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Legal standards of disclosure in a variety of jurisdictions require physicians to inform patients about the likely consequences of treatment, as a condition for obtaining the patient's consent. Such a duty to inform is special insofar as extensive disclosure of risks and potential benefits is not usually a condition for obtaining consent in non-medical transactions.What could morally justify the physician's special legal duty to inform? I argue that existing justifications have tried but failed to ground such special duties directly in basic and general rights, such as autonomy rights. As an alternative to such direct justifications, I develop an indirect justification of physicians' special duties from an argument in Kant's political philosophy. Kant argues that pre-legal rights to freedom are the source of a duty to form a state. The state has the authority to conclusively determine what counts as "consent" in various kinds of transactions. The Kantian account can subsequently indirectly justify at least one legal standard imposing a duty to inform, the reasonable person standard, but rules out one interpretation of a competitor, the subjective standard.

There is substantial published evidence showing that countless people enroll each year in ethically deficient clinical trials. Many of the trials are problematic because the quality of the science used to justify their launch may not be sufficiently vetted while many other trials may lack requisite social value. This poses the question: why do people volunteer for them? The answer resides in large part in the fact that informed consent practices have historically masked, rather than disclosed, the information that would alert research candidates to the ethically problematic nature of the trials. The “reasonable person” and “key information” provisions in the revised US Common Rule create the opportunity to correct this historical shortcoming. Two sources are employed to shed light on what the “key information” is that should be disclosed to a “reasonable person”: the original disclosure aims of the Nuremberg Code, as well as an extensive body of meta-research evidence. Those sources jointly support a range of new disclosures in the informed consent process that would unmask the heretofore undisclosed information. The resulting proposed new disclosures pertain to the overall success prospects of clinical trials, the quality of the prior research that both forms the basis of clinical trials and informs assessment of their risks and benefits, the potential social value of clinical trials, and the commercial purposes of clinical trials.

The debate over risk-related standards of decisional capacity remains one of the most important and unresolved challenges to our understanding of the demands of informed consent. On one hand, risk-related standards benefit from significant intuitive support. On the other hand, risk-related standards appear to be committed to asymmetrical capacity—a conceptual incoherence. This latter objection can be avoided by holding that risk-related standards are the result of evidential considerations introduced by (i) the reasonable person standard and (ii) the standing assumption that patients have capacity. This evidential approach to justifying risk-related standards of capacity avoids the most significant challenges faced by extant views while grounding risk-related standards in two fairly uncontroversial views in biomedical ethics.

Background Efforts to improve informed consent have led to calls for providing information a reasonable person would want to have, in a way that facilitates understanding of the reasons why one might or might not want to participate. At the same time, advances in large-scale genomic research have expanded both the opportunities and the risks for participants, families, and communities. To advance the use of effective consent materials that reflect this landscape, we used empirical data to develop model consent language, as well as brief questions to assist people in thinking about their own values relative to participation. Methods We conducted in-person interviews to gather preliminary input on these materials from a diverse sample (n = 32) of the general population in Nashville, Tennessee. We asked them to highlight information they found especially reassuring or concerning, their hypothetical willingness to participate, and their opinions about the values questions. Results Consent information most often highlighted as reassuring included the purpose of the biobank, the existence and composition of a multidisciplinary oversight committee, the importance of participants’ privacy and efforts to protect it, and controlled access to a scientific database. Information most often highlighted as concerning included the deposition of data in a publicly accessible database, the risk of unintended access to data, the potential for non-research use of data, and use of medical record information in general. Seventy-five percent of participants indicated initial willingness to participate in the hypothetical biobank; this decreased to 66% as participants more closely considered the information over the course of the interview. A large majority rated the values questions as helpful. Conclusions These results are consistent with other research on public perspectives on biobanking and genomic cohort studies, suggesting that our model language effectively captures commonly expressed reasons for and against participation. Our study enriches this literature by connecting specific consent form disclosures with qualitative data regarding what participants found especially reassuring or concerning and why. Interventions that facilitate individuals’ closer engagement with consent information may result in participation decisions more closely aligned with their values.

The revised Common Rule adopts the reasonable person standard to guide research disclosure. Some members of the research community contend that the standard is confusing and ill-suited to the research oversight system. Yet the revised rule is not as radical as it might seem. During the 1970s, judges started using the standard to evaluate negligence claims brought by injured patients who said doctors had failed to obtain informed consent to the harmful procedures. In its influential Belmont Report, the National Commission recommended application of a “reasonable volunteer standard” to guide IRBs evaluating research disclosures. Evidence also suggests that IRBs often invoke the reasonable person standard in deliberations about consent forms. But past application of the standard has been informal and uneven. Robust application of the reasonable person standard will require researchers and IRBs to learn more about what ordinary people want and need to know about the studies they are invited to join. Input from people with personal experience as study participants could be particularly useful to this effort.

Among various kinds of disclosures typically required in research as well as in clinical scenarios, risk information figures prominently. A key question is, what kinds of risk information would the reasonable person want to know? I will argue, however, that the reasonable person construct is and always has been incapable of settling this very question. After parsing the nebulous if not "contentless" character of the reasonable person, I will explain how Western courts have actually adjudicated cases of "negligent nondisclosure," that is, cases in which patient-plaintiffs allege that their informed consent rights were violated by the failure of their health providers to inform them of reasonably foreseeable risks that subsequently materialized. To support my argument, I will scrutinize the landmark decision by the United Kingdom's Supreme Court in Montgomery v. Lanarkshire Health Board and, in particular, Justice Brenda Hale's concurrence.

One of the significant modifications to the Common Rule is the requirement that prospective participants are given information sufficient for a “reasonable person”. However, there is limited research on what types of information patients, caregivers, and providers consider “key information”. Although certain aspects of informed consent (IC) may be considered standard, considering individualized needs and preferences of patients is necessary for patient-centered consent. In the current study, we qualitatively examined the specific types of information that patients and caregivers involved in hematopoietic cell transplantation (HCT), as well as their providers, believe are important and necessary as part of the IC process in order to make a decision about participating in clinical research; and further, how these perspectives are aligned. Our findings suggest opportunities for improving the IC document and process by emphasizing information of importance to patients such as the benefits to others and contributions to science that are associated with participation in clinical research. Further, increasing patient engagement during the IC process may enable providers to streamline information that is aligned with patient information needs and preferences.

