The Cambridge textbook of bioethics

514M. H. Cohen

as beneficence (the obligation to help the patient), non-maleficence (the obligation to ‘‘do no harm’’), and autonomy (the obligation to honor a patient’s freely made medical choices) (Institute of Medicine of the National Academies, 2005). In general, medical paternalism has tended to trump over patient autonomy interests in CAM therapies, whereas it may now be time to acknowledge the possibility for human transformation afforded by CAM therapies at the boundary of medicine and religion (Cohen, 2004a) alongside historical concerns for preventing healthcare fraud (Cohen, 2003).

To this end, ethical decision-making regarding clinical advice about CAM therapies consider the following factors: severity and acuteness of illness; curability with conventional treatment; invasiveness, toxicities, and side effects of conventional treatment; quality of evidence of safety and efficacy of the CAM treatment; degree of understanding of the risks and benefits of conventional and CAM treatments; knowing and voluntary acceptance of those risks by the patient; and persistence of patient’s intention to utilize CAM treatment (Adams et al., 2002).

Consequently in situations where an illness is not severe or acute, and is not easily curable with conventional treatment, and/or the conventional treatment is invasive and carries toxicities or side effects that are unacceptable to the patient, then, assuming the CAM therapy is not proven unsafe or ineffective, it may be ethically compelling to try the CAM approach for a limited period of time with monitoring conventionally (Adams et al., 2002). The ethical posture is even further improved if the patient understands the risks and benefits, is willing to assume the risk of trying such an approach, and insists on this route. In this case, a monitored ‘‘wait-and-see’’ approach respects the patient’s autonomy interest, while satisfying the clinician’s obligation to do no harm (Adams et al., 2002).

The Institute of Medicine report used this framework and also described two ethical values additional to beneficence, non-maleficence, and autonomy to enrich clinical decision making in integrative care. The two additional considerations

are medical pluralism and public accountability. The report defined ‘‘medical pluralism’’ in terms of ‘‘acknowledgement of multiple valid modes of healing and a pluralistic foundation for healthcare,’’ even if some CAM practices are ‘‘rooted, at least in part, in forms of evidence and logic other than used in biomedical sciences, often with long traditions and theoretical systems of interpretation divergent from those used in biomedicine’’ (Institute of Medicine of the National Academies, 2005, p. 169). The report defined ‘‘public accountability’’ in terms including attending to the ‘‘needs and desires of multiple constituents within the public sector (e.g., licensed clinicians and other healers, patients, professional organizations, regulatory boards, and other government authorities),’’ as well as the ‘‘heterogeneity of communities and interests within each set of constituents’’ (Institute of Medicine of the National Academies, 2005, p. 173).

Law

In general, basic principles of health law apply whether a therapy is labeled ‘‘conventional’’ or ‘‘CAM’’ (Cohen, 1998). The critical arenas of legal analysis are (i) licensure, (ii) scope of practice, (iii) malpractice liability, (iv) professional discipline, (v) access to treatments, (vi) third-party reimbursement, and (vii) healthcare fraud. These areas are broadly described with case examples by Cohen (1998), though it is worth briefly summarizing some of the major legal rules that would apply whether discussing integrative pediatrics (Cohen and Kemper, 2005), integrative oncology (Cohen, 2006), integrative cardiology (Schouten and Cohen, 2004), or any other medical specialty or healthcare practice.

This chapter focuses primarily on US law and regulation, although the issues cut across other common law nations, such as the UK (Stone and Matthews, 1996), Canada (Boon, 2002), and Australia (Cohen, 2004b). For example, the Sixth Report, entitled Complementary and Alternative Medicine, issued by the UK House of Lords Committee on Science and Technology (2002) made many regulatory

recommendations that paralleled those made the same year in the Final Report by the US White House Commission on Complementary Medicine Policy (2002). Similarly, scholarly counterparts in the UK have argued that the highly individualized, more intuitive, whole-person approach of complementary medicine requires a more dynamic form of ethics-directed self-regulation that facilitates consumer choice while protecting against dangerous and abusive healthcare practices. In a similar vein, the Canadian federal government, like its counterpart in the USA, is deeply concerned with regulation of consumers’ use of natural health products for nutritional purposes (Boon, 2003) (known in the USA as regulation of dietary supplements [Cohen, 2003]).

