# IRB Newsletter Archive If you would like to subscribe to the HUA IRB monthly newsletter, please go to . Open all sections Close all sections ### 2026 IRB Newsletters expand\_more [**January:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2026-01/January%202026%20HUA%20IRB%20Newsletter.pdf) Approved Studies Project; Draft NIH Controlled-Access Data Policy and Proposed Revisions to NIH Genomic Data Sharing Policy; *PI and Faculty Sponsor Responsibilities* [**February:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2026-02/February%202026%20HUA%20IRB%20Newsletter.pdf) NIH Policy on Research Involving Human Fetal Tissue; Department of Defense Research and Artificial Intelligence; Undergraduate Ethics Training Dates; *Noncompliance* [**March:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2026-03/March%202026%20HUA%20IRB%20Newsletter.pdf) NIH Definition of Clinical Trial; NIH Data Management and Sharing Plan; IRB Training Request Form [**May:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2026-05/May%202026%20HUA%20IRB%20Newsletter%20test.pdf) An End-of-Year How-To; IRB Training Request Form; *The Vote:* *Statement of Policies and Procedures Governing the Use of Human Subjects in Research at Harvard University* *(Part 1)* [**June:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2026-06/June%202026%20HUA%20IRB%20Newsletter.pdf) Introduction to Monthly IRB Trainings; Huron Research Suite Support; *The Vote:* *Statement of Policies and Procedures Governing the Use of Human Subjects in Research at Harvard University* (Part 2) ### 2025 IRB Newsletters expand\_more [**January:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2025-01/January%202025%20HUA%20IRB%20Newsletter.pdf) OHRP Resources including: International Compilation of Human Research Standards, LGBTQI+ Fact Sheet, Interactive Scenarios, Draft Guidance on Conditions for Including Tissue biopsies in Clinical Trials; and from NIH - Genomic Controlled-Access Data Changes [**February:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2025-02/February%202025%20HUA%20IRB%20Newsletter.pdf) 2025 Federal Research Policy Changes; The Common rule - A Revision; URTP Training Dates - Spring 2025; The Broad Research Ethics Consultancy (BREC); *Deception and Incomplete Disclosure* [**March:**](https://cuhs.harvard.edu/news/2025/03/check-out-our-march-2025-newsletter) 2025 Federal Research Policy Changes; URTP Training Dates -- Spring 2025; *Human Subjects Research (and Common Misconceptions)* [**April:**](https://cuhs.harvard.edu/news/2025/04/check-out-our-april-2025-newsletter) Closing External IRB Submissions; Smart IRB Updates; Principal Investigator Assessment -- New Tool Available; Harvard Earth Day E-Waste Recycling [**May:**](https://cuhs.harvard.edu/news/2025/05/check-out-our-may-2025-newsletter) An End-of-Year How-To; The 3 Ps: Submitting a New Study vs. Modification; *Certificates of Confidentiality* [**June:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2025-06/June%202025%20HUA%20IRB%20Newsletter.pdf) Loss of Funding, UPIRTSOs, and Reports of New Information (RNIs); An End-of-Year How-To (Continued); Training Resources; GAO Report on Human Genomic Data; *Definition of Research* [**July:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2025-07/July%202025%20HUA%20IRB%20Newsletter.pdf) International Research; Biological Material Import/Transport [**August:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2025-08/August%202025%20HUA%20IRB%20Newsletter.pdf) OVPR Bulk Data Guidance; Library Support for Qualitative Research; *Data Use Agreements* [**September:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2025-09/September%202025%20HUA%20IRB%20Newsletter.pdf) Welcome Back!; IRB Lifecycle Guide - Your Lifeline for All Things IRB; Funding and ESTR; *PI Eligibility and Assurance* [**October:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2025-10/October%202025%20HUA%20IRB%20Newsletter.pdf) SDN List Screening for Non-Harvard Collaborators: What You Need to Know; URTP Trainings; *Scientific and Scholarly Review* [**November:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2025-11/November%202025%20HUA%20IRB%20Newsletter.pdf) NIH Policy on Enhancing Security Measures for Human Biospecimens Export Control