career development (K), fellowship (F), and training (T) applications.
- 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. This will be updated with the implementation of the Revised Common Rule.
- Exemptions Infographic - This one-page infographic is a guide to simplify the 3 human subjects research exemptions most commonly used at the NIH. It summarizes Exemptions 1, 2 and 4 providing basic definitions, examples of studies that meet and do not meet the criteria of the exemption, and things one must consider when engaged in exempt human subjects research. This will be updated with the implementation of the Revised Common Rule.