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Beyond personal preference, what are the arguments for using the phrase "the data are" versus "the data is"?

Ethical health research and privacy protections both provide valuable benefits to society. Health research is vital to improving human health and health care. Protecting patients involved in research from harm and preserving their rights is essential to ethical research. The primary justification for protecting personal privacy is to protect the interests of individuals. In contrast, the primary justification for collecting personally identifiable health information for health research is to benefit society. But it is important to stress that privacy also has value at the societal level, because it permits complex activities, including research and public health activities to be carried out in ways that protect individuals’ dignity. At the same time, health research can benefit individuals, for example, when it facilitates access to new therapies, improved diagnostics, and more effective ways to prevent illness and deliver care.The intent of this chapter1is to define privacy and to delineate its importance to individuals and society as a whole. The value and importance of health research will be addressed in Chapter 3.Go to:CONCEPTS AND VALUE OF PRIVACYDefinitionsPrivacy has deep historical roots (reviewed by Pritts, 2008; Westin, 1967), but because of its complexity, privacy has proven difficult to define and has been the subject of extensive, and often heated, debate by philosophers, sociologists, and legal scholars. The term “privacy” is used frequently, yet there is no universally accepted definition of the term, and confusion persists over the meaning, value, and scope of the concept of privacy. At its core, privacy is experienced on a personal level and often means different things to different people (reviewed by Lowrance, 1997; Pritts, 2008). In modern society, the term is used to denote different, but overlapping, concepts such as the right to bodily integrity or to be free from intrusive searches or surveillance. The concept of privacy is also context specific, and acquires a different meaning depending on the stated reasons for the information being gathered, the intentions of the parties involved, as well as the politics, convention and cultural expectations (Nissenbaum, 2004; NRC, 2007b).Our report, and the Privacy Rule itself, are concerned with health informational privacy. In the context of personal information, concepts of privacy are closely intertwined with those of confidentiality and security. However, although privacy is often used interchangeably with the terms “confidentiality” and “security,” they have distinct meanings. Privacy addresses the question of who has access to personal information and under what conditions. Privacy is concerned with the collection, storage, and use of personal information, and examines whether data can be collected in the first place, as well as the justifications, if any, under which data collected for one purpose can be used for another (secondary)2purpose. An important issue in privacy analysis is whether the individual has authorized particular uses of his or her personal information (Westin, 1967).Confidentiality safeguards information that is gathered in the context of an intimate relationship. It addresses the issue of how to keep information exchanged in that relationship from being disclosed to third parties (Westin, 1976). Confidentiality, for example, prevents physicians from disclosing information shared with them by a patient in the course of a physician–patient relationship. Unauthorized or inadvertent disclosures of data gained as part of an intimate relationship are breaches of confidentiality (Gostin and Hodge, 2002; NBAC, 2001).Security can be defined as “the procedural and technical measures required (a) to prevent unauthorized access, modification, use, and dissemination of data stored or processed in a computer system, (b) to prevent any deliberate denial of service, and (c) to protect the system in its entirety from physical harm” (Turn and Ware, 1976). Security helps keep health records safe from unauthorized use. When someone hacks into a computer system, there is a breach of security (and also potentially, a breach of confidentiality). No security measure, however, can prevent invasion of privacy by those who have authority to access the record (Gostin, 1995).The Importance of PrivacyThere are a variety of reasons for placing a high value on protecting the privacy, confidentiality, and security of health information (reviewed by Pritts, 2008). Some theorists depict privacy as a basic human good or right with intrinsic value (Fried, 1968; Moore, 2005; NRC, 2007a; Terry and Francis, 2007). They see privacy as being objectively valuable in itself, as an essential component of human well-being. They believe that respecting privacy (and autonomy) is a form of recognition of the attributes that give humans their moral uniqueness.The more common view is that privacy is valuable because it facilitates or promotes other fundamental values, including ideals of personhood (Bloustein, 1967; Gavison, 1980; Post, 2001; Solove, 2006; Taylor, 1989; Westin, 1966) such as:Personal autonomy (the ability to make personal decisions)IndividualityRespectDignity and worth as human beingsThe bioethics principle nonmaleficence3requires safeguarding personal privacy. Breaches of privacy and confidentiality not only may affect a person’s dignity, but can cause harm. When personally identifiable health information, for example, is disclosed to an employer, insurer, or family member, it can result in stigma, embarrassment, and discrimination. Thus, without some assurance of privacy, people may be reluctant to provide candid and complete disclosures of sensitive information even to their physicians. Ensuring privacy can promote more effective communication between physician and patient, which is essential for quality of care, enhanced autonomy, and preventing economic harm, embarrassment, and discrimination (Gostin, 2001; NBAC, 1999; Pritts, 2002). However, it should also be noted that perceptions of privacy vary among individuals and various groups. Data that are considered intensely private by one person may not be by others (Lowrance, 2002).But privacy has value even in the absence of any embarrassment or tangible harm. Privacy is also required for developing interpersonal relationships with others. Although some emphasize the need for privacy to establish intimate relationships (Allen, 1997), others take a broader view of privacy as being necessary to maintain a variety of social relationships (Rachels, 1975). By giving us the ability to control who knows what about us and who has access to us, privacy allows us to alter our behavior with different people so that we may maintain and control our various social relationships (Rachels, 1975). For example, people may share different information with their boss than they would with their doctor.Most discussions on the value of privacy focus on its importance to the individual. Privacy can be seen, however, as also having value to society as a whole (Regan, 1995). Privacy furthers the existence of a free society (Gavison, 1980). For example, preserving privacy from widespread surveillance can be seen as protecting not only the individual’s private sphere, but also society as a whole: Privacy contributes to the maintenance of the type of society in which we want to live (Gavison, 1980; Regan, 1995).Privacy can foster socially beneficial activities like health research. Individuals are more likely to participate in and support research if they believe their privacy is being protected. Protecting privacy is also seen by some as enhancing data quality for research and quality improvement initiatives. When individuals avoid health care or engage in other privacy-protective behaviors, such as withholding information, inaccurate and incomplete data are entered into the health care system. These data, which are subsequently used for research, public health reporting, and outcomes analysis, carry with them the same vulnerabilities (Goldman, 1998).The bioethics principle of respect for persons also places importance on individual autonomy, which allows individuals to make decisions for themselves, free from coercion, about matters that are important to their own well-being. U.S. society also places a high value on individual autonomy, and one way to respect persons and enhance individual autonomy is to ensure that people can make the choice about when, and whether, personal information (particularly sensitive information) can be shared with others.Public Views of Health Information PrivacyAmerican society places a high value on individual rights, personal choice, and a private sphere protected from intrusion. Medical records can include some of the most intimate details about a person’s life. They document a patient’s physical and mental health, and can include information on social behaviors, personal relationships, and financial status (Gostin and Hodge, 2002). Accordingly, surveys show that medical privacy is a major concern for many Americans, as outlined below (reviewed by Pritts, 2008; Westin, 2007). As noted in Chapter 1, however, there are some limits to what can be learned from surveys (Tourangeau et al., 2000; Wentland, 1993; Westin, 2007). For example, how the questions and responses are worded and framed can significantly influence the results and their interpretation. Also, responses are biased when respondents self-report measures of attitudes, behavior, and feelings in such a way as to represent themselves favorably.In a 1999 survey of consumer attitudes toward health privacy, three out of four people reported that they had significant concerns about the privacy and confidentiality of their medical records (Forrester Research, 1999). In a more recent survey, conducted in 2005 after the implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, 67 percent of respondents still said they were concerned about the privacy of their medical records, suggesting that the Privacy Rule had not effectively alleviated public concern about health privacy. Ethnic and racial minorities showed the greatest concern among the respondents. Moreover, the survey showed that many consumers were unfamiliar with the HIPAA privacy protections. Only 59 percent of respondents recalled receiving a HIPAA privacy notice, and only 27 percent believed they had more rights