Guidance; Upcoming ESTR Notices; Don't Forget to Submit!; *Private vs. Public Observations* [**December:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2025-12/December%202025%20HUA%20IRB%20Newsletter.pdf) Winter recess reminder: *Incomplete Disclosure, Deception, and Debriefing* ### 2024 IRB Newsletters expand\_more [**February 2024:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/february_2024_hua_irb_newsletter.pdf) Interviews and Surveys: What does the IRB Need to Know; *Expert Interviews* [**March 2024:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/march_2024_hua_irb_newsletter.pdf) IRB Staff Changes, OHRP Informed Consent Training, International Devices, *OUE Review* [**April 2024:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/april_2024_hua_irb_newsletter.pdf) As Summer Research Approaches, OHRP Key Information Draft Guidance, *External IRB Submissions*, IRB Staff Change [**May 2024:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2025-02/May%202024%20HUA%20IRB%20Newsletter.pdf) Leaving Harvard? Closing a Study? An End-of-Year How-To, Prompt Reporting Requirements, *Multi-Site/collaborative Study vs. Single-Site Study vs. Research Location* [**June 2024:**](https://cuhs.harvard.edu/news/2024/07/check-out-our-june-2024-newsletter-0) Website Changes; Modifications: Including Exempt Study Modifications, Modification Scope, Modifications - Staff Changes [**July 2024:**](https://cuhs.harvard.edu/news/2024/07/check-out-our-july-2024-newsletter) OHRP Training Programs to Support The Research Community, NIH Consent Resource, HGSE IRB Reviewer Update, *Data Use Agreements* [**August 2024:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2024-08/August%202024%20HUA%20IRB%20Newsletter_0.pdf) Who and Where: Institutional Agency and ESTR; *De-identified, Coded, and Anonymous* [**September 2024:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2024-09/September%202024%20Harvard%20University%20Area%20IRB%20Newsletter.pdf) Welcome Back!; A Refresher: Exempt and Expedited Research; *PI Eligibility* [**October 2024:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2024-10/October%202024%20HUA%20IRB%20Newsletter.pdf) Undergraduate Training Dates; New Team Members This Fall?--A Reminder; Cybersecurity; *Pilot Studies* [**November 2024:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2024-11/November%202024%20HUA%20IRB%20Monthly%20Newsletter.pdf) 'Tis the Season; Declaration of Helsinki - A Revision; Repository Application; *Sensitive Data* [**December 2024:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2024-12/December%202024%20HUA%20IRB%20Monthly%20Newsletter.pdf) Winter Recess Reminder; Research Security Training Requirement Announcement ### 2023 IRB Newsletters expand\_more [**January 2023:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/january_2023_harvard_university_area_irb_monthly_newsletter.pdf) Welcome Back from Winter Recess, New Year Resolution - Suggestions for Common Submission Problems, Engagement [**February 2023:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/february_2023_harvard_university_area_irb_monthly_newsletter.pdf) NIH Data Management and Sharing Policy (DMSP) Now Live!, NIH DMSP Survey to Assess Needs of the Harvard Research Community, Determination versus Approval [**March 2023:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/march_2023_harvard_university_area_irb_monthly_newsletter.pdf) NIH DMSP Survey to Assess Needs of the Harvard Research Community, Harvard Medical School & Yale Symposium – Registration Now Open, GAO Report on the Oversight and Effectiveness of IRBs, Pilot studies - Do they require IRB oversight? [**April 2023:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/april_2023_harvard_university_area_irb_monthly_newsletter.pdf) Oh, We've Got Ethics Training!, Last Chance for Harvard Undergraduate In-Person Training for Spring 2023, Exempt Research - Everything You Wanted to Know, Exculpatory [**May 2023:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/may_2023_harvard_university_area_irb_monthly_newsletter.pdf) Reminder about Closure Requests on Exempt Studies, A (very) Brief Overview of Faculty Sponsor and PI Eligibility, Primary Contact or PI Proxy - what's the difference? [**June 