What Happens If Reviewers Have Concerns?

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To avoid reviewers raising concerns, make it obvious that you've thought through every issue, and show explicitly how you will comply with all human subjects requirements.

Whether you're applying for a grant or contract, reviewers and NIAID staff examine your application carefully. Reviewers assess how well your application meets each requirement, judging its comprehensiveness and whether your plans to include special populations and protect subjects are acceptable.

Any problems, such as inadequate protection of human subjects or inclusion of special populations, may negatively affect your priority score, causing reviewers to designate a human subjects concern. This creates a bar to award until you resolve it to the satisfaction of the NIH Office of Extramural Research. A human subjects involvement code or a human subjects inclusion code on the summary statement may indicate that NIAID is barred from issuing the award.

When risks are serious and protections unacceptable, reviewers may propose the application be "Not Recommended for Further Consideration." Reviewers may also suggest changes, such as limiting the scope of the work.

If you're submitting a clinical research application, make sure you read Create a Data and Safety Monitoring Plan in this tutorial, so you can steer clear of the problems mentioned above.

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