Many researchers may be initially intimidated at the thought of working with an IRB. The truth is that IRBs are put in place to make sure your study is the best and most ethical it can be. Working with an IRB is not a scary thing, instead it is a great opportunity to improve your study and ensure maximum efficiency and appropriate ethics.
What is an IRB?
An Institutional Review Board (IRB) works to minimize the risks for study participants and ensure that those risks are reasonable. The IRB uses a risk versus reward analysis for each study, making sure the dangers are appropriate for the potential reward. They are also in charge of ensuring that the selection of participants is ethical and that informed consent is obtained and properly documented for each participant. The FDA and the Department of Health and Human Services (HHS) also have many monitoring rules in place, so the IRB board is tasked with ensuring that the principal investigators are able to monitor a study’s data. But perhaps their most important job is to ensure the safety of all of the study participants and that their confidentiality is protected.
Every accredited research organization maintains an IRB. A principal investigator must submit a research plan, called a protocol, to an IRB for approval prior to the conduct of the study. The IRB also monitors the study design itself, and guarantees that the research group performs an accurate cost to benefit analysis.
Why is an IRB important?
The IRB has been set up in order to maintain rules and ethics in research, especially on humans. Even recent studies in the United States have pushed the boundaries of what is ethical and what is not. The triplet study in the 1960s separated three triplets at birth in order to test the unsolved question; is nature or nurture a more deciding factor in seeing how a child will behave and grow up? This study drew criticism over the fact that the study director, Peter B. Neubauer, separated the children at birth without telling the biological parents and failing to inform the boys. They only found out by two of the triplets attending the same college; they eventually found the third through a newspaper article. Many academics today believe that the study never would have been allowed to go forth if he was working with an IRB, and the doctor most likely would have been sued for malpractice today. You can read more about the triplet study here.
When you are working with an IRB, you should be prepared to answer a multitude of questions about your study. One of the main questions that the IRB will ask is whether or not your technology’s contribution to society will be significant enough to be worth whatever risk you are taking. In simpler terms, is this research worth the risk?
Some other common questions you should ask yourself before getting involved with the IRB are: How is my risk measured? Do I need to test vulnerable populations like children or the elderly? Is my study high-risk or minimal-risk? What are the most important practices?
Lessons Learned: Research Protocols and Ethics
Keep in mind these pointers when working with an IRB:
- Remember that you are the expert of your own research.
- That being said, it is also important to learn how to communicate that research with others. How will you show others the goals and benefits of what you have set out to test? The IRB needs to understand everything you are trying to accomplish.
- When dealing with the IRB it is important not to see them as the enemy.
- When meeting with them make sure you take notes and revisit them often. They want to see your study succeed, just as you do. But, they also want it to meet all of their guidelines. Don’t try to be defensive with them, you don’t want to start on the wrong foot.
- Remember that not every study is the same.
- What may be easy for another research group could be difficult for you.
- Find studies with similar work to compare with yours to see what works and what doesn’t. If you find similar past studies it many be worthwhile to find contact the study researchers to find out what worked best for them and what they might have changed in dealing with the IRB.
- Organization and timelines are important.
- The IRB can tell when a researcher is not organized or not considering their originally drafted timelines. You want to make sure that you stick to your plan, or adjust according to setbacks with open communication and honesty (not only with the IRB, but also with yourself.
- Make sure you follow all of the IRB’s suggestions and protocol or you will risk many delays.
- It is not worth it to do something “your way” when you will most likely have to redo it to the board’s liking anyway.
- Keep in mind this important question throughout your study: Will my work advance science?
- Using objectivity, keeping in mind human rights, and recognizing the difference between facts and theory will all help you understand whether or not your research will further society in some way.
- Know the IRB members and their roles.
- Getting to know them personally and doing your research will help you when talking with the IRB. You need to know who might take more convincing to support your study and who you know will immediately understand its benefits.
- None of the members want you to fail, they want you to consider every single aspect of your study.
Data security is the most important job of a protocol. Statistical design can help with data security. Whether it be randomizing data while collecting it or just randomizing subject IDs, there are many ways that you can incorporate a statistical methodology in your study. You want to ensure the confidentiality of your participants at all times. You can seek out someone with statistics experience to help randomize and protect your data.
