1 st Training Seminar on Planning and Preparing for EHES at the National Level Legal and ethical issues Susanna Conti Istituto Superiore di Sanità (ISS)

EHES 1st Training Seminar - Rome, February 2010 Introduction Two fundamental ethical concerns in performing a HES are: safeguarding of privacy; and informed consent, in addition to the ethical conduct of the research itself.

EHES 1st Training Seminar - Rome, February 2010 Ethical conduct of research: General considerations The Declaration of Helsinki is the pillar of ethical standards. Other important documents include, the Belmont Report; and two acts of the Council of Europe: Recommendation of the Committee of Ministers No. R(90) 3 concerning medical research on human beings; Oviedo Convention on Human Rights and Biomedicine. However, national legislation varies by country and must be followed.

EHES 1st Training Seminar - Rome, February 2010 Ethics committee An ethics committee (local/national) ensures the ethical conduct of research. The committee must approve of (in addition to the conduct of the HES itself): informed consent, safeguarding of privacy, and use of data and samples, also for future research. Ethics committee approval can be time consuming (up to one year); thus it must be started as soon as possible (during planning).

EHES 1st Training Seminar - Rome, February 2010 Safeguarding of privacy (Data protection) As stated in the Declaration of Helsinki, …Every precaution should be taken to respect the privacy of the subject [and] the confidentiality of the patient's information…. In Europe, the most important document is: Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data.

EHES 1st Training Seminar - Rome, February 2010 Safeguarding of privacy (Data protection) Since individual sensitive data are collected by HES, the protocol should comply with the specific countrys national Data Protection Act. However, it must be ensured that this act cover all aspects of data protection, such as: i) access to data, ii) exchange of data, iii) record linkage, and iv) anonymisation procedures. Assuring participants that their privacy will be protected can influence the participation rate.

EHES 1st Training Seminar - Rome, February 2010 Informed consent Informed consent is a process of communication between an individual and a healthcare professional The goal is to ensure a full understanding of the studys scopes and methods and how the data will be used. This is an ethical and a legal obligation.

Informed consent material (1) Information on the HES is provided on an informed consent form, which the participant must sign. It can also be provided on a separate document (orinformation notice). The information notice can precede the informed consent form, leaving sufficient time to read and understand the information. An invitation letter can also be used to introduce the study to candidates.

Informed consent material (2) All information material must be complete and clear, avoiding scientific/technical terms and excessively long descriptions. Telephone help-lines can be used to provide candidates with clarifications. Translation into other languages can be considered.

Informed consent material: Items for consideration Declaration of having read and understood the information Assurance of data confidentiality Request for general consent (vs. consent for specific parts of the study) Possibility to withdraw at any time Future uses of data specified in detail Request/statement to contact subject for follow up or additional research Request/statement to link/merge data with other registries Request/statement to store biological samples Explicitly stated that certain tests will not be performed General statement that tests will be performed, without specifying which Explicitly stated which tests will be performed Name of person receiving the consent Request/statement to provide results to the general practitioner Consent forms specific for minors

Conclusions: Summary of main legal/ethical concerns Legal and ethical issues can be varied and complex, and it must be ensured that the main concerns are addressed: Approval by ethics committee of the study protocol, ensuring compliance with national legislation on ethical conduct of all aspects of the HES Data confidentiality: compliance with Data Protection Act, in terms of data access, exchange, linkage and anonymisation Informed consent: participants complete understanding of all aspects of the study

Conclusions: National legislation Although these concerns are covered in European-level legislation, it must be ensured that they are addressed by the legislation of the country where the HES is being performed. In fact, national legislation, which can vary widely, can have a great effect on the specific activities of the HES and the uses of the data collected.