How are clinical trial participants protected? » top

Clinical trials follow a carefully controlled protocol, or study plan. All IDCTU clinical trial protocols are developed in conjunction with guidance from medical experts, clinical staff, the National Institutes of Health, and a third party (Clinical Research Management). Once a protocol is written, it is also subjected to careful review by the University Hospitals Institutional Review Board (IRB) before the trial can begin. During the study, research staff members consistently monitor participants and report results to the principal investigator. Volunteers may also discontinue a study at any time, for any reason with no penalty.

What are the risks associated with participation in a clinical trial? » top

Since clinical trial medication/treatments are investigational, the risk of side effects and adverse reactions cannot be entirely known. However, the federal government has regulations and guidelines to protect participants from unreasonable risks. As such, clinical trial protocols are designed to be as safe as possible for participants and have safety measures incorporated into them. All known risks will be disclosed in the informed consent document.

Where do I park to participate in a clinical trial? » top

Parking is available in the Adelbert Visitor Parking Garage right next door to Rainbow Babies and Children’s Hospital. Dahms Clinical Research Unit is located on the 7th floor of Rainbow Babies and Children’s Hospital. As a clinical trial participant, your parking will be validated. A map is available here.

What should I consider before participating in a clinical trial? » top

It is important to be as informed as possible before participating in a clinical trial. You should be clear about what to expect during your participation, and who to contact if you have a question or concern. Some other questions to consider may include:

  • What is the purpose of the trial?
  • Has the medicine/treatment been previously tested in humans?
  • How long will the trial last?
  • What kinds of tests/experiments are involved in the trial?
  • Who will be in charge of my care?

How long do clinical trials last? » top

The Phase 1 trials we conduct at the IDCTU can last anywhere from a few days to several weeks. The duration of each available study is listed in its desription under Current Studies.

What are the different types of clinical trials? » top

All of the trials conducted by the IDCTU are treatment trials, which test experimental treatments/medications, however other types of trials include prevention, diagnostic, screening, and quality of life trials. Clinical trials of all types are conducted in Phases (1-4), with Phase 1 being the smallest, most preliminary trials, and Phase 3 being the largest trials. Phase 4 trials are used when additional information is needed about an existing medication/treatment.

Feel free to contact us if you have any additional questions or check out the NIH website's FAQ for further information.