than they had before receiving the notice (Forrester Research, 2005). One out of eight respondents also admitted to engaging in behaviors intended to protect their privacy, even at the expense of risking dangerous health effects. These behaviors included lying to their doctors about symptoms or behaviors, refusing to provide information or providing inaccurate information, paying out of pocket for care that is covered by insurance, and avoiding care altogether (Forrester Research, 2005).A series of polls conducted by Harris Interactive suggest, however, that the privacy of health information has improved since implementation of the Privacy Rule. Prior to its creation, a 1993 survey by Harris Interactive showed that 27 percent of Americans believed their personal medical information had been released improperly in the past 3 years. In contrast, 14 percent and 12 percent of respondents believed this had happened to them in 2005 and 2007, respectively (Harris Interactive, 2005 Harris Interactive, 2007). In the 2005 survey, about two-thirds of respondents reported having received a HIPAA privacy notice, and of these people, 67 percent said the privacy notice increased their confidence that their medical information is being handled properly (Harris Interactive, 2005).Responses to other questions on recent public opinion polls conducted by Harris Interactive only partially corroborate these findings. In one survey, 70 percent of respondents indicated that they are generally satisfied with how their personal health information is handled with regard to privacy protections and security. Nearly 60 percent of the respondents reported that they believe the existing federal and state health privacy pro tection laws provide a reasonable level of privacy protection for their health information (Harris Interactive, 2005). Nonetheless, half of the respondents also believed that “[P]atients have lost all control today over how their medical records are obtained and used by organizations outside the direct patient health care such as life insurers, employers, and government health agencies.” In another survey, 83 percent of respondents reported that they trust health care providers to protect the privacy and confidentiality of their personal medical records and health information (Westin, 2007). However, in that survey, 58 percent of respondents believed the privacy of personal medical records and health information is not protected well enough today by federal and state laws and organizational practices.A number of studies suggest that the relative strength of privacy, confidentiality, and security protections can play an important role in people’s concerns about privacy (reviewed by Pritts, 2008). When presented with the possibility that there would be a nationwide system of electronic medical records, one survey found 70 percent of respondents were concerned that sensitive personal medical record information might be leaked because of weak data security, 69 percent expressed concern that there could be more sharing of medical information without the patient’s knowledge, and 69 percent were concerned that strong enough data security will not be installed in the new computer system.Confidentiality is particularly important to adolescents who seek health care. When adolescents perceive that health services are not confidential, they report that they are less likely to seek care, particularly for reproductive health matters or substance abuse (Weddle and Kokotailo, 2005). In addition, the willingness of a person to make self-disclosures necessary to mental health and substance abuse treatment may decrease as the perceived negative consequences of a breach of confidentiality increase (Petrila, 1999; Roback and Shelton, 1995; Taube and Elwork, 1990). These studies show that protecting the privacy of health information is important for ensuring that individuals seek and obtain quality care.The potential for economic harm resulting from discrimination in health insurance and employment is also a concern for many people (reviewed by Pritts, 2008). Polls consistently show that people are most concerned about insurers and employers accessing their health information without their permission (Forrester Research, 2005; PSRA, 1999). This concern arises from fears about employer and insurer discrimination. Concerns about employer discrimination based on health information, in particular, increased 16 percent between 1999 and 2005, with 52 percent of respondents in the later survey expressing concern that their information might be seen by an employer and used to limit job opportunities (Forrester Research, 2005; PSRA, 1999). Reports alleging that major employers such as Wal-Mart base some of their hiring decisions on the health of applicants suggest that these concerns may be justified (Greenhouse and Barbaro, 2005).Studies show that individuals are especially concerned about genetic information being used inappropriately by their insurers and employers (reviewed by Pritts, 2008). Even health care providers appear to be affected by these concerns. In a survey of cancer-genetics specialists, more than half indicated that they would pay out of pocket rather than bill their insurance companies for genetic testing, for fear of genetic discrimination (Hudson, 2007). Although surveys do not reveal a significant percentage of individuals who have experienced such discrimination, geneticists have reported that approximately 550 individuals were refused employment, fired, or denied life insurance based on their genetic constitution (NBAC, 1999). In addition, a study in the United Kingdom suggested that life insurers in that country do not have a full grasp on the meaning of genetic information and do not assess or act in accord with the actuarial risks presented by the information (Low et al., 1998). There is, therefore, some legitimate basis to individuals’ concerns about potential economic harm and the need to protect the privacy of their genetic information. Recent passage of the Genetic Information Nondiscrimination Act in the United States will hopefully begin to address some of these concerns.4Patient Attitudes About Privacy in Health ResearchIdeally, there would be empirical evidence regarding the privacy value of all the specific Privacy Rule provisions that impact researchers, but there are only limited data on this topic from the consumer/patient perspective. A few studies have attempted to examine the public’s attitudes about the use of health information in research. However, few have attempted to do so with respect to the intricacies of the protections afforded by the Privacy Rule or the Common Rule,5which are likely not well known to the public.A review by Westin of 43 national surveys with health privacy questions fielded between 1993 and September 2007 identified 9 surveys6with one or more questions about health research and privacy (Westin, 2007). In some, the majority of respondents were not comfortable with their health information being provided for health research except with notice and express consent. But in others, a majority of respondents were willing to forgo notice and consent if various safeguards and specific types of research were offered. For example, a recent Harris Poll found that 63 percent of respondents would give general consent to the use of their medical records for research, as long as there were guarantees that no personally identifiable health information would be released from such studies (Harris Interactive, 2007). This is similar to the percentage of people willing to participate in a “clinical research study” (Research!America, 2007; Woolley and Propst, 2005) (see also Chapter 3). A 2006 British survey also found strong support for the use of personally identifiable information without consent for public health research and surveillance, via the National Cancer Registry (Barrett et al., 2007).Westin noted that opinions varied in the surveys according to developments on the health care scene and with consumer privacy trends. He concluded from this review that the majority of consumers are positive about health research, and if asked in general terms, support their medical information being made available for research. However, he also noted that most of these surveys presented the choice in ways that did not articulate the key permission process, and that there was much ambiguity in who “researchers” are, what kind of “health research” is involved, and how the promised protection of personal identities would be ensured (Westin, 2007).Reviewing the handful of detailed studies examining patient views of the use of their medical information in research through surveys, structured interviews, or focus groups, Pritts determined that a number of common themes emerge (reviewed by Pritts, 2008):Patients were generally very supportive of research provided safeguards are established to protect the privacy and security of their medical information (Damschroder et al., 2007; Kass et al., 2003; Robling et al., 2004; Westin, 2007; Willison et al., 2007).Patients were much more comfortable with the use of anonymized data (e.g., where obvious identifiers have been removed) than fully identifiable data for research (Damschroder et al., 2007; Kass et al., 2003; Robling et al., 2004; Whiddett et al., 2006).Patients were less comfortable with sharing information about “sensitive” conditions such as mental health with researchers (Damschroder et al., 2007; Robling et al., 2004).In studies where patients were able to provide unstructured comments, they expressed concern about the potential that anonymized data would be reidentified. They were also concerned that insurers or employers or others who could discriminate against subjects could potentially access informa tion maintained by researchers (Damschroder et al., 2007; Kass et al., 2003; Robling et al., 2004). Some feared that researchers would sell information to drug companies or other third parties (Damschroder et al., 2007).Although supportive of research, the majority of patients in these studies expressed a desire to be consulted before their information was released for research (Damschroder et al., 2007; Kass et al., 2003; Robling et al., 2004; Westin, 2007; Whiddett et al., 2006; Willison et al., 2007). Some surveys also show that even if researchers would receive no directly identifying information (e.g., name, address, and health insurance number), the majority of respondents still wanted to have some input before their medical records were