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Human Subjects Research Requirements SOP

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

This SOP is for grants only.

Purpose

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.

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 Grantees

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 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.

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 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.

Register Clinical Trials and Send Annual Data

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

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:

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 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

Human Subject SOPs

Trans NIAID Clinical Research Toolkit

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

NIH Guide Notices

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

Other

45 CFR 46, Protection of Human Subjects, HHS

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

Office of Extramural Research, NIH

4.1.15 Human Subjects Protections, NIH Grants Policy Statement

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​​

Content last reviewed on November 28, 2016