December 12, 2018
The Common Rule News – December 12, 2018
Issue 12: FDA-Regulated Studies; Externally Reviewed Studies
HSD’s Common Rule Webpage
How are FDA-regulated studies affected by the revised Common Rule?
Are there any issues for UW studies reviewed by an external (non-UW) IRB?
The Food and Drug Administration (FDA) has its own set of human subjects regulations that are similar but not identical to the Common Rule. However, FDA-regulated research must comply with the Common Rule if the research is federally funded or if the researcher’s institution applies the Common Rule to all research. The UW IRB, like most academic IRBs, applies the Common Rule to all research. This means that FDA-regulated UW research must comply with both sets of regulations: FDA and the Common Rule.
FDA guidance. The FDA has released guidance about the interaction between the two sets of regulations. Key points:
- The revised Common Rule consent requirements don’t conflict with FDA regulations.
- All FDA-regulated studies must undergo continuing review (“Status Reports”) at least once a year and therefore cannot take advantage of the revised Common Rule change about continuing review, even if they are minimal risk studies.
- FDA-regulated studies qualify for exempt status only if they fit into Category 6 “Taste and Food Quality Studies”.
Harmonization is Coming
The federal 21st Century Cures Act (dated December 2016) requires the FDA to “harmonize” its regulations with the revised Common Rule. The proposed harmonization may be released for public comment within the next one to two years. IRBs and researchers eagerly await this simplification of the regulatory environment.
IRB Review from External (non-UW) IRBs
An increasing number of UW studies are reviewed by an external (non-UW) IRB instead of the UW IRB. This is because of specialization among IRBs and/or the desire to have only one IRB do the review for all of the organizations involved in a specific study. There is no specific impact of the revised Common Rule on the nature and requirements of external IRB arrangements. However, if you routinely use an external IRB (such as the Hutch IRB or Seattle Children’s IRB), remember that every IRB in the country is revising its forms, consent templates, and SOPs because of the revised Common Rule.
Word of the Week
An External IRB is any non-UW IRB that reviews UW research instead of the UW IRB. This is increasingly common because of specialization among IRBs (for example, the Hutch reviews many UW oncology studies) and because of the growing interest in having just one IRB review all of the organizations involved in a specific study. This so-called Single IRB approach is required by NIH for multi-site clinical trials. The revised Common Rule will require the use of a single IRB for all federally-funded collaborative research, beginning on January 20, 2020. A January issue of this newsletter will preview this eventual requirement.
Question from Campus
Q. I’m still confused about whether I need to include the new consent elements in the consent form for the study you want me to send to WIRB for review instead of the UW IRB.
A. If your study is federally funded, you need to include the new consent requirements of the revised Common Rule, regardless of which IRB is doing the review unless the IRB grants a waiver to exclude one or more of the new elements.
Summary of Changes
HSD’s Common Rule webpage has a summary of the changes. Each issue of this special newsletter will focus on one of these changes – providing in-depth details about how it will affect researchers, the IRB review process, consent forms, application forms, and the Zipline e-IRB system. It will also link to any resources that are available to help with the change. The schedule of topics and newsletter dates are posted on the HSD Common Rule webpage.
Review Turnaround Times in January and February
HSD expects our processes to take longer than usual in January and February, as we too become familiar with the changes and the new requirements. In addition, the SR-99 Alaskan Way Viaduct closure may negatively affect our normal staffing.
The Twelves Issue
No, it’s not what you think
This 12th issue of our Common Rule News is being published on the 12th day of the 12th month. This has no significance, but being the detailed-oriented people we are and being a bit punchy after producing so many newsletters in such a short time, we thought we would point this out.
Issue 13: January 9, 2019
Focus: Switching Existing Studies to the Revised Common Rule; the January 2020 Single IRB Requirement
Back issues available on the HSD Common Rule webpage