September 9, 2019
For the Record: A Special Six-Month Series, September 9, 2019
- Special Six-Month Series of Newsletters
- Single IRB Requirement Expanding Soon
- UW IRB as the Single IRB
- Major Zipline e-IRB System Upgrade
- New NIH Fetal Tissue Policy: Consent Forms for Grant Applications
A New Look for a Special Six-Month Series of Newsletters
Beginning with this issue
This issue is the beginning of a special six-month series of bi-weekly newsletters.
The purpose is to highlight two pending major changes that will affect most researchers:
- Expanded Single IRB policy (coming on January 20, 2020)
- Major Zipline e-IRB system upgrade (at the end of the calendar year)
Each issue will focus on specific topics related to these important changes. We will emphasize what these changes mean to you, how we will help you navigate these changes, and how they will (or won’t) affect what you do to obtain IRB approval. We will also continue to report on other meaningful regulatory changes and HSD/IRB improvements.
All issues will be archived in the usual HSD Announcements section of our webpage.
The Single IRB Requirement is Expanding Soon
Effective January 20, 2020
The requirement to have a Single IRB provide the review for all domestic institutions involved in a study is expanding. This will affect many UW researchers.
The current policy is a NIH policy that applies only to NIH-funded multi-site studies in which each site is conducting the same research procedures – for example, a standard multi-site clinical trial.
The pending policy is part of the revised Common Rule federal regulations. It applies to all federally-funded research that involves more than one domestic institution. In other words, it applies to collaborative research as well as classic multi-site research, and research funded by other federal agencies in addition to NIH.
This will have a significant impact at the UW IRB as well as all across the country. There will be differences in:
- Preparation of grant proposals, including the need to consult with HSD in many circumstances
- Possible grant budget impacts, as IRBs begin charging fees to review research conducted at other institutions
- Responsibilities of the lead PIs
- The formatting, submitting, and review of IRB applications
- What an IRB needs to consider when reviewing for another institution
- Responsibilities of IRB offices
Each future issue of this newsletter will focus on one or two of these topics.
Major Zipline e-IRB System Upgrade
End of this calendar year
The UW’s Zipline e-IRB system will be upgraded to a major new version, at the end of this calendar year.
Why is the upgrade necessary? We know that major upgrades are disruptive, so we have delayed doing one as long as possible. Now the version we use is no longer supported by the software company. In addition, the upgrade is necessary to accommodate:
- The changing requirements associated with using or being a Single IRB, and
- The revised Common Rule regulatory changes that were implemented last January. HSD developed some temporary work-arounds that are becoming too cumbersome to maintain.
Major changes. Most of the changes involve:
- Improvements in the “user experience” – for example, more intuitive ways to navigate through an application
- Changes in how study team members are identified
- Regulatory-based changes required to accommodate the UW serving as a Single IRB
What to expect.
- Future newsletter issues will focus on specific changes.
- All-new web-based Instructions will be available in advance.
- We are hoping to provide a test site for researchers, allowing them to submit “practice” applications and explore new features.
- The system will be unavailable for a few days during the actual upgrade. The number of days and when they start will be announced well in advance.
New NIH Fetal Tissue Policy: Consent Forms for Grant Applications
Effective for NIH grants with due dates on or after September 25, 2019
NIH recently released a policy called Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research (NOT-OD-19-128) as well as clarifying information (NOT-OD-19-137) and FAQs.
The new requirements apply to NIH applications submitted on or after September 25, 2019 that propose the use of human fetal tissue obtained from elective abortions. The new requirements include the obligation to attach to the grant application or provide NIH during the Just-in-Time process:
- A blank copy of the IRB-approved consent form for the research, and
- A letter signed by the PI attesting to compliance with specific consent-related requirements outlined in the NIH policy.
HSD has inserted a section into the standard UW consent form template, so that the standard template can be used for this purpose.