QIP is committed to providing on-going support and education to the Harvard Longwood Medical Area (Harvard Chan School, HMS, HSDM) research community. Human Research refresher credit will be available for those who attend three or more sessions in an academic year.
Feel free to bring your lunch to our sessions and we will provide dessert!
IRB Determinations for Beginners (and Students)
- Wednesday, 10/26, 12:30-1:30pm, Countway 403
- 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). Additionally, attendees will get inside the mind of the IRB and discuss case studies as a group to determine what mode of review the IRB would determine appropriate. This session will also touch on specific information for students conducting human research, including common road blocks (and how to avoid them), FAQs, and recommendations.
- Monday, 11/21, 12-1pm, Countway Minot
- Social Media, Internet-based Research, and Ethics: Challenges and StrategiesWith the ever-increasing use of social media, study participants are just one of many groups becoming increasingly connected online. The session will discuss the benefits and challenges of study participants interacting within various internet-based environments and explore implications to the study team when leveraging such venues. Additionally, IRB considerations for investigators and research participants using online platforms will also be discussed.
- Wednesday, 12/7, 12-1pm, Countway Ballard
- Student Session – 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). Additionally, attendees will get inside the mind of the IRB and discuss case studies as a group to determine what mode of review the IRB would determine appropriate. This session will also touch on specific information for students conducting human research, including common road blocks (and how to avoid them), FAQs, and recommendations.
- Tuesday, 1/10, 12-1pm, TMEC 128
- Ensuring Data Confidentiality: IRB Considerations and IT Data Security Measures (and device encryption consultations!)How are the Harvard Research Data Security Levels determined for protocols? How do you make sure that you are complying with Harvard’s policies on data protection? Can you put your sensitive data on a flash drive or transmit it electronically? How can IT assist you with ensuring High Risk Confidential Information is maintained and shared securely? Come get the answers to these questions and many more straight from IT data security officers and IRB administrators.For anyone who brings along a device to the session, one-on-one consultation with IT regarding password protection and encryption will be available (which may be able to happen on the spot!).
- Presentation – Kim Serpico
- Presentation – Joe Zurba
- Thursday, 1/19, 122:30-1:30pm, Minot (Countway) CANCELLED
- Student Education Session – This session is geared towards Harvard Longwood Medical Area students who will be conducting research for a class or dissertation. Many times these projects are planned in a short amount of time and are submitted at the last minute to the IRB (if at all). As a result, students can risk not getting a determination in time to complete their project. This session will cover common road blocks (and how to avoid them), FAQs, and recommendations specifically for students conducting human subjects research.
- Tuesday, 2/28, 11am-12pm, Countway 403
- Meet the IRB Review Specialist Team!Ever wonder who reviews your IRB applications? Come and find out! The Harvard Longwood Medical Area IRB assigns Review Specialist by academic department. Each IRB Review Specialist has a portfolio of departments across HSPH, HMS, and HSDM. At this session, the IRB Review Specialist Team will introduce themselves and what departments they serve. Afterward there will be an open meet and greet so you can meet the Review Specialist that serves your department. Bring questions, comments, feedback, etc. We look forward to meeting you!
- Register here
- Wednesday, 3/8, 12-1pm, Countway Ballard
- ClinicalTrials.gov: Final Rule and NIH Policy – Striving for Transparency –The requirements for registration and results reporting on ClinicalTrials.gov are expanding. Are you up to date with the requirements? Did you know that NIH funded studies will be required to register and report results? Attend this educational session to learn more about:
- The purpose of the new requirements (HHS Final Rule & NIH Policy) within the historical context of striving for clinical trial transparency and the creation of the ClinicalTrials.gov database.
- The key ways that the HHS Final Rule expands the current clinical trial registration and results reporting requirements under FDAAA.
- The NIH Policy requirements and learn how this new policy will affect your registration and results reporting responsibilities.
- Register here
- Wednesday, 4/19, 12-1pm, Countway Minot
- Thursday, 5/11, 12-1pm, Countway Ballard
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.