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 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 Human Subjects. |
