If you’re in this part of the journey, you have likely successfully defended your research proposal and are now submitting it to your Institution’s Review Board or the IRB for short. Excellent work, friend!
Why do I need IRB Approval?
Obtaining IRB approval is an essential step in your research for a few reasons:
Conducting unsanctioned research is one way to ensure you will NOT complete your degree.
Gaining IRB Approval is one step that safeguards your study design from adversely impacting study participants (you know, fellow living, breathing human beings).
Applying for approval helps you focus your study concretely, giving you a better sense of what will happen once approved, though I suspect this is a secondary gain.
What is the IRB?
Representative image of a doctoral candidate submitting their study application to the IRB.
It’s not so much what as it is a who, or more accurately, several whos.
According to the US Department of Health and Human Services (USDHHS), an institutional review board is a group of scholars charged with “reviewing research proposals to ensure that every study involving human subjects upholds all federal, state, and institutional regulations. They also ensure that studies are considered ethical and protect your study’s participants (or subjects).” This oversight group can also run under the banner of Ethics Review Committees.
Concerning the makeup of these committees, a few regulations are in place to ensure group diversity and that members possess the relevant professional experience to serve meaningfully. Here are a few guidelines that IRB member selection needs to involve, according to the USDHHS:
The Common Rule – there must be at least five members of varying backgrounds
The IRB must include the perspective of a scientist
The IRB must consist of the view of a non-scientist
The IRB must involve the perspective of someone not affiliated with the institution
As a group:
The IRB must be “sufficiently qualified” in research experience, relevant expertise, and variance of the membership.
“Variables that may contribute to IRB group diversity involve training, educational background, race, gender, cultural background, and community attitude sensitivities.”
As a point of note, IRBs may be a smaller subset of an institutional Human Resources Protection Program Department. These larger departments are found in organizations that conduct much human research.
Fun Fact: educational institutions are not the only organizations where you’ll find an IRB. The American Psychological Association notes that institutions that receive federal funding and conduct human research are beholden to IRB research governance. This restriction includes medical research concerning humans. For this reason, you’ll also see the Food and Drug Administration (FDA) pop up when learning about IRBs.
What does the IRB do?
A IRB hand protecting a study participant from harm.
In a nutshell: IRBs protect human participants (people). That’s it. How they do it and what they protect participants from requires a little more explanation. This group of researchers, both within and outside of your organization, reviews research study plans to ensure that subjects will not endure harm from participating in a study. Here’s an excerpt from the FDA explaining what IRBs do from their POV:
“Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.”
Why do we need them anyways?
No one here assumes a researcher intends to hurt other people, but without oversight, they could still unintentionally hurt people. Don’t believe me? Sadly, a quick review of past research incidents clarifies why research oversight is needed. Let’s look at these examples that show why supervision is required to protect people when conducting research.
From a limited research foray, it looks like the ethics of research conversation began in the early 1600s when Francis Bacon posited that “scientific research should benefit humanity” (Resnik, 2022). Though the declaration seemed promising, bad actors warranted the creation of a safeguards system.
Instead of covering every instance in robust detail, here’s a non-exhaustive shortlist of incidents involving human endangerment, biased study results reporting, and theft from Resnik’s article featured in the National Institute of Health’s publications:
1796 – Edward Jenner attempted to immunize an eight-year-old James Phipps with “fluids from a cowpox pustule.” Phipps contracted a cold afterward but recovered from the procedure. While nothing tragic happened here, this experiment notes the risk inherent in specific types of research.
1885 – After a rabid dog bit nine-year-old Joseph Meister, Louis Pasteur gave him an experimental vaccine for rabies but did not test it on animals first. At the time, he was practicing without a license.
1897 – Five patients were injected with the yellow fever bacteria without having given consent by Giuseppe Sanarelli. The patients all contracted the disease, and three died from the experiment.
1909 – Robert Millikan failed to accredit his student or fully report the results of his oil drop experiments but still received a Nobel Prize for his research.
1932 – 1972: Tuskegee Syphilis Study – “A US dept of Health, Education, and Welfare study did not disclose to the participants, 400 African American men, that they were study participants and withheld vital treatments for those afflicted with the disease.”
1939 – 1945: The Nuremberg Doctors’ Trials - In 1946, Nazi doctors were “tried and convicted of conducting horrible and demonstrably unethical experiments on Holocaust concentration camp prisoners.” Experiments included exposing people to freezing temperatures, low air pressure, radiation, electricity, infectious disease exposure, wound healing, and surgical studies. The extent and malice of this study led to the creation of The Nuremberg Code, which served as a foundation to prosecute scientists for their crimes.
1944 – 1980: The US Department of Energy sponsored a study that exposed people, unbeknownst to them, to radiation. This sample included cancer patients and pregnant women.
The list goes on, but you get the idea. Without research oversight, people could be hurt or shortchanged, and inaccurate reporting could lead to distrust in academic research. It’s clear that research integrity and sound ethical practices must be protected.
What is the IRB Application process like?
Two doctoral candidates applying to the IRB.
The application is relatively straightforward:
Step 1: Complete the pre-requisite research training.
Step 2: Draft your Consent Form
Step 3: Fill out the Application Form
Attach your Appendices
Step 4: Wait for the application, either an approval, a request to revise, or a denial
The first step in this adventure may occur before your proposal defense. This work involves taking training courses and receiving a certification regarding the safeguards and requirements for conducting human research. The program I went through was run by the Collaborative Institutional Training Initiative (CITI), and the program was the Social and Behavioral Research – Basic/Refresher curriculum. I accidentally took a more involved certification than required to finish my dissertation. After a quick check-in with the IRB, they approved the longer course as suitable to continue, so all-in-all, it was a happy accident.
The training reviewed the history and procedures concerning human research, including:
the Belmont Report and its Principles
Faculty Advisors
Students in Research
Federal Research Regulations
Assessing Risk
Informed Consent Procedures
Privacy and Confidentiality
Internet-Based Research
HIPAA Privacy Protections
Vulnerable Subject Groups
Conflict of Interests in Human Subjects Research
The curriculum was hosted online and took about 4 hours to complete from start to finish. Overall, the tone and cadence of the courses are what you likely would expect if you’ve ever completed an asynchronous course online.
The following task concerns creating your research consent form. This form will be reviewed and given to each prospective participant so they are aware of the following:
The purpose of the study and what it’s looking to examine (Note: unless this is approved with an allowable deception, but this usually occurs only in specific fields, and IRB approval for such studies is narrower from my understanding)
The procedures involved in participating
The benefits of the study
The costs or incentives of participating (Note: this is not allowable in most studies due to a conflict of interest.)
People that are conducting and assuming responsibility for the study.
Confidentiality statements
Policies regarding the protection of their personally identifiable information (PII), risks they would incur from participating in the study
The use of the information
Voluntary participation statements
There are two main types of consent forms, and creating the right one will be pivotal when applying to the IRB. The first is an Implied Consent Form, and the other is an Informed Consent Form.
Implied consent is as it sounds, you include the forms for participant review before conducting any research, and the record acts as a notification of the study details; however, signatory authorization from the participant is not required. Informed consent involves all of the same information BUT requires the participant to sign the form in agreement with their permission. Check with your chair to determine the most appropriate form for your study.
Other elements you’ll need to prepare prior to applying involve any qualifying questions to ensure you get the participants you’re looking for, including demography questions and your interview questions if you are conducting a qualitative study using the interview process.
From here, you’re on to step 3, applying for IRB approval. This step will vary by institution and discipline; however, you’ll likely need to complete a form. Make sure you read the directions twice and check all the details. This protective measure will increase your odds of a successful application. Your dissertation chair and you will need to sign the form. After the form is filled out correctly, you’ll need to attach proof of your certification, your consent form, your prequalifying questionnaires, and your interview or survey questions in the appendix of the application. Again, it’s best to check everything before sending it off.
Extra Research Approval Fun-ness You May Encounter
If you are surveying faculty or staff in your institution, an additional approval step or two may be involved. Work with your chair to see if studying institutional staff is allowed and, if so, what other procedures may happen to gain approval. For example, if I were to recruit participants at my place of study. I would have needed to send an approval form to the Vice President of Academic Affairs and gain their approval in addition to the IRB before conducting the study. Once you have done it all and confirmed you have correctly satisfied the requirements with your chair, it’s time to send off your complete application to your IRB, and then the wait begins.
Possible Outcomes of Your IRB Application
There are likely four possible outcomes for your application, and pending the verdict will determine what you do next:
Approved – Phenomenal job! This verdict means you are now “All systems go” to recruit your research subjects and gather data.
Minor Revisions Required – You still did great! Make those tweaks, resubmit, and assuming you did it correctly, you should be good to go (but wait to hear that from the IRB first, don’t take my word for it.)
Revisions Required – You’re doing good; the IRB may have determined something is either amiss or could adversely impact participants in your study as it’s currently designed. Work with your chair to make the necessary changes and resubmit.
Justification for Non-Approval – In this case, much information is missing, or the study presents as problematic to participants. Don’t lose heart; I know it’s disappointing. Take some time to process, and when you’re ready, review the feedback and adjust accordingly.
Once you receive approval from the IRB, it’s time to gather that glorious data. In the next post, we’ll discuss data gathering and some challenges you might encounter. Until next time!