Respect for Persons,Beneficence, and Justice
In July of 1974 The National Research Act was signed into law. Through this act, The Belmont Report was developed over 4 year period of time that included an intense four day conference followed by monthly meetings until it was completed in April of 1979. The Belmont Report sets out to define the ethical principles and guidelines for the protection of human subjects of research. The report was established prior to Barney Clark and the artificial heart and therefore was the guidelines that the doctors and researchers had to follow. The report highlights three essential ethical elements that are pertinent in human research and their ...view middle of the document...
The probability that the intervention would be successful
f. The feasible alternatives
g. The prognosis is the intervention/therapy is not given
5. Offer a recommendation
6. Ensure comprehension
7. Acknowledge any emotional reaction from the patient and respond
8. Validate the patient’s decision
The case questioned the quality of the informed consent received from the patient. Two of the nine basic rules for obtaining valid informed consent might not exist in the Barney Clark case: Barney’s conditions and the information disclosed might not adequately validate the informed consent that he rendered. The lack of a valid informed consent can result in the prosecution of the physician in the court of law, which is detrimental to both the physicians involved in the case and the medical profession. Prior to the operation, Barney Clark’s condition steadily worsened. His heart beat feebly, his blood pressure dropped dangerously low, and he required oxygen supplementation. It was under these mentally and physically crippling conditions that he placed his signature on the consent form. In order to ensure Barney Clark’s competency, physicians must determine whether the influences arising from these conditions diminish his capacity for a valid consent. Physicians must also ensure that they have disclosed fully to Barney Clark all of the probable risks associated with the operation.
However a truly informed consent in research is difficult, more specifically when it comes to the disclosure of pertinent information. All of the pertinent information especially about the risks and benefits are not known. There are hopes and fears but no hard facts. The “reasonable volunteer” standard can be used in which the person is informed that the procedure is not fully understood and that it is experimental, therefore understanding that their participation is more for the advancement of knowledge than for their personal benefit. The term therapeutic misconception has been used in research, such that the patient still believes in the therapeutic benefit to them. However through interviews with Barney Clark prior to his death, it is evident that Mr. Clark was acting in an altruistic fashion. The chance to participate in the study was offered to Mr. Clark a month prior to the implementation, however he didn’t feel ready yet. As his conditioned worsened he decided to go through with the operation. He told his wife, "First of all, I don't think it will work. I'm weaker and more tired than those animals I've seen, and I don't think it's going to save my life. But I have been kept alive for the last year on medicines that other people have given their lives to give me. Now its my turn to pay those people back."5 He was then placed in the ICU and asked to sign the consent form. While it is argued that he signed the consent form in “great pain” it is evident that this was not a...