Evaluation of the Informed Consent Process of a Multicenter Tuberculosis Treatment Trial.

ABSTRACT:

Background

Ethical principles obligate researchers to maximize study participants' comprehension during the informed consent process for clinical trials. A pilot evaluation of the consent process was conducted during an international clinical trial of treatment for pulmonary tuberculosis to assess the feasibility of conducting an evaluation in a larger population and to guide these future efforts.

Methods

Study staff administered an informed consent assessment tool (ICAT) to a convenience sample of trial participants, measuring comprehension of consent components as derived from the Common Rule and FDA Title 21 Part 50, and satisfaction with the process. Participating site staff completed a consent process questionnaire about consent practices at their respective sites and p

SUBMITTER: Chapman KN 

PROVIDER: S-EPMC5351885 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature