A therapeutic jurisprudence perspective on participation in research by subjects with reduced capacity to consent: a comment on Kim and Appelbaum

Behavioral Sciences and the Law

Behav. Sci. Law 24: 485–494 (2006)

Published online in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/bsl.703

A Therapeutic JurisprudencePerspective on Participationin Research by Subjectswith Reduced Capacityto Consent: A Commenton Kim and Appelbaum1

Bruce J. Winick, J.D.*,y

and Kenneth W. Goodman, Ph.D.z

CAPACITY TO CONSENT TO RESEARCH: AN AREA

OF THE LAW IN NEED OF CLARIFICATION

The law on the protection of human subjects in biomedical and behavioral research

remains unclear for research subjects of reduced capacity. Principles of international

human rights law severely restrict such research. The Nuremberg Code prohibits such

research when not consented to by a competent research subject.2 The Helsinki

Declaration softens this absolute prohibition somewhat.3 Federal, and to a much

lesser extent state, law seeks to regulate research with human subjects, but leaves

many issues open. The National Commission for the Protection of Human Subjects

of Biomedical and Behavioral Research’s influential Belmont Report identifies the

relevant bioethical principles as respect for human dignity and autonomy, benefi-

cence, and justice.4 The National Commission suggests that in certain circum-

stances, notably involving children and those institutionalized as mentally infirm,

Copyright # 2006 John Wiley & Sons, Ltd.

*Correspondence to: Bruce J. Winick, University of Miami School of Law, Coral Gables, FL 33146,U.S.A. E-mail: [email protected] Bruce J. Winick, Professor of Law and Professor of Psychiatry and Behavioral Sciences.zKenneth W. Goodman, Ph.D., Associate Professor of Medicine and Philosophy and Director, Universityof Miami Bioethics Program.1Scott Kim and Paul Appelbaum, The Capacity to Appoint a Proxy and the Possibility of Concurrent ProxyDirectives, this issue.2The Nuremberg Code (1948), reprinted in Nazi Doctors and the Nuremberg Code 2 (George J. Annas &Michael A. Grodin eds., 1992). The ‘‘Code’’ is actually the 10 principles on human experimentation setforth in the judgment of the Nuremberg Military Tribunal in the case of United States v. Karl Brandt. SeeThe Medical Case, in I & II Trials of War Criminals Before the Nuremberg Military Tribunals

(1949), reprinted in Jay Katz, Experimentation with Human Beings 292 (1972).3Helsinki Declaration, reprinted in Nat’l Comm’n for the Protection of Hum. Subjs. of Biomedical &Behav. Res., Research Involving Prisoners 21–1–21–6 app. (1976).4The Nat’l Comm’n for the Protection of Hum. Subjs. of Biomedical & Behavioral Res., The

Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of

Research (1978), available at http://www.fda.gov/oc/ohrt/IRBS/belmont.html (last visited June 23, 2005)[hereinafter Belmont Report].

consent to participation in research may be appropriate, even for those not able to

provide full informed consent, when a surrogate decision maker approves it.5 In

such circumstances, the National Commission would require the assent of the

individual, a standard reflecting some understanding of the research and of the

individual’s ability to terminate it, but not full competence.6 In such circumstances,

there also must be appropriate safeguards to protect the individual.7 These safe-

guards can include an Institutional Review Board, which conducts a review of the

research protocol, including the level of risk presented, consent (or assent) moni-

tors, and independent monitors of the research process.8

However, the proposals of the National Commission were never fully imple-

mented. Regulations of the U.S. Department of Health and Human Services

contained in the Code of Federal Regulations fail to address many of the key issues.

Although they authorize research with children in certain circumstances, they do not

deal with the special problems raised by research with those suffering from mental

disability. These regulations prohibit participation in research unless the investiga-

tor has obtained ‘‘a legally effective informed consent of the subject or the subject’s

legally authorized representative.’’9 When the individual is not competent to provide

informed consent, the key question is when his representative can consent on his

behalf. The regulations fail to answer this question. They define ‘‘legally authorized

representative’’ as someone authorized under ‘‘applicable law’’ to consent on behalf

of the subject.10 Federal law provides no further guidance concerning when a

5Id. For a discussion of some justifications for including less-than-fully-competent or incompetentsubjects in research, see generally Jason Borenstein & Kenneth W. Goodman, Ethical Issues in GeriatricPsychiatry, in Geriatric Psychiatry: Evaluation and Management (Marc E. Agronin & GabeJ. Maletta eds., 2006). For a general, albeit controversial, review and analysis of the issues raised byresearch on impaired patients, see Nat’l Bioethics Advisory Comm’n, Research Involving Persons

with Mental Disorders That May Affect Decisionmaking Capacity (Dec. 1998).6The term ‘‘assent’’ was used to ‘‘describe authorization by a person whose capacity to understand andjudge is somewhat impaired by illness or institutionalization, but who remains functional.’’ The Nat’l

Comm’n for the Protection of Hum. Subjs. of Biomedical & Behavioral Res., Research Involving

Those Institutionalized as Mentally Infirm, Reports and Recommendations for Public Comment,43 Fed. Reg. 11, 332 (Mar. 17, 1978). This standard contemplates ‘‘that the subject know whatprocedures will be performed in the research, choose freely to undergo those procedures, communicatethis choice unambiguously, and be aware that subjects may withdraw from participation.’’ Id. Thestandard was ‘‘intended to require a lesser degree of comprehension by the subject than would generallysupport informed consent.’’ Id.7Belmont Report, supra note 4.8The protection of research participants from potential harm and abuse:

. . . relies on scientific and ethical reviews at several levels. Investigators and their colleagues mustconsider participant protections during the development of research studies, and must implementthese protections throughout the conduct of protocols. Human participant issues are also carefullyconsidered during expert peer review by NIH. Local institutional review boards (IRBs) are requiredunder existing regulations (45CFR46) to review research design, benefits, risks, and human subjectprotections, including consideration of the informed consent process. NIH Institute staff may furtherevaluate human subject issues, review consent documents, address ethical concerns with investiga-tors directly, and work with OPRR to resolve potential problems.’’

Expert Panel, Research involving individuals with questionable capacity to consent: Ethical issues and practicalconsiderations for Institutional Review Boards, Report to the National Institutes of Health (Feb. 1998),available at http://www.nih.gov/sigs/bioethics/reports/exec_sum.htm (last visited June 23, 2005) [herein-after Expert Panel]. For a list of specific recommendations concerning IRB review of such research,including composition and functioning of the IRB, surrogate decision making, and the use of independentmonitors and subject advocates, see id.945 C.F.R. § 46.116 (2005).1045 C.F.R. § 46.102 (2005).

486 B. J. Winick and K. W. Goodman

Copyright # 2006 John Wiley & Sons, Ltd. Behav. Sci. Law 24: 485–494 (2006)

representative may act on behalf of the individual, and the issue thus is left

principally to state law. However, state law rarely if ever addresses the question of

when a surrogate or proxy can authorize research. When the individual while

competent has executed an advance directive instrument that designates a health

care proxy and authorizes the proxy to elect participation and research, the proxy

presumably would have the authority to consent to research participation on behalf

of the individual,11 but few people execute advance directive instruments, and even

those who do rarely deal with future participation in research. As a result, the law

remains unclear in this area.

The law also reflects somewhat conflicting concerns. On the one hand, we wish

to avoid the abuses that have occurred with human experimentation—abuses such

as the U.S. military’s radiation experiments, the Tuskegee syphilis study, and the

atrocities committed by Nazi doctors.12 On the other hand, there is a pressing

need to advance scientific knowledge, for the benefit of both existing patient/

subjects and for future generations of patients.13 For us truly to understand

conditions such as Alzheimer’s disease and chronic mental illness, we need

research involving people suffering from these conditions. Yet, many individuals

in these categories will not possess sufficient competence to decide on

research participation for themselves.14 The paper by Drs. Kim and Appelbaum

suggests a relaxation of traditional competency rules in this area so as to facilitate

increased research. Their proposal addresses an important unresolved issue, and

does so with thoughtfulness and sensitivity. On the whole, we applaud their

suggestions.

