Ethic and Legal Issues

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

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  3. Ethic and Legal Issues
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INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2)

Published by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Internatonal Council for Harmonisation (ICH)Regulatory Authorities

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together the medicines regulatory authorities and pharmaceutical industry around the world.

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UNESCO. International Declaration on Human Genetic Data, 2003.

Published by Unesco

Genetic DataUNESCO

The purpose of the Declaration is to ensure the respect of human dignity and protection ofhuman  rights  and  fundamental  freedoms  in  the  collection, processing, use  and  storage  ofhuman genetic data, in keeping with the requirements of equality, justice and solidarity

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Secretariat of the Convention on Biological Diversity. Nagoya Protocol On Access To Genetic Resources And The Fair And Equitable Sharing Of Benefits Arising From Their Utilization To The Convention On Biological Diversity. Canada, 2011. ISBN: 92-9225-306-9.

Published by United Nations

Genetic ResourcesNagoya ProtocolTranslational Research

The Protocol  provides
a strong basis for greater legal certainty and transparency for both providers
and users of genetic resources. It also promotes the use of genetic resources and associated traditional knowledge,  strengthens the opportunities for fair and equitable sharing of benefits from their use. 

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ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population. EMA/CPMP/ICH/2711/1999. Step 5.

Published by European Medicines Agency

Paediatric FormulationPaediatric Medicinal Product DevelopmentPharmacokinetic

This document describes that paediatric drug development has evolved since the original ICH E11 Guideline (2000), requiring consideration of regulatory and scientific advances relevant to pediatric populations. This addendum does not alter the scope of the original guideline which outlines an approach to the safe, efficient, and ethical study of medicinal products in the pediatric population.

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

Published by JAMA

EthicsHuman SubjectsResearch

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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Clinical Trials Facilitation and Coordination Group Guidance document for sponsors for a Voluntary Har monisation Procedure (VHP) for the assessment of mul tinational Clinical Trial Applications

Published by EMA

Clinical Trials

The main objectives of the assessment of the CT are to ensure the quality of the IMP and the safety of the trial subjects.

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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.

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