Module232025

07/05/2025

The most important ethical concept in clinical research? All major instruments state that the interests of the individuals involved in research always take precedence over the interests of science and society.

Instrument

Date

Specific Text

Art.2: The interests and welfare of the human being shall prevail over the sole interest of society or science. Art.4, para I; Art.5, para h: The interests of the patient always prevail over those of science and society. Art.3, para 2: The interests and welfare of the individual should always have priority over the sole interests of science or society. Art.3: A clinical trial may be conducted only if: (a) the rights, safety, dignity and well-being of subjects are protected and prevail over all other interests. Art. 7: (The primary purpose of medical research) can never take precedence over the rights and interests of individual research participants.

Oviedo Convention

1998

Directive 2001/20/EC (The Clinical Trials Directive) Universal Declaration of Bioethics and Human Rights Regulation 536 (The Clinical Trials Regulation)

2001

2005

2014

Declaration of Helsinki

2024

The Organisation for Professionals in Regulatory Affairs

15

ETHICS CHALLENGES IN PAEDIATRIC CLINICAL TRIALS My personal top 10 (based on ~600 protocols reviewed 2017-2023)

10. Paediatric Assent and Information Sheets (length, complexity)

The Organisation for Professionals in Regulatory Affairs

16

8