HS-IRBs News - August 2009
Health Sciences and Minimal Risk IRBs, IRB News / Volume 1, Number 8, August 2009
Printer Friendly Newsletter August 2009
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.
- Downloading IRB Correspondence: All IRB correspondence will be stored within ARROW and study teams will be able to download any IRB correspondence whenever needed. Due to technical requirements, IRB correspondence in ARROW will have a different look from current letters. For example, IRB correspondence will no longer contain signatures, but will still retain IRB letterhead and will also be watermarked.
- How actions are structured in ARROW: As mentioned in the last newsletter, ARROW is built to reflect every stage of the IRB review process. Each stage is represented by what is called at “state” (e.g., pre-submission, IRB pre-review, approved). Within each state, study teams can perform certain actions. These actions are called activities and each state has its own set of activities. Activities include actions like submit modification response, withdraw, and submit study completion report.
- Tracking a study’s history: Every study within ARROW has what is called a history log that can be seen by the study team as well as IRB staff and IRB members. The history log contains a comprehensive list of activities that have been completed for that study, including date, time, and who completed the activity. The history log will provide an easy way for study teams and the IRB alike to keep track of what happened when with a particular study and will bring more transparency to the IRB review process.
Streamlining the IRB review process for multi-site research
Conducting multi-site research can be challenging and the IRB review process can be complicated, involving duplicative effort on the part of study teams and IRBs alike. The HS-IRBs Office has been working over the past two years to identify ways to streamline the IRB review process for research involving multiple sites within Wisconsin. Through close coordination with IRB colleagues at other institutions, the HS-IRBs are proud to announce two new initiatives designed to reduce the administrative burdens sometimes posed by IRB review for multi-site research while ensuring that the highest standards for human subjects protection are maintained.
The Wisconsin IRB Consortium (WIC)
WIC is a collaboration involving the UW-Madison HS-IRBs and the IRBs at Aurora Health Care, Marshfield Clinic, and the Medical College of Wisconsin. Development of WIC began in 2007 with the goal of creating a process that, when possible, would identify a single IRB of record for multi-site studies involving any combination of the 4 WIC institutions. WIC is in its pilot phase and determinations about whether deferral of IRB review to a single institution is appropriate are made by the relevant IRBs on a case-by-case basis. Study teams interested in using WIC must submit a WIC request form before submitting an IRB application to any WIC institution. Details regarding the WIC process (including directions for submission) can be found on the WIC website.
Meriter-UW-Madison IRB Partnership
Meriter Hospital and UW-Madison have recently finalized an agreement that establishes a formal working partnership between the Meriter IRB and the HS-IRBs. The agreement provides a framework for determining what types of studies fall under the purview of each institution’s IRB. For several types of studies (e.g., retrospective chart reviews, many types of research involving biological specimens), study teams will be eligible to have their studies reviewed by a single IRB of record. Study teams interested in using the Meriter-UW-Madison IRB Partnership must submit a request form before submitting an IRB application to either institution. Please contact the HS-IRBs main office for details regarding the Partnership review process.
Tips to make the HS-IRBs submission process go smoothly
The Health Sciences IRBs recognize that research teams may have submissions that they need to submit simultaneously to the IRB or already have a prior submission under IRB review and need to send in further submissions. In general the IRB cannot review more than one submission at a time and must resolve one action before proceeding to the next. This will be especially true in the electronic submission and tracking system, ARROW. Another reason why the separation of review of submissions has become necessary is that the HS IRBs Office has subdivided review functions amongst different staff. For example, the staff who handle continuing reviews are not the same as those who handle changes of protocol.
The HS IRBs Office receives over a thousand submissions per year. With ARROW the receipt of these submissions and their status will be more easily tracked by both the IRB and the research team. Until then, please assist us in serving you better by keeping the following in mind:
- When submitting materials to the HS IRBs Office other than applications for new projects, please include a protocol number and PI name on the materials. If a particular staff reviewer requested the documents, please reference this with the submission by providing a copy of the email in which that individual requested the materials as the first document of the submission.
- If the HS IRBs Office has already received an IRB submission that is still in process, you may wish to hold the new submission until the prior one is resolved, unless it is a reportable event.
- If another submission (e.g., a change of protocol with a cooperative group deadline or continuing review of a protocol close to expiring) should take priority over a submission that is still in process with the IRB, please contact either the staff reviewer assigned to the current submission or the Submission Specialist, Molly Lumley, to discuss which submission should take priority in IRB review.
- If submissions are related, such as a change of protocol and a reportable event (e.g., unanticipated problem, noncompliance, adverse event), please draft a memo or cover letter to be included with the submission detailing the IRB protocol number, which submissions are related and the dates those submissions were sent to the IRB that we can coordinate the review.
- Please ensure the information on the Cover Sheet, especially the assigned IRB protocol number, matches the assigned IRB protocol number on the IRB application.
Please note, reportable events (e.g., new information, potential non-compliance, adverse events) should be submitted to the IRB within 14 business days of the event per institutional policy.
- 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.