Why do we invite PIs and Student PIs to our IRB meetings?

It can seem intimidating to come before the IRB and present your research, especially if you’re not sure what to expect. What is the purpose? What will the IRB say or do?

Basically, you don’t have to be there at all. But if you are doing research that requires full board review, the IRB wants to review it carefully and often has questions. If you’re there to answer their questions, the reviews go much more smoothly, and your study is more likely to be approved rather than tabled (more on that below).

Do I need to bring anything?

We will have all your submission materials accessible (there is a large computer monitor in the room), so don’t worry about bringing those unless you want to have copies to reference/flip through yourself.

If you’re testing a new device that you’ve created or modified, we love it if you can bring it along! It is extremely helpful to see the device in person.

If you have any other charts, graphs, etc. that weren’t included in the submission, you can email those to us ahead of time and we’ll distribute them and/or display them during the meeting.

Who will be there?

Our IRB currently has 16 members + 10 alternates. Typically, 10-15 IRB members attend.

  • Most will be faculty at UWM. This means they are teachers and researchers. They evaluate your proposal from the perspective of a colleague, teacher, and/or mentor.
  • 1-2 community members will usually be present. In addition to being generally very nice people, they provide a valuable outside (non-UWM) perspective to the IRB.
  • 1-2 student members will usually attend. Our student members are doctoral students who are working on their own research as well.
  • IRB office staff members (Melissa, Melody and Leah) will also be there. By the time you get to the meeting, you’ll have talked with at least one of us at some point, and we’re the ones who let you know the specific date, time, and location of the meeting.

What will happen at the meeting?

Our meetings are open meetings, in accordance with Wisconsin state law. This means the doors will be open and you can come in when you arrive. We may be discussing something else when you get there, so if that’s the case, you can either come in and sit down, or, if you prefer, wait in the hall (just make sure one of us has seen you so we know you’re there). If the review ahead of yours is taking longer than expected and it will be a while, or if we need to go into closed session, we’ll be sure to let you know.

Once we’re ready to review your study, the chair will typically ask you to introduce yourself and give us an overview of your research. You should also plan to explain the importance of the research and what the potential benefit will be. Everyone will have reviewed the materials already, but it’s still helpful to hear a summary from the researcher.

Your study will be assigned to 1-2 primary reviewers. These individuals have expertise more closely aligned with your area of research and will do an in-depth review. They usually start the discussion process, asking you questions they have about your study, and the other members join in with any additional questions. We’ll ask for clarification on anything that was unclear, or how you chose the subject population, procedures, etc.

Remember, most questions are simply that – questions! We’re asking because we want to make sure we thoroughly understand your plan. You shouldn’t feel like the questions are a criticism or that you’re doing things wrong. There may be some things we think should be changed, but if so, we’ll be direct and tell you.

Don’t worry about trying to take notes. The IRB office staff take detailed notes, so you can just focus on answering the IRB members’ questions. You’ll receive a letter via email within 1-2 business days outlining the specific changes needed in your materials.

Once the IRB’s questions are answered, we’ll thank you for coming and you can leave.

What happens next?

After you’ve left, the chair will ask for any final discussion and then the IRB will vote on your study. To approve the proposal, the IRB must agree that all the following criteria are met:

  • Risks to subjects are minimized.
  • Risks are reasonable in relation to anticipated benefits.
  • Selection of subjects is equitable.
  • Informed consent will be sought from each prospective subject or their legally authorized representative.
  • When appropriate, the research plan makes adequate provision for:
    • monitoring the data to ensure the safety of subjects
    • protecting the privacy of subjects
    • maintaining the confidentiality of the data
  • Additional safeguards are in place when some or all subjects are likely to be vulnerable to coercion or undue influence.

There are 4 possible votes:

  • Approve as-is (uncommon), meaning there are no clarifications or revisions needed at all.
  • Approve with conditions (most common), meaning your study qualifies for approval if you make specific changes requested by the IRB.
  • Table (second most common), meaning the IRB doesn’t have enough information to say that the approval criteria are met. You’ll work with office staff to address the questions and the IRB will review it again.
  • Disapprove (very, very rare), meaning the regulatory approval for criteria can’t be met, even with changes. However, there’s almost always a way to make a study approvable.

As mentioned above, you’ll receive an email within 1-2 business days after the meeting with details of any revisions requested. If your study has been tabled to the next meeting, we’ll let you know.

If you have any questions along the way, please feel free to ask. We’re happy to help!