ETHICAL CHALLENGES OF DART FOR SOCIAL SCIENCES RESEARCH Prof. Nicolas Favez University of Geneva

Ethical challenges of DART Data Access and Research Transparency -> possible conflicting issues with the legal and ethical principles of research Behind the data -> the participants Who is the owner of the data? Who can decide how the data will be used? Legal challenge: several legal frameworks regulate the use (and re-use) of data Ethical challenge: Nurnberg Code – Declaration of Helsinki – Belmont Report -> informed consent is at the core of research with human subjects 2

Ethical challenges of DART LRH: Loi fédérale sur la recherche sur l’être humain HFG: Bundesgesetz über die Forschung am Menschen Came into effect on 1 January 2014 Establishes cantonal ethics committees Regulates medical and pharmacological researches but some psychological and sociological studies fall in the scope of the law Data sharing allowed if: no genetic or biological data (unless there is consent from the participant). For other data -> see LPD/DSG 3

Ethical challenges of DART LPD: Loi fédérale sur la protection des données DSG: Bundesgesetz über den Datenschutz Came into effect on 19 June 1992 Regulates the use of personal data (e.g. data conservation, confidentiality) Strong restrictions on « personal data » sharing (depends also on cantonal laws; « personal data » = non anonymous data, or all data that allow identification). Possible without consent only if there is a contract between the researchers in order to ensure data protection 4

Ethical challenges of DART Legal problem: no clear definition of « personal data » Ethical problem: even if data sharing is in accordance with the lawS, is it ethical when participants are not informed about the use of their data? All ethical problems are not regulated by the LRH/HFG Possible solution: the consent form should / have to mention the possible data sharing and clarify the conditions of sharing 5