December 2023 updates

New IRB Analyst

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 51ÁÔĆć. 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 51ÁÔĆć 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 51ÁÔĆć collaborators and/or 51ÁÔĆć 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.

Spring 2023 Updates and News

Hello everyone! We have a handful of updates and reminders for you as you are wrapping up the spring semester.

Retiring or leaving 51ÁÔĆć?

If you are leaving 51ÁÔĆć 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

IRB Application Form Now Active in I-Manager

The new IRB Application Form is now active! To submit a new study for IRB review, you’ll complete the IRB Application Form in I-Manager. Instructions for using the IRB Application Form and a preview of the application questions are on our ·É±đ˛ú˛őľ±łŮ±đĚý
under the Forms tab (click on IRB Application Form).

The biggest change is that you won’t complete a separate protocol form and attach it to the submission. Instead, you’ll answer the protocol questions within the I-Manager IRB Application Form. There’s programming within the form so that questions will appear based on your responses. You’ll still attach your consent forms, recruitment materials, data collection instruments, and any other relevant study documents to the IRB Application Form in I-Manager.

The IRB Application Form is for new study submissions and won’t affect your current studies. You’ll need to continue to use and follow your protocol form for current studies.

We are excited for you to start using the IRB Application Form. We hope it will make the submission process more efficient. If you experience any issues with the new form, please let us know: irbinfo@uwm.edu / 414-662-3544.

Coming Soon: New IRB Application Form in I-Manager

The IRB office is excited to announce that a new IRB Application Form for submitting new studies in I-Manager is coming soon. The biggest change is that you won’t complete a separate protocol form and attach it to the submission. Instead, you’ll answer the protocol questions within the I-Manager IRB Application Form.

 

The new IRB Application Form has been designed with streamlined and modernized features. The submission form will only show you the questions that you need to answer, and will skip over questions that aren’t relevant for your study. The questions themselves have also been revised for clarity and accuracy, to make sure we’re collecting all of the information to properly review the study. The questions will be similar, but not quite the same as those in the current protocol form.

 

Our goal is that the IRB Application Form will make submitting a new study more efficient and intuitive. We also believe that it will improve our office’s ability to review new studies in a timely fashion.

 

The new IRB Application Form will launch on August 9, 2021. To help you learn about the changes, we’ll be sharing instructions and resources within the next two weeks. In addition, we’ll be launching a Canvas training course on the IRB submission process. We’ll keep you posted with further information.

Click here to view a PDF of the New IRB Application Form. All application questions are shown in the PDF. However, there is programming within the form, so many questions will appear only if you answer earlier questions a certain way when you’re completing the form in I-Manager.