Are you conducting a clinical trial? Are you sure you’re not?
Investigators who conduct clinical trials have certain additional responsibilities. Up until now, UWM has had very few studies that qualified as clinical trials. However, the NIH has a new, broader definition. Many investigators may suddenly find out they are conducting clinical trials under the new definition. OHRP has also adopted this new definition in the revised Common Rule.
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
If you answer Yes to all of the following, you are conducting a clinical trial, and special requirements will apply:
- Is your research federally funded?
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect a health-related biomedical or behavioral outcome?
Risk is not mentioned. Minimal risk studies may still be clinical trials. Likewise, there do not have to be multiple arms. A study may be a clinical trial even if all participants are assigned to the same intervention.
Examples of Clinical Trials
- Evaluating whether a diet or exercise plan is effective.
- Evaluating whether school children who learn about healthy food make healthier choices at lunch.
- Assigning participants to conditions to test working memory.
- Comparing wrist strain with two types of crutches.
- Studying the effects of mindfulness meditation on quality of life.
- Examples from NIH: https://grants.nih.gov/policy/clinical-trials/case-studies.htm
What do researchers need to do?
These requirements for clinical trials apply to all federally-funded studies, not just those funded by NIH. If your study is not federally-funded, these extra processes are optional.
- Review UWM’s guidance: http://uwm.edu/irb/guidance-documents/clinical-trials/
- ALL study team members (not just PI) must complete Good Clinical Practice (GCP) training through CITI.
- Make sure your consent document has the required language (see our template).
- Register your study at https://clinicaltrials.gov. You can also find detailed instructions and help here.
- Update your listing on https://clinicaltrials.gov
- After enrollment is complete, upload your consent form to https://clinicaltrials.gov.
- Within 12 months of study completion, post the study results.
- This is required for NIH-funded studies, but may not be required by other funding agencies. Check with your funding source.
The goal of registering studies is to increase transparency and sharing of research results worldwide, reduce publication bias, and provide information to potential participants about possible research interventions.
How the UWM IRB is implementing the changes
- The five questions above have been the new study xForm so that you – and we – can easily determine whether a study is a clinical trial or not.
- Anyone who is involved in the design, conduct, oversight, or management of clinical trials is considered “research personnel” and must complete Good Clinical Practice (GCP) training.
- When we review a new clinical trial submission, we will verify that all research personnel have completed GCP training through CITI. If not, we will remind you of this requirement, and will hold final IRB approval for your study until GCP training is complete.
- GCP training will need to be renewed every 3 years.
- When you register your study on https://clinicaltrials.gov, you will receive a registration number (NCT #). We will ask for your NCT # on all amendments and continuing reviews as a way to ensure you have complied with this requirement.
For IRB Members
New questions have been added to the reviewer checklist to trigger you to make the determination of whether or not a study is a clinical trial, and to ensure the correct language is in the consent document.