Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). International Ethical Guidelines for Health-related Research Involving Humans. 2016. 

Published by Council for International Organizations of Medical Sciences (CIOMS) 

Epidemiological StudiesClinical TrialsObservational ResearchBiobanking

The Working Group decided to broaden the scope of the 2002 Guidelines from “biomedical research”
to “health-related research”. The Working Group considered biomedical research too narrow since that
term would not cover research with health-related data.

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Recommendation CM/Rec (2016)6 of the Committee of Ministers to member States on research on biological material of human origin 

Published by Council of Europe

Biological Materials of Human OriginBiomedical ResearchGeneticsRights

Member States should protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity, the right to respect for private life and other rights and fundamental freedoms with regard to any research activity governed by this recommendation.

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Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: convention on human rights and biomedicine (better known as Oviedo Convention) (Article 10)

Published by Council of Europe

PatientsHuman RightsBiomedicine

It is a framework Convention aiming at protecting the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.

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World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects

Published by JAMA

ResearchEthicsHuman Subjects

The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

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European Medicines Agency. Guideline on registry-based studies. Committee for Human Medicinal Products (CHMP). EMA/426390/2021

Published by European Medicines Agency

Real World EvidenceReal Word DataRegistry-Based StudyFeasibility AnalysisHuman Medicinal ProductsPatient Registry

The objective of this Guideline is to provide recommendations on key methodological aspects that are
specific to the use of patient registries by marketing authorisation applicants and holders (MAAs/MAHs)
planning to conduct registry-based studies

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