Ethics of Emerging RCT Designs: Risk analysis and informed consent

Clinical Center

Investigators

Linked publications & trials

Abstract

1. Data collection in the PCORI sponsored study (PI: Andrew Vickers, Sloan-Kettering) of two stage consent for pragmatic trials has resumed after a hold due to the COVID crisis. A preliminary study's results was published in Clinical Trials. This collaboration work is ongoing. 2. We completed a practical guide for IRBs in identifying the sources of research risks in pragmatic trials that compare already in use, standard treatments. These trials have been quite controversial despite their seeming lack of research risk. We developed a practical guide grounded in rigorous ethical analysis that can help IRBs navigate this often confusing area. 3. With colleagues in Canada, I am part of a working group examining the ethics of pragmatic cluster RCTs for dialysis, with the aim of producing an overarching guidance document. This work continues.