This SOP is for grants only.
To ensure that institutions receiving an HHS grant for activities involving human subjects comply with federal, U.S. Department of Health and Human Services (HHS), and NIAID regulations.
NIH sets policies for human subjects research according to federal law 45 CFR 46, Protection of Human Subjects, which applies to all domestic and international grants.
Applicants and Grantees
Find NIH policies in these documents:
- Competing grant applications
- See Part II Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan in the SF 424 Application Guide for your grant application package.
- Read the funding opportunity announcement as well as the NIH Guide notice for additional instructions.
- Follow the NIAID Clinical Terms of Award.
- Additional research requirements may apply to international research. Talk to your program officer, or go to When to Contact an NIAID Program Officer.
- Noncompeting grants (progress reports). Follow the Research Performance Progress Report (RPPR) instructions and complete the PHS Inclusion Enrollment Report and select "Planned" for enrollment type.
Before preparing a grant application, first determine whether your project qualifies as human subjects research.
- See the NIAID tutorial page Research Using Human Subjects and the Decision Trees for Human Subjects Requirements.
- Read the December 30, 2004, Guide notice to see how NIH clarified both the definition of human subjects research and instructions for research involving coded private information and biological specimens.
- Find more definitions in the SF 424 Application Guide.
Your human subjects research may also meet the NIH definition of a clinical trial. Go to Does your human subjects research study meet the NIH Definition of a clinical trial? to determine whether your project proposal meets the clinical trial criteria.
If it does, you can apply only to a funding opportunity announcement for which clinical trials are required or optional. If you are proposing to conduct an investigator-initiated clinical trial, follow NIAID's instructions at Investigator-Initiated Clinical Trial Resources and Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP.
Make sure you address protection of human subjects (risk, adequacy of protection against risks, potential benefits of the research to subjects, and importance of the knowledge gained), data and safety monitoring, and the inclusion of women, children, and minorities.
Inadequate protection or inclusion plans may negatively affect your overall impact score. See the SF 424 Application Guide for more information.
If there is a scientific rationale for examining subpopulation differences in a foreign population, consider designing your study to accommodate those differences, and discuss inclusion of the groups in your application. For details, see NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research.
Be aware of financial conflicts of interest. See Financial Relationships and Interests in Research Involving Human Subjects and the Financial Conflict of Interest for Awardees SOP. If you identify a conflict, find a way to reduce, eliminate, or manage it, and notify the chief grants management officer that you've taken those steps.
Ensure that all clinical trial staff have completed Good Clinical Practice training and that each person’s training is refreshed at least every three years, as required by the Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials.
For more help in writing an application, read Research Using Human Subjects.
Registering and submitting data. You must register applicable clinical trials on ClinicalTrials.gov, and NIH urges you to register all of them. Not registering your trial or submitting annual data is a criminal offense that could have repercussions on your award.
To submit data annually or to register, go to the ClinicalTrials.gov Protocol Registration System. If you have questions, contact your program officer.
Progress report. In the human subjects section of your progress report, create a ClinicalTrials.gov heading. Certify you've completed required submissions by following the instructions on FDAAA and Clinical Trials Supported by NIH Grants.
For additional information, read
Your institution must obtain a Federalwide Assurance and register its institutional review board (IRB) or independent ethics committee (IEC) with the HHS Office for Human Research Protections. You must get IRB or IEC approval for your application.
You must also document training for investigators and key staff in the protection of human subjects.
Follow these links:
- Electronic Submission System for Federalwide Assurances. See the Human Subjects Federalwide Assurances SOP.
- Electronic Submission System for IRB or IEC Registrations. See Human Subjects Certifications: IRB or IEC SOP.
- Certification of training in the protection of human subjects. See Human Subjects Research Training SOP.
To protect subjects from forced disclosure of personal information, NIH will automatically issue a Certificate of Confidentiality through a term and condition of award. For more information, go to the NIH Certificates of Confidentiality (CoC) website.
An application will receive a bar to award if the scientific review group is concerned about the protection of human subjects (a code 44 on the summary statement)—see Human Subjects Involvement Codes.
It can also get a bar for unacceptable gender, minority, or children inclusion—for a list of those codes, see Human Subjects Inclusion Codes.
At the end of the fiscal year, an application may get a restriction—code 48—instead.
For details, read Bars to Grant Awards—Human Subjects SOP.
For grant questions, contact Ann Devine.
For review questions, contact Hortencia Hornbeak.
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ClinRegs—for country-specific clinical research regulatory information, including comparison information, presented in plain language.
NIH Guide Notices
Policies & Standards, HHS
Research Ethics Training Curriculum by Family Health International