I’m pleased to announce that we have hired a new IRB Analyst, Aimee Hamilton. Aimee started just after Thanksgiving and has eagerly jumped into her role here at 51����. She joins us from Children’s Wisconsin, where she was a clinical research coordinator and worked closely with the IRBs at both Children’s and MCW. You can contact her at hamiltal@uwm.edu / 414-290-1361, or through the IRB office�� (irbinfo@uwm.edu / 414-662-3544).

Collaborative studies

Several reminders regarding collaborative studies:

• You must consult with our office if you are working on a project with a collaborator at another institution, even if the study already has IRB approval elsewhere. Our IRB is responsible for oversight of research conducted by our faculty, staff, and students. We need to have either our own IRB review or a reliance (deferral) agreement in place with the other institution.
• If another IRB is overseeing the study, you should still be providing the 51���� IRB with several things:
  • Copies of approval letters (initial, amendments, continuing reviews) as they are issued.
  • Immediate notification if the study is suspended.
  • Reporting of noncompliance or unexpected problems involving risk, if they involve the 51���� collaborators and/or 51���� participants.

Deleting data in Qualtrics

If you have a participant who requests that their Qualtrics data be deleted, or if you need to delete your research data out of Qualtrics and retain only a de-identified copy, you can delete data associated with a particular participant’s email. To do so, you would follow the directions linked here () under the section entitled “Deleting All Records Associated with an Email”. If you follow these steps, all participant records held by Qualtrics will be deleted, and the data cannot be recovered. You can scrub the responses for personal information and retain your own local, sanitized copy of the responses.

Warning about fraud and bots

Unfortunately we are continuing to hear frequent reports of fraudulent responses and bot attacks on online surveys. Strategies to avoid fraud and bots are rapidly evolving, so we recommend the following:

• Review our
• Consult with colleagues and literature for new practices
• Avoid posting surveys offering payment in social media, on websites, etc. Instead request permission for use of listservs or to recruit in private groups.
• If recruiting through Amazon MTurk, use the Master’s or Premium qualifications, which requires workers to meet certain thresholds of reliability. Prolific is a similar platform that vets all its participants.

Important: In your efforts to prevent fraud, you might miscategorize a legitimate response. You should always offer participants who are believed to be fraudulent the opportunity to discuss with you if they feel they were excluded in error.

The post December 2023 updates appeared first on Institutional Review Board.

Retiring or leaving 51����?

If you are leaving 51���� or retiring, please contact our office to let us know so we can get your studies closed or transferred appropriately. If you need your departure to remain confidential for the time being, just let us know. See attached for more detailed guidance on whether and how to close and transfer your IRB protocols.

Confidentiality during virtual focus groups

Earlier this year, we received a report of a situation where a research participant recorded the focus group they participated in. When doing virtual focus groups, check your meeting settings to ensure only the host (researcher) can record. However, please note that this only prevents recording within Zoom/Teams; it is still possible to record the meeting using other types of software. For that reason, we also recommend that you ask all participants not to record the focus group session via other software or devices.

IRB Office phone number in consent forms

The IRB office transitioned to a new phone number with the switch to Teams in 2020. However, we are still seeing a number of consent forms, including in new study submissions, with outdated contact information for the IRB. Please check all your consent forms and ensure they are updated to our new phone number, 414-662-3544. You don’t need to submit an amendment for this administrative change.

Helpful tips for amendments submitted with new process

For studies that were approved beginning Fall 2021, there is a new process for amendments where you are actually creating a copy of the existing Application xForm and editing the relevant sections. A few helpful tips:

• The first time you submit an amendment with this new process, several questions will appear at the beginning of the form asking you to describe the changes, why you are making them, etc.
• In all subsequent amendments, this text will be saved from the last one. However, you can delete the old amendment description and only list the new/current changes. This helps clarify for us what is a new change vs. what was previously approved, and also avoids cluttering up the form too much.
• After the basic amendment description, go through the entire form and edit anything that has changed. You don’t need to worry about highlighting or marking the changes in the form itself. The system will automatically highlight any question that has been edited, and we have a “View Audit” button that allows us to see what specifically was changed. However, attachments will still need all changes marked in some way (tracked changes is preferred).
• If you are adding a new document, it’s helpful if you can add a note or indicate in the amendment description that the document is new and have not been previously reviewed/approved.

