Resource Index

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• Cooperative Research
  • The Revised Common Rule's Cooperative Research Provision (45 CFR 46.114)
  • OHRP Single IRB Exception Determinations
• Exemptions from IRB Review
  • Exemptions: Common Rule Bulletin #2
  • Implementation of the 2018 Common Rule [within the NIH IRP] (OHSRP memo-1/15/2019)
  • OHRP Human Subject Regulation Decision Charts: 2018 Requirements (Exemptions)
  • OHRP Overview of Changes to Exemptions in the Revised Common Rule (Focusing on Exemptions 1, 2, 3, and 5)
  • OHSRP Education Session: Exemptions from IRB Review and the Revised Common Rule: What Has Changed and What Has Stayed the Same? (6/13/2019) Slides and Videocast
• Informed Consent
  • Biospecimens/Data Requirements in ICF: Common Rule Bulletin #3
  • Broad Consent: Common Rule Bulletin #6
  • Key Information: Common Rule Bulletin #1
  • OHSRP Education Session: Important Changes to Informed Consent: The Regs, the Policies, the Procedures and Forms, Oh My (4/3/2019) Slides and Videocast
  • Posting of ICFs: Common Rule Bulletin #5
  • “Reasonable Person” Standard in ICF: Common Rule Bulletin #4
  • OHSRP Education Series 2020 Informed Consent One Year after the 2018 Common Rule Revisions Updated Information and Processes (1/14/2020) Slides and Videocast

• Please visit our Covid-19 page for more information.  

• Please visit our Exempt Research Page for information.

• Acronyms Commonly Used in Research
• Adverse Event Reporting
  • FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection
  • FDA webpage: “What is a Serious Adverse Event?”
• Covid-19
  • OHSRP webpage: FDA Information regarding Covid-19
  • FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19
• Drug label changes per FDA-How to Receive Email Updates from FDA
• Expanded Access
  • 21 CFR 312 Subpart I: Expanded Access to Investigational Drugs for Treatment Use
  • FDA Guidance: Expanded Access to Drugs for Treatment Use (updated 2017)
  • How to submit an Expanded Access Request (FDA)
  • Individual Expanded Access Applications: Form 3926 (2017)
• IND Safety Reporting-see section on IND safety reporting-Sponsor vs IRB Reporting Policies
• MRI: A Framework for Device Classification for Clinical Research Protocols using MRI in the In Vivo NMR Center (4/17/2020)
• OHSRP Education Session:  Bench to Bedside to Market: FDA Regulation of Medical Devices (11/4/2019):
•  Slides for Development and Regulation of Medical Devices,
•  Slides for In Vitro Diagnostic Tests as Devices), and
• Videocast including both sessions
• Policies
  • Policy 500, Research Involving Drugs, Biological, and Nutritional Products and Policy 500 Presentation
  • Policy 501, Research Involving FDA Regulated Devices and Policy 501 Presentation
  • Policy 502, Expanded Access, Including Emergency Use of Investigational Drugs, Biologics, and Medical Devices (Test Article) and Policy 502 Presentation

• Please Visit our Not Human Subjects Research page.

Please visit our Reportable Events Page for more information.

• • Assent requirements-see Policy 402 Research Involving Children and Policy 402 Presentation
  • Capacity to give consent: what is it? Who has it? (Bioethics Grand Rounds-02/05/2020) Videocast
  • Conducting Informed Consent During the COVID-19 Outbreak (OHSRP Guidance 7/13/2020)
  • Consent and assent related templates and forms
  • Consent language library
  • Obtaining Remote Consent and Guidance for Protocol Language for Remote Consent 
  • OHSRP Education Series presentations:
    • Important Changes to Informed Consent: The Regs, the Policies, the Procedures and Forms, Oh My (4/3/2020) Slides and Videocast
    • Informed Consent One Year after the 2018 Common Rule Revisions: Updated Information and Processes (1/14/2020) Slides and Videocast
  • OHRP Informed Consent FAQs
  • OHRP Simplifying Informed Consent (November 2020)
  • OHSRP FAQs
  • FAQs as pdf
  • Participants lacking capacity to consent to HSR: Policy 403 Research Involving Adults Who Lack Decision-making Capacity to Consent to Research Participation and Policy 403 Presentation
  • Policy 301 Informed Consent 
  • Short form consents
  • Vulnerable Populations: For consent requirements, see specific policies in 400 Series - Regulatory Protections for Vulnerable Populations

• Please visit our International Research page for more information.

• Accessing training completion records in the NIH CITI portal and transferring CITI records to NIH
• CITI training access link via the NIH CITI portal
• FWA Coverage and Training Requirements for Volunteers Serving as AIs on NIH Protocol
• Policy 103 Education Program and Policy 103 guidance
• OHSRP Training FAQs

• Please visit our IRB Member Review Resources page for more information.

