Informed consent is more than just a form; it is a process that actively involves the participant. It is an "ongoing exchange of information between the investigator and [participant]" per the OHRP.

The healthcare landscape is undergoing a significant transformation, with health information exchanges (HIEs) and health data utilities (HDUs) playing a pivotal role in facilitating the secure ...

Health data’s potential can be vertigo-inducing, with seemingly limitless insights available to be mined from data sets old and new. The risks, too, can turn the stomach: faulty and biased algorithms; ...

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 ...

Canadian researchers have published new guidelines intended to make consent forms used in clinical research easier for patients to understand. The guidelines describe 75 core elements for consent ...

Informed consent is one of the most important aspects of conducting ethical research with human participants. Respecting the autonomy of research participants, the investigator must provide complete ...

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 ...

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, ...

Radiotherapy or Surgery of the Axilla After a Positive Sentinel Node in Breast Cancer: 10-Year Results of the Randomized Controlled EORTC 10981-22023 AMAROS Trial Informed consent is a basic ethical ...

Obtaining informed consent is more than getting a signature on a form. Informed consent is one of the primary ethical considerations underlying research with human subjects. ALL human subject research ...