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Home ELSI Knowledge Base Guidelines for good research

Guidelines for good research

European Hierarchy of Norms

The resources that you can find on our Knowledge Base follow the logic of the European Hierarchy of Norms.

Soft law

Soft law is the term applied to EU measures, such as guidelines, recommendations, declarations and opinions, which – in contrast to regulations, directives, and decisions – are not binding on those to whom they are addressed.

A regulation shall have general application. It shall be binding in its entirety and directly applicable in all Member States.
A directive shall be binding, as to the result to be achieved, upon each Member State to which it is addressed, but shall leave to the national authorities the choice of form and methods.

A decision shall be binding in its entirety. A decision which specifies those to whom it is addressed shall be binding only on them.
Recommendations and opinions shall have no binding force.

For more information, click here.

EU law

EU law is based on primary legislation and secondary legislation.
Primary legislation is made up of:

  • the EU Treaties, which are binding agreements between EU member countries,
  • the Charter of Fundamental Rights (since the Treaty of Lisbon),
  • general principles established by the Court of Justice of the European Union.

Secondary legislation comprises all the acts adopted by the EU institutions which enable the EU to exercise its powers.

International agreements with non-EU countries or with international organisations are an integral part of EU law. These agreements are separate from primary law and secondary legislation and form a sui generis category. According to some judgments of the CJEU, they can have direct effect and their legal force is superior to secondary legislation, which must therefore comply with them.

With the entry into force of the Treaty of Lisbon in December 2009 and the abolition of the former ‘pillar’ structure, most EU policies are subject to the Community method except for the common foreign and security policy. Article 288 of the Treaty on the Functioning of the EU (TFEU) defines the acts that may be adopted and provides that only acts of those types may be adopted:

  • regulations,
  • directives,
  • decisions,
  • recommendations, and
  • opinions.

More information: https://eur-lex.europa.eu/summary/glossary/norms_hierarchy.html

Legal framework

The resources that you can find on our Knowledge Base follow the logic of the European Hierarchy of Norms.

Research involving minors

Regulation on medicinal products for paediatric use

PAEDIATRICS, MINORS, LAW

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance)

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Convention on the Rights of the Child

PAEDIATRICS, MINORS, LAW

The United Nations Convention on the Rights of the Child (commonly abbreviated as the CRC or UNCRC) is an international human rights treaty which sets out the civil, political, economic, social, health and cultural rights of children.

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Human rights

Charter of Fundamental Rights of the European Union

human rights, law

IT enshrines certain political, social, and economic rights for European Union (EU) citizens and residents into EU law.

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Data sharing and data protection

GDPR

data sharing, law, data protection

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)

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Directive on privacy and electronic communications

data sharing, law, data protection

Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector.

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Biobanking and biomedical research

Traceability requirements

biobanking, law

Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells

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Handling human tissues and cells: technical requirements

biobanking, law

Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells

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Handling human tissues and cells: donation, procurement, testing, processing, preservation, storage and distribution

biobanking, law

Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells

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Legal protection of biotechnological inventions

biobanking, law

Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions

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Guidelines, recommendations, and ethical standards

Research on Humans

The Oviedo Convention (1997)

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

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Revised Declaration of Helsinki (2024)

The Declaration of Helsinki lays down ethical principles for medical research involving human subjects, including the importance of protecting the dignity, autonomy, privacy and confidentiality of research subjects, and obtaining informed consent for using identifiable human biological material and data. Previously, the Declaration of Helsinki addressed WMA members and constituents. The new version of the Declaration says tit is the moral obligation of physicians to ensure that their patients and the participants in research are respected and treated with dignity.

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Declaration of Taipei on ethical considerations regarding health data bases and biobanks

This Declaration is intended to cover the collection, storage and use of identifiable data and biological material beyond the individual care of patients. In concordance with the Declaration of Helsinki, it provides additional ethical principles for their use in Health Databases and Biobanks.

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International Ethical Guidelines for Health-related Research Involving Humans

Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO)

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WHO: Handbook for Good Clinical Research Practice

This handbook is intended to assist national regulatory authorities, sponsors, investigators and ethics committees in implementing GCP for industry-sponsored, government-sponsored, institution-sponsored, or investigator-initiated clinical research.

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Biobanking

ISBER Best Practices: Recommendations for Repositories

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Research Integrity

BBMRI-ERIC's Code of Conduct for Health Research

The purpose of the Code of Conduct for Health Research initiative is: To contribute to the proper application of the regulation, considering the specific features of processing personal data in the area of health; To clarify and specify certain rules of the GDPR for controllers who process personal data for purposes of scientific research in the area of health; To help demonstrate compliance by controllers and processors with the regulation; and To help foster transparency and trust in the use of personal data in the area of health research.

