Biomedical Research With "Decisionally Incapacitated" Human Subjects:
Legalization of a Defunct Normative Bioethetics Theory

12. Invalid risk/benefit ratios: Since no "decisionally incapacitated" patient, "consent agent" or IRB can possibly know what the actual "risks" are (e.g., in "expected benefit" research which contains no risk categories, or in non-therapeutic "no expected benefit" research which has blurred the categories of "slight increase over minimal risk" with "high risk"; or because in the May draft the Advanced Directive is valid for "research-in-general"); and since no one can know what the actual "benefits" would be to possible future "classes" of patients, to "society", to the advancement of scientific knowledge, etc., no one can possibly calculate a valid risk/benefit ratio.

13. Invalid "substituted judgments": If it is impossible to calculate a valid risk/benefit ratio, no "decisionally incapacitated" patient could possibly give a valid informed consent to sign such an Advanced Directive for Research Participation, nor could any "consent agent" possibly give a valid "substituted judgment" that the patient would have wanted to participate were he/she competent.

14. Legal accountability: The May draft purports that the courts will be essentially removed from any involvement in the participation of the "decisionally incapacitated" in such research - including high risk/non-therapeutic research. In fact, in both drafts there is a legal "immunity" clause which purports to shield all researchers, physicians, consent agents, IRB members, etc., from all civil or criminal liability if a patient should incur any harms or injuries while participating in any such research. This would even be in violation of the present OPRR regulations.23 In effect, purportedly there would be no recourse or due process accorded any patient injured or harmed during his/her participation in any research protocol - including high risk therapeutic and non-therapeutic research. It is doubtful that such absolutions could effectively deprive research subjects of their state and federal constitutional rights, or insulate researchers, consenters or IRB members from litigation for infringement of those rights. Even, it would seem, a state that was complicit in the deprivation of those rights, would subject itself to serious liabilities.

15. Follow-up care/compensation for harms: There are no provisions for any follow-up medical care, or any compensation for harms and injuries to patients incurred while participating in any of this research - including high risk/no direct benefit research. This would even seem to violate at least the spirit of the present federal OPRR regulations. Their obvious importance is pointed out, e.g., in the Nuremburg Code: "In every one of the experiments the subjects experienced extreme pain or torture, and in most of them they suffered permanent injury, mutilation, or death, either as a direct result of the experiments or because of lack of adequate follow-up care"24 (emphasis mine).

16. Distortion of the principle of "justice": Guaranteeing total civil and criminal legal immunity for researchers, physicians, consenters, and IRB's, while legally precluding all patients from any due process when harmed or injured while participating in any research protocols, and legally precluding any follow-up medical care or compensation for harms and injuries sustained during participation in research, are clear and obvious distortions of the principle of "justice". Clearly the "balance" is rather heavy on the side of the benefits and interests of researchers, drug companies, research institutions, etc., over the benefits and interests of the people of the State of Maryland who will be the participants in this research.

17. Exceptions and waivers: Unless one were familiar with the federal OPRR regulations, one would not be aware that the IRB can waive25 any part of this proposed statute in the interests of the advancement of scientific knowledge, to obtain information that can not be obtained in any other way, for national security, etc.

18. Emergency room research: There is explicit language in both drafts which put this proposed statute in "sync" with the controversial new changes in the FDA's regulations concerning the waiving of informed consent by "incompetent" patients (physically or psychologically incompetent) in emergency room research.26 These new changes in the FDA regulations have been harshly rejected even by many of the leaders within bioethics. Yet, they have just been swiftly incorporated into the federal OPRR regulations and thereby into the Common Rule. This language in the proposed statute would seem to put "decisionally incapacitated" patients in double-jeopardy for being human subjects of research, especially in the event that they happened to find themselves in emergency rooms after car accidents, medication reactions, drug over-doses, seizures, etc.


Despite efforts to ground their "ethical" considerations on the bioethics principles, or their to appeal to "consensus" (which could obviously change depending on the composition of the members), the Working Group seems totally unaware that the bioethics principles on which they explicitly ground this proposed statute are widely interpreted, contentiously disputed, are no longer practically operative, and that they are in fact normative and therefore biased and hardly "neutral" for our "pluralistic, democratic" society (the best kept secret in bioethics). Indeed even utilitarianism, communitarianism, and "consensus ethics" are normative - not neutral. Therefore, how can the Working Group justify imposing its normative ethical "positions" and "consensus opinions" on the rest of the citizens of Maryland by means of the legalization of these very highly controversial and defunct ethical theories and opinions? Neither legalization nor consensus makes a position, policy or statute neutral or ethical. Nor should any such ethical theory or opinion be so legalized.


