Resources

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).

Meetings are virtual on Teams. We’ll share login information with you in advance of the meeting.

Do I need to bring anything?

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

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. When you join virtually, feel free to share your screen.

Who will be there?

Typically, 10-15 IRB members attend any given meeting.

• 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 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 you are free to join whenever is convenient for you. If you join at the scheduled time and the IRB is discussing something else, feel free to join or wait, whichever you prefer. 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 (extremely 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!

What is a clinical trial?

1. NIH definition (applies to federally funded studies):
   • The study must involve human participants.
   • The participants are prospectively assigned to an intervention.
   • The study is designed to evaluate the effect of the intervention on the participants.
   • The effect being evaluated is a health-related biomedical or behavioral outcome.
   • https://grants.nih.gov/policy/clinical-trials/definition.htm
   • Examples: https://grants.nih.gov/policy/clinical-trials/case-studies.htm
2. FDA definition (applies to studies involving drugs, devices, or biologics regulated by the FDA):
   • Clinical trials, also known as clinical studies, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy.

What does the Clinical Trial Rule apply to?

1. Most interventional studies of drug, biological, and device products that are regulated by the FDA. The requirements do not apply to Phase 1 trials of drug and biological products, or small feasibility studies of device products.
2. All federally funded (including NIH) clinical trials. Includes Phase 1 clinical trials and trials that do not involve any FDA-regulated product such as trials involving only behavioral interventions.
3. The International Committee of Medical Journal Editors (ICMJE) requires registration as a condition of the publication of research results generated by a clinical trial.
4. Additional information about what trials should be registered and laws/policies requiring registration can be found at https://clinicaltrials.gov/ct2/manage-recs/background

Training requirements for clinical trials

• All investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP).
  • Staff = Individuals, identified by the investigator, who are responsible for study design, coordination, data collection, and/or data management.
• To be completed prior to IRB approval of the clinical trial.
• UWM researchers will find GCP training online through CITI. Biomedical and social behavioral options are available.
• More information about training can be found at https://grants.nih.gov/policy/clinical-trials/good-clinical-training.htm

Registering a clinical trial on ClinicalTrials.gov (NIH-funded and FDA-regulated)

• Must be done no later than 21 days after enrollment of the first subject.
• Required information: descriptive information, recruitment information, location and contact information, and administrative data.
• The record must be updated at least once every 12 months.

Posting the results on ClinicalTrials.gov (NIH-funded and FDA-regulated)

• Results must be posted no later than 12 months after primary completion date; possible delay of up to an additional two years for trials of unapproved products or of products for which initial FDA marketing approval or clearance is being sought, or approval or clearance for a new use is being sought.
• The following information must be posted:
  • participant flow
  • demographic and baseline characteristics
  • outcomes and statistical analyses
  • adverse events
  • protocol and statistical analysis plan
  • administrative information

Posting the consent form (All federally funded)

1. For each clinical trial conducted or supported by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal website that will be established as a repository for such informed consent forms.
2. If the Federal department or agency supporting or conducting the clinical trial determines that certain information should not be made publicly available on a Federal website (i.e., confidential commercial information), such Federal department or agency may permit or require redactions to the information posted.
3. The informed consent form must be posted on the Federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.
4. The approved websites for posting the informed consent form are:
   1. ClinicalTrials.gov – Please see instructions below
   2. A docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021) – Additional information and instructions for posting can be found at the Informed Consent Posting page of the HHS site.

Who is responsible for registering and posting results on ClinicalTrials.gov or posting the informed consent form?

The principal investigator.

Consequences of not following the posting requirements

1. Identifying the clinical trial record as non-compliant in ClinicalTrials.gov.
2. May impact federally funded studies.
3. May be considered in future funding decisions.
4. Civil monetary penalties of up to $10,000 per day.

Effective dates for studies requiring clinical trials registration and GCP training

1. NIH-funded and FDA-regulated – January 1, 2017
2. Federally funded – January 21, 2019

Instructions for registering a clinical trial

1. Visit https://clinicaltrials.gov/ct2/manage-recs/how-register
2. Request a ClinicalTrials.gov account
   1. Email irbinfo@uwm.edu
      1. Subject line = ClinicalTrials.gov account request
      2. Email should include your name, email address, telephone number, study title, and UWM IRB #
   2. After 1-3 business days you will receive an email with a temporary password to ClinicalTrials.gov
3. ClinicalTrials.gov log in instructions
   1. Visit https://clinicaltrials.gov/ct2/manage-recs/register
      1. Enter Organization: UWisconsinMilwaukee
      2. Enter your user name
      3. Enter your password
      4. To update your password select Accounts on the main page
4. Register your study and enter the required elements. Helpful information and instructions can be found at https://clinicaltrials.gov/ct2/manage-recs/how-register
5. Be sure to update your record at least once every 12 months. See #5 and/or #6 above for required information. Additional information can be found at https://clinicaltrials.gov/ct2/manage-recs/how-edit

NIH requirements and instructions can be found at https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

These recommendations were developed by a subcommittee of the Chancellor’s Advisory Committee for LGBTQ+ Advocacy (CACLGBT+A)

General Recommendations for Collecting Demographic Information About Gender (PDF)

This document explains why an old standard format for this question, asking subjects to identify themselves using the dichotomous sex variable Male or Female, is a poor ethical practice. The best practice guidance lays out a standard format for collecting demographic data about gender (and sex if necessary) that is respectful of study subjects who are intersex, have gender transitioned, and/or have nonbinary gender identities.

Recommendations for Research Specifically Focused on Gender / Sexuality (PDF)

This document is relevant when researchers will be asking questions about sexuality, sexual orientation, sex variance, gender identity and/or gender expression. It discusses harms that can arise, and provides suggested formats for research questions intended to prevent such harms.

Additional Resources

• GENiUSS Report (PDF)
• APA Guidelines for Transgender People (PDF)
• Transgender Health Research and IRB Review (PDF)