Have You Participated in the Federal Demonstration Partnership Exempt Wizard?
The University of Washington, along with a number of other institutions, has chosen to participate in a demonstration run by the Federal Demonstration Partnership (FDP) of an electronic "wizard" that will allow investigators to "self-determine" if their project requires review by an IRB or if it meets the federal definitions of exempt. To obtain sufficient data to test the efficacy of the demonstration, each institution has been requested to ask a limited set of researchers that have had recently reviewed projects to complete the "wizard."
We recently selected a set of approximately 100 recent exempt and expedited determinations. For each study, the investigator of the study received an email asking if they would be interested in participating. If so, investigators were requested to complete the smart form, using the information from their exempt determination.
The "wizard" is still underway at other institutions. In the near future, we may be asking additional UW investigators to take part in this demonstration project.
If you have questions/feedback/comments regarding the FDP Exempt Wizard project, submit these to the FDP at email@example.com using the phrase "wizard demonstration" in the subject line. If you have questions that pertain directly to your study, please contact the UW HSD Office at UW HSD FDP.
Thank you for your assistance with this timely project!
Aligning our Forms with the New FCOI Rules
We’ve made minor updates to the Financial Conflict of Interest (FCOI) section of most of our forms. The changes reflect the changes to the federal and UW requirements about FCOI that were implemented in August 2012, including the significantly revised FCOI policy GIM-10 and the development of a new system for disclosing financial interests. Our forms now:
- Use the preferred terminology (“financial conflict of interest” rather than “significant financial interest”);
- Refer to the use of a web-based system (“FIDS”) to disclose financial interests, in place of the GIM-10 paper form;
- Ask for the assurance of the principal investigator that all key personnel are aware of their responsibilities regarding FCOI, instead of an assurance that all key personnel have complied with GIM-10.
New Pilot Program: Committee J
When an application is submitted to our office, it goes directly to a minimal risk or full board committee depending on the box checked on the application. When a study is inaccurately or inadvertently submitted to the wrong type of committee, it goes through initial review and then must be transferred to the appropriate committee.
This transfer process slows down review considerably.
We are piloting a new project to make this process more efficient by combing a minimal risk committee and a full board committee into one committee J/EJ, headed by Blair Maman and Neena Makhija.
We anticipate this will reduce wait time and increase efficiency and consistency of review for campus.
New and Revised Documents
You may have noticed that HSD has been releasing new or revised policy, procedure, and guidance documents at a brisk pace. This is a major effort that will continue during the coming year, due to:
- Campus requests
- HSD's goal of increasing transparency and knowledge about the IRB review process
- The increased frequency of federal regulatory changes
We generally release and post all new and revised documents on the last Friday of every month. We use this newsletter to alert you to those new documents. We hope you like our format for presenting the information, and we welcome feedback and suggestions. (firstname.lastname@example.org)
||Financial Conflict of Interest
UPDATED FCOI Language in Modification Form, Human Subjects Review Application (13-11), Status Report Form, Use of Identifiable Biological Specimens/Data Form, Repository Form, Initial Application: Exempt Status Request, Consent Form Sample Template, IRB Conflict of Interest Guidance, Financial Conflict of Interest Policy and Procedure.
||Changes correspond to the new process and policies following the update to PHS financial conflict of interest regulation 42 CFR 50.
|Link for more information
||See the article in this, eNews, and the forms themselves, linked above.
||January 25, 2013
Quick Tips from HSD
Dropping a Research Procedure
Dear Quick Tips,
I received IRB approval 4 months ago for my dissertation research. I'm studying stress and study habits in Introductory Psych students. One part of my research involved having the students take a survey at the beginning and end of the quarter.
I ought to be a subject in my own study! I've tried everything but I just can't get seem to get the SurveyMonkey website to show the survey correctly. So I'm giving up on the survey part of my study. Rather than bother your office with a Modification, I'm going to just drop the survey.
Please DO send us another Modification! We really need to prospectively review and approve the removal of ANY research procedure or group of subjects (except when necessary to eliminate apparent immediate hazards to subjects). I can tell that dropping the survey will benefit you (and your stress levels), but our review needs to look at whether the removal changes the risk/benefit analysis of your research.
Note: If you forward this newsletter to another email recipient, please
delete the Manage Your Subscriptions or Unsubscribe link, below.