Education and Social/Behavioral Science Institutional Review Board (ED/SBS IRB) Newsletter, IRB Insider / Volume 7, Issue 1, September 2018
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.
- The study team member pages will be streamlined to reduce the amount of information study teams need to enter into the application.
- The existing study location will be replaced with a new, shortened section to better focus on IRB reliance issues (i.e., when UW-Madison will serve as the reviewing IRB).
- As a result of the above changes, where and how external personnel are listed in the application will also be changing. The most significant of these changes is that study teams will no longer need to obtain NetIDs to list external personnel in the application. Study teams will either enter external personnel manually one time in the application or list them in a delegation log.
Training and Outreach Sessions
The ED/SBS IRB office offers workshops throughout the year. The following are the upcoming workshops for Fall 2018:
- IRB Meet & Greet on September 19 @ 10am-12:30pm
This event offers the chance for students, faculty, and staff to become more familiar with the ED/SBS IRB office and staff. All are welcome, but individuals new to research or UW-Madison are strongly encouraged to attend! There will be a short presentation, followed by informal/drop-in time to interact one-on-one with the IRB Staff for introductions and any questions about the IRB process.
- An Introduction to the IRB on October 2 @ 2-3pm
This session offers an overview of the IRB process and procedures. This includes required training, working in ARROW, developing a protocol application and supporting documents, and the IRB review process.
- How to Avoid Delays in the IRB Approval Process on October 31 @ 10-11am
This session will address the most frequent errors seen by Staff Reviewers when reviewing protocol submissions and how to avoid them. Also, a checklist of items that can slow the approval process of a protocol submission will be reviewed
- Consent Considerations on December 6 @ 2-3pm
This session will review, in detail, each of the consent processes that may be used when conducting research. Also, the most frequent errors seen by Staff Reviewers when reviewing consent forms and documents and how to avoid those errors will be discussed.
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.
- 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.
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.
- 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
additional information within ARROW to explain why the request may not
be feasible or to give a more detailed rationale for the proposed
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.
- 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 email@example.com.
- To schedule an Outreach Session for your class, department, or group to learn more about the IRB, visit the IRB Workshops & Outreach 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!