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.
May 2022
Collaborative Research: What Are My Options?
Thursday, May 26th, 2:00pm-3:00pm
Register Here (the Zoom link will be provided at the end of your confirmation email)
Presented by: Julie Chamberlain, 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!
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SEPTEMBER 2021
Welcome Back! IRB Updates and Meet the ORARC Staff
Presenters: ORARC Staff
Wednesday, September 29, 10:30am-11:30am
Welcome back! Come hear the latest and greatest from ORARC staff. Topics to be discussed include remote research, updates to ESTR, 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 ORARC staff.
PowerPoint Presentation-Welcome Back
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OCTOBER 2021
IRB Basics for All (Basics/Student Session)
Wednesday, October 6th, 1:00pm-2:00pm
Please join us remotely to learn which type of determination your study will most likely receive and how to submit it for review to the HLC IRB. 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). We will also discuss common road blocks (and how to avoid them), FAQs, recommendations, as well as information for students conducting human research.
PowerPoint Presentation-IRB Basics
Collaborative Research: What Are My Options?
Thursday, October 28th, 2:00pm-3:00pm
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!
Session PowerPoint Presentation
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NOVEMBER 2021
Anticipating Ancillary Review: When Research Requires More Than IRB Review
Presented by: Kim Serpico, Associate Director, IRB Operations
Harvard University has several institutional policies that require Ancillary Review of human subjects research projects. While the IRB does not conduct the Ancillary Reviews, they do facilitate their completion and compliance. The IRB’s role is to recognize the need for Ancillary Review, and connect the department that conducts the review to the IRB application. Many Ancillary Reviews require completion before IRB approval can be granted. These details are important for researchers to know for planning and logistical purposes, as Ancillary Review can be a potentially complex and lengthy process.
Come to this session to learn all about Harvard-specific Ancillary Reviews and bring your questions/examples.
Attendees will learn:
- What kinds of Ancillary Reviews there are (there are 15+!)
- How and when Ancillary Review is triggered by the IRB
- When researchers should start the Ancillary Review process, and how
- Which Ancillary Reviews are required prior to IRB approval and which are not
- How long Ancillary Reviews take
- Who is the point person in each Ancillary Review office
Ancillary Review Ed Session 11-30-2021
Appendix M Harvard Ancillary Reviews
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JANUARY 2022
Fabrication, Falsification, or Plagiarism? You may be witnessing/committing research misconduct
Presented by: Delia Christiani, Associate Dean, Regulatory Affairs & Research Compliance
Attend this interactive session to learn what constitutes Research Misconduct, how to 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 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.
Session PowerPoint Presentation
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FEBRUARY 2022
IRB Basics for All (Basics/Student Session)
Presenters: Amy Harchelroad, QA/QI Specialist, ORARC and Alyssa Speier, QIP Director, ORARC
IRB Basics Presentation Slides
Learn how to determine which kind 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). This session will also touch on specific information for, including common road blocks (and how to avoid them), FAQs, recommendations, as well as students conducting human research.
FEBRUARY 2022
Harvard Human Subjects Payment Policy
Feb 2022 Human Subjects Payment Policy
Presenter: Karen Kittredge, Manager of Policy and Business Process, Harvard University
Confused about how to process payments for Human Subjects? Wondering if they can be paid in cash or with a gift certificate? Need some help letting PIs know what administrators need in order to process a payment? Attend this session to hear the answers to these and other questions right from the source!
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MARCH 2022
Clinical Trials: The What, How and Why of Registering
PowerPoint Presentation from session
Presenter: Amy Harchelroad, QA/QI Specialist and Julie Chamberlain, IRB Reliance & QA/QI Specialist
This session will discuss reasons and avenues for clinical trial reporting, with a focus on ClinicalTrials.gov. We will learn about tools and resources for trial registration and reporting in the ClinicalTrials.gov system and provide tips and tricks for keeping records up to date and compliant. We will also discuss the real world implications and importance of clinical trial access to a broad population and the role of ClinicalTrials.gov in supporting this access.
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April 2022
Adding Community Voice to Research: How the Community Coalition of Equity in Research can help
PowerPoint Presentation from session
Presenter: Dr. Rebekka Lee, Director of the Harvard Catalyst Community Engagement program
The Community Coalition for Equity in Research, developed by the Harvard Catalyst Community Engagement program, works to build community voice and considerations for health equity into public health and clinical research, as well as strengthen community-academic relationships throughout Massachusetts. This 14-member coalition is co-led by Karen Emmons, the Harvard Catalyst Community Engagement program faculty lead, and Michael Curry, CEO at the Massachusetts League of Community Health Centers. The coalition offers researchers high-quality community input on research projects and provides a trusted communication channel between researchers and community stakeholders. An ideal time for getting community input on research is prior to protocol development as researchers are preparing their initial IRB submission. In this monthly education session, Dr. Rebekka Lee, Director of the Harvard Catalyst Community Engagement program will provide an overview of the coalition approach and describe how you can bring your research for review by our community stakeholder members.
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.