ObjectiveIn approximately half the states in the USA, and more recently in the UK, informed consent is legally defined as what a reasonable patient would wish to know. Our objective was to discern the information needs of a hospitalised, ‘reasonable patient’ during the informed-consent process.DesignWe performed a cross-sectional study to develop a survey instrument and better define ‘reasonable person’ in relation to informed consent in a hypothetical scenario where an invasive procedure may be an option.SettingA 10-question survey was administered from April 19 through 22 October 2018 to three groups: student nurses (n=76), health professions educators (n=63) and a US national population (n=1067).Primary and secondary outcome measuresThe primary outcome measure was the average intensity, on a 5-point scale, by which survey groups wished to have each of 10 questions answered. The secondary outcome was to discern relationships between survey demographics and the intensity by which participants wanted an answer.ResultsDespite substantial demographic differences in the nursing-student group and health-professions-educator group, the average intensity scores were within 0.2 units on nine of 10 questions. The national survey revealed a strong desire to have an answer to each question (range 3.98–4.60 units). It showed that women desired answers more than men and older adults desired answers more than younger adults.ConclusionsBased on responses to 10 survey questions regarding wishes of people in a situation where an invasive procedure may be necessary, the vast majority want an answer to each question. They wanted to know about all treatment options, risky drugs, decision aids, who will perform the procedure, and the cost. They wanted their advocate present, periodic review of their medical record, a full day to review documents and expected outcomes and restrictions after the procedure.

All medical treatments have potential harms as well as benefits, and it is vital that everyone has a good understanding of what these might be, how dramatic they might be and how likely. In fact, in the UK, the Montgomery judgement in the supreme court in 2015 (see Box 1) has made it a legal necessity for patients to be given comprehensible, personally relevant information about all reasonable treatment options, including none.1 So, how should we ensure good, clear communication of relevant evidence? Box 1. ### The Montgomery judgement In 1999, Nadine Montgomery was preparing for the birth of her son Sam. She was of small stature, with diabetes, and was concerned about being able to give birth naturally. Unfortunately, difficulties did arise during birth, and Sam suffered brain damage as a result. Her obstetrician had not discussed the risk of this particular complication occurring, deeming it best Nadine attempted a vaginal birth. On appeal at the supreme court, Nadine Montgomery won her case. This laid down a new legal basis for informed consent, in line with the General Medical Council guidelines;1 > “The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.” > > “The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient's position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it. ” > > “The assessment of whether a risk is material cannot be reduced to percentages. The significance of a given risk is likely to reflect a variety of factors besides its magnitude” > > “The doctor’s advisory role involves dialogue, …

OBJECTIVE In this article, we evaluate and compare the frailties of two different standards of disclosure of information regarding the risks of medical procedures applied in recent judicial decisions in the United Kingdom. As an alternative, we present the tenets and philosophical grounds of an agency model of consent and a person-based standard of disclosure. METHODS Critical philosophical analysis of the background assumptions of two standards of disclosure and their relative "tests of negligence" applied in recent legal judgements in the United Kingdom. RESULTS Both standards, the "Professional Practice Standard" (the traditional standard employed in Sidaway versus Board of Governors of the Bethlem Royal Hospital, 1985) and the allegedly new "Reasonable Person Standard" (mentioned in Montgomery versus Lanarkshire Health Board, 2015), can lead to malpractice if the medical-patient relationship is not guided by attitudes of respectful care. The traditional standard is disrespectful as it does not take patients as full agents, presupposing that the patient's right is only a negative right to refuse what was deliberated only by the practitioner. The "new" standard can be disrespectful if the practitioner, concerned only with what a hypothetical reasonable individual would take as relevant for choosing between alternatives of treatment, does not know how to respect their real patient in a genuine shared decision-making process. CONCLUSION We conclude that in order to know how to obtain valid informed consent, doctors need to engage in real conversations with their patients, revealing as much information as they, taken as real persons, need to be part of a genuine shared and respectful decision-making process.

In 2017, federal officials issued a revised version of the Common Rule, the federal regulations that govern much of the human subject research conducted in the United States. Two provisions on information disclosure have reportedly provoked confusion among researchers and people responsible for research oversight. These provisions incorporate the familiar and foundational legal concept known as the reasonable person standard, applying this to research disclosure. Although other, long-standing Common Rule provisions require reasonableness judgments, the new provisions differ in that they require reasonableness to be judged from the ordinary person's perspective instead of the perspective of scientists, clinicians, and other experts generally involved in designing and reviewing human studies.

The autonomy of patients participating in research means that a proper informed consent process must take place. This means that information must be given according to a reasonable person standard implying what legally and ethical a reasonable person participating in the research would want to know. The research must assure that the patient has understood all the information given and that a voluntary choice has been made. This means that no form of coercion must take place and that information must not be manipulated in such a way as to influence the participant. No undue pressure or persuasion must either occur. Particular attention must be paid to vulnerable groups and participants must be competent and have the capacity to consent. Where necessary the use of a proxy to act on behalf of a patient who does not have legal capacity must be used and the best interests of the patient must be asserted. In research consent must always include a signed consent form which again is duly explained and authorized by the research ethics committee.

Laura Odwazny and Benjamin Berkman have raised several challenges regarding the new reasonable person standard in the revised Common Rule, which states that informed consent requires potential research subjects be provided with information a reasonable person would want to know to make an informed decision on whether to participate in a study. Our aim is to offer a response to the challenges Odwazny and Berkman raise, which include the need for a reasonable person standard that can be applied consistently across institutional review boards and that does not stigmatize marginal groups. In response, we argue that the standard ought to be based in an ordinary rather than ideal person conception of reasonable person and that the standard ought to employ what we call a liberal constraint: the reasonability standard must be malleable enough such that a wide variety of individuals with different, unique value systems would endorse it. We conclude by suggesting some of the likely consequences our view would have, if adopted.

In March 2015, the Supreme Court published its decision in Montgomery v Lanarkshire Health Board, a case involving the failure to warn a pregnant diabetic woman of the risk of shoulder dystocia and the possibility of having a caesarean section to avoid this risk. The risk materialised and the baby suffered oxygen deprivation. The lower courts had applied the test for the standard of care that had been in place since 1985, which has been criticised for protecting doctors not patients. The Supreme Court has introduced a new, autonomy-based, patient-centred standard. This article examines the case and explains the importance of the change for future midwifery practice. When disclosing risks, midwives must identify what a reasonable person in the woman's position, with this woman's specific characteristics, would consider a significant risk. They could be held liable for non-disclosure even if the woman does not ask about specific risks.

