BrUOG 274: Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?
Obtaining informed consent as part of a clinical study is a cornerstone of current day
medical ethics; however, this has not always been the case. The development of the informed
consent has been necessitated out of abuses committed in the name of medicine.
Informed consents have become increasing lengthy and complex. It is not unusual for an
Oncology Clinical Research informed consent to be greater than 20 pages. Investigators will
utilize the QuIC-A survey to evaluate patient understanding of the basic elements of
informed consent required by federal regulations. The QuIC-A survey has been condensed from
20 questions to 14 questions by eliminating the 6 phase specific questions. The remaining
14 questions are designed irrespective of phase and address the basic elements of informed
Investigators hypothesize that as informed consents have become more lengthy and
complicated, in part due to required regulatory language and legal clauses inserted to
protect the institution performing research, patient comprehension of the basic elements of
informed consent has been hindered.
Observational Model: Cohort, Time Perspective: Prospective
Understanding of all elements of informed consent via questionnaire
Comprehension of the important elements of the informed consent forms using questionnaire
United States: Institutional Review Board
|Rhode Island Hospital||Providence, Rhode Island 02903|
|The Miriam Hospital||Providence, Rhode Island 02903|