ETHICS ASSESSMENT OF RESEARCH AND INNOVATION:

A COMPARATIVEANALYSIS OF PRACTICES AND INSTITUTIONS IN

THE EU AND SELECTED OTHERCOUNTRIES

Rowena Rodrigues, Trilateral Research

Findings of the SATORI project, Work Package 1

October 2015

Deliverable 1.1• Summary of results of WP 1.

• Detailed picture of: de facto EU ethics assessment (EA) landscape.

• Covers EA across scientific fields, different kinds of organisations carrying out assessment.

• In-depth study of EA in nine EU countries, US and China.

• Annex - detailed studies of EA in different scientific fields, types of organisations and countries, in addition to a number of issues and approaches in EA.

• Link to deliverable: http://satoriproject.eu/media/D1.1_Ethical-assessment-of-RI_a-comparative-analysis.pdf

Methodology

• Interviews: 230 interviews with representatives of

organisations engaging in EA and guidance, and

experts in Europe, the US and China.

•Extensive desk research including literature

surveys.

Main report

The Annexes

Ethics assessment: who plays a role?

Three major kinds of ethics assessment

Project and practice-oriented assessment Policy-oriented assessment Assessment of professional conduct

Note: substantial differences between these three types of assessment.

Ethics guidance

Statement of ethical guidelines, principles, rules, codes, and recommendations.

Ethical guidance can be used to directly guide individual and collective decisions, behaviours and practices in R&I.

Usually advisory, sometimes mandatory.

The intersection of ethics assessment and impact assessment

Issues, principles & approaches • Basis of research ethics within the EU framework:

explicit commitment to human rights.• Six major issues in research: use of human subjects,

use of animals, scientific integrity, collegiality, institutional integrity and social responsibility.

• EIA (of techno/innovation) might (typically) consider: – potential societal harms– risks and implications for fundamental rights, justice,

well-being of citizens and the common good– potential impacts on health, environment, work,

leisure, social relations, politics, values, etc.

Comparative analysis: scientific field

Comparative analysis: scientific field• Shared ethical concerns: research integrity and social

responsibility.• Differences in:

• degree to which methods of EA are formal and institutionalised,

• specific ethical concerns raised by distinct methods and subject matter, and

• the particular risks of different harms caused by research.

• Medical & Life Sciences (esp. biomedical research) has most extensive development (literature and institutional structures).

• Changes to other fields due to: data protection legislation & public awareness of ethical concerns.

Comparative analysis: scientific field

Differences in principles and issues:

Medical sciences: Focus on the relationship between medical researcher and human subject. Medical ethical principles: autonomy, informed consent, beneficence, human dignity, and justice.

Life sciences: Focus on relationship of researchers toliving biological systems, ecosystems and the environment. Ethical principles: animal welfare, ecosystems integrity, sustainability, health and environmental risks, naturalness and playing God.

Comparative analysis: scientific fieldNatural sciences: Focus on truth and accuracy. Principles: scientific integrity, data integrity, freedom from bias, and honesty. Social sciences: Focus on the relation between the researcher and human beings and social structures. Principles: informed consent, equality, anonymity, confidentiality, privacy, fairness, non-discrimination, human rights, avoidance of cultural and social bias, and respect. Also: data integrity, research integrity, objectivity.

Computer and information sciences: Focus on the processing, storage and dissemination of information. Ethical principles: informational privacy, security, intellectual property, censorship and freedom of information.

Comparative analysis: scientific fieldEngineering sciences: Focuses on the technologicalintervention into society. Ethical principles: socialresponsibility, well-being, impacts on rights, the precautionary principle, sustainability, and the good of society.

Humanities: Focuses on the study of humanculture and the human condition. Ethical issues include: proper conduct of the interpretation and construction of narratives, the proper role of works of imagination and art in society and evaluation of them, and responsibilities in the preservation of cultural heritage.

Challenges highlighted by EA organisations

Lack of user friendly policiesLack of user friendly policies

Increase in Increase in bureaucracybureaucracy

Comparative analysis: country

All countries are currently expanding their efforts in the area of ethics assessment and guidance.

Significant differences in the extent to which ethics of R&I is institutionalised.

Different focuses on ethical principles & issues.

Role of the government significantly varies.

Role of CSOs also varies; some play a more significant role than others.

Countries examined: Austria, China, Denmark, France, Germany, The Netherlands, Poland, Serbia, Spain, UK & USA.

EU & global EA and guidanceEU

• Ethics review is well organised at European Commission level; supported and enhanced by European research funding organisations.

• Variety of organisations at Commission and European Parliament carrying out EA/guidance as part of their mandate

• Specific laws and policy mechanisms set a solid base for ethics assessment of R&I.

GLOBAL•Increasing interconnectivity between regional actors.•Varied implementation of global standards. •Practical barriers to implementing global ethical standards: language, timing.•Concerns expressed: adaptability to local conditions, existence of excess of standards.

Next steps

• Identification of best practices.

• Development of proposals for harmonisation and shared standards.

• If possible, proposal of common principles, protocols, procedures and

methodologies for EA of R&I in the EU and beyond.

Follow SATORI on Twitter: @SATORI_EU

http://satoriproject.eu/

Stakeholders Acting Together on the Ethical Impact Assessment of Research and Innovation (SATORI) received funding from the European Commission’s Seventh

Framework Programme (FP7/2007-2013) under Grant Agreement n° 612231.