1 Relman, Arnold S., Assessment and Accountability: The Third Revolution in Medical Care, 319 New Eng. J. Med. 1220 (1988)Google Scholar. Dr. Relman was then Editor-in-Chief of the Journal.

2 The literature on quality assessment and improvement first emerged in the late 1960s and early 1970s. See, e.g., Robert H. Brook, Quality of Care Assessment: A Comparison of Five Methods of Peer Review (1973); John W. Williamson, Dep't of Hew, Public Health Services, Outcomes of Health Care: Key to Health Improvement, Outcomes Conference I-II: Methodology of Identifying, Measuring, and Evaluating Outcomes of Health Service Programs, Systems, and Subsystems 75-101 (1969); W., Jeffrey Fessel & E.E., Van Brunt, Assessing Quality of Care from the Medical Record, 286 New Eng. J. Med. 134 (1972)Google Scholar; Sanazaro, Paul J. et al., Research and Development in Quality Assurance: The Experimental Medical Care Review Organization Program, 287 New Eng. J. Med. 1125 (1972)Google Scholar; Williamson, John W., Evaluating Quality of Patient Care: A Strategy Relating Outcome and Process Assessment, 218 JAMA 564 (1971)Google Scholar.

It has since grown at a fast rate. See, e.g., Avedis Donabedian, The Definition of Quality and Approaches to its Assessment (1980)[Hereinafter Donabedian, The Definition of Quality]; Institute of Medicine, Improving the Quality of Care in Nursing Homes (1986) [Hereinafter Institute of Medicine, Nursing Homes] ; Institute Of Medicine, Medicare: A Strategy for Quality Assurance, Vol. I (Kathleen N. Lohr ed., 1990) [hereinafter Institute of Medicine, MedCare]; Berwick, Donald M., Continuous Improvement as an Ideal in Health Care, 320 New Eng. J. Med. 53 (1989)Google Scholar; Robert H. Brook et al., Assessing the Quality of Medical Care Using Outcome Measures: An Overview of the Method, Med. Care, Sept. 1977, Supp. at 1; Avedis, Donabedian, A Primer of Quality Assurance and Monitoring in Medical Care, 20 U. TOL. L. Rev. 401 (1989)Google Scholar; Avedis, Donabedian, The Quality of Care: How Can It Be Assessed?, 260 JAMA 1743 (1988)Google Scholar [hereinafter Donabedian, The Quality of Care]; Ellwood, Paul M., Outcomes Management: A Technology of Patient Experience 318 New Eng. J. Med. 1549 (1988)Google Scholar; Sheldon, Greenfield, The State of Outcome Research: Are We On Target?, 320 New Eng. J. Med. 1142 (1989)Google Scholar; Kane, Robert L. & Nicole, Lurie, Appropriate Effectiveness: A Tale of Carts and Horses, 18 Quality Rev. Bull. 322 (1992)Google Scholar; Kane, Rosalie A. & Kane, Robert L., Long-Term Care: Variations on a Quality Assurance Theme, 25 Inquiry 132 (1988)Google Scholar; Kassirer, Jerome P., The Quality of Care and the Quality of Measuring It, 329 New Eng. J. Med. 1263 (1993)Google Scholar; Phelps, Charles E., The MethodologtcFoundations of Studies of the Appropriateness of Medical Care, 329 New Enc. J. Med. 1241 (1993)Google Scholar; Wennberg, John E. et al., An Assessment of Prostatectomy for Benign Urinary Tract Obstruction: Geographic Variations and the Evaluation of Medical Outcomes, 259 JAMA 3027 (1988)Google Scholar. There are now a number of journals devoted to quality assurance, including Quality Review Bulletin, the American Journal of Medical Quality (originally Quality Assurance and Utilization Review), and Quality Assurance in Health Care. See Richards, Daniel T. & Joseph F. O'Donnell, Quality Assurance, 270 JAMA 2102 (1993)Google Scholar (reviewing two new ones).

Quality assessment and improvement have also spawned a legal literature. See, e.g., Brennan, Troyen A., Improving the Quality of Medical Care: A Critical Evaluation of the Major Proposals, 10 Yale L. & Pol'y Rev. 431 (1992)Google Scholar [hereinafter Brennan, Improving the Quality]; Furrow, Barry R., The Changing Role of the Law in Promoting Quality in Health Care: From Sanctioning Outlaws to Managing Outcomes, 26 Hous. L. Rev. 147 (1989)Google Scholar; Havighurst, Clark C. & Blustein, James F., Coping with Quality/Cost Trade-Offs in Medical Care: The Role of PSROs, 70 NW. U. L. REV. 6 (1975)Google Scholar; Timothy Stoltzfus, Jost, The Necessary and Proper Role of Regulation to Assure the Quality of Health Care, 25 Hous. L. Rev. 525 (1988)Google Scholar; Mehlman, Maxwell J., Assuring the Quality of Medical Care: The Impact of Outcome Measurement and Practice Standards, 18 Law Med. & Health Care 368 (1990)Google Scholar. Of course, if the malpractice litigation system is considered a mechanism of quality control, the literature becomes enormous. The Harvard Malpractice Study is a particularly important effort to use a broad measure of quality the incidence of adverse events to assess the malpractice system. See Paul C. Weiler Et al., A Measure of Malpractice: Medcal Injury, Malpractice Litigation, and Patient Compensation (1993).

