Proxy Consent Research Articles

Informed Consent or Informed Coercion? Decision-Making in Pediatric Psychopharmacology

The legal definition of informed consent is considered in relation to clinical questions that arise when psychoactive medications are prescribed to minors. These clinical questions are numerous and profound: Should informed consent be defined differently for children? Who should give consent? When is consent legal and clinically relevant? How does the physician know when the child has understood and assented? A new theoretical model of informed consent and assent for children is presented, and pertinent legal literature is reviewed. This clinical systems model of informed consent goes beyond simple proxy consent, recognizes different components and levels of consent, and emphasizes the involvement of multiple parties. Particular attention is given to the clinical problems resulting from the influence of multiple persons, the communication between them, the inner understandings of the treatment by the individuals involved, their actions in the treatment, and the change in these factors over time. The impact of these factors on the child carries a risk of coercion, and may run counter to the therapeutic goals of treatment and the developmental interests of the child. Common deviations and modifications of the ideal model in clinical practice are considered. Seven cases which challenge usual consent procedures are presented and are examined from legal, ethical, and clinical perspectives. The model is specifically discussed to help guide clinicians in avoiding direct or indirect coercion of the child in the guise of treatment with informed consent.

The Theory and Practice of Autonomy.

Preface Acknowledgments Part I. Theory: 1. The nature of autonomy 2. The value of autonomy 3. Moral autonomy 4. Autonomy, science, and morality 5. Is more choice better than less? Part II. Practice: 6. Consent, representation, and proxy consent 7. Autonomy and informed consent 8. Paternalism: some second thoughts 9. The serpent beguiled me and I did eat: entrapment and the creation of crime 10. Behaviour control and design Epilogue Bibliography Index.

The use of aversive stimuli in treatment: the issue of consent.

It has been argued that, in the consideration of the use of aversive stimuli in treatment, the issues are ideological and philosophical as well as technical. Adopting Horner's (1990) definition of what is meant by 'aversive' in the ideological debate, it is suggested that the crucial issue is the inability of making clients to give their informed consent. It is proposed that proxy consent might be an alternative, but that this would be unacceptable if aversive procedures could be shown to be never in the best interests of the client, or shown to violate clients' rights or to be against the interests of society because of anticipated harm or injustice to others. It is concluded that it is difficult to be certain that it is ever in the best interests of the client for aversive procedures to be employed, that aversive interventions appear not to violate clients' rights necessarily (except possibly the right to dignity and respect while the intervention is operating, and perhaps the right to choice at the beginning of the intervention), but that the inescapable difficulty in the use of aversive interventions is the likelihood that they will be misused with other clients than the ones for whom they may be initially designed.

The ethics of cardiac arrest research

In cardiac arrest research, prior informed consent is not available to resolve the conflict between the rights and well-being of subjects and the possible benefit to future patients. The right to autonomy is the fundamental right that is protected by the legal doctrine of informed consent. As a fundamental right, it cannot be balanced against other goods. Rather, it is a constraint, or trump, on the balancing of goods and can be overridden only for a narrow range of reasons: its recognition in a given case conflicts with another basic right, infringing the right will prevent great harm to others, and excluding a particular case from its scope will recognize and advance the right in the long run. Proxy consent, deferred consent, and presumed consent to cardiac arrest research are examined to determine if they qualify as justified infringements of the right to autonomy. The conclusion is that only presumed consent can be used, provided that the researcher can honestly say that outside of the randomized clinical trial of two or more treatments, a physician would have no basis for choosing one over the others.

Advancing research with Alzheimer disease subjects: investigators' perceptions and ethical issues.

