Consent forms continue to be at a higher reading level than the recommended sixth to
eighth grade, making it difficult for participants to comprehend information before enrolling in …

Multiple studies have documented major limitations in the informed consent process for the
recruitment of clinical research participants. One challenging aspect of this process is …

Abstract 'Right To Try'(RTT) laws originated in the USA to allow terminally ill patients to
request access to early stage experimental medical products directly from the producer …

Background: Research suggests that participants do not always adequately understand
studies. While some consent interventions increase understanding, methodologic …

Abstract Introduction Phase III/IV clinical trials are expensive and time consuming and often
suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult …

OBJECTIVE: In the United States, data from federally funded genomics studies are stored in
national databases, which may be accessible to anyone online (public release) or only to …

The patient empowerment movement, spurred by AIDS activism in the 1980s, quickly
evolved to encompass how study participants are considered and treated in clinical …

Background Obtaining consent has become a standard way of respecting the patient's rights
and autonomy in clinical research. Ethical guidelines recommend that the child's parent/s or …

In research ethics regulation, health care and research are depicted as serving distinct
goals, and policies are in place to prevent what is seen as patients' misconceived …

Obtaining written informed consent from participants before enrolment in a study is essential.
A previous study showed that only 50% of the participants in clinical trials understood the …