Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials. Issue 4 (8th July 2022)

• Record Type: Journal Article
• Authors: Bellomo, Tiffany; Fokas, Jennifer; Tsao, Noah; Anderson, Clare; Becker, Christopher; Gioscia‐Ryan, Rachel; Meurer, William
• Is Part Of: Ethics & human research. Volume 44:Issue 4(2022)
• Page Start: 14
• Page End: 25
• Publication Date: 2022-07-08
• Subjects: human research ethics -- human subjects research -- acute ischemic stroke -- informed consent -- randomized controlled trials -- literature review; Medical ethics -- United States -- Periodicals; Human experimentation in medicine -- Periodicals; Informed consent (Medical law) -- United States -- Periodicals; 174.2805
• DOI: 10.1002/eahr.500133
• Languages: English
• ISSNs: 2578-2355

Abstract

ABSTRACT: We sought to investigate the experiences of researchers in existing active‐control trials in acute ischemic stroke comparing investigational therapy to tissue plasminogen activator (tPA) in order to identify the approaches and challenges in obtaining informed consent. Out of 401 articles evaluated, 14 trials met inclusion criteria. Trial representatives were contacted to complete a survey concerning the consent process. None of the 14 trials published materials related to the informed consent process. Trials with 75% to 100% of patients directly consented had shorter door‐to‐treatment (DTT) times than trials that directly consented less than 50% of patients. Trials that had translators available (for recruiting participants who were not native speakers in the local language) and translated consent documents had longer DTT times. The study findings suggest that differences in the standards of informed consent internationally may allow more patients with moderate strokes to provide direct consent without delaying DTT time. Future trials should emphasize transparency to the public and scientific community in the informed consent process.