Advancement of Alzheimer disease (AD) research will not only depend on increased participation of patients with AD as subjects, but researchers will likely face increasingly difficult ethical issues. Presented are the results of a survey of researchers at the 15 federally funded Alzheimer Disease Research Centers concerning the ethical issues for subjects with AD participating in research. Experiences from 99 projects are assessed. Major findings include a significant lack of uniformity on the assessment of competency of subjects to consent to research, proxy informed consent overwhelmingly provided informally by family members, no wide use of durable powers of attorney and guardians, perception by the investigators that most projects present only minimal risks to the subjects, and Institutional Review Boards not being viewed by the investigators as preventing or inhibiting the advancement of AD research. It is recommended that research is needed to develop greater clarity in assessment of capacity of subjects to provide informed consent, that ethical and legal empowerment of family members to provide proxy consent be sustained, and that the issue of risk/benefit ratios for AD participants in research be reevaluated in the light of potentially greater risks to subjects.

Source Data Verification in Clinical Trials Involving the Temporarily Incapacitated Subject: Is There a Missing Link in the Notion of Proxy Consent?

Source Data Verification in Clinical Trials Involving the Temporarily Incapacitated Subject: Is There a Missing Link in the Notion of Proxy Consent?

A case for obtaining informed consent from young children

Researchers of young children have historically relied on proxy consent from parents as a substitute for obtaining informed consent from children. However, proxy consent does not fully meet the requirements of informed consent. Because children are capable of giving a degree of informed consent, subject to developmental restrictions, researchers concerned with ethical treatment of young children can take steps to ensure that the rights of children are honored. Strategies researchers can use to help young children understand the research process and be better able to give informed consent are discussed.

A Casebook of Medical Ethics

1. Paternalism in the Therapeutic Relationship 1.1 Ambivalence Toward Electroconvulsive Therapy 1.2 Treatment Refusal in the Medical Intensive Care Unit 1.3 An Uncooperative Leukemia Patient 1.4 Rehabilitation of a Dependent Patient 1.5 Alternative Approaches to Informed Consent 1.6 Previous Refusal of Treatment by a Presently Comatose Patient 1.7 A Family's Refusal of Blood Transfusions for a Mother and Her Son 1.8 Deciding Whether to Discharge a Suicidal Patient 1.9 A Request for Sex-Reassigning Surgery 1.10 Divulging Information Concerning an Infant's Condition 2. Duties to Patient and Family 2.1 A Daughter's Insistence on Aggressive Treatment 2.2 Parental Refusal of Cancer Treatment on Religious Grounds 2.3 Informed Consent and the Dying Adolescent 2.4 Treatment Refusal for an Infant with Possible Brain Damage 2.5 Venereal Disease and Adolescent Confidentiality 2.6 Contraceptives for an Adolescent 2.7 Request for Abortion for a Retarded Daughter 2.8 Request for Hysterectomy for a Retarded Eleven-Year-Old 2.9 Conflict About Maintaining a Brain-Dead Woman for the Sake of Her Fetus 2.10 Choosing the Method of Delivery for a Fetus with Hydrocephalus 3. Deciding for Others 3.1 A Bedridden and Cognitively Impaired Elderly Patient 3.2 Who Should Decide for a Patient in Persistent Vegetative State? 3.3 Nasogastric Tube Feedings for an Elderly Stroke Patient 3.4 A Prolonged Stay in the Neonatal ICU 3.5 Deciding Treatment When the Preliminary Diagnosis is Trisomy 18 3.6 Risk/Benefit Assessment of Surgery for a Child Suffering from Strokes 3.7 Responding to a Family's Decision for Laetrile 3.8 Selecting Therapy for a Mentally Retarded Teenager 3.9 Birth Control for a Retarded Woman 3.10 A Family's Lack of Commitment 4. Medical Research Involving Human Subjects 4.1 Limited Consent in Alcoholism Research 4.2 Disclosure of Preliminary Results in a Randomized Clinical Trial 4.3 Constraints on Consent in a Phase I Clinical Trial 4.4 Proxy Consent for Incompetent Trauma Patients 4.5 Undue Inducement in the Recruitment of Research Subjects 4.6 Nontherapeutic Research Procedures Involving Children 4.7 Discomfort from Repeated Nontherapeutic Research Procedures Involving Competent Adults 4.8 Physicians' Treatment Preferences and Recruitment of Subjects for a Randomized Clinical Trial 4.9 Parental Preferences and a Child's Involvement in a Randomized Clinical Trial 4.10 Compensating Research Injuries 5. Physicians, Third Parties, and Society 5.1 Request for Surgery the Physician Considers Unnecessary 5.2 Providing Free Care 5.3 Risk of Litigation as a Factor in Decision Making 5.4 Pressures to Provide Customary Care 5.5 Confidentiality and Child Abuse 5.6 Rejection of a Consultant's Advice 5.7 Abortion Resulting in a Live Birth 5.8 Costly Nutrition for a Terminal Patient 5.9 Cost Factors in the Choice of Treatment for Kidney Stone Disease 5.10 Artificial Insemination for a Single Woman Topical Index to Cases

