The Quality Improvement Program (QIP) is committed to providing on-going support and education to the Harvard Longwood Campus (Harvard Chan School, HMS, HSDM) research community. Human research training refresher credit will be available for those who attend three or more sessions in an academic year.
All sessions will be held via Zoom.
Upcoming 2022/23 Education Series
February: Don’t Let Research Misconduct Ruin Your Career: What is research misconduct and how to avoid it.
Tuesday, February 7th, 1:00pm-2:00pm
Register here
Presenter: Delia Wolf Christiani, HSPH Research Integrity Officer
Attend this interactive session to learn what constitutes Research Misconduct, how to recognize, avoid, and report it, and where to find resources for support regarding a potential and/or an actual allegation. Dr. Christiani, the HSPH Research Integrity Officer (RIO), will use real-life examples to discuss the Chan school’s policies and procedures on responding to allegations of research misconduct including the steps that will be taken upon receiving an allegation as well as the rights and responsibilities of the RIO, complainant, respondent, and deciding official.
Past 2022/23 Education Series and Presentation Slides
September: Welcome Back! IRB Updates and Meet the ORARC Staff
Thursday, September 29th, 1:00pm-2:00pm
Presenter: Kim Serpico, Associate Director of IRB Operations, HLC IRBs
Welcome back! Come hear the latest and greatest from ORARC staff. Topics to be discussed include an overview of the Office of Regulatory Affairs & Research Compliance, updates to ESTR (the IRB’s submission system), new policies, a review of the most common IRB requirements, and some new tools the IRB is offering. Bring questions – we’ll have plenty of time for Q&A and time to meet the members of the ORARC staff.
Presentation Slides: ORARC Welcome Back Updates
October: IRB Basics for All (Basics/Student Session)
Thursday, October 13th, 1pm-2pm
Presenters: Amy Harchelroad, QA/QI Specialist and Alyssa Speier, QIP Director
Learn how to determine which type of IRB determination your study will receive. This presentation will cover Not Human Subjects Research and Exemption determinations as well as when reviews are conducted on an Expedited basis vs. by the Convened IRB (“Full Board” review). Additionally, we will touch on common road blocks (and how to avoid them), FAQs, recommendations, as well as students conducting human research.
Presentation Slides: IRB Basics
October: Collaborative Research: What Are My Options?
Wednesday, October 26th, 11:00am-12:00pm
Presenter: Julie Chamberlin, ORARC IRB Reliance & QA/QI Specialist
Are you working with non-Harvard Longwood Campus collaborators? Would you like to cut back on the administrative burden of multiple IRB reviews and designate one institution as the IRB of record? Come to this session to find out what options are available to you when working with non-HLC collaborators. Everything from requesting a cede review/IRB Authorization Agreement (IAA) to Individual Investigator Agreements will be discussed. Come, and let us help you streamline and simplify your administrative burden!
Presentation Slides: Reliance Basics Ed Session
November: Congratulations, you have IRB Approval! Now what?
Tuesday, November 15th, 1:00pm-2:00pm
Presenter: Julie Chamberlin, ORARC IRB Reliance and QA/QI Specialist and Lisa Gabel Senior QA/QI Specialist
Were you aware that investigators have responsibilities after they obtain IRB approval? Join us at this session to discuss what you should do in order to run a compliant and organized Human Research Study. Our session will cover what documentation to maintain, recommended logs and tools to use, and other tips to help stay compliant.
Presentation Slides: Post Approval Basics
November: Keeping the Record Straight: Data Management Requirements, Strategies and Tools
Tuesday, November 29th, 1:00pm-2:00pm
Presenter: Julie Goldman, Countway Library Research Data Services Librarian
This session will get you up to speed with new data management and sharing requirements. Discover what successful data management entails; what a data management plan is and how to go about building one; and strategies for recording keeping ensuring your data will be readable and understandable in the future.
Presentation Slides: Record Keeping
December: Closing time, Your Research Can’t Stay Here: What Researchers Departing HLC Schools Should Know
Tuesday, December 6th, 2022 11:00am-12:00pm
Presenter: Kim Serpico, Associate Director of IRB Operations for the Harvard Longwood Campus (HLC) Schools
Finished with your human research study? Leaving a Harvard Longwood Campus School and have an open Human Subjects research protocol? Transferring your human research to your new institution? Join us to discuss the off-boarding process with the HLC IRBs and your responsibilities when it comes to your research records once your study is over! Bring lots of questions!
Presentation Slides: Departing PIs and Study Closure
January: IRB Basics for All (Basics/Student Session)
Wednesday, January 25th, 1:00pm-2:00pm
Presenters: Amy Harchelroad, QA/QI Specialist and Alyssa Speier, QIP Director
Learn how to determine which type of IRB determination your study will receive. This presentation will cover Not Human Subjects Research and Exemption determinations as well as when reviews are conducted on an Expedited basis vs. by the Convened IRB (“Full Board” review). Additionally, we will touch on common road blocks (and how to avoid them), FAQs, recommendations, as well as students conducting human research.
Presentation Slides: IRB Basics
January: Auditing & Reporting Slip-ups When Conducting Human Research
Tuesday, January 31, 11am-12pm
Presenters: Alyssa Speier, QIP Director and Julie Chamberlin, ORARC IRB Reliance & QA/QI Specialist
Are you curious about the most common Human Research investigator audit findings and, even more importantly, how to avoid them? Do you have questions about RNI’s (Reportable New Information) …what they are and/or how to report them? Join us for a discussion of these topics including tips from IRB and Auditing insiders. We will review when an RNI is required, what to include in your submission, and how to limit the need for them by setting your study up for success and compliance right from the start. There will be plenty of time for specific examples and questions from the audience.
Presentation Slides: Reporting RNIs and Common Audit Findings
Do you have an idea for an education session not listed or would you like QIP to develop a customized session for your department, lab or class? Contact Alyssa Speier for more information or to submit a topic.