disclosed (Damschroder et al., 2007; Robling et al., 2004; Willison et al., 2007). For example, in a 2005 Australian survey, 67 percent of respondents indicated they would be willing to allow their deidentified health records to be used for medical research purposes, but 81 percent wanted to be asked first (Flannery and Tokley, 2005).Studies indicate that public support for research and willingness to share health information can vary with the purpose or type of activity being conducted (reviewed by Pritts, 2008). Studies have found there was less support for activities that were primarily for a commercial purpose, or that might be used in a manner that would not help patients (Damschroder et al., 2007; Willison et al., 2007). Some participants expressed concern that some researchers were motivated by monetary rewards and that decision makers would act out of self-interest (Damschroder et al., 2007).One recent study suggests that the biggest predictor of whether patients are willing to share their medical records with researchers is the patients’ trust that their information will be kept private and confidential (Damschroder et al., 2007). In this study, the patients who most trusted the Veterans Affairs system to keep their medical records private were more likely to accept less stringent requirements for informed consent. Thirty-four percent of veterans who participated in intensive focus groups using deliberative democracy were willing to allow researchers associated with the Veterans Health Administration to use their medical records without any procedures for patient input, subject to Institutional Review Board (IRB) approval, and another 17 percent reported that patients should have to ask for their medical records to be excluded from research studies (opt-out).But participants in focus groups also have expressed a desire to be informed of how their health information was used for research. This desire was tied to a sense of altruism—they wanted to know that their information was useful and that they may have contributed to helping others by allowing their medical records to be used for research (Damschroder et al., 2007; Robling et al., 2004). The veterans also recommended methods to give research participants more control over how their medical records are used in research. These recommendations included requiring that participants are fully informed about how their medical records are being used in research; providing assurances that the research being conducted will benefit fellow veterans; updating research participants about findings and ongoing research; and setting out clear and consistent consequences for anyone who violates a patient’s privacy (Damschroder et al., 2007).The recent Harris poll7commissioned by the Institute of Medicine (IOM) committee for this study found that 8 percent of respondents had been asked to have their medical information used in research, but declined. When asked why, 30 percent indicated they were concerned about the privacy and confidentiality of their personal information, but many other reasons were also commonly cited (ranging from 5 to 24 percent of respondents), including worry that participation would be risky, painful, or unpleasant; lack of trust in the researchers; or belief that it would not help their condition or their family (Westin, 2007).Some studies also suggest that individuals’ attitudes toward the use of their medical records in research may be influenced by a person’s state of health. Although the commissioned Harris Poll found that people who are in only fair health, who have a disability, or who had taken a genetic test were slightly more concerned than the public about health researchers seeing their medical records (55 percent versus 50 percent), other data suggest that people with health concerns may be more supportive of using medical records in research. For example, qualitative market research by the National Health Council showed that individuals with chronic conditions have a very favorable attitude toward the implementation of electronic personal health records (EPHRs). During the focus group discussions, participants noted that EPHRs could be very advantageous in medical research and were supportive of this use even though many had expressed concern about the privacy and confidentiality of EPHRs (Balch et al., 2005 , 2006). Although the Council did not specifically ask about attitudes toward health research and privacy, these results suggest that individuals with chronic conditions may be more likely to grant researchers access to their medical records, and to place less emphasis on protecting privacy than members of the general population.Also, a Johns Hopkins University survey of patients having, or at risk for, serious medical conditions examined these patients’ attitudes about the use of their medical records in research, and compared those results to polls from the general population. Thirty-one percent of respondents stated that medical researchers should have access to their medical records without their permission if it would help to advance medical knowledge.In contrast, the recent Harris poll of the public found that 19 percent of respondents would be willing to forgo consent to use personal medical and health information, as long as the study never revealed their identity and it was supervised by an IRB (Westin, 2007). An additional 8 percent indicated they would be willing to give general consent in advance to have personally identifiable medical or health information used in future research projects without the researchers having to contact them, and 1 percent said researchers should be free to use their personal medical and health information without their consent at all. Thus, 28 percent of respondents would be willing to grant researchers access to their medical records without giving specific consent for each research project. Thirty-eight percent believed they should be asked to consent to each research study seeking to use their personally identifiable medical or health information, and 13 percent did not want researchers to contact them or to use their personal or health information under any circumstances. However, those who preferred not to be contacted at all were actually less likely than those who would grant conditional permission to have declined participating in a research study. Notably, 20 percent of respondents were unsure how to respond to the question about notice and consent for research.Among the 38 percent who said they wanted notice and consent, 80 percent indicated that they would want to know the purpose of the research, and 46 percent wanted to know specifically whether the research could help their health condition or those of family members. Sixty-two percent indicated that knowing about the specific research study and who would be running it would allow the respondent to decide whether to trust the researchers. A little more than half of the respondents (54 percent) said they would be worried that their personally identifiable information may be disclosed outside the study. Among those 54 percent, three-quarters agreed with the statement “I would feel violated and my trust in the researchers betrayed.” Between 39 and 67 percent were concerned about discrimination in a government program, by an employer, or in obtaining life or health insurance (Westin, 2007).However, about 70 percent of all respondents indicated that they trusted health researchers to protect the privacy and confidentiality of the medical records and health information they obtain about research participants. Furthermore, among respondents who had participated in health research, only 2 percent reported that any of their personally identifiable medical information used in a study was given to anyone outside the research staff, and half of those disclosures were actually made to other researchers or research institutions (Westin, 2007).In summary, very limited data are available to assess the privacy value of the Privacy Rule provisions that impact researchers. Surveys indicate that the public is deeply concerned about the privacy and security of personal health information, and that the HIPAA Privacy Rule has perhaps reduced—but not eliminated—those concerns. Patients were generally very supportive of research, provided safeguards were established to protect the privacy and security of their medical information, although some surveys indicate that a significant portion of the public would still prefer to control access to their medical records via consent, even if the information is anonymized. Studies indicate that public support for research and willingness to share health information varies with health status and the type of research conducted, and depends on the patients’ trust that their information will be kept private and confidential. An understanding the public’s attitude toward privacy is important throughout the rest of this report, because many of the IOM committee’s recommendations affect the nature of the privacy protections afforded by the federal health research regulations.Go to:HISTORICAL DEVELOPMENT OF LEGAL PROTECTIONS OF HEALTH INFORMATION PRIVACYThe medical community has long recognized the importance of protecting privacy in maintaining public trust in doctors and researchers, and codes of medical ethics reflect a desire to increase this public trust. Since the time of Hippocrates, physicians have pledged to keep information about their patients private and confidential (Feld and Feld, 2005). The Hippocratic Oath states, “What I may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account one must spread abroad, I will keep to myself….” This pledge to privacy has been included in the code of ethics of nearly all health care professionals in the United States. For example, the first Code of Ethics of the American Medical Association in 1847 included the concept of confidentiality (OTA, 1993).The value of health information privacy has also been recognized by affording it protection under the law (reviewed by Pritts, 2008). The rules for protecting the privacy of health information in the clinical care and health research contexts developed along fairly distinct paths until the promulgation of the federal privacy regulations under HIPAA.8Prior to HIPAA, health information in the clinical setting was protected primarily under a combination of federal and state constitutional law, as well as state common law and statutory protections

Why did Justice Karnan decline to undergo medical checkup?

