Alzheimer's Dementia

The National Institute on Aging (NIA) has historically been concerned with the protection of human subjects. In July 1977, the NIA sponsored a meeting to update and supplement guide­ lines for protecting those participating in Federal research pro­ jects. Although the basic guidelines had been in effect since 1966, it had been neglected to include the elderly as a vulnerable population. In November 1981, the NIA organized a conference on the ethical and legal issues related to informed consent in senile dementia cases. The present volume offers the latest and best thinking on Alzheimer's Dementia to have emerged from the dialog that was first embarked upon at the NIA meeting. Indeed, the issues and concerns it treats now seem even more relevant than they appeared historically because of the vastly greater awareness in the community of the entire spectrum of problems Alzheimer's disease confronts us all with. Our interest and concern is both humanitarian and self­ serving. Clearly older people must be protected from in­ appropriate research and careful attention must be paid to the circumstances under which research is conducted on those older persons who have given anything less than full consent. It is equally necessary, however, for the research enterprise to be protected so that today's elderly and those of the future can benefit from the fruits of research.

Contenu

1 Legal and Science Background.- Current Frontiers in Research on Alzheimer's Disease.- Risks and Benefits of Research.- Testing and Measurement of Alzheimer's Dementia.- Fibrous Proteins Changes.- Monoclonal Antibodies.- Neurotransmitter Systems.- Etiological Factors.- Genetic Factors.- Down's Syndrome.- Chromosomal Abnormalities.- Transmittibility of Alzheimer's Dementia.- Environmental Factors.- Summary.- References.- Current Regulations for the Protection of Human Subjects.- The Period of Growing Awareness: 1947-1959.- The Period of Policy Development: 1959-1966.- The Period of Regulatory Growth: 1966-1981.- The Period of implementation: 1981-the present.- Clinical Symptoms Accompanying Progressive Cognitive Decline and Alzheimer's Disease: Relationship to "Denial" and Ability to Give Informed Consent.- Relevance of Findings for Issues Related to Informed Consent.- Conclusion.- Notes and References.- The Physician-Researcher: Role Conflicts.- Professional Roles.- Some Considerations of the Conflict.- Resolution of the Conflict.- Summary.- References.- 2 Personal Perspectives.- Impact of Alzheimers Disease and the Role of the Patient's Family.- Case Histories.- Stages of Family Coping.- Current Research.- Financial Survival.- Emotional Stress.- Advocacy for Persons with Senile Dementia.- Internal Rights Protection Advocates.- Legal Advocates.- Long-Term Care Ombudsmen.- Protection and Advocacy Agencies.- Legal Services Corporation.- Self Advocacy.- Rights Issues in Research.- Conclusion: The Patient as Person.- Notes and References.- Ethical Issues in the Care of the Patient Involved in Alzheimer's Disease Research.- Research and Patient Care.- Patient Care and Ethics.- Patient Care Factors.- Summary.- Notes and References.- 3 Historical, Legal, and Ethical Background.- Research Objectives and the Social Structuring of the Research Enterprise: An Historical and Ethical Perspective.- Justifications for Social Permission to Experiment on Humans.- Social Utility.- Justice.- Freedom of Science and the Scientist.- Love and Justice.- The Relation Between Science and Technology.- Sacrifice.- Anthropological Justification.- Emerging Moral Boundaries.- Alzheimer's Dementia: Contemporary Tensions Between Clinical Needs and Moral Boundaries.- Notes and References.- Research on Senile Dementia of the Alzheimer's Type: Ethical Issues Involving Informed Consent.- Problems of Evaluating Competence.- Conflict of Interest.- Respect for Autonomy vs Paternalism.- Paternalism, Justice, and Quality of Care.- Ethics and Methodology.- Conclusions.