2023:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/june_2023_harvard_university_area_irb_monthly_newsletter.pdf) AAHRPP Re-Accreditation Site Visit Coming Soon; Leaving Harvard? Plan and Take Action Prior to Your Departure; Helpful Reminders: Data Use Agreements, Current Version of the HUA IRB Protocol Template, Paying Participants, Use of the Harvard Name and Insignias; Individual Investigator Agreements [**July 2023:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/july_2023_harvard_university_area_irb_monthly_newsletter.pdf) Hot off the Press! DRAFT Limited IRB Review Guidance Ready for Your Review; It's Summer and the IRB is Open for Business; Some Great Information and Related Resources from our Friends at Harvard Catalyst; Payments to Research Subjects [**September 2023:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/september_2023_harvard_university_area_irb_monthly_newsletter.pdf) Welcome to Harvard!, IRB Lifecycle Guide -- Your Lifeline for All Things IRB, Managing Relationships -- The Compliance Kind, PI Assurance, Farewell to Departing Staff [**October 2023:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/october_2023_harvard_university_area_irb_monthly_newsletter.pdf) Keep that Thinking Cap On, Human Subjects Protection Training, URTP Training Dates, Training Documentation in ESTR, University Administrator Resources by Role, Human Subjects Research [**November 2023:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/november_2023_harvard_university_area_monthly_newsletter.pdf) Ancillary Review - Faculty Sponsor; Data Safety; Provostial Review [**December 2023:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/december_2023_harvard_university_area_irb_monthly_newsletter.pdf) Winter Recess Reminder; 6 Tips to Speed Your Review Webpage; Identifiability ### 2022 IRB Newsletters expand\_more [**January 2022:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/january_2022_hua_irb_newsletter.pdf) ESTR Unavailable January 13 - 14, IRB Office Remote Again, PIPL Data Considered Sensitive, Changes to Documentation for GDPR, Exculpatory [**February 2022:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/february_2022_hua_irb_monthly_newsletter.pdf) Is it Human Subjects Research? We have a form for that!, If Scheduling Your IRB Office Hours Using the Online Booking Tool, Check Your Spam/Junk Folder, What Type of Data Is This?, Fee Webinar Series on the Common Rule from the Office for Human Research Protection (OHRP), Human Subjects Research [**March 2022**:](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/march_2022_hua_irb_monthly_newsletter.pdf) New NIH Data Sharing Policy, Proposed Revisions to the NIH Genomic Data Sharing Policy, URTP Training Dates, Does an Oral History Project Require IRB Review? [**April 2022**:](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/april_2022_hua_irb_monthly_newsletter.pdf) New NIAAA Data Sharing Policy -- Effective Immediately, Revision to Department/School Distribution Coming Soon, Removing Study Team Members?, Collaborating with Another Institution? Check out our updated website page, Submit button, Deception and Incomplete Disclosure [**May 2022:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/may_2022_harvard_university_area_irb_monthly_newsletter.pdf) Lotteries and Raffles as a Form of Subject Compensation, We Love to Hear from You, but We Don't Need To! Modifications on Exempt Determinations and Continuing Review on studies that follow the 2018 Requirements, Multi-Site/Collaborative vs. Single-Site vs. Location - What Is the Difference? [**June 2022:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/june_2022_hua_irb_monthly_newsletter.pdf) ESTR Etiquette, HRPP and HRPP Plan [**July 2022:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/july_2022_harvard_university_area_irb_monthly_newsletter.pdf) Leaving Harvard?, Who Owns Research Data?, Agency and Engagement of Visiting Scholars (Fellows and Faculty) [**August 2022:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/august_2022_hua_irb_monthly_newsletter.pdf) NIH Data Management and Sharing Policy, Are You an Undergraduate Planning to Conduct Research with People?, What it Means to be a Faculty Sponsor [**September 