Q: What is the IRB and should I care?
A: IRB stands for Institutional Review Board. We are a committee of interdisciplinary faculty and non-faculty tasked with the review of research prior to its conduct, to ensure the protection of the well-being and rights of participants. Unfortunately, the history of research is littered with examples of the violation of human rights. Federal guidelines regulate IRBs to prevent the unethical treatment of human participants. Prioritizing the fair and ethical treatment of potential research participants is a top priority for us as members of a Christian community of researchers. We apply these federal standards to all of our research, believing that we are following the example of Jesus in caring for his people, especially the least of these (e.g., those most vulnerable to the violation of their human rights).
Q: Does my research require IRB approval?
A: IRB approval is required for projects that meet the federal definitions of research and human participants. Please refer to these definitions in the handbook. Projects that do not meet these definitions is subject to the ethical standards of their field and not to IRB review and approval. Note that failing to be defined as “human participant research” is not a statement about the quality of the scholarship, but rather a statement about the federal definitions for human participant and research.
Q: What happens when I submit my application?
A: Per the handbook, after you email your full and complete application to email@example.com, you should receive confirmation of receipt of your application within one or two business days. From there, your application undergoes a pre-review, checking for completeness (e.g., are all required documents included, is the formatting correct, are all the questions answered). If elements are missing, the application is returned for correction. Once a complete application is received, it is forwarded to the committee for review. Applications that are exempt-status or expedited are reviewed on an as-received basis. Researchers can expect to hear back from the IRB within 2 to 3 weeks from the final submission date. Applications that require full board review are subject to the review cycle of the committee, as posted under the meeting calendar.
Q: How do I prepare a successful IRB application?
A: After review of an application, a researcher can receive one of three responses: approve as is, revisions required, or disapproval of research. Most applications require revisions, often minor clarifications. Some, however, require extensive revisions, considerably lengthening the review process. To avoid the lengthy revision process, researchers are advised to consider the following:
• Pay special attention to the informed consent documents. There is a checklist of required elements included in the IRB handbook; your consent form should clearly address each of those points, as relevant to your research. Items should only be excluded if they are not relevant (e.g., all research has potential risks and benefits—basic elements 3 and 4—not all research involves risks if the participant should become pregnant during the tenure of the study—additional element 1). If you are removing an element of informed consent (alteration of consent) or are not planning to collect participants signatures (wavier of documentation of consent), this needs to be justified in the application.
• Proofread all applications. Remember your audience is interdisciplinary; eliminate unnecessary jargon while maintaining technical accuracy. An IRB application is a professional submission and the quality should match that expectation.
• Describe all elements of the research process fully and clearly. Your IRB application should include every step of your research process such that someone who did not write it could conduct the study exactly as you intended. (Don’t worry, the IRB is confidential and the details of your application will not be released.)
• Include all necessary documents.
• Remember that IRB review focuses on a key principle: the risk-benefit ratio. It is okay for a research project to have risk, so long as it is communicated clearly and the potential benefits outweigh it. If the potential benefits are small (e.g., minimal scientific merit of the study), then any risks are potentially too many risks.
Q: What if I have questions?
A: Check the handbook. Although not many people enjoy reading handbooks, the IRB handbook was written specifically with you, a researcher, in mind. Please take time to review the requirements in the handbook before creating your application. Some IRB proposals include elements that are explicitly prohibited in the handbook and cannot be approved for that reason. Please prepare prior to your engagement with the IRB application by reading the IRB handbook. If you still have questions, please reach out to us at firstname.lastname@example.org. We are here to help! (Also, if you searched the IRB handbook for an answer and were unable to find it or the answer you found was confusing, please share that feedback with us. We take your comments seriously and actively work to clarify and simplify the process while maintaining the integrity of the IRB office and responsibilities.)