In the USA, licensure refers to the requirement in most states that healthcare providers maintain a current state license to practice their professional healing art. Historically, medical licensing statutes made the unlicensed practice of ‘‘medicine’’ a crime and defined the practice of ‘‘medicine’’ broadly in terms of ‘‘diagnosis’’ and ‘‘treatment’’ of ‘‘any human disease’’ or ‘‘condition’’ (Cohen, 1998). This put non-licensed practitioners of the healing arts at risk of prosecution for unlawful medical practice.

Over time, chiropractors, massage therapists, naturopathic physicians, practitioners of acupuncture and traditional oriental medicine, and other CAM therapy providers attempted to gain licensure on a state-by-state basis. Providers of CAM therapies may or may not be licensed depending on a particular state’s licensing scheme. Chiropractors, for example, are licensed in every state, whereas massage therapists and acupuncturists are licensed in well over half the states, and naturopathic physicians in at least a dozen states. In most states, practitioners lacking any healthcare license are at risk of prosecution for practicing medicine without a license (Cohen, 1998).

State licensing statutes and regulations by the applicable professional board usually define a CAM provider’s scope of practice, the legally authorized boundaries of care within the given profession (Cohen, 1998). For example, chiropractors can

offer nutritional advice, acupuncture, or colonic irrigation in some states but not others (Cohen, 1998). Exceeding one’s scope of practice can lead to charges of practicing other healing arts (such as, for example, medicine) without a license. Some institutions will further limit the practice boundaries of affiliated CAM providers beyond the existing limitations of the practitioner’s legally authorized scope of practice: for example, restricting acupuncturists on hospital staff from offering patients herbal medicine even though the acupuncture licensing statute may consider herbal medicine within acupuncturists’ scope of practice (Cohen and Ruggie, 2004).

Malpractice refers to negligence, which is defined as failure to use due care (or follow the standard of care) in treating a patient, and thereby injuring the patient. While medical standards of care specific to a specialty are applied in medicine, each CAM profession is judged by its own standard of care – for example, claims of chiropractic malpractice will be judged against standards of care applicable to chiropractic treatment (Cohen, 1998). In cases where the provider’s clinical care overlaps with medical care – for example, the chiropractor who takes and reads a patient’s radiograph – then the medical standard may be applied (Cohen, 1998).

Claims for healthcare malpractice resulting from inclusion of CAM therapy can involve allegations of misdiagnosis, failure to treat, failure of informed consent, fraud and misrepresentation, abandonment, vicarious liability, and breach of privacy and confidentiality (Schouten and Cohen, 2004). These are discussed more fully by these authors, but it is worth highlighting some common elements. Firstly, because the definition of malpractice includes both providing substandard care and thereby injuring the patient, adding complementary diagnostic systems (such as those of chiropractic or acupuncture, either by referral or by using modalities within the scope of one’s clinical licensure) is not problematic in itself, so long as the conventional bases are not neglected (Cohen and Eisenberg, 2002). Conversely, a conventional provider who fails to employ conventional diagnostic

methods where such methods could have averted unnecessary patient injury, or who substitutes CAM diagnostic methods for conventional ones and thereby causes patient injury, risks a malpractice verdict (Cohen and Eisenberg, 2002). Similarly, it is not malpractice for a CAM provider to use modalities within his or her legally authorized scope of practice, so long as the provider refers to medical care where necessary and appropriate.

Secondly, the legal obligation of informed consent (whether involving conventional medicine or CAM therapies) is to provide the patient with all the information material to a treatment decision – in other words, information that would make a difference in the patient’s choice to undergo or forgo a given therapeutic protocol (Ernst and Cohen, 2001). Failure to provide adequate informed consent can constitute malpractice. The Institute of Medicine’s Report on Complementary and Alternative Medicine (2005, p. x) stated: ‘‘The goal should be the provision of comprehensive medical care that is based on the best scientific evidence available regarding benefits and harm, that encourages patients to share in decision making about therapeutic options, and that promotes choices in care that can include CAM therapies, when appropriate.’’

