Enhancing Quality of Informed Consent (EQUIC-DP) Developmental Phase

Informed Consent Clinical Trial

Official title:

CSP #476DP - Enhancing Quality of Informed Consent (EQUIC-DP) Developmental Phase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00032552
• Other study ID #: 476DP
• Status: Completed
• Phase: N/A
• First received: March 27, 2002
• Last updated: March 23, 2010
• Start date: April 1999
• Est. completion date: February 2006

Study information

• Verified date: March 2010
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 632
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Depends on 'parent' study

Exclusion Criteria:

Study Design

N/A

Related Conditions & MeSH terms

• Informed Consent

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System	Ann Arbor	Michigan
United States	VA Medical Center, Birmingham	Birmingham	Alabama
United States	VA Western New York Healthcare System at Buffalo	Buffalo	New York
United States	VA Medical Center, Durham	Durham	North Carolina
United States	Edward Hines, Jr. VA Hospital	Hines	Illinois
United States	Michael E. DeBakey VA Medical Center (152)	Houston	Texas
United States	Richard Roudebush VA Medical Center, Indianapolis	Indianapolis	Indiana
United States	MIMA Century Research Assoc. (CSP #424) (DP)	Melbourne	Florida
United States	VA Medical Center, Minneapolis	Minneapolis	Minnesota
United States	New York Harbor HCS	New York	New York
United States	VA Medical Center, Northport	Northport	New York
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	VA Medical Center, Philadelphia	Philadelphia	Pennsylvania
United States	VA Sierra Nevada Health Care System	Reno	Nevada
United States	Mayo Clinic Rochester (CSP #424) (DP)	Rochester	Minnesota
United States	VA Puget Sound Health Care System, Seattle	Seattle	Washington
United States	VA Medical Center, St Louis	St Louis	Missouri
United States	West Palm Beach VA Medical Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measuring the process and outcome if informed consent		immediately during patient interview	No