The UK Supreme Court Montgomery judgment marks a decisive shift in the legal test of duty of care in the context of consent to treatment, from the perspective of the clinician (as represented by Bolam rules) to that of the patient. A majority of commentators on Montgomery have focused on the implications of the judgment for disclosure of risk. In this article, we set risk disclosure in context with three further elements of the judgment: benefits, options, and dialogue. These elements, we argue, taken together with risk disclosure, reflect the origins of the Montgomery ruling in a model of consent based on autonomy of patient choice through shared decision-making with their doctor. This model reflects recent developments in both law and medicine and is widely regarded (by the General Medical Council and others) as representing best practice in contemporary person-centred medicine. So understood, we suggest, the shift marked by Montgomery in the basis of duty of care is a shift in underpinning values: it is a shift from the clinician's interpretation about what would be best for patients to the values of (to what is significant or matters from the perspective of) the particular patient concerned in the decision in question. But the values of the particular patient do not thereby become paramount. The Montgomery test of duty of care requires the values of the particular patient to be balanced alongside the values of a reasonable person in the patient's position. We illustrate some of the practical challenges arising from the balance of considerations required by Montgomery with examples from surgical care. These examples show the extent to which Montgomery, in mirroring the realities of clinical decision-making, provides elbowroom for best practice in person-centred clinical care.

As addressed by Sugarman (2017), the additional informed consent requirements incorporated in the revised Common Rule present some of the most intriguing aspects of the updated regulatory scheme. T...

In bioethics literature, the primary justification for the requirement of informed consent has been the protection of autonomous choices. To allow patients to be autonomous decision-makers, physicians are supposed to disclose and share information related to all treatment, procedures and risks. Advocates of the autonomy-based informed consent model argue that in informed consent cases, the disclosure of information should be according to the reasonable person standard or reasonable patient standard, rather than the average competent physician standard. In the Indian medicolegal context, the concept of consent has evolved through the discussion of informed consent and by referring to the concepts of informed consent in other countries, such as the USA, the UK and Canada. In cases of medical negligence in India, the concept of "real or valid consent" has been adopted from British case law rather than the "informed consent" of the USA. This paper examines the doctrinal rules of the concept of real or valid consent through an analysis of Samira Kohli's case - a landmark court case and a major precedent case in India that referred to "real or valid consent". In analysing this case, the paper will examine the judiciary's decision on the nature of and standard for the disclosure of information. Thus, the paper will reflect on the underlying ethical and legal principles of the doctrine of real or valid consent in the Indian context. This paper uses a hermeneutic approach to the landmark case to provide a qualitative interpretation of the Indian medical judiciary's concept of consent and the autonomy of the patient.

Consent evolved from judge-made law in Great Britain in 1767. The term informed consent entered the judicial lexicon in 1957. The first court case to articulate a reasonable person standard adopted by the high courts in Canada and Australia was heard in the U.S. in 1972. Today, informed consent continues to develop in four areas: (i) the court-based doctrines of consent and informed consent in clinical care in judge-made law; (ii) federal regulations related to research on human study participants; (iii) shared decision making adopted by care organizations and medical societies in the US, Canada, and Europe; and (iv) areas including decision analysis, discourse analysis, ethics, linguistic analysis, patient–physician communication, risk and evidence communication, and social theory. In this paper, we will focus on consent and informed consent in the first part of the twenty-first century. We will examine a range of information and decision making frameworks from the oldest court-established frameworks of consent and informed consent to recent conceptions of information and decision making in evidence-based decision making and shared decision making in the patient–physician relationship. This paper is divided into three parts: I. What informed consent is, II. What informed consent isn't, and III. Future challenges in informed consent and shared decision making.

The use of deception in research is generally permitted so long as participants are debriefed at the conclusion of their participation. Several authoritative research ethics guidelines allow investigators to omit debriefing under certain circumstances, however. Here we examine various justifications for forgoing debriefing in deceptive research, including concerns about subject pool contamination, the risk that revealing the deception will be harmful or distressing to participants, and issues of practicability. We conclude that, contrary to current practice, omitting debriefing is ethically acceptable only when debriefing is impracticable, the deception is innocuous, and no reasonable person would object to involvement in the research.

The difference between battery and negligence with regard to the effect of hypothetical consent and its justification by the different degrees to which the non-disclosure of information by the doctor violates the patient's autonomy is discussed. Four situations of medical non-disclosure are examined and show that hypothetical informed consent should continue to exclude liability in negligence, provided that the doctor rather than the patient bears the legal burden of proof as to causation and that causation is determined by asking what the particular claimant, not the reasonable person would have done.

Informed consent is a cornerstone of contemporary healthcare as well as of contemporary healthcare research. However, what counts as informed consent differs significantly from one setting to the other. This review begins with a brief discussion of the notion of informed consent itself and then applies it to the research setting. It gives a brief sketch of how the requirement for informed consent in research evolved from the Prussian Directive of 1900 to the current national and international guidelines and regulations, and outlines the various requirements that must be met for such consent to be valid. In research, the complete standard of disclosure is mandatory whereas in therapy an ‘objective reasonable person standard of disclosure’ is generally considered sufficient. In therapy, the discussion of expectations for a positive outcome and of hope for a cure form part of the consent process; in research, this must be handled differently so as to avoid unduly enticing potential research participants. For similar reasons, rewards for participating in the research must be kept to a minimum. Venue-shopping is also considered unethical. Since potential research participants who lack decision-making capacity cannot give consent, substitute decision-makers must take over the decision-making role. In considering whether to enrol incompetent persons in research, substitute decision-makers must follow either the previous competently expressed wishes of the now-incompetent persons or use what is known as the objective reasonable person standard. However, an incompetent person’s refusal to give assent is considered binding in nontherapeutic research and overrules even the duly empowered substitute decision-maker’s decision, and the wishes that have previously been expressed by the now-incompetent person in an advance directive are considered binding even if that may exclude the individual from participating in potentially life-saving trials. The article also distinguishes between deferred consent, presumed consent, prospective consent and substituted consent, and evaluates their acceptability in light of current ethical and legal considerations. The right of research participants to withdraw from any project is explained and the current standards for data management in the case of such a withdrawal are discussed. A separate section deals with consent to research in the emergency setting. It is shown why a signature on a consent form does not in itself mean that consent has been obtained, and why the concept of minimal risk that is used by some ethics committees is seriously flawed. Since legal standards of informed consent differ from jurisdiction to jurisdiction, the discussion highlights some of these differences and suggests ways to minimise any difficulties that might arise for multicentred trials involving distinct jurisdictions.

Without informed consent, any invasive procedure becomes an assault. The prevailing legal and ethical standard is that the physician has a fiduciary duty to give enough information to the patient so that a reasonable person can make an informed decision to accept or refuse the proposed treatment. The patient's frailty, delirium and/or dementia, and end-of-life concerns and expectations can make informed consent a difficult task. This review examines informed consent requirements for adults and provides communication tools to enable shared decision making while engendering patient-physician trust.