Thirdly, while there are few judicial opinions setting precedent regarding referrals to CAM therapists, the general rule of conventional care – that there is no liability merely for referring to a specialist – should apply whether referral is to a practitioner labeled conventional or CAM (Studdert et al., 1998). The major exceptions to this noliability rule involve a negligent referral (one that delays necessary care and thereby causes harm to the patient, as in referral to a CAM provider that delays necessary conventional care), a referral to practitioner that the referring provider knew or should have known was ‘‘incompetent,’’ and a referral involving ‘‘joint treatment,’’ in which the referring clinician and the practitioner receiving the referral actively collaborate to develop a treatment plan and to monitor and treat the patient (Studdert et al., 1998). ‘‘Integrative’’ care suggests a

sufficiently high degree of coordination between the referring provider and the one receiving the referral that a court conceivably could find that a ‘‘joint treatment’’ has occurred and, therefore, liability may be apportioned among conventional and CAM providers sharing diagnostic and therapeutic information (Studdert et al., 1998; Cohen, 2000).

Professional discipline refers to the power of the relevant professional board to sanction a clinician, most seriously by revoking the clinician’s license. The concern over inappropriate discipline, based on medical board antipathy to inclusion of CAM therapies, has led consumer groups in many states to lobby for ‘‘health freedom’’ statutes – laws providing that physicians may not be disciplined solely on the basis of incorporating CAM modalities. More recently, the Federation of State Medical Boards (2002) has issued Model Guidelines for Physician Use of Complementary and Alternative Therapies for: ‘‘(1) physicians who use CAM in their practices, and/or (2) those who co-manage patients with licensed or otherwise state-regulated CAM providers.’’ These guidelines explicitly state that discipline should not be premised on inclusion of CAM therapies alone but should depend on whether the physician has delivered therapies lacking in safety and efficacy. The guidelines are not binding but rather offer a framework for individual state medical boards to regulate physicians integrating CAM therapies.

Third-party reimbursement typically involves a number of insurance policy provisions, and corresponding legal rules, designed to ensure that reimbursement is limited to ‘‘medically necessary’’ treatment; does not, in general, cover ‘‘experimental’’ treatments; and is not subject to fraud and abuse (Cohen, 1998). In general, insurers have been slow to offer CAM therapies as core benefits – largely because of insufficient evidence of safety, efficacy, and cost effectiveness – though a number of insurers have offered policy-holders discounted access to a network of CAM providers.

Finally, healthcare fraud refers to the legal concern for preventing intentional deception of

patients. Overbroad claims regarding the potential success of a CAM therapy sometimes can lead to charges of common law fraud, and its related legal theory, misrepresentation (Cohen, 1998). Further, under Medicare and Medicaid fraud and abuse law, if the clinician or institution submits a reimbursement claim for care that the clinician knew or should have known was medically unnecessary, the practitioner could be liable for fraud under applicable federal law (Cohen, 1998).

Policy

The term ‘‘policy’’ often evokes government regulatory policy, though with respect to CAM therapies, policy can also refer to institutional policies and policy by professional medical associations and other actors.

Government policies run the gamut of issues such as which providers should be licensed (Cohen, 1998) to questions of regulating dietary supplements and other natural health products. Within the UK, questions of licensure have been particularly complex, as presently only the professions of osteopathy and chiropractic have statutory licensure, while others (such as acupuncture) rely on professional self-regulation (Stone, 2005).

Hospitals, free-standing clinics, nursing homes, and other healthcare institutions need to attend to institutional policy issues relating to CAM therapies, such as policies for confirming credentials, informed consent procedures, policies relating to limiting potential malpractice liability exposure, and institutional rules regarding continuance of patient use of dietary supplements (Cohen et al., 2005a, b).

The policies of professional medical associations concerning CAM therapies have been shifting over time toward greater acceptance of the fact that many patients do use such therapies on their own and routinely request relevant information about CAM therapies from their physicians. Increasingly, it behooves the medical practitioner to become familiar with the evidence base regarding those CAM therapies commonly in use.

For example, the American Medical Association House of Delegates passed a resolution in May 2006 stating that it would ‘‘support the incorporation of complementary and alternative medicine (CAM) in medical education as well as continuing medical education curricula, covering CAM’s benefits, risks, and efficacy.’’ The British Medical Association (2004), in its Annual Representatives Meeting Policies, enacted a Complementary Medicine Policy, stating that: ‘‘complementary therapy should be regulated by statutory authority.’’ As noted, some healthcare regulatory authorities outside of government have begun to enact more specific policies; a salient example would be the

Model Guidelines for Physician Use of Complementary and Alternative Therapies issued by the US Federation of State Medical Boards (2002).

Empirical studies

The many empirical studies of CAM therapies have been reviewed by various panels of medical experts, most notably in the USA by the Institute of Medicine (Institute of Medicine of the National Academies, 2005) and in the UK by the Prince of Wales’ Foundation for Integrated Health (2005).

The Institute of Medicine of the National Academies report (2005, Ch. 5 and Table 5-3) culled the best available evidence regarding CAM therapies as did the Cochrane review (Manheimer et al., 2004). With some stated limitations, the former highlighted use of a number of therapies including acupuncture for headache, calcium for prevention of hypertensive disorders and related problems in pregnancy and for bone loss, calcium and vitamin D for corticosteroidinduced osteoporosis, cranberries for preventing urinary tract infection, echinacea for preventing and treating the common cold, electromagnetic fields for osteoarthritis, folic acid and folinic acid for reducing side effects in patients receiving methotrexate, inositol for respiratory distress syndrome in preterm infants, transcutaneous electrical nerve stimulation (TENS) for rheumatoid arthritis in the hand and osteoarthritis in the knee, and TENS and acupuncture for primary dysmenorrhoea.

To supplement the discussion of the Institute of Medicine of the National Academies, primary sources for literature reviews include PubMed (http://nccam.nih.gov/camonpubmed/[maintained by the US National Library of Medicine]), the Clinical Trials site for the National Institutes of Health (www.clinicaltrials.gov), and the Cochrane Collaboration reviews (Manheimer et al. [2004]) and (http://www.compmed.umm.edu/Cochrane/ cam_reviews.html). The US National Center for Complementary and Alternative Medicine also provides reviews by treatment or therapy (http:// nccam.nih.gov/health/bytreatment.htm).

Within the UK the Prince of Wales’ Foundation for Integrated Health has conducted a number of detailed reviews regarding possible integration of CAM therapies in particular areas such as supportive and palliative care (Prince of Wales’ Foundation, 2005). The Foundation has also produced a report entitled Searching the Evidence: Complementary Therapies Research (2006), which reviews evidence relating to women’s health, pain management, and mental health.

How should I approach complementary and alternative medical therapies in practice?

In view of the above resources for empirical studies, clinicians can perform their own literature review to determine the relative liability risk pertaining to clinical integration of CAM therapies by assessing whether for a particular CAM therapy

(i) the medical evidence supports both safety and efficacy; (ii) the medical evidence supports safety, but evidence regarding efficacy is inconclusive; (iii) the medical evidence supports efficacy, but evidence regarding safety is inconclusive; or (iv) the medical evidence indicates either serious risk or inefficacy (Cohen and Eisenberg, 2002).

In the first instance, clinicians can recommend the CAM therapy without undue fear of liability, as a therapy deemed both safe and effective could be recommended regardless of whether it is classified as conventional or CAM. In the last instance, a

therapy that is either seriously risky or ineffective should be avoided and discouraged. Many CAM therapies will fall within the middle two groups, where liability is conceivable but probably unlikely; this would be particularly pertinent in (ii), where the product presumably is safe provided the clinician provides the patient with appropriate risk–benefit disclosure and warnings about possible contraindications and adverse reactions. In both (i) and (ii), clinicians can allow the patient to use the CAM therapy in question, while providing appropriate caution and continuing to monitor conventionally (Cohen and Eisenberg, 2002).

If the patient’s condition deteriorates, then the physician should consider intervening conventionally (Cohen and Eisenberg, 2002). The clinician must remain alert to the medical evidence regarding CAM therapies, and particularly herbal therapies, which may contain previously unclassified hazards; the categorization of therapies over time into any given region of the framework may change according to new medical evidence (Cohen and Eisenberg, 2002). Further, since, as noted, injury to the patient is part of the definition of malpractice, the perception of injury – including a poor physician–patient relationship – can lead to litigation, while improving the therapeutic alliance tends to reduce liability risk (Schouten and Cohen, 2004).

In general, clinicians can attempt to limit liability risk through the following:

Determine the clinical risk by assessing the medical evidence and thereby deciding whether to a recommend; allow, caution, and monitor; or avoid and discourage (Cohen and Eisenberg, 2002).

Continue to monitor conventionally and intervene conventionally when medically necessary, so that the standard of care likely will be met and the possibility of patient injury minimized (Cohen and Eisenberg, 2002).

Engage the patient in a robust informed consent and shared decision-making process, clearly laying out risks and benefits, and documenting the conversation in the medical record (Cohen and Eisenberg, 2002).

When contemplating referral to a CAM provider, undertake reasonable investigation of the practitioner’s credentials, practice style, malpractice and disciplinary history, and general competence in order to be satisfied that the referral is unlikely to increase the risk of patient injury and of vicarious or shared liability (Eisenberg et al., 2002).

Obtain consultation and document this in the patient’s record to help to establish the standard of care in the community, and keep clear medical records that show how treatment options were discussed and decisions made with patients (Schouten and Cohen, 2004).

Physicians also should familiarize themselves with documentation standards suggested by the

Federation of State Medical Boards (2002) guidelines, and whether these are applicable in their state or home institution.

The legal doctrine of ‘‘assumption of risk’’ may, in some US states, be available as a defense to medical malpractice involving use of CAM therapies if the patient has knowingly, intelligently, and voluntarily make a choice to try such therapies in addition to or in lieu of conventional care (Schneider v. Revici, 1987). The few US cases on these issues so far have allowed both an express (Boyle v. Revici, 1992) and implied (Charell v. Gonzales, 1997) assumption of risk defense, suggesting that although courts generally tend to disfavor attempts to waive liability for medical malpractice (Tunkl v. Regents of the University of California, 1963) some courts may allow patients to make affirmative choices regarding use of CAM therapies, relieving physicians or some or all of liability.

The case

Dr. N’s conversation with Ms. M concerning treatment options involving CAM therapies such as homeopathy should not, in itself, raise liability concerns. In fact, by describing the risks and benefits of the proposed approach, Dr. N can satisfy the obligation of informed consent and engage

Ms. M in shared decision making. By monitoring and standing ready to intervene conventionally when medically necessary, Dr. N could further limit potential malpractice liability risk.

A state whose legislation allows medical board discipline for ‘‘any departure from prevailing and acceptable medical standards, irrespective of patient harm,’’ could conceivably discipline Dr. N merely for discussing homeopathy in this case, though a number of states have ‘‘medical freedom’’ laws that would protect Dr. N from such unwarranted consequences. Furthermore, if Dr. N were to follow the Federation of State Medical Boards (2002) guidelines, disciplinary consequences would similarly be unlikely.

Once again, the above review and analysis are grounded in US law, and although an international, comparative law perspective is beyond the scope of this chapter, the salient issues and areas of controversy cut across nations, with particular resonance among common law countries, which will share basic definitions of practitioner licensure, informed consent, and medical malpractice.

REFERENCES

Adams, K. E., Cohen, M. H., Jonsen, A. R., and Eisenberg, D. M. (2002). Ethical considerations of complementary and alternative medical therapies in conventional medical settings. Ann Intern Med 137: 660–4.

American Medical Association (2006). House of Delegates, Resolution 3-06 (A-06). Chicago, IL: American Medical Association.

Boon, H. (2002). Regulation of complementary/alternative medicine: a Canadian perspective. Complement Ther Med 10: 14–19.

Boon, H. (2003). Regulation of natural health products in Canada. Clin Res Regul Aff 20: 299–312.

Boyle v. Revici (1992). 961 F.2d 1060 (2d Cir).

British Medical Association (2004). Annual Representatives Meeting Policies: Complementary Medicine Policy. London: British Medical Association.

Charell v. Gonzales (1997). 660 New York Supplement 2d 665, 668 (S.Ct., N.Y. County, 1997), affirmed and modified to vacate punitive damages award, 673 New York

Supplement 2d 685 (App Div., 1st Dept., 1998), reargument denied, appeal denied, 1998 New York Appellate Division LEXIS 10711 (App. Div., 1st Dept., 1998), appeal denied, 706 Northeastern Reporter 2d 1211 (1998).

Cohen, M. H. (1998). Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives. Baltimore, MD: Johns Hopkins University Press.

Cohen, M. H. (2000). Beyond Complementary Medicine: Legal and Ethical Perspectives on HealthCare and Human Evolution. Ann Arbor, MI: University of Michigan Press.

Cohen, M. H. (2003). Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health and Healing in Human Transformation. Ann Arbor, MI: University of Michigan Press.

Cohen, M. H. (2004a). Healing at the borderland of medicine and religion: regulating potential abuse of authority by spiritual healers. J Law Relig 18: 373–426.

Cohen, M. H. (2004b). Legal and ethical issues in complementary medicine: a US perspective. Med J Aust 181: 168–9.

Cohen, M. H. (2006). Legal and ethical issues relating to use of complementary therapies in pediatric hematology/oncology. J Ped Hematol Oncol. 28: 190–3.

Cohen, M. H. and Eisenberg, D. M. (2002). Potential physician malpractice liability associated with complementary/integrative medical therapies. Ann Intern Med 136: 596–603.

Cohen, M. H. and Kemper, K. J. (2005). Complementary therapies in pediatrics: a legal perspective. Pediatrics 115: 774–80.

Cohen, M. H. and Ruggie, M. (2004). Integrating complementary and alternative medical therapies in conventional medical settings: legal quandaries and potential policy models. Cinn Law Rev 72: 671–729.

Cohen, M. H., Hrbek, A., Davis, R., et al. (2005a). Emerging credentialing practices, malpractice liability policies, and guidelines governing complementary and alternative medical practices and dietary supplements recommendations: a descriptive study of 19 integrative healthcare centers in the US. Arch Int Med 165: 289–95.

Cohen, M. H., Sandler, L., Hrbek, A., et al. (2005b). Policies Pertaining to complementary and alternative medical therapies in a random sample of 39 academic health centers. Alt Ther Health Med 11: 36–40.

Eisenberg, D. M., Cohen, M. H., Hrbek, A., et al. (2002). Credentialing complementary and alternative medical providers. Ann Intern Med 137: 965–73.

Ernst, E. E. and Cohen, M. H. (2001). Informed consent in complementary and alternative medicine. Arch Intern Med 161: 2288–92.

Federation of State Medical Boards (2002). Model Guidelines for Physician Use of Complementary and Alternative Therapies in Medical Practice. Washington, DC: Federation of State Medical Boards.

Institute of Medicine of the National Academies (2005).

Complementary and Alternative Medicine in the United States. Washington, DC: National Academies Press.

Manheimer, E., Berman, B., Dubnick, H., Beckner, W. (2004). Cochrane Reviews of Complementary and Alternative Therapies: Evaluating the Strength of the Evidence. Ottawa: Cochrane Collaboration.

Prince of Wales’ Foundation for Integrated Health (2005).

Evaluation of the National Guidelines for the Use of Complementary Therapies in Supportive and Palliative Care. London: Prince of Wales’ Foundation for Integrated Health.

Prince of Wales’ Foundation for Integrated Health (2006).

Searching for Evidence: Complementary Therapies Research. London: Prince of Wales’ Foundation for Integrated Health.

Schneider v. Revici (1987) 817 Federal Reporter 2d 987 (2d Cir.).

Schouten, R. and Cohen, M. H. (2004). Legal issues in integration of complementary therapies into cardiology. In Complementary and Integrative Therapies for Cardiovascular Disease, ed. W. H. Frishman, M. I. Weintraub, and M. S. Micozzi. Edinburgh: Elsevier, pp. 20–55.

Stone, J. (2005). Development of Proposals for a Future Voluntary Regulatory Structure for Complementary HealthCare Professions: A Report Commissioned by The Prince of Wales’ Foundation for Integrated Health. London: The Prince of Wales’ Foundation for Integrated Health.

Stone, J. and Matthews, J. (1996). Complementary Medicine and the Law. Oxford: Oxford University Press.

Studdert, D. M., Ersenberg, D. M., Miller, F. H., et al. (1998). Medical malpractice implications of alternative medicine. JAMA 280: 1620–5.

Tunkl v. Regents of the University of California (1963) 383 Pacific Reporter 2d 441.

UK House of Lords Committee on Science and Technology (2002). Sixth Report: Complementary and Alternative Medicine. London: Stationery Office.

