Human Subjects Research Requirements

This SOP is for grants only.

Purpose

To ensure that institutions receiving an HHS grant for activities involving human subjects comply with federal, HHS, and NIAID regulations.

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. Find NIH policies in these documents:

• Competing grant applications
  • For electronic submissions, 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.
  • For paper submissions, use the PHS 398 Part II Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan.
  • 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 Contact Staff for Help.
• Noncompeting grants (progress reports). Follow the PHS 2590 Instructions and complete the Targeted/Planned Enrollment Table.

Is the Project Human Subjects Research?

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

• See NIAID's tutorial page Are You Conducting Human Subjects Research? 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 PHS 398, SF 424 (R&R) Application Guide, or our Glossary of Funding and Policy Terms.

Follow NIAID's Process for an Investigator-Initiated Clinical Trial

If you are proposing to conduct an investigator-initiated clinical trial, follow NIAID's mandatory approach. For details, go to Investigator-Initiated Clinical Trial Resources and the Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP.

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 PHS 398 instructions 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.

For more help in writing an application, read our NIAID Human Subjects Application and Grant Handbook.

Register Clinical Trials and Send Annual Data

Registering and submitting data. You must register applicable clinical trials—see the glossary term applicable clinical trial—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 NIH's FDAAA and Clinical Trials Supported by NIH Grants.

For additional information, read:

• Clinical Trials.gov Protocol Registration System
• NIH Fact Sheet—Registration at ClinicalTrials.gov

Document Certification, Federalwide Assurance, Training

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 Certifications: Training SOP.

To protect your subjects from forced disclosure of personal information, you may request a Certificate of Confidentiality. For more information, read our Certificates of Confidentiality SOP.

If You Get a Bar or Restriction

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.

Contacts

For grant questions, contact Ann Devine.

For review questions, contact Hortencia Hornbeak.

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with this link and your message. Thanks for helping us clarify and expand our knowledge base.

Links

Clinical Terms of Award at NIAID's Human Subjects Resources

Human Subjects SOP List

Trans NIAID Clinical Research Toolkit

NIH Guide Notices

Data and Safety Monitoring and Further Guidance for Phase I and II

Other

45 CFR 46, Protection of Human Subjects, HHS

• 45 CFR 46 Subpart A, Basic HHS Policy for Protection of Human Research Subjects.

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

Guidance on Research Involving Coded Private Information or Biological Specimens, OHRP

HHS Provides Guidance on Financial Relationships and Interests in Research Involving Human Subjects

Research Involving Human Subjects, NIH

Office of Biotechnology Activities, NIH

NIAID Clinical Terms of Award Restriction for China

NIH's Office of Extramural Research

NIH Grants Policy Statement, section on Human Subjects

Policies & Standards, HHS

Protection of Human Subjects: Assurance Identification/IRB Certification/Declaration of Exemption form

Research Ethics Training Curriculum by Family Health International

Special Protections for Children as Research Subjects, OHRP

Privacy Act of 1974