Ethics of Emerging RCT Designs: Risk analysis and informed consent

Clinical Center

Investigators

Linked publications, trials & patents

Abstract

1. Data collection in the PCORI sponsored study (PI: Andrew Vickers, Sloan-Kettering) of two stage consent for pragmatic trials continues. This collaboration work is ongoing. 2. With colleagues at Memorial Sloan Kettering, a PCORI study of decision architecture randomization design (DART) as an efficient and ethical means of conducting embedded comparative effectiveness trials. This work is ongoing. We are currently analyzing the ethics of pragmatic trials that include individualized decision-making even when a randomized design is used, and the impact of such a design on the risk analysis of the pragmatic trial. 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. 4. Analysis of research risk in standard of care pragmatic RCTs, showing that by incorporating individual clinical decisions into an RCT, most pragmatic SOC RCTs can be treated as minimal risk. This has broad implications for such trial design's need for various types of informed consent.