Keeping Above Board: Dealing with the IRB

As a graduate student, you will be conducting original research. And, if that research involves living people, there’s a good chance that it will need the oversight and approval of an institutional review board, or IRB. Now, this is, in technical terms, some high level shit; you are not going to be drafting the study protocols for your research or interfacing with the IRB. That is your mentor’s job (see my previous articles on just how important that person is). However, if you stick with academic research, chances are good that this will be something you’ll need to deal with at some point. So, if you feel like getting a head start on getting a heads up on dealing with an IRB, then read on.

IRBs are in-house committees whose job it is to make sure that all research involving human subjects meets governmental and institutional requirements. IRBs ensure that research studies are conducted in an ethical and responsible manner and that the rights and welfare of human subjects are protected.

Any research that involves human subjects is likely to require at least the consideration of IRB approval (research involving animals goes through a separate approval board known as an Institutional Animal Care and Use Committee, or IACUC). Examples of research studies that likely require IRB approval include clinical trials, surveys or questionnaires, studies that collect biological samples from human subjects, and observational studies that involve direct interaction with human subjects.

Some types of research, such as studies that only use de-identified data or public information, may be exempt from IRB review. There is actually a labyrinthine, 15-page flowchart that explains what exemptions to this rule exist. It’s generally better to err on the side of caution, however; when it comes to human research, it is most assuredly not better to ask forgiveness than permission. 

IRBs are important for several reasons. First, they ensure that research studies involving human subjects are conducted in accordance with ethical principles, such as respect for persons, beneficence, and justice. This means that human subjects are treated with dignity and respect, that their privacy and confidentiality are protected, and that their participation in the study is voluntary and informed - y’know, your standard safe, sane, and consensual. Second, IRBs help to ensure that the risks to human subjects are minimized and that the potential benefits of the research outweigh any potential harm. This means that researchers must provide a detailed description of the study design, methods, and procedures, including any potential risks and benefits, so that the IRB can evaluate the overall risk-benefit ratio of the study. Finally, IRBs also help to ensure that research studies are conducted in compliance with federal, state, and local regulations and guidelines, including the Common Rule, which is a set of ethical principles governing research with human subjects.

The exact process for IRB review can vary depending on the institution and the type of study being conducted, but generally, the IRB review process includes the following steps: the process begins whenthe researcher submits a protocol to the IRB, which includes a detailed description of the study design, methods, and procedures, as well as any potential risks and benefits to human subjects. The IRB then conducts an initial review of the protocol to determine if it meets the criteria for approval. The IRB may request additional information or modifications to the protocol before approving it. If the protocol is deemed to have minimal risk to human subjects, the IRB may conduct an expedited review, which is carried out by a single IRB member or a small group thereof. If, instead, the protocol is deemed to have greater than minimal risk to human subjects, the IRB may conduct a full board review, which involves a meeting of the entire IRB committee to discuss the protocol and make a final decision on approval. 

Once a study is approved, the IRB conducts continuing reviews at regular intervals to ensure that the study is being conducted in accordance with ethical principles and that the risks and benefits to human subjects remain acceptable. If at any time any adverse events occur during the course of the study, you as the researcher are required to immediately report them to the IRB, which will determine whether any modifications to the protocol are necessary to ensure the safety of human subjects. Likewise, if you anticipate that changes need to be made to a research protocol for whatever reason, those proposed changes will need to be submitted to the IRB for review and approval before they can be implemented.

Working with an IRB requires careful attention to detail and a willingness to address any concerns that may arise. This can sometimes be a complex and time-consuming process, but it is a critical step in ensuring that research studies involving human subjects are conducted in an ethical and responsible manner. When working with an IRB and responding to their feedback, be aware of and keep in mind the relevant federal, state, and local regulations and guidelines that govern human research protection. Don’t treat this like board game night with your buddies where you read through the rules for the first time while trying to play; know the rules before you step up to the table. 

Be proactive in your communications with the IRB. Don’t wait until the last minute for submissions, and don’t wait for problems to arise before you go to IRB. This includes responding promptly to the IRB's questions and feedback and providing any additional information or documentation that may be requested.

Throughout the process, be open to the IRB’s feedback and to address any concerns that they may have in a thoughtful and thorough manner. Keep detailed records of all communication with the IRB, including any modifications to your protocol and any feedback that you receive. This will help to ensure that your study is conducted in accordance with the IRB's requirements and will also help to document your compliance with human research protection regulations.

Finally, if you are unsure about how to respond to the IRB’s feedback or if you have any questions about the human research protection regulations, seek assistance from your institution's research compliance office or from a qualified consultant. When in doubt, ask about.

To sum up, in a world where it feels like you have to jump through a million hoops just to scratch your head, IRBs can feel like just another layer of red tape. It’s important to realize, however, the vital role they play. Human research doesn’t exactly have a spotless track record. IRBs are among the guard rails that work to prevent things like the Tuskegee syphilis study or Stanford prison experiment from happening. When conducting research on human subjects, it’s essential that you work within them.