Creation and Governance of Human Genetic Research Databases


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ISBN: 92-64-02852-8
Published: Oct. 2006
Pages: 159

Large-scale study of populations may contribute significantly to science’s understanding of the complex multi-factorial basis of disease and to improvements in prevention, detection, diagnosis, treatment and cure.

This book summarises the proceedings of a conference on human genetic research databases.  It examines what they are and provides a number of examples. It looks at how they have been established, governed, and funded. And it looks at how they are managed and commercialised, exploring what the policy implications are for governments.

Scientists have known for years that complex diseases, such as cancer, heart disease, stroke, and diabetes, arise from a combination of lifestyle, environmental, genetic and random factors. Large-scale study of populations may contribute significantly to science’s understanding of the complex multi-factorial basis of disease and to improvements in prevention, detection, diagnosis, treatment and cure. As a result of developments in biotechnology and bioinformatics, the opportunity to store and analyse increasingly large amounts of genetic data have rendered possible the creation of large-scale population databases. Genetic research, involving the use of such databases containing human genetic and genomic data, information, and biological samples, is thus becoming increasingly feasible.

More recently, the databases being developed include data, information and biological samples from whole populations. Large-scale population databases which contain a significantly broader range of information about individuals also raise a number of issues and concerns. While some of these are not new, the increasing breadth and scope of such databases amplifies them. Moreover, the combination of a broader set of genetic data and personal information in these databases raises new issues about the use of such information, especially in a non-clinical or non-research context. In addition, as such databases will increasingly be international in scope, and cover populations from numerous jurisdictions, new sets of questions will arise.

The OECD organised a workshop in order to begin the process of considering, at the international level, policy challenges associated with the establishment, management and governance of human genetic research databases. This report provides an overview of the complex issues that were discussed at that workshop and which need to be considered or addressed, in recognition of the significant contribution that human genetic research databases could play in translating scientific advances into innovation in health.

See also the OECD Guidelines on Human Biobanks and Genetic Research Databases.

Table of contents

(The full volume can be browsed free online on the OECD Online Bookshop.)

Executive Summary (English) / Résumé (français)

Chapter 1. Introduction

Chapter 2. Human Genetic Research Databases
-- Examples of Human Genetic Research Databases
-- The Personalised Medicine Reserach Project (Marshfield Project)
-- Genome Database of the Lativan Population (Latvia Project)
-- Icelandic Health Sector Database (Icelandic HDB)
-- Estonian Genome Project (Estonian Project or EGP)
-- The United Kingdom Biobank (UK Biobank)
-- Translational Genomic Research in the African Diaspora (TgRIAD)
-- GenomEUtwin
-- The International HapMap Project
-- Public Population Project in Genomics (P3G)
-- What is a Human Genetic Reseach Database?

Chapter 3. Establishment of a HGRD
-- Nature and Scope of Database
-- Funding of a Database
-- Legal Structure
-- Privacy and Confidentiality
-- Public Engagement in the Establishment of a Population Database

Chapter 4. Data and Sample Collection and Management
-- Data and Samples
-- Ownership of Data and Samples
-- Consent
-- Right to Withdraw
-- Results
-- Education and Training of Data Collectors and Researchers

Chapter 5. Database Management and Governance
-- Management and Governance of Database
-- Security of Databases
-- Access to Population Databases
-- Demise of Database

Chapter 6. Commercialisation Considerations
-- Intellectual Property
-- Commercialisation
-- Benefit Sharing

Chapter 7. Conclusions
-- Policy Themes Arising from the Workshop
-- Is Genetic Information Special?
-- Public Perceptions
-- Public Trust
-- Human Rights Norms and Existing Legal Networks
-- International Harmonisation
-- Protection of Identifiable Information
-- Linkability
-- Revisiting Basic Principles
-- Commercialisation Policy
-- Future Areas of Work

Workshop Agenda
List of Participants

The full volume can be browsed on the OECD Online Bookshop.

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