UW Research

August 1, 2023

For the Record-August 1, 2023: HSD Homepage Redesign, Short Form Consent Policy Clarification, RCR Training Changes

In this Issue:

HSD Homepage Redesign

Launching August 31, 2023

The Human Subjects Division is excited to announce a new design for our homepage launching on August 31. The goal of this project is to improve site navigation by providing clear pathways to the most needed information for all types of researchers, from students working with the IRB for the first time to experienced study staff. Our homepage will be under construction on August 31 and it may be more difficult to find materials that day as we make updates. Contact hsdinfo@uw.edu if you have any questions or need assistance. The website will be fully available by September 1.

Changes will include:

  • Streamlined homepage featuring quick access to the most used resources
  • New “Getting Started” page targeted to students and other researchers new to working with the IRB
  • New “Application Forms” page making it easy to find key forms in one place
  • Significantly reorganized “Topic Based Guidance” page, making it easy for you to find all of our resources about notable topics in one centralized location
  • Easier access to our “Consent Templates” page
  • Significant revisions to our “About Us” page
  • Improved search results using the Office of Research site search bar

Thank you to all the members of our campus community who participated in interviews and provided in-depth feedback about our draft designs. Your insights helped to ensure that our final design is better suited to the needs of the UW research community.

Short Form Consent- Clarification of HSD Policy

Revised Guidance Published July 27, 2023

Regulations and Policy
Human subjects regulations allow use of short form consent for the infrequent and unanticipated enrollment of an individual with limited English proficiency in a study: (1) for which no consent form in the subject’s language has been prepared; and (2) there is insufficient time and opportunity to obtain a written translation of the IRB-approved English consent form.

Clarification
In June, HSD announced a change in policy for when short form consent may be used. In response to researcher feedback, the policy has now been revised to clarify that:

  • For research that involves more than minimal risk, the short form method may only be used for studies that provide the prospect of direct benefit that is not available outside the research context.

A definition of  “prospect of direct benefit”  is now provided as well as some additional explanation of what not available outside the research context means.

For more information, refer to the Short form consent requirements on HSD’s website.

Changes to Responsible Conduct of Research (RCR) Training Requirements for National Science Foundation (NSF)

For Proposals Submitted or Due Starting July 31, 2023

The National Science Foundation’s Responsible and Ethical Conduct of Research (RECR) training requirement has expanded to include all faculty and senior personnel supported by NSF for proposals submitted or due on or after July 31, 2023. RCR training is intended to help sensitize the university research community to the wide range of ethical and professional issues that must be considered to ensure a climate of research integrity. Visit the Responsible Conduct of Research (RCR) page on the Office of Research website for more information, including RCR training contacts.

UW provides training for all researchers supported by NSF through the Collaborative Institutional Training Initiative (CITI). Information on accessing the training is available on the RCR Training Instructions page.

New Consent Templates and Guidance 

Reminder

On June 1st, HSD published new consent materials to support a participant-focused consent process and form. These new tools will assist researchers with designing a consent process that is compliant with the regulatory consent changes implemented in 2018. Full details can be found in the June edition of For the Record. Key points include:

  • Designing Consent web guidance that provides information about what must be included in the consent process/form. It may be used to supplement the instructions embedded in the templates or can be used to create a consent process/form without starting from a UW template. It includes a section specific to designing consent for multi-institutional research.
  • Consent Templates that will assist researchers with designing a participant-focused consent process and form which emphasizes the key information most likely to influence a subject’s enrollment decision. The templates are flexible so researchers can modify them to suit the needs of their study population.
  • Example Consent forms that demonstrate some of the many ways consent may be designed while also satisfying regulatory and UW IRB policy requirements.

Transition period. HSD recognizes that this new approach to consent represents an important but significant change. To ease the transition, HSD will accept consent forms submitted on the old, Standard template until October 1, 2023. However, researchers are encouraged to begin using the new templates and approach as soon as possible.

Questions. Contact hsdinfo@uw.edu with any questions about the new materials.