Human Subjects and Clinical Trial Information

We provide expertise and guidance on completion of the human subjects and clinical trial information forms required for NIH grant submissions.

Guidance documents, forms, templates and helpful links are listed below. In addition, investigators may contact the Regulatory Service to request a review of their grant for feedback on the adequacy of human subject and clinical trial sections prior to submission of the application to NIH.

Forms/Templates

• PHS Human Subjects and Clinical Trials Information (fillable form - Adobe Acrobat required) for due dates on or after January 25, 2023
• Human Subjects Study Record (fillable form - Adobe Acrobat required) for due dates on or after January 25, 2023
• Template to Prepare Human Subjects & Clinical Trial Sections
• Planned or cumulative enrollment table
• Inclusion Enrollment Data Report Template (age, race, ethnicity & gender) – CSV file for upload to HSS
• Annotated Form Set for PHS Human Subjects and Clinical Trial Information (FORMS-F)
• Recruitment and Retention Plan Template (sample language)
• Multi-PI Leadership Plan template (sample language)
• NIH data sharing plan template (sample language)
• Data Management and Sharing Plan development tool

Guidance Documents and Materials

• Human Subjects and Clinical Trial Information sections to complete (per type of study)
• Inclusion Plans guidance (women, children, minorities, individuals across the lifespan)
• Data and Safety Monitoring Plan (DSMP) and Board (DSMB) guidance for NIH grants
• Protocol Synopsis Guidance (with word counts)
• Single IRB (UNC as reviewing IRB) (suggested language for grant applications)
• Single IRB for multicenter clinical research NIH guidance
• Dissemination Plan & CT.gov suggested language for grant submissions
• Institutional Certification for Human Genomic Data Sharing (UNC)
• Checklist for evaluating whether a clinical trial or study is an Applicable Clinical Trial (ACT)

Websites/Videos

• NIH website on Human Subject Research
• General application guide for NIH and other PHS agencies (Forms H) - see Human Subjects and Clinical Trial Information guidance
• NIH Annotated Form Sets H (includes Human Subjects and Clinical Trial Information)
• NIH slides – preparing the Human Subjects Sections
• Walk-through of the PHS Human Subjects and Clinical Trial form (video)
• NIH Definition of Clinical Trials Case Studies
• NIH website on Certificates of Confidentiality
• NIH Institutional Certifications
• NIH Inclusion Across the Lifespan Infographic: guidance for applying the policy
• Overview of new policies on Human Subject Research (video)
• Writing the Human Subject Section (training video from NC State)
• UNC Resources for Data Management and Sharing Plans