But it will take much more to change clinical practice The UK Supreme Court’s decision in the Montgomery case is a landmark judgment, establishing beyond doubt the court’s commitment to protecting patients’ right to self determination. 1 The judgment concerns Nadine Montgomery, a woman with diabetes whose son was born with serious and permanent disabilities after a shoulder dystocia during delivery. Montgomery’s obstetrician had not warned her of the risk of shoulder dystocia during vaginal delivery or discussed alternatives such as caesarean section. The court held that the doctor should have done both: doctors have a duty to ensure that each patient is aware of any material risks of any recommended treatment and of any reasonable alternative treatments. The test of materiality is whether a reasonable person in that particular patient’s position would be likely to attach importance to the risk, or whether the doctor is—or should reasonably be—aware that that particular patient would be likely to attach importance to it. The message for clinicians is: know your patient and provide tailored information. The patient must be given sufficient information, but what constitutes sufficient? Two standards of disclosure have been employed: the professional standard (the court relies on medical …

Consider the following patient: a 40 year old man who has had back pain that radiates down his left leg, on and off for two months. He performs his normal activities and does not have any “red flag” symptoms like fever or weakness. He’s using two commonly prescribed pain medications (ibuprofen and acetaminophen) as needed, and they help somewhat. The pain is slightly better than when it started but not much. He is frustrated and wants to feel better. What can the doctor do for him? First, she can reassure him that the duration of his symptoms is not uncommon for sciatica, a pinched nerve in the back, and there is no reason to believe that something more dangerous is going on. Second, she can advise against invasive steps, such as surgery, which research shows to be useless and potentially dangerous. Third, she can offer a medication that might help, such as a muscle relaxer, tricyclic antidepressant (TCA), or anticonvulsant. Each of these can reduce sciatic pain, though only in a minority of patients and usually by only a moderate amount. Each medication has risks, most commonly symptoms such as drowsiness, dry mouth, constipation, or dizziness, which resolve when the medication is stopped. These medications also have rare severe side effects, such as allergic reactions that could be life threatening. Let’s say that the doctor is considering prescribing amitriptyline, a TCA. Should she utilize the techniques that Alfano suggests to improve the patient’s chance of benefit and reduce the risk of side effects? As Alfano (2015) describes, research shows that mentioning a side effect, such as dry mouth, can increase the chance of its occurring, due to the “expectation-confirmation” mechanism. Recognizing this, the doctor could use the authorized concealment approach that Alfano describes, which builds on an earlier suggestion by Miller and Colloca (2011). Is this approach ethical? A critic might complain that authorized concealment blocks informed consent by eliminating discussion of an important issue. In fact, demonstration of the expectation-confirmation mechanism simply proves what doctors have long suspected and used to justify nondisclosure, as discussed and seminally critiqued by Jay Katz (1984). One can defend authorized concealment by arguing that the side effect has in fact been disclosed, just vaguely, and the doctor and patient are discussing what sort of discussion to have. The process that Alfano describes is a far cry from the complete lack of disclosure that Katz and others have fought against, where doctors don’t even mention the possibility of side effects or of alternative treatments for the patient to consider. In authorized concealment, the patient decides for himself whether hearing about the risk is worth the cost of increasing its chance of occurring. In addition, Alfano’s defense of authorized concealment is strictly circumscribed, to apply only to symptomatic side effects, not to more dangerous or irreversible ones. Amitriptyline has such potential side effects, including blood abnormalities and heart attacks. Even if describing these could increase the chance of their occurring, Alfano’s position does not justify authorized concealment of them, since they are presumably too important to the patient’s making an informed decision about whether to take the medication. Katz (1984) would certainly approve of this limit to authorized concealment, but Carl Schneider (1998) might not. Imagine that some blood abnormality occurs in 1 in 1000 patients taking amitriptyline and causes severe problems for one month when it occurs. Schneider’s (1998) reviews research showing that many patients may have trouble understanding this danger or the probability of its occurring and may react irrationally to information about it. Patients may thus rationally defer to the doctor to decide whether the benefit of the medication is worth the risk. Note that from this perspective a physician may also ethically conceal purely symptomatic side effects as well, without asking for authorization. Deciding whether to utilize authorized concealment, or other techniques, depends in part on questions about the magnitude of the effect. If the chance of dry mouth is 20% in an uninformed patient, and this goes up to 23% if that side effect is mentioned, then authorized concealment may simply not be worth it. Even asking the patient for authorized concealment may confuse or concern individuals, causing anxiety or even raising the chance of developing other symptoms. As Alfano says, such questions could be empirically studied. But there are also more global impacts that may be hard to empirically measure: just bringing up the possibility of authorized concealment or deception may reduce the patient’s trust in the truthfulness and completeness of what his physician says. One patient asked to authorize concealment may feel valued and respected, but another who is asked may simply not know what to think, or may start to question other times the doctor seemed less than completely forthcoming. Another technique that Alfano describes is “priming” to increase the chance that the medication will work, taking advantage of the attentional-somatic feedback loop. The doctor may increase the chance of amitriptyline’s reducing the patient’s pain by failing to mention that it works in only a minority of patients, and by projecting a strong conviction that it will work for this patient. Priming raises more ethical questions than authorized concealment since it does not involve the patient’s agreement. In fact, the doctor cannot ask the patient to agree: If the doctor tells the patient that knowing the true probability of the medication working may reduce the chance, then many patients will figure out that the probability must not be very good. Perhaps a discussion could have happened earlier, before this specific problem arose, where the doctor asked the patient for consent to utilize “fake optimism” in the future. The main problem with this approach is that the patient is being asked to make a choice about situations where the medical problem, prognosis, potential therapies, magnitude of benefit and risk, etc., are all undefined. The doctor could ask the patient to trust her to decide when to utilize fake optimism, but this asks for a lot. A patient who agreed would be putting a good deal of trust in the doctor’s judgment, both about the situation and about what the patient would want to know. Schneider (1998) argues that this is exactly the sort of trust that we put in our doctors, and he argues that we should. And, again, if Schneider is right, then it looks like we might also trust our doctors to decide when to conceal symptomatic side effects, without asking for our authorization. Now the concerns of Katz (1984) and others come to the fore, since we have traveled so far from shared evaluation of risks and benefits. We are back to medicine’s old habit, of doctors deciding when it is good for the patient to consider risks and benefits. The fact that amitriptyline has a low chance of reducing risk may convince a patient that it’s not worth the risks it carries, both the common, symptomatic ones, but also the unlikely but serious ones. This suggests that amitriptyline’s low efficacy would be material to a reasonable patient, and, according to the Reasonable Person Standard (Beauchamp & Childress, 2009, pp. 122–23) the low efficacy should be disclosed. On the other hand, one might argue that a fully informed and reflective reasonable person, recognizing the dangers of knowing this piece of information, would feel that the information is not that important. As is often the case, the devil is in the details of applying the standard. Once again, the magnitude of the effect may be particularly relevant. If the effect is small, leaving out a key fact about the medication’s probability of working may simply not be worth it. Or, to put it another way, a doctor who justifies her reticence based on the priming effect may be giving an inadequate defense for this failure of communication. The doctor could truthfully say to the patient that the medication works in only a minority of people, but could also put this in the most positive light, saying that it may work and that she has seen it work before. In this way, the doctor is being encouraging without being deceptive. Early in the paper, Alfano convincingly argues that “placebo” is not a natural kind term. His point is somewhat unsurprising, since the concepts of medicine and psychology are rarely (if ever) natural kinds. His example of congestive heart failure is apt, since that category encompasses a range of conditions of with extremely variable physiology, causes, treatments, and prognosis. We group conditions together as “congestive heart failure” due to their common characteristics and practical management, but their differences are also crucially important. Similarly, although the expectation-confirmation mechanism and attention-somatic feedback loops differ, utilizing either to improve outcomes raises similar ethical issues. Placebo may be an ethical category as much as a biological and psychological one.