An important subdivision of the legal, medical, and health services literature on quality focuses on the use of medical practice guidelines to promote quality. See, e.g.. Institute of Medicine, Clinical Practice Guidelines: Directions for a New Procram (Marilyn J. Field & Kathleen N. Lohr eds., 1990) [hereinafter Institute of Medicine, Clinical Practice Guidelines]; Anderson, Gerard F. et al., Medical Technology Assessment and Practice Guidelines: Their Day in Court, 83 Am. J. Pub. Health 1635 (1993)Google Scholar; Brennan, Improving the Quality, supra; Brennan, Troyen A., Practice Guidelines and Malpractice Litigation: Collision or Cohesion, 16 J. Health Pol. Pol'y & L. 67 (1991)Google Scholar; Hall, Mark A., The Defensive Effect of Medical Practice Policies in Malpractice Litigation, 54 Law & Contemp. Probs. 119 (1991)Google Scholar; Clark C, Havighurst, Practice Guidelines as Legal Standards Governing Physician Liability, 54 Law & Contemp. Probs. 87 (1991)Google Scholar; Leape, Lucian L., Practice Guidelines and Standards: An Overview, 16 Quality Rev. Bull. 42 (1990)Google Scholar; Mehlman, supra.

3 For the purposes of this Article, consumers of health care include current patients, people currently enrolled in health plans, individuals choosing health plans, and employers electing what plans to offer employees.

4 Witness each era's popular vision of the physician on television. The Era of Expansion featured Ben Casey and Dr. Kildare, physicians in big-city high-tech hospitals, both series beginning in 1961. The Era of Cost Containment abandoned this awed fascination with the hospital for the folksy low-tech practice of general practitioner Dr. Marcus Welby (1969-76), the gallows humor of MASH surgery during the Korean War (1972-83), and the unglamorous reality of an inner city hospital in St. Elsewhere (1982-88). The third era now upon us has its characteristic vision too. In the Fall of 1987, at the end of Dr. Relman's Era of Cost Containment, the hospital in St. Elsewhere was taken over by the huge, profit-oriented Ecumena Hospitals Corporation, subjecting the staffto the'business of medicine. TIM Brooks & Earle Marsh, The Complete Directory to Prime Time Network TV Shows, 1964-Present 235-36, 533-34, 553, 773-74 (1992). The doctor show of the Era of Assessment and Accountability appears to be Northern Exposure, with Dr. Joel Fleischman isolated in Cicely, Alaska, stripped of the high-tech equipment of his television forebears, and regularly reminded of his contractual obligations by Maurice Minnifield. Id. at 652-53. The characters names alone trace an evolution: the thrill of kill-dare; yielding to the reassuring well-be; and finally Fleischman, demoted to butcher (in German) and the archetypal outsider, transplanted from the Upper West Side. Cf Richard Malmsheimer, Doctors Only: The Evolving Image of the American Physician 131 (1988) (Welby was perhaps too obviously well-named).

5 Physicians of the era were overwhelmingly males. Indeed, Arnold Relman recounts that it was not until 1970-71 the end of the Era of Expansion that [t]he percentage of female matriculants [at medical schools] began to rise abruptly . In 1969-1970 approximately nine percent of new first-year students were women . Relman, Arnold S., The Changing Demography of the Medical Profession, 321 New Eng. J. Med. 1540, 1540 (1989)Google Scholar. Relman suggests that the gender shift is linked to the shift in the economic conditions of medical practice:

[M]edicine is now viewed by white male college graduates as a much less attractive career than heretofore . [T]he most important.. . [explanations] are the rising cost of medical education and a growing concern about future professional autonomy and economic opportunity. Women have shown a greater preference for salaried practice and less remunerative specialties .

Id. at 1541. See generally Regina Markell Morantz-Sanchez, Sympathy and Science: Women Physicians in American Medicine (1985) (discussing the history of women physicians).

6 See Jay Katz, The Silent World of Doctor and Patient (1984).

7 Joseph Fletcher, Morals and Medicine 34 (1960) (first published in 1954).

8 See Katz, supra note 6, at 59-71 (discussing Salgo v. Leland Stanford Jr. University Bd. of Trustees, 317 P.2d 170 (Cal. Dist. Ct. App. 1957) and Natanson v. Kline, 350 P.2d 1093, clarified and reh'g denied, 354 P.2d 670 (Kan. I960)).

9 Paul Ramsey, The Patient as Person: Explorations in Medical Ethics (1970).

10 Canterbury v. Spence, 464 F.2d 772 (D.C. Cir.), cert, denied, 409 U.S. 1064 (1972). But see Katz, supra note 6, at 71-80 (discussing die limits of Canterbury). 11 See Warren T. Reich, How Bioethics Got Its Name, Hastings Center Rep., Special Supp., Nov.-Dec. 1993, at S6-S7 (part of a collection of articles entitled The Birth of Bioethics).

12 See David J. Rothman, Strangers at the Bedside: A History of How Law and Bioethics Transformed.Medical Decisionmaking (1991).

13 The National Commission for the Protection of Human Subjects ran 1974-78; the Department of Health, Education, and Welfare's Ethics Advisory Board 1978-80, and the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research 1978-83. The Congressional Biomedical Ediics Advisory Committee technically ran 1985-89, but in reality died in partisan squabbling and never functioned. See Office of Technology Assessment, Biomedical Ethics in U.S. Public Policy Background Paper, Pub. No. OTA-BP-BBS-105 at 4, 7-13 (1993) [hereinafter Office of Technology Assessment, Biomedical Ethics] .

14 Judge Robinson's opinion in Canterbury, 466 F.2d at 272, inaugurated a new era in the history of informed consent, and provoked an outpouring of ethical literature trying to influence future judicial developments. See Katz, supra note 6, at 75; Ruth R. Faden & Tom L. Beauchamp, A History and Theory of Informediconsent 132-40 (1986). The first major termination of treatment case was In re Quinlan, 355 A.2d 647 (N.J.), cert, denied, 429 U.S. 922 (1976). It has provoked a similar outpouring.