Justice Karnan didn’t consent for medical check up. He said there were no Parents/ Attendants available in Kolkata who are looking after him. He is staying there on his own, without any family members.Indian law allows for legal proceedings to be stayed if a person is mentally incompetant.INDIAN LAW ON CONSENTIndian law recognises two related but distinct concepts of unsound mind i.e. mental incompetence and mental illness.Although these concepts have been treated as synonymous at times, the law does distinguish between the two.Mental illness is a medical condition while unsoundness of mind or incompetence is a legal finding.The Indian Contracts Act, 1872 is the only law in the country that defines a sound mind or mental competence. According to the law, a person is of sound mind if at the time of making a contract, he is “capable of understanding it and forming a rational judgment as to its effects upon his interests”. e.g. a child though mentally incompetent cannot be called as mentally ill.Similarly senility i.e. in old age in some persons it has been known that a loss of memory and absent mindedness sets in which is not inconsistent with the acts of a sane man. Lack of competence is inferred only if, due to age, the mind has become vacuous and delusory.The other condition is consenting under influence of intoxication. That is voidable. i.e. immediately after you turn sober you can cancel/ repudiate the consent if do not want to acquiesce (agree) to the consent.Lucid interval means a temporary restoration to sanity after which the condition may relapse/ deteriorate. A window/ period of time when a person who was insane has his intelligence restored long enough for him to fully understand the nature of his acts and responsibilities. An act done during a lucid interval is valid;similarly, in Criminal law, insanity is not a valid defense if the offense was committed during a lucid interval.Thus, mental illness is neither necessary nor sufficient for a finding of unsound mind or mental incompetence.COMPETENCE AND INFORMATION WHILE SEEKING CONSENTThere are two more additional aspects to be borne in mind: first, valid consent can be obtained only from a patient who is competent to consent and secondly, such consent must also be informed consent.To be competent to give a legally effective consent, the patient must be endowed with the ability to weigh the risks and benefits of the treatment that is being proposed to him.The law presumes that such an ability is generally acquired with the attainment of the age of maturity.A person who has attained the competent age and who has sound mind can give valid consent to the medical practitioner for any treatment. Persons who have attained the age of 18 are generally considered to have attained the age of maturity and are competent to give consent.The law thus presumes capacity, rationality, autonomy, and freedom if the person has attained the age of so called maturity.___________Consent means an agreement, compliance or permission given voluntarily without any compulsion. Section 13 of The Indian Contract Act states that 'two or more persons are said to consent when they agree upon the same thing in the same sense'. Common meaning of consent is permission whereas the law perceives it as a contract i.e. an agreement enforceable by law.In consent there are four separate but correlated elements that are: voluntary ness, capacity or competence, knowledge and decision-making.Voluntary ness suggests willingness of patient to undergo treatment.Capacity or competence means a degree of ability of the patient to understand the nature and consequences of the treatment offered.Knowledge means that sufficient amount of information about the nature and consequence of the treatment has been disclosed to the patient.Decision-making means the ability to take decisions regarding consent. To be legally valid all these elements must be present in the consent.The principle of autonomy is enshrined within Art. 21 of the Indian Constitution, which deals with the right to life and personal liberty. The expression personal liberty under Art. 21 is of the widest amplitude and covers a wide variety of rights, including the right to live with human dignity and all that goes along with it, and any act which damages, injures, or interferes with the use of any limb or faculty of a person, either permanently or temporarily. Maneka Gandhi v Union of India. AIR 1978 SC 597.However, the common law application of consent is not fully developed in India, although the Indian courts have often referred to these principles. In such situations, obviously one has to refer to the principles of the Indian Contract Act and the Indian Penal Code.The relationship between a medical professional and his patient is a contract by parties competent to contract giving rise to contractual obligations.Parties are generally competent (in accordance with the Indian Majority Act)(i) if they have attained the age of 18,(ii) are of sound mind, and(iii) are not disqualified by any law to which they are subject to.Furthermore, there is a stipulation in the contract law stating that consent of any party (in our case it is the patient) that is obtained by coercion, undue-influence, mistake, misrepresentation or fraud, will render the agreement invalid.However, in England, the General Medical Council guidelines state that the consenting age is 16 years old. A young person can be treated as an adult and can be presumed to have the capacity to decide. If the child is under the age of 16 he or she may have the capacity to decide, depending on his/her ability to understand what is involved. Where a competent child refuses treatment, a person with parental responsibility or the court may authorize investigation or treatment which is in the child's best interests. Interestingly, the position is different in Scotland where those with parental responsibility cannot authorize procedures a competent child has refused.______________________Consent in Criminal LawSection 88 of Indian Penal Code, 1860Legal Provisions of Section 88 of Indian Penal Code, 1860.Section 88- Act not intended to cause death, done by consent in good faith for person's benefit:Nothing which is not intended to cause death, is an offence by reason of any harm which it may cause, or be intended by the doer to cause, or be known by the doer to be likely to cause, to any person for whose benefit it is done in good faith, and who has given a consent, whether express or implied, to suffer that harm, or to take the risk of that harmIllustrationA, a surgeon, knowing that a particular operation is likely to cause the death of Z, who suffers under a painful complaint, but not intending to cause Z's death, and intending in good faith, Z's benefit performs that operation on Z, with Z's consent. A has committed no offence.Section 89- Act done in good faith for benefit of child or insane person, by or by consent of guardian:Nothing which is done in good faith for the benefit of a person under twelve years of age, or of unsound mind, by or by consent, either express or implied, of the guardian or other person having lawful charge of that person, is an offence by reason of any harm which it may cause, or be intended by the doer to cause or be known by the doer to be likely to cause to that person:Provisos-Provided-First: - That this exception shall not extend to the intentional causing of death, or to the attempting to cause death;Secondly: - That this exception shall not extend to the doing of anything which the person doing it knows to be likely to cause death, for any purpose other than the preventing of death or grievous hurt, or the curing of any grievous disease or infirmity;Thirdly: - That this exception shall not extend to the voluntary causing of grievous hurt, or to the attempting to cause grievous hurt, unless it be for the purpose of preventing death of grievous hurt, or the curing of any grievous disease of infirmity ;Fourthly:- That this exception shall not extend to the abetment of any offence, to the committing of which offence it would not extend.Act not intended to cause death, done by consent in good faith for person’s benefit:The section, along with sections 89 and 92 of the Code, deals with acts done for the benefit of others whereas section 93 deals with communication made for the benefit of a person. Therefore, these sections 88, 89, 92 and 93 should be read together to understand the similarities and dissimilarities of these provisions.The section states that when something is done by a person which may cause any harm to another, or