- Notes and References.- An Alternative Approach to Informed Consent in Research with Vulnerable Patients.- The Dilemma.- The Pressure for Research.- Stepping Back from Voluntariness.- Exemplary Care.- Collective Patient Control of Care.- General Implications of Nonvoluntary Approaches to SDAT.- The Social Context.- Conclusion.- Notes and References.- Technical Aspects of Obtaining Informed Consent from Persons with Senile Dementia of the Alzheimer's Type.- Clarity.- Risk.- The Informed Consent Form: To Be or Not To Be.- Readability.- The Two-Part Consent Form.- Procedural Adjuncts To Obtaining an Informed Consent.- References.- 4 Institutional Issues.- The Need for Alternatives to Informed Consent by Older Patients: Psychological and Physical Aspects of the Institutionalized Elderly.- The Institutional Environment.- The Institutionalized Elderly.- Improved Care.- Summary.- Notes and References.- Legal Issues in Research on Institutionalized Demented Patients.- Rights for Those of Diminished or Developing Capacity.- Research in General.- The Kaimowitz Case.- The Institution of the Nursing Home.- Privacy Rights and the Substituted Judgment Doctrine.- Substituted Judgment as the Basis for Consent to Research.- An Alternative: Consent Prior to Dementia.- Possible Liability.- Notes and References.- Issues of Equity in the Selection of Subjects for Experimental Research on Senile Dementia of the Alzheimers Type.- Ethics and Equity: The Limits of Regulation.- Some Principles for Equity in the Selection of Subjects.- Concern for the Least Advantaged.- Compensation.- The Voice of the Afflicted.- 5 Competency to Give Consent.- Competency to Consent to Research.- Competency and Consent.- Tests of Competency.- Evidencing a Choice.- Factual Comprehension.- Rational Reasoning and Manipulation of Information.- Appreciation of the Nature of the Situation.- Reasonable Outcome of Choice.- Conclusion.- References.- Assuring Adequate Consent: Special Considerations in Patients of Uncertain Competence.- Outline of the Legal Structure.- The Two-Tiered Approach to the Regulation of Medical Research.- Informed Consent to Ordinary Medical Procedures.- Informed Consent to Research Procedures.- The Presumption of Competency.- Incompetency.- What Is Incompetency?.- Who Decides Whether the Patient/Subject Is Incompetent?.- Who Makes Decisions for the Patient/Subject Who Is Incompetent?.- Conclusion.- Notes and References.- Assessment of Competence to Give Informed Consent.- Informed Consent Criteria.- Autonomy vs Paternalism.- Community and Consent.- Autonomy and Consent.- Assessment of Competence.- The Perception of Knowledge.- Beyond the Impasse.- Notes and References.- 6 Proxy and Derived Consent.- Autonomy and Proxy Consent.- Autonomy.- Four Senses of Autonomy Action.- Models of Proxy Consent.- Specific Authorization.- General Authorization With Instructions.- General Authorization Without Instructions.- Instructions Without Authorization.- Substitute Judgment.- Deputy Judgment.- Autonomy and Proxy Consent.- Specific Authorization.- General Authorization With Instructions.- General Authorization Without Instructions.- Instructions Without Authorization.- Substitute Judgment.- Deputy Judgment.- Summary.- Partial Competence of the Principal.- Recommendations.- Notes and References.- Derived Consent, Proxy Consent: Legal Issues.- Common Law Consent Requirements.- Therapeutic.- Mixed Therapeutic and Nontherapeutic.- Nontherapeutic.- Statutory Consent Requirements.- Right To Refuse Consent to Life-Prolonging Procedures.- Nontherapeutic Procedures and No Duty To Confer a Benefit.- Analogy to Those Institutionalized as Mentally Infirm.- Application of the National Commission's Recommendations to SDAT Individuals.- Subject Advocate, Durable Power of Attorney, and Ulysses Contract.- A Tentative Model.- Conclusion.- Notes and References.- Clinical Research in Senile Dementia of the Alzheimer's Type: Suggested Guidelines Addressing the Ethical and Legal Issues.