15 The Harvard Committee's 1968 recommendations on brain death helped set the stage for state legislation on brain death starting with Kansas in 1970. A 1972 law review article was subsequently influential. See Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain, Death, A Definition of Irreversible Coma, 205 JAMA 337 (1968)Google Scholar; Alexander Morgan Capron & Kass, Leon R., A Statutory Definition of the Standards for Determining Human Death: An Appraisal and a Proposal, 121 U. Pa. L. Rev. 87 (1972)Google Scholar; see also President's Commission for the Study of Ethical Problems in Medicine and Biological and Behavioral Research, Defining Death 62-70 (1981) [hereinafter President's Commission, Defining Death]. There were also state judicial decisions on brain death starting in the 1970s. See, e.g.. State v. Fierro, 603 P.2d 74 (Ariz. 1979); Commonwealth v. Golston, 366 N.E.2d 744 (Mass. 1977), cert, denied, 434 U.S. 1039 (1979); People v. Eulo, 482 N.Y.S.2d 436 (1984); In re Bowman, 617 P.2d 731 (Wash. 1980). See generally President's Commission, Defining Death, supra, at 136-46.

State legislation on advance directives began with California's enactment in 1976 of the Natural Death Act. See Cal. Health & Safety Code 7185 to 7194.5 (West Supp. 1994); see also Alan Meisel, The Right to Die 324 (1989 & Supp. 1993).

16 See Linda L. Emanuel et al., Recommendations for Accountability in Ethical Aspects of Patient Care (Mar. 1994) (on file with the author); Mehlman, supra note 2, at 373.

17 See 42 U.S.C.A. 11101-52 (West Supp. 1994). The statute requires the reporting of certain information about physicians and others to the Secretary of Health and Human Services (see 11131), but section 11137(b)(1) renders the information confidential. Regulations make information from the National Practitioner Data Bank unavailable to the public, except that an attorney or individual acting pro se in a malpractice action or claim against a hospital may request information about a practitioner named in the suit. However, that information will only be disclosed if the hospital itself failed to request it on the regular basis mandated by the statute and regulations. See 45 C.F.R. 60.11(a)(5), 60.13 (1993).

18 See, e.g., Note, Provider-Specific Quality-of-Care Data: A Proposal for Limited Mandatory Disclosure, 58 Brook. L. Rev. 85 (1992) [hereinafter Note, Provider-Specific Quality-of-Care Data]. On the controversy over publicizing hospital morbidity and mortality statistics, see Office of Technology Assessment, The Quality of Medical Care: Information for Consumers 201 (1988); Berwick, Donald M. & Wald, David L., Hospital Leaders Opinions of the HCFA Mortality Data, 263 JAMA 247 (1990)Google Scholar; Hartz, Arthur J. et al., Hospital Characteristics and Mortality Rates, 321 NEW ENG. J. Med. 1720 (1989)Google Scholar; Luft, Harold S. et al., Does Quality Influence Choice of Hospital?, 263 JAMA 2899 (1990)Google Scholar.

19 For an example of reliance on professionals to represent patients interests in quality, see the National Practitioner Data Bank, which must be used by hospitals to check any physician applying for clinical privileges or a staff position, and to check at least every two years all physicians already granted privileges or such a position. See 45 C.F.R. 60.10 (1993). This is an indirect protection of patients. Similarly, the Data Bank is open under certain circumstances to plaintiffs attorneys but not their clients, as noted supra note 17.

20 Mark Pauly regards this as inevitable: [T]here is little chance of returning to the era in which authorities were trusted to assure medical services quality. In the role of the consumer, or in the role of voter, citizens will be making choices based on outcomes. Pauly, Mark V., The Public Policy Implications of Using Outcome Statistics, 58 Brook. L. Rev. 35, 53 (1992)Google Scholar.

21 See infra notes 41-44 and accompanying text.

22 See, e.g., The Act Up/New York Women and AIDS Book Group, Women, AIDS, and Activism (1990); Randy Shilts, and the Band Played on: Politics, People, and the AIDS Epidemic (1987).

23 See, e.g., Elsa Brenner, New Activism Over Breast Cancer, N.Y. TIMES, Oct. 24, 1993, at Sec. 13WC, p. 1.

24 Work on quality assessment has been particularly important in the Medicare program. For an overview, see Institute of Medicine, Med.Care, supra note 2.

25 There is a smattering of suggestions in the literature that we might apply quality assessment to ethics, either by assessing the quality of ethics consultants and committees, or (more rarely) by assessing the ethical behavior of health professionals within a health care organization. On the former score, see, for example, articles in 18 Quality Rev. Bull. (1992), including Anzia, Daniel J. & John La, Puma, Quality Care and Clinical Ethics, 18 Quality Rev. Bull. 21 (1992)Google Scholar; Troyen, Brennan, Quality of Clinical Ethics Consultation, 18 Quality Rev. Bull. 4 (1992)Google Scholar; John La, Puma & E., Rush Priest, Medical Staff Privileges for Ethics Consultants: An Institutional Model, 18 Quality Rev. Bull. 17 (1992)Google Scholar; Mark, Siegler, Definingthe Goals of Ethics Consultations: A Necessary Step for Improving Quality, 18 Quality Rev. Bull. 15 (1992)Google Scholar; see also Fletcher, John C., Standards for Evaluation ofEthics Consultation, in Ethics Consultation in Health Care 173 (John C. Fletcher et al. eds., 1989)Google Scholar, Singer, Peter A. et al., Ethics Committees and Consultants, 1 J. Clinical Ethics 263 (1990)Google Scholar. Sigfrid Fry-Revere calls for bioethics accountability, but with no mention of quality assessment tools, in The Accountability of Bioethics Committees and Consultants (1992). On the latter score assessing the ethical behavior of health professionalssee Emanuel et al., supra note 16; Sister Mary Rose, Whiteneck, Integrating Ethics with Quality Assurance in Long Term Care, 14 Quality Rev. Bull. 138 (1988)Google Scholar.

