StATS: Submitting a research protocol to the IRB (created 2004-07-29).

I usually just watch and advise as others submit research protocols to our Institutional Review Board (IRB). But now I might end up having to submit one myself. I want to perform a secondary data analysis on a data set that was collected several years ago. It should be an educational experience. If I do learn anything valuable, I'll put it on this weblog.

One excellent suggestion I heard is that you should treat the IRB submission as the first draft of the publication that you will eventually send off to the New England Journal of Medicine. Since you don't have ESP, you can't write the results section just yet. But you can write the sections on background, significance, and methods and you can supply most of the bibliography.

One of the most important roles for the IRB is to assess the value and information that this research is expected to produce and balance it against the risks, discomforts, and inconveniences imposed on the research subjects. I talk a bit about scientific validity and IRB review on my web pages, and this weblog entry will give me an opportunity to expand on this topic.

Here are some of the questions that our IRB asks on their submission form:

Here's where it gets interesting.

I need to write more about conflict of interest. I've mentioned this topic in my web log entry on February 25, 2004. Here, the IRB is probably most interested in financial conflicts of interest.

This project has not had prior review. The IRB wants to make sure that the scientific value of the study outweighs the risks to the research subjects. If research comes from a funded NIH grant, then that represents an endorsement of the scientific merit of the study. That doesn't mean that the IRB won't also look at the scientific merit, but it does provide them with some level of assurance of the quality of the scientific goals of this research.

I'm going to argue that this study is exempt because it only involves the use of anonymized data that already exists.

The objective of this study is to examine factors that influence infant weight loss between birth and discharge from the birth hospital in a sample of infants who were discharged with their mothers. The primary outcome variable is percent weight loss. We will look at factors like the type of delivery, the age of the mother, and so forth. We also want to investigate factors that influence whether a lactation consultant was assigned to the new mother.

I'll need a bit of help for this section, as I am not the subject matter expert. We should probably write a couple of paragraphs: one on the background and one on  significance. A bibliography of any related research in the area will also be useful.

The IRB needs this information to help decide if the problem we are studying is worthwhile and will provide useful information to clinicians and/or researchers in this area.

This is a bit less relevant, perhaps, because the data was already collected, but I'll spend some time explaining how the sample was collected. This is a cohort of mothers and children recruited from 14 hospitals in the Kansas City metropolitan area.

Again, this just provides an opportunity to review the process by which the data was collected. If the IRB wants me to change any of these details, perhaps they will offer me a time machine.

Again, this reviews the basic process of the previous research. There was no randomization and no treatment in the study. There are groups (boy babies versus girl babies, young mothers versus old mothers), but these groups do not represent the predominant focus of the research. We just wanted to characterize the factors that influenced breastfeeding for new mothers in the original study and now we want to also characterize the factors that influence weight loss between birth and discharge from the birth hospital.

The original data collection involved an interview with the mother at the birth hospital, a review of the medical records of the birth, and a telephone follow-up call seven to ten days after birth.

This is important to specify for this project, because the risk of a confidentiality breach is the only serious risk in this study. I will show that all important direct personal identifiers (name, address, medical record number) and indirect identifiers (birthdate and zip code) have not been collected or have already been removed from the data set. This is a very important issue in general and I have a web page about confidentiality and privacy concerns.

There are no drugs in this study, of course, but if there were, the IRB would need to know if this was an already approved drug or one that is currently under investigation.

The same issues apply for new medical devices.

We are not physically intervening with these subjects in this study. If we were, we would describe this investigational procedure in detail.

There are no financial obligations in this study. For those studies where this is an issue, the IRB is concerned with whether some of the financial obligations might create a conflict of interest and also whether undue financial burdens are being imposed on the research subject.

This is obviously research not involving greater than minimal risk. The category of risk will determine the level of IRB review as well as whether one or both parents need to provide permission.

As I further prepare the IRB submission, I will update this page. I may also add a few links the help to further clarify the issues that the IRB faces when reviewing research protocols.

This page was written by Steve Simon while working at Children's Mercy Hospital. Although I do not hold the copyright for this material, I am reproducing it here as a service, as it is no longer available on the Children's Mercy Hospital website. Need more information? I have a page with general help resources. You can also browse for pages similar to this one at Category: Ethics in research.