J. Sugarman et al., GETTING MEANINGFUL INFORMED CONSENT FROM OLDER ADULTS - A STRUCTURED LITERATURE-REVIEW OF EMPIRICAL-RESEARCH, Journal of the American Geriatrics Society, 46(4), 1998, pp. 517-524
OBJECTIVES: To perform a structured literature review of the published
empirical research on informed consent with older adults in order to
make recommendations to improve the informed consent process and to hi
ghlight areas needing further examination. DESIGN: Relevant literature
was identified by searching electronic databases (AGELINE, BIOETHICSL
INE, Cancer-Lit, Ethics Index, Health, LegalTrac, MEDLINE, PAIS Intern
ational, PsycInfo, and Sociofile). Studies were included if they were
reports of primary research data about informed consent and, if patien
ts or other subjects were used, older subjects were included in the sa
mple. Data related to the aspect of informed consent under study (recr
uitment, decision-making capacity, voluntariness, disclosure of inform
ation, understanding of information, consent forms, authorization, and
policies and procedures) were abstracted and entered into a specially
designed database. MEASUREMENTS: Characterization of the population,
age of subjects, setting, whether informed consent was being studied i
n the context of research or treatment, study design, the nature of ou
tcome or dependent variables, independent variables (e.g., experimenta
l conditions in a randomized controlled trial or patient/subject chara
cteristics in a nonrandomized comparison), and results according to th
e aspect of informed consent under study. RESULTS: A total of 99 artic
les met all the inclusion criteria and posed 289 unique research quest
ions covering a wide range of aspects of informed consent: recruitment
(60); decision making capacity (21); voluntariness (6);disclosure (30
); understanding (139); consent forms (7); authorization (11); policie
s (13); and other (2). In the secondary analyses of numerous studies,
diminished understanding of informed consent information was associate
d with older age and fewer years of education. Older age was also some
times associated with decreased participation in research. Studies of
disclosure of informed consent information suggest strategies to impro
ve understanding and include a variety of novel formats (e.g., simplif
ied, storybook, video) and procedures (e.g., use of health educators,
quizzing subjects, multiple disclosure sessions). CONCLUSIONS: A syste
matic review of the published literature on informed consent reveals e
vidence for impaired understanding of informed consent information in
older subjects and those with less formal education. Effective strateg
ies to improve the understanding of informed consent information shoul
d be considered when designing materials, forms, policies, and procedu
res for obtaining informed consent. Other than empirical research that
has investigated disclosure and understanding of informed consent inf
ormation, little systematic research has examined other aspects of the
informed consent process. This deficit should be rectified to ensure
that the rights and interests of patients and of human subjects who pa
rticipate in research are adequately protected.