Well-being

Well-being refers to the overall physical, mental, and emotional health of individuals participating in clinical trials.

Definitions

ICH E6(R2)

1.62 Well-being (of the trial subjects):

The physical and mental integrity of the subjects participating in a clinical trial .

Fundamental obligation

Ensuring the well-being of trial subjects is a fundamental ethical requirement in clinical research. This obligation aims to protect participants from harm and uphold their rights and interests throughout the study.

Ensuring well-being

Ensuring the well-being of trial subjects is a responsibility of each stakeholder that involves adherence to ethical guidelines and continuous safety monitoring. However, it can be challenging to measure and compare well-being directly.

Examples of relevant activities

Maintenance of subjects’ well-being has multiple application points. Providing full information to trial participants on trial risks and benefits guarantees patient autonomy. Monitoring of health conditions, including information about adverse events, not only delivers clinical data required for answering study questions but also provides quantitative data on the physical well-being of participants. Institutional review boards (IRB) or ethics committees (EC) are crucial in periodically reviewing the ethical aspects of a study, while data safety monitoring boards oversee its scientific integrity.

See also

Another relevant pages

• Informed consent

Links to this page

• Regulation (EU) No 536/2014 ‎ (← links)