|A newsletter for research & medical education||June 2010|
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 themů 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
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