Education and Social/Behavioral Science Institutional Review Board (ED/SBS IRB) Newsletter, IRB Insider / Volume 7, Issue 2, December 2018
Important Revisions to the Initial Review Application
ARROW was updated in September with several changes to the initial review application. These changes reduce researcher burden as well as prepare the way for the ARROW single IRB review project (launching in early 2019 - more information forthcoming). The most significant changes include:
- Revised study team member pages
- Elimination of read-only and edit access distinction
- Only the PI and points of contact will have default edit access
- External personnel will no longer be listed on these pages and will not require netIDs. If external personnel need to take human subjects training, please see the next section below. If the study requires Good Clinical Practice training, we will make an exception and grant NetIDs to external personnel so they can take the online GCP training.
- Use of a new widget to more easily collect information about study team member roles and reduce amount of data entry required
- New study location section with fewer questions that focus primarily on IRB reliance issues. If you UW is serving as the IRB of record for external personnel, please see our guidance document here for more information
- Only a few questions will need to be answered in this section if the study does not involve reliance issues
- Other changes
- New self-service grant edit access activity to allow study team members besides the PI and POCs to edit the application
- Revamped section on international research
- Revised page for sharing of data, images, or specimens with external sties or personnel
- Various questions in the ED/SBS IRB application now have a "Standard IRB Language" button below it which provides a list of common responses to those questions that study teams can choose from and expand or modify as necessary. Please note that the responses in the list provided are not all-inclusive. If you do not see a response in the list that relates to your study, please be sure to write a response that does relate to your study
A number of documents on our website have been updated to reflect these and other changes being made to the form. If you have questions about any of these changes, please email email@example.com.
New HRPP Resources for Training Options for External Personnel
Institutional policy requires that external personnel for whom a UW-Madison IRB is serving as the IRB of record complete human subjects protections training. In some cases, individuals may have not already completed such training and/or are not affiliated with an entity with access to such training. To assist study teams in navigating these situations, the HRPP website now includes a page with resources for training options for external personnel,
- PDF-versions of the UW-Madison biomedical as well as the social and behavioral research courses to eliminate the need for external personnel to obtain a netID and have computer access to complete the training
- Links to Good Clinical Practice training modules for those studies requiring GCP training and for those external personnel who do not otherwise have access to such training
- Please note that NIH has removed its free, online human subjects protections course and has not indicated whether it will replace it in the future
If you have questions about human subjects protections and/or GCP training, please contact firstname.lastname@example.org.
Human Subjects Training for UW-Madison Personnel
For researchers who have submitted applications to the ED/SBS IRB, we have required all study team members to take the the UW Social and Behavioral CITI training. However, we will now accept Biomedical or VA training in lieu of Social and Behavioral training. That being said, if any study team members have not completed any of these trainings and the application they are listed on will be submitted to the ED/SBS IRB, we prefer those study team members take the Social and Behavioral Course.
Training and Outreach Sessions
The ED/SBS IRB office offers workshops throughout the year. The following are the upcoming workshops for Spring 2019:
- "International Research & Summer Projects" on February 6 @ 10-11am
This session addresses issues unique to international research, travel, and other summer projects.
- "Considerations for Qualitative Research, Research with Minors, and Research involving Technology" on March 7 @ 2-3pm
This session will focus on additional considerations for performing qualitative research, research with minors, research involving technology and other unique research areas.
For more information about these workshops and to register, visit the IRB Workshops & Outreach page of our website.
- "I Have IRB Approval - Now What?" on April 16 @ 10-11am
Interaction with the IRB does not end after obtaining initial approval for your project. This session explores the complete life-cycle of a human subjects research project after IRB approval, including: Changes, Continuing Review, Reportable Events, Study Completion, Data Storage, and Potential Audits
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: 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!