Title

Consenting Patients to Oncology Based Clinical Trails: Do Clinical Researchers' Fully Understand the FDA Required Elements of the Consent Form Document?

Document Type

Presentation

Publication Date

12-7-2010

Comments

Advisor: Rickie Brawer, PhD, MPH. Thomas Jefferson University.

Abstract

The scope of this project is to gauge the clinical researchers’ obtained knowledge of the consent form process through a survey intended to test the understanding of the essential elements and readability standards required by the FDA for consent to clinical trials. A comprehensive survey of fifteen validated questions was developed based on several IRB training exams from several institutions, historical clinical trial participant understanding comprehension surveys, and reading level comprehension tests. The survey was scored using a simple point system that gave the survey-taker one point for each correct answer and zero points for an incorrect answer in three sections: the FDA essential elements of the consent, HIPAA regulations and readability. The surveys were distributed via email to 115 researchers including investigators, coordinators, regulatory personnel, and research nurses within the Jefferson Kimmel Cancer Center Network which encompasses 23 centers in Pennsylvania, New Jersey, New York and Delaware. There were a total of 47 survey participants at 12 institutions. The survey yielded results that saw an average score of 7.47 out of a possible 18 points. The survey revealed that even though there was a slight variability in scores based on role, experience and institution less than half of the questions resulted in a positive score. In conclusion the survey showed that significant gaps exist in the clinical researchers’ understanding of the essential elements of informed consent, the HIPAA regulations, and readability level comprehension. To increase knowledge of these essential elements of the consent form additional trainings, seminars, on-line modules and consent process observation programs and should be taken into consideration by the local IRB. In addition there needs to be more stringent federal oversight in regards to the readability standards.