Healthy Clinical Trial
Official title:
CSP #476SM - Enhancing Quality of Informed Consent (EQUIC-SM) Self-Monitoring
Patients in 'parent' cooperative studies projects are interviewed about their experiences in the informed consent process.
Intervention: Self-Monitoring Questionnaire (a questionnaire relating to the process of IC
self-administered by study coordinators) and evaluation of the informed consent process
using the Brief Informed Consent Evaluation Protocol (BICEP) developed during the EQUIC-DP
phase.
Primary Hypothesis: We hypothesize that by focusing attention on what may have become a
routinized process, the quality of the IC encounter will be enhanced. We will evaluate the
success of this intervention by having the patient-subject complete a telephone
questionnaire, the BICEP (Brief Informed Consent Evaluation Protocol), after the IC process
is completed.
Primary Outcomes: The quality of the informed consent process, as measured by the BICEP
(Brief Informed Consent Evaluation Protocol). The BICEP also offers a method to certify
informed consent in routine use.
Study Abstract: Enhancing the Quality of Informed Consent Self-Monitoring (EQUIC-SM) is one
component of a VA Cooperative Studies Program-wide initiative on informed consent (EQUIC).
Its objective is the field testing and iterative improvement of one intervention in the
informed consent (IC) process, self monitoring. Self-monitoring involves having the person
obtaining IC complete a Self-Monitoring Questionnaire, or SMQ after the IC encounter with a
patient-subject being recruited for a participating study. We conceive of the SMQ as an
activation device which prompts the person obtaining IC to monitor how he/she conducts the
IC encounter. RESEARCH DESIGN: EQUIC-SM will be conducted in conjunction with participating
clinical trials of the VA CSP at multiple VAs throughout the country. Patient-subjects will
be recruited from among participants in these parent studies. Parent studies will be
randomized to SM protocol or to control sites.
METHODOLOGY: Patient-subjects will be informed about EQUIC-SM at the time that they are
first presented with information about the parent study. The person obtaining consent will
use a scripted description of EQUIC-SM. If the subject agrees, verbal consent for EQUIC-SM
will be obtained. The same parent study informed consent process will be used for both the
SM protocol and control arms of EQUIC-SM; however in the SM protocol arm, the person
obtaining consent will complete the SMQ after the IC process. In both arms, patient-subjects
will be asked to complete the BICEP interview after the parent study IC process is
completed. FINDINGS: Investigators will use the results of EQUIC-SM to assess the value of
the self-monitoring technique in improving the quality of informed consent. The premise is
that focusing the attention of the person obtaining informed consent on the IC process will
enhance the quality of the IC encounter, and thus of the informed consent obtained.
SIGNIFICANCE: Practitioners of clinical trials have a responsibility to ensure that patients
participation in research be informed and voluntary. This responsibility implies that we
should strive continuously to improve the effectiveness of methods for informing prospective
research volunteers about experimental studies, thereby enhancing the protection of their
interests. If the self-monitoring technique tested in EQUIC-SM proves to enhance the quality
of informed consent, this technique may be adapted for wider use in conducting clinical
trials, thus representing an important step towards this goal.
;
Time Perspective: Cross-Sectional
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