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Issues in Informed Consent 01/27/2011

Posted by ALT in Mental Health Research, Patient Rights and Advocacy.

A friend asks you if you would like to go to a movie.  Odds are good that before you say yes or no, you’re going to need to know some additional information – who all is going, is the popcorn any good, does the movie involve Will Smith battling an alien creature, etc. 

That’s informed consent: data-driven decision making. 

You, the person who has been propositioned, need access to a body of knowledge that will allow you to effectively weigh the risks and benefits before agreeing to anything.

If your friend didn’t answer your questions accurately, or worse yet, withheld important information purposely in order to elicit a particular response, you’d probably be upset.  It was his responsibility to supply you with the most accurate information possible about what to expect; to do anything less would be dishonest, unethical.

Informed consent is a legal matter when it comes to medicine and research.  Before a doctor proposes a particular course of treatment, he needs to inform the patient of all known risks and benefits – this could include information from both scientific research/clinical trials, and qualitative or experiential knowledge of the treatment from actual practitioners and consumers.  Likewise, before a participant can be enrolled into a study like the national evaluation, they need to know exactly what to expect from their participation and what the purpose of the study and the value of their contributions to it are.  A doctor or researcher who fails to help the patient or participant give true informed consent is committing a grave violation of trust, not to mention a criminal offense that is subject to malpractice lawsuits. 

Below are a few illustrations of some of the moral and ethical issues surrounding the informed consent process.  How can researchers and doctors take these incidents as “lessons learned,” improving their practice and the relationships of trust and communication they have with the public?


 In 1951, Henrietta Lacks, a poor African American woman living in Baltimore, Maryland, learned that she had cervical cancer.  During surgery at Johns Hopkins Hospital, a portion of her cervix, including a large tumor, was removed.  Unbeknownst to her or her family, cells from this sample were reproduced in a laboratory at the hospital, becoming HeLa, the world’s first immortal cell line – cells that can be reproduced endlessly in the lab without dying.  Her cells were used in the creation of the polio vaccine, planted near nuclear test sites, sent into outer space… all without the knowledge of her family.  HeLa cells were the beginning of the multi-billion dollar biotechnology industry, and vials of HeLa are still bought and sold today, for about $200 apiece (no profits from the sales or commercialization of HeLa have gone to the Lacks family).

The family was unaware of the second life Henrietta had taken on for nearly 20 years.  And their relationship with the scientific community since has been plagued by misunderstanding and abuse. 

The New York Times has written a nice piece about the Lacks, and there is also an excellent BBC documentary on the topic, called The Way of All Flesh.

The question is – how could researchers and scientists ethically allow this kind of misunderstanding and obfuscation to occur?  And are abuses like this happening today?

Capable of Consent?

When is a person capable of judging for him or herself the risks and benefits during an informed consent process?  There are some clear examples of people who aren’t capable of doing it – a 3-year-old child, or a person in a coma, for example.  The issue of competency when it comes to consent is not always so clear cut, however.  Take the case of Paul Henri Thomas:

In June 1999, Paul Henri Thomas thought clearly enough to sign a consent form, giving his doctors permission to place electrodes near his temples and send jolts of electricity through his brain as part of his treatment at Pilgrim Psychiatric Center.

He underwent the painful and controversial electro- shock procedure three times, on June 9, 11 and 14. But after that third treatment, he had refused to submit to it again.

That’s when his doctors began saying Thomas, 49, no longer had the mental capacity to make decisions on his own, so they obtained a court order to force the electroshock therapy upon him.

The revelation of a kind of Catch-22-the strange circumstance that Thomas was fine when he consented to the procedure but mentally incompetent when he refused it-took center stage at a hearing [on March 15, 2001] to determine whether doctors may again shock Thomas against his will.

Thomas, who has been a patient at Pilgrim since May 1999, is challenging the state’s application to continue giving him shock treatments-a controversial form of therapy to treat a variety of mental illnesses. Thomas contends he is not mentally ill.

At the third day of Thomas’ hearing yesterday, his attorney questioned a witness for Pilgrim.

“In June he was competent to consent and received three treatments, and some time after that he became incompetent. Is that correct?” asked Kim Darrow, an attorney for the state Mental Hygiene Legal Service, which is representing Thomas.

“I’m unable to answer that,” responded Dr. Robert Kalani, Pilgrim’s associate medical director.

But State Supreme Court Justice W. Bromley Hall swiftly cut off Darrow’s line of questioning, saying Thomas’ capacity to make decisions about his health may have changed since he consented to the treatment.

“There are a lot of people walking around with capacity for whatever,” Hall said in the Central Islip courtroom. “The fact that you have capacity today doesn’t mean you will have capacity tomorrow,” he added, prompting gasps from Thomas’ supporters…

Testimony ended with Darrow asking Kalani, given that Thomas has called the procedure “torture” and “evil,” how has it improved his life.

“Do you think you have improved the quality of life for Mr. Thomas?”

“I think we have,” Kalani answered.

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