HS-IRBs News January 2012
Health Sciences and Minimal Risk IRBs, IRB News / Volume 4, Number 1, January 2012
2011 Year in ReviewWith the start of a new year, we wanted to share with you a snapshot of the HS and MR IRBs in 2011 by the numbers:
New applications reviewed by the full IRB: 421
Emails sent to asktheirb: 841
Exemptions granted: 380
Calls to the ARROW helpline: 1182
Personnel changes approved: 1177
Full and expedited changes submitted to the HS and MR IRBs: 738
Completed deferral and IRB of record requests: 98
Total number of submissions of all types reviewed by the HS and MR IRBs: 4334
We thank the research community for their assistance in 2011 and look forward to another busy year!
Important Reminders about the ARROW Helpline
Please keep in mind that all calls to the ARROW helpline are now directed to voicemail. IRB staff monitor voicemails from 9AM to 3PM Monday through Friday and return all calls received before 3PM on that same day. Calls received after 3PM are returned the next business day. When leaving a message, please include the following information in your message:
- IRB study number
- A description of the issue or question about which you are calling
Having this information helps us provide better service by allowing us to investigate issues before returning calls. Please also remember that a large number of resources are available on the Health Sciences IRBs ARROW Help page.
HS-IRBs Staff News
We wish a fond farewell to Catherine Rogers, who will be leaving the office soon. Catherine has been an integral part of the HS-IRBs review staff for several years and has lead office educational initiatives, such as IRB member training. We wish Catherine all the best and she will be very missed.
New and Improved Multisite Research Web Page
The multisite research has been substantially revised, including changes to the format, new reference documents, and revisions to existing FAQs. We hope these changes will make information about multisite and collaborative research more accessible and easier to use. New documents include:
- Frequently Asked Questions about Exemptions, Not Human Subjects Research Projects, and Collaborative Research Requirements
- Wisconsin IRB Consortium (WIC) Reliance Fact Sheet
- Checklist for Investigator-Initiated Multisite Studies
Revised documents include updated guidelines on when the HS-IRBs will agree to serve as IRB of record as well as when the HS-IRBs will consider deferring IRB oversight to another institution. Instructions for submitting IRB of record, deferral requests, and WIC requests also have been updated. Please also see these revised documents:
- Overview of IRB Requirements for Multisite and Collaborative Research
- How to Add a New Site to an Approved Study
We hope you take a moment to check out the new page and let us know what you think.
New: HS-IRBs Presentation/Training Online Request Form
The HS-IRBs Office is available to provide presentations and training on a variety of topics to groups or departments. To assist people with requesting presentations, a Consultation & Group Presentation Request is now available on the HS-IRBs website. To request a presentation on topics like introduction to the IRB review process or any ARROW training (group or individual), please complete the online form. Requests should be submitted at least 4 weeks in advance of the preferred date for the presentation. After the request has been reviewed by the HS-IRBs office, you will be contacted by email. Please keep in mind that the availability of IRB staff to provide presentations depends on staffing needs and other office commitments.
Please note that the presentation request form should NOT be used by individual researchers seeking assistance with an application or specific issue. To request a one-on-one consultation, please complete the Document 20861 is unavailable at this time. request form.
HS-IRBs Community-Based Research Working Group to Conduct Focus Groups
The Health Sciences IRBs Office continues to see an increase in community-based and type 2 translational research requiring IRB review and oversight. This type of research can pose unique regulatory challenges. As a result, the HS IRBs Office previously formed a working group with the goal of improving the HS IRBs review processes for community-based research. In February, the working group, with support from the UW Collaborative Center for Health Equity (CCHE), will be conducting focus groups to begin soliciting feedback from researchers who conduct community-based research through UW-Madison. Updates on the outcomes of the focus group sessions and additional opportunities for providing feedback will be included in future newsletters.
Reminder: New and Revised Guidance Issued in 2011
For those who may have missed previous announcements, here is a brief recap of important new or revised guidance issued in 2011:
- Guidance on the Five Year Renewal Policy and Replacement Studies in ARROW
- Commercial Products Language
- Communicable Disease Testing Guidance
- Guidance on Presenting Changes of Protocol to IRB
- Health Sciences IRBs Protocol Exceptions and Deviations Guidance
- Personnel Change Guidance
- Versioning Study Documents
Questions? We're Here to Help!
Whether you have a question about a specific protocol, a general question about the submission process, or need clarification about research policy, we have several ways you can reach us.
- For 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.
- For 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.
- For assistance with ARROW or technical questions, email email@example.com.
- To receive the newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing firstname.lastname@example.org.
- To receive updates about WIRB, please sign up for the WIRB listsserv by emailing email@example.com with a request to be put on the list.
- 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.