Legal and ethical issues

Available at: http://urn.fi/URN:ISBN:978-952-302-700-8 Based on EHES Manual, Part A. Planning and preparation of the survey, 2nd edition (2016) Available at: http://urn.fi/URN:ISBN:978-952-302-700-8 These slides can be used freely, translated and adapted to national use (e.g. concerning national legislation).

Definition of “legislation” and “ethics” and their relationship A law or legal regulation Ethics A set of moral principles Legislation and guidelines address ethical conduct in medical research

Ethical aspects addressed by legislation The implications for a national HES can vary National legislation which needs to be considered when planning the survey 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

Medical research acts (1) In the EU, many Medical Research Acts are based on the Declaration of Helsinki: "Ethical Principles for Medical Research Involving Human Subjects” The research personnel must protect the participants’: life and health dignity and integrity right to self-determination privacy and confidentiality of personal information

Medical research acts (2) Implications for a national HES Data collection, access, and use Use of biological samples Informed consent All communication with the participants

Acts on rights of patients (1) 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 adequate healthcare and continuity of care receive information on own health confidentiality

Acts on rights of patients (2) Implications for a national HES: Feedback of own laboratory results and measurements given to the participant When needed providing the feedback in collaboration with the participant’s GP or advice to contact the GP

Data protection act (1) In the EU, most Data Protection Acts make reference to Regulation (EU) 2016/679 of the European Parliament and of the Council Personal data can only be gathered legally under strickt conditions, for a legitimate purpose. Persons or organizations which collect and manage personal information much protect it from misuse and must respect certain rights of the data owner.

Data protection acts (2) Implications for data collection, access and use:: Sampling frames: availability of contact information and other personal information Assuring confidentiality of data during the fieldwork and in all stored data files Linkage of survey data to other databases/registers Duration of data storage (can also be in Archives Acts) Information leaflets and informed consent describing how personal data is protected

Biobank acts Control the activities of biobanks and the handling of biobank samples 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 later May require separate informed consents for the survey and for the biobank

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 ethical conduct.

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)

Role of ethics committee Ethical conduct of HES is evaluated by an ethics committee The appropriate ethics committee must be defined (e.g. within the organization responsible for the survey, local or regional medical ethics committee) In some cases, more than one committee must be consulted for the national HES Obtaining approval: Potentially time-consuming (up to one year) Needs to be begun early in the planning phase

Safeguarding of privacy and 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.

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 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 for informed consent 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.

Informed consent: General considerations (1) Specific material and means of obtaining informed consent depend on national needs, logistics, resources, and ethical requirements All information must be complete and clear no scientific or technical terms or excessively long descriptions

Informed consent: General considerations (2) Obtaining consent needs to be carefully planned, and fieldwork staff must be trained. Specific situations (e.g., subjects who may require a family member or caretaker to provide consent) need to be planned for, in accordance with national legislation/regulations.

Informed consent form Document containing information on the survey and participant’s signature Can require a single signature (indicating consent for the entire HES) or signatures for specific items (e.g. record linkage, sample storage) May also need to be signed by the survey personnel obtaining the consent to confirm that the participant was informed The model of informed consent form in EHES manual (Part A) can be adapted for national use

Supporting material for informed consent (1) Information leaflet: separate document with all important information on HES The informed consent form itself can be brief A separate invitation letter can also be used to introduce the HES to subjects 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 Muokkaa otsikko

Supporting material for informed consent (2) Supplementary material and resources may include: Telephone help-lines (to provide clarifications) Web-site Material translated into several languages for minority groups

Informed consent: Items to be covered (1) Information on HES, including: Description of the aims and purposes Voluntariness of participation Possibility to withdraw at any time Collection of personal data, including: Measurements performed during the examination and use of biological samples Duration and number of visits Information on risks (if any)

Informed consent: Items to be covered (2) Compensation and incentives (if any) Reporting and use of data and blood samples, including: Receipt of own test results Future uses of data a detailed description of future uses may not be possible a more general description may be sufficient Record linkage with other databases

Informed consent: Items to be covered (3) Confidentiality/privacy, including: Assurance of data confidentiality Mention that the data will be stored, analyzed and handled in accordance with legislation on Data Protection and Privacy The data protection authority and/or ethical committee that has provided permission for the HES Name and contact information of the person/entity responsible for privacy and data protection in this survey

Informed consent: Items to be covered (4) Biobanks and long-time storage of samples Additional studies and/or follow-up mentioned, if needed Contact information for clarifications about the survey Declaration of having understood the information Person giving the information and receiving the informed consent

Acknowledgements Slides prepared by: Susanna Conti, Mark Kanieff, Laura Paalanen Experiences and feedback from the EHES network have been utilized in the preparation of these slides

Disclaimer The views expressed here are those of the authors and they do not represent the Commission’s official position.