26 See supra note 25.

27 See, e.g., Arthur L. Caplan, Ethical Qualifications Concerning Quality in Health Care, Midwest Medical Ethics, Fall 1989, at 9.

28 See, e.g., Wennberg et al., supra note 2.

29 For a brief explanation of the distinctions between the three, see Donabedian, The Quality of Care, supra note 2.

30 Avedis, Donabedian, Quality in Health Care: Whose Responsibility Is It?, 8 AM. J. Med. Quality 32 (1993)Google Scholar.

31 See, e.g., Veatch, Robert M., Justice and Outcomes, 4 J. Cun. Ethics 258 (1993)Google Scholar.

32 I do not address in this Article the question of whether data on the ethical behavior of individual physicians should also be released to patients and consumers as an instrument of direct public accountability. On some of the distinct legal issues surrounding release of data on individual physicians, see Note, Provider-Specific Quality-of-Care Data, supra note 18; James B. Simpson, U.S. Congress, Or am of Technology Assessment, Release of Physician-Specific Quality of Care Information: Legal Issues (1988).

33 See, e.g., Mehlman, supra note 2, at 375 (writing in 1990 that [a]t this stage, outcome measurements must be regarded as still experimental); see also Tannenbaum, Sandra J., What Physicians Know, 329 New Eng. J. Med. 1268 (1993)Google Scholar; Kassirer, supra note 2.

34 Brennan, Improving the Quality, supra note 2, at 431-33 & n.6.

35 See Katz, supra note 6, at 93-94.

36 See Jost, supra note 2, at 525 (citation omitted).

37 See Berwick, supra note 2.

38 The President's proposal is the Health Security Act, H.R. 3600, S. 1757, 103d Cong., 1st Sess. (1993) [hereinafter Health Security Act]. This Article discusses the bill as introduced in 1993. Changes are anticipated. The other seven proposals as of the writing of this Article are: S. 491, H.R. 1200 (Rep. McDermott, Sen. Wellstone, lead sponsors); H.R. 3080, S. 1533 (Rep. Michel, Sen. Lott); H.R. 3222, S. 1579 (Rep. Cooper, Sen. Breaux); H.R. 3698, S. 1743 (Rep. Stearns, Sen. Nickles); H.R. 3704, S. 1770 (Rep. Thomas, Sen. Chafee); H.R. 3918, S.

39 White House Domestic Policy Council, The President's Health Security Plan: The Clinton Blueprint 4 (1993).

40 Id. at 7.

41 Id. at 12.

42 See, e.g., Health Security Act, supra note 38, at 1325(a)(2)(D); 1327; 1410; 5001-13.

43 Under the Clinton plan, each state that does not opt for a single-payer plan would be divided into regional alliances offering consumers in their areas a choice of health plans; larger corporations could form corporate alliances to do the same. See id. 1300-11.

44 The Council is also responsible for evaluating the impact of the Act itself on quality and access. 5005(b). The Council further supervises the development of clinical practice guidelines and associated methodologies by the Administrator for Health Care Policy and Research (AHCPR). 5006. The Council also directs the AHCPR to support research on different aspects of performance and quality. 5007.

In addition to the Council, the National Health Board establishes a National Quality Consortium of 11 members from academic health centers, schools of public health, and health professional schools. 5009. The Consortium advises the Council and AHCPR. 5009(b)(6).

45 For example, Rep. Cooper's bill which relies on voluntary Health Plan Purchasing Cooperatives (HPPCs, the precursors to the Clinton bill's health alliances) to pool individuals and small businesses required to offer coverage has a mechanism similar to the Health Security Act's for collecting quality data on health plans and reporting that data to consumers arid employers. The bill establishes a Health Care Standards Commission as an independent agency in the Executive branch. See H.R. 3222, supra note 38, at 1301. Among other duties, the Commission establishes a Benefits, Evaluations, and Data Standards Board (the BEDS Board) to recommend standards for information to be provided by health plans and how to evaluate health services. 1303. The Commission establishes standards for minimum acceptable quality for health plans. 1202(e). Each health plan then provides pertinent information to the relevant HPPC and the Commission, including on treatment outcomes. 1203. The HPPCs analyze the information and distribute it to eligible individuals and employers so they can compare health plans on price, outcomes, and enrollee satisfaction at least annually. 1104. The Cooper bill includes a section on patients rights, specifically the right to use advance directives, but with no cross-reference to the quality sections. 4111.

Sen. Chafee's bill, which relies on a mandate for individuals to buy insurance and provides vouchers for low-income people, also requires that quality data on health plans be conveyed to enrolled individuals. Title III of the bill is devoted to [q]uality [a]ssurance and [simplification. See S. 1770, supra note 38, t it III. Under this title, the Secretary of Health and Human Services (HHS) develops and publishes standards for quality assurance programs. 3001. In developing those standards, the Secretary ensures appropriate performance measures. 3001(c). Health plans must annually provide quality data including information on outcomes and effectiveness to the Secretary, the Health Care Coverage Area (HCCA), and enrolled individuals, using a format specified by the Secretary. 3001(b). The Chafee bill includes a separate title, Title VII, devoted to the Patient's Rights To Self-Determination Regarding Health Care. This focuses on advance directives and the Patient Self-Determination Act. But this title and the quality title make no reference to each other.

