There has been an increased focus over the past couple of years on patient rights, resulting in a renewed emphasis on informed consent by healthcare regulators, such as The Joint Commission. This ...

Obtaining a patient’s consent is not the same as having a patient sign a consent form. While a written, countersigned document provides important evidence if consent is disputed in court, in order for ...

While many people indicate “I have read and agree to the terms and conditions”, very few actually take the time to read through everything to truly understand the small print. One journalist estimates ...

Informed consent is one of the primary requirements of research involving human participants. It is important to remember that informed consent is an ongoing process, not a document or single event.

Fostering global data sharing that allows collaborative work on scarce and disparate resources is essential for research into rare diseases (RDs). 1 The challenges posed by new sequencing technologies ...

The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed consent practices. Below, we summarize key takeaways from ...

Failure to obtain informed consent can result in significant consequences Exceptions to informed consent apply only in limited circumstances Elements of valid informed consent include patient capacity ...

Research participants have commonly been found to lack basic understanding of fundamental aspects of the studies in which they are participating. The informed consent process is one of many aspects of ...

The U.S. Food & Drug Administration (FDA) issued final guidance (Final Guidance) regarding informed consent titled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, ...

It's time to revise the informed consent process and create a reasonable-patient standard through shared decision-making between physicians and patients, according to a viewpoint piece in the Journal ...

Over the past 50 years, the informed consent process has become increasingly regulated and standardized, while the challenges remain persistent and hard to overcome. 8 Consent forms are increasingly ...