Background: Advances in medicine rely to a great extent on people's willingness to share their data with researchers. With increasingly widespread use of digital technologies, several Web-based communities have emerged aiming to enable their users to share large amounts of data, some of which can possibly be employed for research purposes by scientists, or to conduct participant-led research (PLR). Scholarship has recently addressed the necessity of interrogating how existing ethical standards can and should be applied and adapted in view of the specificities of such Web-based activities. So far, no study has explored participants' beliefs about and attitudes toward ethical oversight when it comes to platforms that involve medical data sharing.
Objective: This paper presents the protocol for a survey study aimed at understanding users' beliefs about Web-based data-sharing platforms regarding how research ethics principles should be applied in such a setting. Furthermore, the study aims at quantitatively assessing the relationship between participants' perspectives on ethical oversight and other variables such as previous participation in research, beliefs about data sharing, and attitudes toward self-experimentation.
Methods: We are conducting a Web-based survey with users of a popular Web-based data-sharing platform, Open Humans. The survey has been sent to approximately 4640 users registered for the Open Humans newsletter. To fill out the survey, participants need to have an account on Open Humans. We expect a 5%-10% response rate (between 200 and 400 completed surveys out of approximately 4000 survey invitations sent). Independent variables include past data-sharing behavior and intention, beliefs about data sharing, past participation in research, attitudes toward self-experimentation, perceived knowledge of the platform's guidelines and terms, perceived importance of having transparent guidelines, and governance-related beliefs. The main dependent variable is participants' expectations regarding who should ensure that ethical requirements are met within research projects conducted on open data-sharing platforms, based on Emanuel et al's ethical framework. We will use chi-square tests to assess the relationship between participants' expectations regarding ethical oversight and their past behavior, future intentions, beliefs, attitudes, and knowledge.
Results: Data collection started on June 13, 2018. A reminder to fill out the survey was sent to participants in mid-July. We expect to gain insights on users' perspectives on the ethical oversight of Web-based data-sharing platforms and on the associated experiences, beliefs, and sociodemographic characteristics.
Conclusions: When digital tools allow people to engage in PLR including medical data, understanding how people interpret and envision the ethical oversight of their data-sharing practices is crucial. This will be the first study to explore users' perspectives on ethical oversight of Web-based data-sharing platforms. The results will help inform the development of a framework that can be employed for platforms hosting various kinds of research projects to accommodate participants' ethical oversight needs.
International registered report identifier (irrid): RR1-10.2196/10939.
Keywords: data sharing; ethics; mobile phone; patient participation; patient-generated health data; questionnaire; survey.
©Marta Fadda, Anna Jobin, Alessandro Blasimme, Bastian Greshake Tzovaras, Mad Price Ball, Effy Vayena. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 28.11.2018.