How Volunteers are Protected

  • To protect the rights and welfare of clinical research participants, U.S. Federal Agencies including the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) oversee much of the medical research in the U.S.
  • Institutional Review Boards (IRBs) oversee the centers where clinical research studies are conducted.  IRBs review and approve study protocols to ensure that a clinical trial is ethical and that volunteers’ rights are protected.
  • A participant in a clinical trial has access to the IRB that is overseeing the research and access to a volunteer advocate, the physician and staff conducting the trial.
  • Some IRBs are accredited much like hospitals can be “accredited” and some research investigators and staff are “certified.”

What is Informed Consent?

Informed Consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate.  The Study Coordinator will explain the details of the study, as well as the risks and benefits of participating.  Potential study participants (and caregivers, when applicable) will have the chance to ask questions about the study.  If a potential study participant decides to participate he/she will be asked to sign an Informed Consent document which includes details about the study, such as its purpose, duration, required procedures and key contacts.  Participants may decide to withdraw from the study at any time, for any reason, even if he/she has signed the Informed Consent.

Phone:  1-731-541-6910

West Tennessee Healthcare (WTH) does not exclude, deny benefits to, or otherwise discriminate against any person on the grounds of race, color, national origin, age, religion, disability, Limited English Proficiency or sex, including discrimination based on gender identity, sexual orientation, sex stereotyping or pregnancy in admission to, participation in, or receipt of the services and benefits under any of its programs and activities, whether carried out by WTH directly or through a contractor or any other entity with which WTH arranges to carry out its programs and activities.

For further information about this policy, contact Amy Garner (731) 541-9914.