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The European Code of Conduct for Research Integrity

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance)

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Guideline for Promoting Research Integrity in Research Performing Organisations

This guideline points to nine topics that must be addressed in a Research Integrity Promotion Plan.

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Code of Practice on Secondary Use of Medical Data in Scientific Research Projects

This Code of Practice aims to provide a set of harmonised rules applicable to secondary use of medical data. It is intended to be useful to research projects involving multiple legal entities established in one or more EU member countries.

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WCRIF Guidance on Research Integrity

The mission of the WCRIF is to promote research integrity through support for the ongoing organization and development of the World Conferences and all related activities.

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Research involving minors

Consenting to medical treatment without parental consent

The EU Charter of Fundamental Rights provides that everyone has the right to access preventive health care and the right to benefit from medical treatment according to national law and practice (Article 35).

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Ethical considerations for clinical trials on medicinal products conducted with minors

Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use.

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Guideline 17: Research involving children and adolescents

International Ethical Guidelines for Health-related Research Involving Humans. Children and adolescents must be included in health-related research unless a good scientific reason justifies their exclusion. As children and adolescents have distinctive physiologies and health needs, they merit special consideration by researchers and research ethics committees.

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Human Rights

European Convention on Human Rights (1950)

Convention for the Protection of Human Rights and Fundamental Freedoms

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Protection of the human rights and dignity of persons with mental disorder. Council of Europe.

Recommendation 2004(10). The objective of this new Protocol is to develop, for the first time in a legally binding instrument, the provisions of Article 7 of the Convention on Human Rights and Biomedicine, as well as those of Article 5 § 1 (e) of the European Convention on Human Rights.

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Genetics Research

Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997)

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Guidelines for the implementation of the Universal Declaration on the Human Genome and Human Rights (UNESCO, 1999)

These Guidelines seek to identify not only the tasks devolving on the different actors in the implementation of the Declaration but also modalities of action for their achievement.

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International Declaration on Human Genetic Data (UNESCO, 2003).

One of the aims of this Declaration are: to ensure the respect of human dignity and protection of human rights and fundamental freedoms in the collection, processing, use and storage of human genetic data, human proteomic data and of the biological samples from which they are derived, referred to hereinafter as “biological samples”, in keeping with the requirements of equality, justice and solidarity, while giving due consideration to freedom of thought and expression, including freedom of research.

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Prohibition of Cloning Human Beings

Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (the Oviedo Convention), on the Prohibition of Cloning Human Beings

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OECD Guidelines on Human Biobanks and Genetic Research Databases

These guidelines aim to provide guidance for the establishment, governance, management, operation, access, use and discontinuation of human biobanks and genetic research databases, which are structured resources that can be used for the purpose of genetic research.

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Covid-19

Statement on the processing of personal data in the context of the COVID-19 outbreak (European Data Protection Board, 2020).

Several considerations should be considered to guarantee the lawful processing of personal data and in all cases, it should be recalled that any measure taken in this context must respect the general principles of law and must not be irreversible

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Statement on European Solidarity and the Protection of Fundamental Rights in the COVID-19 Pandemic

By the European Group on Ethics in Science and New Technologies

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Position on the Responsibility of Research Ethics Committees during the COVID-19 Pandemic

Rules for Research Ethics Committees by the European Network of Research Ethics Committees –EUREC

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Guidance on the management of clinical trials during the Covid-19 pandemic

It should be noted that the simplification measures proposed in this document will only last during the current public health crisis until the revocation of this Guidance, when there is a consensus that the period of the COVID-19 outbreak in the EU/EEA, has passed.

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Data Sharing

BBMRI-ERIC Policy for Access to and Sharing of Biological Samples and Data

This access policy presents three areas of guidance: i) ethical principles; ii) governance procedures; and iii) practical procedures for access.

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International Sharing of Personal Health Data for Research (2021)

The ALLEA, EASAC and FEAM joint initiative on resolving the barriers of transferring public sector data outside the EU/EEA

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OECD Principles and Guidelines for Access to Research Data from Public Funding

A set of guidelines based on commonly agreed principles to facilitate cost-effective access to digital research data from public funding.

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International code of conduct for genomic and health-related data sharing (Global Alliance for Genomics and Health)

This Code establishes a set of foundational principles and guidelines for responsible research conduct and oversight of research data systems, guided by the enforceable human rights of privacy, non-discrimination, and procedural fairness.

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Data Protection Code of Conduct Cookbook

The Data protection Code of Conducts enables safe attribute release between Identity and Service Providers within EU.

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Table of contents

ELSI Team

elsi-helpdesk@bbmri-eric.eu

Published 27/09/2021 Updated 30/10/2024

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