Even the most universal medical research ethics codes express that it is not sufficient for the end or goal of a past, present or future research protocol to be good or beneficial for the "greatest number" or for the advancement of scientific knowledge in order for it to be ethical. Prior sound animal studies, the legitimacy of the purposes for performing the research, the scientific qualifications of the researchers, the inalienable rights of each individual human research subject, the validity of the informed consent processes, the designs of the protocols, the means used to attain those "beneficent" goals, the circumstances and conditions under which the research protocols are conducted, the integrity of the research data, the legal responsibilities of the researcher and the institutions, and the following up with medical care and compensations for harms must also be part of any ethical evaluation. And there are some research protocols which are inherently wrong - in fact, illegal - regardless of any risk/benefit ratios, even though human subjects, like Martha, have given their "valid" informed consents.

Neither Martha, nor any other human being - "decisionally incapacitated" or otherwise - has such an absolute "duty" to be so purely altruistic as to take part in experimentation in order to advance scientific knowledge, provide the means for finding better medications or cures for diseases for others, obtain scientific information which can only be obtained by means of the invasion of their minds or bodies, or aid the national security. Nor should such a "duty" be legislated into any law -local, state, federal or international.

Because "decisionally incapacitated" human subjects like Martha are human persons, with the same inherent rights as all other human beings; because no human beings should be used as unethical means to any goals - no matter how lofty; because of the obvious vulnerability of "decisionally incapacitated" persons to exploitation and their compromised ability to give truly meaningful informed consent and our inability to know certainly their desires to participate in medical research; because of the past and on-going abuses involving research with the mentally ill;27 and because the present system of protections for the mentally ill in research are wholly insufficient and inadequate and thus realistically unable to protect them, the more reasonable way of "respecting persons" would be to acknowledge that, in order to respect them as non-autonomous persons, only minimal risk specified research for the direct benefit of a particular patient could be ethically consented to, and then only if the research holds out at least as much direct benefit as available standard medical therapies, and only as consented to by a legitimate legally authorized representative. In any other research, participation should be authorized by a court of law.

This does not mean that research in mental diseases or any other mental disorders must come to a grinding halt - only that the process of "scientific progress" must be ethical as well as the intended goal, even if it takes a little longer.28 This is not an "anti-scientific research" position. But it is an "anti-unethical scientific research" position. There is a difference. If to be concerned about the kind of unethical scientific research as proposed in this proposed statute is simply dismissed, as Assistant Attorney General Schwartz puts it, as a matter of "fundamental differences of perspective", then we surely have a problem.


1 Office of the Maryland Attorney General, J. Joseph Curran, Jr., Attorney General, Jack Schwartz, Assistant Attorney General, INITIAL REPORT OF THE ATTORNEY GENERAL'S RESEARCH WORKING GROUP (October 1996 draft, hereinafter referred to in text as OD)(with Schwartz's Letter, hereinafter referred to in text as OD/S), and May 1997 draft, hereinafter referred to in text as MD). It is noted that almost all of the research proposed in this proposed statute has recently been rejected as unconstitutional by the New York Supreme Court, Appellate Division (see T.D. v. The New York State Office of Mental Health, 1996 WL 695417 (N.Y.A.D. 1 /Dept.). See also Philip J. Hilts, New York Court strikes down rules for psychiatric studies of children and mentally ill, THE NEW YORK TIMES, Dec. 27, 1996, at A1; Frank J. Ayd, Jr., M.D. (ed.), "'Decisionally incapacitated' persons and a proposed Maryland statute", 35 THE MEDICAL-MORAL NEWSLETTER 3/4, 9-16 (1998). [Back]

2 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, U.S. Department of Health, Education and Welfare, THE BELMONT REPORT: ETHICAL PRINCIPLES AND GUIDELINES FOR THE PROTECTION OF HUMAN SUBJECTS OF RESEARCH (1978)(hereinafter THE BELMONT REPORT). [Back]

3 U.S. Code of Federal Regulations, Title 45 Public Welfare, Part 46 - Dept. of Health and Human Services - PROTECTION OF HUMAN SUBJECTS (1991) (hereinafter noted as OPRR REGULATIONS). [Back]

4 THE BELMONT REPORT, supra note 2. There exists an extensive literature on this issue. Compare the Belmont Report's treatment of autonomy with that of: PRINCIPLES OF BIOMEDICAL ETHICS (Thomas L. Beauchamp & James Childress, 1979), at 60, 135, 169; and CONTEMPORARY ISSUES IN BIOETHICS (Thomas L. Beauchamp & LeRoy Walters eds., 1982), at 23-39. See also PRINCIPLES OF HEALTH CARE ETHICS (Ranaan Gillon ed., 1994) (which contains dozens of articles and debates, especially in Part I); and many of the articles infra. [Back]

5 See Beauchamp & Childress, supra note 4, at 7-9; Beauchamp & Walters, supra note 4, at 1-3. [Back]

6 See Dianne N. Irving, "Which ethics for science and public policy?", 3 ACCT. IN RES. 77, 77-100 (1993); D. Irving, "Academic fraud and conceptual transfer in bioethics: Abortion, human embryo research and psychiatric research, in LIFE AND LEARNING: PROCEEDINGS OF THE FOURTH UNIVERSITY FACULTY FOR LIFE CONFERENCE, JUNE 1994 (Joseph W. Koterski, ed., 1995), at 193-215; D. Irving, "Quality assurance auditors: Between a rock and a hard place" 3 QUALITY ASSURANCE: GOOD PRACTICE, REGULATION, AND LAW 1, 33-52 (1994); and many of the articles infra. [Back]

7 Daniel Callahan, "Bioethics: private choice and common ground", HASTINGS CENTER REP. May-June 1994, at 31; Albert Jonsen, "Preface", in WHAT ABOUT PRINCIPLES: FERMENT IN U.S. BIOETHICS (DuBose et al., eds., 1994); see also Ranaan Gillon, supra note 4; Amy Gutmann and Dennis Thompson, Deliberating about bioethics, HASTINGS CENTER REP. May-June 1997, at 38-41; Leonard S. Rubenstein, "Standards of accountability for consent in research", in ETHICS IN NEUROBIOLOGICAL RESEARCH WITH HUMAN SUBJECTS: THE BALTIMORE CONFERENCE ON ETHICS (Adil E. Shamoo, ed., 1997), at 129-138. [Back]

8 John Fletcher, E. Dommel & D. Cowell, "A trial policy for the intramural programs of the National Institutes of Health: consent to research with impaired human subjects", 7 IRB 1985, at 1-6; Philip Candilis et al., "A survey of researchers using a consent policy for cognitively impaired human research subjects", 15 IRB 1993, at 1-4; Trey Suderland & Ruth Dukoff, "Informed consent with cognitively impaired patients: an NIMH perspective of the durable power of attorney", 4 ACCT. IN RES. 217, 217-226 (1996). [Back]

9 See THE BELMONT REPORT, supra note 2, at 3. [Back]

10 Declaration of Helsinki, in United States Department of Health and Human Services, OFFICE FOR THE PROTECTION OF RESEARCH RISKS: 1993, PROTECTING HUMAN RESEARCH SUBJECTS: INSTITUTIONAL REVIEW BOARD GUIDEBOOK (1993), at A6-3 to A6-6. See also, Nuremburg Code, at A6-1 to A6-2; United Nations (1947) Universal Declaration of Human Rights; United Nations (1991) Principles for the Protection of Persons with Mental Illness and for the Improvement of Mental Health Care; and International Covenant on Civil and Political Rights (ratified, Sen. Comm. on Foreign Affairs 1992). For a review, see Eric Rosenthal, "The International Covenant on Civil and Political Rights and the rights of research subjects", in Shamoo (ed.), supra note 7, at 265-272. [Back]

11 Declaration of Helsinki, supra note 10, at A6-3 to A6-9. [Back]

12  [Back]

Declaration of Helsinki, supra note 10, at A6-4 to A6-6.

