November 28, 2018
The Common Rule News – November 28, 2018
Issue 10: Review of Grant Applications
HSD’s Common Rule Webpage
Review of Grant Applications
What is the requirement that is being eliminated?
Does this mean the grant application won’t need to be included with IRB applications?
Lighter Fare Than Usual
After the Thanksgiving holidays, many of us want to pare down our eating for a while. We thought you might feel the same about the ample diet of information we’ve been feeding you, so this issue is shorter than usual.
Review of Grant Applications
This requirement is being eliminated
IRB approval certifications One of the terms and conditions that must be met by a researcher’s institution before a federal agency will release research funding is certification of IRB approval of the research. This requirement is part of the Common Rule. Unbeknownst to many, the current Common Rule has a second certification requirement: The grant application or proposal itself (as distinct from the study) must also be reviewed and approved by an IRB.
Before federal agencies adopted the “Just-in-Time” process, the grant certification requirement meant that researchers who were struggling to write a grant application in time for a deadline had to also squeeze in time to prepare an IRB application. Federal agencies required documentation of the IRB’s grant certification to be submitted with the funding application. This led to the development of contorted concepts such as Approval in Principle and abbreviated IRB applications. It also led to a great deal of resentment: Most grant applications are not funded the first time they are submitted, meaning that most of those IRB applications were wasted effort for researchers, the UW IRB and HSD staff. No one was happy.
Just-in-Time. NIH pioneered the adoption of a federal “Just-in-Time” process several years ago. This means that some grant application elements (including certification of IRB approval) are submitted several months after the application has been submitted. The only researchers required to submit the Just-in-Time information are those whose applications have a review score that suggests they are likely to be funded. In other words, no more wasted effort on unnecessary IRB applications.
Simultaneous review of research and grant application. With Just-in-Time, the IRB’s review of the research and the grant occurs simultaneously. This has been invisible to UW researchers except for IRB questions about inconsistencies between the grant application and the IRB application. But this grant certification requirement is still awkward because the grant application: (1) is often outdated by the time the research study is submitted for IRB review; and (2) contains detailed information about the costs of a study, personnel, and administrative issues that go beyond the review mission of the IRB.
The Change and What it Means
The revised Common Rule eliminates the requirement for certification of a federal grant application, stating (in the Preamble): “Experience suggests that review and approval of the grant application is not a productive use of IRB time.” In essence, this change removes a dangling historical requirement.
Impact on researchers. At the UW, the grant certification has been seamlessly piggybacked onto the study certification process. The only effect of eliminating this requirement will be no more IRB questions about inconsistencies between the grant application and the IRB application. The UW IRB will still require the grant application to be submitted as part of the IRB application because it is a valuable source of additional details about background, context, and study design, even if specific procedures have been revised since the grant was written. As in the past, the IRB will not review budget information, bio-sketches, or other administrative information.
Documents Released this Week
Available Friday, November 30th
Word of the Week
Certification is the official notification of a study’s IRB approval from an institution to the federal department or agency that is financially supporting the study. This certification requirement is part of the original and the revised Common Rule. The original Common Rule has also required certification of IRB approval of the grant application (as distinct and separate from the study).
Question from Campus
Q. I’m doing a study that the UW IRB reviewed and approved last year. After reading your newsletter, I can tell that it would qualify for exempt status if it was reviewed under the revised Common Rule. Can I stop my study, re-apply so I get exempt status, and then start again?
A. Yes, you could, but you would be doing lots of unnecessary work. HSD will have a formal process for “switching over” already-approved studies to the revised Common Rule. It will not require a new application for studies like yours that were IRB-approved and will now qualify for exempt status. Stay tuned for details in an upcoming issue before January 21st.
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.
Issue 11: December 5, 2018
Focus: Continuing Review (Status Reports)
Back issues available on the HSD Common Rule webpage