Informed Consent -- A Process, Not a Piece of Paper
Before someone may be enrolled in a clinical trial, they must give what is known as their informed consent.
That is, they must be fully informed about the research they are considering participating in and they must be given the opportunity to choose freely to participate or not to participate.
It would be great if all clinical trials could be explained to potential subjects in a brief and easy-to-understand way. Actually, they are supposed to be explained as simply, but completely, as possible. But it doesn't always turn out that way.
Science is not simple. It usually takes many words to provide a full and comprehensible explanation to individuals who are not assumed to know the science or the medicine involved. That is why best practices include an oral as well as a written description of the clinical trial.
First, a member of the study team, often a nurse coordinator or a physician, explains the purpose of the research, what will happen to participants and what is known about the benefits and risks involved. This oral explanation could be a one-on-one conversation, a presentation to a group of potential participants, or a video or audio presentation. A key aspect of any oral explanation is that potential participants are given an opportunity to ask questions and have them answered before they make their decisions.
Next, the potential participant is given a written document, referred to as a Consent Form, to read and sign. This Consent Form is often rather long, primarily because it is supposed to contain the information needed to make an informed decision about whether or not to participate. It is signed because it documents the voluntary participation of the research subjects.
No one should agree to be in a clinical trial if they do not feel they know enough about what they are getting into. If you feel you have not received sufficient information to make a decision you are comfortable with and your questions are not answered to your satisfaction, then do not volunteer to participate.
If all goes as it should, the Informed Consent Process -- conversations with the study team and a review of the Consent Form-- should enable you to make a truly informed decision to participate or not participate.
-Joe
Related Links: FDA Approves New Vaccine for Kids' Diarrhea, Health Groups Want Tougher FDA
Technorati Tags: informed consent, consent forms, clinical trials
That is, they must be fully informed about the research they are considering participating in and they must be given the opportunity to choose freely to participate or not to participate.
It would be great if all clinical trials could be explained to potential subjects in a brief and easy-to-understand way. Actually, they are supposed to be explained as simply, but completely, as possible. But it doesn't always turn out that way.
Science is not simple. It usually takes many words to provide a full and comprehensible explanation to individuals who are not assumed to know the science or the medicine involved. That is why best practices include an oral as well as a written description of the clinical trial.
First, a member of the study team, often a nurse coordinator or a physician, explains the purpose of the research, what will happen to participants and what is known about the benefits and risks involved. This oral explanation could be a one-on-one conversation, a presentation to a group of potential participants, or a video or audio presentation. A key aspect of any oral explanation is that potential participants are given an opportunity to ask questions and have them answered before they make their decisions.
Next, the potential participant is given a written document, referred to as a Consent Form, to read and sign. This Consent Form is often rather long, primarily because it is supposed to contain the information needed to make an informed decision about whether or not to participate. It is signed because it documents the voluntary participation of the research subjects.
No one should agree to be in a clinical trial if they do not feel they know enough about what they are getting into. If you feel you have not received sufficient information to make a decision you are comfortable with and your questions are not answered to your satisfaction, then do not volunteer to participate.
If all goes as it should, the Informed Consent Process -- conversations with the study team and a review of the Consent Form-- should enable you to make a truly informed decision to participate or not participate.
-Joe
Related Links: FDA Approves New Vaccine for Kids' Diarrhea, Health Groups Want Tougher FDA
Technorati Tags: informed consent, consent forms, clinical trials
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