Avoid collecting information or extra data just because you think you might need it later. Trying to do everything at once might seem efficient in the short run, but in the long run it could even delay your study. If you think you are being rushed, you may need to reevaluate your timeline. It is usually better to split up the study and take smaller amounts of information at a time, especially if that information will be used for separate analysis.
Assembling a Team
Before you create a team for your study you should ask a few important questions to yourself: Who can help you with your methodology? Do you have the right equipment? Does your staff embody all that the study needs? Do you have a timeline for everyone? Does anyone need clearance? This question is especially relevant when working with agencies like the Department of Defense (DOD). Assessing your own personal strengths and weaknesses is also important when formulating a team. If you are an expert in statistical reasoning you might need a team member who’s an expert in medicine or another field. It’s impossible for you or your team member to do everything themselves, especially in an interdisciplinary study.
Designing a Study
Study design is one of the most important parts of creating a study, especially involving human participants. There is no one-size-fits-all when it comes to study design. Before creating a study you need to ask yourself multiple questions: Has your goal been reached by others in the past in the correct way? What mistakes have been made before you tried to create your own study? What’s your population and how will you create a sample from that population? Who will benefit from the findings of your study? Could it be done better with a simulation instead of risking human lives?
The answers to these questions might seem overwhelming but it is important to remember the impact a study might have on an individual participant. That is why IRB boards are put in place; they want to make sure that your study has an outcome that will help society more than the potential risk you are taking.
PICOT is a great acronym to keep in mind when working with an IRB. Below are some of the steps to consider on your journey working with an IRB:
P – Patient/Population/Problem. You want the IRB to know that the participants are your first priority. You don’t want to refer to them as ‘data’, it may make you seem like a ‘Frankenstein doctor’.
I – Issue/Intervention. Make sure you think of confounding variables for your study. If you are a new PI make sure to contact other researchers in the field in order to strengthen your study from the get-go.
C – Comparison. Asking for help from researchers in the same field or PIs from older studies is important to make sure that your study does not repeat past mistakes.
O – Outcome. Brainstorming with teammates will help you envision your outcome easier. Make sure that everyone is on the same page and that everyone has a final goal in mind.
T – Time frame. Creating and sticking to a time frame is an important part of every study. Making sure that you are organizing and every member of your team is on the same page will help you stick to this time frame.
Sometimes the most important, yet most difficult, part of a study is proving that your particular methods are adequate, and that you have enough experience to be able to understand the data. The likelihood that everyone on the IBR board is a statistician is low; this means that you will need to display the information in order to convince everyone else as well.From a statistical standpoint it is important to understand how many variables you will be testing early on. Different methods will apply in each case.
Tests with a single variable may address whether a certain probability model fits the data or whether a population parameter (like the mean) equals a specified value. Tests for two variables address whether there is association between variables or whether one variable is different between groups. You also need to understand whether or not the study variables are categorical or numerical.
Always keep in mind that you have to share this information with other people, so make sure it is easily understandable or there is a clear way to display the information. Also remember the importance of sample size. Using a large sample size is important for precise findings, but that might not be easily done. Trade offs between sample size and time constraints or data loss are common. In terms of data analysis it is also important to have a back-up plan for whichever type of analysis you plan to do. Don’t oversell your analysis because it could change at any point.
Frequently Asked Questions
It depends on the study and the board. The range for studies approved by an IRB are usually around 1-2 years. It depends on how many studies the IRB oversees and what the details of your particular study are.
It may take up to 3 years to finalize your statistical methods. This of course depends on your level of experience. In the beginning of your career it might be harder for you to develop statistical methods but once you have done it a few times it will come more naturally.
Most likely no. You will most likely need a lot of help in that regard and in that case you might want a statistician on your team.
You might need a medical research monitor or someone in a particular field on staff. If the IRB has any indication that you might not know something they could suggest a monitor for you and your team. That individual will possess the necessary credentials for whatever field they’re in (like a medical doctor).
Dr Analee Miranda is an applied mathematician with 15 years of experience. She first learned about statistical methods at the Air Force Research Lab (AFRL) in the Sensors Directorate program, where she worked for 6 years. There, she tested on participants in order to develop a non-Doppler biometric radar system. In recent years, she has been teaching math and statistical work to scientists and engineers.