On This Page:

1. Risks to Subjects
2. Adequacy of Protection Against Risks
3. Potential Benefits to Subjects and to Others
4. Importance of Knowledge to be Gained
5. Inclusion

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:

a. Risks to Subjects

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:

• Research that involves no more than minimal risk (46.404);
• Research that involves more than minimal risk but may provide direct benefit to individual subjects (46.405); and
• Research that involves a minor increase over minimal risk, does not present the prospect of direct benefit to individual subjects, but is likely to yield generalizable knowledge about the subjects' disorder or condition (46.406)

There is one category of research that is not otherwise approvable under Subpart D:

• Research that is not otherwise approvable but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children (46.407)

b. Adequacy of Protection Against Risks

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.

c. Potential Benefits to Subjects and to Others

No information in addition to that required by the PHS 398 Instructions needs to be included in this section.

d. Importance of Knowledge to be Gained

No information in addition to that required by the PHS 398 Instructions needs to be included in this section.

e. Inclusion