# Continuing Education ## IRB Member Continuing Education Archive ### 2026 expand\_more January 2026: HRP-001--SOP - Definitions; [**Reporting and Management of Concerns**](https://irbmemberspage.hsites.harvard.edu/sites/g/files/omnuum10236/files/2026-01/Reporting%20and%20Management%20of%20Concerns%201.2026.pdf) (PDF) February 2026: [Issues to Consider in the Research Use of Stored Data or Tissues](https://www.hhs.gov/ohrp/regulations-and-policy/guidance/issues-to-consider-in-use-of-stored-data-or-tissues/index.html) (first section); HRP-504 - Template - HUA Repository Protocol April 2026: [Research with Prisoners](https://irbmemberspage.hsites.harvard.edu/sites/g/files/omnuum10236/files/2026-04/Prisoner%20research%204.2026.pdf); HRP-415 - Checklist - Research Involving Prisoners ### 2025 expand\_more January 2025: HRP-314 - Worksheet - Criteria for Approval and Additional Considerations; HRP-302 - Worksheet - Calculation of Approval Intervals; [**OHRP** **Continuing Review Guidance**](https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-continuing-review-2010/index.html) (2010); [**Continuing Review**(PDF)](/file_url/137) February 2025: [Updates on 2025 **Federal Research Policy Changes**](https://research.harvard.edu/research-policies-compliance/2025-federal-policy-changes/) June 2025: [**Reporting and Management of Concerns** (PDF)](https://irbmemberspage.hsites.harvard.edu/sites/g/files/omnuum10236/files/2025-06/Reporting%20and%20Management%20of%20Concerns%206.2025.pdf) August 2025: [**Expedited Review** (PDF)](https://irbmemberspage.hsites.harvard.edu/sites/g/files/omnuum10236/files/2025-08/IRB%20Board%20CE%20-%20Expedited%20Review%20August%202025.pdf) October 2025: **Consultant Review and** [**Scientific and Scholarly Review Refresher**](https://irbmemberspage.hsites.harvard.edu/sites/g/files/omnuum10236/files/2025-10/HUA%20IRB%20CE_Scientific%20and%20Scholarly%20Review%20Refresher%2010.2025.pdf): HRP-051-SOP-HUA-Consultation; HRP-046-SOP-HUA-Scientific or Scholarly Review; HRP-320-WORKSHEET-Scientific or Scholarly Review November 2025: 12J - [**Human Fetal Tissue in Research**](https://irbmemberspage.hsites.harvard.edu/sites/g/files/omnuum10236/files/2025-11/Human%20fetal%20tissue%20refresh%2011.2025.pdf); [Massachusetts law, MGL Chapter 112C, § 12J(a)](https://malegislature.gov/Laws/GeneralLaws/PartI/TitleXVI/Chapter112/Section12J); HUA IRB Investigator Manual - page 81; HRP-045 – SOP – HUA – Use of Human Fetal Tissue in Research; HRP-445-CHECKLIST-Use of Human Fetal Tissue in Research ### 2024 expand\_more January 2024 - [Human Fetal Tissue (PDF)](/file_url/130) February 2024 - [Informed Consent -- Respect for Persons, Elements (PDF)](/file_url/131); [The Belmont Report](https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html); HRP-314 - WORKSHEET - Criteria for Approval; HRP-502c - TEMPLATE - HUA Exempt Human Research Consent Script; HRP-502 - TEMPLATE - HUA Adult Consent Form March 2024 - [Informed Consent -- Special Populations (PDF)](/file_url/132); Investigator Manual; HRP-502b -- TEMPLATE -- HUA Parental or Guardian Permission; HRP-502a -- TEMPLATE -- HUA Child Assent; HRP-416 - CHECKLIST -- Research Involving Children; HRP-417 -- CHECKLIST -- Research Involving Cognitively Impaired Adults; HRP-013 --SOP-- HUA -- Legally Authorized Representatives, Children, Guardians. April 2024 - [Reporting and Management of Concerns (PDF)](/file_url/133); HRP-001 - SOP - HUA - Definitions; HRP-024 - SOP - HUA - New Information; Reporting to OHRP (1): Unanticipated Problems [video](https://www.youtube.com/watch?v=cvly9PoAqIo); Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events: OHRP [Guidance](https://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-unanticipated-problems/index.html#Q1) (2007) September 2024 - [Informed Consent -- Documentation (PDF);](/file_url/134) HUA Investigator Manual; HRP-314 - Worksheet - Criteria for Approval and Additional Considerations; HRP-411 - Checklist - Waiver of Written Documentation of the Consent Process October 2024 - [Informed Consent -- Waiver of Consent(PDF);](/file_url/135) HUA Investigator Manual; HRP-314 - Worksheet - Criteria for Approval and Additional Considerations; HRP-410 - Checklist - Waiver or Alteration of Consent Process December 2024 - [Informed Consent - Final Odds and Ends](/file_url/136); HUA Investigator Manual; HRP-315 - Worksheet - Advertisements; [Topics for Guidance: Secondary Data, Data Security, Contracts and Collaboration](https://cuhs.harvard.edu/topics-guidance-secondary-data-data-security-contracts-and-collaboration-0) ### 2023 expand\_more January 2023 - [COMS and Radiation PowerPoint](/file_url/124) May 2023 - [OVPR (Office of the Vice Provost for Research), OUE (Office of Undergraduate Education) and OGC (Office of General Counsel)](/file_url/125). See also HRP-309-Worksheet-HUA Policies concerning Ancillary Reviews; see HRP-335-Worksheet-Provost Review. June 2023 - [HRPP 2023 PowerPoint Presentation](/file_url/126) See also HRP-101 - HUA Human Research Protection Program Plan; HRP-103 - HUA Investigator Manual; HRP-318 - Worksheet - Additional Federal Agency Criteria. July 2023 - [HSR and Board Actions 2023](/file_url/127) See also HRP-309 - Worksheet - Harvard Policies; HRP-314 - Worksheet - Criteria for Approval and Additional Considerations; HRP-330 - Worksheet - HIPAA Authorization; HRP-331 - Worksheet - FERPA Compliance; HRP-336 - Worksheet - Harvard Research Data Security Level Decision Aid. August 2023 - [AAHRPP Training Slides - Criteria for Approval ](/file_url/128) See also HRP-314 - Worksheet - Criteria for Approval and Additional Considerations November 2023 - [IRB Members AAHRPP Updates: Meeting Preparation and Minutes](/file_url/129) See also HRP-40—SOP—HUA—IRB Meeting Preparation; HRP-43—SOP—HUA—IRB Meeting Minutes; HRP-340 - Worksheet - HUA IRB Meeting Documentation ### 2022 expand\_more January 2022 - [HRP-051 Consultation](/file_url/113) - PowerPoint presentation February 2022 - [Expedited Categories](/file_url/114) April 2022 - [What is FDA Regulated (part 2, Devices)](/file_url/115) May 2022 - [Harvard Policies Tour: Payment Policy](/file_url/116) June 2022 - [Harvard Policies Tour: fCOI](/file_url/118), [Before and After Meeting](/file_url/117) July 2022 - [Harvard Policies Tour: PI Eligibility and Faculty Sponsor Assurance](/file_url/119) September 2022 - [IRB Website and Member Resources Review](/file_url/120) October 2022 - [Overview of Scientific and Scholarly Review](/file_url/121), [Scientific and Scholarly Review Slide Presentation](/file_url/122) November 2022 - [Reporting and Management of Concerns](/file_url/123), From the ESTR Library: HRP-024- SOP - HUA - New Information, HRP-001- SOP - HUA - Definitions, HRP-321- Worksheet - Review of Information Items December 2022 - [The Harvard Research Data Security Policy](/file_url/156), [OVPR Research Data Management Webpage](https://research.harvard.edu/2020/06/26/research-data-management/), HRP-336-Worksheet - Harvard Research Data Security Level Decision aid, HRP-340 - WORKSHEET - HUA - IRB Meeting Documentation Aid ### 2021 expand\_more March 2021 - [What is a RNI?](/file_url/151) August 2021 - [Before and After Meeting](/file_url/146) September 2021 - Data Security Level Classification (See HRP-336 Worksheet in the ESTR Library) October 2021- [International Research Reminders](/file_url/111) December 2021 - [What is FDA Regulated?](/file_url/112) ### 2020 expand\_more November 2020 - [FDA Basics - HUA Edition](/file_url/99) December 2020 - [Scientific and Scholarly Review Refresher](/file_url/100) ### Pre-2020 expand\_more [PRIM&R IRB Member Training Webinar](/file_url/98)