Department of Health and Human Services (DHHS) regulations for the protection of human participants require that informed consent information be presented in language understandable to the participant ...

When applicable, one or more of the following elements of information shall also be provided to each participant: Disclosure or non-disclosure of particular studies presented in the planned project.

Note: Always use lay language that is appropriate to the population being asked to sign the form. Use short paragraphs, bullets and subheadings to increase readability. See the informed consent form ...

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 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, ...

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 ...

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 ...

Obtaining informed consent is a basic ethical obligation and a legal requirement for researchers. This requirement is founded on the principle of respect for persons. Potential participants must be ...

Informed consent is a process that’s required for most medical procedures. However, there’s often confusion about what informed consent is, what it means, and when it’s needed. In a healthcare setting ...