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 ...

The IRB determines, for each protocol it reviews, which of the following elements and disclosures must be included in the informed consent process. Investigators can avoid delay in the review process ...

On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new ...

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 ...

Increasingly, medical procedures in the United States are being performed in ASCs. According to statistics released earlier this year, the Centers for Disease Control and Prevention’s National Center ...

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 ...

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, ...

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 ...

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 ...