Monday, January 30, 2012

The IRB Application

We are, gratifyingly, seeing more and more research under development by our non-research faculty. And many of those who are conducting classroom research are using surveys to do so. Last week, I wrote a blog post about how to avoid certain problems when developing questions. This week, I want to focus on the actual IRB application.

As you all are aware, before you can conduct any human subject research, you must have submitted an application to the IRB and have received an approval. This approval may indicate that your project is exempt, or that it was approved after expedited or full board review. To make that happen, you need to complete the IRB application (, and submit it to the college Human protections Administrator (who currently is me). But I have noted that there are times when the application is not really completed very well; it will take more than just a few minutes to complete it adequately. Note that certain questions do require some time. Notably, these includes questions 5, 8, 9 and 11. Each of these questions has multiple parts. And each requires some thought- you should think through all the issues that will arise when you gather data.

Question 5: This has parts a through i, and it addresses the project methodology. You wil be asked to provide an hypothesis (for more detailed forms of research) or goals. What are you trying to do in your project? You will need to describe your methods, and it will not be sufficient to simply provide a one-word answer such as “survey.” Of whom? Via paper or internet? Provide detail here. Who will be surveyed? How are they to be selected? How will your data be analyzed? Will you be using descriptive statistics or more rigorous statistics? How long will the study last? HO w will you protect participant confidentiality? How will you use the study results- for a paper? For presentation at ACC-RAC? All of these questions require some thought and some detail in being addressed.

Question 8: This asks about the participants, what are the inclusion and exclusion criteria and who is to be involved. You will be asked about age range, gender and ethnicity; if students, your answer should reflect that. You will also be asked to describe your relation to the students, as well as risks or benefits- for surveys, normally there are few to note.

Question 9: This deals with your data sources. For surveys of students, students are obviously the source of the data. So, the question will ask you to note how you are de-identifying the information to protect student anonymity. And if you are involving patients, it asks about HIPAA protections.

Question 11: This addresses how you plan on recruiting your participants and how you plan on collecting informed consent. In most surveys, many of which are found exempt, student willingness to participate is seen as consent. But in some research, you must have an informed consent form for participants to sign. We can help you determine which might be the case.
Finally, please note that the final page requires a supervisor’s signature. We cannot process without it.

I stand ready to help prepare this document, as well as plan research. Just let me know.

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