Understanding Clinical Trials
What is a clinical trial?
Participants in clinical trials can play a more active role in their own health care, gain access to potentially new treatments that are not available to the public, have access to expert medical care during the trial, and help others by contributing to medical research. In addition, participants receive study related medical care and medication at no cost. Compensation for time and travel is available.
Who can participate in a clinical trial?
People volunteer to participate in a clinical trial. They may be people who have, or are at risk for having, the disease the drug or treatment is designed for. The drug or treatment may also be tested in healthy volunteers. Volunteers must meet the criteria for participation, which are different for each clinical trial.
What happens during a clinical trial?
Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set out by the protocol.
The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
What are my rights as a participant?
All participants are guaranteed rights that ensure they are treated professionally and respectfully. When you take part in one of our studies, you have the right to:
- Be treated with respect.
- Make your decision without feeling any pressure from the research staff.
- Know the risks of participation in the study.
- Know what alternatives are available.
- Know the name, credentials and contact information of the studyâ€™s principal investigator.
- Know the purpose of the study.
- Know who will have access to your information.
- Know what procedures may be performed and what drugs or medicines may be used.
- Seek additional help or clarification during the informed consent process and at any time during the study.
- Withdraw from the study without penalty.
What are my responsibilities as a participant?
All participants are expected to comply with the specific requirements of the study protocol. In addition, study participants are expected to adhere to a general set of requirements that apply to ALL participants. They include:
- Following the directions of the investigator and research staff (including but not limited to study drug compliance and return).
- Making sure your contact information is up to date.
- Arriving for all scheduled appointments or calling ahead if you are unable to keep an appointment.
- Arranging your own transportation to and from the study site.
- Providing “to the best of your ability” accurate information about your medical history if it is relevant to the study.
- Seeking healthcare for any medical conditions unrelated to the study.
- Informing the research staff of any negative experiences or any hospitalizations you have while participating in the study.
- Informing the research subject advocate and, if necessary, the Institutional Review Board if you feel your rights as a study subject have been violated.
- Asking the researchers to completely answer any questions you may have at any time during the study.