Table 3 Selected ethical guidelines and recommendations

International Ethical Guidelines for Health-related Research Involving Humans [17]

Council for International Organizations of Medical Sciences (CIOMS), 2016

Ethical guideline, applies to activities designed to develop or contribute to generalizable health knowledge

Universal scope, not defined whom it is addressed to

Declaration of Taipei on Ethical Considerations Regarding Health Databases and Biobanks [31]

World Medical Association (WMA), 2016

Ethical guideline, applies to the collection, storage and use of identifiable data and biological material beyond the individual care of patients

Universal scope, primarily addressed to physicians. The WMA encourages others to adopt the principles.

Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects [37]

World Medical Association (WMA), 2013

Ethical guideline, applies to medical research involving human subjects, including research on identifiable human material and data.

Universal scope, primarily addressed to physicians. The WMA encourages others to adopt the principles

Framework for Responsible Sharing of Genomic and Health-Related Data [10]

Global Alliance for Genomics and Health (GA4GH), 2014

A principled and practical framework, applies to the sharing of genomic and health-related data (for biomedical research)

Universal scope, addressed to all entities or individuals using genomic and health-related data

The collection, linking and use of data in biomedical research and health care: ethical issues [16]

The Nuffield Council on Bioethics, 2015

Report that sets out ethical principles and recommendations, related to the design and governance of data initiatives and data use for biological and medical research

United Kingdom / universal, addressed to anyone approaching a data initiative

Joint statement of purpose—vision, principles, and goals [12]

Funders of public health research, 2011

Joint statement of funders, applies to sharing research data to improve public health

Universal, addressed to funders and the research community

Principles and Guidelines for Access to Research Data from Public Funding [18]

Organisation for Economic Co-operation and Development (OECD), 2007

A legally non-binding recommendation, often referred to as soft law. Applies to research data that are gathered using public funds for the purposes of producing publicly accessible knowledge

Primarily addressed to OECD Member Countries and intended to assist all actors involved when trying to improve the international sharing of, and access to, research data

Recommendation of the Council on Human Biobanks and Genetic Research Databases [19]

Organisation for Economic Co-operation and Development (OECD), 2009

A legally non-binding recommendation, often referred to as soft law. Provides guidance for the establishment, governance, management, operation, access, use and discontinuation of human biobanks and genetic research databases

OECD Countries, to be applied as broadly as possible, in particular to aid policy makers and practitioners who are establishing new human biobanks and genetic research databases. Can also usefully be applied to existing biobanks and databases

Recommendation of the Council on Health Data Governance [22]

Organisation for Economic Co-operation and Development (OECD), 2017

A legally non-binding recommendation, often referred to as soft law. Applies to the access to, and the processing of, personal health data for health-related public interest purposes

OECD member countries and all levels of government, encourages non-governmental organisations to follow this recommendation

Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers [9]

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA), 2013

Joint policy of organisations representing pharmaceutical industries

Members of EFPIA and PhRMA