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MACARTHUR COMPETENCE

ASSESSMENTTOOL FORCLINICAL

RESEARCH(MACCAT–CR)

The MacArthur Competence Assessment Tool for

Clinical Research (MacCAT–CR) provides a semi-

structured assessment format for evaluating abilities

related to the decisional capacity of subjects in clinical

research. Four component abilities of a decisional

capacity standard are assessed: understanding, appre-

ciation, reasoning, and choice. Administration of the

instrument begins with the disclosure of selected infor-

mation about a given research project, on the basis of

which these abilities are measured. The MacCAT–CR,

which takes 15 to 20 minutes to administer, has

demonstrated good reliability and validity and has

been used both to explore the relative abilities of dif-

ferent subject groups and to assess the capacities of

particular research subjects prior to entry into studies.

Informed consent of research subjects is a nearly

universal requirement of ethical codes, federal regula-

tions, and common law. For subjects’ consent to be

valid, they must be competent (i.e., they must have

adequate decisional capacity—the terms are used

interchangeably in this entry) to offer consent. Because

persons are generally presumed to be competent to

make decisions of all sorts, barring evidence to the

contrary, the question of whether subjects are compe-

tent does not arise for most research subjects; the

casual interactions between subjects and researchers

are sufficient to sustain the presumption of subjects’

capacity. However, some subject groups may have an

elevated probability of incapacity, making it desirable,

particularly in higher-risk studies, to perform an

explicit assessment of their capacity. The demonstrated

variability in clinical judgments of competence has

encouraged the development of competence assess-

ment instruments for this purpose.

The MacCAT–CR grows out of the four-part con-

ceptualization of decisional capacity that underlay the

MacArthur Competence Assessment Study and that is

based on existing case law; statutes; and bioethical,

psychological, and medical literature. Understanding

is the first of these four components of competence.

Research subjects, at a minimum, must have the abil-

ity to understand the basic elements of disclosure

required by the U.S. Federal Common Rule, including

the purpose of the research project, the procedures

involved, material risks, possible benefits, and alterna-

tives to research participation. The second component,

Appreciation,reflects the importance of subjects’ abil-

ities to apply the disclosed information to their own

situations, including their recognition that the

research project is aimed at generalizable knowledge,

not at optimizing the treatment they receive, and that

they are truly free to decline to participate without

penalty. Reasoning,the third component, focuses on

subjects’ abilities to manipulate the information dis-

closed to them, comparing and weighing the conse-

quences of the alternatives before them. The final

component is Choice,the ability to select the desired

option and to sustain a consistent decision.

Because the information that subjects must

understand will differ across research projects, the

MacCAT–CR provides a format for disclosure of

study-specific information that is standardized for all

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