To a great extent, the law in this area will be shaped by the conflicting

considerations of the need to protect patient/subject rights in the research context

and the need to expand the frontiers of science and human knowledge. While strong

utilitarian considerations argue for expansion of the opportunities for research with

these populations, the traditional value we place on the protection of human rights

and dignity justifies imposing restrictions on such participation. When individuals

are sufficiently competent to waive these restrictions the balance is and ought to be

struck in favor of allowing participation, but when an individual is unable to

comprehend the risks and rationally decide society is generally reluctant and even

unwilling to permit participation. Both of these conclusions can be seen as deriving

from the value of respect for persons. This principle requires that individuals

generally be treated as autonomous, but also that persons with diminished auton-

omy are entitled to protection from harm.15 We believe that the debate has

insufficiently taken into account an additional consideration—the therapeutic

dimension.

11See Patricia Backlar, Anticipatory Planning for Research Participants With Psychotic Disorders LikeSchizophrena, 4 Psychol. Pub. Pol’y & L. 829 (1998) (analyzing advance directive instruments forresearch).12Diane E. Hoffmann et al., Regulating Research with Decisionally Impaired Individuals: Are We MakingProgress? 3 DePaul J. Health Care L. 547, 548, 596 (2000).13Expert Panel, supra note 8.14Id. (‘‘[T]he best hope for improving diagnosis, treatment, and preventive interventions for these diseaseprocesses requires the conduct of research involving those who experience these illnesses directly, andwhose decisional abilities may be permanently or transiently impaired.’’).15Belmont Report, supra note 4.

A therapeutic jurisprudence perspective on Kim and Appelbaum 487


THERAPEUTIC JURISPRUDENCE CONSIDERATIONS

By focusing attention on the therapeutic jurisprudence considerations that participa-

tion in research raises, we hope to clarify the debate. Therapeutic jurisprudence

suggests that the law and legal practices have inevitable consequences for the

psychological wellbeing of those affected.16 Therapeutic jurisprudence is an inter-

disciplinary field of legal scholarship that has a law reform agenda. It seeks to identify

the therapeutic and antitherapeutic effects of law, and reshape law in order to diminish

its antitherapeutic consequences and maximize its therapeutic potential.17

In the research contexts under consideration, the question is whether permitting

participation in research with less than traditional informed consent would be

therapeutic or antitherapeutic for research subjects, and to a lesser extent, for

others—the families of those who would like to participate in research and society

generally. These therapeutic considerations may not fully resolve the debate. Many

considerations—including the need to protect vulnerable populations from harm, the

protection of individual rights, and justice values, among others—must be taken into

account in resolving the legal ambiguities that exist in the research context. Ther-

apeutic considerations also should be taken into account. While they may not resolve

the debate, they will help to sharpen the issues for more enlightened consideration.

In contexts involving therapeutic research, therapeutic jurisprudence considera-

tions may more clearly tip the balance. When participation in research has a reasonable

potential of ameliorating symptoms or preventing further advancement of an illness,

we should be more willing to relax informed consent requirements. At least when the

risks of participation in research are reasonably small, and appear to be outweighed by

potential benefits, we should be more comfortable about allowing such research.

Unless the individual, when competent, has expressed the desire not to partici-

pate in research or to avoid particular kinds of risk, it may be reasonable to assume

that the individual, if competent, would opt for research that posed a favorable risk/

benefit ratio. When a surrogate decision-maker not laboring under a conflict of

interest and reflecting the patient’s best interests has determined that participation

in research would be desirable in the circumstances, we should be willing to accept

this determination so long as the individual—borrowing a page from pediatric

research—assents to it.18 To avoid conflict of interest, the surrogate should not be

16See generally Law in a Therapeutic Key: Developments in Therapeutic Jurisprudence (David B.Wexler & Bruce J. Winick eds., 1996) (anthology of therapeutic jurisprudence work and commentary).17See, e.g., David B. Wexler & Bruce J. Winick, Essays in Therapeutic Jurisprudence (1991); Bruce J.Winick, Civil Commitment: A Therapeutic Jurisprudence Model (2005) [hereinafterCivil Commitment];Bruce J. Winick, Therapeutic Jurisprudence Applied: Essays on Mental Health Law (1997) [hereinafterTherapeutic Jurisprudence Applied]; Judging in a Therapeutic Key: Therapeutic Jurisprudence and

the Courts (Bruce J. Winick & David B. Wexler eds. 2003); Practicing Therapeutic Jurisprudence: Law

