HS-IRBs News September 2017
Health Sciences and Minimal Risk IRBs, IRB News/Volume 9, Number 9, September 2017
Upcoming IRBs for Beginners Workshop
The Health Sciences IRBs for Beginners Workshop provides training on the HS IRB's processes, regulatory approval process, resources, and ARROW online application system. The two-hour workshop is held several times each year in the HSLC computer lab (room 2121), and is meant for individuals new to the HS IRBs processes or for those looking for help on how to effectively submit an IRB application. The workshop consists of two sections meant to provide the regulatory framework and technical skills to submit an application. The date and registration link can be found below.
If you have questions, please contact Jake Rome at firstname.lastname@example.org.
- Wednesday, November 1st - 10AM to 12PM, HSLC 2121 - Registration available here.
Continuing Review Updates
In light of revised institutional policy and forthcoming regulatory changes, the continuing review workflow and form will be changed starting October 2nd, 2017. For studies that meet the criteria outlined in revised policy, the IRBs may decide not to require continuing review and the study will have a "Approved No CR" status in ARROW. Study teams managing these studies will no longer receive continuing review notifications from ARROW but will receive an annual reminder about ongoing IRB requirements. For studies that have expiration dates on or around October 2nd, IRB staff have been in touch with those study teams who appear to have studies that qualify for the exception. New resources, including an FAQ and a Decision Tree, have been developed to help study teams, and revisions have been made to other website documents.
In addition to the new "Approved No CR" status, study teams will notice that the continuing review form has been streamlined. Study teams will see questions that only apply to their type of research, and this will make the continuing review process more efficient and less time-consuming. Specific changes include:
If you have any questions about how the revised continuing review policy may apply to your study, please contact Emily Jenner or Jessie Johnson.
- For studies that enroll or have enrolled subjects, the options on enrollment and withdrawal statuses have been revised. Additional questions will be hidden or shown, depending on responses to questions. For instance, answering that study is permanently closed to enrollment will generate new questions that would otherwise not be seen. The form will also auto-populate a response to the number of subjects the IRB has approved for enrollment, so study teams do not have to refer back to the original application to find that number.
- For studies that do not enroll and have never enrolled subjects, the form has been shortened. Study teams will no longer need to answer non-applicable questions regarding enrollment.
Upcoming Changes to ARROW Application
In partnership with our colleagues in the Vice Chancellor for Research and Graduate Education's IT area, the HS IRBs Office is continually making improvements to ARROW to make the IRB review process easier for study teams. Planned improvements for the September update include:
If you have questions about these updates, please contact email@example.com.
For more information on upcoming changes to ARROW, please see Vice Chancellor for Research and Graduate Education’s ARROW Updates page.
- Self-Service Removal of Personnel:
Study teams will be able to remove study team personnel studies using a new self-service activity. This new activity, called “Remove Personnel,” will be available to Principal Investigators (PIs) and Points of Contact (POCs) on studies reviewed by the Health Sciences IRBs that are either approved or expired. Since this activity will be self-service, this means study teams will no longer need to submit a personnel change only to remove study team members. Please see our FAQ for more information.
- Streamlining Administrative Section of the Initial Review Form:
The first section of all application forms for new studies submitted to the HS IRBs includes a number of administrative questions. This section of the form is being revised in phases to simplify it and leverage other data systems on campus to provide relevant information rather than asking study teams to do so. These changes will help streamline the application and make it more user-friendly for researchers.
In this update, the PI status question now links to the campus HRS database. PIs with a UW-Madison appointment will confirm their appointment instead of selecting it from a series of options and manually providing department information on the funding pages. The application will recognize when a "Request for Approval to Serve as PI" form is necessary and automatically branches to an upload option.
Future changes will include updates to how people are listed in the application as well as how funding information is requested.
Coming Soon: Revised Common Rule Page
The HS IRBs' website will soon include a page dedicated to upcoming changes to the Common Rule, the federal regulations governing human subjects research. This page will include descriptions of the main changes, how they are being implemented by the HS IRBs, and when information sessions for study teams will be held. The new page will be announced in this newsletter as well as through our listserv.
WIRB Presentation and Q&A
Please join us for a presentation by WIRB on Wednesday, October 11, from 2pm - 3:30pm, HSLC 1345.
Our institutional liaison from Western IRB, Christopher Gennai, CIP, will discuss WIRB submission forms (Initial Review, Change in Research and Continuing Review Report) with special attention to the Promptly Reportable Information requirement. Christopher will continue by diving deeper into protocol deviations and the event surrounding the deviation. The session will also include time for questions and answers.
If you have questions, please contact firstname.lastname@example.org.