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Abstract

Beneﬁt and harm are canonical principles in bioethics. Providers must do no harm and act in the best interests of their patients. A fundamental principle of research ethics is that research is unethical if its harms outweigh its beneﬁts. Applying these principles requires understanding the concepts of harm and beneﬁt, whether and how they can be distinguished, whether they are asymmetrical (such as that preventing harm is more important than providing beneﬁt), and how they are to be identiﬁed.

Introduction

A canonical principle of bioethics is “nonmaleﬁcence.” Drawn from the Hippocratic oath translated as “ﬁrst do no harm,” non-maleﬁcence requires health-care providers “not to inﬂict evil or harm.” (Beauchamp and Childress 1983, p. 108) Another canonical principle is “beneﬁcence,” acting in the best interests of patients. Beauchamp and Childress (1983, p. 149) distinguish two aspects of beneﬁcence: providing beneﬁts (which include preventing and removing harm) and balancing beneﬁts over harms. The idea of a favorable harm/beneﬁt ratio also is incorporated into standards of research ethics that require that beneﬁts outweigh risks of harm if human subjects are to be included. The Declaration of Helsinki reads: “Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects” (World Medical Association 1964, p. 16). The US federal regulations governing research with human subjects provide that risks to man subjects must be minimized in relation to anticipated beneﬁts to subjects and outcomes of knowledge (45 C.F.R. §46.111(1), (2)).

But what is harm? What is beneﬁt? How can they be distinguished, as it appears they must be if non-maleﬁcence and beneﬁcence are different principles? Are there asymmetries between harm and beneﬁt, such that harm is morally weightier than beneﬁt? Answering these questions raises difﬁcult conceptual, normative, and epistemological issues.

Conceptual Clarification/Definition

Many different conceptual accounts of harm and beneﬁt have been offered in the philosophical literature. Liberal political and legal theorists have developed interest-based accounts of harm. One issue for these accounts is whether all types of detriments to interest should be regarded as harms or whether the concept of harm should be limited to especially serious types of detriments. Another issue is whether harm can be understood counterfactually, by asking whether a person is worse off with respect to interests than he or she otherwise would have been. Critics of comparative counterfactual accounts delineate what it is to be harmed deontological, for example, in terms of violations of rights or threats to autonomy.

Ethical Dimension

Perhaps the most thoroughgoing philosophical discussions of harm can be found in political and legal philosophy, where the so-called harm principle is advanced to delineate permissible uses of social coercion from uses thought to be impermissible. In On Liberty, Mill famously wrote that the sole justiﬁcation warranting the use of organized coercion against competent adults is to prevent them from harming others. Their own good, or judgments of society about what would be wise or right, cannot sufﬁce to legitimate intervention. Implementation of the “harm principle” thus conceived requires speciﬁcation of what is meant by “harm.” Interpreters differ in how they understand Mill’s own account of harm, with some seeing harm as constrained to physical or perhaps also psychological damage and others seeing it as encompassing any deleterious interference with rights. On the latter view, health-care interventions that violate rights to privacy or informed consent would in that sense count as “harms,” even if they are beneﬁcial to a patient’s health.

Central to liberal legal and political theory, the harm principle has drawn much attention to the problem of conceptualizing harm. In his magisterial four-volume Moral Limits of the Criminal Law, Joel Feinberg (1984, p. 33) characterized harm as a setback to interests. For Feinberg, “interests” are things in which people have a stake, objectively considered, such as economic resources or education or health; detriments to interests can deleteriously affect individuals’ abilities to satisfy a comparatively wide range of subjective preferences. On this view, medical care which compromises ﬁnancial interests would in that sense be a harm, although it might in other respects be beneﬁcial. On Feinberg’s account, posthumous harms also are conceptually possible, if interests survive death; examples might include experimentation on a corpse, unwanted forms of burial, or release of medical information that is damaging to a person’s reputation or prior relationships (Feinberg 1977; Grover 1989).

Feinberg’s is a general interest-based account of harm. Edmund Pellegrino and David Thomasma (1988) develop an account of beneﬁcence limited to health-related beneﬁt. On their view, improvements in a patient’s heart condition would fall under the principle of beneﬁcence, but improvements in the patient’s family relationships or economic circumstances would not be so classiﬁed.

These discussions focus on the scope of harm.

