Ethical Considerations in the Design and Conduct of Clinical Trials of Artificial Intelligence.

ABSTRACT:

Importance

Safe integration of artificial intelligence (AI) into clinical settings often requires randomized clinical trials (RCT) to compare AI efficacy with conventional care. Diabetic retinopathy (DR) screening is at the forefront of clinical AI applications, marked by the first US Food and Drug Administration (FDA) De Novo authorization for an autonomous AI for such use.

Objective

To determine the generalizability of the 7 ethical research principles for clinical trials endorsed by the National Institute of Health (NIH), and identify ethical concerns unique to clinical trials of AI.

Design, setting, and participants

This qualitative study included semistructured interviews conducted with 11 investigators engaged in the design and implementation of clinical trials

SUBMITTER: Youssef A 

PROVIDER: S-EPMC11380101 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature