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
  Purpose

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.

...


Condition
Healthy Volunteers
Participant Satisfaction

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Sub-Study Evaluating the Quality of Different Methods of Obtaining Informed Consent"

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 250
Study Start Date: October 2008
Estimated Study Completion Date: September 2011
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794729

Locations
United States, Connecticut
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00794729     History of Changes
Other Study ID Numbers: 999909011, 09-CC-N011
Study First Received: November 19, 2008
Last Updated: September 15, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Healthy Volunteers
Consents

ClinicalTrials.gov processed this record on September 11, 2014