Legal and ethical issues

1. Legal and ethical issues EHES Training Material

2. Definition of “legislation” and “ethics” and their relationship • Legislation • A law or legal regulation • Ethics • A set of moral principals • In medical research, there exist legislation and guidelines that address ethical conduct

3. Ethical aspects addressed by legislation • Depending on the type of legislation, the specific ethical aspects and the implications for a national HES can vary • Types of legislation include (examples): • Medical research acts • Acts on the rights of patients • Data protection acts (also known as “Personal data acts”) • Biobank acts • There may be overlap among the types of legislation in terms of the ethical aspects covered

4. Medical research acts • In the EU, many Medical Research Acts are based on the Declaration of Helsinki: "Ethical Principles for Medical Research Involving Human Subjects” • These acts specify that research personnel must protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research participants • Implications for a national HES • Data collection, access, and use • Use of biological samples • Informed consent • All communication with the participants

5. Acts on rights of patients Like Medical Research Acts, Acts on the Rights of Patients cover many ethical aspects, for example: • Right to courtesy, respect, dignity, responsiveness, and timely attention to health needs • Right to have adequate healthcare and continuity of care • Right to receive information on own health • Right to confidentiality Implications for a national HES: • Feedback of own laboratory results and measurements given to the participant, when needed in collaboration with the participant’s GP

6. Data protection acts In the EU, most Data Protection Acts make reference to Directive 95/46/EC of the European Parliament and of the Council (under revision, new draft available) These acts are intended to protect individuals regarding the processing of personal data and the free movement of such data Implications for HES data collection, access, and use, including: • Sampling frames: availability of contact information and other personal information • Confidentiality of data • Linkage of survey data to other databases/registers • Duration of data storage (can also be in Archives Acts) • Informed consent: Assuring data will be kept confidential

7. Biobank acts Biobank Acts control the activities of biobanksand the handling of biobanksamples Implications for HES in sample collection and storage, including: • Duration of sample storage (can also be in Archives Acts) • Informed consent: Ensuring that participants understand how their samples are stored and how they can be used

8. Guidelines on the ethical conduct of medical research • Guidelines generally cover all ethical aspects of research, from how participants are treated to the use of data • Although not enforced by law, they often constitute the basis for legislation and provide crucial information on ethicalconduct

9. European ethical guidelines Examples of guidelines on ethical conduct of research: • Declaration of Helsinki: "Ethical Principles for Medical Research Involving Human Subjects” • Oviedo Convention on Human Rights and Biomedicine • Recommendation of the Committee of Ministers No. R(90) 3 concerning medical research on human beings • International Ethical Guidelines for Epidemiological Studies of the Council for International Organizations of Medical Sciences • Guidelines for proper conduct of epidemiological research of the European Epidemiology Federation (IEA)

10. Role of ethics committee • Ethical conduct of HES evaluated by ethics committee • Appropriate ethics committee must be defined (e.g., in-house, local, regional); in some cases, more than one committee must be consulted for national HES • Obtaining approval: • Potentially time-consuming (up to one year) • To be begun earlyin the planning phase

11. Safeguarding of privacy and informed consent In planning and performing a national HES, two key issues warrant special consideration: • Safeguarding of privacy (data protection) • Informed consent Appropriately addressing these issues is not only a legal/ethical obligation, but it can motivate individuals to participate It can also affect the participant’s willingness to undergo all of the measurements and the extent to which he/she is comfortable answering all types of questions, including those on sensitive topics

12. Safeguarding of privacy (Data protection) • Personal Data – any information relating to an identifiable person (i.e., one who can be directly or indirectly identified, in particular by reference to an identification number or to one or more factors specific to his/her physical, physiological, mental, economic, cultural or social identity) (Directive 95/46/EC) • Data collected for HES are “personal” and thus must be safeguarded • HES protocol should comply with national legislation (“Data Protection Act” or “Personal Data Act”)

13. Aspects of safeguarding of privacy (Data protection) Diverse aspects of data protection must be addressed, such as: • Data access: who is allowed to see all of the data; typically, few persons are allowed to access the database that includes identification data, such as names and dates of birth • Data exchange: with whom the data can be shared • Record linkage: for example, with existing health registries • Anonymisation: ensuring that the individual cannot be identified • Duration of storage of data: how long data can be kept in a database • Identification, use, and storage of biological samples • Principles and rules for sharing and use of the EHES data for future use are described in the EHES Manual, Part C.

14. Informed consent Informed consent: • “Voluntary consent freely given by an individual for participation in a study, after being informed of the purpose, methods, procedures, benefits and risks” (JM Last, “Dictionary of Epidemiology”) • Obtaining informed consent is a process of communication between an individual and the survey personnel (in HES, the consent can be obtained by a person without formal medical training, such as a receptionist/secretary). • In this process, the right to withdraw at any time must be clearly communicated • Goal: To ensure that the participant has both knowledge and a full understanding of the HES aims and methods and how data and biological samples will be used

15. Informed consent form • Document containing information on HES and participant’s signature • Can require a single signature (indicating consent for the entire HES) or signatures for specific items • May also need to be signed by the survey personnelobtaining the consent • See model of informed consent form in EHES manual (Part A), which can be adapted for national use

16. Additional informed consent material • Information leaflet: separate document with all of the important information on HES; in this case the informed consent form itself can be brief • A separate invitation letter can also be used to introduce the HES to candidates • The informed consent form and other material should be provided before the examination, leaving sufficient time for reading and understanding it, for asking questions, and for discussing the material before measurements or samples are taken • See EHES Manual (Part A) for examples of material and how to provide it

17. Additional informed consent material • Supplementary material and resources: • Telephone help-lines (to provide clarifications) • Web-site • Material translated into several languages for minority groups

18. Informed consent: Items to be covered (1) Information on HES, including: Description of HES Voluntariness of participation Possibility to withdraw at any time Collection of personal data, including: Measurements performed during the examination (or not performed) and use of biological samples Duration of visit Information on risks (if any) Compensation and incentives (if any)

19. Informed consent: Items to be covered (2) • Use of results, including: • Receipt of own test results • Future uses of data (a detailed description of future uses may not be possible; thus a more general description should be provided) • Record linkage with other databases • Confidentiality/privacy, including: • Assurance of data confidentiality • Specific mention of Data Protection Act • Person/entity responsible for data protection

20. Informed consent: Items to be covered (3) • Biobanks and long-time storage of samples • Additional studies and/or follow-up mentioned, if needed • Contact information for clarifications about HES • Declaration of having understood the information

21. Informed consent: General considerations • Specific material and means of obtaining informed consent depend on nationalneeds, logistics, resources, and ethical requirements • All information must be complete and clear (i.e., no scientific/technical terms or excessively long descriptions) • Obtaining consent needs to be carefully planned, and fieldwork staff must be trained • Specific situations (e.g., candidates who may require a family member or caretaker to provide consent) need to be planned for, in accordance with national legislation/regulations

22. Acknowledgements • Slides • Susanna Conti, Mark Kanieff