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Evaluating the Quality of Different Methods of Obtaining Informed Consent

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00794729
First received: November 19, 2008
Last updated: September 15, 2011
Last verified: September 2011

November 19, 2008
September 15, 2011
October 2008
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Complete list of historical versions of study NCT00794729 on ClinicalTrials.gov Archive Site
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Evaluating the Quality of Different Methods of Obtaining Informed Consent
Sub-Study Evaluating the Quality of Different Methods of Obtaining Informed Consent"

This is a sub-study of a drug development study conducted by Pfizer, Inc. It will evaluate how well people who participate in research studies understand from the study consent form what the purpose of the study is, the risks and benefits of participating, the procedures they will undergo and their right to withdraw from the study before it ends. It will compare the understanding and satisfaction of those who are given a standard consent form with those who are given a simpler, concise consent form and examine how their understanding of the information is affected by the length, complexity, format, and reading level of the document.

People 18 years of age and older who are participating in a Pfizer drug development study and who are able to read and write English may be eligible for this sub-study.

Participants in Pfizer's drug development study who agree to participate in this sub-study are randomized to receive either the standard consent form or the concise consent form. The standard consent consists of a detailed, multiple page consent form. The concise form is simpler, written at a lower reading comprehension level. Both forms contain all of the required elements of informed consent according to federal regulations, and include information needed to make a decision about participating in the study. Each form also contains information regarding participation in this sub-study. The standard group signs the standard consent form; the concise group is given the standard consent after reviewing the concise form and is asked to review and sign it.

After reviewing the consent form for the main study, participants complete a 20-minute questionnaire that includes questions that measure understanding of study information such as its purpose, risks and benefits, compensation schemes, and other information. Additional questions ask about how the participants made the decision to enroll in the study.

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This informed consent study is a sub-study of phase 1 drug development studies conducted by Pfizer International and is designed to evaluate research participant understanding and satisfaction after being randomized to receive written study information from either a standard consent form or a concise consent form.

Observational
Time Perspective: Prospective
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  • Healthy Volunteers
  • Participant Satisfaction
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
September 2011
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  • INCLUSION CRITERIA:

All willing adults at least 18 years old who come to the Pfizer CRU to consider volunteering for a phase 1 study for which there is a consent sub-study and who are able to read and answer questions in English are eligible to participate in the sub-study. Only adults (over 18 years old) who can provide their own consent will be included. Because the consent forms for Pfizer studies are written in English, the sub-study will only include individuals who can read and answer questions in English.

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00794729
999909011, 09-CC-N011
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National Institutes of Health Clinical Center (CC)
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National Institutes of Health Clinical Center (CC)
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP