IRB Newsletter Archive

2024 IRB newsletters

Newsletter  February:  Interviews and Surveys: What does the IRB Need to Know; Expert Interviews

Newsletter  March:  IRB Staff Changes, OHRP Informed Consent Training, International Devices, OUE Review.

Newsletter  April:  As Summer Research Approaches, OHRP Key Information Draft Guidance, External IRB Submissions, IRB Staff Change

2023 IRB Newsletters

Newsletter  January: Welcome Back from Winter Recess, New Year Resolution - Suggestions for Common Submission Problems, Engagement

Newsletter February: NIH Data Management and Sharing Policy (DMSP) Now Live!, NIH DMSP Survey to Assess Needs of the Harvard Research Community, Determination versus Approval

Newsletter March: 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?

Newsletter April: 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

Newsletter May: 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?

Newsletter June: 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

Newsletter July: 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

Newsletter September: Welcome to Harvard!, IRB Lifecycle Guide -- Your Lifeline for All Things IRB, Managing Relationships -- The Compliance Kind, PI Assurance, Farewell to Departing Staff

Newsletter October: Keep that Thinking Cap On, Human Subjects Protection Training, URTP Training Dates, Training Documentation in ESTR, University Administrator Resources by Role, Human Subjects Research

Newsletter November: Ancillary Review - Faculty Sponsor; Data Safety; Provostial Review

Newsletter December: Winter Recess Reminder; 6 Tips to Speed Your Review Webpage; Identifiability

2022 IRB Newsletters

Newsletter  January 2022: ESTR Unavailable January 13 - 14, IRB Office Remote Again, PIPL Data Considered Sensitive, Changes to Documentation for GDPR, Exculpatory

Newsletter  February 2022: 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

Newsletter  March 2022: 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?

Newsletter April 2022: 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

Newsletter  May 2022: 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?

Newsletter  June 2022: ESTR Etiquette, HRPP and HRPP Plan

Newsletter  July 2022: Leaving Harvard?, Who Owns Research Data?, Agency and Engagement of Visiting Scholars (Fellows and Faculty)

Newsletter August 2022: NIH Data Management and Sharing Policy, Are You an Undergraduate Planning to Conduct Research with People?, What it Means to be a Faculty Sponsor

Newsletter September 2022: Welcome to Harvard, IRB Lifecycle Guide -- Your Lifeline for All Things IRB, What Type of Data Is This?, Debriefing

Newsletter October 2022: 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

Newsletter November 2022: 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

Newsletter December 2022: 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

NewsletterJanuary 2021 - We're Accredited!, IRB Office Hours Now at Harvard Law School, Repositories

NewsletterFebruary 2021 - Reminder: Review Timeline, Reminder: School/Department Approval for In-Person Research, Funding Deadline? Other Sensitive Deadline?  Leave a Comment!, Exculpatory

Newsletter March 2021 - New Phase for Resumption of In-Person Research, New Agreements Tool - WAIT, URTP Training Dates, IRB Lifecycle Guide, Manage Relationships, Exempt

Newsletter April 2021 - WAIT Tool Update, Conducting Research as a Student, FWA, Agency, and Engagement and Why It's Important in Collaborative/Multi-Institutional Research

Newsletter May 2021 - 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

Newsletter June 2021 - IRB Lifecycle Guide - Your Lifeline for All Things IRB, Informed Consent & You, 118 Determination

Newsletter July 2021 - 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

Newsletter  August 2021 - Keep Your IRB Submission Up to Date!, Harvard Catalyst Community Engagement Program, External IRB Submissions

Newsletter September 2021 - 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

Newsletter October 2021 - 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

Newsletter November 2021 - 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

Newsletter December 2021 - Office Closed for Winter Recess, Tips for a successful IRB Review, HRPP & HRPP Plan

2020 IRB Newsletters

NewsletterJanuary 2020 - AAHRPP Tip Sheet #1, Single IRB requirements, Review of the Revised Rule, Harvard IRBs Master Agreement, IRB Determination and Approval Dates

NewsletterFebruary 2020 - Telephone Consumer Protection Act (TCPA), Study Team Member, Sending comments in ESTR, Minimal Risk Studies and Consent Forms,Tracking Harvard Staff on External IRB Submissions

NewsletterMarch 2020 - Data Safety System, Revised HRDSP, Local Context Forms, Principal Investigator Assurance

NewsletterCOVID-19 Update (March 12 2020) 

NewsletterApril 2020 - New and Modified COVID-19 studies, Delay of HRDSP, Written Documentation of Consent

NewsletterMay 2020 - Pilot of Updated Research Data Security Policy Guidance, Collaboration Tools Matrix, ESTR Upgrade Planned May 29-June 1, Documented Consent, Data Use Agreements

NewsletterJune 2020 - Re-Starting Research at Harvard, COVID Procedures:  What to Submit and What Not To Submit To IRB, ESTR Release - Upgrade, In ESTR: Comment VS. Response, Anonymous, De-Identified, and Coded Data

