Clinical trial NCT00032552: Enhancing Quality of Informed Consent (EQUIC-DP) Developmental Phase
Official title: CSP #476DP - Enhancing Quality of Informed Consent (EQUIC-DP) Developmental Phase
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Informed Consent
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2002-03-28
Enrollment: 632
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans

Brief summary: Patients in 'parent' cooperative studies projects are interviewed about their experiences in the informed consent process.

Detailed description: Intervention: Immediately after giving informed consent for the parent study and before randomization, research subjects will be asked for consent to participate in EQUIC-DP.

The parent-study staff will provide the research subject with privacy and place a call to the coordinating center. Staff (at the EQUIC coordinating center), who will be administering the Brief Informed Consent Evaluation Protocol (BICEP) to the research subject, will introduce themselves. Then, the subject will be interviewed using a BICEP structured assessment questionnaire of approximately 12-20 open ended questions, aimed at determining the success and validity of the informed consent process of the parent study. The results of the interviews will be used to fine-tune and adjust both the process of assessing informed consent in this manner as well as the questionnaire itself.

Primary Hypothesis: Enhancing the Quality of Informed Consent Development Phase (EQUIC-DP) is a pilot and instrument-development study that will be used as the base for a VA Cooperative Studies Program-wide initiative on informed consent, called EQUIC (Enhancing the Quality of Informed Consent). EQUIC-DP has as its primary aim the field testing and iterative improvement of a method for measuring the success of an informed consent encounter with a patient-subject.

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: Practitioners of clinical trials have a responsibility to ensure that patients participation in research is informed and voluntary. This implies that we should continuously strive to improve the effectiveness of methods for informing prospective research volunteers about experimental studies, thereby enhancing the likelihood that their interests are respected. Innovations in informed consent should be tested in realistic contexts (i.e., in clinical trials) and when appropriate with randomization at the first opportunity. In this proposed project we take efforts to improve the quality of informed consent, based on experimentation with informed consent in ongoing clinical trials in the VA Cooperative Studies Program. The CSP is uniquely situated to serve as a testing ground for informed consent, not only because of concerns for enhancing consent for human experimentation, but also because of the centralized coordination of wide variety of clinical studies representing an extraordinary range of patient capacities and vulnerabilities. Moreover, such an effort is a special responsibility of the VA given the profound trust placed in the research enterprise by veterans.

Eligibility criteria: Inclusion Criteria:

Depends on 'parent' study

Exclusion Criteria:

Primary outcomes:
measure: measuring the process and outcome if informed consent
timeFrame: immediately during patient interview
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: VA Medical Center, Birmingham
state: Alabama
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: Melbourne
country: United States
facility: MIMA Century Research Assoc. (CSP #424) (DP)
state: Florida
city: West Palm Beach
country: United States
facility: West Palm Beach VA Medical Center
state: Florida
city: Hines
country: United States
facility: Edward Hines, Jr. VA Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Richard Roudebush VA Medical Center, Indianapolis
state: Indiana
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
city: Minneapolis
country: United States
facility: VA Medical Center, Minneapolis
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester (CSP #424) (DP)
state: Minnesota
city: St Louis
country: United States
facility: VA Medical Center, St Louis
state: Missouri
city: Reno
country: United States
facility: VA Sierra Nevada Health Care System
state: Nevada
city: Buffalo
country: United States
facility: VA Western New York Healthcare System at Buffalo
state: New York
city: New York
country: United States
facility: New York Harbor HCS
state: New York
city: Northport
country: United States
facility: VA Medical Center, Northport
state: New York
city: Durham
country: United States
facility: VA Medical Center, Durham
state: North Carolina
city: Philadelphia
country: United States
facility: VA Medical Center, Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center (152)
state: Texas
city: Seattle
country: United States
facility: VA Puget Sound Health Care System, Seattle
state: Washington
Study officials:
affiliation: VA Palo Alto Health Care System
name: Philip Lavori, PhD
role: STUDY_CHAIR
References: