IRB Insider

Education and Social/Behavioral Science Institutional Review Board (ED/SBS IRB) Newsletter, IRB Insider / Volume 7, Issue 1, September 2018

Staffing Update

We are pleased to welcome Olyvia Kuchta to ED/SBS IRB Office as a Staff Reviewer.  She is replacing Kamie LeClair who left the IRB Office in June. Olyvia comes to us from Children's Hospital of Wisconsin where she was an IRB Coordinator.

*Coming Soon*: Improvements to the ARROW Initial Review Application

At the end of September, ARROW will be updated with the following improvements:

Please contact the ED/SBS IRB Office if you have any questions about these upcoming improvements.

Training and Outreach Sessions

The ED/SBS IRB office offers workshops throughout the year.  The following are the upcoming workshops for Fall 2018:

For more information about these workshops and to register, visit the IRB Workshops & Outreach page of our website.

Would your class, department, or group be interested in learning more about the IRB?

Our office can plan an outreach session tailored to your needs!  An IRB staff member would be happy to come to a department meeting, research methods class, or hold a brown bag session to help faculty, students, and other researchers learn more about the process.  We can also address specific topics such as international research, research campus, qualitative research, research with minors, research involving social media or other new technologies, and more.  To schedule an outreach event, please contact a member of the IRB Staff

Revised Common Rule Updates

On April 19, 2018, the federal Department of Health and Human Services (HHS) released a proposal to delay the general compliance date for the revised Common Rule until January 21, 2019 and on June 18, 2018 the proposal to delay until January 21, 2019 was accepted.

More information can be found on our revised Common Rule webpage.

Reminder: Tips for Responding to IRB Requests during the IRB Review Process

As mentioned in a previous newsletter, applications submitted to the ED/SBS IRB undergo an administrative review and pre-review process by IRB staff. During this process, study teams receive comments through ARROW called reviewer notes. The purpose of this review is to help study teams ensure their applications are complete and meet institutional policies and regulatory requirements, thereby avoiding unnecessary delays in the IRB approval process.

During the pre-review and IRB review processes, study teams receive questions or comments through ARROW via reviewer notes. If you have questions about or disagree with a request from IRB staff/member, or the convened IRB, you can take the following steps:


IF THE STUDY IS IN ADMINISTRATIVE REVIEW OR PRE-REVIEW:
IRB staff will refer any continued disagreements to the IRB Director or the convened IRB.

IF THE STUDY HAS UNDERGONE REVIEW BY THE CONVENED IRB:

As the liaisons between the IRB and study teams, the staff reviewer can provide guidance about whether the proposed 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 disagreement over the convened IRB’s requests persist, the committee may invite the investigator to an IRB meeting to allow the research team to provide new information and answer member questions.

Reminder: Good Clinical Practice (GCP): Social and Behavioral Research Best Practices for Clinical Research

As of May 2018, key personnel on studies meeting the NIH definition of a clinical trial, including those with social science or behavioral interventions, need to complete Good Clinical Practice training if the study is NIH funded. A new CITI course entitled "GCP - Social and Behavioral Research Best Practices for Clinical Research" meets these requirements. Email notifications were sent out users needing to complete this training on 3/27/2018.  NOTE: "GCP for Drug/Device Researchers" will satisfy the requirement for social or behavioral interventions.

ARROW's Human Subjects Training Snapshot will inform study teams which GCP course should be taken for that given study as well as the personnel that have not yet completed the appropriate course.For additional information, see Good Clinical Practice (GCP) Training Guidance and Instructions and/or contact the Office of Research Compliance at UW CITI Support (608-262-1703) for guidance.

Reminder: Human Subjects Training for Non-UW-Madison Personnel

Non-UW-Madison personnel, for whom UW-Madison is serving as the IRB of Record for, no longer have to take UW-Madison's CITI human subjects training IF personnel have completed/will complete comparable human subjects research training elsewhere. If you have questions, please contact the ED/SBS IRB Office.

Reminder: Self-Service of Removal of Personnel

Study teams are able to remove study team personnel studies using a new self-service activity. This new activity, called “Remove Personnel,” is available to Principal Investigators (PIs) and Points of Contact (POCs) on studies reviewed by the ED/SBS IRB that are either approved or expired. Since this activity is self-service, this means study teams no longer need to submit a personnel change only to remove study team members. Please see our FAQ for more information.


Have questions?  The ED/SBS IRB Staff are here to help!
Whether you have questions about a specific protocol, have general questions, or need help getting started, there are many ways to contact the ED/SBS IRB office.