HS-IRBs News - July 2009

Health Sciences and Minimal Risk IRBs, IRB News / Volume 1, Number 7, July 2009

Printer Friendly Newsletter July 2009

Correction to Health Sciences IRB Meeting Schedule

A schedule of Health Sciences IRB meeting is posted on the IRB website.  It contains an error.  The Health Sciences IRB will meet on August 31, 2009 but not September 1, 2009.  The deadline for submission of continuing review protocol progress reports for review at the August 31, 2009 meeting remains August 14, 2009

ARROW update

Work on ARROW development has picked up pace and internal technical testing of the system for bugs will begin in August, which is an exciting milestone for this project. After internal testing is complete, the HS-IRBs office will move toward alpha and beta testing, expected to take place later this year. We are looking for volunteers to help us with beta testing. Following an initial training session, volunteers will be asked to commit between 2-4 hours per week for about 3 weeks. If you are interested in being involved in beta testing ARROW, please contact Carol Pech at cap@medicine.wisc.edu.

ARROW Facts

As development of ARROW continues, we want to begin introducing some features of the system as well as some administrative changes that the new system will bring.

HS-IRBs office withdrawing submissions timed out due to lack of response

In preparation for ARROW, the HS-IRBs have begun withdrawing submissions that have timed out due to lack of response.  Affected submissions will be those either with outstanding modification requests or outstanding issues raised during pre-review for which the study team has not responded within the following time periods:

Submission Type

Timeline

Initial Review submission during prereview

6 months (this time frame will be shortened in the future)

Initial Review submission, modifications from the IRB requested

6 months

Change submission during prereview

3 months

Change submission, modifications from the IRB requested

6 months

 

 





Example 1: Dr. John Doe submitted an Initial Review Application in October 2008. It has been in prereview since it was received. IRB staff provided Dr. Doe with suggested changes in November 2008. Dr. Doe has not responded to the pre-review requests by April 2009. The HS-IRBs office will initiate withdrawal procedures for this study because no action has been taken by the PI to address outstanding issues in more than three months.

Example 2: Dr. Jane Smith submitted a Change of Protocol for a study in October 2008. It underwent prereview and was reviewed by the HS-IRB in December 2008. Modifications were requested by the HS-IRB. Dr. Doe has not responded to the modification requests. The HS-IRBs office will initiate withdrawal procedures for this change of protocol because no action has been taken by the PI to address outstanding issues in more than six months.

The office will send an email to the PI and point of contact notifying them of the withdrawal action.  Please contact the main office at 263-2362 with questions.

Introducing Staci Taylor Lowe

The Health Sciences IRBs Office is pleased to announce the addition of Staci Lowe, PhD, to its staff.  Dr. Lowe is a staff reviewer for the two health sciences IRBs and comes to the team with a wealth of research experience.  Dr. Lowe received her PhD from Cornell University in Policy Analysis and Management/Social Policy and worked as an Associate Researcher with the Center for the Study of Diversity in Healthcare and was a Clinical Research Scholar with the Institute of Clinical & Translational Research and Population Health Sciences at the University of Wisconsin-Madison. 

Tips for working with non-UW-Madison/UW Health collaborators

Many researchers work with individuals not affiliated with UW-Madison, UW Hospital and Clinics, UW Health, or the Madison VA (also referred to as external personnel). The HS-IRBs work hard to support study teams pursuing such collaborative projects. Study teams can help the IRB review process for such projects go more smoothly by keeping these tips in mind:

Tips to researchers to facilitate processing of paper materials

Please collate your IRB applications and supporting materials that are submitted to the HS-IRBs, so that there are separate, complete packets of information (as opposed to clipping all copies of consent forms together, all copies of the continuing review form together).  If collating is not done prior to submission, this leads to delays in processing and missing of documents, especially when the protocol has many supporting documents (e.g., multiple consent forms and corresponding HIPAA authorization forms).


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.

  • 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 asktheirb@medicine.wisc.edu. 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 irbreliance.wisc.edu.

  • Assistance with ARROW or technical questions, email askarrowirb@medicine.wisc.edu.
  • Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing join-hs_irbs_announcements@lists.wisc.edu.
  • WIRB updates, please sign up for the WIRB listsserv by emailing submitwirb@medicine.wisc.edu 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.