as a Helping Profession (Dennis P. Stolle, David B. Wexler & Bruce J. Winick eds. 2000).1845 C.F.R. §§ 46.404–409 (2005) (Health and Human Services Regulations authorizing research withchildren). Although assent represents something less than competent consent, it nonetheless, in contextsinvolving both children and people suffering from mental disorder, represents a degree of autonomydeserving a measure of respect. In this respect, we suggest that there is a strong analogy between researchwith those with mental disability and research with children. When a patient with mental illness objects toparticipation in research (or to continued participation), such research should not be permitted (or should bediscontinued). This differs from research involving children where, for younger children, parents mayauthorize research even over their child’s objection. However, when a patient with mental illness assents toresearch, provided other safeguards are satisfied, proxy consent reflecting the individual’s values or bestinterests should be allowed to authorize research participation.



directly involved in the research in ways that suggest divided loyalties. For

instance, in the unlikely event a surrogate were a physician, she should be totally

independent of the research. In such a case, her fiduciary duty to the patient

provides a strong measure of assurance that participation would be reasonable in

the circumstances—satisfying considerations of beneficence and non-maleficence.

Similarly, in most instances, when the surrogate is a family member or friend

designated previously by the patient when competent, these considerations would

seem to be satisfied, particularly in the presence of safeguards to protect the

individual from harm—such as IRB review, an independent research monitor or

data safety and monitoring board, etc. In such instances, unless the research were

in a category that seemed ultra-risky—participation in psychosurgery research for

example—considerations of beneficence and protection from harm would seem

reasonably to be satisfied.19

Obviously, in such a context, considerations of individual autonomy cannot be

perfectly achieved. We generally defer to individual self-determination concerning

such important matters,20 and health care decision making generally,21 but we must

recognize that individuals who are not fully competent likewise experience dimin-

ished autonomy, and that accepting their choices may lead to harm. Competence

and autonomy are not dichotomous or binary categories. Rather, they fall along a

continuum.22 So long as an individual can provide assent that reflects some degree

of autonomy or self-determination, even if reduced, the value of protecting that

autonomy may tip the balance in favor of accepting the individual’s decision,

particularly if we have adequate assurances that the consequences appear reasonable

and of low or acceptable risk.23

Respecting self-determination or autonomy, even when reduced, can have

important therapeutic value. An individual’s sense of dignity and personhood

would be frustrated when his choices are rejected on the ground that he is

incompetent. The literature on the psychology of procedural justice stresses the

importance of voice and validation, and of being treated with dignity and

19While we use here familiar language reflecting the principles advocated in the Belmont Report and itssequelae (see generally Tom L. Beauchamp & James F. Childress, Principles of Biomedical Ethics

(2001)), we are mindful of a number of criticisms of this approach (see generally Bernard Gert,Morality: Its Nature and Justification (2005)). In fact, we intend our arguments to be applicable,mutatis mutandis, under any of several leading moral theories.20See generally Bruce J. Winick, On Autonomy: Legal and Psychological Perspectives, 37 Vill. L. Rev. 1705(1992) (analyzing right to autonomy and its foundations in political theory, legal and constitutionaltheory, and psychological principles).21See, e.g., Sell v. United States, 539 U.S. 166 (2003) (characterizing the right to be free of unwantedantipsychotic medication as a ‘‘significant’’ liberty interest, and subjecting its deprivation to a stringentform of strict scrutiny); Cruzan v. Director, Missouri Dept. of Hospitals, 457 U.S. 261 (1990) (assumingthat due process protects a liberty interest in making health care decisions, including discontinuation oflife-prolonging treatment); Bruce J. Winick, The Right to Refuse Mental Health Treatment 189–222 (1997).22Id. at 369; Bruce J. Winick, Competency to Consent to Treatment: The Distinction Between Assent andObjection, 28 Hous. L. Rev. 15 (1991).23Id. (applying this approach in defining competence to make treatment decisions); Bruce J. Winick,Competency to Consent to Voluntary Hospitalization: A Therapeutic Jurisprudence Analysis of Zinermon v.Burch, 14 Int’l J. L. & Psychiatry 169 (1991) [hereinafter Competency to Consent] (applying thisapproach in the context of consent to voluntary psychiatric hospitalization); Bruce J. Winick, ReformingIncompetency to Stand Trial and Plead Guilty: A Restated Proposal and a Response to Professor Bonnie,85 J. Crim. L. & Criminology 571 (1995) (applying this approach to redefine competency to standtrial).



