“prejudice,” and “negligence” may not roll off the tongue in daily conversation. But university researchers often include such terms in the consent forms given to people who are asked to volunteer as ...

This article was originally on a blog post platform and may be missing photos, graphics or links. See About archive blog posts. Participation in clinical trials is critical to progress in medicine.

People who sign consent forms feel more trapped—not more empowered—than those who give consent verbally, according to new ...

Thank you for reminding the research and scholarly community of the fundamental importance of striving to obtain each subject’s true informed consent prior to her or his participation in research ...

The consent forms that people sign before participating in research are widely considered difficult to understand and sometimes inaccurate. The lack of clarity was implicated in a high-profile legal ...

Federal regulations require that researchers obtain legally effective, documented, voluntary informed consent from prospective subjects (or subjects' legally authorized representatives) before ...

Potential research subjects must be accurately informed of what a project involves, and given the opportunity to decide of their own free will whether or not to participate. This process may be brief ...

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 ...

On March 1, 2024, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services’ (HHS’s) Office for Human Research Protections (OHRP) released a draft guidance ...

Clinical research consent forms for certain FDA-regulated clinical trials are now required to contain a specific statement advising participants that clinical trial information will be entered into ...

The Revised Common Rule requires all clinical trials to post an unsigned consent form on a publicly available website. The Revised Common Rule is in effect for studies approved on or after January 21, ...