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HS IRBs News April 2018

Exemption Training Session

Although the changes to the Common Rule have been delayed, UW-Madison is going ahead with implementing new exemption categories for research that is not federally funded, VA supported, or FDA-regulated. The Health Sciences IRBs Office is offering a training session to help research teams understand these new categories and when they apply. The session will explain the new campus exemption categories, provide a refresher regarding the exemption categories for federally-funded research, and describe updates made to ARROW to accommodate the different exemption categories available based on the regulations that do or do not apply to the human subjects research. To learn more about these changes, please sign up below:

• May 14, 2018 - 12:00 - 1:30pm, 4201 HSLC (Harting Mullins Board Room) - register here

Please note that this session is the same as those previously offered in February and March.

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.

Please see the HS IRBs' Upcoming Changes to Human Subjects Regulations and Policies webpage to stay informed about the impact the revised rule may have on research.

Tips for Responding to IRB Requests during the IRB Review Process

Applications submitted 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 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, an IRB member reviewer (e.g., for expedited reviews), 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.

Reminder: HS IRBs' Reliance Team Can Help with NIH Single IRB Review Policy

Health sciences researchers should contact the Health Sciences IRBs' Reliance Team as soon as possible when drafting a proposal or application for federal funding on a multi-site protocol.

The Reliance Team can advise study teams regarding:

• information to include in your grant
• the appropriate IRB to oversee the research
• budgeting for IRB review
• putting together a communication plan, which is required by the NIH policy
• other implications of the single IRB review policy for the study team, such as additional roles and responsibilities the study team may incur as a result of using a single IRB

Our single IRB basics page also includes links to other resources on single IRB review, including a single IRB review FAQ. 

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

For health sciences researchers conducting clinical trial research involving drugs, devices, biological agents, or radioisotopes, ARROW has been monitoring for Good Clinical Practice (GCP) training since August 2016. Key personnel on these studies must complete the "Good Clinical Practice for Drug/Device Researchers" in CITI.

Beginning in May 2018, key personnel on all other studies meeting the NIH definition of a clinical trial, including those with social science or behavioral interventions, will also 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: While "GCP for Drug/Device Researchers" will satisfy the requirement for social or behavioral interventions, the "GCP - Social and Behavioral Research Best Practices for Clinical Research" does not fulfill the requirements for clinical trial research involving drugs, devices, biological agents, or radioisotopes.

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.

Questions? We're Here to Help!

Whether you have a question about a specific protocol, a general question about the submission process, or need clarification about research policy, we have several ways you can reach us.

• 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 asktheirb@medicine.wisc.edu. 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 irbreliance.wisc.edu.

• Assistance with ARROW or technical questions, email askarrowirb@medicine.wisc.edu.
• Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing join-hs_irbs_announcements@lists.wisc.edu.
• WIRB updates, please sign up for the WIRB listsserv by emailing submitwirb@medicine.wisc.edu with a request to be put on the list.
• 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.