13 See generally early works by A.S. Tannenbaum & R.A. Cook, "Report on the Mentally Infirm", in RESEARCH INVOLVING THOSE INSTITUTIONALIZED AS MENTALLY INFIRM: APPENDIX (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978): at 1-2; Bernard Barber, INFORMED CONSENT IN MEDICAL THERAPY AND RESEARCH (1978): at 10-13. For more current works, see Rubenstein, supra note 7; an excellent legal analysis by Robert A. Destro, Government oversight, in Shamoo (ed.), supra note 7, at 81-99; Jessica Wilen Berg, Legal and ethical complexities of consent with cognitively impaired research subjects: proposed guidelines, 24 J.L. MED. & ETHICS 18, 18-35 (1996). Although the OPRR Regulations define "minimal risk" as that in which "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" (section 46.102 (i)), it is questionable whether this definition could realistically refer to all competent adults, much less to children or to persons who are mentally ill or otherwise incapacitated. [Back]

14 Declaration of Helsinki, supra note 10, at A6-4 to A6-5. See also Robert F. Weir & Jay R. Horton, "Genetic research, adolescents, and informed consent, THEOR. MED. Dec. 1995, at 347-373; Walter Robinson, Commentary, Family dynamics and children in medical research, J. CLIN. ETHICS, Winter 1996, at 362-364; Adil E. Shamoo & Dianne N. Irving, Accountability in research using persons with mental illness, 3 ACCT. IN RES. 1, 1-17 (1993); A. Shamoo and D. Irving, "A review of patient outcome in pharmacologic studies from the psychiatric literature, 1966-1993", 3 J. SCIENCE AND ENGINEERING ETH. 4, at 395-405 (1997); Uninformed patients used as guinea pig, THE WASHINGTON TIMES, Dec. 16, 1996, at A8; Vera Hassner Sharav, Independent family advocates challenge the fraternity of silence, in Shamoo (ed.), supra note 7; Janice Becker, Expanding on a mother's testimony, in Shamoo (ed.), supra note 7; Robert Aller and Gregory Aller, An institutional response to patient/family/complaints, in Shamoo (ed.), supra note 7, at 155-172; K.J. Rothman & K.B. Michels, Sounding board - the continuing unethical use of placebo controls, in Shamoo (ed.), supra note 7, at 289-297; but see Robert Temple, Problems in interpreting active control equivalence trials, in Shamoo (ed.), supra note 7, at 279-287. [Back]

15 See Rubenstein, supra note 7; Berg supra note 13; Weir supra note 14. See also Paul S. Appelbaum, Patient's competence to consent to neurobiological research, 4 ACCT. IN RES. 241, 241-251 (1996); Jesse A Goldner, An overview of legal controls on human experimentation and the regulatory implications of taking Professor Katz seriously, in Health Law Symposium. Legal and Ethical Controls on Biomedical Research: Seeking Consent, Avoiding Condescension, 38 ST. LOUIS L.J. 3, 63 (1993); Dianne N. Irving, Psychiatric research: reality check, J. CAMI, Spring 1994, at 42-44; Adil E. Shamoo & Dianne N. Irving, The PSDA and the depressed elderly: "intermittent competency" revisited, J. CLIN. ETHICS, Spring 1993, at 74-80; Lisa Anne Hawkins, Living-will statutes: a minor oversight, 78 VA. L.REV., 1581, 1581-1615 (1992); K.C. Glass and M.A. Somerville, Informed consent to medical research on persons with Alzheimer's disease: ethical and legal parameters, in ALZHEIMER'S DISEASE RESEARCH: ETHICAL AND LEGAL ISSUES (Berg et al., (eds.), 1991), at 30-59; H. Helmchen, The problem of informed consent in dementia research, 9 MED AND LAW 1206, 1206-1213 (1990). [Back]

16 Declaration of Helsinki, supra note 10, at A6-5; see also, Dianne N. Irving, "Psychiatric research; Reality check", 5 J. CALIFORNIA ALLIANCE FOR THE MENTALLY ILL, 1, at 42-44 (1994). [Back]