For more details related to submitting an amendment, please see our website.

Good luck to you as you finish out your semester!

Your friendly IRB staff,

Melody & Leah

The post Spring 2023 Updates and News appeared first on Institutional Review Board.

The post IRB Application Form Now Active in I-Manager appeared first on Institutional Review Board.

The post Coming Soon: New IRB Application Form in I-Manager appeared first on Institutional Review Board.

The post New online course available appeared first on Institutional Review Board.

All sessions��are held in Engelmann 242/248.

IRB Basics
This training session covers a basic overview of the IRB, how to prepare a submission, helpful hints, and a demonstration of I-Manager. Repeats approximately monthly.

• Friday, January 31, 10:30-11:30 am
• Tuesday, February 25, 2:30-3:30 pm
• Wednesday, April 8, 3-4 pm

��

Post-Approval Review.�� Wednesday, February 12, 2:30-3:30 pm
Every semester, we select certain expedited and more than minimal risk studies for a post-approval review. What can you expect if your study is selected? We’ll go through the process step by step.

��

International Research.�� Friday, February 21, 2:30-3:30 pm
Doing research abroad can be a daunting task, and there are many��special ethical and practical considerations. Come find out what you need to know – BEFORE you go!

��

Informed Consent Workshops
Informed consent��is a crucial part of human subjects research. It is your responsibility as a researcher to ensure that all your study participants understand what they are agreeing to. These workshops will��teach you how to obtain truly��informed consent. You can sign up for one, two, or all three.

• Part 1: The consent form.�� Tuesday, January 28, 2:30-3:30 pm
  This��workshop will��go beyond the templates; you’ll learn the art of��writing a consent document that your participants can actually understand. You’ll see examples of good consents and … less good … consents, and will also have a chance to try your hand at writing with immediate feedback.
• Part 2: The consent process.�� Thursday, March 12, 10-11 am
  The consent process is not a one-time event that begins with a form and ends with a signature. From recruitment through the end of the study, you’ll learn��how to obtain consent ethically and respectfully, and ensure that your subjects are willing, understanding participants. You’ll also have a chance to role-play an informed consent discussion.
• Part 3: Waivers and alterations.�� ��Friday, April 10, 3-4 pm
  In some circumstances, alterations or waivers of consent can be appropriate and necessary to conduct research. Learn when and how to request waivers of consent.

In-Class Presentations
We also give presentations to individual classes. To request an in-class training session, send an email to irbinfo@uwm.edu. Include your name, the location, course title, some date/time options that work for you, and what topic(s) you would like us to cover.

If you would like to request an in-class presentation for a class that meets after 4 pm, please let us know as early in the semester as possible. We may not be able to accommodate all evening class requests.

The post Spring 2020 in-person training sessions available appeared first on Institutional Review Board.

We have compiled the results and written detailed responses to many of your questions, comments, and concerns. We have already implemented some suggestions, and are working to implement others.

Please check out !

The post 2019 IRB User Survey Results appeared first on Institutional Review Board.

New this semester: We’ve added a third informed consent workshop, which focuses on waivers and alterations of consent. We’ll cover complete waivers, waivers of documentation (signature), parental permission waivers, and alterations (deception). You’ll learn when they can be used and how to request one.

The post Fall 2019 Training Sessions appeared first on Institutional Review Board.

Once their electronic submissions go live, you’ll also see options for beginning Biosafety or IACUC new studies. Make sure you choose an IRB new study submission.

Otherwise, nothing is changing, and you’ll continue to submit your new studies, amendments, etc. the same way as before.

The post IRBManager will now be I-Manager appeared first on Institutional Review Board.

IRB Basics:��An introduction to the IRB process and tips for your first IRB submission.

Post-Approval Review: What to expect if your study is selected for a post-approval review.

International Research:��What you need to consider if you are doing research outside the US.

Informed Consent Workshop:��This will be in two parts. Part 1 will focus on the informed consent document. Part 2 will focus on the informed consent process.

Classroom training (by request):��An IRB office staff member will come to your classroom to conduct a session on a topic of your choice.

For more details and to register for a session, visit:��/irb/training/register-trainings/

The post Spring 2019 training sessions now available appeared first on Institutional Review Board.