IRB: Ethics Review

Once your proposal has been accepted, the next step is the Institutional Review Board review (ethics board). The first step is to go to the research center, find the IRB website, and download the IRB application. One of the first items listed is that you need to take a short ethics course online (it is free), I recommend the NIH one. When you are done with the course, save the certificate to your computer, you will need to submit it to the IRB. Double check the IRB website for any relevant information sheets about your population. 

What is the IRB looking for? They want to know that you have thought out every detail of your study. The most common error students make is not providing enough detail, or not being clear in the information provided. As you begin to complete the IRB application, think about each item and consider: will someone unfamiliar with your study understand what you have written? Keep in mind that the board typically does not read your proposal, they rely on the information you provide in your application. 

The IRB is most concerned with your interactions with your participants, so go into great detail in this area. Think through each aspect of your study, some examples: Who will be approaching possible participants? What will they say? What happens to participants at each step of the process? Go into excruciating detail. If you find yourself assuming things (e.g., “I’ll use a room at XX for the interview”) stop and rethink it- do you have permission to use the room? Will it be private? Can people easily get there and find it? Will using the building give the impression that the organization is sponsoring the study? An example, of the last question would be using a church, you would want to be clear that the church is not affiliated in any way with your study. 

Let’s work through a fake study and think through some of the issues in the research methods. Let’s say we want to look at car shopping decisions and the relationship with self-efficacy (self-confidence). The plan is to do a mixed method study, we’ll use a standardized, brief self-efficacy survey and briefly interview the customer (What was your decision at the dealership regarding buying a car? What led you to make the decision that you did?). We decide that we want to use a local Nissan dealership, so first we approach the general manager, John Smith, and see if there is some way to make this work. John is open to the dealership participating but does not want us to interfere with customers in their decision making process. We initially discuss having everyone that speaks with a salesperson complete the 5 question survey. A brief consent form will be included and ask whether a researcher can contact them by phone and asks for their name and phone number. We will then call each customer that agrees and ask our questions. 

What are issues we need to consider? First we need a letter from John Smith stating everything that his people will and won’t do, and any information that the dealership will provide to us (so let’s wait on getting the letter until we have finalized the details). Second, we want to make it very clear that the researchers are not affiliated in any way with the dealership, that the person is not required to participate, and no one will treat them differently regardless of their choice in participating. One issue the IRB is going to have is with the salesperson giving out the survey, which gives the appearance of the dealership sponsoring the study. Is there a way around this? Perhaps at the end of the salesperson interaction he or she could give them a flyer with a link to an online survey (and the consent form) on survey monkey? As a researcher we need to consider that this is going to lower our participant rate, but will make it more acceptable to the IRB. We will probably have to continue the study longer and will need to mention this issue in the limitation section of the paper. 

Let’s consider our study’s inclusion criteria. People may participate if they are 18 years and older and if they are able to read English, which is the language of the survey. We should ask their age at the beginning of the survey. The exclusion criteria are being under 18 and unable to read English.

What other demographics might be a factor in purchasing a car? Perhaps marital status, having children, sharing decision making, employment, income per year? We would want to check the literature, make a decision, and add these into the survey. How will we determine who is interviewed? We will need to preset a rule for this. It could be the first 10 people who agree to be interviewed or if we think marital status is important we could say the first 5 with a partner/ spouse and the first 5 single/ divorced people who volunteer will be selected. The important thing is to select the criteria in advance and stick to it. 

Here is our current method:

1.      Get permission letter from John Smith

2.      Prepare flyer for salespeople with a link in survey monkey

3.      Prepare survey monkey with a consent form, the survey, and ask if person can be contacted for an interview, and have them give their email or phone number.

4.      Have a brief meeting with salespeople explaining the study and that we would like them to give a flyer to every customer, whether they buy a car or not.

5.      Wait to see if we get participants

6.      Contact those willing to be interviewed

7.      Call for interviews, record interviews

8.      Transcribe interviews

9.      Analyze qualitative data, developing coding

10.   Download survey data from survey monkey

11.   Analyze survey results compared to coding

12.   Send results to participants and dealership 

After a month, we only have three participants! We need to rethink our method, some possible options: we could go to the dealership and hand out the flyer personally as the person is leaving the dealership, sometimes the personal contact will help. We could increase the number of dealerships, each will require that we go through the first 4 steps listed above. Whatever, our final decision we will need to complete a “Change of Procedure” form for the IRB (available on their web site).  

A few final thoughts on the IRB process, you may need to go through several revisions of your methods. Work through each of the IRB’s comments and think them through. If you can’t figure out a solution, ask for a conference call with the IRB and your chair and they will brainstorm with you. Again, always be professional in your interactions, they are not trying to delay your progress. They just want your study to be the best one possible that protects you and your participants.  

Next time we will take a look at data collection.