How Human Subjects Applications are Reviewed

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When preparing your application, you should consider how it will be read by reviewers. In addition to the regular review criteria for scientific merit, reviewers use four other criteria to judge human subjects research applications. Keep them in mind when planning your project and application:

• Risks to subjects.
• Adequacy of protection against risks.
• Potential benefits to the subjects and others.
• Importance of the knowledge to be gained.

You also need to provide justifications for inclusion or exclusion of populations (gender, minorities, and children). To learn more, read the following:

• Electronic applications. Under Part II, Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan, see the following:
  • 5.6 NIH Policy on the Inclusion of Women and Minorities in Clinical Research.
  • 5.7 NIH Policy on Inclusion of Children in the Grant Application Guide for your Grant Application Package.
• Paper applications. Under Part II, Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan, see the following:
  • 5.6 NIH Policy on the Inclusion of Women and Minorities in Clinical Research.
  • 5.7 NIH Policy on Inclusion of Children, in the PHS 398 for more information.

Peer reviewers will gauge the adequacy of your plans to protect subjects from research risk and to include required populations, an assessment independent of your IRB's or IEC's. If your description is inadequate or your application does not comply with requirements, your priority score may suffer and your application may get a bar to award.

Read our human subjects warning, and see NIAID Decision Trees for Human Subjects Requirements to learn how reviewers determine whether you meet requirements.

Inadequately addressing any required item may negatively affect your score. In rare circumstances, if you fail to address any required item, your application may not get a review or receive a score. To cut your risks, leave no questions about what you propose to do. Clearly state how you will include diverse groups and protect subjects from study-related risks, and describe the benefits of your research to patients and public health.

Although your institution determines whether your research is considered human subjects, the scientific review officer works with peer reviewers to confirm or amend this determination to comply with NIH's Implementation of Office for Human Research Protections (OHRP) Guidance on Research Involving Coded Private Information or Biological Specimens.

For additional information, see Are You Conducting Human Subjects Research? in this tutorial.

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