Biomaterial Database

Obtaining informed consent in Alzheimer's research. 1995

L S Resau

Johns Hopkins Alzheimer's Disease Research Center, Bayview Medical Center, Baltimore, MD 21224, USA.

While current drug studies focus on treating cognitive symptoms and pose little risk to dementia subjects who participate, future drug studies may very well impose greater risks. Investigators are challenged in both present and future AD research to respect and safeguard the rights and welfare of a vulnerable population while promoting the highest quality research to investigate the causes, treatment, and prevention of Alzheimer's disease. In procuring informed consent for research, researchers should exercise caution in concluding that an AD subject is not competent to consent to participate in research protocols based solely on the presence of dementia. Informed consent should be sought from a competent AD subject, and if indeed the participant is not fully competent, the investigator should obtain full informed consent from a proxy while obtaining assent from the subject. Finally, while the augmentation of advance consent directives with informal family consent or durable power of attorney may make for a qualitatively better informed consent for dementia research, it should not be legally required before research takes place. Advance consent directives should be seen as an adjunct to the current proxy consent/subject assent and not a substitution.

UI	MeSH Term	Description	Entries
D007258	Informed Consent	Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment.	Consent, Informed
D004341	Drug Evaluation	Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals.	Evaluation Studies, Drug,Drug Evaluation Studies,Drug Evaluation Study,Drug Evaluations,Evaluation Study, Drug,Evaluation, Drug,Evaluations, Drug,Studies, Drug Evaluation,Study, Drug Evaluation
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000544	Alzheimer Disease	A degenerative disease of the BRAIN characterized by the insidious onset of DEMENTIA. Impairment of MEMORY, judgment, attention span, and problem solving skills are followed by severe APRAXIAS and a global loss of cognitive abilities. The condition primarily occurs after age 60, and is marked pathologically by severe cortical atrophy and the triad of SENILE PLAQUES; NEUROFIBRILLARY TANGLES; and NEUROPIL THREADS. (From Adams et al., Principles of Neurology, 6th ed, pp1049-57)	Acute Confusional Senile Dementia,Alzheimer's Diseases,Dementia, Alzheimer Type,Dementia, Senile,Presenile Alzheimer Dementia,Senile Dementia, Alzheimer Type,Alzheimer Dementia,Alzheimer Disease, Early Onset,Alzheimer Disease, Late Onset,Alzheimer Sclerosis,Alzheimer Syndrome,Alzheimer Type Senile Dementia,Alzheimer's Disease,Alzheimer's Disease, Focal Onset,Alzheimer-Type Dementia (ATD),Dementia, Presenile,Dementia, Primary Senile Degenerative,Early Onset Alzheimer Disease,Familial Alzheimer Disease (FAD),Focal Onset Alzheimer's Disease,Late Onset Alzheimer Disease,Primary Senile Degenerative Dementia,Senile Dementia, Acute Confusional,Alzheimer Dementias,Alzheimer Disease, Familial (FAD),Alzheimer Diseases,Alzheimer Type Dementia,Alzheimer Type Dementia (ATD),Alzheimers Diseases,Dementia, Alzheimer,Dementia, Alzheimer-Type (ATD),Familial Alzheimer Diseases (FAD),Presenile Dementia,Sclerosis, Alzheimer,Senile Dementia
D013619	Tacrine	A cholinesterase inhibitor that crosses the blood-brain barrier. Tacrine has been used to counter the effects of muscle relaxants, as a respiratory stimulant, and in the treatment of Alzheimer's disease and other central nervous system disorders.	Tetrahydroaminoacridine,1,2,3,4-Tetrahydro-9-acridinamine,1,2,3,4-Tetrahydroaminoacridine,9-Amino-1,2,3,4-Tetrahydroacridine,Cognex,Romotal,THA,Tacrine Hydrochloride,Tenakrin
D016223	Advance Directives	Declarations by patients, made in advance of a situation in which they may be incompetent to decide about their own care, stating their treatment preferences or authorizing a third party to make decisions for them. (Bioethics Thesaurus)	Health Care Power of Attorney,Medical Power of Attorney,Healthcare Power of Attorney,Psychiatric Wills,Ulysses Contracts,Advance Directive,Attorney Healthcare Power,Attorney Medical Power,Contract, Ulysses,Contracts, Ulysses,Directive, Advance,Directives, Advance,Psychiatric Will,Ulysses Contract,Will, Psychiatric,Wills, Psychiatric
D016743	Mental Competency	The ability to understand the nature and effect of the act in which the individual is engaged. (From Black's Law Dictionary, 6th ed).	Competency, Mental,Incompetency, Mental,Competence,Incompetence, Mental,Mental Competence,Competence, Mental,Mental Incompetence,Mental Incompetency