Human Subjects Research Requirements in Grants SOP

This standard operating procedure (SOP) includes the following sections: PurposeProcedureContacts, and Links.

Purpose

To ensure that institutions receiving grants from the U.S. Department of Health and Human Services (HHS) for activities involving human subjects comply with federal regulations and HHS and NIAID policies.

Procedure

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 Grant Recipients

Find NIH policies in these documents:

Is the Project Human Subjects Research?

Before preparing a grant application, first determine whether your project qualifies as human subjects research.

Follow NIAID Process for a Clinical Trial

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 notice of funding opportunity for which clinical trials are required or optional. Follow NIAID’s instructions at Investigator-Initiated Clinical Trial Resources and Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP.

Find more NIAID information and advice at Clinical Trial Research.

Comply With Requirements

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 Conflict of Interest: HHS Guidance and the Financial Conflict of Interest for Awardees SOP.

Ensure that all clinical trial staff have completed Good Clinical Practice training and that each person’s training is refreshed at least every 3 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.

Register Clinical Trials and Send Annual Data

Registering and submitting data. You must register clinical trials on ClinicalTrials.gov when they fall under NIH’s Policy and Regulation on ClinicalTrials.gov Registration and Reporting. 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. Learn about Requirements for Registering and Reporting NIH-Funded Clinical Trials in ClinicalTrials.gov.

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 Requirements for Registering and Reporting NIH-Funded Clinical Trials in ClinicalTrials.gov.

For additional information, read

Document Certification, Federalwide Assurance, Training

Your institution must obtain a Federalwide Assurance and register its institutional review board (IRB), single institutional review board (sIRB), or independent ethics committee (IEC) with the HHS Office for Human Research Protections. You must get IRB, sIRB, 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:

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.  

If You Get a Bar or Restriction

An application will receive an award restriction if the scientific review group is concerned about the protection of human subjects (a code 48 on the summary statement)—see Human Subjects Involvement Codes.

It can also get a bar to award for unacceptable gender, minority, or age inclusion—for a list of those codes, see Human Subjects Inclusion Codes.

For details, read Bars and Restrictions to Grant Awards—Human Subjects SOP.

Contacts

For grant questions, contact Samuel Ashe.

For review questions, contact Ann-Marie Brighenti.

Use the contacts listed above for questions about your specific situation. If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at deaweb@niaid.nih.gov.

Links

Single IRB for Multisite or Cooperative Research

NIAID Staff Guidance—NIH Policy on Dissemination of NIH-Funded Clinical Trial Information

Rules and Policies: Special Considerations—for NIAID human subjects SOPs

Rules and Policies for Clinical Research

ClinRegs—for country-specific clinical research regulatory information, including comparison information, presented in plain language.

Data and Safety Monitoring

Clinical Trial Safety Monitoring and Reporting Requirements Flowchart

Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, FDA

Coded Private Information or Specimens Use in Research, Guidance, OHRP

Financial Conflict of Interest: HHS Guidance

Human Subjects Research, NIH

NIAID Clinical Terms of Award Restriction for China

Office of Extramural Research, NIH

4.1.15 Human Subjects Protections, NIH Grants Policy Statement

Policies & Standards, HHS

Special Protections for Children as Research Subjects, OHRP

Privacy Act of 1974

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