A valid consent for treatment must fulfill three basic requirements. First, consent must be given voluntarily without undue influence, coercion or misrepresentation. Second, the person giving consent must be competent and if the patient herself is not competent, the person giving consent in her place must have the legal authority to do so. Third, the consent must be specific to the treatment and those providing it. In addition to these requirements, consent must be informed, which means that the patient must have received sufficient information to make an informed decision. The paper discusses these requirements and how to determine what information must be provided to the patient to ensure that a fully informed decision can be made. All information that a reasonable person in the patient's circumstances would need to make a decision must be provided. This information includes the risks of the procedure, the consequences of declining treatment, alternatives, success and failure rates, recommendations, and any actual or potential conflicts of interest. A physician is responsible for ensuring that this information is provided, and that the patient understands the information. If a patient claims that she has not been properly informed, in a lawsuit she will have to show that a reasonable person in her position would have made a different decision if adequately informed, which is often difficult. However, the consent process is not just concerned with avoiding liability. The education process to inform the patient's choice regarding treatment is a key aspect of the relationship between physician and patient. It highlights the primary importance of good communication and respect for the patient's right to autonomy.

This research focuses on the analysis regarding disclosure of financial conflicts of interest (FCOI) after Gelsinger v. University of Pennsylvania (Penn). The main legal issue was that the participants did not have enough opportunity to make an autonomous decision about participating in the research because he was not informed about the researchers' and the institution's substantial FCOI. The disclosure system was adopted by the Code of Federal Regulations. Under the regulation, researchers and institutions need to report FCOI over $5,000 to the institution, and the internal review boards have to report to the federal authority if needed. In case of human research, the disclosure to Food and Drug Administration is mandatory. FCOI disclosure system would help participants to make an autonomous decision, and increase trust to the research process and researchers. Moreover, the system would let researchers keep fiduciary duty while (possibly) lowering legal liability in case of a lawsuit. There were discussions about the disclosure methodology in the United States. However, there have not been a lot of discussions in Korea even after the “Humidifier Disinfectant” case. Therefore, new legislations need to be considered. First, the system requires disclosure funded by not only government but also private institutions. Second, like California Supreme Court, the subject would be reviewed under the reasonable person standard by participants, including patents, equity, and stock. Third, the disclosure needs to include simple or brief explanation to the FCOI to be better understood by the participants. Fourth, the disclosure should be in the informed consent process., Graphical Abstract

Patients are entitled to disclosure of those risks and hazards that would influence a reasonable person in making a decision to consent to medical treatment. The Texas Medical Disclosure Panel has identified some procedures that do or do not require written informed consent. The obligation to obtain consent for a listed procedure is satisfied by obtaining signed and witnessed written consent in the form established by the Panel. Procedures not addressed by the Panel also require informed consent and are governed by the Reasonable Person Standard. The obligation to obtain informed consent is that of the physician performing the procedure.

Publisher Summary This chapter focuses on medical malpractice, which refers to a medical professional's negligence in treating or diagnosing a patient. Patients suing for medical malpractice must prove that the physician's breach of duty was the proximate cause of, or a substantial factor in bringing about the harm suffered by the patient. The proximate cause of an event is that act or omission which, in natural and continuing sequence, unbroken by an efficient intervening cause, produces the event, and without which, that event would not have occurred. Thus the physicians may face liability for giving unending prescriptions of addictive medications to addicted patients or to patients with a known history of addiction. The doctrine of informed consent requires physicians to reveal to patients the nature of the ailment, the nature of the proposed treatment, the probability of success of the contemplated therapy and its alternatives, and the risk of unfortunate consequences associated with such treatment. A patient alleging that his or her physician failed to disclose a risk of treatment has to prove that there was a material risk unknown to the patient, that the physician failed to disclose that risk, and that disclosure of the risk would have led a reasonable person in the patient's position to reject the treatment. Expert testimony on whether a physician obtained the patient's informed consent to treatment with narcotics is relevant and admissible in addiction cases, sometimes even if the expert witness does not share the same area of specialization as the defendant physician.

A careful consideration of the alternatives to research participation is an essential element of making an informed choice to enroll in a biomedical research study. While there is general agreement on the importance of informing prospective subjects about alternatives to research participation, little is known about how investigators communicate this information. The purpose of this study was to attempt to assess the quality of information about alternatives contained in informed consent documents in oncology randomized controlled trials. Our study indicates that there is room for improvement concerning the discussion of alternatives to research participation in informed consent documents in oncology randomized controlled trials. Though most of the documents in our study met the minimal disclosure standard found in the U.S. federal regulations, less than a third met the reasonable person standard, a widely accepted principle endorsed by the common law and various ethics guidelines and documents. There was a statistically significant difference between the alternative discussions in local and model forms (P < 0.0014). The alternatives discussions in local informed consent documents were more likely to receive higher scores than those in model consent documents, with an odds-ratio of 3.5 to 1.

