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Working with Sensitive Research Data (WSRD)

In 2016, QDR launched an initiative aimed at developing strategies for ethically and legally sharing sensitive data generated through research with human participants. The project seeks to develop a multi-stakeholder epistemic community, drawing representatives from various institutions in the American academic ecosystem into sustained dialogue about how to protect human participants while pursuing research openness.

Funders and journal editors, for example, increasingly call on grantees and authors to share the data and materials underlying their inquiries so they can be reused to verify and replicate research findings and to answer new research questions. Repositories have worked to make the infrastructure for data sharing more sophisticated, developing various workflow-, technology-, and policy-based solutions for restricting access to shared sensitive research data and keeping them safe. Institutional Review Boards (IRBs) seek to ensure that social scientists protect the people they involve in their research from harm. The “Common Rule” (Title 45, Subpart 46 of the Code of Federal Regulations), which governs the work of IRBs, was recently revised (effective January 21, 2019) in ways that will significantly impact their work.

The creation of a robust network among these stakeholders will help each actor to better appreciate the perspectives, roles, and responsibilities of the others, and to fulfill their missions in ways that are sensitive to the others’ goals and methods. Below we outline the work we have done, and ongoing aspects of the project.

Study of IRB Guidance

In 2017, QDR reviewed the web sites of IRBs at the 50 R1 U.S. universities that received the most funding from the National Science Foundation’s Directorate for Social, Behavioral & Economic Sciences in fiscal year 2016. We collected and analyzed the documentation, rules, procedures, guidance, and model language with regard to informed consent and data sharing. We discovered that most IRBs had not yet begun to carefully consider how their regulations interact with data sharing, and that few IRBs offered researchers concrete guidance on sharing human participants data, or templates for informed consent scripts that anticipate data sharing.

Due to the central position of IRBs in scholarly research, these were very consequential omissions. The status quo created and reinforced inconsistencies with regard to research practices and generated uncertainty and confusion among researchers. 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 and conducted in ways that allow the responsible sharing of human participants data.

Workshop Series

Since 2016, QDR has held a workshop series called “Protecting People, Sharing Data” that convenes diverse actors in the academic ecosystem to examine and address the tension between the two important goals reflected in its title.

  • The first workshop (May 2016) was attended by social scientists, IRB members, and personnel from data repositories. This workshop conveyed information that informed the development of our practices and operations with regard to sensitive human participants data.
  • The second workshop (September 2017) was attended by IRB officials, as well as data repository personnel. The event 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 third 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.

While steadfast in their commitment to protect human subjects, the senior IRB staff who have attended these workshops 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 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. If you would like to express your support for these texts, please contact us at qdr@syr.edu, and we would be happy to assist you in adding yourself as a signatory to the document.

NSF Grant

In August 2018, the National Science Foundation’s Office of Advanced Cyberinfrastructure awarded QDR and the Inter-university Consortium for Political and Social Research (ICPSR) a grant to build durable structures and channels to promote, broaden, deepen, and encourage sustained communication and collaboration among IRBs and data repositories. The grant, “Optimizing Openness in Human Participants Research: Harmonizing Standards for Consent Agreements and Data Management Plans to Empower the Reuse of Sensitive Scientific Data”, continues the WSRD initiative and has several phases, outlined below.

PHASE ONE (October 2018 to March 2019)

  • We are developing and refining the materials to be employed in the workshops held in the second phase of the grant. Specifically, we are gathering and analyzing literature and reports on the evolution of repositories’ and IRBs’ policies and practices for handling sensitive research data, and extending our own research on how IRBs treat data sharing.
  • We are also conducting individualized interviews and focus groups with senior IRB personnel across the United States in order to assess baseline IRB knowledge about, and openness to, the responsible sharing of sensitive research data.
  • We are drafting a glossary of standardized terms for discussing the sharing and reuse of sensitive research data (both quantitative and qualitative) with the goal of encouraging the use of a shared vocabulary across institutions and scientific disciplines.
  • We are developing templates for IRB protocols (and for consent statements in particular) applicable to multiple scenarios in various disciplines and templates for DMPs. The materials should improve communication between IRBs and repositories and facilitate researchers’ interactions with both.

PHASE TWO PLANNED ACTIVITIES (April through November 2019)

  • We will engage in outreach to three research communities, and to a broader set of IRBs, via four structured, interactive workshops. In those workshops, we will solicit attendees’ input on and concerns about the materials generated in the project’s first phase, allowing us to iteratively develop and refine them.
  • The first three workshops will be held at:
    • the American Educational Research Association (AERA) Annual Meeting in April 2019 in Toronto, Canada
    • the American Political Science Association (APSA) Annual Meeting in September 2019 in Washington, DC
    • the Computational Social Science Society of the Americas (CSS) Annual Conference in October 2019 in Santa Fe, NM
  • The fourth workshop will be held at the annual “Advancing Ethical Research Conference,” sponsored by the Public Responsibility in Medicine and Research (PRIM&R) organization, in November 2019 in Boston, MA. Reaching a broader set of IRB professionals well help us to confirm our findings about the challenges IRBs’ relative isolation has generated, and begin to envision appropriate solutions. We will also discuss with PRIM&R how we can collaborate to foment a dynamic dialogue among key institutional stakeholders on continued changes in standards and technologies for research and for safely sharing human participants data.

PHASE THREE (December 2019 to September 2020)

  • We will draw on the concrete feedback on our materials received in the second phase to (1) generate clear model guidance, consent script templates, and other materials relating to sharing sensitive research data that IRBs can adopt, adapt, and use for teaching and training in these areas; and (2) to refine our glossary of terms relating to the generation and sharing of sensitive human participants data

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. QDR is very excited to be part of these discussions through its WSRD initiative, and invites you to join them as well. If you have an interest in these issues, please contact us to learn more (qdr@syr.edu).