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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
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 firstname.lastname@example.org.
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.
- Key personnel and read v. edit access: The IRB application in ARROW will include a list for key personnel. Study teams will be able to divide their key personnel into those who have read only access to the application and those who have edit access to the application. Key personnel with edit access also will receive all email notifications for the system. This will provide large study teams with some flexibility in controlling who has the ability to edit the IRB application.
- Seeing where an application is: ARROW is built to reflect every stage of the IRB review process. Each stage is represented by what is called at “state.” States in ARROW include pre-submission, IRB pre-review, awaiting correspondence, approved, and many others. For every study or application, ARROW will display what state it is in. This will allow study teams to know at a glance where their application is in the IRB review process.
- Timers: Throughout the IRB review process, ARROW has several timers for study teams, IRB staff, and IRB members. These timers will provide reminders that additional action is required before an application can move to the next stage of the review process. For example, if modifications are pending, study teams will receive reminders that a response is required before the review process can continue.
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:
Initial Review submission during prereview
6 months (this time frame will be shortened in the future)
Initial Review submission, modifications from the IRB requested
Change submission during prereview
Change submission, modifications from the IRB requested
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:
- When planning a new study, be sure to identify the IRB of record for all external personnel in the IRB application and/or protocol.
- Only external personnel for whom UW-Madison is serving as IRB of record should be listed as key personnel. All other external collaborators must be listed in the protocol.
- When adding external personnel to an existing study, check to see whether they are affiliated with an institution with an IRB and, if so, whether that IRB will oversee their role in this study.
- If UW-Madison is serving as IRB of record for external personnel, an IRB authorization agreement (IAA) or independent investigator agreement (IIA) is often needed. These agreements are between institutions (IAA) or between an institution and individual (IIA). The HS-IRBs Office facilitates the process for securing these agreements.
- To request the HS-IRBs to serve as IRB of record, please use the Request to Serve as IRB of Record form found under the Forms tab on the HS-IRBs website.
- Please keep in mind that arranging IRB oversight for external personnel may take time and study teams should plan accordingly.
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).
- The HS-IRBs strongly encourages the use of staples, paper clips, binder clips and rubber bands to compile submissions (e.g., to bind together all pages of the Submission Cover Sheet together, all pages of the application together) and to differentiate the total submission for other submissions received by the IRB (e.g., bind together all parts of the submission with clips, etc.).
- Please do not bind
together IRB submissions for separate protocols, as this will increase the
likelihood of submission delays due to mishandling.
- 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.