where the intention of the doer is to cause harm to another, or where the doer knows that harm is likely to be caused to another, the same does not amount to an offence if the act is done for the benefit of the other in good faith and he has given express or implied consent to suffer that harm, or to take the risk of that harm, and provided the doer has no intention to cause death. The authors of the Code observed:“It is often the wisest thing that a man can do to expose his life to great hazard. It is often the greatest service that can be rendered to him to do what may very probably cause his death. He may labour under a cruel and wasting malady which is certain to shorten his life, and which renders his life, while it lasts useless to others and a torment to himself. Suppose that under these circumstances he, undeceived, gives his free and intelligent consent to take the risk of an operation which ………… in a large proportion of cases has proved fatal, but which is the only method by which his disease can possibly be cured, and which, if it succeeds, will restore him to health and vigour. We do not conceive that it would be expedient to punish the surgeon who should perform the operation, though by performing it he might cause death, not intending to cause death but knowing himself to be likely to cause it.”i) As per the Indian Penal Code twelve years is the age for giving consent. Section 88 and Section 90 of the IPC suggest that the age for giving valid consent for any medical procedure is twelve years. Hence a doctor taking consent for medical or surgical treatment from a person aged twelve years or more can be legally said to have taken a valid consent and cannot be held criminally liable on this account. However Sections 87 IPC mentions eighteen years as the age for giving consent for acts not intended and not known to be likely to cause death or grievous hurt. However these acts are not necessarily for the benefit of the person. Hence Section 87 IPC is not applicable to the medical profession as here the acts are done for the person's benefit.ii) The general practice is that the patient or parent/guardian sign the consent form. Doctors do not sign it.iii) In many cases verbal consent is considered adequate and written consent dispensed with.____________Consent for medical examination and treatmentThe consent obtained, of course, after getting the relevant information will have its own parameter of operation to render protection to the medical practitioner. If the doctor goes beyond these parameters, he would be treating the patient at his risk, as it is deemed that there is no consent for such treatment at all. A doctor who went ahead in treating a patient, to protect the patient's own interest, was held liable as he was operating without consent. Ram Bihari Lal v Dr. J. N. Srivastava. AIR 1985 MP 150.The patient was suspected to have appendicitis. After obtaining due consent, she was subjected to an operation. However, upon incision, it was found that her appendix was normal and not inflamed. To protect the interest of the patient, the doctor removed her gangrenous gall bladder. Later, it was discovered that the kidney of the patient was affected. The doctor was held liable as he was operating without consent. This case law also signifies the traditional notion of paternalism prevalent among the members of the medical fraternity. It is a notion where the doctor takes-up the role of a parent of the patient and starts deciding on behalf of the patient himself. Unfortunately, the law does not accept this notion. The first priority of law is always the right of autonomy of the patient provided he is endowed with necessary capacity. A medical practitioner who believes that a medical procedure is appropriate and necessary for a patient's wellbeing can perhaps be forgiven for believing that the principle of autonomy should be sacrificed in the best interest of the patient. In the present case, had the doctor stopped after realizing that the patient's appendix was normal, he would have been protected as he was working under the valid consent of the patient, and more importantly, mere error of judgment is not culpable. When he proceeded in removing her gall bladder, he was acting sans valid consent, which was an extreme case of professional paternalism and gross disobedience to the right of the patient's autonomy.Hence, some commentators like Mill, et al. have advocated for minimal level of paternalism in the interest of the medical profession and the overall inability of humans in taking rational decisions, during the time of crises. Mill, J.S., ‘On Liberty’ Harmondsworth: Penguin; 1982. p. 68.Regarding proxy consent, when the patient is unable to give consent himself, there are no clear regulations or principles developed in India. If such a situation exists, the medical practitioner may proceed with treatment by taking the consent of any relative of the patient or even an attendant. In one case, the wife of a patient informed the hospital authorities in unambiguous terms that she had no objection to her husband undergoing bypass surgery, her consent was deemed sufficient for the purpose of any formalities with which the hospital was required to comply. C A Muthu Krishnan v M. Rajyalakshmi. AIR 1999 AP 311.Interestingly, in this case the relationship between the patient and his wife were strained.A patient was operated on for sterilization. While giving consent he deposed that he is married and has two baby girls. In fact, he was undergoing an operation only for getting the money as incentive. After the operation, his father contended that the patient was of unstable mind and was not competent to give consent. The court held that if there are no circumstances for a doctor to sense foul play or doubt about the capacity of the patient, he is protected. Satishchandra Shukla vs Union of India And Ors on 30 September 1985 in the Madhya Pradesh High Court; 1987 ACJ 628.These two cases demonstrate that a doctor acting reasonably under normal circumstances is always protected and he is never expected to play the role of an investigative agency.Recently, the apex court gave an impacting judgment in the area. Wherein the court observed that “where a surgeon is consulted by a patient and consent of the patient is taken for diagnostic procedure/surgery, such consent can't be considered as authorization or permission to perform therapeutic surgery either conservative or radical (except in a life-threatening emergent situation)”. Samera Kohli v Dr. Prabha Manchanda and Another. 2008; (1) SCALE 442.For the first time in India, the court ruled that however broad consent might be for diagnostic procedure, it cannot be used for therapeutic surgery. Furthermore, the court observed that “where the consent by the patient is for a particular operative surgery it can't be treated as consent for an unauthorized additional procedure involving removal of an organ only on the ground that it is beneficial to the patient or is likely to prevent some danger developing in the future, where there is no imminent danger to the life or health of the patient”. This proposition puts fetter upon the role of a “paternal doctor” in the Indian scenario. In this case, a 44-year-old unmarried female consulted her doctor and was advised to undergo a laparoscopy. A few consent forms were taken from her of which one was for admission and another one was for the surgery. The relevant one among such consent forms gave the doctor an allowance to carry out a “diagnostic and operative laparoscopy” and there was an additional endorsement that a “laparotomy may be needed”. When the patient was in the operation theater (and was unconscious), another proxy consent was taken from her attending mother for a hysterectomy. Her uterus, ovaries, and fallopian tubes were removed. Subsequently, when an action was brought, it was held that the operation was conducted without real consent and the doctors were held liable.This decision is of very far reaching consequences, pushing the development of consent law to new heights. It is contended that it is not only informed consent which is imperative now, but the same shall be “prior informed consent” unless there is imminent threat to the patient's life.In addition, this decision curtails the scope of proxy consent from the person having parental authority or an attendant.On the other hand, where there is reason to believe that a patient is unable to understand the nature of the treatment and its benefits or side effects before making the decision, it is necessary to consider whether an adult presumption of capacity is rebutted in that particular case. If the patient is incompetent to give consent, then the consent may be obtained from the attendant of the patient.