We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

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.

Ethicists have suggested that written consent forms encourage participants in phase 1 cancer trials to expect benefit from the experimental agent and to overlook serious risks. Of 272 forms, 268 ...

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 voluntary nature of participation in research requires the investigators to inform each participant they may discontinue participation in an ongoing research study, without penalty or loss of ...

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 ...

Before using photographs, video and audio recordings of individuals for the purpose of media, marketing, development, and/or customer service, the University of Alabama at Birmingham, UAB Medicine and ...

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; ...

When submitting a project through the eIRB system, researchers can request either a waiver of the need for signatures/documentation, or a waiver to alter or omit the entire consent process. In either ...

A lot has been written about ensuring that the language of informed consent forms is at a level that is easily understandable, and for good reason. The Food and Drug Administration requires all ...

Background: Consent forms have become too long and often do little to help people understand the risk elements of their participation in research, instead focusing on risk reduction for research ...