HRPP Newsletter September 2021
UW HRPP policies recently underwent significant changes, including a reduction in the number of human subjects research policies. With the move to the HRPP Toolkit, much of the old policy content has been incorporated into Toolkit documents. New policies are more focused than previous policies and reference the Toolkit, instead of restating federal regulations.
The site supplement protocol template is a resource template in the Toolkit to be used as a supplement to a main protocol that may not include all of the elements of the UW IRB template protocol. This will most likely only occur in multi-site studies. Study teams may choose to update the main protocol with any additional information requested by the IRB; however, the site supplement is another useful option to provide sufficient information for the IRB review.
Common examples of when this supplement template is helpful to study teams, or asked for by the IRB, include:
- sponsor or coordinating center does not want changes to the main protocol, and
- UW site is not participating in all aims of the protocol, or
- UW is conducting an additional aim to the main protocol, or
- UW site recruitment procedures are not detailed or vary from other sites in the main protocol
Upcoming Non-Protocol Based Application (nPBA) trainings
As mentioned in the August newsletter, work on a new application, the nPBA, is underway. The anticipated release of the nPBA is late 2021. The IRB office will hold training sessions related to the nPBA in the coming months. Please stay tuned as more information, including dates and times of the trainings, will be forthcoming.
UW-Madison Qualtrics – Survey Deletion or Transfer Information
When a project is deleted in Qualtrics, the survey and data is only “soft deleted”. That means that the survey and data are still recoverable. Only the UW-Madison Qualtrics Brand Administrators can permanently delete a survey. If you need to permanently delete a survey to comply with a records retention schedule or research data lifecycle, please follow the instructions here.
When graduate students complete their degrees or investigators change institutions, it is common for them to want to transfer surveys to a Qualtrics account at their new institution. New guidance, linked here, describes the agreements and approvals required before data can be shared or transferred.
Advance Planning for Single IRB Review
RELIANT is seeing an increase in requests from researchers for UW-Madison to serve as the reviewing IRB for multisite studies. Many of these requests are coming to our attention late in the process, often only after study teams have received a high funding score or funding has been awarded. Conducting a study for which you will be serving as the lead site is complex and putting reliance agreements in place with other sites can be time consuming. To better assist you when you are considering asking the UW to serve as the single IRB of record, please do the following:
- Contact RELIANT (email@example.com) as soon as you know you are planning to conduct a non-exempt multisite study and do not wait until you have submitted a proposal for funding. This will allow time for us to meet with you to ensure the UW is the best reviewing IRB option for your study and to orient you to the requirements of a lead study team.
- If your study has no external funding, single IRB review is often not the best option for your study. It is frequently much quicker for each site to obtain their own IRB approval than enter into reliance agreements. Please reach out to RELIANT if you are planning a multisite study that will not have external funding so we can assist you.
- A reminder that studies that qualify for exemption are not required to use a single IRB review model and the UW will not cede IRB review or serve as the reviewing IRB for such projects. Please contact us if you have questions about conducting multisite exempt research.
ARROW SmartForm Format Changes
In preparation for future ARROW upgrades, all initial review forms (past and current) will be reformatted (see screenshot below); follow-on submissions and ceded applications will not be affected by these formatting changes at this time. Most notably, each question will now have its own title; this is in addition to the page title. The formatting changes will take effect on 9/11.