Guardians of data: A letter from the IRB on best research practices
Utah State University faculty often mentor undergraduate and graduate students on original research projects. For projects that will enroll human participants, faculty apply for approval from the USU Institutional Review Board (IRB). When we do so, faculty become the Principal Investigators of record at the USU IRB as per USU policy, providing another point of evidence for faculty members’ role as guardians of the project.
Faculty guard the students as they plunge into a novel intellectual and research pursuit, so students may develop needed skills without placing research participants at risk. Mentors guard students by providing a “safety net” for their learning to occur. Faculty further protect the public by ensuring that students’ projects are relevant, methods are appropriate, and data collection procedures are consistent with the standards of the discipline; this minimizes harm to human participants. Faculty guard the scientific community by ensuring that data analyses are carried out without error and thus findings are useful. Faculty also guard the data. What that means is that faculty ensure that data are safely stored, kept at USU, and are shared responsibly. For students who move on to careers at universities or research centers who wish to have access to their data, they can submit requests to their new IRBs for use and storage of the data they need.
Faculty who may feel overwhelmed by data guardianship may benefit from knowing that data can be easily stored in an external device (e.g., memory stick) that can be placed in a locked filing cabinet without requiring much room or cost. Additionally, USU will soon be providing access to faculty and students to Box (box.com), a secure file sharing system to which both faculty and students will have free access thus eliminating the need for any physical storage. Data files can be easily shared in Box for the duration of the collaboration.
Guardianship of the data does not imply ownership of project ideas or authorship order in ensuing publications. Excellent mentors know that conversations about collaborative boundaries are necessary at multiple stages of project development and execution. Faculty guardianship of thesis and dissertation data simply reflects the developmental nature of the mentor-mentee relationship; a more skilled researcher takes responsibility for various technical aspects of the project while a less seasoned student researcher works on strengthening needed methodological and data analytic skills. Having the support of a mentor in guarding thesis and/or dissertation data provides an excellent opportunity for mentors to model the best standards for protection of human participants in research.
Two overarching principles guide USU’s practices regarding data. First, it is the duty of every USU researcher to record and share data in such a way as to ensure that research outcomes can be replicated and verified by others. Second, USU has a contractual obligation and the institutional authority to own and manage data in accordance with public expectations and regulatory requirements.
As we have all experienced, trainees learn most of what they know about conducting research by watching the process in their mentors’ research environments. The care we take in planning for data collection, recording research results, applying appropriate data analysis and – increasingly –preserving and sharing our data, become the touchpoints for trainees to understand the importance we place on our stewardship of research data. The Council of Biology Editors puts it succinctly: “
When USU researchers undertake work with outside sponsors, and especially with the federal government, USU becomes the party to the contract, and therefore the owner of the data generated. Federal policy from both the Office of Management and Budget (OMB) and from specific individual agencies set the societal expectation that the grantee (i.e., the institution) owns the data, and has both the rights and the responsibilities that attach to that ownership. For example, OMB specifically requires that data be retained for a period of at least three years beyond the closeout of the project. USU relies to a large extent on its faculty to act as stewards of data for the projects that they and their students conduct. One question I ask audiences of researchers as a thought exercise is: “If you were to publish a paper on your current area of research and, in 3 years, you were accused of having falsified or fabricated the data, what would you have to prove that you had done the work as described?” Designing data collection, retention and sharing processes in our research groups so that they at least meet the bar set by this question will result in more rigorous and robust data management practices.
– Russ Price, USU Federal Compliance Officer