Background Failure on the part of doctors to fully inform their patients of possible side affect of medications is the cause for 10% of all malpractice lawsuits and 40% of Rheumatology lawsuits in United States of America (USA) (1,3). What constitutes a risk is controversial;in one court case a 1% risk of hearing loss required disclosure whereas in another case a 1.5% risk of visual loss did not (2). Currently there is a divide in the United States concerning how physicians are expected to inform their patients. There are two main legal rules up for consideration, the Medical Practice Standard (MPS) (follows the ideology that information should be given at the discretion of physicians) and the Reasonable Person Standard (RPS)(maintains that it is a physician9s duty to give their patients all the information that they might want). Objectives To develop a standard format for rheumatologists when discussing the risks of prescription drugs with their patients which would fulfill all legal standards. Methods We sent a questionnaire to thirteen rheumatologists who are considered key opinion leaders in the Middle East countries. They were asked “Do you routinely tell your patients in lay terminology about the following side effects of biological drugs?” They were then asked to check all those items that were routinely discussed out of twelve possible side effects that were derived from the American College of Rheumatology patient information leaflet. This questionnaire was also given to twenty patients taking biological drugs asking what side effects they would like to know about. Those items that were selected by at least fifty percent of the doctors were deemed the MPS and by fifty percent of the patients were made the RPS. Results See table. Conclusions There is a significant discordance between what patients want to know and what their doctors inform them of. To resolve this issue in our practice we have adopted a protocol of informing patients of side effects, giving them a ACR patient information leaflet, and having them sign a consent form. We believe that this will lead to better understanding and compliance from patients and lower risks of litigation. References Department of Health Education and Welfare: Report of the Secretary9s Commission on Medical Malpractice (DHEW publication (OS) 73-89) U.S. Government Printing Office: Washington, DC, 1973. Scott v. Wilson, 396 S.W.2d 532 [Tex. Civ. App. 1965] and Yeats v. Hearms, 393 P.2d 982 [Kan. 1964]. Studdert DM, Mello MM, Brennan TA. Medical malpractice. N Engl J Med. 2004;350(3):283-292. Disclosure of Interest None declared

During the 1970s many women with breast cancer began to insist that clinicians deal less paternalistically with them, inform them of treatment options, and let them use their own values to determine which approaches were best. Their demands for better communication and choice had a well-documented impact on the women’s movement, the rejection of patriarchal institutions, the patients’ rights movement, and the denunciation of the authoritarian medical culture. In this paper I want to examine how these activists also helped to revolutionize the research culture by insisting that it be a cooperative venture. Their leverage was the power to defeat randomized clinical trials (RCTs) that did not include genuine options or consent. This struck at the heart of research practices since the RCT is generally regarded as the gold standard for evaluating alternative interventions. Many investigators during this period regarded gaining consent to be a misguided requirement. They argued that the women could not understand what was at stake and claimed that incorporating consent and choice would only ruin the structural integrity of the trials (Zelen 1979, 1241). In the 1970s and 1980s, many clinicians also resisted enrolling their patients in trials. These clinicians did not want to communicate the uncertainties about which therapies were best. They feared that informed consent would destroy trust in the doctor-patient relationship, and maintained they should simply pick the therapy that they believed was best for their patients (Taylor 1984, 1361). For some investigators and clinicians who were saturated in a positivistic philosophy of science, it was hard to admit that values were integral to science and needed to be justified. Consequently, the women’s demands for respect of their perspective seemed unreasonable. This is a philosophical paper about why it is rational to insist that research be a cooperative venture and uses this example about women’s demand for better How Women Helped Make Research a Cooperative V enture

Standard views on surrogate decision making present alternative ideal models of what ideal surrogates should consider in rendering a decision. They do not, however, explain the physician's responsibility to a patient who lacks decisional capacity or how a physician should regard surrogates and surrogate decisions. The authors argue that it is critical to recognize the moral difference between a patient's decisions and a surrogate's and the professional responsibilities implied by that distinction. In every case involving a patient who lacks decisional capacity, physicians and the treatment team have to make judgments about the appropriateness of both the surrogate and the surrogate's decision. They have to assess the surrogate's decisional capacity and attitude toward the patient as well as the reasons that support the surrogate's decision. This paper provides a model for acceptable surrogate decisions and a standard for blocking inappropriate surrogates. Only decisions based on widely shared reasons are allowable for surrogate refusal of highly beneficial treatment.

The emergence of bovine spongiform encephalopathy (BSE) in British cattle has received significant media attention since its discovery in 1986. Transmission of this prion from cattle to humans has been documented, and the BSE prion is believed to be the causative agent for variant Creutzfeldt-Jakob disease (vCJD). Evidence of this spread is a significant threat to public health, and, although there has never been a proven case, there is a theoretical risk of transmission between humans by blood transfusions. In addition, recent animal studies have documented spread in this fashion, raising the question of whether vCJD should be included as part of informed consent for blood transfusions. The process of informed consent requires disclosure of material risks, defined as the risks that a reasonable person, under such circumstances, would want to know. Consent should, therefore, include the risks of a transfusion reaction, as well as the known infectious risks of blood. It should also include the unknown or theoretical risks of blood transfusions because full disclosure of even remote risks preserves the patient/physician trust relationship, which if breached, is very difficult to mend. Given the high level of public awareness, the potential lethality of the infection, and the theoretical risk of transmission by blood, vCJD can be considered a material risk, and consequently, it is reasonable to include it in the informed consent process.

Suddenly, I was a “them.” The moment that should have been the most joyous in my life became the most tragic. In the shift from health care professional to mother of a critically ill newborn, I learned things that redefined both my life and my professional identity. Never before had the “us vs them” divide been so clear. I had worked in the “us” role for years and was comfortable and confident in my ability to understand “them.” I knew that health care professionals were supposed to be powerful, authoritative, and knowledgeable. Families, I knew, were supposed to be vulnerable, dependent, and fragile. I thought that I was able to bridge that divide pretty well. With the birth of my child, Amanda, I became a “them.” In that moment, I was thrust into the role of the NICU mother. I had long sympathized with and supported such mothers. I could now truly empathize with those parents whom I had witnessed standing helplessly next to the small bassinets in the most technological of settings, crying many tears and uttering daily prayers of healing and thankfulness for modern medicine. When it was my own baby, I tried to draw on all that I had learned and taught in my role as a bioethicist. My experience provided little solace. My knowledge base failed me. From this experience, I have come to understand the world of the patient and the limits of empathy. I continue to struggle with three questions that my daughter’s illness occasioned all too personally: the nature of the questions physicians pose to our patients/families; the reliability of the informed consent process; and the just allocation of health care resources. As health professionals, we pose questions to parents that now seem incomprehensibly unfair. As I was struggling to deal with the incredible stresses and uncertainties of my baby’s critical illness, I could not also deal with decisions about whether to let her die. Questions about life and death are hard, and are supposed to be hard, but now those questions seemed impossible. I was fortunate not to address questions about forgoing life-sustaining treatment, not to face death directly. My daughter’s heart defect could be surgically repaired. The surgery went well and her long-term prognosis was excellent. However, I was haunted by the “what ifs,” questions perhaps yet to come. What if they discovered other problems during surgery? What if the surgery didn’t go well? What if she experienced postsurgical complications? What if there are related problems later in her life? I dreaded the questions and could not begin to fathom the answers. What if I had to make the decision to let Amanda go? My concerns about the questions I feared also raised questions about the informed consent process. How much did I need to know? Given my distraught state, could I actually make any decisions? Was I really being asked to make decisions, when the medical recommendation seemed so clear? What if I had refused treatment deemed medically necessary? The legal standard for disclosure of information in the informed consent process requires revealing all that a “reasonable person” would need to know to make an informed decision. In my stressed, exhausted, tearful, postpartum state, I do not know that I could have claimed to be a reasonable person. I teach my medical students that a subjective standard, in which physician disclosure is guided by the particular patient/family, may be ethically preferable. I continue to believe that is the best standard, but in the days after Amanda’s diagnosis, I could not have guided the disclosure process. I needed my daughter’s cardiologist and