Other discussions consider how to determine what it is to be harmed on a particular dimension. One view is that these characterizations must be comparative and counterfactual. An individual is harmed when things go worse for her on a dimension: rights, interests, health-related interests, and the like. Puzzling cases for this approach include harms that result in net gain, such as a surgical intervention that makes a patient worse off on one dimension (e.g., arm functionality), but that overall is beneﬁcial (e.g., excising breast cancer that has spread to lymph nodes). One approach to this kind of case is to point out that the individual is prima facie worse off by the arm dysfunction but overall better off because of the cancer remission – that is, to note that judgments of harm are context sensitive (Klocksiem 2012).

Another problem case for the comparative counterfactual approach is differentiating between harms and failures to beneﬁt. For example, is there a difference between a patient not being offered a care intervention by a hospital because of low reimbursement rates for the procedure and a hospital in the community not offering the intervention at a low cost to everyone in the community (so that the patient who could otherwise not afford it is able to access it)? Klocksiem (2012) has recently argued in defense of the comparative counterfactual approach that it is highly context sensitive: Deciding whether an individual is worse off than he otherwise would have been requires specifying the alternative world in which the alleged harm would not have occurred. Alastair Norcross (2005) has developed a similar argument about the importance of context to determinations of harm. The difference between a hospital not offering care to an admitted but underinsured patient and a hospital not offering extensive charity care in the community, on this view, turns on background assumptions such as whether hospitals are expected not to cut patients off because of their insurance status (in which case, not offering the care would be a harm) or to offer a wide range of uncompensated care in their communities (in which case not offering the care would be a failure to beneﬁt). To be sure, from a consequentialist normative perspective, the difference between harm and failure to beneﬁt is ethically irrelevant; we should try to do what, all things considered, would produce the greatest overall good. On the other hand, non-consequentialists argue that it is important to distinguish harm from failure to beneﬁt because there is something worse about harming than not beneﬁting; this contention that harms and beneﬁts are asymmetrical is addressed below.

The “nonidentity problem” poses an additional complex challenge to comparative counterfactual accounts of harm in the reproductive context. It works like this. A couple could conceive a child at time T, but because of a medication the prospective mother is taking, there is a risk that the child will be born with a disability (e.g., a limb malformation). The prospective mother will no longer need the medication in a year and could wait to try to conceive until that point in time. On a counterfactual, if a child is conceived at T, she/he is not harmed because if the couple had waited, she/he would not have existed at all (assuming that overall existence is better for her than nonexistence, which is likely to be true except for the most severe of disabilities). One possible answer to this is to understand harm and beneﬁt not as what happens to particular individuals but in terms of whether the world as a whole is better off; this answer is available to consequentialists whose only concern is the overall good in the world but not to ethical theorists who are concerned about individuals or distributive considerations. In defense of the comparative counterfactual approach, Klocksiem’s answer is once again contextual: If we compare the possible world in which a child was conceived at time T but the mother was not taking the medication, we can argue that the child was harmed by the medication; but if the comparison is to a world in which she/he would not have been conceived at all, she/he is not harmed.

Other answers to the nonidentity problem discard the counterfactual comparative account of harm. Harman, for example, argues that whether someone is harmed is a matter of being in a bad state, such as “pain, early death, bodily damage, or deformity” (Harman 2004, p. 93). There is a comparative dimension to this view – what makes these states bad is that they are deviations from a “healthy bodily state” (Harman 2004, p. 96). The comparative dimension is not counterfactual, however, as it does not assess someone’s state in terms of what otherwise might have been for her. On her view, there is an asymmetry between harm and failing to beneﬁt; the moral reasons against harming are far stronger than those against failing to beneﬁt. Harman’s view also yields an explanation for the case of a nonconsensual but beneﬁcial operation. For her, the assessment of whether the patient is harmed by the surgery is not a matter of whether she is better off than she otherwise would have been. Instead, what matters ethically is whether the reasons to harm (that it is justiﬁable to override a patient’s unwise choice) are weightier than the reasons to beneﬁt (that the operation will improve the patient’s health).

