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Research Data and the IRB

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While most researchers have interacted with the Institutional Review Board (IRB) successfully at least once, few can say they fully understand what does and does not require IRB approval, and how to ensure one's research is approved quickly. There are many good resources available to help researchers with this important process, and in CLA-OIT we have worked closely with the IRB to document the processes of our research services to simplify and clarify the process.

What is an IRB?

Federal law requires that all human subjects research be approved by an IRB; while it's not necessary for every institution to have its own, in practical terms the tremendous volume of research at Research-1 institutions guarantees that each has its own IRB or IRBs. The University of Minnesota's IRB is run by the Human Research Protection Program within the oversight of the Office of the Vice President for Research. The IRB's website is the first, and best, resource for any IRB-related questions on campus.

There is a great demand on IRBs at large research institutions, which can make it difficult for IRBs to communicate to faculty researchers a clear and consistent explanation of their procedures, requirements, and expected outcomes. This can lead to distrust, and at many larger institutions the IRBs are viewed as unpredictable or unsystematic.

Fortunately, this is not the case at the University of Minnesota. Our IRB is a bit of a trailblazer in its attempts to guarantee that researchers get a consistent, predictable, understandable, and timely response to their research requests. Our IRB was accredited in 2004 by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and has been an active advocate within AAHRPP for quicker, streamlined processes for researchers in all disciplines.

CLA Researchers

The IRB has purview over all research that involves human subjects. While that includes drug tests and medical procedures, it also involves interventions, evaluations, surveys, experiments, and just about any other primary data collection involving a living person. Regardless of your discipline, if you are directly collecting data from another person, and you plan to share the results of that collection with others through publication or presentation, your research probably falls under the purview of the IRB. To help determine whether projects require review, the IRB provides a convenient checklist of criteria, which can be accessed by going to the IRB's website and clicking on the link, "Does my research need IRB review?" If you're not sure, it's always best to check with the IRB directly by sending an email to irb@umn.edu or giving them a call at 612-626-5654.

What can CLA-OIT do to help?

CLA-OIT offers many services for human-subjects researchers, including online surveys and experiment programming. In 2005 we initiated an ongoing conversation with members of the IRB about how best to help our researchers with confidentiality issues in human-subjects research. We design our data collection systems and procedures to meet the IRB's expectations for data privacy, participant confidentiality, and security. The law does not allow IRBs to grant blanket approval to standard processes or procedures; but we spend a good deal of time talking with HRPP about what they expect and how we can meet those expectations. This open communication reaps benefits for us, for the IRB, for our researchers, and for the participants in our researchers' projects. The standard documentation of our processes has been written into hundreds of IRB protocols (applications), and the people who handle social and behavioral science approvals are intimately aware of what we do and how we do it. While this does not by any means guarantee approval, it does give a clear starting point for documentation of the technical aspects of a project.

What does this mean for CLA researchers?

First and foremost, the key to smooth research approval is open communication. Several times we've seen a quick phone call to the IRB placed before completing paperwork save a lot of time and trouble later. The people at our IRB are open and receptive.

Second, if you are thinking about working with CLA-OIT on your project, or if you have complex technical needs and aren't sure how you'll be meeting them, give us a call before you submit your IRB protocol. We can provide standard language to describe many technical aspects of projects, and in other cases we may be able to help you avoid costly or research-limiting mistakes.

Third, remember that IRB protocols can always be amended if you later discover that your research requirements aren't as you expected; it's better to amend your protocol to accurately reflect what you want than to collect bad data on your original approval.

Finally, remember that the research support staff here at the University are here to help you, the researcher. If you have any questions or concerns, pick up the phone and call the IRB at 612-626-5654 or call CLA-OIT at 612-624-4357 (4-HELP).

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