Educational Resources for Institutional Officials

OHRP created this list of resources to help IRB members learn about and succeed in their role in protecting research subjects.

Learn about upcoming OHRP educational events
https://www.hhs.gov/ohrp/education-and-outreach/upcoming-educational-events/index.html

Join OHRP’s mailing list 
https://www.hhs.gov/ohrp/news/sign-up-for-announcements/index.html

View OHRP’s Online Assurance Training
https://www.hhs.gov/ohrp/education-and-outreach/human-research-protection-program-fundamentals/index.html

Watch educational videos
The videos below cover material that is particularly relevant to IRB members

• OHRP Reporting Requirements
• IRB Records, Parts I and II
• When the Assurance Comes A Knockin': OHRP's FWA and IRB Registration Process
• When the Feds Come A Knockin': How to Prepare for an OHRP Compliance Evaluation of Your Program

More videos can be found on OHRP’s Online Education page: https://www.hhs.gov/ohrp/education-and-outreach/online-education/index.html

Find OHRP guidance
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/index.html

Review commonly used guidance for Institutional Officials

• Assurance Process FAQs:
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/assurance-process/index.html
• IRB Registration Process FAQs:
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/irb-registration-process/index.html
• Compliance Oversight Procedures for Evaluating Institutions (2009):
https://www.hhs.gov/ohrp/compliance-and-reporting/evaluating-institutions/index.html
• Guidance on Reporting Incidents to OHRP (2011):
https://www.hhs.gov/ohrp/compliance-and-reporting/guidance-on-reporting-incident/index.html
• Determining When Institutions are Engaged in Research (2009):
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/determining-when-institutions-are-engaged-in-research/index.html
• Extending an FWA to Cover Collaborating Investigators (2005):
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/extension-of-institutional-fwa-via-individual-investigator-agreement/index.htm
• Institutional Review Board Written Procedures: Guidance for Institutions and IRBs (2018):
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/institutional-issues/institutional-review-board-written-procedures/index.html
• Minutes of Institutional Review Board Meetings Guidance for Institutions and IRBs (2017):
https://www.hhs.gov/ohrp/minutes-institutional-review-board-irb-meetings-guidance-institutions-and-irbs.html-0
• Unanticipated Problems Involving Risks and Adverse Events Guidance (2007) at:
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-unanticipated-problems/index.html

Please also review relevant materials on the Revised Common Rule at:
https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/index.html