INTRODUCTION: Respondent's position/function in the Ethical Committee

What is your professional/scientific background? How often do you serve in this EC?

TOPIC 1: Respondent’s understanding of biomedical big data and previous experience in this respect

What makes you consider a project as “big data”? Are there cases where you are uncertain about whether a project is big data or not? Does your EC (regularly or occasionally) review big data projects? If yes, how often? How many of those involved biomedical data? If no, why? Who does review them instead? Are online research projects and studies involving publicly available data repositories reviewed by your EC? Should they?

TOPIC 2: Respondent’s opinion concerning the promises and challenges brought by biomedical big data

What are the major scientific benefits that you see associated with biomedical uses of big data? Is there a social need to maximize data availability for research? What are, in your view, the major ethical and social challenges associated with using big data for research? Any issue specific to healthcare research? (If the participant immediately links the answer to healthcare research, ask whether there are more general issues outside the medical context) Do you feel that biomedical big data projects pose unprecedented/novel/unique ethical challenges? If yes, which ones? If not, do you think they change existing challenges? Do you see any particular impact on privacy? Where do you see a fair balance between the social need of maximizing data and the individual need of protecting privacy? How can individuals consent to the use of their data? How should they? How do you define “risk” in big data projects? How do you assess risk benefits in healthcare big data projects? How would define “minimal risk” in relation to biomedical big data research? How do you assess minimal risk in other research context?

TOPIC 3: Existing guidelines and criteria adopted to handle biomedical big data-related issues

Do you follow any specific guidelines to assess biomedical big data projects? If yes, which ones? Are you aware of guidelines from national or international organizations? When evaluating a big data project in healthcare, what do you mainly look at? Data type? Data volume? Data collection methods? Analytic methods? Have you ever heard of algorithmic transparency?

TOPIC 4: Assessing respondents’ needs for guidelines in relation to big data

Do you feel that your EC is adequately equipped to evaluate biomedical big data projects? If not, what expertise, tool or mechanism would be required? Do you think the EC has the responsibility to evaluate big data projects? If yes, explain why. If not, which authority should do that instead? (Prompt: data protection office?) Do you think novel review bodies are needed? If so, do you see them as complementary or substitutive of EC?

TOPIC 5: Respondent’s suggestions to develop an inclusive guideline policy concerning big data in healthcare

If you could contribute to the drafting of new guidelines, what would your main recommendations be? Which values would be paramount? Who do you think should develop such guidelines (e.g., WHO, national govs, private corporations, etc.)? At which level (international vs. national)?