July 5, 2022
For the Record- July 5, 2022: Updated Guidance for Single IRB, Records Retention
In this Issue:
- Minor Process Changes and Updated Guidance for Single IRB Review
- Changes to Research Record Retention Schedule
- Slower Turnaround Times in July and August
Minor Process Changes and Updated Guidance for Single IRB Review
The federal Single IRB (sIRB) mandates went fully into effect in January 2020. These mandates apply to most federally-funded, non-exempt human subjects research and require that a single IRB review all aspects of multi-institutional research on behalf of all engaged institutions. Based on HSD’s experience reviewing sIRB studies during the past two years, it is making minor changes to its sIRB process in order to improve efficiency and transparency.
What is changing:
- For the initial review of relying sites, UW study teams will now be responsible for collecting any required relying site applications and site-specific materials such as consent forms, and submitting them in Zipline for review by the UW IRB. This task was previously done by HSD staff via email.
- Why? UW study teams are better positioned than HSD staff to support relying institution study teams with completing required site materials. Additionally, the email-based process did not provide UW study teams enough information about the status of a site submission or allow for tracking of turnaround times for IRB review of relying sites.
- HSD will accept the use of the SMART IRB Master Reliance Agreement in more circumstances in which it is the Single IRB.
- Why? Nearly 1,000 institutions nationwide have now signed onto the SMART Agreement. For these institutions, the use of the SMART Agreement may streamline the reliance process.
What is staying the same:
- The circumstances in which the UW IRB can serve as the sIRB.
- UW researchers proposing federally-funded research projects subject to the sIRB mandates should contact HSD prior to submitting proposals to the funding agency if they are proposing that the UW serve as the sIRB. HSD cannot guarantee UW IRB review for any multi-institutional research for which it has not been consulted.
- HSD staff will continue to negotiate the terms of new, study-specific reliance agreements directly with relying institutions’ IRB or HRPP offices and upload these agreements to Zipline. This is because HSD staff are in the best position to understand the terms of the agreements and it is more efficient for HSD to work directly with the other institution rather than through the study team(s).
- The webpage UW as the Single IRB now has more details on HSD’s policies for serving as a single IRB, including a list of key information that study teams and relying institutions may find helpful.
- The webpage Steps in the Single IRB Review Process for Initial Applications now has more information about how HSD will establish reliance agreements, what information is required from relying institutions, how that information is communicated to the UW IRB, and roles and responsibilities for initial sIRB review.
- The new webpage Steps in the Single IRB Review Process for Follow-on Submissions contains specific information about roles and responsibilities for continuing review, study and site level modifications, and reporting new information to the UW IRB.
- Zipline instructions for the initial review of relying sites have been revised and reorganized, including a new video explaining the process.
Please contact the HSD Reliance Team at email@example.com if you have any questions.
Changes to Research Record Retention Schedule
The UW General Records Retention Schedule (Research and Grant/Contract Records) has been revised as follows:
Personally identifiable information (e.g., name, DOB, SSN, contact info, medical record number) that can connect records/data back to a study participant and are collected as part of research activities may now generally be disposed of at study closure (Note – longer retention periods may be required by study sponsors or federal agencies). Previously identifiers were required to be retained for at least 6 years after study closure. This change was implemented to provide greater flexibility for researchers working with highly sensitive data or vulnerable populations where identifiability of data may pose increased risks to participants.
Research Data – Drug & Device Development
The retention period for research documentation and raw data (including personal identifiers) obtained during a FDA-regulated study to develop a drug or device has been revised to incorporate greater flexibility that aligns with federal requirements. In some instances, if you are aware of the FDA status, records may now be disposed of as soon as two (2) years after the investigation is completed/discontinued. Previously all records were required to be retained for 30 years after study closure. Please review the record retention schedule to determine what retention period applies for a specific study.
Please contact Record Management Services at firstname.lastname@example.org if you have any questions.
Slower Turnaround Times in July and August
Many HSD staff are taking time off this summer. While we will ensure that there is adequate coverage, we anticipate that turnaround times will be slower in July and August. We appreciate your patience and understanding. To minimize the impact to your research, we encourage you to ensure your applications are complete and submitted as early as possible. For any externally imposed urgent deadlines, please be sure to call these out in your submission so we can prioritize accordingly.