HS-IRBs News March 2012
Health Sciences and Minimal Risk IRBs, IRB News / Volume 4, Number 3, March 2012
New: Quick Check Pre-Review Pilot Project
Beginning in mid-April 2012, the Health Sciences IRBs will be piloting a new quick check pre-review process for investigator-initiated and/or trainee studies undergoing full IRB review. Quick check pre-review is a brief form of pre-review that will focus only on certain sections of the IRB application. Quick check pre-review is designed to help study teams by providing them with feedback on key sections of the IRB application early in the review process. This will allow study teams to address major concerns as soon as possible and hopefully shorten the overall time an application spends in pre-review.
For applications that qualify, quick check pre-review will be conducted within 2 weeks of the application being assigned to an IRB staff reviewer for pre-review. Study teams will be notified via reviewer notes in ARROW of any significant issues with a protocol or certain areas of the application that are identified during the quick check pre-review. The quick check process will NOT replace the current pre-review process and study teams should still expect to address issues during the regular pre-review process.
This pilot quality improvement project will last approximately 3 months and will then be evaluated. Time from receipt of an application to approval will be reviewed as well as study team feedback to determine whether the quick check process will continue.
For a full description of this pilot project (including what types of studies qualify for quick check pre-review), please see [Link for document 22914 is unavailable at this time.] . If you have any questions about this pilot project, please contact Carol Pech at email@example.com.
Introducing HS-IRBs' Community Research Specialist
In response to the growing volume and complexity of community-based research studies reviewed by the HS-IRBs, we are proud to announce that Staci Taylor Lowe is now serving as the community research specialist for the office. Staci holds a
PhD in social policy from Cornell University and has worked on numerous
research and evaluation studies based in community settings. She has worked in
the SMPH for eight years in both research and administrative capacities.
In her new role, Staci will serve as the IRB staff reviewer for most community-based research applications submitted to the HS and MR IRBs. Staci also can assist community-based researchers by:
- Providing consultations about the IRB review process
- Assisting researchers in identifying and addressing IRB issues most salient to CBR studies before an application is submitted the IRB
- Developing educational resources useful to the CBR community
- Serving as a liaison between research teams and the IRB
New ARROW Activity: Using the Record Human Subjects Training SnapshotBy mid-April, a new activity will be available in ARROW that will allow study teams to check human subjects training status and dates for all study team members listed on an IRB application. The new activity is called Record Human Subjects Training Snapshot. The new activity will list training expiration dates for all study team members listed in the IRB application. It also will display in the History tab whether any study team members do not have the required training or have expired human subjects research training certification. Study teams should use this activity before submitting new initial review applications or personnel changes to ensure that study team members have current human subjects research training certification. For more information on how this new activity works and how to use it, please see [Link for document 23550 is unavailable at this time.] .
Coming Soon: Resource Page for New Investigators
We are working on a new resource page on the HS-IRBs website for new investigators. This page will include a step-by-step guide to the IRB process, including determining whether a project requires IRB review, what do if a project requires IRB review, and information about submitting applications to the HS or MR IRB. If you have suggestions for information that should be included for new investigators, please contact Chelsea Dahmen at firstname.lastname@example.org.
New Initial Review Application Guidance
New FAQs have been posted for a few areas of the initial review application that can be challenging to complete:
- Completing the Research Design and Procedures Section
- Selecting the Review of Records/Data/Images Option on the Special Procedures Page
- Completing the Subject Identification and Recruitment Section
Study teams - particularly those new to the IRB review process - are encouraged to review these and other FAQs when preparing their IRB applications to help the review process go as smoothly as possible.
Reminder: No Deadlines for Submitting Initial Reviews or Changes to the HS-IRBs
We have recently received several questions about deadlines for submitting new initial review applications or changes of protocol to the HS-IRBs. This is just a reminder that the HS-IRBs no longer have any deadlines for submitting new applications or changes. All applications submitted to the HS-IRBs must first undergo scientific review, if applicable, and pre-review before being scheduled for an IRB meeting or approved by an IRB member. Exemptions also undergo the same pre-review process. Study teams are reminded that continuing reviews should be submitted 6 weeks prior to the study's expiration date.
Update: Logging Out of ARROW
- 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 email@example.com. 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 firstname.lastname@example.org.
- Assistance with ARROW or technical questions, email email@example.com.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing firstname.lastname@example.org.
- 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.