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 ...

Although exempt research is exempt from some of the federal regulations, in most cases of interaction with participants, a consent process is indicated. It’s important to understand that even though ...

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, ...

The goal of the informed consent process is to ensure that the research subject is treated with respect and human dignity. The process does this by safeguarding and advocating for the subject's right ...

The use of deception or incomplete disclosure limits the subject's ability to make a fully informed decision of whether to participate in the research — one of the essential ethical concerns in human ...

The University IRB applies all Department of Health and Human Services (DHHS) requirements for informed consent to greater than minimal risk research: DHHS general requirements (at 45 CFR 46.116) (see ...

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 ...

“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 ...

Purpose: Complex and sometimes controversial information must be conveyed during the consent process for participation in biorepositories, and studies suggest that consent documents in general are ...