Notice

Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.

Updates regarding government operating status and resumption of normal operations can be found at USA.gov.

Human Subjects Warning

Repercussions for failing to meet any of the human subjects requirements are two tiered:

  1. 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.
  2. If your plans for compliance with human subjects requirements are inadequate, your overall impact/priority score may be negatively affected. Further, your application will be 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 "44," 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.

Content last reviewed on February 3, 2014