respect.24 People subjected to judicial or administrative hearings that are treated in

these ways experience a greater degree of satisfaction and comply more willingly

with the outcome of the proceeding. For the same reasons, people seeking to

participate in research that they think will be beneficial for them will feel that they

are being treated without dignity and respect when they are prohibited from such

participation on the basis that their choice is not sufficiently competent.25 When

their assent to such research is rejected, they are more likely to experience a lack of

voice and validation that evidence suggests will produce feelings of dissatisfaction,

humiliation, and perhaps even anger. They may experience this as an affront to

their humanity and sense of equal citizenship.26 Prohibiting people suffering from

a serious health problem from attempting to deal with it in the way they would like

to, particularly if recommended by their physicians, can be experienced as an

insult to their sense of personhood and self-value.

Furthermore, labeling the individual as incompetent can impose negative self-

attributional consequences, diminishing functioning and motivation, and some-

times producing a form of learned helplessness and of clinical depression.27 Even

people of diminished autonomy may experience these negative psychological

consequences of having their choices rejected on the ground that they are

incompetent.28 Respecting assent, even expressed by individuals with diminished

competence, can be good for their senses of self-esteem and self-efficacy,29 senses

that might be particularly diminished and fragile for patients with dementia or

serious mental illness.

With the advent of living wills and other advance directive instruments,

we increasingly and appropriately resolve these issues in favor of allowing the

24See E. Allan Lind & Tom R. Tyler, The Social Psychology of Procedural Justice 26–34 (1988);John Thibaut & Laurens Walker, Procedural Justice: A Psychological Analysis (1975); Tom R.Tyler, Why People Obey the Law (1990); Tom R. Tyler & Yuen J. Huo, Trust in the Law (2002);Stephen LaTour, Determinants of Participation and Observer Satisfaction with Adversary and InquisitorialModes of Adjudication, 36 J. Personality & Soc. Psychol. 1531 (1978); E. Allan Lind et al., Procedure andOutcome Effects on Reactions to Adjudicated Resolutions of Conflicts of Interest, 39 J. Personality & Soc.Psychol. 643, 652–653 (1980); E. Allan Lind et al., Voice, Control, and Procedural Justice: Instrumental andNoninstrumental Concerns in Fairness Judgments, 59 J. Personality & Soc. Psychol. 952 (1990); NormanG. Poythress, Procedural Preferences, Perceptions of Fairness, and Compliance with Outcomes, 18 Law & Hum.Behav. 361 (1994); Tom R. Tyler, The Psychological Consequences of Judicial Procedures: Implications forCivil Commitment Hearings, 46 SMU L. Rev. 433 (1992).25See Winick, Civil Commitment, supra note 17, at 25–26 (applying procedural justice in civilcommitment context); Tom E. Hughes & Lon N. Larson, Patient Involvement in Health Care: AProcedural Justice Viewpoint, 29 Med. Care 297 (1991) (applying psychology of procedural justice tohealth care context); Tyler, supra note 24 (applying psychology of procedural justice in civil commit-ment contexts).26See Winick, Civil Commitment, supra note 17, at 146 (commenting on perceptions of patients in civilcommitment when treated without voice, validation, dignity, and respect).27See Bruce J. Winick, The Side Effects of Incompetency Labeling, 1 Psychol. Pub. Pol’y & L. 6 (1995)(analyzing the negative psychological effects of incompetency labeling). These may include thesyndrome of learned helplessness. see, e.g., Martin E. P. Seligman, Helplessness: On Depression,Development and Death (1975); Human Helplessness: Theory and Applications (Judy Garber &Martin E. P. Seligman eds., 1980); Winick, Therapeutic Jurisprudence Applied, supra note 17, at401.28Winick, Civil Commitment, supra note 17 at 17–39; Bruce J. Winick, A Therapeutic JurisprudenceApproach to Dealing with Coercion in the Mental Health System, __ Philosophy, Psychiatry & Psychol.(in press); Winick, supra note 27.29See Albert Bandura, Self-Efficacy: The Exercise of Control (1997); Albert Bandura, Social

Foundations of Thought and Action: A Social Cognitive Theory 413 (1986); Albert Bandura, Self-Efficacy: Toward a Unifying Theory of Behavior Change, 84 Psychol. Rev. 191 (1977).



individuals, when competent, to express choices for the future or to designate proxy

decision-makers with whom they are comfortable.30 However, when the individual

fails to enter into an advance directive instrument or otherwise to make his or her

wishes known with sufficient clarity, we are less certain what to do, and few people

execute such instruments or otherwise make their views known. Even when they do

not, the proposal by Drs. Kim and Appelbaum would permit surrogate decision

making,31 and therapeutic jurisprudence considerations support this proposal.