• Acronyms Commonly Used in Research
• Ancillary reviews
  • CRADA information
  • Blood volumes limits policy at NIH (MAS Policy for the Clinical Center)
  • Deputy Ethics Counselors (DEC)
    • DEC Contacts
    • Policy 102 Investigator Conflict of Interest and Government Royalties 
    •  Policy 202 Board Member Conflict of Interest
  • Institutional Biosafety Committee
  • Policy 106 Ancillary Reviews and Policy 106 Presentation
  • RSC/RDRC
    • Radiation Dose Library for Common Procedures
    • RSC and RDRC Review: IRB and RSC Review of Research Protocols Using Radiation and Radiation Dosimetry Calculations for NIH protocols
    • RSC FAQs
    • RSC Forms & Policy Documents
  • Scientific Review
    • OHSRP resource page
    • NIH Scientific Review Process
• COVID-19-IRB information regarding COVID-19
• Identifiable information: Guidance for Determining Whether Data Constitutes Individually Identifiable Information Under 45 CFR 46
• Genomics
  • NIH Genomic Data Sharing (NIH OSP)
  • Secondary Genomics Findings Service (Les Biesecker 11/19/2018) Videocast
• International Research
  • Information to be included in protocols conducted in another country  (scroll down to section 700 of the page)
  • IRB review and informed consent documents to be used in research conducted in other countries (scroll down to section 700 of the page)
  • Policy 700 International Research and Policy and Policy 700 Presentation
• IRB Oversight: IRB Oversight for my NIH Protocol: Who Needs it and How to Get it (OHSRP Decision Tree)
• MRI
  • Device Classification for Clinical Research Protocols using MRI in the In Vivo NMR Center
  • Guidance on Gadolinium Administration in Human Subjects Research at the NIH Intramural Research Program
• NIH IRP Guidance on Pregnancy Testing
• Obtaining Remote Consent and Guidance for Protocol Language for Remote Consent 
• OHRP Engagement of Institutions in Human Subjects Research (2008)
• OHRP Independent Review of Research
• OHRP Investigator Responsibilities FAQs
• OHRP Reporting to OHRP: Unanticipated Problems (2020)
• OHRP What are IRBs?

Please visit our Reportable Events page for more information. 

• Contact email for C&T: OHSRPCompliance@od.nih.gov
• Definition (See Policy 802, section 4.5)
• OHRP Reporting to OHRP: Unanticipated Problems (2020)
• OHSRP Education Series archived presentations (webpage with slides and videocast links for each session)
• OHSRP Education Presentation: Two Years Since Release of the “NEW” OHSRP Research Related Event Reporting Policies: How is the IRP Doing? (5/4/2021) Slides and Videocast
• Policies
  • Policy 101 Organizational Structure of the OHSRP, and Policy 101 Presentation 
  • Policy 104 Managing Research-Related Complaints from Research Subjects, and Policy 104 Presentation
• Responsibilities of C&T (See Policy 801, section 5.2.1)
• Staff in C&T
  • Brenna Hansen: hansen@nih.gov
  • Dorinda Metzger: metzger@nih.gov
  • Peg Sanders: sanders@nih.gov

• Enrollment of NIH staff (as related to privacy considerations) see Policy 404 Research Involving NIH Staff as Subjects and Policy 404 Presentation
• Privacy FAQs (as related to the Privacy Act of 1974)
• NIH Privacy Glossary (NIH Office of the Senior Official for Privacy, 2017)
• Privacy language required in informed consent documents, See Consent Templates
• Privacy Rule (HIPAA Privacy Rule), For Implications of HIPAA on recruitment at non-NIH recruitment sites see OHSRP Information Sheet: Recruitment and Screening of Potential Participants for Research Reviewed by the NIH IRB
• Policy 107: Privacy and Confidentiality and Policy 107 Presentation

• FDA Information Sheet: Recruiting Study Subjects: Guidance for Institutional Review Boards
• Policy 302 Subject Recruitment and Compensation
• OHSRP Recruitment Information Sheet
• OHRP Guidance: IRB Review of Clinical Trial Websites
• NIH Social Media Guidelines

• Federalwide Assurance Numbers (OHRP database)
• Decision Tree: IRB Oversight for my NIH Protocol: Who needs it and How to Get it
• FWA Coverage and Training Requirements for Volunteers Serving as AIs on NIH Protocol
• OHRP What are IRBs?
• OHSRP Guidance: What is the NIH Federalwide Assurance (FWA) and how does this relate to multi-site research conducted by the NIH Intramural Research Program (IRP)?
• Policies and guidance documents
  • FWA Coverage and IRB Reliance in Collaborative Research
    • Policy 100, the NIH IRP’s HRPP 
    • Policy 105 IRB Reliance and Collaborative Research 
    • Policy 109 Coverage under the NIH Federalwide Assurance 
• NIH sIRB Policy in the context of the IRP during COVID-19 Pandemic
• OHSRP Education Series presentations:
  • What you Need to Know about Single IRB Review Part 1 (7/7/2020) Slides and Videocast
  • What You Need to Know About Single IRB Review Part 2 (8/4/2020) Slides and Videocast
• Reliance and Single IRB Resources
• Workflow Diagram: Reliance Arrangements
  • NIH is Lead Site Study Team and Serving as the Single [Reviewing] IRB
  • NIH Study Team Relying on an External Reviewing IRB

Please visit our Reportable Events page for more information.

Please visit our Secondary Research page for more information.

• Please Visit our Sharing Data and Specimens page here. 

• Please visit our Reportable Events page for more information.

• Please see our Vulnerable Populations page for more information.