Workshop on Health Examination Surveys (HES) Legal and ethical issues Susanna Conti, M. Kanieff, G. Rago Istituto Superiore di Sanità (ISS) (National Public Health Institute, Italy)

HES Workshop, Luxembourg, 9-11 April 2008 Introduction Two fundamental ethical concerns in performing HESs: Safeguarding of Privacy Informed Consent Our recommendations focus on these two issues and include: Model of an informed consent form (which contains more specific recommendations)

HES Workshop,Luxembourg, 9-11 April 2008 General considerations on ethical conduct of research Ethical standards are mandated by specific legislation. Internationally, the Declaration of Helsinki is considered to be the pillar of ethical standards. However, national-level legislation varies by individual country. This legislation must be consulted when planning a HES.

HES Workshop, Luxembourg, 9-11 April 2008 Ethics committee The ethical conduct of research must be guaranteed by an ethics committee, whether local, regional, or national. Approval of all aspects of the research, including issues discussed herein: Safeguarding of privacy Informed consent Use of data and biological materials (also for future analyses)

HES Workshop,Luxembourg, 9-11 April 2008 Safeguarding of privacy (data protection, subjects’ rights) [1] “Every precaution should be taken to respect the privacy of the subject [and] the confidentiality of the patient's information.” “Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995”. In individual countries, privacy is safeguarded by a “Data Protection Act” (or “Personal Data Act”) Given that HESs include sensitive data regarding health, the protocol must comply with the specific country’s Data Protection Act.

HES Workshop,Luxembourg, 9-11 April 2008 Safeguarding of privacy [2] It must be ensured that Data Protection Act cover all aspects, such as: Access to data Exchange of data Record linkage Anonymisation procedures.

HES Workshop,Luxembourg, 9-11 April 2008 Informed Consent: General considerations Concept of obtaining informed consent must be clear: Participant’s complete understanding of the HES’s scopes, methods, and use of data. Goes beyond signing a form Process of communication between individual and healthcare professional Both an ethical and a legal obligation and relevant to both the performance of the study and protecting privacy

HES Workshop,Luxembourg, 9-11 April 2008 Informed Consent Form: General considerations [1] Provision of complete and clear information (simple terminology, nothing confusing or intimidating) Choice of most suitable format, making necessary changes (e.g., single signature vs. signature for each activity) Compliance of informed consent form with national legislation (e.g., access to data and storage of samples in biobanks). Approval by ethics committee

HES Workshop,Luxembourg, 9-11 April 2008 Informed Consent Form: General considerations [2] Other measures, such as: Providing descriptive material well before requesting consent, allowing for sufficient time to understand the implications of participation Telephone help-lines Translation into other languages.

RECOMMENDED ITEMS TO INCLUDE ON AN INFORMED CONSENT FORM HES Workshop,Luxembourg, 9-11 April 2008

HES Workshop,Luxembourg, 9-11 April 2008 General Clear explanation of the HES (mention of pertinent public-health benefits) Who is conducting the HES and among whom How the candidate was chosen (e.g., from electoral rolls) Explanation of the consent form itself Assurance that participation is voluntary, that the individual can withdraw at any time, and that data will be kept confidential.

HES Workshop,Luxembourg, 9-11 April 2008 What participation will entail Scheduling of visit Topics covered on the questionnaire Measurements (height, weight, blood pressure) Collection of blood/urine/saliva samples What tests will and will NOT be performed Consideration: Participants should be assured that samples will not be used for other purposes, providing examples (e.g., HIV testing, drug testing); DNA testing should be disclosed.

HES Workshop,Luxembourg, 9-11 April 2008 Time needed to participate Time required for interview, measurements, and sample taking (number of visits and hours) Consideration: Important for candidates in deciding whether to participate; excessive time could discourage participation.

HES Workshop,Luxembourg, 9-11 April 2008 Health risks Disclosure of any potential risks related to sample taking

HES Workshop,Luxembourg, 9-11 April 2008 Incentive for participating Clear description of compensation, if provided Consideration: Payment or other forms of incentive may not be allowed in certain countries.

HES Workshop,Luxembourg, 9-11 April 2008 Providing results of the tests to participants Specific question on whether or not participant would like to receive results Consideration: Must be considered whether participant could be upset by any of the results. Must be specified if participant’s general practitioner is involved in collecting information and providing results.

HES Workshop,Luxembourg, 9-11 April 2008 Data access, storage, and linkage Specification of who will have access to the data, of how the data will be stored, and of any linkage with other data. Considerations: Data protection laws may vary (e.g., it may be legal to provide data to general practitioners or insurance companies). The participant must be aware of this. Laws on the duration of data storage may vary by country. The participant should be assured that his/her data will be anonymous.

HES Workshop,Luxembourg, 9-11 April 2008 Data confidentiality and privacy Description of procedures for maintaining data confidentiality. Information on what to do if participant feels that his/her privacy has been violated.

HES Workshop,Luxembourg, 9-11 April 2008 Use of data after the study or if participant withdraws Description of how data will be used, emphasising confidentiality. Statement that participant has the right to request that all data be eliminated. Consideration: Whether or not data from persons withdrawing must be discarded may depend on specific legislation.

HES Workshop,Luxembourg, 9-11 April 2008 Use of biological materials after the study is completed Description of how material will be used, including description of biobanks and emphasising that samples will NOT be tested for organisms such as HIV. Consideration: There may be legal limitations regarding the storage (including duration) and use of biological materials.

HES Workshop,Luxembourg, 9-11 April 2008 Request to contact the participant for future research Participant provided with the opportunity to refuse to be contacted for future studies.

HES Workshop,Luxembourg, 9-11 April 2008 Contact Information Information on whom the participant can contact for questions or concerns. Consideration: Important that participant be able to clarify questions or doubts, which could increase the participation rate.

HES Workshop,Luxembourg, 9-11 April 2008 Principal Investigator Name of Principal Investigator and contact information

HES Workshop,Luxembourg, 9-11 April 2008 Thank you very much for your attention.