In fact, it has been shown that many challenges associated with enrolling

dementia patients, for instance, in research protocols are administrative or logistical.

Thus, on one account, approximately half of eligible subjects could not participate

in research because of complications associated with the consent process; 19% of

surrogates did not adequately understand the nature of the research protocol; and

there was no available surrogate in 32% of the cases studied.32

Barring individuals in this circumstance from participation in therapeutic research

could be strongly antitherapeutic for a number of reasons. These reasons include the

psychological damage that could be caused as well as the exclusion of this class of

individuals from the health benefits of such research should it prove successful.

Excluding individuals suffering from dementia or major mental illness who have

diminished decision making ability from participation in research studies would

deprive individuals with these conditions ‘‘of the improved health care research can

produce.’’33 Barring such a large class of people suffering dementia and major mental

illness from participation in research could produce a class of ‘‘therapeutic orphans.’’34

30Winick, Civil Commitment, supra note 17, at 216–218; Winick, supra note 21, at 391–399;Symposium, Advance Directive Instruments for Health and Mental Health Care: Legal,Ethical, and Clinical Issues, 4 Psychol. Pub. Pol’y & L 577–928 (Bruce J. Winick guest ed.,1998); Bruce J. Winick, Advance Directive Instruments for Those with Mental Illness, 51 U. Miami L. Rev.57 (1996).31While we favor surrogate decision making in limited circumstances, we note the existence ofadministrative and logistical challenges in this context. Thus, on one account, approximately half ofeligible subjects with dementia ould not participate in research because of complications associated withthe consent process; 19% of surrogates did not adequately understand the nature of the researchprotocol, and there was no available surrogate in 32% of the cases studied. Shari. A. Baskin et al.,Barriers to Obtaining Consent in Dementia Research: Implications for Surrogate Decision-Making, 46 J. Am.Geriatr. Soc. 287 (1998). For a discussion of other justifications for including less-than-fully-competent or incompetent subjects in research, see generally Jason Borenstein & Kenneth W. Goodman,Ethical Issues in Geriatric Psychiatry, in Geriatric Psychiatry: Evaluation and Management (Marc E.Agronin & Gabe J. Maletta eds., 2006). For a general, albeit controversial, review and analysis ofresearch on impaired patients, see National Bioethics Advisory Commission, Research Involving

Persons with Mental Disorders That May Affect Decisionmaking Capacity (December 1998).32Shari A. Baskin, J. Morris, J. C. Ahronheim, D. E. Meier, & R. S. Morrison, Barriers to ObtainingConsent in Dementia Research: Implications for Surrogate Decision-Making, 46 J. Am. Geriatr. Soc. 287(1998). For a discussion of other justifications for including less-than-fully-competent or incompetentsubjects in research, see generally Jason Borenstein & Kenneth W. Goodman, Ethical Issues in GeriatricPsychiatry in Geriatric Psychiatry: Evaluation and Management (Marc E. Agronin & Gabe J.Maletta eds, 2006). For a general, albeit controversial, review and analysis of research on impairedpatients, see National Bioethics Advisory Commission, Research Involving Persons with Mental

Disorders That May Affect Decisionmaking Capacity (December 1998).33Rebecca Dressler, Mentally Disabled Research Subjects: The Enduring Policy Issues, 276 JAMA 67, 67(1996).34Backlar, supra note 11, at 835; Robert J. Levine, International Codes and Guidelines for Research Ethics:A Critical Appraisal, in The Ethics of Human Research Involving Human Subjects: Facing the 21stCentury 235–259 (Harold Y. Vanderpool ed., 1996); Stephen G. Post, Full-Spectrum Proxy Consent forResearch Participation When Persons with Alzheimer Disease Lose Decisional Capacities: Research Ethics andthe Common Good, 17 Alzheimer Dis. & Assoc. Dis., 3, 4 (2003).



