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Basic Ethical Principles in Medicine and Human Subjects Research

1.Beneficence means to do the good and/or to promote the good. The traditional notion of doing The good in clinical medicine means to act in the patient's best interest. In clinical research, beneficence may refer to the individual subject or to society and medical progress, in general. In clinical research, upholding the principle of beneficence vis?a?vis study subjects is quite complicated because the primary goal of research is to produce new knowledge that may lead to better treatment of future patients, not to take care of individual study subjects. Further clouding our understanding of beneficence in the research setting is that the clinical care ancillary to the research procedures that subjects receive while they are subjects is often excellent and sometimes far better than the individual might receive if s/he were not a research participant.

Also, although the protection of the rights and welfare of present subjects is always to be the first consideration, and is central to acting beneficently towards research volunteers, this should not be confused with benefits study subjects might gain from research participation. Although overlapping concepts, beneficence and benefits refer to two different concepts.

Questions you might ask yourself related to the concept of beneficence.

·Are there any benefits that study subjects can reasonable anticipate from participation in the experimental aspects of the study (i.e., direct benefits)?

·Are there any benefits study subjects can reasonably anticipate from participation in the adjunctive aspects of the study (i.e., indirect benefits)?

·How does the study propose protecting subjects?

·What are the plans, and who is responsible for assuring the plans are followed, to provide subjects with high standards of clinical monitoring throughout the study?

·If subjects can be expected to become ill, or more ill during the study than before they entered the study, does the study plan spell out clinical end points that will trigger clinical treatment?

·Is clinical treatment of unpleasant or uncomfortable symptoms a study requirement to remove a subject from the research (what is called off-study criteria)?

·If so, what are the implication of going off-study for the subject, particularly related to treatment and its costs?

·What are the protocol's plan for orderly discharge and follow up?

2.Nonmaleficence is the oldest Western medical ethics principle, coming to us from the ancient writings of Hippocrates. Nonmaleficence means to do no harm and/or to prevent harm. On the face of it, not doing harm or avoiding harm to patients and research subjects seems to be straightforward. But it is not. For example, in clinical medicine, surgery causes harm by cutting through organs or bone, but it is harm in the service of healing. In research, the ethical implications are even more complicated in that often subjects are put at risk of unknown and unknowable harms in the hopes of discovering better ways of treating disease. Research requires putting present persons at risk of harm, burden and/or inconvenience to learn how better to care for future patients.

Given this reality of the research setting, upholding the principle of nonmaleficence is complicated, ethically and technically. It is, however, a primary responsibility of researchers and IRBs to sort through the complexities and prevent harm as much as is reasonably possible. To do this, IRBs must spend much time and effort estimating what the harms of a particular protocol and/or study procedure might be and making judgments about whether the potential harms are acceptable. If so, the IRB works with investigators to devise ways to minimize the potential harms and to assure that subjects are appropriately informed of the risk of potential harms that they might face.

Questions you might ask yourself related to the concept of nonmaleficence.

·What are the anticipatable risks of the experimental procedures?

·Are there any anticipatable risks related to other aspects of study participation?

·Are there potential risks that are not spelled out in the protocol and/or consent/assent documents?

·Is the scientific question being asked sufficiently important (i.e. will it yield important generalizable knowledge that will advance the field) to risk subjects experiencing the potential harm(s) posed by the study?

·Are the potential harms posed by the study acceptable?

·How does the study plan propose minimizing the potential risk of harm(s)?

3.Respect for persons, sometimes referred to as the Autonomy Principle has a two?fold meaning. First, it means that we respect each individual's values, perspectives and capacities. In this context, the principle of respect for persons calls us to assist others to act as self-determining agents to the fullest degree possible. The second part of the meaning of the principle of respect for persons, however, requires that where persons have limited autonomy, appropriate protections be provided.

In research, efforts to uphold the principle of respect for persons is exemplified by the process of informed consent. Requiring the informed, voluntarily given consent of an individual to participate in research demonstrates commitment to protecting the individual's right to self?determination. Honoring the spirit of informed consent provides the context for advancing personal values and individual choice.

But the second part of the principle of respect for persons reminds us that not all persons are capable of advancing their right of self-determination. Some among us are limited in their ability to make their own choices and the principle of respect for persons requires that for such persons, necessary protections be put in place. This requirement has special implications for research subjects with psychiatric illness that may impair their ability to make their own research decisions. Although it is important to note that having a psychiatric diagnosis does not generally render an individual unable to make independent decisions, the existence of a severe and disabling psychiatric disorder should alert investigators and IRBs to the possibility that decisional impairments may exist presently and/or in the future and additional protections may be warranted.

Questions you might ask yourself related to the concept of autonomy?

·Are the procedures for obtaining consent clearly spelled out in the protocol?

·Does the protocol identify any potential barriers to obtaining fully informed consent from subjects?

·How is it made clear to the prospective subject (and the subject already in the protocol) that participation is voluntary, i.e. that the person does not need to agree to participate and/or that the subject can withdraw from the study at will?

·Is there a possibility that a prospective or on-going subject might not be able to make his or her own decisions?

·If that is a possibility, what additional safeguards are in place?

·Are consent documents written in language the research volunteer and/or his/her surrogate can understand?

·Is the process of gaining informed consent more than a one-time paper signing event, but rather a real process of information exchange and communication?

