 | |
IN THIS IRB NEWSLETTER: Lessons from a Post-Approval Monitoring visit: An Interview with Lily Marino It’s 10 PM. Do you know where your files are? New Guidance: Reliance Roles and Responsibilities Four Resources to Strengthen Stewardship of Research Data Husky Tip: Need NHSR Documentation for a Publication? Upcoming Events and Training | |
Lessons from a Post-Approval Monitoring visit: An Interview with Lily Marino When one of Dr. Quigley’s studies was selected by its funding agency for routine compliance monitoring, the team asked the Northeastern IRB for a monitoring visit first to prepare. Lily, a PhD student in the lab, was heavily involved in the visit. In this interview, Lily explains that the team expected something like a hearing and got a collaborative walkthrough instead. They came away with practical fixes that left their study better prepared for the funder’s review. Any team can request a visit. | |
It’s 10 PM. Do you know where your files are? After IRB approval, the hard part begins! Have you been keeping up with all of the requirements for record retention? Have your team’s practices drifted away from what you wrote in the protocol? If your federal funder comes knocking for an audit, will you be ready? Find out with our Investigator Self-Assessment of Study Files. This checklist guides you through the key items to check for your post-approval responsibilities. If you’d like a second set of eyes, consider requesting an investigator-initiated Post-Approval Monitoring visit from the DHR team. These visits include interviews with your team and review of your files.
We have limited slots, so reach out early! (If you have an upcoming audit from an external funder/regulator, notify us ASAP so we can schedule a monitoring visit before the audit.) | |
New Guidance: Reliance Roles and Responsibilities Reliance agreements can be confusing, especially if you’re working with another institution for the first time. A common point of confusion is figuring out who is responsible for what in the reliance process and once an agreement is in place. We’ve added a new section to our reliance page that walks through the roles of each IRB and the study team, so you know what to expect and can plan ahead. If you have questions or are starting a new collaboration, stop by drop-in hours. We’re happy to talk it through. Find the guidance under “Roles and Responsibilities in a Reliance Arrangement” here. | |
Four Resources to Strengthen Stewardship of Research Data Figuring out how to store, secure, and share research data can feel like a lot to navigate. Many researchers aren’t sure where to start or who to ask. Several offices across Northeastern have been working together to make this easier, and they’ve put together resources to help. We’re sharing an overview from the NU-RESearch Quarterly that outlines the tools they have and explains where to find them. | |
Husky Tip: Need NHSR Documentation for a Publication? Occasionally, a journal may request documentation that an activity was determined Not Human Subjects Research (NHSR) at the time the work was conducted. This can be challenging if you self-determined that the activity did not require IRB oversight. If you find yourself in this situation, we recommend completing Human Subjects Research Determination Form. As you work through the form, it should become evident whether your project does or does not meet the regulatory definition of human subjects research. This is a self-determination form and does not need to be submitted to our office. In our experience, most journals accept a completed Human Subjects Research Determination Form as sufficient documentation if the activity did not require IRB oversight. Because the work was already conducted, the DHR/IRB cannot perform a retroactive IRB review or issue a retroactive determination. | |
Upcoming Events and Training Our Fall schedule of IRB 101 and IRB Topics is in full swing. As always, please be sure to visit our Calendar of Events for the most up-to-date educational offerings, including drop-in hours, as well as details on how to join each session.
| |
Suggestions or feedback? Complete our DHR Satisfaction Survey or email [email protected]! If you received this, you are already subscribed. To add others to the newsletter, please have them Subscribe. |