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 for the foreseeable future.
Upcoming Dates and Topics:
May 2021
Investigator Panel: So You Think You Are Ready to Conduct International Human Subjects Research?
Tuesday, May 18th, 1:30pm-2:30pm
Are you interested in or have you been struggling with conducting transcontinental research? We have compiled the expert panel below of researchers and study staff who have done just that and are willing to share what it’s really like! Bring any questions you have to share via Zoom chat which will be posed to the panel by our moderator.
Moderator
Leslie Howes, MPH, CIP; Director, Office of Regulatory Affairs & Research Compliance, HSPH
Panel
Bizu Gelaye, PhD, MPH; Assistant Professor, Dept. of Epidemiology, HSPH
John Naslund, PhD; Instructor in Global Health and Social Medicine, HMS
Rocky Stroud II; Assistant Director of Research Operations, NeuroGAP-Psychosis & NeuroMEX, HSPH
Aisha Yousafzai, PhD; Associate Professor of Global Health, HSPH
Past QIP Education Series Sessions
IRB Updates: Tips and Tricks
Welcome back! Come hear the latest and greatest from ORARC, IRB, and ESTR leadership. Topics to be discussed include COVID-19 research operations, 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!
Presented by: Kim Serpico, Associate Director, IRB Operations and Alisa Jahns, Senior Product Manager
IRB Basics for All
Presented by: Alyssa Speier, Associate Director, Office of Regulatory Affairs and Research Compliance and Amy Harchelroad, QA/QI Specialist
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.
Working with Data: How to determine if you need IRB review
Presented by: Alma Castro, Senior IRB Review Specialist
This session will go over when analysis of data is considered Not Human Subjects Research, when it would be considered Exempt, and when it would fall under a non-Exempt category (e.g. requiring Expedited review or review at a convened IRB meeting). We will go over definitions of primary analysis vs secondary analysis and review the different types of data available such as de-identified data, coded data, publicly available data, etc. We will also demonstrate how to use the IRB Decision Tool. Case studies and examples will be used to demonstrate how research, which involves analysis of data only, is reviewed in different ways by the IRB and what the PI/investigators responsibilities are in each case.
Don’t let non-compliance ruin your career – common mistakes of non-compliance and how to avoid them
Non-compliance in human research happens, but how to identify, mitigate, and avoid it makes a big difference in terms of ensuring subject safety, research integrity, and building ones career in research. Dr. Delia Wolf Christiani, Associate Dean of Regulatory Affairs & Research Compliance, invites PIs, co-investigators and study staff members for a presentation focusing on common violations/mistakes in the areas of informed consent, investigator responsibilities, protocol deviation, IRB approval, and regulatory documentation, followed by a discussion on actions and approaches to correct and avoid these violations.
Presented by: Delia Wolf Christiani, Associate Dean, Regulatory Affairs & Research Compliance
Clinical Trials: Creating and Updating Your Record
This session will discuss reasons and avenues for clinical trial reporting, with a focus on ClinicalTrials.gov. We will learn about what studies are required to be registered and/or have results reported, along with tools and resources for trial registration and reporting in the ClinicalTrials.gov system. We will also discuss tips and tricks for keeping records up to date and compliant
Presented by: Amy Harchelroad, QA/QI Specialist, Office of Regulatory Affairs and Research Compliance and Eleanor Kuszmar, Associate Director, Research Compliance, Academic and Research Integrity
Fabrication, Falsification, or Plagiarism? You may be witnessing/committing research misconduct
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. Speakers will discuss the Chan school policies and procedures on responding to allegations of research misconduct, including rights and responsibilities of Research Integrity Officer (RIO), complainant, respondent, and deciding official, as well as what steps will be taken upon receiving an allegation.
Presented by: Delia Wolf Christiani, Associate Dean, Regulatory Affairs & Research Compliance and Alyssa Speier, Associate Director, Office of Regulatory Affairs and Research Compliance
Avoiding and Reporting Slip-ups when Conducting Human Research
Are you curious about what types of findings are most common during investigator audits and, even more importantly, how to avoid them? Do you wonder what information you are required to submit to the IRB after approval? Do you have questions about RNI’s (Reportable New Information)? Join us for a discussion of these topics including tips from IRB and Auditing insiders. We will discuss 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 right from the start. There will be plenty of time for specific examples and questions from the audience.
Presented by: Alyssa Speier, Associate Director, Office of Regulatory Affairs and Research Compliance and Alma Castro, Senior IRB Review Specialist
IRB Basics for All
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.
Presented by: Alyssa Speier, Associate Director, Office of Regulatory Affairs and Research Compliance and Amy Harchelroad, QA/QI Specialist
Using data from the EU? GDPR and other related Mysteries solved
This presentation will provide an overview of the General Data Protection Regulation’s (GDPR) definitions, principles and requirements, and how the Regulation can impact projects utilizing “Personal Data” from the European Economic Area and United Kingdom.
Often, research involving European collaborators necessitates support and review from multiple offices, most frequently HUIT Information Security, Sponsored Research and the IRBs. The reason additional support may be necessary is due to the specific privacy and security obligations that attach to Personal Data, as well as explicit contractual requirements prescribed in the GDPR. Rachel will outline relevant reviews, the compliance system that supports such reviews, and some basic steps researchers and administrator can take to aid the process
Presented by: Rachel Talentino, Research Compliance Officer, Office of the President and Provost
March 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
Recording available upon request.
April 2021
Collaborative Research: What Are My Options?
Presented by: Julie Chamberlain, IRB Reliance & QA/QI Specialist and Nicole Insalaco, Senior IRB Review 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!
Recording available upon request.
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.
