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.
The NIH's Definition of Children to Change
The NIH has issued Guide Notice NOT-OD-16-010 "Inclusion of Children in Clinical Research: Change in NIH Definition". Starting with applications/proposals submitted for due dates on or after January 25, 2016, for the purposes of inclusion policy, the age of a child will be defined as individuals under 18 years old instead of under 21 years old, the current NIH definition of a child for inclusion policy considerations. Applicants/offerors for NIH funding will still be expected to justify the age range of the proposed participants in their clinical research, with particular attention paid to addressing the inclusion (or exclusion) of children (or subsets of children). However, now that threshold applies to individuals under the age of 18 rather than under the age of 21. For more information on the child inclusion policy: https://grants.nih.gov/grants/funding/children/children.htm.
Human Chimera Research
The NIH issued Guide Notice NOT-OD-15-158 "NIH Research Involving Introduction of Human Pluripotent Cells into on-Human Vertebrate Animal Pre-Gastrulation Embryos". The Notice informs the research community that the NIH will not fund research in which human pluripotent cells are introduced into non-human vertebrate animal pre-gastrulation stage embryos while the Agency considers a possible policy revision in this area. Applications for such research will not proceed through the peer review process and no awards will be issued for research that fits the description.
A Notice of Proposed Rulemaking (NPRM) for the Federal Policy for the Protection of Human Subjects (The Common Rule; 45 CFR 46) was released on September 8, 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.
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.