John E. Marcotte

We appreciate Reierson’s thoughtful commentary on our 2019 paper, which described our experiences, ethical process, judgment calls, and lessons from a 2016-2017 data-sharing pilot between Crisis Text Line and academic researchers. The commentary raises important questions about the ethical conduct of health research in the digital age, particularly regarding informed consent, potential conflicts of interest, and the protection of vulnerable populations. Our article focused specifically on the noncommercial use of Crisis Text Line data for research purposes, so we restrict our reply to points relevant to such usage. While we acknowledge the limitations of Crisis Text Line’s Terms of Service as a means of informing users about data sharing for research, we maintain that our guidelines were ethically sound and aligned with well-established practices for institutional review board (IRB) review and researcher training. We emphasize the critical role of IRBs in ensuring that research involving vulnerable populations, including minors, is conducted ethically and with appropriate safeguards. Regarding potential conflicts of interest, we argue that unpaid, nonfiduciary advisory board service for a nonprofit organization does not constitute a conflict requiring disclosure. The transparent nature of our collaboration with Crisis Text Line, as evidenced by the authorship and acknowledgments in our paper, further underscores our commitment to ethical research practices. We recognize the complexity and evolving nature of the challenges surrounding data-sharing partnerships in digital health research. As the field progresses, we remain committed to ongoing, transparent engagement and to refining best practices in collaboration with colleagues, stakeholders, and the public. Our response aims to provide clarity and context for the concerns raised in the commentary while reaffirming the integrity and value of our original work. Ultimately, we maintain that our paper contributed meaningfully to the ongoing discourse on ethical data sharing and laid the groundwork for future improvements in this critical area of digital health research.

UNSTRUCTURED We appreciate Reierson’s thoughtful commentary on our 2019 paper, which described our experiences, ethical process, judgment calls, and lessons from a 2016-2017 data-sharing pilot between Crisis Text Line and academic researchers. The commentary raises important questions about the ethical conduct of health research in the digital age, particularly regarding informed consent, potential conflicts of interest, and the protection of vulnerable populations. Our article focused specifically on the noncommercial use of Crisis Text Line data for research purposes, so we restrict our reply to points relevant to such usage. While we acknowledge the limitations of Crisis Text Line’s Terms of Service as a means of informing users about data sharing for research, we maintain that our guidelines were ethically sound and aligned with well-established practices for institutional review board (IRB) review and researcher training. We emphasize the critical role of IRBs in ensuring that research involving vulnerable populations, including minors, is conducted ethically and with appropriate safeguards. Regarding potential conflicts of interest, we argue that unpaid, nonfiduciary advisory board service for a nonprofit organization does not constitute a conflict requiring disclosure. The transparent nature of our collaboration with Crisis Text Line, as evidenced by the authorship and acknowledgments in our paper, further underscores our commitment to ethical research practices. We recognize the complexity and evolving nature of the challenges surrounding data-sharing partnerships in digital health research. As the field progresses, we remain committed to ongoing, transparent engagement and to refining best practices in collaboration with colleagues, stakeholders, and the public. Our response aims to provide clarity and context for the concerns raised in the commentary while reaffirming the integrity and value of our original work. Ultimately, we maintain that our paper contributed meaningfully to the ongoing discourse on ethical data sharing and laid the groundwork for future improvements in this critical area of digital health research.

Research data have expanded in their gradation of the risks associated with both re-identification and harm, which has created a need for multiple levels of access controls beyond public and restricted access. Public-access data have typically been available for download from websiteswhile restricted-access data usually require an application and formal authorization process. The old paradigm of classifying data as public-access or restricted-access is no longer sufficient. Access to research data requires more nuance to ensure the protection of human subjects.In this paper, we describe seven tiers of access to research data. Each tier adds requirements that are necessary to mitigate disclosure risk and confirm appropriate management of the data. Improper handling of the data includes attempting to find a specific individual or household or failing to follow disclosure protection rules for data and output included in papers and presentations. By establishing a ladder of access conditions, each higher tier meets and exceeds the requirements of the lower tiers. While the highest tier meets all requirements, this tier will impede legitimate research for most data. The challenge for repositories is to provide access in a manner that promotes research while specifying security that provides appropriate protections against the risks of re-identification and harm. The tiers operationalize risk management options. The requirements of the research data determine the appropriate tier.Several articles and reports develop frameworks for providing access to research data. We review these frameworks as well as the current practices at data archives and describe how our approach differs from these paradigms. While tiered access to research data is not a new idea, more than two or three levels are needed to meet the diverse needs of the research community. The tiered approach enables repositories to require sufficient security controls without creating unnecessary impediments to research

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet

UNSTRUCTURED Data sharing between technology companies and academic health researchers has multiple health care, scientific, social, and business benefits. Many companies remain wary about such sharing because of unaddressed concerns about ethics, data security, logistics, and public relations. Without guidance on these issues, few companies are willing to take on the potential work and risks involved in noncommercial data sharing, and the scientific and societal potential of their data goes unrealized. In this paper, we describe the 18-month long pilot of a data-sharing program led by Crisis Text Line (CTL), a not-for-profit technology company that provides a free 24/7 text line for people in crisis. The primary goal of the data-sharing pilot was to design, develop, and implement a rigorous framework of principles and protocols for the safe and ethical sharing of user data. CTL used a stakeholder-based policy process to develop a feasible and ethical data-sharing program. The process comprised forming a data ethics committee; identifying policy challenges and solutions; announcing the program and generating interest; and revising the policy and launching the program. Once the pilot was complete, CTL examined how well the program ran and compared it with other potential program models before putting in place the program that was most suitable for its organizational needs. By drawing on CTL’s experiences, we have created a 3-step set of guidelines for other organizations that wish to develop their own data-sharing program with academic researchers. The guidelines explain how to (1) determine the value and suitability of the data and organization for creating a data-sharing program; (2) decide on an appropriate data sharing and collaboration model; and (3) develop protocols and technical solutions for safe and ethical data sharing and the best organizational structure for implementing the program. An internal evaluation determined that the pilot satisfied CTL’s goals of sharing scientific data and protecting client confidentiality. The policy development process also yielded key principles and protocols regarding the ethical challenges involved in data sharing that can be applied by other organizations. Finally, CTL’s internal review of the pilot program developed a number of alternative models for sharing data that will suit a range of organizations with different priorities and capabilities. In implementing and studying this pilot program, CTL aimed both to optimize its own future data-sharing programs and to inform similar decisions made by others. Open data programs are both important and feasible to establish. With careful planning and appropriate resources, data sharing between big data companies and academic researchers can advance their shared mission to benefit society and improve lives.