FAQs

An Institutional Review Board or IRB is an administrative body that reviews all components of a human clinical trial in order to protect the rights and well being of human research participants. An IRB is usually composed of doctors, scientists, advocates, researchers, and specialized community members. An IRB is also known as an ethical review board (ERB), research ethics board (REB) or independent ethics committee (IEC). All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that approves and regularly reviews the research effort.

In addition, each trial or study has a Principal Investigator or PI that oversees the conduct and safety of the trial at a specific clinical site. A PI is usually a leading physician specializing in the disease or condition being studied, and is supported by a staff of additional physicians, nurses, and scientists.

Yes, and is even encourage to do so! Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol or cause adverse reactions to the patient. 

 Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study. 

A sponsor is a company, institution, organization, or person who oversees or pays for the administration, data collection, and analysis of a clinical trial. Examples of sponsors include but are not limited to:

• the Department of Veteran’s Affairs (VA)
• A sponsor is a company, institution, organization, or person who oversees or pays for the administration, data collection, and analysis of a clinical trial.
• Examples of sponsors include but are not limited to:
• individuals such as physicians
• medical institutions
• foundations
• volunteer or community groups
• private companies such as:
  • pharmaceutical
  • biotechnology
  • or medical device companies
• federal agencies such as:
  • the National Institutes of Health (NIH)
  • Department of Defense (DOD)
  • the Department of Veteran’s Affairs (VA)

Ideas for clinical trials usually come from researchers like scientists or physicians themselves. After researchers test new therapies or procedures in laboratory and/or animal studies, the treatments with the most promising early results advance into Phase I clinical trials. As trials advance, a greater picture is given into how well new treatments are working, the side effects, and what dosage work best or worst. 

Most of the time participating in a trial does not require insurance, and even the majority of the time people do have insurance. In fact, most studies even pay a modest amount to the patients for their time and willingness to volunteer.