Along similar lines, Shiffrin (2012) contends that the standard account of harm as a worsening of one’s situation (in some respect) and beneﬁt as an improvement does not ﬁt well with the intuition that harm and beneﬁt are asymmetrical, i.e., that harms are worse than non-beneﬁts. On her view, some losses are not harms and some harms are not losses. Among the class of harms are “physical injuries, many physical disabilities, many mental disabilities, some material inabilities, pain, failure/ruin of certain important projects and relationships, some losses, and death” (Shiffrin 2012, pp. 382–383). But not all desire nonfulﬁllment is harm, nor all removal of opportunity costs. Rather than a comparative interest-based account, she explores whether the condition of the will of the agent helps to explain the asymmetries. Her hypothesis is that “what we classify as harms must be the sorts of things that could reliably give rise to reason to avoid, prevent, or alleviate them consistent with our maintaining the social and interpersonal conditions of meaningful autonomy” (Shiffrin 2012, pp. 382–383). Pain and disabilities are harms on this account when they “forcibly impose experiential states that clash with one’s will.. .” (Shiffrin 2012, p. 386). This tension with what people would will, on Shiffrin’s view, explains when and why the departures from healthy bodily states that Harmon identiﬁes as harms should be so categorized.

David Benatar (2006) argues for an extreme version of the asymmetry between harming and failing to beneﬁt. His argument aims to explain why it may be wrong to procreate in certain cases (such as when conceiving now would yield a child in unfavorable circumstances that could be avoided by waiting a short time to conceive), but it is not wrong to fail to procreate at all. As crisply formulated by Elizabeth Harman (2009), Benatar’s argument goes as follows: All lives contain their share of harm. The presence of harm is bad and the absence of harm is good. On the other hand, the presence of beneﬁt is good but the absence of beneﬁt is not bad. Thus by procreating, we bring the bad of harm and the good of beneﬁt into existence. But by not procreating we avoid the harm – which is good – but we don’t cause the absence of pleasure. So comparing harms, there are extensive harms associated with being in existence over not so being, but comparing beneﬁts, there are no beneﬁts foregone by not being born. According to Harman, the asymmetry results from Benatar’s assumption that harm and beneﬁt must be experienced; the person who is born experiences both pleasures and pains in existence; not bringing someone into existence means that there is not someone experiencing a pain (morally good) but not that there is someone not experiencing a pleasure (morally neutral, as there is no one at all). It follows that the moral reasons against procreating are far stronger than the moral reasons in favor of so doing. Thus it is better never to have been born, and procreation is a serious moral wrong, or so Benatar asserts. To this reasoning, Harman objects that Benatar equivocates on whether harm and beneﬁt are impersonal: The claim that no one fails to receive a beneﬁt by not being born assumes a personal account, but the claim that there is not someone experiencing pain assumes an impersonal account.

Evaluating harm and beneﬁt: Normative Questions. Are harms worse, from an ethical point of view, than failures to beneﬁt? Are the moral reasons in favor of avoiding or preventing harm weightier than the moral reasons in favor of providing beneﬁts? The discussion of the conceptual questions reveals how normative judgments – such as the acceptability of a baseline state of affairs or the wrongness of certain types of outcomes – can affect judgments about the meaning of harm. But these normative questions are important in their own right.

For act consequentialists, what matters in evaluating outcomes is the overall balance of harms and beneﬁts resulting from a particular act. To be sure, diminishing marginal utility may affect this ratio: Imposition of a $1000 co-payment for health care for a rich man has very limited harmful consequences in comparison to that co-payment for a poor person for whom it may effectively preclude access to care. Rule consequentialists may take a different position on this, depending on how their view is formulated, for example, on the view that we should adopt rules about healthcare ﬁnancing that would have the best overall good results, rules such as means testing for premiums might be adopted.

The intuition relied on by philosophers such as Harman or Shiffrin that there are asymmetries between harm and beneﬁt may rest in a deontological approach. Shiffrin’s location of the intuition that harms and beneﬁts are asymmetrical in a view of autonomy is illustrative (Shiffrin 2012, pp. 376–382). As she sketches the view, what makes something a harm is that it impedes one’s ability to implement one’s plans or projects. More broadly, according to Shiffrin, “the value of autonomous action lies both in the object of achieving harmony between an agent’s will and the contents of her experience and environment, and in the means of its achievement . . . what autonomy rights protect is an agent’s ability to exert control over her mind, her body, and some aspect of her environment” (Shiffrin 2012, p. 382). On this view, policies that interfere with such exertion of control are harms worthy of particular moral attention. Examples might be deception, failures of informed consent, assisted living policies that impede residents’ exercise of independence, or lack of access to forms of reproductive care that enable people to exercise control over their fertility.

