Advertisement

Topics

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

2014-08-27 03:56:17 | BioPortfolio

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.

Study Design

N/A

Conditions

Informed Consent

Location

VA Medical Center, Birmingham
Birmingham
Alabama
United States
35233

Status

Completed

Source

Department of Veterans Affairs

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:17-0400

Clinical Trials [561 Associated Clinical Trials listed on BioPortfolio]

Clinical Informed Consent Format Evaluation

This study evaluates the effectiveness of a patient-centered short written informed consent form and a patient-centered short video informed consent in a randomized controlled trial (contr...

Informed Consent Formats by Information Preference and Priority

This study will test whether different formats of medical informed consent documents can help improve understanding and confidence in decision-making for clinical trials. The study will be...

Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium

The investigators hypothesis is that patient comprehension of telemedicine-enabled research informed consent is not inferior to standard face-to-face research informed consent. The procot...

EQUIC-CC: Enhancing Quality of Informed Consent - Customized Consent

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

Improving the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents

The investigators employed a randomized control study design to evaluate the efficacy of a video intervention augmenting informed consent discussions in improving parental and youth inform...

PubMed Articles [828 Associated PubMed Articles listed on BioPortfolio]

Patient reported measures of informed consent for clinical trials: A systematic review.

The subjective assessment of the adequacy of informed consent for clinical trials, and the potential difficulties associated with it, has led several studies to develop objective measures of informed ...

Delving Deeper Into Informed Consent: Legal and Ethical Dilemmas of Emergency Consent, Surrogate Consent, and Intraoperative Consultation.

Informed consent is gaining an ever-important place in modern medicine. The practice of patient-centered medicine along with evidence-based medicine requires a balance between the patient's wishes and...

Taking Respect Seriously: Clinical Research and the Demands of Informed Consent.

There is broad agreement among research ethicists that investigators have a duty to obtain the informed consent of all subjects who participate in their research trials. On a common view, the duty to ...

Recall and Retention of Consent Procedure Contents and Decisions: Results of a Randomized Controlled Trial.

Residual tissue samples, i.e., samples excised for diagnosis or during treatment, are commonly used for medical research. In the Netherlands, they can be used provided the patient did not opt out of t...

A 20 Year review : The use of Exception from Informed Consent and Waiver of Informed Consent in Emergency research.

Due to the acuity and time sensitive needs of their clinical condition, patients presenting with certain emergent pathologies may lack capacity to provide meaningful prospective informed consent to pa...

Medical and Biotech [MESH] Definitions

Informed consent given by someone other than the patient or research subject.

Informed consent given by a parent on behalf of a minor or otherwise incompetent child.

Groups of persons whose range of options is severely limited, who are frequently subjected to COERCION in their DECISION MAKING, or who may be compromised in their ability to give INFORMED CONSENT.

Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment.

Voluntary authorization by a person not of usual legal age for diagnostic or investigative procedures, or for medical and surgical treatment. (from English A, Shaw FE, McCauley MM, Fishbein DB Pediatrics 121:Suppl Jan 2008 pp S85-7).

More From BioPortfolio on "Enhancing Quality of Informed Consent (EQUIC-DP) Developmental Phase"

Advertisement
Quick Search
Advertisement
Advertisement

 

Searches Linking to this Trial