Research has been integral to the expansion of knowledge throughout the history of medicine. Its goal is to benefit not just the subjects themselves but to aid society as a whole through the discovery of new information, new medicines, or new methods of care. Debate surrounding the benefits and burdens of research subject selection and involvement has arisen because of situations involving those who cannot give voluntary informed consent and those to whom the research can be directly beneficial. In response to this debate, it would seem that the welfare and of the patient, or potential subject, must be considered before the benefits that the research could offer society. In light of this statement, however, those unable to give consent should not be excluded entirely from research, since this would inevitable cause a marked decline in the scope and success of medical research, to the detriment of society. If the research involves little risk to the patient, and at the same time benefits him or her in some way, a guardian’s consent to include their charge in the research presents sufficient grounds to do so.
Multiple reasons for this assessment exist. A potential subject should be allowed to participate in medical research if informed consent is obtained in a situation where the patient is made aware of the risk involved. The situation changes when an potential subject who cannot provide an informed consent, either due to age or mental incapacity. In this case, if the research in question maintains a low level of risk, and offers either a direct or indirect benefit to the patient, regardless of its therapeutic value, a guardian’s consent should suffice to involve that patient as a subject in the research. This argument corresponds to a surrogate, or libertarian, solution to the dilemma of burdens of the research subject. According to this notion of weighing benefits and risk, the benefits of being a research subject should be distributed in such a way that people can only be made subjects when the risks involved in the research are understood.
This reflects a paternalism in this system of burdens and benefits which stems from the problems that arise both in patient and care giver due to conflicts of interest and psychological ramifications involved in high risk research. When dealing with the burdens of selecting a research subject from a group of individuals who cannot give informed consent, the need to maintain a low level of risk becomes imperative. One of the strongest criticisms of this guardian solution involves the nature of the guardianship: while guardians often choose for their charges in many situations—schooling, religion, method of rearing—there is no justification for a guardian to put their charge in hazardous or risky situations. By keeping the risks of the research to a minimum, however, a guardian can in good conscience allow those under their protection to participate in research beneficial to them. The level of risk, however, should not exceed that of a regular examination.
While some risk-benefit strategies suffer criticism because of their leniency in defining the level of risk, this system removes problems caused by terminology such as minor increase over minimal risk (Protection of Human Subjects, 1991, 102 i) , by necessitating that the research involve only the most basic of risks—the same as in seeking care for an illness as a patient. One of the implications of this argument involves the irrelevance of whether the research is therapeutic or non therapeutic. If benefits can be found in both types of research, and, if in all cases dealing with potential subjects who cannot give informed consent, the level of risk is low, then the benefits would potentially outweigh the risks for the patient in both therapeutic and non therapeutic research.
In therapeutic research, the benefits to the subject are easily discerned, since patients receive direct treatment for their illnesses. Therapeutic research does not, however, imply that involving a patient as a subject in the research provides a course of action in the patient’s best interest. A patients can receive treatment without involving themselves in research, and research may include unwanted increases in cost and inconvenience. This being the case, non therapeutic research which involves equivalent levels of risk and which is determined to be beneficial to the patient should not be excluded simply because the goal of the research does not directly benefit the patient. Involvement in the research itself may serve as adequate benefit to justify the patient’s involvement.
If a patient enjoys participating in the research, or if the patient’s psychological demeanor is improved, for example, through the company of the researchers or his presence in their facility, this could be determined to be a significant enough benefit by the guardian to allow their charge to participate. This answers the criticism that a guardian cannot volunteer others to participate in something hazardous and without benefit: the risks involved are no greater than seeking normal medical treatment during an examination (although lesser risks, such as assessing learning skills through a test of reading ability, would also be permissible even though they do not occur during a routine medical examination), while benefits to the patient clearly exist. An important method of assessing the benefit to the patient in especially non therapeutic research involves seeking that patient’s assent.
Even children, or mentally debilitated adults will be capable of conveying whether or not they are happy in the research, or whether they feel uncomfortable in that setting. Where it is impossible to gain this assent, perhaps because the patient cannot give any response due to severe disability, the benefits of the research to society can justify the patient’s involvement in medical research, provided, of course, that the same minimal level of risk remains intact. In this way, the research does not harm the patient and the unresponsive patient benefits society. In discussing the benefits of medical research, a measure of risks in comparison to benefits again serves as a key factor in the determination of subject participation and selection.
The most sensible method of selection would involve choosing a subject who would benefit from the research despite the risks involved. The criteria for including potential subjects who could not make an autonomous choice should remain unchanged: a low level of risk remains the prerogative. For competent individuals, capable of autonomous choice, an understanding of the risks involved, followed by an informed consent to participate in the research, constitute sufficient grounds to ethically justify their inclusion as subjects in the research. In all cases, however, the benefits must outweigh the risks of research. Considering those who can give informed consent, the justification for even very risky research exists: the altruistic benefits perceived by the potential subject justify his or her decision to participate in the high risk research.
While in the case of the incompetent patient an effort is made to reduce risk to an insignificantly low level, since it cannot exceed the equivalent of a routine examination, in the case of the competent patient, the level of risk can rise to a point where it the physician can comprehend and ascertain its extent, thus creating a position where the physician can provide the patient with enough information to make an informed decision. When the level of risk rises to the point where the physician can no longer adequately perceive its range or possible repercussions, the potential subject cannot logically make an informed decision to consent to the research. In this case, the risks become undeniable and cannot be outweighed by the benefits, either therapeutic or altruistic.
According to the above arguments, when considering the extreme cases of patients who desperately desire to be included in certain medical research because its therapeutic value may immediately extend their lives, it seems that preferring these patients over others would be unjust unless the design of the research necessitated the inclusion of subjects in such a condition. In the example of AIDS research, in order to test the effectiveness of drugs that might retard the progress of HIV in the body, HIV-positive candidates are necessary to the success of the experimental design. In other situations, if benefits of research are available to the subjects involved, those who do not display the greatest need should not be discriminated against, especially if public funds, attained through taxation are responsible for the research. In considering the particular case of AIDS research, however, informed consent can only be attained when the risks are calculable.
Clearly, not every risk can be ascertained, but a relative certain prediction of what may happen can be made, allowing for an informed decision. There comes a point where the consequences of participation in medical research cannot be ascertained to any reliable extent, precluding an informed decision. A situation in which subjects are monetarily compensated for their involvement in high risk research introduces a conflict of interest not easily overcome. The indigent, attracted by the compensation, seem more likely to apply as candidates for this research. Poverty creates a vulnerability because the choice to participate may not be voluntarily autonomous. The position of poverty may coerce hesitant potential subjects into consenting to high risk research because of the potential of compensation. The fundamental principle behind these arguments involves the comparison between the risks and benefits of participating and medical research. Only if the benefits exceed the risk is the participation is justified.
If the risks are incalculable, the benefit cannot logically be determined as exceeding risk, so no informed consent could be made in such a situation. While this seems utilitarian at first glance, since benefits are maximized, it deviates from this system because the benefit to the individual supersedes the benefit to society. Only in the case where an incompetent patient cannot assent to the research should the benefits of relatively low risk research to society justify the subjects participation. The distribution of burdens and benefits should be made on this modified risk-benefit system, keeping in mind that in the case of competent potential subjects, the altruistic benefits can outweigh calculable risks, thus making the selection of those who are desperate for potentially therapeutic treatment unjustified. Both groups are equally qualified to participate in the research, and both groups could be said to derive the same amount of benefit from participation in the research, thus making the preference of one over the other a case of treating equals unequally
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