Ethic and Legal Issues

In this section you will find relevant documents to guide you on ethical and legal issues in the RD field

  1. Showing 107 results for:
  2. Regulatory Science
  3. Ethic and Legal Issues
All Subjects

Guidelines 3/2018 on the territorial scope of the GDPR (Article 3) – version adopted after public consultation

Published by European Data Protection Board

General Data Protection RegulationGPDR

The territorial scope of General Data Protection Regulation1
(the GDPR or the Regulation) is
determined by Article 3 of the Regulation and represents a significant evolution of the EU data
protection law compared to the framework defined by Directive 95/46/EC2.

View this resource Bookmark this resource

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)

Published by Official Journal of the European Union

Data ProtectionProcessing of Personal DataTranslational Research

The protection of natural persons in relation to the processing of personal data is a fundamental right. This Regulation is intended to contribute to the accomplishment of an area of freedom, security and justice and of an economic union, to economic and social progress, to the strengthening and the convergence of the economies within the internal market, and to the well-being of natural persons.

View this resource Bookmark this resource

EDPB Document on response to the request from the European Commission for clarifications on the consistent application of the GDPR, focusing on health research

Published by European Data Protection Board English

  EC ConsultationGeneral Data Protection RegulationGPDR

In its guidelines (currently in preparation and due in 2021) on the processing personal data for scientific
research purposes, the EDPB will elaborate further on these issues while also aiming to provide a more
comprehensive interpretation of the various provisions in the GDPR that are relevant for the processing of personal data for scientific research purposes.

View this resource Bookmark this resource

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

BiomedicineHuman RightsPatients

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.

View this resource Bookmark this resource

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.

View this resource Bookmark this resource

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) 

BiobankingClinical TrialsEpidemiological StudiesObservational Research

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.

View this resource Bookmark this resource