46 There is a long debate about what patient satisfaction data do and do not reveal about quality. See, e.g., Geary, Paul D. & McNeil, Barbara J., Patient Satisfaction as an Indicator of Quality Care, 25 Inquiry 25 (1988)Google Scholar. Patient satisfaction and dissatisfaction will be relevant to, but not dispositive of ethics evaluation.

47 See supra note 45.

48 Such required behavior includes discussion of treatment options with the patient, respect for patient decision making, allowing the patient to forgo life-sustaining treatment, and providing means of ethics consultation or review. These requirements are articulated by numerous sources, including the American Medical Association's Council on Ethical and Judicial Affairs in 1992 Code of Medical Ethics: Current Opinions, and The American College of Physicians Ethics Manual (3d ed., 1993). The Joint Commission on Accreditation of Healthcare Organizations now imposes these requirements through accreditation standards. See the Commission's 1994 Accreditation Manual for Hospitals 155-57 (1993) [hereinafter Joint Commission, 1994 Accreditation Manual for Hospitals].

49 The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation (George J. Annas & Michael A. Grodin eds., 1992); see also When Medicine Went Mad: Bioethics and the Holocaust (Arthur L. Caplan ed., 1992).

50 See Jones, James H., Bad Blood: The Tuskegee Syphilis Experiment 4, 204, 206-19 (1981)Google Scholar.

51 The bioethics literature recognizes the line between research and treatment (or practice) as a basic, though sometimes contested, division. See, e.g., Robert J. Levine, The Ethics and Regulation of Clinical Research 3-4 (2d ed., 1988).

52 See Faden & Beauchamp, supra note 14, at 162-63.

53 See Levine, supra note 51.

54 Rothman, supra note 12, at 3.

55 Id. at 105.

56 Id. at 142-43.

57 See generally The Birth of Bioethics, Hastings Center Rep., Nov.-Dec. 1993, Special Supp., at Sl-5.

58 Id.

59 Levine, supra note 51, at xi.

60 Id., describing the National Research Act, Pub. L. No. 93-348, 88 Stat. 342 (1974) (codified in scattered sections of 42 U.S.C.).

61 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, U.S. Dep't of Health, Education, and Welfare, Pub. No. (OS) 78-0013 (1978).

62 See 21 C.F.R. 56.101-.124 (1993) (discussing the composition and functions of IRBs reviewing research regulated by the Food and Drug Administration); 45 C.F.R. 46.101-.409 (1993) (discussing HHS policies toward human research subjects and IRB requirements).

63 There has been debate over whether IRBs produce effective enforcement of the human subjects regulations, given their documented inconsistency, the fact that they are not bound by precedent, and concerns that they are captive to their respective research institutions. See, e.g., Jerry, Goldman & Katz, Martin D., Inconsistency and Institutional Review Boards, 248 JAMA 197 (1982)Google Scholar; Carol Levine & Arthur L. Caplan, Beyond Localism: A Proposal for a National Research Review Board, IRB, Mar.-Apr. 1986, at 7; Robert J. Levine, Inconsistency and IRBs: Flaws in the Goldman-Katz Study, IRB,Jan.-Feb. 1984, at 4; Philip J. Hilts, Agency Faults U.C.L.A. Study for Suffering of Mental Patients, N.Y. TIMES, Mar. 10, 1994, at Al, All.

64 Rothman, supra note 12, at 145.

65 See Institutional Review Boards, 21 C.F.R. 56.107(d) (1993) (community member required on IRB); Protection of Human Subjects, 45 C.F.R. 46.107(d) (same); MD. Health-GEN. Code ANN. 19-372 (1990 & Supp. 1993) (community members permitted on ethics committees); Hoffmann, Diane E., Regulating Ethics Committees in Health Care InstitutionsIs It Time?, 50 MD. L. REV. 746, 751-52 (1991)Google Scholar (same).

66 See Wolf, Susan M., Ethics Committees and Due Process: Nesting Rights in a Community of Caring, 50 MD. L. REV. 798 (1991)Google Scholar [hereinafter Wolf, Ethics Committees and Due Process].

67 See, e.g., the work of the Boston Women's Health Book Collective, such as The New Our Bodies, Ourselves: A Book by and for Women (1992).

68 See, e.g., Thompson, Dennis F., Understanding Financial Conflicts of Interest, 329 New Eng. J. Med. 573, 575 (1993)Google Scholar.

69 See Susan M. Wolf, Ethics Committees in the Courts, Hastings Center Rep., June 1986, at 12.

70 See Haw. Rev. Stat. 663-1.7 (Supp. 1992); MD. Health-GEN. CODE ANN. 19-371 (Supp. 1993); NJ. ADMIN. CODE 8:43G 5.1(h) (1992).

71 See 45 C.F.R. 84.55 (1993).

72 See Office of Technology Assessment, Biomedical Ethics, supra note 13, at 7-15.

73 IRBs are an exception, in that their approval is required for federal research funding. Yet there is a real question of how effective IRBs have been and how willing to say no. See supra note 63.

74 See Meisel, supra note 15, at 103-06 & Supp. 1993 at 83-86.

75 See, e.g., Brophy v. New England Sinai Hosp., 497 N.E.2d 626 (Mass. 1986); Richard, Delgado & Peter, McAllen, The Moralist as Expert Witness, 62 B. U. L. REV. 869 (1982)Google Scholar.