Identifying harms and beneﬁts: Questions of epistemology. Core to Mill’s argument against paternalism was the idea that the individual is the best judge of his own interests. This could be an empirical claim, about whether individuals are more likely to be wrong than others are about what will affect their interests, such as whether a medication will be effective against their pain. Or, it could be a conceptual claim, as in the interpretation of the maxim volenti non ﬁt injuria that if something was chosen by the individual, it is logically impossible for it to be a harm to her. Or, it could be the normative version of the volenti maxim that harm prevention does not outweigh the interference with individual choice.

Beyond these empirical, conceptual, or normative possibilities, there are also questions about the epistemology of harm. These questions are especially pressing in health care, where patients are vulnerable to various forms of what Fricker identiﬁes as epistemic injustice (Fricker 2007). If so, epistemic injustice may cloud understanding of when patients are harmed or beneﬁted. To illustrate, testimonial injustice occurs when others in a position of power discount the testimony of those whose identity is suspect: patients, persons with disabilities, persons with low socioeconomic status, or persons falling into disfavored racial or ethnic groups. According to Carel and Kidd (2014), testimonial evidence from patients (e.g., about how they are feeling) may be discounted because of their supposed cognitive unreliability or emotional instability. Common examples cited of such discounting include the perception that women are less likely to know their own interests or judgments on the part of health-care professionals and that people with disabilities have lower quality of life than they themselves would judge.

Standpoint epistemology claims that how the knower is situated affects what and how she knows. Differently situated knowers – for example, knowers who are women, or African American, or people with disabilities – know different things than people who are not so situated. Applied to harm, this would mean that people in these different circumstances have better knowledge about what is harmful to them than people who are not so situated. Notably, these are claims to objective knowledge, not the claim that some knowledge is subjective, as made, for example, by Tom Beauchamp: “A health professional’s conception of both harm to and beneﬁt for a patient can differ sharply from that of the patient, but the health professional’s understandings of beneﬁts also often depend on the patient’s view of what constitutes a beneﬁt or a worthwhile risk. Different patients take different views about what constitutes a harm and a beneﬁt, and when each view is reasonable it is morally unacceptable to maintain that the notions of medical beneﬁt and harm are objectively independent of the patient’s judgment” (Beauchamp 2013).

An illustration: harm and beneﬁt in research ethics. Favorable risk-beneﬁt ratios are a core tenet of research ethics. The US federal regulations governing research with human subjects illustrate and raise several further issues about harm and beneﬁt. Under the regulations, approval of research requires that risks to subjects are minimized and reasonable in relation to anticipated beneﬁts (45 C.F.R. § 46.111(a)(1), (2). “Risk” and “beneﬁt” are not deﬁned terms under the regulations, except for the speciﬁcations that only risks and beneﬁts associated with the research itself may be considered (as distinguished from risks and beneﬁts associated with any treatment individuals might ordinarily be receiving apart from the research and that long-range risks or beneﬁts of the knowledge gained in the research for public policy are not to be considered (45 C.F.R. § 46.111(a)(2)).

Risk, of course, is not actual harm; it represents a probabilistic judgment that harm is sufﬁciently likely to occur, given its level of seriousness, to be considered in judging the permissibility of the research. By comparison, “beneﬁts” are not similarly assessed probabilistically; it is “anticipated beneﬁts” that matter under the regulations, not the probability of beneﬁt. This difference likely tracks the intuitive asymmetry identiﬁed by Harman and Shiffrin and described above: that a harm that might even be probable is morally weighty in judging the permissibility of research, whereas a mere probability of a beneﬁt is of lesser importance. In legal philosophy in particular, there are extensive discussions of when and whether the risks of harm matter in the same way as harm itself. In criminal law, actions that risk harm (e.g., attempted homicide) are punished less severely than actions that result in harm (e.g., homicide). The law of negligence, as in medical malpractice, requires a showing of actual damages in order to shift losses to the defendant, although nominal damages can be recovered for intentional torts such as battery without a showing of harm.

The US federal regulations also set aside general social harms and beneﬁts of knowledge as warranting consideration in judgments about the permissibility of research. Thus the possibility that knowledge would be used adversely in war or might contribute to social improvement overall is not to be considered the assessment. Underlying this judgment is surely the view that harms and beneﬁts to individual research subjects are paramount. An additional theoretical possibility, however, might be the judgment that only individuals rather than societies are the kinds of entities that can be harmed or beneﬁted.

Conclusion

Harm and beneﬁt are core to the application of bioethics principles in treatment and research. Understanding them raises complex issues (some quite technical) in moral theory and epistemology. Bioethicists should be aware of these deeper theoretical issues and the work in legal, political, and moral philosophy that explores them.

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