Ethics for researchers Facilitating Research Excellence in FP7 Research and Innovation EUROPEAN COMMISSION Directorate-General for Research and Innovation Directorate B – European Research Area Unit B.6 – Ethics and gender Contact: Isidoros Karatzas European Commission B-1049 Brussels E-mail: [email protected] [email protected] EUROPEAN COMMISSION Ethics for researchers Facilitating Research Excellence in FP7 Directorate-General for Research and Innovation 2013 Science in society /Capacities FP7 EUROPE DIRECT is a service to help you find answers to your questions about the European Union Freephone number (*): 00 800 6 7 8 9 10 11 (*) Certain mobile telephone operators do not allow access to 00 800 numbers or these calls may be billed LEGAL NOTICE Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the following information. The views expressed in this publication are the sole responsibility of the author and do not necessarily reflect the views of the European Commission. More information on the European Union is available on the Internet (http://europa.eu). Cataloguing data can be found at the end of this publication. Luxembourg: Publications Office of the European Union, 2013 ISBN 978-92-79-28854-8 doi 10.2777/7491 © European Union, 2013 Reproduction is authorised provided the source is acknowledged. Cover Image © Sergey Nivens, #49108932, 2013. Source: Fotolia.com. Table of Contents Introduction ...................................................................................................................... 2 Chapter I: Research Ethics ................................................................................................. 3 True Research Excellence .................................................................................................................... 3 History and Legal Basis of Research Ethics .......................................................................................... 3 The Nuremberg Code ...................................................................................................................................... 3 The European Charter of Fundamental Rights ............................................................................................... 5 Chapter II: The 7th Framework Programme: The Ethics Review Procedure .......................... 6 The 7th Framework Programme: Article 6 – Ethical Principles ............................................................ 6 The Ethics Review Procedure .............................................................................................................. 7 Ethics Screening .............................................................................................................................................. 8 Ethics Review .................................................................................................................................................. 8 Ethics Follow-up and Audit ............................................................................................................................. 8 Chapter III: Ethical Issues ................................................................................................. 10 1. Data Protection and Privacy .......................................................................................................... 12 2. Informed Consent .......................................................................................................................... 14 3. Research on Human Embryo's and Foetuses ................................................................................ 16 4. Dual Use ......................................................................................................................................... 18 5. Animal Research ............................................................................................................................ 20 6. Research Involving Developing Countries ..................................................................................... 21 Conclusions ..................................................................................................................... 22 Three Tips to Be More Ethically Prepared ........................................................................ 23 Twelve Golden Rules to Ethical Research Conduct ........................................................... 24 1 Introduction Designed for all researchers who are preparing an application to receive funding from the European Union for their research, this document describes the most important aspects of research ethics and indicates the main points of attention for the Ethics Review procedure as a part of the 7th Framework Programme (FP7). For research funded by the European Union, ethics is an integral part of research from beginning to end and ethical compliance is pivotal to achieve real research excellence. After a briefly explaining the history and legal basis of research ethics (Chapter 1) it is illustrated how exactly the Ethics Review procedure is integrated in the application and evaluation process. (Chapter 2) Chapter 3 will help you to understand the core subjects of research ethics and provides a practical roadmap to help with the preparation of your proposal. SCIENTIFIC MISCONDUCT Scientific misconduct includes (negligent or intended) fabrication (making up data or results), falsification (changing or misreporting research data or improper manipulation of experiments) and plagiarism (using ideas or words without accurate reference). These practices go against all scientific values and can undermine the scientific progress. Even more, it can cause harm. The European Commission condemns all forms of scientific misconduct. There is no place for these practices in research funded by the European Union. 2 Chapter I: Research Ethics True Research Excellence Ethical research conduct implies the application of fundamental ethical principles to scientific research. All possible domains of scientific research can raise ethical issues. Ethics is not just about the theories and the complex philosophical reasoning. Ethics is everywhere. In everything we do there can be an ethical component. When conducting research, there is clear need to make a thorough ethical evaluation. Ethics is often misunderstood by researchers as hindering the scientific progress. While it is true that research ethics intends to put boundaries to what is and is not possible (under a certain perspective), it does not intend to regulate research or go against research freedom. The way research ethics is interpreted at the European Commission, aims to be collaborative and constructive. Also, by considering ethics at the conceptual stage of the proposal, the quality of the research is 1 enhanced. THE NUREMBERG CODE The Nuremberg Code is one of the most important documents in the History and Legal Basis of Research Ethics history of research ethics. The Code was formulated in 1947 in For a good understanding of the field, it is important to take a look Nuremberg, Germany, by the at the history of research ethics. Research ethics is most developed American judges of the as a concept in medical research, but the general principles apply Nuremberg Tribunal, who had to for all fields of research. Informed consent and confidentiality are as judge doctors of the Nazi-regime important for a sociological study as they are for clinical research. accused of murderous and torturous human experiments. As a reaction to malpractices that were revealed during the The Nuremberg Code, with Nuremberg trials, the World Medical Association (established in principal focus on medical Paris in 1947) adopted a declaration on research ethics in 1964, in research, consists of only 10 rules, Helsinki, Finland.2 Since, the Declaration of Helsinki has been indicating the most basic and reviewed for several times, but the general focus and core ideas fundamental principles. Consent, proportionality, necessity and the remain the same.3 The Declaration of Helsinki sets forward ethical right to withdraw are at the core principles for the conduct of medical research on human subjects, of this document. Although the including research on identifiable human material and data. The Nuremberg Code has never basic principle behind the declaration is that, for all research, the officially been adopted as law, it well-being of the individual research subject must take precedence has had a major influence on over all other interests. The declaration sets principles for the human rights law and medical conduct of medical research and additional principles for medical ethics. Previous ethics codes 4 research combined with medical care. focussed on the obligations of the investigator towards the research Although research ethics is most developed within the context of subjects. The Nuremberg Code medical research, research ethics is of crucial importance for all reverses that logic: The rights are scientific domains. Professional and academic associations have directly awarded to the research often provided guidance documents and ethics codes, adapted to subjects. This was, at that time, a the specificities of their research domains. Good examples are the fundamentally different view on research ethics. Code of Ethics from the International Sociological Association, The 3 Code of Ethics and Conduct from the British Psychological Society and the ethics guidelines