2022:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/september_2022_harvard_university_area_irb_monthly_newsletter.pdf) Welcome to Harvard, IRB Lifecycle Guide -- Your Lifeline for All Things IRB, What Type of Data Is This?, Debriefing [**October 2022:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/october_2022_hua_irb_monthly_newsletter.pdf) Reminder! Ensure that Your Study Team is Up To Date in ESTR, This is a Busy Time of Year for Us, Research that Might Require IRB Oversight [**November 2022:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2025-02/November%202022%20Harvard%20University%20Area%20IRB%20Monthly%20Newsletter.pdf) Are You Ready for the New NIH Data Management and Sharing Policy?, CITI Training Completion Now Available in the Harvard Training Portal, Study Team Members [**December 2022:**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/december_2022_harvard_university_area_irb_monthly_newsletter.pdf) More Resources to Prepare You for the NIH Data Safety Management Policy, Plan for Winter Recess, GSAS Student Dissertations and Agency, Remember to Use the Most Current Version of the IRB Protocol Template, Scientific and Scholarly Review ### 2021 IRB Newsletters expand\_more [**January 2021**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2025-02/HUA%20IRB%20Newsletter%20January%202021.pdf) - We're Accredited!, IRB Office Hours Now at Harvard Law School, Repositories [**February 2021**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2025-02/February%202021%20HUA%20IRB%20Newsletter.pdf) - Reminder: Review Timeline, Reminder: School/Department Approval for In-Person Research, Funding Deadline? Other Sensitive Deadline? Leave a Comment!, Exculpatory [**March 2021**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/2025-02/HUA%20IRB%20Newsletter%20-%20March%202021.pdf) - New Phase for Resumption of In-Person Research, New Agreements Tool - WAIT, URTP Training Dates, IRB Lifecycle Guide, Manage Relationships, Exempt [**April 2021**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/hua_irb_newsletter_april_2021.pdf) - WAIT Tool Update, Conducting Research as a Student, FWA, Agency, and Engagement and Why It's Important in Collaborative/Multi-Institutional Research [**May 2021**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/hua_irb_newsletter_may_2021.pdf) - Conducting Research in Brazil, MTurk ID's -- Yep, they are an "Identifier", Policy on the Use of Harvard Names and Insignias, Leaving Harvard? Plan Ahead and Take Action Prior To Departure [**June 2021**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/hua_irb_newsletter_june_2021.pdf) - IRB Lifecycle Guide - Your Lifeline for All Things IRB, Informed Consent & You, 118 Determination [**July 2021**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/hua_irb_newsletter_july_2021.pdf) - Resumption of Research - COVID-19 Update, CITI Training Now Available in Spanish, Just Arriving at Harvard? Or Are You Departing Harvard? Tips for a successful transition, Prompt Reporting Requirements [**August 2021**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/hua_irb_newsletter_august_2021.pdf) - Keep Your IRB Submission Up to Date!, Harvard Catalyst Community Engagement Program, External IRB Submissions [**September 2021**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/hua_irb_newsletter_september_2021.pdf) **-** New GDPR Document - Just Released, What's New on Our Website, What to Know When Your Harvard Research Study Will Involve MGB, DoD Research Regulations [**October 2021**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/hua_irb_newsletter_october_2021.pdf) - Who is an Agent of Harvard?, Personal Information Protection Law (PIPL), What it Means to Be a Faculty Sponsor, What's New on Our Website, Coercion and Undue Influence [**November 2021**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/hua_irb_newsletter_nov_2021.pdf) **-** PIPL - New Information Posted, URTP - What You Need to Know, URTP In-Person Training Dates, Recruiting from Harvard Guidelines, ESTR Not Available this Weekend, Principal Investigator Eligibility [**December 2021**](https://cuhs.harvard.edu/sites/g/files/omnuum921/files/cuhs/files/hua_irb_newsletter_december_2021.pdf) **-** Office Closed for Winter Recess, Tips for a successful IRB Review, HRPP & HRPP Plan