______________In the UK, there are several ethical issues raised regarding the proxy consent on behalf of such persons. Even the Law Commission Report (Mental Incapacity, 1995) suggests few reforms. Irrespective of the age, for a person who is incompetent due to unsoundness of mind, consent will be obtained from the guardian of the patient. In India, the court has not come across borderline cases of an adult refusing treatment leading to emergency and leaving the doctor in a dilemma, unlike in the west.Even if the medical board finds that Justice Karnan has a mental illness, it does not automatically imply he is of unsound mind. Clause 5 of the Mental Health Care Act, 2017 says “determination of a person’s mental illness shall alone not imply or be taken to mean that the person is of unsound mind unless he has been declared as such by a competent court”. Irrespective of his mental health status, therefore, the Supreme Court will have to satisfy itself that Justice Karnan is incapable of understanding his actions and is unable to form a rational judgement of the effects of his actions on his interests, and thus make a declaration that Justice Karnan is of unsound mind, before halting legal proceedings. Indian law allows for legal proceedings to be stayed if a person is of unsound mind._____________________________________Informed Consent in PsychiatryIn its ethical dimension informed consent encourages respect for individual autonomy in medical decision-making. There are however conditions and circumstances that limit autonomy and therefore also autonomous choice. People with a learning disability or a mental or physical illness may be temporarily incapacitated to make autonomous choices due to their condition. In these cases the concepts of capacity and competence become paramount in determining the extent to which a person's autonomy is restricted. Competence is a legal term, and courts decide on the competence of a person based on the inputs provided to it by the doctors who give an opinion on the capacity of the patient to comprehend facts and make independent decisions. Capacity in contrast is a medical term and doctors determine a person's capacity to make certain choices.Lepping P. Consent in Psychiatry- an ethical review. Psychiatric Bulletin. 2003; 27:285-9.____________It is worth noting that this distinction often breaks down in practice. When clinicians determine that a patient lacks decision making capacity the practical consequences may be the same as those attending a legal determination of incompetence.Two basic preconditions have to be met to render a person incapable of managing his or her own affairs. Firstly, there needs to be an objective cognitive deficit that impairs problem solving and decision-making. Secondly, there must be an incapability to sensibly delegate responsibility to someone else.Some authors have suggested a 'sliding scale' of ability to take into account that different decisions require different levels of understanding. Thus decisions of most potential risk, such as death, demand greater levels of capacity than decisions of minor potential risk. Buchanan A, Brock D. Deciding for Others.Cambridge: Cambridge University Press; 1989. p. 51-70.____________Hence if the consequences for welfare are grave our need to be able to certify that the patient possesses the requisite capacity increases, but if little in the way of welfare is at stake, we can lower the level of capacity required for decision making. Every effort should be made to minimize the time taken to determine a patients' capacity. O'Reilly RL. Mental Health Legislation and the right to appropriate treatment.Can J Psychiatry. 1998 Oct; 43(8): 811-5.____________Some psychiatric disorders can impair decision-making functions to some extent, but not to the point where patients would be considered legally incompetent. In such cases, clinicians can make disclosure in a manner that takes patients' limitations into account. This may include simplifying elements of the disclosure, offering information in smaller amounts stretched out over time, and repeating disclosure several times. The implication of these accommodations to patients' impairments is that some patients may be asked to consent to treatment (when it needs to be implemented promptly) before having received a disclosure comparable to that offered to non-impaired persons.Some psychiatric patients may not be in his senses, i.e. manifest impairments of decision-making capacities that are likely to resolve quickly especially if effective treatment can be implemented. In such cases short term treatment of the patient can be initiated, even in the absence of a fully adequate consent, obtaining such consent as soon as the patients' condition permits it. This practice is acceptable when recovery of decision-making capacities is likely to occur.Psychotherapy and other psychiatric records may contain sensitive and deeply personal information about patients. These records should not be released without patient consent. Patients should understand to whom the information will be disclosed, what information will be discussed, how the information will be used and what the potential consequences might occur. Beck P. The confidentiality of psychiatric records and the patients right to privacy.Can J Psychiatry. 2001 Apr; 46(3): 6.____________ORDER CONTRADICTS MENTAL HEALTH ACTEven as the bench has posted the case for further hearing on May 9, doubts have been expressed by observers on whether Justice Karnan can be subjected by the Supreme Court to a medical examination without his consent. Justice Karnan himself has reportedly refused to subject himself to such medical examination, and has questioned the authority of the Supreme Court to assume that he suffers from mental illness.Worryingly, the bench’s order appears to be inconsistent with the Mental Health Care Act, 2017 – which defines “informed consent” under Section 2(1)(i) as follows:“Informed consent” means consent given for a specific intervention, without any force, undue influence, fraud, threat, mistake or misrepresentation, and obtained after disclosing to a person adequate information including risks and benefits of, and alternatives to, the specific intervention in a language and manner understood by the person”.Although the Supreme Court’s order does not use the expression “mental illness”, the fact that the proceedings referred to it in the context of his defiance of the court’s previous orders, cannot be ignored. Section 3(2) of the Act says:“No person or authority shall classify a person as a person with mental illness, except for purposes directly relating to the treatment of the mental illness or in other matters as covered under this Act or any other law for the time being in force.”Section 3(3) of the Act says:Mental illness of a person shall not be determined on the basis of• political , economic, or social status or membership of a cultural, racial or religious group, or for any other reason not directly relevant to mental health status of the person;• Non-conformity with moral, social, cultural, work or political values or religious beliefs prevailing in a person’s community.Section 4(1) of the Act further says:Every person, including a person with mental illness shall be deemed to have capacity to make decisions regarding his mental health care or treatment if such person has ability to(a) understand the information that is relevant to take a decision on the treatment or admission or personal assistance; or(b) appreciate any reasonably foreseeable consequence of a decision or lack of decision on the treatment or admission or personal assistance; or[c] communicate the decision under sub-clause (a) by means of speech, expression, gesture or any other means.Moreover, a constitution bench of the Supreme Court in Selvi v State of Karnataka, has declared that narco tests, and lie detectors can only be administered with consent of the accused, in order to meet the requirements of Articles 20(3) and 21 of the Constitution.If that is the high standard which the court has set for an investigation of a crime, directing Justice Karnan’s medical examination without his consent – under the unstated assumption that he might be suffering from mental illness, so as to make him incapable of defending himself in the ongoing contempt proceedings – appears to be a disproportionate response from the highest court.

