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Informed Consent

Posted 12/28/2013

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  There is actually a debate about whether true "informed consent" exists. As you likely know, informed consents are the usually long and complex forms given to people who are considering joining a clinical trial. The consent lays out the scientific basis for the trial and the knows risks and possible benefits. It also includes the various rules of the trial and sometimes additional information thought to be important for the participant to understand. In my experience, most people thinking about clinical trials are pretty overwhelmed by the whole situation in general and this document in particular. Usually, people are given a copy to take home before signing, with the request to read and think about it. Sometimes, of course, the signing happens sooner.

  Whenever it happens, I know that some patients and families read every word and try to understand and puzzle out the complexities. Others skim it and sign, and I suspect some don't read it at all. There is a parallel conversation re the motivations of people joining clinical trials and the depths of their understanding of the possibilities. Although, when asked, most participants state that they are hoping to further scientific knowledge and help others, and I surely believe that this altruistic motive is real, the bottom line (I think) is that most people are hoping that the drugs will be personally helpful. Of course! There is nothing wrong with that wish, but the murkiness deepens when people understand the likelihood, or not, of that outcome.

  This is an excellent article from CancerNet about this. If you ever have been or think you ever might be part of a clinical trial, this is worth reading.

  Patient Safety and Informed Consent

Key Messages:
• Clinical trials are regulated and monitored by independent committees and federal agencies to ensure the study is safe and scientifically relevant.
• Informed consent is an ongoing process designed to protect the rights and safety of people participating in clinical trials.
• Volunteers may stop participating in a clinical trial at any time for any personal or medical reason, and they will continue to receive all necessary standard medical care.
Because patient safety is the highest priority in clinical trials, every research study must follow a rigorous review and oversight process.


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