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, ...

Journal of Empirical Research on Human Research Ethics: An International Journal, Vol. 16, No. 1/2 (February-April 2021), pp. 78-88 (10 pages) HIV cure research carries serious risks and negligible ...

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.

Expedited studies are research projects that meet one of the categories under 46.110 and involve minimal risk. Full board studies are those the IRB determines does not fall under exempt or expedited ...

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 ...

The principle of respect for persons demands that participants enter the research voluntarily and with adequate information. When deceptive methodologies are used, participants are given incomplete or ...

Predicting protocol completion in randomized clinical trials (RCTs): The occurrence of adverse events in the first treatment cycle. This is an ASCO Meeting Abstract from the 2015 ASCO Annual Meeting I ...

Conversations about clinical trial diversity have finally gone mainstream, but the numbers haven’t quite caught up. Improvement may rely on homing in on one key aspect: informed consent. “Informed ...