Author: Kathryn Lynch, OMSIII, LECOM Erie
Updated: Dec 26, 2023
There are many steps to obtaining IRB approval for your research study. They are as follows:
The first item on your to-do list when starting a research study is finding something you are passionate about! Study a topic that piques your interest. You will be spending countless hours and energy on your research, so it should be something you enjoy learning about. It will also help you speak more enthusiastically about it when it comes to presenting at a conference or talking about it when interviewing. How do you know what you are interested in? Ask yourself these questions: What am I passionate about? What do I like to read about? What have I found in clinical practice that needs improvement? What are my questions regarding a specific research study, process, or medical treatment/intervention?
Once you have identified a topic, the next step is to do preliminary research. Determine a gap in the literature or clinical practice. Avoid repeating studies as it is a waste of time, money, and other resources. In today’s ever evolving field of medicine, we cannot afford to spend time on repetition. While conducting your literature review, ask yourself the following: Has a study been conducted on this topic before? How can I modify pre-existing studies without reinventing the wheel? (In other words, how can I adapt a pre-existing study to investigate what I want to find?)
The literature review is also a great time to begin constructing your own idea. Start drafting the research proposal, decide what type of study you will need to conduct, consider what your study population could be, what might your interventions include, and what timeline will you need to accomplish it all?
Once you have come up with a plan, you need to identify a research mentor. This can be accomplished with a simple Google search. Reach out to those within your institution or on LinkedIn. Other great resources can be found in your own backyard, whether it’s within your hometown hospital or through your professional, or even personal, networks. Perhaps you do not know anyone who directly works within the area you wish to research; however, networks spread far and wide so ask for assistance. You never know who one of your colleagues or superiors knows. It only takes one “yes” in a sea of “nos” to make your idea come to life.
Once you find your research project mentor, it is time to determine your need for the Institutional Review Board (IRB). The IRB is an administrative body used to protect the rights and wellness of research subjects. The basic rule is as follows: any research involving human subjects must be evaluated by an IRB prior to initiation of the study. All hospitals and universities should be connected to an IRB. Sometimes, it is contracted out. For example, my hospital utilizes a local medical school’s IRB for clinical research evaluation while it utilizes an out-of-state IRB for its non-clinical research. Be prepared for a lengthy review process. Some IRBs only convene once or twice monthly to review proposals, so plan for these delays.
Once you have identified who the IRB is and what it needs, it is time to start writing the proposal and gathering all the requested forms. Each IRB will have specific specifications for what should be included in your proposal. Typical proposals for clinical research might include the following: title of the project, identification of research personnel (principal investigator, study coordinator, etc.), project goal and alignment with institutional goals, project design, estimated sample size, location/department in which the project will be completed, resources required, summary of evidence-based literature review, project aim/objectives, hypothesis, methods, study duration, participant inclusion/exclusion criteria, outcomes/measures, and consent process.
Once you have written your proposal and edited it (never forget to edit), it is time to submit for IRB approval. Double-check all forms for completion. You will more than likely need to complete and submit your CITI certification, as well, at this time. Once your packet is submitted, it is time to wait.
Within the next few weeks, you will receive notification of a preliminary decision. Typically, you will be required to revise your original proposal and answer any additional questions the board has posed to clarify your study and ideas. Questions and revisions will be presented in a numerical (or other organized) format. Answer the questions in the same format as received and re-submit all requested paperwork.
Upon final approval, congratulations! It is now time to start your research study. The IRB exists to protect research subjects and may also need to be reconsulted for changes made to the study’s timeline or processes. Be prepared for delays and plan for them. While the IRB exists to ultimately protect research subjects, it also exists to assist the researchers in doing what is best for their subjects and ensuring safe outcomes to further advance the medical profession.