17 See Mathy Mezey et al., Life-sustaining treatment decisions by spouses of patients with Alzheimer's disease, J. AM. GERIATRICS SOC., Feb. 1996, at 144-150; David C. Thomasma, A communal model for presumed consent for research on the neurologically vulnerable, 4 ACCT. IN RES. 227, 227-239 (1996); Ralph Baergen, Revisiting the substituted judgment standard, J. CLIN. ETHICS, Spring 1995, at 30-38; Rosalind E. Ladd & Edwin N. Forman, Adolescent decision-making: giving weight to age-specific values, THEOR. MED., Dec. 1995, at 333-345; Jeremiah Suhl et al., Myth of substituted judgment: surrogate decision-making regarding life support is unreliable, 154 ARCHIVES OF INTERNAL MED., 90, 90-96 (1994); John Hardwig, The problem of proxies with interests of their own: toward a better theory of proxy decisions, J. CLIN. ETH. Spring 1993, at 20-27; James Coyne King, The search for objectivity in applying the substituted judgment rule in medical care cases, 37 BOSTON BAR JOURNAL 10, 10-12, 14 (1993); Robert A. Perlman et al., Contributions of empirical research to medical ethics, THEOR. MED, Sept. 1993, at 197-210; Lynne E. Lebit, Compelled medical procedures involving minors and incompetents and misapplication of the substituted judgment doctrine, J. OF LAW AND HEALTH (1992-1993), at 107-130; Alexander M. Capron, Substituting our judgment, HASTINGS CENTER REP. March-April 1992, at 58-59; Ezekiel J. Emanuel & Linda L. E. Emanuel, Proxy decision-making for incompetent patients: an ethical and empirical analysis, 267 JAMA, 2067, 2067-2071 (1992); Jan Hare et al, Agreement between patients and their self-selected surrogates on difficult medical decisions, 152 ARCHIVES OF INTERNAL MED., 1049, 1049-1054 (1992); Thomas G. Gulkeil & Paul S. Appelbaum, Substituted judgment: best interests in disguise, HASTING CENTER REPORT, June 1983, at 8-11. For court decisions, see Illinois. Appelate Court, First District, Fourth Division. In re C.A. North Eastern Reporter, 2nd series. 1992 Oct 15 (date of decision). 603:1171-1194; Illinois. Supreme Court. Curran v. Bosze. North Eastern Reporter, 2nd series. 1990 Dec. 20 (date of decision). 566:1319-1345; Florida. District Court of Appeal, Second District. In re Guardianship of Browing. Southern Reporter, 2nd series. 1989 Apr. 10 (date of decision). 543:258-276; Missouri. Supreme Court, en banc. Cruzan by Cruzan v. Harmon. South Western Reporter, 2nd Series. 1988 Nov 16 (date of decision). 760:408-445. See also, George J. Annas, Precatory and mindless mimicry: the case of Mary O'Connor, HASTINGS CENTER REP., Dec. 1988, at. 31-33. [Back]

18 See THE BELMONT REPORT, supra note 10, at 4. See also James F. Childress, The place of autonomy in bioethics, HASTINGS CENTER REP. Jan./Feb. 1990, at 12-17; PROTECTING THE VULNERABLE: AUTONOMY AND CONSENT IN HEALTH CARE (Margret Brazier and Mary Lobjoit, 1991). [Back]

19 See Beauchamp & Childress, supra note 4, at 45-47; Beauchamp & Walters, supra note 4: at 23, 35-36. [Back]

20 Health and Human Services Oversight Hearings on Bioethics, May 8, 1997. See Sheryl Gay Stolberg, "Unchecked" experiments on people raise concern, THE NEW YORK TIMES, May 14, 1997, at A1. In that article, Gary Ellis states, "There is unchecked human experimentation taking place ... My estimate is that there is a substantial reservoir of research activity that occurs beyond the boundary of existing rules and policies", (at A16). In that same article Art Caplan comments on one of the problems with the existing I.R.B. Board regulations under the present Common Rule: "The old model presumes that you would do research to find out some important new basic facts about health ... Current research might be for a pharmaceutical company to put a new drug on the market to compete with the five ones that are already there for, say, insomnia or weight loss. The risks and benefits may be different", (at A16). For this and other problems with existing federal I.R.B. Boards, see generally Jay Katz, Human experimentation and human rights, 38 ST. LOUIS UNIV. LAW REV., 7, 7 (1993); Goldner, supra note 15; J. Thomas Puglisi & Gary B. Ellis, Neurobiological research involving human subjects: perspective from the Office for the Protection from Research Risks, in Shamoo (ed.), supra note 7, at 273-277; Sue Hoppe, Institutional Review Boards and research on individuals with mental disorders, in Shamoo (ed.), supra note 7, at 101-109; Robert A. Destro, supra note 13, at 81-99; Robert J. Levine, Proposed regulations for research involving those institutionalized as mentally infirm: a consideration of their relevance in 1995, in Shamoo (ed.), supra note 7, at 45-54; Frederick J. Frese, A consumer/professional's view of ethics in research, in Shamoo (ed.), supra note 7, at 191-194. [Back]

