Patient consent has been considered the most important protection against legal liability for injuries due to medical experimentation. This was a natural reaction to the Nazi concentration camp experiments. The theory is based on the assumption that a patient would not freely consent to an unreasonable experiment. This assumption is valid for experiments like those carried out by the Nazis, but it does not hold for the more usual type of experiment.
Most patients do not have the necessary technical knowledge to appreciate the fine distinctions between an experiment that may provide information but cannot help them (nontherapeutic experiment) and an experiment that may benefit them (a therapeutic experiment). Patients are very prone to accept any recommendation made by their physician and to feel strongly that the physician would not recommend anything that was not necessary. The effect of these two tendencies is that patients consent to experiments in the same way they consent to routine therapy. This lack of appreciation of the seriousness of the problems involved in research works against the assumption of risk that usually accompanies an informed consent. This situation may be viewed either as a failure of informed consent or as a policy decision not to allow a researcher to shift the responsibility for an experiment to the subject to the experiment.
This is not meant to minimize the importance of getting an informed consent. Research, as an intentional act that subjects the patients to risks outside routine medical therapy, is an area where the courts could be expected to assign punitive damages if an investigator was shown to be misleading patients to secure their cooperation. Yet, even if a proper informed consent is obtained, the court will still weigh the risk against the merit of the experiment. An experimenter who exposed a patient to a risk out of proportion to the potential benefit of the experiment would be estopped from arguing that the patient assumed the risks of that experiment.
There are several important differences between obtaining consent to a medical experiment and obtaining consent for routine therapy. The patient must be informed of all risks of an experiment. This is a significant change from the rule that governs routine therapy. Consent to routine therapy is judged on the information provided by other providers in the same circumstances. This community standard does not exist (at least legally) for experimental therapy; thus all risks of an experiment must be disclosed.
Another problem arises in research where the patients do not know which therapy they actually receive. Full informed consent must be obtained for each possible therapy; then a special form must be signed, stating that the patient consents to either therapy. The experimenter must also realize that the patients have the right to know the treatment they are receiving. The patient may exercise this right at any time. The excuse that it will ruin the experiment cannot be used to deny the patients this information.
The consent form used for medical experiments should be standardized and should meet the following requirements:
* The consent must be in writing on a specific form.
* The consent form must be approved by the IRB.
* The consent form must be clearly titled "Consent to Medical Experimentation."
* The consent form should state whether the patient may personally benefit from the experiment and what this potential benefit would be.
* The consent form should describe the accepted therapy for the patient's condition and how the experiment differs from the accepted care.
* The consent form must describe all the known risks of the experiment.
* The consent must clearly state that the experiment may be terminated at any time and routine therapy resumed.
* The consent should be obtained by someone other than the patient's physician.
* If the subject is legally incapacitated, the legal relationship of the person signing the consent must be specified.
* Any monetary or other compensation should be clearly spelled out in the consent form.
The institution must guard against both explicit and implicit coercion in obtaining consent. The patient must not be put in a position of choosing between being an experimental subject and receiving no care at all. Thus, the patient must be guaranteed a full course of routine therapy if the patient decides to end the experiment. Paying patients to undergo experiment should be carefully scrutinized. The patient's time and inconvenience should be compensated, but the rate of pay should not be so high as to override the patient's judgment in balancing the risks and benefits of the therapy. The researcher should avoid the appearance of subjects selling their bodies to science.
Many institutions include a waiver of liability for injuries received during an experiment. For example, many facilities include this type of waiver as part of their standard consent form:
"I have been informed that, should I suffer any physical injury as a result of participation in this research activity, all of the necessary medical facilities are available for treatment. However, I understand that I cannot expect to receive any payment for hospital expenses or any financial compensations for such injury."
This type of waiver is not a good idea for risk management. The courts are extremely critical of medical experimentation, and it can be assumed that the health care providers involved in the experiment would be held liable for any medical expenses resulting from the experiment. If the providers went into court to contest this, they could expect to be subject to any additional damages beyond the medical expenses. A waiver does not shift the responsibility to the subject. If may even encourage litigation by encouraging an injured patient to seek legal help. For these reasons, it is preferable for the providers to assume the burden of caring for injured subjects and to explicitly state this in the consent form.
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