Working With Human Subjects

Nuts and Bolts of the Process

If you’re systematically collecting information from human beings, then you’re conducting research with human subjects. The data collection might take the form of surveys, interviews, observations, email exchanges, or other interpersonal communications or interactions. It’s actually easiest to assume that your interactions fall under the federal guidelines for research with human subjects and then to ask RICRO whether you need to complete the review process. Kathy Partin, Director of RICRO, and her staff have been most gracious about helping students and faculty understand which projects require review.

Typically, most researchers begin the process by crafting a research question and then designing a research plan to answer that question. They may work through a specific research design protocol (as Yin suggests for Case Study Research), or they may start by drafting interview or survey questions, descriptions of study populations, or multiple-method plans. At some point, graduate students start drafting a methodology chapter or pages for their theses or projects. The greatest advantage of working on an IRB review is that the thought processes required by the research protocol (here captured electronically through e-protocol) give researchers a new way to approach the research question so integral to the process overall. In effect, thinking about the research process by means of a research question and design, a methodology chapter, and an IRB review can improve the design, the chapter, and the review. The complementarity of these elements will result in a stronger, more productive research process.

You can begin the IRB review process either by drafting the methodology section of your thesis or project or by completing an eProtocol application. Your advisor will need to be the Principal Investigator on your project, and you will be listed as the Co-Principal Investigator. You or your advisor can go to eProtocol and begin working through the questions. These detailed questions will help you organize the details of your data collection, so plan to work back and forth between the eProtocol and your methodology draft. When completed, your advisor must be the one to submit the eProtocol.

In addition to the eProtocol application, you’ll need to prepare for the IRB all the materials you’ll use for data collection – recruitment texts; interview, survey, or questionnaire questions; consent forms. Again, work back and forth between data collection materials and your methods chapter as well as the other parts required on the eProtocol application. The IRB looks for consistency among all documents, so attention to detail will pay off as you draft, revise, and proofread. Please see the sample packets in the last section of this resource.

One important reminder: only a faculty member can be the principal investigator (PI) on a project with human subjects, and only those faculty members who have completed human subjects protection training can be approved as PIs. The PI need not be your advisor but must be a member of your graduate committee. Graduate students complete the eProtocol application as a Co-PI with an approved faculty member. Student researchers also need to complete the human subjects protection training.

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