Repercussions for failing to meet any of the human subjects requirements are two tiered:
- If your application is missing any or all of the required sections addressing human subjects, it will be considered incomplete. In rare circumstances, NIAID may return it without a review or score.
- Further, your application may be restricted or barred from an award until you resolve the problem by sending your program officer adequate documentation. Concerns about protection of human subjects are coded on the summary statement with a "48," and concerns about adequate representation of women, minorities, or children are coded with a "U" for each subpopulation having a concern. For more information about what the codes are and what they mean, see Human Subjects Involvement Codes and Human Subjects Inclusion Codes.
Human subjects requirements cover protection from research risk, data and safety monitoring of clinical trials, and inclusion of women, minorities, and children in all clinical research, with a special requirement for phase III trials to include plans for analyses capable of showing intervention differences between men and women and between minorities and non-minorities.
For more information, see NIAID Human Subjects Resources.