HS-IRBs News - October 2009
Health Sciences and Minimal Risk IRBs, IRB News / Volume 1, Number 10, October 2009
ARROW beta testers still needed
We are still looking for volunteers to help us with beta testing, which we expect to begin late this year or early next year. Following an initial training session, volunteers will be asked to commit between 2-4 hours per week for about 3 weeks. Beta testing will involve going through different parts of the system and helping identify bugs and other issues. This is a great chance to get early exposure to ARROW and provide feedback about the system. If you are interested in being involved in beta testing ARROW, please contact Carol Pech at firstname.lastname@example.org.
Questions about ARROW?
The HS-IRBs will begin offering ARROW training and educational materials in the near future. In the mean time, the HS-IRBs Office has established a new email address for questions about ARROW: email@example.com. This email account is being monitored by IRB staff who are involved in the development of ARROW and thus able to answer any questions study teams might have about the new system. This email will continue to be used after ARROW is live to handle study team questions and system feedback.
Federally funded submissions requiring fast turnaround
For federally funded submissions requiring fast turnaround (e.g., challenge grants or protocol amendments with a sponsor-required timeframe for IRB approval), please make sure to identify the need for rapid review. This can be done via post-it note on paper submissions and comments in emails for electronic submissions. As always, if you have any questions, please feel free to contact us.
2010 IRB meetings schedules are available
The 2010 IRB meeting schedules for both the Health Sciences IRB and Minimal Risk IRB have been finalized and are available on our website alongside the 2009 schedule under the Health Sciences IRBs News .
Timing of submission self-reports of noncompliance
Please note that campus policy requires research teams to report potential noncompliance that has occurred within 14 days of its discovery by the research team. For guidance on identifying and reporting potential noncompliance, [Link for document 18311 is unavailable at this time.] . A form to report noncompliance to the Health Sciences IRBs.
Automated email reminders about Protocol Development Activities applications
If you have received approval for an Application for IRB Review of Proposal for Protocol Development Activities [also known as a Protocol Development Activities (PDA) Application], the campus IRBs' protocol tracking system sends out an annual automated message to the research team reminding them that no activities involving human subjects may occur under a PDA application. PDA applications generally cover the review of a grant that will later support human subjects research. If IRB approval has been obtained for the activities involving human subjects described in the grant, please close the PDA application with the IRB. To close a protocol, please submit 1 hard copy of a Protocol Closure Report of Previously Approved Research to the Health Sciences IRBs Office, room B-3060. The Protocol Closure Report of Previously Approved Research form is available under the "Forms" link on the Health Sciences IRBs website.
- Urgent issues (e.g., subject safety concerns), please call our main line (608-263-2362) and ask to speak with the staff reviewer on call for the day. Please do NOT use email for these kinds of questions.
- General IRB questions, please call our main line (608-263-2362) to speak with the staff reviewer on call or email firstname.lastname@example.org. These are the quickest ways to get help with general questions.
- Specific questions regarding the status of your review and/or reviewer notes, please contact the staff reviewer assigned to your application.
- Help with single IRB review and reliance questions, email email@example.com.
- Assistance with ARROW or technical questions, email firstname.lastname@example.org.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing email@example.com.
- Consultations: For investigators seeking assistance on a specific program or application, HS-IRBs staff are available for individual consultations. To request a consultation, complete the HS-IRBs Presentation and Consultation Request Form.
- Presentations: The HS-IRBs office is available to provide the research community with presentations and trainings on a variety of topics. To request a presentation, complete the HS-IRBs Presentation and Consultation Request Form.