Therapeutic research, particularly if of minimal or acceptable risk, therefore presents a

fairly easy case, and we should follow the approach that we do in the context of

allowing parents to approve research participation for their minor children with the

child’s assent, using proxy decision makers in this context to play the role that parents

do in the context of research with children.35

Even when the research to be participated in is not clearly therapeutic, however,

there may be therapeutic value in allowing an individual to participate. Allowing

such research participation, of course, may produce therapeutic value for the

society as a whole, but it also may produce therapeutic value for the research

subject, even if the research seems unlikely to ameliorate symptoms or prevent the

progress of the condition. Even when not fully competent, if the individual is clearly

and voluntarily willing to assent to research participation in non-therapeutic

research, and understands at a basic level that he or she is taking some risks, but

can change his or her mind,36 there may be important therapeutic value in allowing

such participation, particularly if we have adequate assurances that the risks are not

severe. Frustrating the individual’s choice, even if not fully competent, can impose

the antitherapeutic self-attributional effects discussed above, can be a serious

affront to human dignity and personhood, and can further diminish self-esteem

and self-efficacy.

Moreover, the individual may feel that, even if the research involved is not likely

to be therapeutic, it might nevertheless be therapeutic. Frustrating the individual’s

ability to try something he may believe in, even if it is unlikely to be effective, may

impose antitherapeutic consequences upon him or her. The individual knows that

he or she is in a difficult situation and may simply wish to take his best shot, that is, to

try something that might have even a small potential for success.37 Disallowing this

risks committing the individual to a sense of helplessness and hopelessness that can

be antitherapeutic, while allowing it may produce a sense of optimism and hope that

itself can improve mood and psychological functioning.38 Participation even in non-

therapeutic research may produce a placebo effect, bringing about positive results

35See supra note 17.36Can individuals suffering from serious mental illness or dementia satisfy this standard? While some maynot be able to do so, many will. Important work by Dr. Appelbaum and Thomas Grisso, performed underthe auspices of the MacArthur Research Network on Mental Health and the Law, demonstrates thatmental illness, even serious mental illness requiring hospitalization such as schizophrenia, does notnecessarily prevent rational decision making about treatment. Paul S. Appelbaum & Thomas Grisso, TheMacArthur Treatment Competence Study. I: Mental Illness and Competence to Consent to Treatment, 19 Law &Hum. Behav. 105, 107, 108 (1995); Thomas Grisso & Paul S. Appelbaum, The MacArthur TreatmentCompetence Study III: Abilities of Patients to Consent to Psychiatric and Medical Treatments, 19 Law & Hum.Behav. 149 (1995). A significant percentage of people with serious mental illness are competent to makevoluntary hospitalization decisions for themselves. See Winick, Competency to Consent, supra note 23. Forempirical verification that patients possess competency to assent in this sense, see Binyamin C.Appelbaum et al., Competence to Consent to Voluntary Psychiatric Hospitalization: A Test of a StandardProposed by APA, 49 Psych. Svc. 1193 (1998). For similar reasons, while some people suffering fromdementia, particularly in later stages of the condition, may be unable to assent in this sense, many will.Whether an individual is competent to assent to participation in research in this sense therefore should bedetermined on an individualized basis.37Cf. Bruce J. Winick, Therapeutic Jurisprudence and the Role of Counsel in Litigation, 37 Cal. W. L.Rev. 105 (2000) (analyzing psychological value of an individual taking his best shot in litigationcontexts).38Martin E. P. Seligman, Learned Optimism, 167–184 (1990) (showing how optimism can alleviatesymptoms of depression and can improve overall health and how pessimism can be antitherapeutic).



that may best be explained as stemming from the positive expectancies that research

participation may itself engender.39

For parallel reasons, disallowing such research might produce antitherapeutic

consequences for the individual’s family and support group. The family naturally

will feel good about trying something for their loved one in distress, even if it appears

unlikely to work. They may experience frustration, powerlessness, helplessness, and

depression if they can do nothing but watch their loved one’s condition further

deteriorate.

