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.