Updating Old Studies: New Forms May be Required for Modifications to Legacy Protocols

As part of our ongoing efforts to streamline IRB processes and ensure compliance with current federal regulations, institutional policies, and best practices, the Northeastern University IRB is implementing updated expectations for federally funded legacy protocols. Researchers requesting modifications or continuing review to federally funded studies initially approved more than five years ago (2020 or earlier)  may be asked to incorporate their protocol details using our current IRB application forms and associated materials.

This change is being made for reasons which include:

• Updated regulatory standards that may not be reflected in older protocols.
• Ensuring accuracy of records to make sure our documentation is accurate and consistent with federal regulations regarding record keeping expectations.
• Changes to Northeastern’s own processes for recordkeeping, document retention, tracking, and compliance.

We understand that this may require some additional effort from research teams, and we are here to support you through the process. If your study falls into this category, the DHR will notify you and provide support on how to transition your submission.

Thank you for your continued commitment to ethical and high-quality research.