21 On "IRB shopping", see Stolberg, supra note 20. In that article, Rep. Shays is represented as being "startled by the testimony, including accounts of ethics panels - called institutional review boards, or I.R.B.'s - set up as profit-making ventures to evaluate proposed experiments for research groups that pay them". Rep. Shays states: "I am struck by the fact that we have I.R.B.'s that can be created by anyone, that we don't even know how many there are. I think the more we get into this the more we are going to realize how casual this process really is", (at A1). In the same article, Art Caplan is represented as commenting on "the boom in research paid for by private industry [that] has created a new phenomenon: commercial review boards that have generated a wave of what Dr. Caplan called 'I.R.B. shopping' by researchers" (A16). On "deferred consent", see generally Robert J. Levine, Research in emergency situations: the role of deferred consent, Editorial, 273 JAMA 1300, 1300-1302 (1995); Robert J. Levine, Deferred consent, 12 CONTROL CLIN. TRIALS, 546, 546-550 (1991); Michelle H. Biros et al., Informed consent in emergency research: consensus statement from the coalition conference of acute resuscitation and critical care researchers, 273 JAMA 1283, 1283-1287, (1995); Kenneth V. Iserson & Douglas Lindsey, Research on critically ill and injured patients: rules, reality, and ethics, 13 J. OF EMERG. MED. 563,563-567 (1995); J.H.T. Karlawish & G. A. Sachs, Research on the cognitively impaired: lessons and warnings from the emergency research debate, 45 J. AM. GERIATR. SOC. 474,474-481. [Back]

22 See THE BELMONT REPORT, supra note 10, at 2-3. [Back]

23 See OPRR REGULATIONS, supra note 3, at 9 (section 46.116). The OPRR regulations therein state: "No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence". [Back]

24 Nuremburg Code, in EXPERIMENTATION WITH HUMAN BEINGS: THE AUTHORITY OF THE INVESTIGATOR, SUBJECT, PROFESSIONS, AND STATE IN THE HUMAN EXPERIMENTATION PROCESS (Jay Katz, 1972), at 306. See also OPRR REGULATIONS, supra note 3, at 10 (section 46.116(6)). The OPRR regulations therein state: "(6) for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained." See also President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, COMPENSATING FOR RESEARCH INJURIES: A REPORT ON THE ETHICAL AND LEGAL IMPLICATIONS OF PROGRAMS TO REDRESS INJURIES CAUSED BY BIOMEDICAL AND REHAVIORAL RESEARCH: REPORT, Vol. 1, Washington, D.C. (1982), at 25-39. See also Aller, Sharav, Becker, and Shamoo and Irving supra note 14. [Back]

25 See OPRR REGULATIONS, supra note 3, at 46.116 (c) (d) and 46.117 (c). [Back]

26 See Department of Health and Human Services, Food and Drug Administration, 21 CFR Parts 50, 56, 312, 314, 601, 812, and 814, PROTECTION OF HUMAN SUBJECTS; INFORMED CONSENT AND WAIVER OF INFORMED CONSENT REQUIREMENTS IN CERTAIN EMERGENCY RESEARCH; FINAL RULES, Federal Register (Wednesday, October 2, 1996). For a few of the comments on this recent waiver of informed consent by FDA and DHHS, see Levine, Biros, Iserson, and Karlawish, supra note 21; Gina Kolata, U.S. ban on medical experiments without patient consent is eased, THE NEW YORK TIMES, Nov. 5, 1996, at A1. [Back]

27 See Shamoo & Keay, Ethical concerns about relapse studies, CAMBRIDGE QUARTERLY OF HEALTHCARE ETH., Summer 1996, at 373-386 (1996); Nancy E. Kass & Jeremy Sugerman, Are research subjects adequately protected? a review and discussion of studies conducted by the Advisory Commissions on Human Radiation Experiments, K.I.E. JOURNAL, Sept. 1996, at 271-282. See also Aller, Becker, Sharav, Irving, Shamoo supra note 14, as well as many other references supra. [Back]

28 See Jay Katz, "Ethics in neurobiological research with human subjects - final reflections, in Shamoo (ed.), supra note 7, at 329-335; Timothy J. Keay, Approximating ethical research consent, in Shamoo (ed.), supra, at 149-153. See also Jay Katz, supra note 20, at; Adina M. Newman, Drug trials, doctors, and developing countries: toward a legal definition of informed consent, CAMBRIDGE QUARTERLY OF HEALTHCARE ETH., Summer 1996, at 387-399; Paul S. Appelbaum, Consent and coercion: research with involuntarily treated persons with mental illness or substance abuse, 4 ACCT. IN RES. 69, 69-79 (1995). [Back]

1, 2,