|Policy & Guidance|
|Compliance & Oversight|
|Research Involving Human Subjects|
|Regulations, Policies & Guidance|
|Research w/Vulnerable Populations|
|Research Using Human Specimens, Cell Lines or Data|
|Human Subjects Protections Training|
|NIH Inclusion Policies and Procedures|
|Frequently Asked Questions|
|Office of Laboratory Animal Welfare (OLAW)|
|Animals in Research|
|Peer Review Policies & Practices|
|Guidance for Reviewers|
|Intellectual Property Policy|
|Acknowledging NIH Funding|
|Invention Reporting (iEdison)|
|NIH Public Access|
Protections in addition to those described in Subpart A required for research involving children are found in Subpart D. If proposed research involves children, the following information (in addition to the information required by the PHS 398 Instructions to be addressed in the Human Subjects section) should be included in the application:
Applicants should consider and identify the risk category that they believe applies to the proposed research, and address the issues raised by the designated category. After consideration by the SRG, the category will be designated by the IRB on behalf of the institution prior to award. The categories of research are described below, and under HHS Regulatory Requirements. The full text can be found at 46.404, 46.405, 46.406, and 46.407.
There are three categories of permitted research under Subpart D:
There is one category of research that is not otherwise approvable under Subpart D:
Under “Recruitment and Informed Consent,” briefly describe the anticipated process for obtaining both assent from children and permission from their parent(s) or guardian(s), as per 46.408. If permission and/or assent are not appropriate for the population, include the information that will be provided to the IRB to justify a waiver of some or all of the elements of informed consent, as per 46.116(c), 46.116(d), or 46.408. A description of the requirements for child assent and parent/guardian permission can also be found here.
No information in addition to that required by the PHS 398 Instructions needs to be included in this section.
No information in addition to that required by the PHS 398 Instructions needs to be included in this section.here.