Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032552
Status:
COMPLETED
Last Update Posted:
2010-03-25
First Post:
2002-03-27
Brief Title:
Enhancing Quality of Informed Consent EQUIC-DP Developmental Phase
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 476DP - Enhancing Quality of Informed Consent EQUIC-DP Developmental Phase
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None