Glossary

TRREE Glossary

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B

Beneficence

Bienfaisance -- Fürsorgliches Handeln

1) Beneficence refers to the ethical obligation to maximize benefits and to minimize harms.

CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, General ethical principles

2) Literally, ‘doing good’. Physicians are expected to act in the best interests of their patients.

World Medical Association, Medical Ethics Manual, Ferney-Voltaire, WMA, 2nd ed., 2009, Appendix A, Glossary

Keyword(s):

Benefit

Bénéfice / avantage -- Nutzen / Vorteil

Which refers to the magnitude of a good outcome.

Keyword(s):

Blinding / Masking

Essai à l’insu / essai en aveugle -- Verblindung

A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).

International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.10