IRB

For the purpose of a course or for a non-honors senior thesis, no. If you are doing honors, then maybe. If you think that the interviews, participant observation, or survey you do for a course work might figure in your honors thesis, then you may need to apply for IRB clearance.

How do I know whether my project needs IRB review?

The IRB reviews research on human subjects that is "systematic" and designed to contribute to "generalizable knowledge." Obviously, whether your study needs IRB review depends on how those words in scare-quotes are interpreted. The Emory IRB interprets them narrowly, so that many qualitative studies either fall outside of IRB review, or they get the lowest level of scrutiny.

Whether a project contributes to "generalizable knowledge" is a matter of the breadth of conclusions, not a matter of the methods used. It is also a matter of the risks that your project might present to the the subjects. This is often obscured when people say that "oral history" and "journalism" do not require IRB review. If the interview is designed to have the subject tell their story, and the conclusions you draw from it are descriptions of that person, the IRB does not consider it as producing "generalizable knowledge." On the other hand, if you will be generalizing about people who are similar to those you interview or observe, it may require IRB review. The Emory IRB says this:

“activities do not require IRB review if objective of the activities is to provide an accurate and evidence-based portrayal of the individuals involved, and not to develop generalizable knowledge. In contrast, if the activity involves collecting and using information about individuals for the purpose of drawing generalizations about such individuals or a population of which they are members, then it will be considered “research” and may need IRB review or an exemption determination.”

If, after talking to Dr. Risjord and/or your advisor, you think your research does not require IRB review, fill out the Non-Human Subject Research Determination Form. This asks a few questions about your project, and if you do not need to apply, the IRB will confirm it for you. But this form doesn’t do the work for you: essentially you are just attesting that your project does not apply.

Start the application as soon as you have a clear idea about what sort of methods you will be using. This may be in the May after your junior year. If you want to do substantial summer research, you might want to get the IRB process started in the early spring.

Assume that the process will take a couple of months to complete. It takes time to draft the protocols, create an informed consent documents (or script), and to fill out the forms. Also, the CITI Training (mentioned below) takes a few hours to complete. Also, there is almost always a back-and-forth as the IRB asks for clarifications, and this can be slow.

There are two possibilities. If the summer will be your only opportunity to do on-site interviews or participation observation, then you’ll need to get IRB clearance. Start your application early in the spring, say, before the end of March.

On the other hand, you do not need IRB clearance to undertake an internship, live in a foreign land, or to talk with potential contacts. You can use your summer to learn about the people or place you are studying. Apply for the IRB at the end of summer, and when you have clearance, you can set up formal interviews (perhaps via the internet) with your subjects. Quotations or identifying information about your participants constitute the dividing line: If you’ve learned something from your travels, you can put it in your thesis without IRB clearance; but if you’re quoting people or giving detailed descriptions of their actions in your thesis, you need IRB clearance before working with them (assuming your project needs IRB in the first place).

In general, yes. You are bound by the ethics of research whether or not your project falls within the scope of IRB review.

Step 1. Take the social and behavioral sciences module of the web-based CITI certification training: http://www.irb.emory.edu/Training/courses/citi.html.

Step 2. Talk to your advisor and/or Professor Risjord about your project. Before starting the IRB application process you want to think through:

• The characteristics of your study population and/or location
• Any risks (typically loss of privacy or confidentiality) to which your project might expose the subjects
• The kinds of questions you'll be asking (if doing interviews) or the sort of thing you're interested in observing (if doing participant observation). If you are doing structured interviews or a survey, you will need a draft.
• How you are going to go about getting informed consent and documenting it.

Step 3. Register with the e-IRB system as a new user. There is an extensive set of tutorial videos and help pages.

Step 4. Prepare your submission. The IRB has prepared several documents that will help you prepare the "Lay Summary" and the "protocol," as well as templates for informed consent documents. Professor Risjord and your advisor can help you figure out how to best present your study to the IRB, as well as figuring out what the questions are asking for.

Step 5. Get 'er done. Submit via the e-IRB system.