76 See, e.g., Cruzan v. Director, Missouri Dep't of Health, 497 U.S. 261, 288, 289 (1990) (O'Connor, J., concurring); Id. at 308, 329 (Brennan, J., dissenting).

77 See generally Meisel, supra note 15, at 96-106 & Supp. 1993 at 71-87; Blake, David C., State Interests in Terminating Medical Treatment, Hastings Center Rep., May-June 1989, at 5.Google Scholar

78 See Delgado & McAllen, supra note 75.

79 See Wolf, Ethics Committees and Due Process, supra note 66.

80 ICRCs provide advice in ongoing cases. See 45 C.F.R. 84.55(f)(1) (Hi) (B) (1993).

81 See KATZ, supra note 6.

82 See Marjorie Maguire, Shultz, From Informed Consent to Patient Choice: A New Protected Interest, 95 Yale L.J. 219 (1985)Google Scholar.

83 See generally Hafemeister, Thomas L., Guidelines for State Court Decision Making in Life-Sustaining Medical Treatment Cases, 7 Issues L. & Med. 443 (1992)Google Scholar; MEISEL, supra note 15, at 3-4 & Supp. 1993 at 1-12.

84 See, e.g., In re Conroy, 486 A.2d 1209 (N.J. 1985).

85 See Annas, George J., Transferring the Ethical Hot Potato, Hastings Center Rep., Feb. 1987, at 20.Google Scholar

86 See In rejobes, 529 A.2d 434, 450 (N.J. 1987).

87 For cases recognizing a cause of action, see, for example, Leach v. Shapiro, 469 N.E.2d 1047 (Ohio Ct. App. 1984) (finding an action for battery, fraud, pain and suffering, bystanders anguish, and punitive damages); Anderson v. St. Francis-St. George Hosp., 614 N.E.2d 841 (Ohio Ct. App. 1992) (finding an action for battery). On the negative side, see, for example, Grace Plaza v. Elbaum, 603 N.Y.S.2d 386, 388 (N.Y. 1993) (noting in dicta that[p] atients who do not consent and communicate that lack of consent are not liable for any treatment provided in contravention of their wishes, but finding no reason to shift treatment costs in this case). See generally MEISEL, supra note 15, at 160 & n.45, 404-05 & n.61 & Supp. 1993 at 144-45, 379-80.

88 See, e.g., Family Privacy and PVS: A Symposium on the Linares Case, 17 Law Med. & Health Care 298 (1989).

89 See Miles, Steven H. & Alison, August, Courts, Gender, and The Right to Die, 18 Law Med. & Health Care 85 (1990)Google Scholar. But see Jasper Hopkins, Courts, Gender, and the Right to Die: A Second Look, in Philosophical Criticism: Essays and Reviews (1994) (criticizing the Miles and August analysis).

90 See MEISEL, supra note 15, at 366 & Supp. 1993 at 357-59.

91 See id. at 375 & Supp. 1993 at 372-73.

92 Omnibus Budget Reconciliation Act (OBRA) of 1990, Pub. L. No. 101-508, 4206, 4751 (codified in scattered sections of 42 U.S.C., especially 1395cc, 1395mm, 1396(a) (West 1992 & Supp. 1994)); see also Wolf, Susan M. et al., Sources ofConcern About the Patient Self-Determination Act, 325 New Eng. J. Med. 1666 (1991)Google Scholar [hereinafter Wolf et al., Sources of Concern].

93 Cf. Michael D. Bayles, Professional Ethics 190 (2d ed., 1989) (The professions have historically evaluated the ethical conduct of their members . Nonprofessionals are minimally involved.). But note that the medical profession has not been fully self-regulating. See generally Paul Starr, The Social Transformation of American Medicine (1982); Emanuel et al., supra note 16.

94 See Dennis F. Thompson, Political Ethics and Public Office (1987).

95 Other signs of feasibility are Medicare assessment of respect for residents rights in long-term care, and Joint Commission assessment of respect for patients rights in acute care. See Institute of Medicine, Nursing Homes, supra note 2, at 78, 81, 82, 85-88; Joint Commission, 1994 Accreditation Manual for Hospitals, supra note 48, at 3, 155-57. However, I treat these as somewhat less telling signs of the feasibility of etfiics quality assessment, since both efforts seem to conflate moral and legal rights, failing to focus on the special issues raised by ethics assessment. The methodologies they suggest are nonetheless in keeping with those enumerated infra.

96 See Alan, Meisel & Roth, Loren H., Toward an Informed Discussion of Informed Consent: A Review and Critique of the Empirical Studies, 25 Ariz. L. Rev. 265 (1983)Google Scholar.

97 Id. at 336.

98 One of the most important contributions of their team from the University of Pittsburgh is CHARLES W. Lidz Et al., Informediconsent: A Study of Decisionmaking in Psychiatry (1984). This includes findings on the insignificant role in decisionmaking process played by consent forms. Id. at 318. See also Paul S. Appelbaum Et. al., Informediconsent: Legal Theory and Clinical Practice (1987). The empirical methods used to study informed consent and patient-physician interaction have expanded to include discourse analysis. See, e.g., Sue Fischer, in the Patient's Best Interest: Women and the Politics of Medical Decisions (1986); Medical Discourse and Systemic Frames of Comprehension (Ronald J. Chenail ed., Advances in Discourse Processes vol. XLII, 1991); The Social Organization of Doctorpatient Communication (Sue Fischer & Alexandra Dundas Todd eds., 1983); Alexandra Dundas Todd, Intimate Adversaries: Cultural Conflict Between Doctors and Women Patients (1989). Another intriguing approach is social psychologists use of attribution theory to uncover systematic errors in patient and physician cognition. See, e.g., Redelmeier, Donald A. et al., Understanding Patients Decisions: Cognitive and Emotional Perspectives, 270 JAMA 72 (1993)Google Scholar.