If we can reasonably assure ourselves that the research involved is not unduly

risky, we should be willing to accept assent in this circumstance even for research

that may itself not be therapeutic. We are, of course, aware of challenges posed by

the therapeutic misconception, something that Dr. Appelbaum himself has done

much to elucidate.40 Patients often harbor the belief that mere participation in

research will be beneficial. Moreover, people cling to artificial hope, and are easily

subject to exploitation. However, we can effect safeguards in such circumstances,

and if those safeguards provide a reasonable degree of assurance that the individual

will not be subject to serious harm then deferring to self-determination or auton-

omy, even when reduced, may be justified by therapeutic considerations.

Another potentially therapeutic consideration that should not be unnecessarily

frustrated is the individual’s natural feeling of altruism. The individual may wish to

participate in research in order to help others, even if participation is unlikely to help

him or her. It is quite natural, when suffering from a serious illness, to wish to help

others who now or in the future will have the same illness, perhaps including those in

the individual’s future generations, if the condition seems to have a genetic

component. An individual who feels this way and wishes to contribute to the welfare

of others, even if research participation may be detrimental to him, should not be

deprived of the feeling of wellbeing that acts of altruism often produce. To frustrate

the individual’s wishes to help others may be a serious affront to his dignity and

personhood and may further diminish self-esteem and self-efficacy. Considering all

individuals who have cognitive deficits as incapable of understanding and partici-

pating in research ‘‘is inaccurate, stigmatizing, and disrespectful of autonomy and

39See, e.g., Howard Brody, Placebos and the Philosophy of Medicine: Clinical, Conceptual, and

Ethical Issues 18–20 (1980) (‘‘[T]he patient’s expectations of symptom change is held to be casuallyconnected to the change that occurs’’); Michael Jospe, The Placebo Effect in Healing 93–108, 130(1978) (analyzing the Hawthorne effect in terms of expectancy theory); Oscar C. Simonton, Getting

Well Again 22 (1978); Henry K. Beecher, The Powerful Placebo, 159 JAMA 1602 (1955) (documentingthe power of the placebo); Frederick J. Evans et al., Expectancy, Therapeutic Instructions, and the PlaceboResponse, in Placebo: Theory, Research, And Mechanisms (Leonard White et al. eds., 215, 222–224(1985) (concluding that the ‘‘placebo response is mediated by expectations generated within the contextof the doctor–patient relationship’’); Jerome D. Frank, Biofeedback and the Placebo Effect, 7 Biofeedback &Self-Regulation 449 (1982) (examining the placebo effect in terms of expectancy theory); PeterHorvath, Placebos and Common Factors in Two Decades of Psychotherapy Research, 104 Psychol. Bull.214, 215 (1988) (‘‘Expectancy factors have been shown to influence therapeutic outcome’’).40Paul S. Appelbaum et al., False Hopes and Best Data: Consent to Research and the TherapeuticMisconception, 17 Hastings Ctr. Report 20 (1987); Paul S. Appelbaum et al., The TherapeuticMisconception: Informed Consent in Psychiatric Research, 5 Int’l J. L. & Psychiatry 319 (1982); Paul S.Appelbaum et al., Therapeutic Misconception in Clinical Research: Frequency and Risk Factors, 26 Rev. Hum.Subjs. Res. 1–8 (Mar/Apr 2004); Paul S. Appelbaum et al., Therapeutic Misconception in Clinical Research:Frequency and Risk Factors, 26 Rev. Hum. Subjs Res. 18 (Sept/Oct 2004); Charles W. Lidz et al.,Therapeutic Misconception and the Appreciation of Risks in Clinical Trials, 58 Soc. Sci. Med. 1589 (2004).



personhood.’’41 Even if the individual lacks full decision making capacity, he may

possess sufficient autonomy to wish to contribute to society in this way; and if our

desire to avoid protecting him from harm does not clearly outweigh the harm that

would occur by frustrating his wishes, we should be willing to allow his less-than-

competent assent to suffice for research participation, at least when adequate

safeguards exist.

These therapeutic considerations favor acceptance of less-than-fully-competent

assent, at least in certain circumstances, support the proposal of Drs. Kim and

Appelbaum and, we hope, provide an added dimension that should be considered in

thinking about what the law should permit or forbid concerning participation in

research.

41Expert Panel, supra note 8.



Documents

A therapeutic jurisprudence perspective on participation in research by subjects with reduced capacity to consent: a comment on Kim and Appelbaum