Publisher Summary This chapter reviews the basis for informed consent and its necessary elements, particularly as they relate to transfusion. The chapter describes the components of a well-developed informed consent policy. Informed consent is a process and not a document. It consists of a dialogue between patient and physician in which the physician discloses to the patient the information needed to make a sound decision about the proposed transfusion. Disclosure does not need to be exhaustive; however, it should provide the patient with the information a reasonable person would want to have before making a decision about undergoing a transfusion. This information must be provided in an appropriate manner, taking into consideration the patient's facility with language, education level, and health care experience. The concept of informed consent has its basis in both law and ethics. From these two sources the concept has developed that physicians may not make decisions for patients but must provide them with the information necessary to make intelligent decisions about treatment. The ethical origin of concept of informed consent is based on regard for the rights of patients, including individual autonomy and self-determination. Patients have the right to make decisions about medical intervention that may affect their well being. In addition to the legal and ethical rationale for obtaining informed consent for transfusion, there are also statutory and regulatory requirements.

OBJECTIVE: To examine the process by which proxies decide about their charges' participation in clinical research. DESIGN: Using eight hypothetical research studies encompassing a variety of risks and benefits, we interviewed 315 competent persons > 65 years old (charges) and, separately, the individuals who would be designated as their proxies if the charges were to become incompetent. The proxies were asked what they thought their charges would decide and what decisions they would make for their charges and for their own participation. SETTINGS: A medical house-call program, two apartment complexes, and three nursing homes. PARTICIPANTS: Charges > 65 years old and their proxies. MAIN OUTCOME MEASURE: Comparison of decisions made by charges and by proxies for their charges. RESULTS: The agreement between the proxies' and charges' decisions was not significantly different from random agreement (range of kappa statistics, 0.05–0.15). Rather, proxies' decisions for their charges were significantly related to the proxies' decisions for themselves (kappas, 0.52–0.86). When the paired proxies' and charges' decisions differed, the proxies were protective, more frequently refusing their charges' participation in the perceived riskier research studies. CONCLUSIONS: Proxies did not know what their charges would decide. Their choices for the charges related more to the proxies' decisions about their own participation (which they knew) than to the decisions of their charges (which they didn't know). This is similar to the process of a reasonable person making the decision, a characteristic of decisions made in the best interests of the patient.

The bias of Cases Journal is to publish unless there are strong reasons why we can't. Bruce Arroll and colleagues tell an interesting story[1] of how neighbours helped two couples conduct single patient trials to determine whether their babies had milk allergy. The story is informative and well told but raises several problems, most of them ethical, that we've had to think through before publishing. Firstly, the authors have no consent for publication from the patients. I spent years struggling with the problem of patient consent when I was editor of the BMJ, and we moved from a position like all other journals of never seeking consent to insisting on consent in all cases. The latter proved to be too extreme a position, particularly for anecdotes from years ago – which we published in the BMJ and were popular. BMJ policy now requires four conditions to be met for a story to be told about a patient without consent. The conditions are: a) The patient is dead and his or her family is untraceable to seek consent from (b) The article contains a worthwhile clinical lesson or public health point which could not be as effectively made in any other way. (c) A reasonable person in the position of the patient's relatives would not be expected to object to the publication of the case. (d) The risk of identification of the patient is minimised by measures designed to prevent the identity of the patient being revealed either to others or to the patient's relatives. It's most unlikely that either the parents or the babies are dead – so the first condition is not met. The article makes an excellent point, but it could probably be made in another way – and possibly has been. So we can't be confident that the second condition is met. The third and fourth conditions are, however, met handsomely, and I find it very hard to imagine the parents or the babies being upset by publication of this report – even in the highly unlikely event that they could be recognised. I'm thus happy to publish despite all four conditions not being met. A second problem is that the babies were given soya-based milk on unconvincing grounds and could have suffered an anaphylactic reaction. The reviewer raised this point, and the authors acknowledge the risk – but dismiss it as small. The patients didn't suffer an anaphylactic reaction, and it would seem absurdly heavy handed to decline to publish an interesting story in unknown patients on the grounds that the patients ran a small risk 20 years ago. A third problem is that we have lots of missing data. We can't see the charts of when the babies were given the different milks and how the timings related to the pattern of symptoms. Nor do we have any follow up data on the babies. We don't even know if the baby who did appear to have cow's milk allergy did better when cow's milk was removed from the child's diet. Nor do we even know the genders of the babies. It would be good to know all of these things, but I judge that the story still has interest and importance without those details. Fourthly, the doctor conducted an experiment in two babies without consent from an ethics committee (or institutional review board). Can this be acceptable? Did the parents understand that there babies were included in a experiment? They must have done: the whole point of the exercise was that it was an experiment. The reality of 20 years ago in most, perhaps all, countries is that there were no ethics committees for primary care research. Indeed, there wasn't much research in primary care. So again it would seem slightly absurd to decline to publish the paper because of the failure to get ethics committee approval. But what if a doctor were to want to conduct such a trial today? Should he or she go ahead without ethics committee approval? Gordon Guyatt, one of the authors of the study, has tackled this questions with others. [2] They argue that if the study is undertaken as part of clinical practice then there is no need for consent from an ethics committee, but the doctors should ensure that the patients understand fully what is happening and get written consent. If, however, the study us undertaken as part of research then approval from an ethics committee is essential. I'm uncertain exactly how you tell whether something is conducted for clinical or research reasons – perhaps the distinction is that one is conducted for the benefit of the patients and the other more for the benefit of the broader community. This doesn't seem to me to be an entirely clear distinction, especially if, as in this case, an experiment conducted for clinical reasons is published. I can only think that it would be wise to contact the chair of the local committee. Ethics committees famously vary in their judgements. I tend to agree with Guyatt and colleagues that an N of 1 trial that is happening as part of routine practice would not need consent from an ethics committee. The patients should, of course, give fully informed consent – preferably in writing – but the nature of much of medical practice is that doctors and patients are constantly "experimenting" to discover, for example, "whether time will sort this out" or "whether this drug might work better than the one you are on at the moment." It would be clearly impractical to consult an ethics committee over every such experiment. The differences with the "experiments" described here are that they are being published and ironically are well designed – with randomisation and controls. They thus feel much more like experiments than the experiments that happen every day in many meetings between doctors and patients. So this paper not only tells an interesting story attractively but has also thrown up enough questions to prompt an editorial longer than the paper – for which perhaps I ought to apologise.

