IRB Insider

Education and Social/Behavioral Science Institutional Review Board (ED/SBS IRB) Newsletter, IRB Insider / Volume 6, Issue 4, April 2018

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. The current compliance date is July 21, 2018. This proposal includes a 30-day comment period, which ends May 21, 2018.

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

Tips for Responding to IRB Requests during the IRB Review Process

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:
  • Call or email the staff member who made the request. You can identify the staff reviewer for your project in ARROW, under "Application Details." The staff reviewer's name is also hyperlinked to his or her email address. The staff member can explain why the request is being made, discuss options for responding, and set up an in-person meeting for more complex issues; or
  • Provide additional information within ARROW to explain why the request may not be feasible or to give a more detailed rationale for the proposed approach.
IRB staff will refer any continued disagreements to an IRB Director or the convened IRB.

IF THE STUDY HAS UNDERGONE REVIEW BY THE CONVENED IRB:
  • Call or email the staff member who made the request. You can identify the staff reviewer for your project in ARROW, under "Application Details." The staff reviewer's name is hyperlinked to his or her email address. The staff reviewer can explain why the committee made the request, discuss options for responding, and set up an in-person meeting for more complex issues; or
  • Provide additional information within ARROW to explain why the request may not be feasible or to give a more detailed rationale for the proposed approach.
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.

Good Clinical Practice (GCP): Social and Behavioral Research Best Practices for Clinical Research Coming in May

Beginning in May 2018, key personnel on studies meeting the NIH definition of a clinical trial, including those with social science or behavioral interventions, will 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.

New Guidance Documents

The The ED/SBS IRB Office has a number of new guidance documents available for study teams to use:

Open for Business!

The ED/SBS IRB office operates all 12 months of the year; we do not close down for the summer!  Researchers are welcome to email, call, schedule an individual appointment, or stop in our office during drop-in hours (see below for more details).

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.

  • For questions regarding a specific protocol, contact the assigned Staff Reviewer.  Instructions for identifying the Staff Reviewer are located here.
  • Drop-in hours are every Wednesday from 2:00-3:00 p.m. and Thursday from 10:00-11:00 a.m.  The IRB staff are located on the 3rd floor of Lathrop Hall (take the west elevator or stairs).
  • IRB staff have 12-month appointments and are available for meetings/consults year-round.  Individual appointments can be scheduled throughout the week.  Contact an IRB staff member to schedule an appointment.  Contact information is available here.
  • For questions about ARROW, email arrow-help@mailplus.wisc.edu.
  • To schedule an Outreach Session for your class, department, or group to learn more about the IRB, visit the Outreach Sessions page of our website.
  • The ED/SBS IRB Office KnowledgeBase is a great resource for researchers and includes FAQs, guidance documents, information for new researchers, and much more!





Keywords:newsletter, news, updates, insider, IRB insider   Doc ID:81584
Owner:Casey P.Group:Education and Social/Behavioral Science IRB
Created:2018-04-12 12:16 CDTUpdated:2018-04-26 17:48 CDT
Sites:Education and Social/Behavioral Science IRB
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