Engaging Complexity

Scenarios for the Responsible Sharing of Sensitive Research Data

By Colin Elman and Diana Kapiszewski

On May 21, QDR held a workshop entitled, “The Impact of Human Subjects Guidance and Informed Consent Scripts on Data Sharing and Research Transparency.” The workshop was the third in the “Protecting People, Sharing Data” series, which comprises one aspect of a broader initiative QDR launched in 2016 aimed at developing strategies for sharing sensitive human participants data by developing strategies for doing so ethically and responsibly.

The workshop series convenes diverse actors in the academic ecosystem to examine and address the tension between the two important goals reflected in its title. On the one hand, scholars have long been expected to conduct their research, including managing their data, in ways that respect ethical and legal constraints, especially when they interact with human participants. On the other hand, there has recently been a growing acceptance that scientists should share their research data and render their work transparent.

Workshop attendants participating intently in Syracuse University's Lubin House library in New York City.
Workshop attendants participating intently in Syracuse University's Lubin House library in New York City.

To date, different stakeholders in the American academic ecosystem have focused on different parts of this dual mandate. Domain repositories, funders, and publishers, for example, increasingly call on grantees and authors to share the data and materials underlying their inquiries so they can be reused to replicate and verify research findings and answer new research questions. Also, these institutions, especially repositories, have worked to make the infrastructure for data sharing more sophisticated. In particular, they have developed a number of workflow-, technology-, and policy-based solutions that offer scholars who share sensitive research data a range of options for restricting access to those data and keeping them safe.

Institutional Review Boards (IRBs) are charged with ensuring that social scientists conduct research in ways that will protect their human subjects from harm. IRBs’ most significant – and often only – interactions with scholars tend to occur early in the research cycle and in isolation from institutions that encourage data sharing. Research transparency imperatives, and the new approaches and mechanisms that permit the ethical and safe sharing of sensitive data, have not typically been included in the guidance IRBs offer to scholars.

Data Sharing and IRB Guidance for Researchers

An empirical study that QDR carried out in 2017 supports this claim: we analyzed the guidance – and model language – with regard to informed consent and data sharing offered on the web sites of IRBs at the 50 U.S. institutions that received the most total funding from the National Science Foundation Directorate for Social, Behavioral & Economic Sciences in FY 2016. Overall we found very few mentions of “data,” “sharing,” “access,” or any related issues in these guidance materials.

Because IRBs guide scholars to make decisions that reverberate through the entire research cycle, this is a very consequential omission. IRBs’ hesitance is likely one reason why some potentially shareable sensitive human participants data remain unavailable to anyone other than the researchers who collected them. QDR believes that by integrating IRBs into ongoing conversations about sharing sensitive data ethically and legally – and leveraging their expertise to develop corresponding advice and templates for scholars – more research will be designed to allow the responsible sharing of human participants data. The ultimate goal of our broad initiative on the ethical and responsible sharing of sensitive human participants data is to build the social infrastructure needed to support a sustained dialogue between IRBs, data repositories, and other stakeholders as well, on the optimal balance between research openness and human participant protection.

Connecting Researchers, Repositories, and IRBs

The workshop series is central to QDR’s broader initiative. The first workshop (May 2016), attended by social scientists, IRB members, and personnel from data repositories, conveyed information that informed the development of our practices and operations. The second workshop (September 2017), attended by IRB officials from 18 U.S. universities, as well as data repository personnel, focused on solutions for mitigating the tension between research openness and sharing sensitive human participants data, including technologically empowered differential access and more varied informed consent scripts. The most recent workshop (May 2018) included IRBs, repositories, funders, and journal editors. Discussion centered on the potential for coordinated generation of clear, consistent guidance for sharing sensitive research data.

The senior IRB staff who have attended these workshops – while steadfast in their commitment to protect human subjects – have been very open to the idea that in many cases scholars can share the data they collected or generated through their research in ways that meet their legal and ethical obligations. Drawing on a consensus for action reached at the end of the second workshop, attendees helped to draft a set of illustrative guidance and informed consent template texts that IRBs can adopt and adapt to help members of their research communities learn about more nuanced options for sharing research data. IRB personnel from several universities across the country have vetted and endorsed the principle underlying the illustrative texts.

Helping scholars consider ways to share sensitive human participants data in responsible and ethical ways represents an important start – but it is only a first step. Additional challenges arise when scholars need to discuss which data they will share and how they will do so with funders and publishers. To date few funders or journals have developed or deployed clear procedures or arrangements for sensitive data generated through interaction with human participants. Their requirements for data sharing always allow exceptions for sensitive data that might put human subjects at risk, but such organizations lack specified procedures for assessing and documenting such exceptions.

As part of this initiative, we hope to encourage funders and journal editors to develop and describe clear procedures for how scholars can bring their concerns about sharing research data to these stakeholders’ attention. We also hope to encourage stakeholders to acknowledge the utility of more variegated arrangements for sharing sensitive data, and introduce more nuanced solutions that allow some data to be shared (e.g., de-identifying data, using credentialing, or placing access controls on data).

Towards a Data-rich Future

In short, social science is taking promising steps toward a new equilibrium in which data sharing is more feasible. There is a new willingness on the part of multiple stakeholders within the social science community – scholars, ethics committees, funders, publishers, and data repositories – to engage with each other. The recent revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule), expected to go into effect in 2019, will have a significant impact on the role IRBs play in the social sciences, and on how sensitive data are engaged throughout the research cycle. Now is thus a critical moment to begin jointly constructing a framework to help researchers navigate the tensions among learning from human subjects, protecting them, and sharing information generated through interaction with them.

If you have an interest in these issues, please contact us to learn more (qdr@syr.edu).