Procedures for protecting the rights and welfare of human subjects are the same, no matter who conducts the research; thus, student researchers like myself are held to the same standards as faculty researchers. If an undergraduate at Duke wants to conduct research that involves human subjects in any capacity, he or she must fill out a long, complicated application and send it to the Duke IRB before beginning the study.
There are different review procedures for research with human subjects, depending upon the research activity and the level of risk. These are (1) review for exemption, (2) expedited review, and (3) full review. When the IRB receives my application, they will determine what type of review my protocol needs. If a project qualifies for review as exempt research, the Director of the IRB program is authorized to approve the application. If it is not exempt, but qualifies for expedited review, one member of the IRB can approve the application. Exempt and expedited reviews can be done at any time. However, if subjects will have to accept more than minimal risk to participate in a study, the application will be reviewed by the full IRB.
I’m hoping and praying that my project qualifies for exemption or expedited review. If it doesn’t, I will be completely at the mercy of the IRB’s timetable, and there is a chance that I won’t gain approval until after I arrive in Ukraine. (However, since I am only conducting interviews and not, say, testing the effects of electroshock therapy on terminally ill children, I don’t think full IRB review of my project will be necessary… but the possibility still exists.)
Although the form took a lot of time and effort to complete, I’m very glad I did it. It really made me think through my research approach at a level of detail that I hadn't before. For example, I had to explain the potential risks and benefits of my research. Here is an excerpt from one of my application responses:
Re: The risk of a breach of confidentiality: "In most cases, interviews will be "on the record" and public, so I will not have to promise confidentiality or worry about a breach. However, it is likely that I will also be interviewing people less formally while in Ukraine. These subjects may share information with me that could have adverse effects should a breach of confidentiality occur. For example, in an informal conversation, an Ark worker may describe to me how he covered his radiation-detecting work badge with lead so as to work extra hours to earn extra money, despite the fact that he may have received a dangerous dose of radiation by doing so. This information could potentially damage the worker’s employability at the Ark should his boss discover it."
The most painful part of the application was preparing the protocol materials themselves. These included consent forms, audio release forms (since I will be recording my interviews), sample interview questions, and recruitment forms. I also had to describe how I will ensure that these materials are culturally appropriate. Fortunately, my Ukrainian professor has agreed to pre-test my interview questions, consent forms, etc. as well to help me translate them into Ukrainian and Russian. I'm very grateful for that... without the promise of her help, I am sure the IRB would have flagged my project as risky.
It sure takes a lot of work to get permission to just talk to people! I will let you know when I hear back from the IRB staff.
Side note: I am in Boston for the weekend, and I had another unexpected, wonderful Ukrainian experience. I will write about it soon.