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The Clinical Trial Volunteer: Guinea Pig with Free Will?
People who participate as research subjects in clinical trials are referred to by those studying them (researchers, clinicians and the companies sponsoring the research) by a variety of names. The most common are:
Volunteer -- this is something you want to do, instead of spending your leisure time gathering toiletries for earthquake or hurricane victims
Participant -- sounds enabling, doesn't it?
Subject -- clinically sterile designation
Patient -- your doctor will take good care of you
Notice that I have not included "Guinea Pig" on the list... for now.
According to the federal regulations governing clinical trials in the U.S., participation in research where risk to the participants is involved is voluntary. It must be documented by the participant's signature. If you wish to volunteer for the clinical trial, you must sign the Informed Consent document. It becomes a part of the official records of the clinical trial, available for review by the research staff, the U.S. Food and Drug Administration, the U.S. Office for Human Research Protections, officials of the institution hosting the clinical trial, and of course the company sponsoring the research. Further, the voluntary decision to participate must be made with a full understanding of the research and its risks.
A full understanding of the research? In practice, this means you are told about the research as it relates to what you will have to undergo and what risks you are likely to be assuming. In addition, you will receive a written explanation in the Informed Consent document, which is supposed to be written in plain English, not requiring an attorney or a physician to interpret. The short, easy-to-read Informed Consent document has yet to be invented. In all fairness, the document is supposed to contain a full description of the research and potential risks. Such detail is not amenable to text messaging.
Okay, so you may not be as fully informed as you could be. But you sign anyway. Your decision is revocable at any time during the research. How many times have you been required to sign a document and felt perfectly free to take back what you've signed up for? Nevertheless, the rules say you are free to withdraw at any time. The exception to this would be in cases where dropping out of the clinical trial would be dangerous to your health.
Knowing what you're signing up for and knowing you have the option to withdraw should give you the advantage over any… guinea pig!
-Joe
Related Topics: Health Decisions, Clinical Trials
Volunteer -- this is something you want to do, instead of spending your leisure time gathering toiletries for earthquake or hurricane victims
Participant -- sounds enabling, doesn't it?
Subject -- clinically sterile designation
Patient -- your doctor will take good care of you
Notice that I have not included "Guinea Pig" on the list... for now.
According to the federal regulations governing clinical trials in the U.S., participation in research where risk to the participants is involved is voluntary. It must be documented by the participant's signature. If you wish to volunteer for the clinical trial, you must sign the Informed Consent document. It becomes a part of the official records of the clinical trial, available for review by the research staff, the U.S. Food and Drug Administration, the U.S. Office for Human Research Protections, officials of the institution hosting the clinical trial, and of course the company sponsoring the research. Further, the voluntary decision to participate must be made with a full understanding of the research and its risks.
A full understanding of the research? In practice, this means you are told about the research as it relates to what you will have to undergo and what risks you are likely to be assuming. In addition, you will receive a written explanation in the Informed Consent document, which is supposed to be written in plain English, not requiring an attorney or a physician to interpret. The short, easy-to-read Informed Consent document has yet to be invented. In all fairness, the document is supposed to contain a full description of the research and potential risks. Such detail is not amenable to text messaging.
Okay, so you may not be as fully informed as you could be. But you sign anyway. Your decision is revocable at any time during the research. How many times have you been required to sign a document and felt perfectly free to take back what you've signed up for? Nevertheless, the rules say you are free to withdraw at any time. The exception to this would be in cases where dropping out of the clinical trial would be dangerous to your health.
Knowing what you're signing up for and knowing you have the option to withdraw should give you the advantage over any… guinea pig!
-Joe
Related Topics: Health Decisions, Clinical Trials