US White House Commission on Complementary Medicine Policy (2002). Final Report. Washington, DC: Government Printing Office.

Aboriginal (North American) peoples 383–4 abortion see termination of pregnancy academic bioethics 1, 316, 330 accountability

of bioethics services 315, 319, 323, 324, 326–7 public 514

‘‘accountability for reasonableness’’ 244, 252, 253, 254, 255

accreditation of healthcare providers Canada 304, 323

USA 245, 313, 323

acquired immunodeficiency syndrome see HIV/AIDS administration of bioethics services 313–20, 322–7

community healthcare example 301–4 administrative ethics 243–8

institutional conflict of interest 223, 226, 227, 228 resource allocation 243, 246, 247–8, 251, 255

adolescents

confidentiality of sexual health advice 46, 478–9 consent 34, 124, 421

see also children adoption studies 175

advance care planning 51, 54, 55–6, 65–70 advance directives

for Buddhists 395

in emergency medicine 472 for Jehovah’s Witnesses 421 living wills 13, 63, 65, 66, 68–70 proxy directives 59, 62, 68

see also do-not-resuscitate (DNR) orders adverse events

in clinical trials 202, 224, 225 corporate responsibility 245 disclosure 27, 37, 40, 257–62

pharmacists’ responsibility to counsel patients 505, 510–11

rates of 260, 506 advertising

direct-to-consumer 496–500, 501–2

to healthcare professionals 267, 268, 270 via pharmacists 508–9

Africa

availability of drugs 254, 360 ethics website 334

life expectancy 369

see also developing countries aid, international 369–74

Aid to Capacity Evaluation 21 AIDS see HIV/AIDS

alcohol abuse, capacity and 469, 470, 471, 472–3 allelic association studies 176

allocation of resources see resource allocation alpha-fetoprotein (AFP) 106

alternative medicine 513–19 Aboriginal peoples 385 Ayurveda 404, 406 Chinese 398–9

America see USA

American Academy of Pediatrics 124

American College of Emergency Physicians 471 American College of Obstetrics and Gynecology 106 American College of Physicians 38

American College of Physicians and Surgeons 259 American Geriatric Society 60

American Medical Association 45, 448, 458, 498, 517 American Society of Anesthesiologists 457, 458 Americans with Disabilities Act (1990) (USA) 107, 163, 483 amniocentesis 105

522 Index

anesthesiology 25, 33, 454–9 analgesia

in end of life care 54, 55, 393 hastening death 72–5

anthrax scare (USA) 281, 284 antibiotics 483, 485

antisocial behavior, genetic basis of 174, 177, 179, 180–1 applied ethics 3, 316

assault 18, 189

see also children, abuse of assent 122

see also consent

assisted reproduction 112–17, 234 eugenics 115–16, 178

religious views on 412, 434, 438 assisted suicide 51, 72–5, 427, 508

see also euthanasia

Association of American Medical Colleges 226 ‘‘assumption of risk’’ 519

Australia

adverse events 260

assisted reproduction 114, 115, 116 confidentiality 45

disclosure 25, 37 organizational ethics 246

autologous blood transfusion 418 autonomy

in alternative medicine 514 capital punishment and 455–6 of children 121 confidentiality and 44

consent and 12, 17, 24, 27, 32, 510 cultural differences 28

Aboriginal peoples 385, 386, 389 Chinese culture 67, 397–8, 401 Hinduism/Sikhism 404

Judaism 426 Protestantism 432

decision making and 54, 59, 65, 67 in end of life care 65, 67, 73, 466 in mental illness 13, 489

in pregnancy 98–9 in surgery 448

autopsy 411 Ayurveda 404, 406

babies see newborns

bad news see truth telling

bed allocation in ICUs 251, 253–4, 255, 462–4, 466–7

bedside rationing 251, 253–5 behavioral genetics 144, 174–81 Belgium 73

Belmont Report (1979) (USA) 185, 188, 195, 214 beneficence

capital punishment and 456 combating torture 355 consent and 17, 24

corporate social responsibility and 364 DNR orders and 455

infectious diseases, treatment of 484 pain control 54

in research 188, 190, 203, 215–16, 217, 227 placebo trials and 187, 191–2, 203, 215

