HS-IRBs News October 2015
Health Sciences and Minimal Risk IRBs, IRB News / Volume 7, Number 10, October 2015
Important: Proposed Changes to Human Subjects Research Regulations Announced
The Department of Health and Human Services has released its notice of proposed rulemaking (NPRM) regarding significant changes to the Common Rule, the federal regulations that govern human subjects research. The proposed revisions affect a broad range of research and study teams are encouraged to review the proposed changes and provide comments. The revised Common Rule and supporting documents are are available on the OHRP website.
The campus HRPP (Human Research Protection Program) is developing a webpage with resources regarding the proposed changes to the Common Rule as well as way for the research community to submit comments or questions to the HRPP. When this page becomes available, we will announce it in a future newsletter and via the HS IRBs listserv.
November Dates for IRB for Beginners Workshop
The Health Sciences IRBs for Beginners Workshop provides training on the HS IRBs' processes and ARROW application system. The two-hour workshop gives participants an introduction to the HS IRBs structure, regulatory approval process, HS IRBs Office resources, and ARROW electronic submission system.The workshop is meant for individuals new to the UW IRB process or for those looking for help on how to effectively submit an IRB application.
The next sessions of workshop will be held:
Monday, November 2nd from 9:00 to 11:00 AM (HSLC 2121)
Tuesday, November 3rd from 2:00 to 4:00 PM (HSLC 2121)
Space is limited to the first 20 interested participants and registration is required. To register, click on the date you would like to attend and complete the registration process through the Office of Talent Management. If you have questions or issues with registration, please email Jake Rome.
Tips for Preparing a Protocol Development Activities (PDA) Application
Study teams are encouraged to keep the following tips in mind when preparing a PDA application:
Check with your grants management specialist and program officer before submitting a PDA: Since some NIH grants management specialists and/or program officers are no longer accepting PDAs to allow for the release of funding, please check with your grants management specialist and program officer before preparing a PDA application. If your grants management specialist and/or program officer will not accept a PDA and you have a short time frame to obtain IRB approval, please contact us as soon as possible so we can assist you in efficiently navigating the IRB review process.
Make sure funding information provided in the application is accurate: We have recently had a few cases of PDA applications being submitted with the incorrect funding information (e.g., wrong MSN number). If the PDA application has already been approved, the only way to correct the funding information is to submit a new PDA application. As a result, we encourage study teams to check with the appropriate person in their department to ensure the funding information is correct before submitting the application.
Changes to Studies Excepted from the Five Year Renewal Policy
When considering making a significant change or funding update to a study that has been open for five years or longer and for which a replacement application has NOT been required (e.g., the study is in data analysis or long-term followup only), please contact the IRB office for guidance before submitting the change of protocol. In keeping with campus policies, significant changes (e.g., adding new aims, collecting new data or specimens, reopening the study to enrollment) or funding updates (e.g., adding a new grant) may require a new application be submitted instead of a change of protocol. Our staff can assist you in determining whether a change to the existing study is appropriate and if not, what type of new application may be needed.
HS IRBs Office Staff Updates
- Molly Lumley, IRB submission specialist, is leaving the HS IRBs Office at the end of this month, as she has taken a position with ICTR’s OnCore Team. Many thanks to Molly for her service to the HS IRBs Office over the past six years, including her work as the submission specialist, web-team member, and IRB Reliance team member. We wish Molly all the best in her new position.
- We will be re-assigning Molly’s submission specialist and other duties to HS IRBs office staff as needed. Questions about items that Molly previously handled can be directed to the main HS IRBs office at 263-2362.