eNews re IRB Review

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Some big positive changes are almost here!

Implementation date: January 31, 2014

The purpose of this special edition of our e-Newsletter is to give advance notice of some major changes that are being implemented at the end of the month.

The primary impact on researchers is:

  1. Policy changes will eliminate the need for many "nuisance" modifications.
  2. The re-formatted Modification form will be much easier to read, navigate, and complete.

 


Policy Changes

Change #1: Who is identified by name on IRB applications.

Beginning January 31, IRB applications will no longer ask for the name of every member of your research team. Instead, applications will ask for the names and contact information for only those individuals in the following specific roles for your research:

  • Lead Researcher: also called the principal investigator.
  • Faculty Advisor: required only when the lead researcher is a student.
  • IRB Contact Person: the person with whom the IRB should communicate.
  • Study Coordinator: the person who manages the day-to-day operations of the study.
  • Subject Contact Person: the person(s) to whom participant questions, complaints, and adverse events should be directed.

For some research, the same individual may fill more than one (or all) of these roles, or there may be more than one individual who fills a specific role. For all other team members, application forms will now ask for only the general qualifications required for certain roles. Example: for a study involving a behavioral therapy intervention, the application should describe the background/experience/licensing requirements (but not names) for individuals who will deliver the behavioral therapy.

Modification forms about a change in the research team will be required only when there are changes to named individuals or the qualifications for a specified role.

Change #2: Who is identified by name on consent forms.

Beginning January 31, consent forms are required to list only the lead researcher and the subject contact person. Previous UW policy required consent forms to name every individual who would interact with the research participants.

Modifications to consent forms because of a change in the research team will be required only when there is a change to the lead researcher or subject contact person.

Change #3: How to identify the involvement of other organizations and institutions.

Beginning January 31, all application forms have a short new section for this specific purpose which also provides guidance to researchers. This should eliminate significant back-and-forth with the IRB.

Change #4: Training verification.

Beginning January 31, researchers are no longer required to provide documentation that training requirements have been fulfilled. Currently, training requirements exist only in connection with federally funded research. A careful analysis showed that the IRB's role in verifying fulfillment of training requirements was redundant with the process followed by the federal funding agencies. Therefore, the IRB's requirement has been eliminated.

 


Revised Modification Form

The new Modification Form is finally here!

Beginning January 31, the Modification Form is a "smart" PDF document. This change to the most frequently used IRB form allows users to select and see only the sections pertinent to the changes being made. It also implements the above policy changes,  meaning fewer modifications forms to complete and submit for IRB approval. The new form also has an updated and easier-to-follow section about the involvement of other organizations and institutions.

Watch for these changes, as well as information about them through outreach sessions on campus, a webcast, training materials, and guidance. Outreach sessions are currently scheduled for:

  • UW Tower Auditorium: Wednesday, 2/12, 1:30 - 2:30 pm
  • Health Sciences, K069: Friday, 2/14, 2:00 - 3:00 pm
  • Harborview, R&T Auditorium: Thursday, 2/20, 12:30 - 1:30 pm

 


 

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January 21, 2014

IN THIS ISSUE

Changes are Here

Policy Changes

Modification Form

 

 


IRBshare is open for business! See the  HSD website for more information.


 

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