Presenter: S. Joffe Affiliation: Dana-Farber Cancer Institute, Boston, MA
For valid informed consent to be obtained, the prospective subject must have an understanding of the medical and research issues involved to make an informed and enlightened decision. Assuring an understanding of the research procedure requires thorough and repeated discussions with the subject on an ongoing basis, both before and after the documentation of consent.
Materials and Methods:
Quality of Informed Consents (QuIC) to 287 adult cancer patients who perticipated in clinical trials
Each patients healtcare provider was also surveyed
72% patients responded
Improved knowledge was associated with college education, English speaking only, not signing the consent form at the initial discussion, the presence of a nurse, and careful reading of the consent form
Majority of respondents were satisfied with the informed consent
Only about half of the patients understood why clinical trials are performed
Misunderstanding of the informed consent was quite common in patients who were enrolled in clinical trial
Health providers may share the same misconceptions
In the setting of oncology clinical trials, educating patients to understand the underlying goals of cancer clinical trials may be difficult to accomplish. Oncology therapeutic protocols often involve multiple modalities, such as standard and high-dose chemotherapy, radiotherapy, surgery, and immunotherapy, which can be administered over a prolonged time period
There may be one or more randomizations between substantially similar therapies, or radically different therapies
These combinations of multiple therapies can make the consent process confusing
May 30, 2014 - Claims of not receiving proper informed consent and clinical performance are the main issues that arise in radical prostatectomy malpractice litigation, according to a study published in the June issue of The Journal of Urology.