RESEARCH TIPS

This column is devoted both to sharing new information and reminding investigators of regulatory requirements and best practices in research. 

This Month’s Subject—NIH Policy & Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects

Did you know?

It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them… The inclusion of children as subjects in research must be in compliance with all applicable subparts of 45 CFR part 46 as well as other pertinent federal laws and regulations.

Massachusetts age of majority; legal capacity is 18.

Proposals for research involving human subject must include a description of plans for including children.  …The investigator should create a section titled “Participation of Children.”  This section should provide either a description of the plans to include children and a rationale for selecting or excluding a specific age range of child, or an explanation of the reason(s) for excluding children as participants in the research.

Justifications for Exclusions

1. The research topic to be studied is irrelevant to children.

2. There are laws or regulations barring the inclusion of children in the research. 

3. The knowledge being sought in the research is already available for children or will be obtained from another ongoing study, and an additional study will be redundant.

4. A separate, age-specific study in children is warranted and preferable.  Examples include:

• Insufficient data are available in adults to judge potential risk in children

• Study designs aimed at collecting additional data on pre-enrolled adult study participants

• Other special cases justified by the investigator and found acceptable to the review group and the Institute Director.

Additional Resources

For full text please see:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html