Why is informed consent important in clinical trials?

Clinical trials as we understand them today are a fairly recent invention, starting with the 1947 UK Medical Research Council's study of streptomycin for tuberculosis treatment, the 1st randomized clinical trial (1).Informed consent is of even more recent vintage. Dwelling at the intersection of law and medicine, birthed by the former, imposed on the latter, informed consent and clinical medicine have had an uneasy relationship from the beginning. While landmark cases started shaping its legal doctrine already in the 19th and early 20th century, informed consent's post-WWII legal lineage in the US is easy to track, with milestone rulings starting in the 1950s through to the 1970s (2, 3, 4),The 1957 Salgo v. Leland Stanford Jr. University Board of Trustees (2) established the precedent of patient self-determination with the judge coining the phrase, informed consent, in his jury instruction, the 1st known instance of its explicit use.The 1960 Natanson v. Kline (3) established the negligence standard, as in the physician having an inherent duty to make a reasonable disclosure of risks and hazards of treatment or face possible malpractice liability.The 1972 Canterbury v. Spence (4) established the reasonable person standard, i.e., the need to disclose what any reasonable person would consider necessary and sufficient to know.According to Ruth R. Faden, Tom L. Beauchamp and Nancy M.P. King, who published the definitive text-book on it in 1986 (5), how informed consent was planted in clinical medicine, how it grew, in other words its clinical medicine lineage, that's largely lost to time. This is perhaps an unavoidable difference because medicine already walks an uneasy tightrope between patient autonomy and welfare. Absence of early peer-reviewed medical studies only emphasizes the initial reluctance with which clinical medicine incorporated informed consent, and is also emblematic of the unease with which the two co-exist. Part of the reason for this unease is the perennial existence of grey areas.Why perennially grey areas? Because the young, the elderly, the frail, the poor, the poorly educated, the intellectually impaired, and the seriously ill are a part of us, a part of us that's much more dependent and thus much more vulnerable to manipulation. As Robert Q. Marston, the then-Director of the US NIH noted in an influential speech on the subject of informed consent, 'Whether or not consent is in fact informed is admittedly difficult to assess. We often are in an uncertain situation in which inadequate information, communication problems, and the inability of the subject to comprehend-or to read-or to listen-can be misleading' (6).Pre-informed consent Clinical Medicine helps understand why it's Important, nay Critical, in Clinical TrialsAs recently as 1964-1966, a study in the US found that >50% of physicians, 53% to be exact, thought it was 'ethically appropriate for a physician not to tell a cancer patient that she had been enrolled in a double blind clinical trial of an experimental anticancer drug and was currently receiving a placebo' (5, page 89).Two of the most prominent egregious abuses in human medical research, namely, Nazi human experimentation during the Holocaust and the Tuskegee Syphilis Study* certainly cast a long shadow, necessitating clear, formal, legally binding guidelines for human experimentation. While case law verdicts helped shape the legal framework for informed consent, the cultural framework, at least in the US, arose from several other cases that drove public debate, illuminated gaps in physician understanding of informed consent, and highlighted the roles and responsibilities of research committees and funders. Careful examination of the details and circumstances of some of these prominent cases helps drive home why informed consent is not only important but indeed critical. Two of several prominent US examples that were crucial in fleshing out informed consent as it exists today are elaborated here.The Jewish Chronic Disease Hospital CaseConducted at the Jewish Chronic Disease Hospital (JCDH) in Brooklyn, New York, and funded by Sloan-Kettering Institute for Cancer Research, the American Public Health Service and the American Cancer Society. With 10 years of research on anti-cancer immune responses under his belt, in July 1963, chief investigator Dr. Chester M. Southam convinced the hospital medical director Emmanuel E. Mandel to permit injection of a suspension of foreign, live cancer cells into 22 JCDH patients.The research question? Do cancer patients reject cancer transplants or not? Obviously comparison with response of cancer-free patients, the controls, was also required.The informed consent aspect? Some were informed orally they were involved in an experiment, but not that they would be injected with live cancer cells. No written informed consent.The final insult to injury, some patients were incompetent to give informed consent.The non-cancer patients, i.e., the controls, weren't informed either that they were getting injected with live cancer cells.The grounds? Might unnecessarily agitate the participants.The defense? That it was customary in medical research that consent 'not be documented even in far more dangerous research' (5, page 161), something that sounds utterly indefensible in the year 2015.As the New York Post reported in 2013, three young physicians, Drs. Avir Kagan, David Leichter and Perry Fersko, courageously went against the prevailing status quo and refused to participate in this study (7). They also brought it to the attention of attorney William Hyman, one of JCDH's Board of Directors, who filed a suit to access hospital records to learn more about the study (8). Hyman's concerns ranged from potential patient abuse, potential reputation damage to the hospital and its possible liability. The Hyman-driven review revealed (5, page 162),The study wasn't presented to the hospital's' research committee.Physicians directly responsible for patient care of subjects involved in the research weren't consulted about the cancer cell injections.Three physicians who had been consulted by Dr. Mandel were against the research arguing 'subjects were incapable of giving appropriate consent'.In 1966, the Board of Regents of the State University of New York censured Drs. Southam and Mandel, finding them guilty of deceit, fraud and unprofessional conduct, writing in its judgment (5, page 162, 9, see Regent' decision from 10 below),'A physician has no right to withhold from a prospective volunteer any fact which he knows may influence the decision. It is the volunteer's decision to make. . . . There is evidenced in the record in this proceeding an attitude on the part of some physicians . . . that the patient's consent is an empty formality. Deliberate nondisclosure of the material fact is no different from deliberate misrepresentation of such a fact. . . . The alleged oral consents that they obtained after deliberately withholding this information were not informed consents and were, for this reason, fraudulently obtained'.The Willowbrook State School CaseAn institution on Staten Island, New York, it was then classified in a manner unthinkable today, a mere 60 years later, namely, as a place for 'defective children'. Originally designed to house 3000, by 1963 it housed >6000. With the children's severe developmental impairments amplified by poor oversight, large numbers weren't even properly toilet trained. Unsurprisingly, such conditions not just predisposed to but also facilitated easy spread of fecal-borne infections. For example, in 1954, many children contracted hepatitis (presumably hepatitis A) within 6 to 12 months of living at Willowbrook.In 1956, Saul Krugman and colleagues started a series of experiments to develop an effective prophylactic. Funded by the US Armed Forces Epidemiological Board, the US Army Medical Research and Development Command, the Health Research Council of the City of New York, and several committees at New York University School of Medicine, including its Committee on Human Experimentation, they deliberately infected newly admitted patients with isolated hepatitis virus strains. Of the 10,000 children admitted to Willowbrook after 1956, ~ 750 to 800 were sent to Krugman's special hepatitis