UW Research

April 1, 2019

For the Record – April 1, 2019

In this issue:

New Guidance on the Return of Individual Research Results

Implementation date: April 12, 2019

HSD has developed a guidance document on the sharing of individual level study information with research participants. The guidance was developed in consultation with a UW Bioethics faculty member who specializes in genetic research. It draws upon a recent recommendation document from the National Academies of Sciences, Engineering and Medicine (NASEM).

Guidance content. The guidance includes a decision-making framework describing which results should be offered to participants. In general, every effort should be made to offer results that are clinically actionable, valid and pose life-threatening or severe health consequences if not treated or addressed quickly. Other clinically actionable results should be offered if this can be accomplished without compromising the research. The guidance also discusses the importance of validity, the applicability of the Clinical Laboratory Improvement Amendment (CLIA), requirements for consent, and considerations for communication of the results.

Effect on UW researchers. The IRB will draw upon this guidance for the review of all new studies submitted on or after April 12th. In their IRB application, researchers will be asked to describe their plans for return of individual results.

Changes to HSD application forms. The IRB Protocol application form is being revised to include questions about return of results, in alignment with the new guidance. When it is implemented on April 12th, the current ZIPLINE SUPPLEMENT: Participant Results Sharing will be retired.

Minor Changes to Zipline e-IRB System

Implementation date: April 12, 2019

Nature of changes. The Zipline e-IRB system is being revised the evening of April 12th. Most of the changes are visible only to HSD staff. However, researchers will notice a few refinements to the Funding Smart Form and the Study Scope Smart Form. In addition, a prominent reminder to click on the SUBMIT button is being added to the submission workspaces.

Accompanying form changes. Changes will also be implemented to a few forms.

  • IRB Protocol form. A few questions are being removed, new questions are added about return of results, and some minor wording changes are made for clarification.
  • Request Authorization: External IRB form. A few minor changes.
  • Status Report form. One small change for clarity.
  • Supplement: Participant Results sharing. This form is being retired.

List of all changes. The Release Notes describing all changes visible to researchers will be posted at the bottom of the Zipline home webpage on April 12th.

IRB Authorization and Individual Investigator Agreements

Implementation date: April 1, 2019

The template forms for these types of agreements are being removed from the HSD website. These two forms are not intended to be used (initiated) by researchers. However, HSD often receives them from researchers who, with the best of intentions, believe that they are helping to expedite the reliance agreement process. In the interest of transparency, HSD prefers to make all of its forms (including those used by HSD staff) externally visible whenever possible. For some forms – like these – their public availability paradoxically can result in confusion and unnecessary work.