UW Research

December 6, 2022

For the Record- December 6, 2022: Subject Expertise Question in IRB Protocol, Consent Language for NIH Required Data Sharing, More

In this Issue:

IRB Protocol Form – Added Subject Matter Expertise Question

New

The UW IRB routinely uses consultants when specific outside expertise is required to inform review of a study. Currently, HSD staff must identify someone with the appropriate expertise who is willing to serve and has no conflict of interest. This can take a significant amount of time and lead to delays in review and approval of the research.

To ensure the IRB has ready access to subject matter expertise, a question has been added to the IRB Protocol form where researchers can identify a potential consultant and provide their contact information. The question applies only to a small subset of new applications (i.e., clinical trials, studies involving the use of a drug, biologic, botanical, or nutritional supplement, studies involving greater than minimal risk), though HSD reserves the right to request consultant information as needed for other studies. The individual named should have no conflict of interest with the research and have agreed to serve in this capacity. The individual may either be from the UW or another institution. A typical consult request involves a brief email or phone call with targeted questions that usually takes no more than 30 minutes to complete.

Consent Language for NIH Required Data Sharing

Implemented November 30, 2022

For research that is subject to the new NIH Data Management and Sharing Policy, research participants will generally need to be informed about plans for sharing their information as part of the consent process. To help facilitate this, we have revised HSD’s standard consent template to include boilerplate language that can be used when de-identified data will be shared through NIH repositories, and that can also be adapted for use when data will be shared through other established repositories.

For more information on the new NIH policy, refer to our October 4, 2022 For the Record article.

COVID Related Requirements for Human Research

Update

Although WA State COVID-19 emergency proclamations and orders ended October 31, 2022, the statewide Face Covering Order issued by the Department of Health remains in place for health care settings, long-term care settings, and correctional and jail facilities.

For research conducted in WA State, researchers and study participants must continue to wear masks in these settings. Check the HSD COVID webpage for details on existing requirements and answers to frequently asked questions. This webpage has also been updated to reflect changes to UW Medicine Visitor Requirements and remove outdated FAQs.

Advance Consultation about the UW as a Single IRB

Reminder

Serving as the Single IRB for a multi-site trial or multi-institutional collaborative research requires a significant commitment of limited HSD and UW IRB resources. Therefore, HSD must be consulted in advance of a funding application if a researcher wants to use the UW as the Single IRB for a study. HSD policy continues to be that it cannot guarantee UW IRB review of any multi-institutional research for which it has not been consulted in advance of any commitment to funding agencies or other institutions.

Updated Tutorial on Navigating the External IRB Process

Published November 30, 2022

HSD has updated the online tutorial on When the UW IRB is Not the Right IRB: Navigating the External IRB Process. The overall look and feel of the tutorial was updated to streamline the experience, and some content was changed to better reflect the current process.

The approximately 15-minute-long tutorial will orient you the external IRB process, including:

  • The requirements to qualify for external IRB review;
  • When an external IRB may review UW research; and
  • The steps in the process.

For those with more time, the tutorial also includes a deeper dive into some common scenarios, including applying the federal Single IRB policy to the UW as both a lead site and a participating site.

Zipline Support Survey

Survey Now Closed

The Human Subjects Division thanks everyone who participated in the Zipline Support Survey this fall. The feedback you provided is informing future projects to improve Zipline support for researchers, including an upcoming project to streamline the HSD home page and make it easier to find existing resources. Everyone who completed the survey had the option to be entered into a coffee card drawing. Winners of the drawing have been selected and notified.