99 See generally, Solomon, Mildred Z. et al., Decisions Near the End of Life: Professional Views on Life-Sustaining Treatments, 83 Am. J. Pub. Health 14, 16 (1993)Google Scholar (only 36% of medical, surgical, and nursing professionals surveyed agreed that [pjatients are informed of different care alternatives). 100 See, for example, New York's statute and regulations on do not resuscitate orders, and the empirical studies of these enactments effects. The statute and key regulation are N.Y. PUB. Health Law 2960-79 (McKinney 1993); 10 N.Y. St. Reg. 405.43 (1992). The studies include Kamer, Russell S. et al., Effect of New York State's do not-resuscitate legislation on in-hospital cardiopulmonary resuscitation practice, 88 Am. J. Med. 108 (1990)Google Scholar.

101 President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Deciding to Forego Life-Sustaining Treatment 169-70 (1983).

102 See Hoffmann, supra note 65; Wolf, Ethics Committees and Due Process, supra note 66.

103 See Hoffmann, Diane E., Does Legislating Hospital Ethics Committees Make a Difference? A Study of Hospital Ethics Committees in Maryland, the District of Columbia, and Virginia, 19 Law Med. & Health Care 105, 106 (1991)Google Scholar; see also Hoffmann, Diane E., Evaluating Ethics Committees: A View from the Outside, 71 Milbank Q. 677 (1993)Google Scholar; Hoffmann, supra note 65, at 756 n.65, 757 n.67.

104 The literature on DNR orders has become voluminous. The important early empirical studies include: Bedell, Susanna E. & Delbanco, Thomas L., Choices About Cardiopulmonary Resuscitation in the Hospital: When Do Physicians Talk With Patients?, 310 New Eng. J. Med. 1089 (1984)Google Scholar; Bedell, Susanna E. et al., Survival After Cardiopulmonary Resuscitation in the Hospital, 309 New Eng. J. Med. 569 (1983)Google Scholar; Evans, Andrew L. & Brody, Baruch A., The Do-Not-Resuscilate Order in Teaching Hospitals, 253 JAMA 2236 (1985)Google Scholar; Farber, Neil J. et al., Cardiopulmonary Resuscitation (CPR): Patient Factors and Decision Making, 144 Archives Internal Med. 2229 (1984)Google Scholar; Levy, Mark R. et al., Do-Not-Resuscitate Orders in a County Hospital, 140 W.J. Med. I 11 (1984)Google Scholar; Arnold, Wagner, Cardiopulmonary Resuscitation in the Aged: A Prospective Survey, 310 New Eng. J. Med. 1129 (1984)Google Scholar; Youngner, Stuart J. et al., Do Not Resuscitate Orders: Incidence and Implications in a Medical Intensive Care Unit, 253 JAMA 54 (1985)Google Scholar.

105 See, e.g., Marion, Danis et al., A Prospective Study of Advance Directives for Life-Sustaining Care, 324 New Eng. J. Med. 882 (1991)Google Scholar; Davidson, Kent W. et al., Physicians'Attitudes on Advance Directives, 262 JAMA 2415 (1989)Google Scholar; Emanuel, Linda L. et al., A Detailed Advance Care Directive: Practicality and Durability, 38 Clinical Res. 738A (1990); Linda L. Emanuel et al., Advance Directives: Stability of Patients Treatment Choices, 154 Archives Internal Med. 209 (1994)Google Scholar; Everhart, Maria A. & Pearlman, Robert A., Stability of Patient Preferences Regarding Life-Sustaining Treatments, 97 Chest 159 (1987)Google Scholar; Finucane, Thomas E. et al., Planning with Elderly Outpatients for Contingencies of Severe Illness: A Survey and Clinical Trial, 3 J. Gen. Internal Med. 322 (1988)Google Scholar; Bernard, Lo et al., Patient Attitudes to Discussing Life-Sustaining Treatment, 146 Archives Internal Med. 1613 (1986)Google Scholar; Ouslander, Joseph G. et al., Health Care Decisions Among Elderly Long-Term Care Residents and Their Potential Proxies, 149 Archives Internal Med. 1367 (1989)Google Scholar; Seckler, Allison B. et al., Substituted fudgment: How Accurate Are Proxy Predictions?, 115 Annals Internal Med. 92 (1991)Google Scholar; Ashwini, Sehgel et al., How Strictly Do Dialysis Patients Want Their Advance Directives Followed?, 267 JAMA 59 (1992)Google Scholar; Silverstein, Marc D. et al., Amyotrophic Lateral Sclerosis and Life-Sustaining Therapy: Patients Desires for Information, Participation in Decision Making, and Life-Sustaining Therapy, 66 Mayo Clinic Proc. 906 (1991)Google Scholar; Tom, Tomlinson et al., An Empirical Study of Proxy Consent for Elderly Persons, 30 Gerontologist 54 (1990)Google Scholar; Uhlmann, Richard F. et al., Physicians and Spouses Predictions of Elderly Patients Resuscitation Preferences, 43 J. Gerontology M 115 (1988)Google Scholar; S., Van McCrary & Botkin, Jeffrey R., Hospital Policy on Advance Directives: Do Institutions Ask Patients About Living Wills?, 262 JAMA 2411 (1989)Google Scholar; Zweibel, Nancy R. & Cassel, Christine K., Treatment Choices at the End of Life: A Comparison of Decisions by Older Patients and Their Physician-Selected Proxies, 29 Gerontologist 615 (1989)Google Scholar.

