The rights and interests of participants as limits to clinical trials

• Published in: Revista clínica espanõla (English edition) Vol. 225; no. 1; pp. 28 - 34
• Main Author: Dal-Ré, Rafael
• Format: Journal Article
• Language: English
• Published: Spain Elsevier España, S.L.U 01.01.2025
• Subjects: Autorización de emergencia; CIOMS; Clinical Trials as Topic - ethics; Clinical Trials as Topic - standards; COVID-19; COVID-19 - prevention & control; COVID-19 Vaccines; Declaración de Helsinki; Declaration of Helsinki; Efficacy; Eficacia; Emergency use authorization; Experimental vaccines; Helsinki Declaration; Humans; OMS; Patient Rights - legislation & jurisprudence; Placebo; Research Subjects; Safety; SARS-CoV-2; Seguridad; Vacunas experimentales; WHO; Vacunas experimentales; Efficacy; Declaración de Helsinki; Eficacia; COVID-19; SARS-CoV-2; Declaration of Helsinki; OMS; Autorización de emergencia; Placebo; Seguridad; Experimental vaccines; Safety; Emergency use authorization; CIOMS; WHO

Point 8 of the Declaration of Helsinki requires that the rights and interests of research participants must always prevail over the scientific interests of the research. Recently, it has been proposed that point 8 be modified to indicate the opposite, that is, that it is acceptable for scientific in...