Consent to Children's Surgery and Intensive Medical Treatment

The autonomous person is usually regarded as rational, independent, mature, and competent. Severely ill children are often distressed, dependent, and immature, and their limited competence is further compromised by their illness. Such vulnerable patients would therefore seem to have little or no autonomy. Since a major criterion of informed consent requires that the patient be autonomous, sick children would in theory be excluded from the consent process. Proxy consent by parents or guardians' is seen as a solution to the problem of the non-autonomous child patient, offering the child the benefits and protection of a mature, informed response to medical proposals. However, as this paper considers, narrow interpretations of autonomy undermine the validity of consent by proxy, as well as by child patients. The first part of the paper discusses the problems raised for consent to children's treatment by narrow interpretations of autonomy in relation to respect, reason, and self-determination. The second part discusses broader interpretations of respect, reason, and self-determination which allow a deeper appreciation of the child's developing autonomy and of parents' proxy consent.

The Legal Status of Consent to Withhold Treatment-Reply

In Reply.— Mr Scofield is certainly correct to emphasize that an individual who executes a living will should be as clear as possible about his or her wishes concerning treatment. Unfortunately, it is not easy to anticipate the variety of treatment choices that may arise. The problem with some living will statutes is not vagueness, moreover, but onerous procedural requirements. The most prudent course, therefore, may be to execute a durable power of attorney for health care and to provide the proxy selected with clear instructions about your preferences. I also agree that there is a need for state legislation that specifies who is authorized to provide proxy consent in the absence of an advance directive, and thank Dr Palmisano for underscoring the point. As Mr Scofield's letter indicates, however, there is always the risk that state legislation will limit choice rather than merely clarify who is authorized to speak

Children with AIDS in the public schools: The ethical issues

The question of whether to allow children with AIDS to attend public school generates explosive emotions and has wide-reaching consequences. This paper focuses on the perspective of parents of well children who may be asked to attend school with children who have AIDS. These parents are poised at the heart of the dilemma: they are the ethical “bottom line,” and an argument that fails to satisfy them ought not to satisfy anyone. The conflicting commitments these parents face are first to the parentchild covenant which requires them to act in their child's best interests, and second, to the principles of beneficence and justice, which require them not to further burden a sick child with ostracism and isolation. Almost exact parallels exist between this issue and that of proxy consent by parents for children's participation in low-risk, non-therapeutic research. The lengthy and important debate between Paul Ramsey and Richard McCormick on this question is analyzed, concluding that McCormick's position in favor of thoughtful proxy consent is the more compelling. Returning to the question of allowing children with AIDS to attend school, the essay shows why the parallels are persuasive. On the ethical level, the apparent conflict of obligations is almost exactly the same; on the pragmatic level, the essay shows why sharing a classroom with a child who has AIDS is comparable to the “low-risk” category that the National Commission for the Protection of Human Subjects found acceptable in its 1978 guidelines. The essay concludes that parents of healthy childrenmay and ought to accept the presence of children with AIDS in the public school.

Proxy consent for incompetent non-terminally ill adult patients.

Proxy consent for incompetent non-terminally ill adult patients.

The clinician's role in protecting patients' rights in guardianship proceedings.

Recent developments in the legal regulation of psychiatric care have increased the frequency with which clinicians may become involved in guardianship proceedings. Most prominent among these developments have been court decisions requiring that guardians-not family members or physicians-provide proxy consent to treatment on behalf of incompetent psychiatric patients (1,2). At the same time, growing interest in geriatric psychiatry has increased the number and visibility of patients who may need a guardian to make decisions about their property or persons (3). The increased prominence of guardianship proceedings has created some difficult dilemmas for clinicians. Hospital and clinic staff are often in the position of initiating or encouraging family members to initiate the guardianship process. Such actions may put clinicians in an oppositional stance relative to their patients, who may resist the idea that they are incompetent to make decisions for them-

Proxy consent and counterfactual wishes.

I discuss conditions for the validity of proxy consent to treatment on behalf of an incompetent person. I distinguish those incompetents who, when previously competent, expressed an opinion on the treatment in question from those who were never competent or who, though previously competent, never expressed an opinion on the proposed treatment. In the former case valid proxy consent usually requires respecting the stated wishes of the patient. The latter case is more difficult. I consider a widely-held principle which appeals to the counterfactual wishes of the incompetent person. I argue that it is unacceptable and propose in its place a principle having to do with the best interests of the patient.

Determining proxy consent.

The paper clarifies the relative merits and proper roles of standards of review in the determination of proxy consent for those unable to make decisions concerning their own medical treatment. The "substituted judgment" standard asks which treatment the incompetent person would choose if competent, while the "best interests" test asks which treatment would benefit the patient. The tests are discussed in relation to the moral principles of autonomy and beneficence which provide their justification. I distinguish six types of cases involving incompetent patients and argue that which standard is appropriate depends on the type of case involved. A "rational choice" standard, which asks "What would the incompetent patient choose if his or her choice were rational?", is proposed as a way of determining best interests.

Consent, competency and ECT: a psychiatrist's view.

This is the third essay on consent to electroconvulsive therapy (ECT) in this issue of the Journal of Medical Ethics. It contains a psychiatrist's criticisms of the lack of procedural guidelines, in Britain's recently amended Mental Health Act, for obtaining consent to ECT from involuntarily committed patients and her comments on preceding articles by Richard Sherlock and Harry Lesser. Taylor discusses practical approaches to obtaining informed consent, as well as dilemmas in assessing competency and in the use of proxy consent. She concludes by raising the question of whether refusal of ECT in cases of severe depression can ever be a competent decision.

Who Speaks for the Child? The Problems of Proxy Consent

Who Speaks for the Child? The Problems of Proxy Consent

Who Speaks for the Child?: The Problems of Proxy Consent

I agreed to review this volume because of the importance of the subject to me. An answer or answers to the question posed in the title are necessary in arriving at therapeutic decisions in the intensive care nursery that I supervise. The book does reflect the problems and inconsistencies in our society between individual rights and proxy consent. It is certainly asking too much to expect succinct consensus in this area. However, despite the timeliness of the subject matter, I found the book disappointing. It was too diffuse and too repetitious to maintain my interest. There were few data presented to support opinions. The chapter by Joseph Goldstein On State Supervention of Parental Autonomy was a refreshing defense of the rights of parents to speak for their child but represents a minority opinion, I believe. The opposite position about state supervention, which seems to have many adherents, is not treated

Autonomy and Proxy Consent

Autonomy and Proxy Consent

Experimentation on children and proxy consent.

This essay explores the plausibility of attempting to justify the imposition of risk on young children, in the course of therapeutic treatment or nontherapeutic research, by an appeal to proxy consent. In particular, Richard McCormick's reliance on this type of defense is examined and rejected, and an alternative basis for determining the justifiability of such treatment is partially sketched – one which avoids any attempt to ‘construct’ consent on the part of the child.