4. The ancient Greek understanding of the justice principle requires us to treat equals equally and unequals unequally. That is, where persons are on an equal basis, such as concerning their health or education, or their ability to pay for health care, such persons ought to be judged equally. But where persons have differences in their health status, their educational backgrounds, their ability to pay for health care insurance, or in other substantive ways, such persons should be treated differently so that the differences are fairly balanced. More modern notions of justice include thinking that if benefit is to be gained by some, that benefit ought not make persons who are disadvantaged any more burdened (Rawls, 1971). In clinical research, we think about fair distribution of research benefits and burdens.

Questions you might ask yourself related to the concept of justice.

·How will subjects be recruited for this protocol?

·If there will be advertising, is the wording reasonable and balanced?

·Is the proposed study population being selected because they have characteristics relevant to the study or are they being recruited for convenience?

·Will the study recruit subjects across all socio-economic strata?

·If subjects are paid, is the proposed payment schedule reasonable or might the payment represent an undue inducement?

Ethical Theories in Medicine and Human Subjects Research

1.Consequentialist ethical theories base judgment of what is right or good on consequences. If the consequences of an act can be anticipated to be good, than the act is considered ethical. The difficulty with this theory is that it is often difficult to anticipate what the consequences of an action will actually turn out to be. This can be especially difficult in clinical research because by the very nature of the experimental setting, there will be uncertainty as to the potential outcomes.

For example, let's consider the difficult ethical issue of conducting a study in which the design is considered to be of no direct medical benefit to the subjects. That is, although subjects may benefit from ancillary aspects of study participation such as careful medical evaluation, being in a safe environment, and receiving social work services, the experimental procedures are not designed to provide any direct benefit to the subjects. This lack of direct benefit is common in a wide variety of studies. For this example, let us consider a study that is using PET scans (PET stands for Positron Emission Tomography and is a type of scan that shows glucose metabolism in the brain) to study glucose metabolism in the brains of persons at the middle stages of Alzheimer's Disease compared to healthy control subjects.

In this example, the Alzheimer's Disease subjects are likely to be too demented to understand the reasons they are undergoing the PET scans, and so will be unable to give their own informed consent. But let us assume, for the moment, that they will not be so ill that they are unable to indicate that they do not want to participate, or once started, that they want to stop (i.e. dissent).

Some persons would argue that the risks of harm and/or distress to the demented subjects is acceptable given that the need to learn about the brains of these persons are the beginning steps towards developing treatments and cure for Alzheimer's Disease. Their argument is that the good consequences of gaining the knowledge outweigh the potential bad, but not intolerable, consequences of harm and/or distress to the subjects of undergoing a PET scan.

Others might argue that the potential harmful and/or distressing consequences of study participation for the demented subjects is too grave and not acceptable, even though there may be negative consequences of not obtaining the information. Which argument do you think is more persuasive and why?

2.Duty-based ethical theories base judgement of what is right or good on whether or not the person performing the act met his/her duties and obligations. The difficulty with this theory is that it is often difficult to know what one's duties are. This is made particularly complex in research because researchers have duties and obligations to gather information and to protect the rights and welfare of human subjects. These dual obligations create the inherent ethical tension that is central to the performance of human subjects research.

Let us consider, again, the study of using PET scanning to study glucose metabolism in the brains of persons at the middle stages of Alzheimer's Disease compared to healthy control subjects. Here, too, the duty?based theories can be employed to argue the case for either approving or disapproving the study.

One might argue that because the IRB's duty is to protect the rights and welfare of research subjects, this study ought not to be allowed. But if, from a consequentialist perspective one thinks the information to be gained is of such importance to future patients with Alzheimer's Disease, it might be possible to justify this study provided the IRB and the investigator agreed to special, additional safeguards to protect the demented subjects from experiencing an unacceptable level of distress and/or discomfort on the basis that we have a duty to advance medical knowledge.

3. Virtue ethics is a theoretical view that says that the goodness or rightness of an act is determined by whether or not the motives of the person performing the act were virtuous. Because of the conflicting need in clinical research to gather data and protect the rights and welfare of human subjects, the dual roles of the physician?investigator are particularly complex ethically. Managing the inherent tensions of these conflicting motivations requires a refined level of self awareness on the part of the physician-investigators and others on the research team (Miller et al, 1998).

4.Assumptions Fundamental to the Moral Theories:
Even the assumptions on which these theories are based will influence the strength of the justifications these theories provide. The assumption fundamental to the consequentialist, duty?based theories and virtue?based theories is that moral judgements are, and ought to be, arrived at strictly on the basis of human reason. In these theories the goal is to have reason devoid of emotion. Moral judgements are thought to be independent of contextualities.

Today, there are critiques of the three major theories, known as feminist and communitarian ethics. These views take issue with the above assumptions. The assumption fundamental to feminist ethics is that moral judgements are, and ought to be, influenced by context, emotion and relationships. The assumptions fundamental to communitarian ethics are that in addition to the influences personal relationships and contextual factors have, and ought to have, on moral decision making, social and cultural norms influence, and ought to influence, moral decisions, as well.

In conclusion, although it is unlikely that we are aware that these moral theories influence our everyday activities, they serve as the unarticulated grounding for our moral judgements and choices. In a shorthand way, these theories can be understood as our moral filters, or our ethical biases. The implications for IRB review is that our value judgements about what we think are good or bad study designs or whether we think a particular study presents too much risk will be filtered through our own moral inclinations. Our personal moral biases will color our views of what makes for good or bad science, acceptable or unacceptable risk.

[Note: From Chapter 3 "Doing Ethical Research: How do we decide?" of the NAMI IRB Training Guide for Consumers and Family Members]

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