From the Director: Highlights of PRIM&R’s Ethics of Data Access, Use, and Sharing for Human Subjects Research Workshop

Elisa Hurley

On March 1, 2017, PRIM&R held a day-long Ethics of Data Access, Use, and Sharing for Human Subjects Research Workshop in partnership with the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (MRCT Center). I am pleased to announce that the proceedings and other information from the day are now available on PRIM&R’s website.

The workshop was spearheaded by PRIM&R’s Public Policy Committee, which seeks to influence public opinion, public policy, and the development of regulation and guidance in the service of advancing the highest ethical standards in the conduct of research. The overarching goal for the workshop was to examine the question of whether our current ethical and regulatory framework adequately protects the rights and interests of individuals and their personal information in the setting of rapidly evolving research policy and practice.

Thirty-nine leaders in the field, representing a range of stakeholders in the data sharing, access, and use landscape, participated in the day’s roundtable discussion, including patient advocates, researchers, institutional representatives including institutional review board members, medical journal editors, ethicists, and policymakers. Participants discussed the ethics of data access and sharing as a component of a range of current and emerging human subjects research activities, including individual-patient level data sharing in clinical trials, the All of Us Research Program, patient-centered outcomes research (PCOR), NIH requirements around genomics and clinical trials, and the learning healthcare system.

The wide-ranging discussion  highlighted the current potential but also the challenges for research, healthcare, and policy as the movement toward greater data access and data transparency alters the research landscape.

The day was divided into four parts, each building on the last. We looked first at the promise and perils of data sharing and the scientific possibilities it creates, and then turned to an exploration of the right and expectations of individuals with respect to their personal data. We then examined what each of these sets of considerations entails for informed consent and its alternatives, and then asked what institutional or regulatory structures might need to be in place to govern new data access and sharing domains, given the principles and concepts that emerged during the day. Here I give a brief summary of each part, but I encourage you to view the workshop proceedings video or read the summary if you are interested in a deeper dive.

In Part I, titled Perspectives on the value of research employing new approaches to the access, use, and sharing of personal information for research, participants pointed out that while research participants by and large want to share their data for future research, and a number of genomic data sharing networks and databases are currently demonstrating the range of benefits associated with share data, there are structural, cultural, and practical obstacles to realizing the scientific potential of widespread access to data. Those obstacles include poor data quality, lack of appropriate incentives for researchers and institutions to both share and make use of shared data, funding deficits, lack of trust in science and failures of interoperability among data sharing platforms and formats.

Participants agreed that increased public transparency about the uses of data and the purposes of shared data research, better engagement of all stakeholders involved in generating and access data and a re-examination of scientific culture and incentives would all go a long way to removing or reducing some of these obstacles. 

In Part II, titled Conceptualizing an individual’s rights, interests, and expectations with regard to their health and other data, participants complicated the notion of privacy as it pertains to people’s interest in and values around their personal data. The question of whether the research ethics community is guilty of “research exceptionalism” when it comes to thinking about privacy, risks, and rights was raised and discussed, as were questions about how well the interests of socially marginalized populations can be aligned with what is considered the “common good.”

Participants highlighted potential approaches to addressing these complicated issues, including penalties for parties who re-identify data in an unauthorized manner, increased opportunities for stakeholder participation in the risks-benefit analysis of how big data is used, and a framework that identifies general principles for determining what research should be conducted with shared data and who stands to benefit and lose from such efforts.

In Part III, titled Implications for consent, authorization, and data stewardship, participants reviewed what research with shared data means for the informed consent process, particularly in light of the revised Common Rule and new technological capabilities that facilitate increased transparency about research (i.e., mobile apps). Participants suggested that the research oversight community consider new avenues, beyond traditional informed consent, for informing participants about what is happening with their information, and honoring their preferences, including opt-out and positive framing. The group discussed broader mechanisms for getting buy-in to data sharing as well, including community engagement efforts and mechanisms for ensuring transparency and “public accountability” for how data is used, which may be especially important for historically marginalized populations.

In Part IV, titled Responsibilities for ethical oversight of research involving data access, use, and sharing, participants examined institutional and IRB responsibilities, institutional conflicts of interest, medical journals’ role in providing impartial oversight of responsible data sharing and use, and how current federal laws affect research with shared data. Participants argued for greater institutional support for researchers and oversight bodies, better education about ethical standards regarding shared data, increased researcher accountability, and a new independent oversight body to oversee conflict of interest issues in this space. In the Part V, the summary and next steps part of the day, participants agreed that in order to foster enhanced data sharing, a framework and infrastructure that engenders “justified trust,” where the focus is on a truly common good, needs to be in place. It was suggested that, as we think about a way forward, we might look, by analogy, to the traditional public health framework. Participants also agreed that a next step might be for the research ethics community to develop a set of common principles for research with shared data which addresses: community engagement; making research relevant to communities; improved education of key stakeholders; honoring people’s desire to be asked regarding collection and use of their data; and clearer, more consistent definitions of terminology for those working with shared research data.

You can find other recommendations that emerged from the day in the executive summary

I invite you to visit the workshop webpage to watch a video recording of each part of the day, read a written summary of the workshop proceedings, and peruse a comprehensive bibliography on data sharing and transparency.

I also invite you to share your perspective on the opportunities and challenges you face as research increasingly involves sharing, storage, use, and access to data. How is increased demand for data sharing and access affecting your institutional policies and procedures? And what would be helpful from PRIM&R for navigating the challenges ahead? We’re eager to hear from you.