unit. Wards of the state never included in the studies, the children's parents had given written consent. At first, parents were informed by either letter or personal interview. Later, informed consent entailed groups discussions with parents of prospective parents.From the beginning, these studies were on the radar of Henry K. Beecher. With a decidedly murky ethical background himself, nevertheless, by the 1960s he'd emerged a pioneer of informed consent with his publication in 1959 of 'Experimentation in Man'. Beecher first listed the Willowbrook study in 1966 as one of 22 'ethically dubious' experiments. His repeat highlighting of this study in his 1970 book, Research and the Individual, brought the matter to the public's attention. Criticism gained momentum with the theologian Paul Ramsey joining in and with Stephen Goldby publishing a sharply critical letter in the Lancet in April 1971 (11), with the full support of the Lancet editors who publicly apologized for having previously overlooked the issue of informed consent.Such public scrutiny forced the researchers to defend themselves in the public arena. Their defense? Since most of the children recruited in the study would contract hepatitis anyway, they weren't placed in greater danger compared to the other institutionalized children. Optimal isolation, better attention, administered the best available anti-hepatitis therapy then available, the researchers asserted that their attempt to give the selected children sub-clinical hepatitis infections would immunize them against specific hepatitis viruses (12). That's not all. Influential editors of several prestigious medical journals, namely JAMA, NEJM, Journal of Infectious Diseases, agreed with this defense, arguing such research was valuable for understanding hepatitis, had potential value to such institutionalized children, had sufficient consent provisions, didn't expose the children to unnecessary risks and was performed by competent investigators (13).The rebuttal? The studyIncreased the children's later life risk for chronic liver disease.Unlike other Willowbrook residents, study children didn't receive protective doses of gamma globulin (14).Both process and legitimacy of consent obtained for the study were also easy to challenge. Consent forms used suggested the children would receive a vaccine against the virus, some parents were only contacted by letter. A key change happened in late 1964. Willowbrook became so overcrowded that new patient admissions ceased while Krugman's special research unit continued accepting children whose parents 'volunteered' them for the study, suggesting implicit coercion into the study as a means for parents getting their children admitted to Willowbrook (15). Study reviewers and we ourselves could easily conclude that social pressures under which such parents gave their consent, especially post-1964, undermined their ability to act in the best interests of their children.As Faden, Beauchamp and King note in their book (5, page 164), while Krugman's research unit was eventually closed, debate about the ethics of the Willowbrook study never resolved satisfactorily (16) and we see remarkable parallels regarding the ethics of informed consent issues here and in the 2009 PATH-ICMR HPV (Human Papilloma Virus) clinical trial**, ***. In both, the subjects of research were minors and parents/guardians offered informed consent on their behalf, one of the perennial grey areas I referenced earlier.The Road to Today's Informed Consent Becomes ClearerWith such recent examples of egregious medical research abuses as the backdrop, in 1973, Robert Q. Marston, the then-Director of the US NIH made an influential speech (6) that highlighted the central role of informed consent in clinical trials, 'That the committee determine that the rights and welfare of the subjects involved are adequately protected, that the risks of an individual are outweighed by the potential benefits to him or by the importance of the knowledge to be gained, and that informed consent is to be obtained by methods that are adequate and appropriate', and that 'if, in a specific case, I were forced to choose between the individual and the general welfare of society, I would choose to protect the individual'.He emphasized (6) that review committees that oversee human experimentation needed to strictly adhere to three basic criteria, namely,' Protection of the rights and welfare of the subjects.Weighing of risks against benefits.Determination that informed consent is to be obtained by methods that are adequate and appropriate.'In the US, it was in 1981 that the Judicial Council of the American Medical Association (AMA) first took an explicit stance on Informed Consent (5, page 96),'INFORMED CONSENT.The patient's right of self-decision can be effectively exercised only if the patient possesses enough information to enable an intelligent choice. The patient should make his own determination on treatment. Informed consent is a basic social policy for which exceptions are permitted (1) where the patient is unconscious or otherwise incapable of consenting and harm from failure to treat is imminent; or (2) when risk-disclosure poses such a serious psychological threat of detriment to the patient as to be medically contraindicated. Social policy does not accept the paternalistic view that the physician may remain silent because divulgence might prompt the patient to forego needed therapy. Rational, informed patients should not be expected to act uniformly, even under similar circumstances, in agreeing to or refusing treatment'.And this is more or less the landscape we've operated in ever since, with adequate and appropriate methods for obtaining informed consent remaining a perennially grey area, especially as clinical trials globalize and involve research subjects with vastly different cultural, linguistic and educational norms.Bibliography1. Marshall, Geoffrey, et al. "Streptomycin treatment of pulmonary tuberculosis: a Medical Research Council investigation." BMJ 2.4582 (1948): 769-782.2. Salgo v. Leland Stanford Jr. University Board of Trustees, 317 P.2d 170, 181 (1957).3. Natanson v. Kline, 350 P.2d 1093, 186 Kan. 393, 186 Kansas 393 (1960).4. Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972).5. Faden, Ruth R., Tom L. Beauchamp, and Nancy M. King. "A history and theory of informed consent." (1986). Oxford University Press.6. Marston, Robert Q. "Medical science, the clinical trial and society." Hastings Center Report 3.2 (1973): 1-4.7. The New York Post, Allen M. Hornblum, Dec 28, 2013. NYC's forgotten cancer scandal8. MATTER OF HYMAN v. Jewish Hosp., 15 N.Y.2d 317, 206 N.E.2d 338, 258 N.Y.S.2d 397 (1965).9. Katz, Jay, Alexander Morgan Capron, and Eleanor Swift Glass. Experimentation with human beings: The authority of the investigator, subject, professions, and state in the human experimentation process. Russell Sage Foundation, 1972.10. Langer, Elinor. "Human Experimentation: New York Verdict Affirms Patient's Rights." Science 151.3711 (1966): 663-666.11. Goldby, Stephen. "Experiments at the Willowbrook state school." The Lancet 297.7702 (1971): 749.12. Krugman, Saul, Joan P. Giles, and Jack Hammond. "Infectious hepatitis: Evidence for two distinctive clinical, epidemiological, and immunological types of infection." Jama 200.5 (1967): 365-373.13. Is Serum Hepatitis Only A Special Type of Infectious Hepatitis? JAMA. 1967;200(5):406-407. doi:10.1001/jama.1967.03120180094017.14. Annas, George J., Leonard H. Glantz, and Barbara F. Katz. Informed consent to human experimentation: The subject's dilemma. Ballinger Pub. Co., 1977.15. Goldman, Louis. "The Willowbrook Debate." World Med 7 (1971): 23-25.16. Ingelfinger, F. J. "Ethics of experiments on children." New England Journal of Medicine 288.15 (1973): 791-792.More details on the journey to, the process of, and grey areas in informed consent available in these answers:* Tirumalai Kamala's answer to Do you believe placebos are morally permissible? Why or why not?** Tirumalai Kamala's answer to Should we have an international forum to resolve clinical trial mishaps?*** Tirumalai Kamala's answer to Is it true that Bill Gates faced trial in India for illegally testing tribal children with vaccines?Thanks for the A2A, Kritika Gupta.

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