bereavement 56 Berger, John 289

bias (statistical) 202, 208 bio-banking 161, 162, 166–72, 209 bioterrorism 281, 282, 283

birth control 393, 419, 438

bladder replacement therapy 153, 158 blame, assignment of 258, 260

blood transfusions, Jehovah’s Witnesses and 33, 124, 416, 417–18, 419–22, 434

bone marrow donation 127, 129, 130–1, 419 brain

imaging 495–6, 498–9, 500–1, 502 neuroregenerative therapies 154, 155, 157

brain death 85–90, 146, 393, 412 during pregnancy 90, 436, 439–40

Brazil 155

breast cancer, genetic testing for 160, 164 British Columbia Transplant Society 147 British Medical Association 38, 517 broad consent 168, 169, 171, 211 Buddhism 391–5

Canada

Aboriginal peoples 383–4 accreditation 304, 323

assisted reproduction 114, 115, 116 bio-banking 168, 169, 170

children

child abuse 132

medical treatment 33, 122, 124 confidentiality 189

consent

disclosure 25, 37, 38 refusal of treatment 434

voluntariness 32, 33 death, diagnosis of 88 euthanasia 73, 74

management of bioethics services 315, 316, 317, 318, 319, 323–7

maternal and fetal interests 99–100 medical errors 257, 259

organ donation 88, 147, 148 organizational ethics 246, 253, 254 reportable diseases 276

research 155, 196

rural healthcare 290, 292 self-referred imaging 499 substitute decision making 59, 60 teaching resources 334, 335

top 10 ethical challenges 310 Canadian Medical Association 38, 60

Canadian Medical Protective Association 259 Canadian Paediatric Association 124

cancer

assisted reproduction after treatment for 113, 114 disclosure of diagnosis 38, 39, 383, 389–90

capacity 17–22, 58

in children 18, 121–5, 124–5, 130 consent 19, 20, 21, 491

in emergency medicine 469, 470, 471, 472–3 in the ICU 466

in mental illness 19, 20, 491

in regenerative medicine 154, 157 in surgery 450

see also substitute decision making capital punishment 454, 455–7, 458–9 cardiac arrest, as definition of death 86

cardiopulmonary resuscitation (CPR) see resuscitation case discussions in training 330–2

casuistry 4, 432

Catholicism 234, 235, 436–41 charity 372

ch’i 398 children

abuse of 132–7

capacity 18, 121–5, 124–5, 130 confidentiality 46, 475, 478–9

decision making for/by 33, 114, 121–5, 128 refusal of treatment 33, 124, 421, 434

genetic testing 160, 161, 164, 179–80 newborn screening 104, 105, 106, 107, 108–9 non-therapeutic interventions 127–31 research on 129, 201, 205, 233

Index 523

truth telling 39, 122, 124–5 voluntariness 32, 33

China

life expectancy 371 sale of organs 147

stem cell research 155, 235 Chinese culture 67, 397–402 Chinese medicine 398–9 chorionic villus sampling 105 Christianity

in Aboriginal communities 387 Catholicism 234, 235, 436–41 Protestantism 234, 235, 430–5 see also Jehovah’s Witnesses

circumcision, male 127

Clinical Ethics Network (UK) 315, 316, 318, 319 clinical trials 201–5

consent in regenerative medicine trials 154, 157 enrollment 204

financial inducements to physicians 187–92, 223, 226, 228

patient factors 205, 214, 216, 219 financial conflict of interest 187–92, 222–8 involving placebos 187, 191–2, 203, 215

HIV trials in developing countries 341, 346–7 physician–researcher dual role 204, 214–19

cloning 155, 156, 157, 232 coercion 31, 32, 115, 216, 455

involuntary admission in mental illness 33–4, 490, 491–2

in treatment of pregnant women 98–101 see also voluntariness

cognitive impairment, incapacity and 19 COI see conflict of interest

collegial review of innovations 195, 197, 198 colostomy 411

coma 85, 89

see also brain death

communicable diseases see infectious diseases communication skills

admission of medical error 261–2 breaking bad news 39, 80–1, 89 children and their families 122, 125 for consent 19, 20–1, 27–8, 157

in end of life care 55 advance care planning 68

conflict avoidance/resolution 80–1, 82 substitute decision making 60–1, 62–3

genetic testing 164