Frequently Asked Questions
What is clinical research?
The National Institutes of Health defines “clinical research” as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Clinical research includes:
Patient-oriented research – This type of research involves a particular person or group of people, or uses materials from humans. This research can include 1) mechanisms of human disease, 2) therapeutic interventions, 3) clinical trials, and 4) development of new technologies
Epidemiological and behavioral studies – These types of studies examine the distribution of disease, the factors that affect health, and how people make health-related decisions.
Outcomes and health services research – These studies seek to identify the most effective and most efficient interventions, treatments, and services.
What questions should I ask before choosing to participate?
Patients considering participating in a clinical trial should talk about it with their physicians and medical caregivers. They should also understand the credentials and experience of the staff and facility involved in conducting the study. Questions to ask a physician or medical caregiver:
How long will the trial last?
Where is the trial being conducted?
What treatments will be used and how?
What is the main purpose of the trial?
How will patient safety be monitored?
Are there any risks involved?
What are the possible benefits?
What are the alternative treatments besides the one being tested?
Who is sponsoring the trial?
Do I have to pay for any part of the trial?
What happens if I am harmed by the trial?
Can I opt to remain on this treatment, even after the trial?
In some studies, participants receive a physical examination and their medical histories are reviewed by either the study physician or a research staff member. The participant’s health will continue to be monitored during and after the trial. A detailed description of what is expected of volunteers will be outlined in consent forms along with specific clinical trial information.
What is informed consent?
Prior to participating, every volunteer has the right to know and understand what will happen during a clinical trial. This is called informed consent, a process that can help you decide if participating in a trial is right for you.
When you give written consent to participate in a clinical trial, you acknowledge that you understand and accept all aspects of the research study, including any risks or benefits involved. However, informed consent is not strictly about signing a document. It is a process that involves ongoing conversations between you and the research staff before, during and even after you decide to become a study volunteer.
To begin, the research staff is obligated to discuss all the pertinent information about the trial with you, its purpose, the procedures involved, the potential risks and benefits. It is your responsibility to ask questions if there is something you don’t understand. You can ask the researcher to repeat the information or explain it in another way using everyday words.
If English is not your first language, research centers can and should be able to produce documents or explanations for you in your preferred language. If not, you shouldn’t participate in the study.
In some instances, a single visit may not be enough time for you to fully understand the information provided. Therefore, it is essential to take the time you need to make an informed decision.