NewsletterJuly 2020 - Resumption of Research - What's Next?, IRB Lifecycle Guide, Federal Wide Assurance (FWA), Agency, and Engagement: Why it's Important in Collaborative/Multi-Institutional Research

NewsletterAugust 2020 - AAHRPP Site Visit Countdown, Lapsed IRB Approvals and Administrative Closure, Parent Permission

NewsletterSeptember 2020 - AAHRPP Site Visit and link to training webpage, Resumption of In-Person Research, GDPR Reminder, Exempt

NewsletterOctober 2020 - AAHRPP Site Visit Success, What to submit to the IRB during COVID, Institutional Official

NewsletterNovember 2020 - Meet Your School/Deptartment IRB Reviewer, Choose URTP as Your Department if you are an Undergraduate Researcher, Don't Forget to Manage Relationships, Human Subjects Research

NewsletterDecember 2020 - sIRB Researcher Responsibilities, Holiday Break Reminder, Conducting International Research? Scientific and Scholarly Review

2019 IRB Newsletters

Newsletter December 2019 - Study Site versus Local Site, ESTR "mini-upgrade",  IRB Office closed for Winter Recess, Distribution/IRB Administrator Changes, IRB Office Hours

Newsletter November 2019 - Changes to Data Security at Harvard, External IRB Requirements, Repository Appication, Distribution/IRB Administrator Revision, Undergraduate Research Ethics Training

Newsletter October 2019 - AAHRPP Highlight - Institutional Policies:  Finders Fees, Mechanical Turk (MTURK) Attention Checks, Key Tips for IRB Submissions, Broad Consent

Newsletter September 2019 - AAHRPP Tip Sheets, Storing Identifiable Data, IRB Office Hours, Benefits of Participation

Newsletter August 2019 - Harvard HRPP Review and Resources, 118 Determination, Review of Research Requiring IRB Review, 3rd Party Subjects

Newsletter July 2019 - Leaving Harvard, IRB Office Hours, Foreseeable Risks

Newsletter June 2019 - AAHRPP Accreditation and Training Sessions, Cooperative Research, Unanticipated Problem Involving Risks To Subjects or Others (UPIRTSO)

Newsletter May 2019-IRB News Extra! - IRB Office Moving to 44-R Brattle, Suite 200, Data Security Review Pilot

Newsletter May 2019 - HUA IRB Office Moving to 44-R Brattle, Suite 200, Lapsed Approval Notice, External IRB Process Update, External IRB Review - Terms You Need To Know

Newsletter April 2019 - ESTR Update, Distribution/IRB Administrator Changes, Training Dates:  Revised Rule and URTP, Repository Application, HRPP and HRPP Plan

Newsletter March 2019 - AAHRPP Accreditation Process, Leaving Harvard, Exculpatory

Newsletter February 2019 - Transitioning Existing Studies to the 2018 Requirements, Benign Behavioral Intervention

Newsletter January 2019 - IRB Office Closed for Winter Recess, Major Changes with the Revised Rule, Revised Rule Presentation Dates, Revised URTP Process, Recruiting Staff/Lab Members as Study Participants, Legally Authorized Representative (LAR)

2018 IRB Newsletters

NewsletterDecember 2018 - Revised Rule Presentation Dates, Working with Native American Populations, Engagement

NewsletterNovember 2018 - Revised Rule Presentation Dates/AAHRPP Training Preparation, New NIH Training Alternative for Non-Affiliates, Seeking Volunteers to Test Electronic "Wizard" in ESTR, Agreements - DUA Submission System, Key Information

NewsletterOctober 2018 - Accreditation Step 1 Application, IRB Submission Forms on the IRB Website, IRB Administrator Job Opening, Compensating Subjects

NewsletterSeptember 2018 - HRPP Plan, Mechanical Turk (MTURK) article in Wired Magazine, IRB Protocol Template Overhaul, Seeking Volunteers for "Exempt Wizard", Mandated Reporter

NewsletterAugust 2018 - Three Burden Reducing Provisions (3BRP), Accreditation Self-Assessment and Revised Documents, Exempt

NewsletterJuly 2018 - Three Burden Reducing Provisions, URTP Summer Undergraduate Training Dates, About Whom

NewsletterJune 2018 - AAHRPP Tip Sheets, GDPR, URTP Summer Undergraduate Training Dates, Identifiability

NewsletterMay 2018 - AAHRPP Standards and Elements, Department Distribution Revision, Deception vs. Incomplete Disclosure

NewsletterApril 2018 - AAHRPP Accreditation, HRPP, General Data Protection Regulation (GDPR), Leaving Harvard, Exculpatory

NewsletterMarch 2018 - Find Your IRB Contact, Harvard Research Data Security Policy (HRDSP), Long Form, Short Form, or Information Sheet

NewsletterFebruary 2018 - New SOPs, Templates, and Forms, Ethics Training Check-In, NIH Clinical Trial, Practicable

NewsletterJanuary 2018 - Revised Rule News

NewsletterJanuary 2018 - Prepare for the Revised Rule, Introducing URTP, Multi-Site Versus Single-Site