November 2, 2020
For the Record – November 2, 2020: New Subject Payment Guidance
- NEW Subject Payment Guidance
- The Single IRB Requirement
- Reminder: Getting Started in Zipline Tutorial
- Department of Defense
NEW Subject Payment Guidance
November 2, 2020
A new HSD webpage called GUIDANCE Subject Payment provides detailed guidance and a framework for designing and evaluating research subject payments. It includes specific tips and identifies the specific issues of concern to Institutional Review Boards (IRBs). The framework is based on several recent peer-reviewed publications by prominent bioethicists that are widely accepted as well-reasoned and useful analyses. Prior to these publications, IRB consideration of subject payment and its potential for being an “undue influence” on the decision to participate was based on sparse federal regulatory guidance. This sometimes resulted in conservative reviews.
Related form change. The subject payment question on the IRB Protocol application has been revised to match this new guidance.
A webpage, not a Word document. This guidance marks the start of a slow but steady transition of guidance information from Word documents to webpages on the HSD site. You will always be able to find all guidance in the usual way through the Policy Procedures Guidance repository but webpage guidance will also be directly available through the Special Topics section of the right-hand navigation menu on the HSD home page. Guidance presented as a webpage has advantages over Word documents:
- Fewer clicks are required to open it.
- The information is easier to navigate and absorb because of web formatting techniques such as “accordions” and “hide-show” features.
- It is more easily available on mobile devices.
- It is still printable, using the Print Preview icon at the top of the webpage or by “printing” as a PDF document that can be saved and circulated.
Thank you. This topic was the most frequently mentioned source of confusion in the last campus satisfaction survey. With this latest guidance, HSD has now addressed the needs identified in that survey – including Return of Results guidance, a Getting Started in Zipline video tutorial, shorter and more navigable Zipline instructions, Single IRB guidance, and expanded methods for electronically documenting consent. HSD is grateful to the many researchers and study staff who took the time to respond to the survey a couple of years ago. We hope that you will continue to provide us with requests and constructive feedback that we can incorporate into our planning and prioritization.
The Single IRB Requirement
Requesting an exception
The National Institutes of Health (NIH) has published a policy notice about requesting exceptions to the regulatory requirement to use a Single IRB for federally-funded multi-site or collaborative research. The notice reiterates that there is a process for requesting an exception to use of a Single IRB. The process, and the criteria for granting an exception, have not changed because of the COVID-19 pandemic.
The policy notice was published in response to the October 8, 2020 guidance from the federal Office for Human Research Protections, entitled Exception to the Single IRB Review Requirements for Certain HHS-Conducted or -Supported Cooperative Research Activities subject to the 2018 Requirements During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. The guidance was issued to emphasize that regulations allow federal granting agencies to issue study-specific exceptions to the Single IRB requirement.
Reminder: Getting Started in Zipline Tutorial
A resource for all new users of the Zipline e-IRB system
A “Getting Started in Zipline” tutorial is available in the Zipline Online Help Library on the HSD website. Access to the tutorial requires logging in with your UW NetID. It is based on user roles – in other words, the information is now tailored to common groups of users so that they get the information most relevant to them. In 15-20 minutes, the tutorial gives some basics and tips to principal investigators, study staff, and student researchers who are new to using Zipline about:
- Successfully submitting a new application in Zipline.
- Effectively responding to any requests for more information or changes from HSD or the IRB.
- Navigating in the system.
Department of Defense
A requirement has been eliminated
Research supported by the Department of Defense has been required to have an independent research/medical monitor, for studies involving more than minimal risk to the subjects. Revised DoD regulations removed this requirement. The relevant questions have been removed from the UW IRB application form SUPPLEMENT Department of Defense.
The IRB may still require researchers to have a monitor or a Data and Safety Monitoring Board (DSMB) for any study for which the IRB thinks it is appropriate. Also, existing DoD-funded studies with a monitor or DSMB must continue to comply with the IRB-approved data and safety monitoring plan unless a modification is submitted to change it.