Evaluating the Quality of Different Methods of Obtaining Informed Consent

Sponsor
National Institutes of Health Clinical Center (CC) (NIH)
Overall Status
Completed
CT.gov ID
NCT00794729
Collaborator
(none)
250
1
34.9
7.2

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Time Perspective:
    Prospective
    Official Title:
    Sub-Study Evaluating the Quality of Different Methods of Obtaining Informed Consent"
    Study Start Date :
    Oct 16, 2008
    Study Completion Date :
    Sep 14, 2011

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      • 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

      Locations

      Site City State Country Postal Code
      1 Pfizer New Haven Clinical Research Unit New Haven Connecticut United States 06510

      Sponsors and Collaborators

      • National Institutes of Health Clinical Center (CC)

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00794729
      Other Study ID Numbers:
      • 999909011
      • 09-CC-N011
      First Posted:
      Nov 20, 2008
      Last Update Posted:
      Jul 2, 2017
      Last Verified:
      Sep 14, 2011
      Keywords provided by , ,

      Study Results

      No Results Posted as of Jul 2, 2017