Ethics of Emerging RCT Designs: Risk analysis and informed consent

Clinical Center

Investigators

Linked publications & trials

Abstract

During the past year, we completed two empirical projects. The first project was led by Neal Dickert of Emory University. We surveyed the US general public regarding the acceptability of various types of informed consent procedures for pragmatic trials in the acute care setting. Dickert NW, Wendler D, Devireddy CM, Goldkind S, Ko Yi-An, Speight CD, Kim SYH. Consent Preferences for Pragmatic Trials in Acute Illness. J Am College Cardiology. 2018: 71(9); 1051-1053.Dickert NW, Wendler D, Devireddy CM, Goldkind S, Ko Yi-An, Speight CD, Kim SYH. Understanding Preferences Regarding Consent for Pragmatic Trials in Acute Care. Accepted for publication. The second project was a survey of the US general public, using an experimental survey design to assess whether a post-randomization consent procedure for two types of pragmatic trials of different stakes was ethically and personally acceptable. It also tested whether the language used to describe the trials affected the subjects' responses, comparing traditional randomized control trial language versus language that avoided that language. A manuscript is in preparation.