n 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 applications. It was the professional responsibility of the doctors and researchers involved to abide by previously established ethical guidelines.

Respect for Persons

Respect for the Persons as it relates to the Barney Clark case can be broken down into three important issues.

Autonomy

The doctors made the assumption that Barney Clark was a fully autonomous person at the time of the artificial heart experiment. In general it is not in doubt that Mr. Clark was an autonomous being, however his terminal condition could have affected his capacity with in the case. While he might have been autonomous in many areas of his life the issue that is relevant to the case was whether he possessed the capacity to make an informed consent.

Informed Consent

The nine basic rules4 for an informed consent are

1. Identifying the appropriate decision maker

2. Having the discussion at a time when the patient is not distracted or in great pain.

3. Determine that the patient is communicating voluntarily

4. Disclose

a. Nature of the proposed intervention

b. The purpose

c. The risks and consequences

d. The benefits

e. 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

9. Summarize

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 spur of the moment decision, but one he grappled with for a month before altruistically committing himself to the surgery. Even after sitting in the ICU waiting the required 24hrs to sign the same consent form again as required on what would have been one of his last breaths he asked the doctors to continue and get it over with.

Confidentiality

The domination of the Barney Clark case in the media leads to the question of confidentiality. It was said that for the 112 days that Clark lived with his artificial heart, members of the media crammed to the hospital, wanting to know every facet of his care, and medical students at the University of Utah were taken to see Clark. Did Barney Clark want such massive media exposure? Or was his operation and recovery a convenient means for the University of Utah hospital to expose itself to the world? Such exposure, on the part of the hospital, is desirable as it equates to public recognition, and eventually, financial gains. If confidentially, of diagnosis and treatment, is one of the tenets of medical ethics, the abandonment of this principle in the Barney Clark's situation should raise eyebrows.

Beneficence

The case questions whether the implantation of the artificial heart represents a situation in which physicians used a human person for the purpose of experimentation (i.e. as a guinea pig). Since it was the first of its kind, the prognosis for the Barney Clark after the operation was, at best, uncertain. His consent form lays out the overwhelming risks. It stated that, “There is no guarantee that the implantation of an artificial heart will add any additional time to my life” and recognized that “there is substantial and serious harm, including death”. It has been argued both ways that the professionals involved acted beneficently. The principle of beneficence leaves troubling ethical dilemmas within this case.

For a reasonable person to undertake such great risk, one would think that there must be a proportional good that could result from the success of the operation. Unfortunately, there is none. Even if the operation was successful in prolonging Barney Clark’s life, his prospects were disheartening, for the rest of his life, he will be tethered to a power source the size of a dishwasher along with a vast array of tubing, air pumps, and other bulky machinery. Existence is desirable, but to exist with such burden could be considered lamentable. With these facts, the motive of the physicians in performing operation is questionable. Did they perform the operation with the intention of doing good for the patient (beneficence)? Or was their primary intention the advancement of medical research irrespective of the consequences to the patient? In the latter case, both the principles of beneficence and non-maleficence and justice are broken. The principle of non-maleficence requires a physician to do no harm, and yet, on the superficial surface, harms seem to have been perpetrated against Barney Clark

However it has been argued as well the professionals involved did act beneficently towards Barney Clark. The Hippocratic Oath that all physicians take requires that the doctors do no harm and maximize the good while minimizing the bad, such that proportionally the doing of the good outweighs the potential harm. However research is difficult in that the results are unknown, both researchers and doctors can’t predict all of the consequences of the treatment. They have to first learn what is harmful through experimentation. In the Barney Clark case, the professionals involved where unsure of the harmful side affects. While the artificial hearts had been placed in animals with a semblance of a working fashion a human is a different story. It can be very well argued that there was going to be little to know direct benefit to Mr. Clark, however to society on a large the long-term benefits have resulted in an improvement of the knowledge of artificial hearts that is demonstrated by the attempts of development currently going on at this time. This is where the much-debated ethical dilemma arises. Human knowledge isn’t sufficient enough to answer many of the questions raised and regardless of the choice made serious moral issues will remain.

Justice

Justice deals with the issues of fairness and who has the rights to the benefits and burdens that are entailed in research. There are many ethical and practical discussions to how resources should be distributed on a society and individual level. With in the Belmont report these were structured down to the fair selection of subjects, however it is important to also consider the financial costs of the research.

Millions of dollars of funding went into producing the Jarvik-7 and it was estimated that if it would work it could cost a minimum to $70,000 per patient.1 Was the cost of the artificial heart worth it and who was going to pay for it? These two questions circled in many ethical debates surrounding the Jarvik-7. The research was expensive, the implementation was expensive and the cost of the maintenance after implementation was expensive. The cost really raises the issue of justice. Who decides how to spend the money and who gets access to it? Many argued that the cost was not proportional to the outcome and even a success would still leave it out of reach for to many. However, research has to begin somewhere. The first computers, for example, where large bulky and cost obscene amount of money, today they are commonplace and affordable for the average family. The Jarvik-7 might not have been a truly complete model but was an initial step towards the researcher's goals of making a functioning artificial heart.