106 See, e.g., Emanuel, Ezekiel J. et al., How Well Is the Patient Self-Determination Act Working? An Early Assessment, 95 Am. J . Med. 619 (1993)Google Scholar.

107 For each of these propositions, see studies supra note 105.

108 See also David, Orentlicher, The Illusion of Patient Choice in End-of-Life Decisions, 267 JAMA 2101 (1992)Google Scholar; Wolf, Susan M., Near DeathIn the Moment of Decision, 322 New Enc. J . Med. 208 (1990)Google Scholar; Wolf, Susan M., Trying Not To Talk Forever: A Tool for Change, 15 Law Med. & Health Care 248 (1987-88).Google Scholar

109 Wolf et al., Sources of Concern, supra note 92.

110 See id.

111 On the debate see, for example, Bradford H. Gray, The Profit Motive and Patient Care: The Changing Accountability of Doctors and Hospitals (1991); Marc A. Rodwin, Medicine, Money, and Morals: Physicians Conflicts of Interest (1993); Thompson, supra note 68. Despite the ethical ferment, both federal and state legislation has been enacted restricting self-referral. See, e.g., 42 U.S.C 1395nn (West 1992 & Supp. 1994); Fla. Stat. Ann. 458.327 (West 1991 & Supp. 1994).

112 See Susan M. Wolf, Health Care Reform and the Future of Physician Ethics, Hastings Center Rep., Mar.-Apr. 1994, at 28, 33 & nn.49-53 [hereinafter Wolf, Health Care Reform].

113 Judith, Swazey et al., Ethical Problems in Academic Research, 81 Am. Scientist 542 (1993)Google Scholar.

114 See Christopher Anderson, Drummond, Survey Tracks Misconduct, To An Extent, 262 Science 1203 (1993)Google Scholar.

115 See, e.g., Rebecca, Dresser, Defining Scientific Misconduct: The Relevance of Mental State, 269 JAMA 895 (1993)Google Scholar; Drummond, Rennie & C., Kristina Gunsalus, Scientific Misconduct: New Definition, Procedures and Office Perhaps a New Leaf, 269 JAMA 915 (1993)Google Scholar.

116 It also means that when states certify the quality of health plans (under a proposal such as the Health Security Act) and health alliances monitor that quality, they will be ignoring ethical behavior.

117 See, e.g., Donabedian, The Definition of Quality, supra note 2, at 79-84.

118 See, e.g., Solomon et al., supra note 99.

119 See Katz, supra note 6, on such patient reactions.

120 See Robert M. Veatch, The Patient-Physician Relation: The Patient as Partner, Part 2, at 277-79 (1991).

121 Of course, asking a group of consumers to choose between different health plans some HMOs, some fee-for-service, some preferred provider organizations (PPOs) or something else does invite them to segregate themselves according to plan cost, how much they value unfettered access to specialists, and other criteria. However, I am arguing that it should not separate them into islands of different ethical practice. Ethics protects patients moral rights and imposes professional duties. Though some institutions have asserted a prerogative to create different ethical rules within their walls, the courts and commentators have rightly been reluctant to approve, or approve without significant restrictions. See, e.g.. Gray v. Romeo, 697 F. Supp. 580 (D.R.I. 1988); In rejobes, 529 A.2d 434 (N.J. 1987); In re Requena, 517 A.2d 869 (N.J. Super. Ct. App. Div. 1986). See generally Miles, Steven H. et al., Conflict Between Patients Wishes to Forgo Treatmeat and the Policies of Health Care Facilities, 321 New Eng. J. Med. 48 (1989)Google Scholar (patients should be notified in advance). Though the Jobes court suggested that a warning of the institution's special rules at the time of admission might allow them to prevail over patients rights later, the courts are usually so skeptical of patients surrender of rights at the door, that it would be surprising to see this enforced. See, e.g., Tunkl v. Regents of Univ. of California, 383 P.2d 441 (Cal. 1963). See generally Mehlman, Maxwell J., Fiduciary Contracting: Limitations on Bargaining Between Patients and Health Care Providers, 51 Univ. Pitt. L. Rev. 365 (1990)Google Scholar. Note that one important exception to the trend toward ethical uniformity has been in the abortion area; institutions divide on whether they perform elective abortions at all, and physicians may opt out See 42 U.S.C. 300a-7 (West 1991) (providers may elect not to perform abortions).

122 See, e.g.. Health Security Act, supra note 38, at 5006, 5009. See generally Institute of Medicine, Clinical Practice Guidelines, supra note 2, at 3-6, 65-66.

123 Cf. Institute of Medicine, Clinical Practice Guidelines, supra note 2, at 70-73 (arguing for the same in developing guidelines in other areas of practice).

124 See, e.g., La Puma & Priest, supra note 25.

125 See, e.g., Brennan, supra note 25; Siegler, supra note 25; Singer et al., supra note 25.

126 On the legal use of practice guidelines, see sources cited supra note 2.

127 See, e.g., Darling v. Charleston Community Hosp., 211 N.E.2d 253 (111. 1965), cert, denied, 383 U.S. 946 (1966); Oehler v. Humana, Inc., 775 P.2d 1271 (Nev. 1989); Thompson v. Nason Hosp., 591 A.2d 703 (Pa. 1991).

128 See, e.g., Jost, supra note 2.

129 See Wolf, Susan M., Toward a Theory of Process, 20 Law Med. & Health Care 278 (1992)Google Scholar; Wolf, Health Care Reform, supra note 112.