The people you will actually meet
At a research site you are most likely to deal with a study coordinator (schedules, paperwork, questions), a nurse or technician (measurements and samples), and the principal investigator, the clinician or scientist who is responsible for how the study runs at that site. Larger studies add pharmacists, data staff, and specialists.
If you are ever unsure who to call, the coordinator is a good first stop. The consent form lists the study contacts, including who to call after hours.
The group that reviews the plan: the IRB
Before people are enrolled, an institutional review board (IRB, sometimes called an ethics committee) reads the plan. It asks whether the risks are reasonable, whether the plan is fair to participants, and whether the consent form is clear. It keeps reviewing the study at least once a year while it runs.
You can ask the study team how to reach the IRB. Most publish a number for participants with concerns that they would rather not raise with the study team.
Safety monitors outside the study
Many studies also have a data and safety monitoring board: a small group of independent experts who look at accumulating results. If the data show that a treatment is clearly helping, or clearly causing harm, they can recommend changing or stopping the study. They are separate from the people running it on purpose.
The sponsor and the regulator
The sponsor pays for and takes responsibility for a study. It might be a university, a hospital, a government agency, a nonprofit, or a company. In the United States, studies of medicines and many devices also follow rules set by the Food and Drug Administration. None of these are Trialuma. We do not run, recruit for, or enroll people in studies.
Questions worth asking about the team
- Who is my main contact, and how do I reach someone at night?
- Who is the principal investigator, and what is their role in my visits?
- Has an IRB approved this study, and how can I reach them?
- Who pays for the study?
General information only. This briefing is not medical, legal, or financial advice, and Trialuma is not a medical provider. Talk with your own doctor about your health.