The IRB Approval Process: A Complete Guide
9 minute read
Getting Institutional Review Board (IRB) approval is a critical part of conducting psychology research. Since psychologists do research on humans, they must take care to treat their participants with dignity and protect their rights. An IRB is a group of people who deeply consider the study that a psychologist wants to run and determine if it is ethically sound. If the study meets their inspection, then the psychologist receives approval to do the research.
Unfortunately, psychology has a history of unethical studies because there were no regulations as to what types of experiments that psychologists could run. Perhaps the most infamous were the Milgram experiments, where the researchers asked participants to shock another participant until the point of serious injury or even death. The participants were later told that there was actually no other participant in the study and that they hadn’t hurt anyone. However, the participants were deeply distressed at what they had done. These experiments, along with other infamous ones like Zimbardo’s prison experiment, drove the development of IRBs. Now psychologists who are conducting research at the university level must get IRB approval before beginning their research.
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As a high school student, whether or not you need to get IRB approval depends on your research goals. You may want to get your research published in a scientific journal or submit your project to a research competition, like the ones I wrote about here for psychology and neuroscience. In these cases, you need IRB approval. However, if you want to publish your result in a different medium, such as a blog post, then you do not need IRB approval. Regardless of whether you need approval, you should consider the points that I cover below to make sure your research is ethical.
Navigating the IRB approval process can be tricky in the beginning, so here is a detailed list of each part of the IRB approval form. An IRB wants to see that you put thought into every section. I also want to emphasize that you must wait to hear back from the board and receive approval before beginning your research.
Compiling a List of Researchers
You’ll need to list all of the researchers involved, no matter how big or how small of a role they have in your study. Different universities have varying requirements for the training that researchers need to complete. For example, I had to complete the Citi Training. Additionally, you will have to indicate one researcher as the PI (Principal Investigator), who takes responsibility for running the study. As a high school student, the PI will most likely be your research mentor.
Detailed Study Design
You need to have all of the study details planned out and communicate these details to the IRB. First, you’ll give a high level description of what participants will do in your study. You’ll also attach a series of documents so that the IRB knows every single detail of the study. For example, if you are conducting an online experiment, you’ll include all of the screens of the experiment, as well as the specific wording you’ll use in recruitment messages and follow-up emails with participants.
In addition to this exact wording, you’ll also provide details of how you will recruit participants. What platform will you use to recruit them? How long will the study take and how will you compensate them for their time? You will also indicate which types of participants will be included or excluded from your study. You may only want to recruit participants of a certain age demographic, and of those participants you’ll exclude those who don’t meet some criteria. Also, as a heads up, participants physically located in the European Economic Area (EEA) are protected by the General Data Protection Regulation (GDPR). The GDPR has stringent rules on what researchers must do to protect participants’ data.
Special Populations List
Speaking of participant recruitment, you have to indicate if any of your participants will be members of vulnerable populations, specifically, minors, prisoners, or pregnant women/fetuses. You must take special care to protect members of these populations. If you want to include minors as participants, then the parent/guardian must sign the consent form on behalf of the minor. I will discuss consent forms later in the article. Additionally, if the minors are old enough as determined by the specific IRB you are using, then you must give the minors an assent form, which is “is specifically designed to simply indicate that the minor is willing to participate in the study and understands what he or she will be expected to do as part of the study.”
In regards to prisoners’ rights, you need to make sure not to coerce prisoners. Coercion means giving participants unreasonably high compensation for participating in the study, thereby limiting the amount of agency they have in deciding to participate. Prisoners have limited access to economic resources, so paying them too much money is a type of coercion.
And of course, you want to make sure that pregnant women/fetuses stay safe during your study. For example, I once participated in a study where I received very mild and completely safe electric shocks. If I had been pregnant, I doubt that I would have been able to participate.
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Risks and Benefits
You will also indicate the potential risks of participating in your study and how you will mitigate and address those risks. Psychology studies can be distressing, so often there will be emotional risk. To address this risk in an IRB form, the magic words are “this study will cause no more than minimal risk to participants.” In other words, you’ll need to explain why your study, at most, will cause participants no more distress than they would experience in their regular lives. If your study is more than minimal risk, it will be harder for you to get IRB approval. You will need to justify why you are running the study. Less common types of risk for psychology studies are social, physical, and financial.
Relatedly, you’ll also list the potential benefits of the study to the individual and society as a whole. For example, you can describe how your participants will learn something about themselves by participating in your study. You can also discuss how your study will add to the knowledge in your field, help people in the “real world”, or both.
Confidentiality / Privacy Plan
It is very important that you keep your participants’ data confidential and private, and you should communicate to the IRB that you have a specific plan for doing so. Use password protection on any cloud software and physical devices that store data from the study. You may also need to encrypt your files when transferring data, depending on how sensitive your data is. Never release any personally identifying information (PII) about your participants, even if you later make the dataset publicly available for researchers to use. PII includes information such as their name, address, email, phone number, etc. To make sure that I never release PII, I just never collect this information in the first place!
A consent form tells participants the details of the study and asks them to sign if they want to participate. The form discusses what they should expect to do during the study, how much they will be paid, how long it will take, what risks or benefits they may experience, etc. With a few rare exceptions, all participants 18 or older must sign a consent form before participating in your study. (Parents/guardians must sign on behalf of their minor, as mentioned earlier.) Additionally, in a consent form, you must explicitly say that participation is voluntary and participants can withdraw from the study at any time without penalty. You also have to include information so that participants can contact the researchers if they have a question about or issue with how the research is being conducted. In the IRB form, you will have to answer additional questions about how you will protect the rights of participants if you are getting consent from non-English-speaking subjects or adults who are unable to consent.
At the end of the study, it is nice to tell participants what the study was about! The debrief statement is a few paragraphs written in plain, non-technical language that tells the participants what you were studying. It may or may not be required for your particular study - that depends on the IRB.
However, if you deceive the participants in some way, then the IRB will almost always require that you include a debrief statement. “Deceive” sounds harsh, but the reality is that sometimes you’ll have to *bend the truth* in a consent form or somewhere along the study. For example, you may tell participants that the study is researching a different topic than the one that it is actually researching. Research deception can be uncomfortable, but remember that deception is often necessary from a research perspective. It is important that participants don’t know what you’re studying, or they may alter their behavior. In a debrief for a study that involves deception, you’ll need to explain exactly how you bent the truth and why it was necessary for the study. Participants should also receive information about how to contact the researchers if they have follow-up questions.
Phew, that was a lot! The good news is that once you’ve filled out an IRB form, it becomes very routine to fill out any subsequent ones.
IRB Approval Response
After you’ve submitted an IRB form, here is what to expect from their response. The response time of an IRB varies by institution and by the complexity of the study. They may list the expected response time on their website. Submit your study early so that you have enough time to wait for their response and conduct your study. The IRB may approve your study immediately, or they may also approve it with modifications. (I’ve never gotten a study completely rejected, although I suppose it is possible if you present them with a really unethical study.) For example, I once conducted a study to encourage participants to exercise more. The IRB approved my study with modifications. I needed to include a few lines about how you should contact your doctor before starting a new exercise program to make sure that participants didn’t overdo it and injure themselves. Then, I sent the IRB the revised consent form that included this information, and they fully approved the study.
Of course, after submitting your IRB form, you may realize that you need to change something in your study. This is normal and fine. You simply submit a modification form to the IRB indicating what you would like to change. Remember that you have to wait for their approval of the modification before you run the study with that modification!
It is essential that psychologists at the university level gain approval from an IRB before conducting their research. High school students may or may not need IRB approval depending on their individual goals. Admittedly, filling out IRB forms can feel a bit tedious and monotonous, but protecting participants' rights is important and when you submit work for consideration through your college applications, it matters whether you’ve followed due process! Make sure that you consider all of these aspects before conducting your research.
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