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The goal of the informed consent process is to ensure that the research participant is treated with respect and human dignity. This is achieved by safeguarding and advocating for the participant's ...

The Roundtable on Health Literacy convened a one-day workshop to explore the effect of regulatory requirements on the production of written and oral health literate communications. An ad hoc committee ...

Informed consent has been defined as "an individual's autonomous authorization of a medical intervention or of participation in research". [1] In professional and legal regulations it is widely ...

Informed consent is vital for any clinical trial. However, the length and complexity of consent information can lead to patients misconstruing key points and failing to understand the implications of ...

Informed consent is the ethical and legal foundation that ensures respect for individual autonomy in clinical research. It requires that potential participants receive clear, comprehensible ...

"If only the doctor had warned me of this terrible complication, I never would have agreed to his treatment." When a patient has a poor outcome, that statement is typically the basis for a malpractice ...

The justices ruled that a child who was deformed by a vaginal birth was a patient before she was born, and can pursue a claim ...

I’m a senior physician with both clinical and clinical research experience. Before this year, I had undergone bilateral total hip replacements and a right total shoulder replacement. (As a younger man ...

A carefully written information and consent form establishes transparency, so that participants understand the risks, benefits, and purposes of a study before they agree to contribute their data or ...