HS-IRBs News July 2014
Health Sciences and Minimal Risk IRBs, IRB News / Volume 6, Number 7, July 2014
New: UW-Madison NetID Soon Required for Human Subjects Research Training/CITI CourseBeginning in August, a UW-Madison netID will be required to take the UW-Madison social-behavioral and biomedical human subjects research training courses, also known as CITI. This change is being made to reduce delays during review process that can occur when a study team member has taken the training without using a netID. Please send any questions or concerns about this change to the campus Human Research Protection Program (hrpp@@grad.wisc.edu).
Tips for Responding to IRB Requests during the IRB Review ProcessNearly all applications to the HS-IRBs undergo an administrative review and pre-review process by IRB staff. During this process, study teams receive comments through ARROW called reviewer notes. The goal of this feedback is to help study teams ensure the IRB application and supporting materials (e.g., formal protocol, consent documents, etc.) are as complete, clear, and consistent as possible before being either reviewed by the full IRB or approved by an IRB member. IRB staff also are able to assist study teams in addressing issues related to compliance with federal regulations, State law, and campus policies governing human subjects research. With the implementation of this pre-review process, the number of studies deferred by the IRB has been significantly reduced and the number approved by the IRB as submitted significantly increased.
During the review process, study teams may receive questions or requests from IRB staff that are unclear to them or with which they may disagree. The review process is intended to work as a dialog between the IRB and study teams, involving a collaborative effort to arrive at an agreement regarding how to ensure the protection of human subjects participating in a research study.
- If a study team disagrees with a request from the IRB, please contact the staff reviewer assigned to the study to discuss the proposed response. As the liaisons between the IRB and study teams, the staff reviewer can provide guidance about whether the response would address the IRB’s concerns as well as any additional information that should be provided as part of the request for reconsideration. In many cases, the staff reviewer or IRB has dropped or modified a request because of clarifications provided by the study team.
- If an IRB request is unclear or the study team is uncertain why the request is being made, please contact the staff reviewer assigned to that application. Staff reviewers can explain the rationale behind the request, which can be helpful to study teams as they craft their responses.
ARROW Outage July 26th
ARROW will be unavailable on Saturday, July 26th from 1PM to 5PM for scheduled maintenance. We apologize for any inconvenience.
New August Dates for IRB for Beginners Workshops
Registration is now open for the next sessions of the IRB for Beginners workshop. The 90-minute workshop is held in the HSLC computer lab and gives participants a first-hand view of the resources available on the HS-IRBs' website as well as basic tools and tips for the ARROW submission system. The workshop will also introduce participants to the IRB’s review process and procedures. This workshop is designed to help people who are new to the HS-IRBs review process.
This workshop is scheduled for the following dates:Tuesday, August 5th 1:00-2:30 PM (HSLC Room 2121)
Thursday, August 7th 9:30-11:00 AM (HSLC Room 2121)
Wednesday, August 13th 2:00-3:30 PM (HSLC Room 2121)
Registration is required. Please email Brooke Mechelke (firstname.lastname@example.org) to reserve your spot. Space is limited.
Update: Adverse Event Reporting Requirements for Studies Involving Gene Transfer
Due to concerns raised about adverse events that occurred in early research studies
involving gene transfer, the HS IRBs required research teams conducting these
studies at the UW to report to the IRB all deaths and other adverse events deemed
serious and unexpected, regardless of their relationship to the study
intervention or whether a formal Data Safety Monitoring Board (DSMB) or Data
Monitoring Committee (DMC) existed for that study. As data regarding research
involving gene transfer has accumulated, the HS IRBs determined that the
reporting requirements for studies involving gene transfer could be changed to
parallel the reporting requirements for other clinical trials. Two guidance
documents were recently revised to reflect this change:
- Gene Transfer Studies Guidance
- Reporting Requirements for Studies Involving Other Investigational Agents, Including Investigational Drugs
- 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.