EDITOR—I wrote the “universal consent form” below a few years ago, but it now seems germane in view of the editorial by Furness and Sullivan on the new human tissue bill.1 “By signing this I agree that my doctor is a reasonable person, applying common sense and trying to do his or her best in circumstances for which society takes collective responsibility. My doctor will attempt to do the …

Twenty-five years of appellate court decisions about informed consent in three influential states were examined to address four issues: 1) the criteria used to define adequate informed consent; 2) trends in court decisions; 3) parallels between court decision making and decision analysis; 4) the contribution of decision analytic concepts to defining "reasonable" medical informed consent. Court standards have evolved in three phases: the "medical community" standard before 1972, the "reasonable person" standard since 1972, and recent inroads toward developing an "individual preference" standard. The latter two standards form the current basis for deciding whether a patient has been adequately informed. Decision analysis offers a framework for communication about medical outcomes and probabilities, and meth ods for assessing preferences. Jurists and physicians should consider whether the legal system should adopt a decision analytic perspective in the doctrine of informed consent. Researchers should address issues raised by use of decision analysis for communication between the physician and the patient. Key words: medical ethics; patient-physician rela tionship; medical informed consent; medical risk; patient preference; legal (court) decision; professional standards; reasonable man; malpractice; negligence. (Med Decis Making 6:224- 230, 1986)

Every individual has a well established right to be free from nonconsensual touching. Violation of that right constitutes the common law tort of battery.1 The application of this principle of tort law to the practice of medicine is certainly not of recent origin. In a 1914 decision, the respected jurist Benjamin Cardozo wrote the following often-quoted language: Every human being of adult years and sound mind has a right to determine what shall be done with his own body, and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages.2

Our working committee was charged to examine and to make recommendations to the National Multiple Sclerosis Society (NMSS) concerning three broad areas of ethical import relevant to the design of therapeutic trials: (1) ethical problems inherent in the design of double-blind trials of new medications, (2) the role of pharmaceutical companies in the design of such trials, if any, and (3) the need for orphan-drug legislation, if any. Its recommendations follow. DISCLOSURE Anything short of full disclosure concerning the therapeutic trial is unethical. Accordingly, patients must be fully informed with regard to diagnosis, the nature of the trial, alternative therapies that are available, known risks involved in the trial, with emphasis on the more serious ones, and any other facts that a reasonable person might wish to consider before deciding to participate. All of this information should be on a written consent form, but there should also be clear

The obligation to maintain the privacy of patients and research participants is foundational to biomedical research. But there is growing concern about the challenges of keeping participant information private and confidential. A number of recent studies have highlighted how emerging computational strategies can be used to identify or reidentify individuals in health data repositories managed by public or private institutions. Some commentators have suggested the entire concept of privacy and anonymity is “dead”, and this raises legal and ethical questions about the consent process and safeguards relating to health privacy. Members of the public and research participants value privacy highly, and inability to ensure it could affect participation. Canadian common law and legislation require a full and comprehensive disclosure of risks during informed consent, including anything a reasonable person in the participant or patient’s position would want to know. Research ethics policies require similar disclosures, as well as full descriptions of privacy related risks and mitigation strategies at the time of consent. In addition, the right to withdraw from research gives rise to a need for ongoing consent, and material information about changes in privacy risk must be disclosed. Given the research ethics concept of “non-identifiability” is increasingly questionable, policies based around it may be rendered untenable. Indeed, the potential inability to ensure anonymity could have significant ramifications for the research enterprise., L’obligation de préserver la vie privée des patients et des participants à la recherche est fondamentale en recherche biomédicale. Toutefois, les défis à relever pour maintenir la confidentialité des informations sur les participants suscitent une inquiétude croissante. Un certain nombre d’études récentes a mis en évidence les manières d’utiliser les nouvelles stratégies informatiques pour identifier ou réidentifier les personnes dans les banques de données de santé gérées par des institutions publiques ou privées. Certains commentateurs ont laissé entendre que les concepts de vie privée et d’anonymat sont « morts » dans leur ensemble, ce qui soulève des questions juridiques et éthiques sur le processus de consentement et sur les garanties relatives à la protection de la vie privée en matière de santé. Les membres du public et les participants à la recherche accordent une grande importance à la protection de la vie privée, et l’incapacité à garantir celle-ci pourrait avoir une incidence sur la participation. La common law et la législation canadienne exigent une divulgation complète et exhaustive des risques lors du consentement éclairé, y compris tout ce qu’une personne raisonnable dans la position du participant ou du patient voudrait savoir. Les politiques en matière d’éthique de la recherche exigent des divulgations similaires, ainsi que des descriptions complètes des risques liés à la vie privée et des stratégies d’atténuation lors du consentement. En outre, le droit de se retirer de la recherche entraîne la nécessité d’un consentement continu, et toute information sur l’évolution du risque pour la vie privée doit être divulguée. Étant donné que le concept de « non-identifiabilité » en matière d’éthique de la recherche est de plus en plus discutable, les politiques qui s’y rattachent pourraient devenir intenables. En effet, l’incapacité potentielle à garantir l’anonymat pourrait avoir des conséquences importantes sur l’activité de recherche.

One should judge today's tort-and-insurance system for medical malpractice by traditional tort standards: would a reasonable person, asked for informed consent, choose this particular system as a means of policing medical care and paying for medical injuries? The short answer is "probably not," but a full analysis must weigh the system's costs against its benefits, then compare the results against those of feasible alternatives. In this calculus, quality medical care is the most important element. Significant costs of today's medical malpractice system include relatively objective fiscal elements like private liability insurance premiums (including self-insurance) that cover awards for economic loss and for pain and suffering, as well as public spending for courtrooms, judges, and juries. Highly subjective and intangible costs also need to be counted, such as the effects on medical practice and the availability of care, the impact of delayed compensation or rehabilitation on injured patients, time costs of plaintiffs and defendants, and damage to professional reputations and patient trust. Traditionally, benefits of the tort system are said to take two formscompensation and deterrence. Claimant-plaintiffs injured by the substandard behavior of a defendant-insured are to be "made whole" for the