IRB FAQs

IRB stands for Institutional Review Board. We are a committee of multidisciplinary faculty and non faculty tasked with reviewing research before its conduct to protect participants' well- being and rights. Unfortunately, the history of research is littered with examples of violating participant rights and well-being. 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).

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 are 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 about the federal definitions for human participants and research.

The different categories of review provide a framework for organizing research. Differences between the Exempt, Expedited, and Full Board review categories generally refer to the level of risk involved in the study. Differences within these categories (e.g., Exempt 1 versus Exempt 2) refer to the specific design of the research proposal. Carefully and accurately select your category so that we can have IRB members with relevant expertise participate in reviewing your application. In addition to the handbook, Health and Human Services has provided a series of decision tree charts to help researchers determine whether their research requires IRB and, if so, what review category. You can access those decision trees here:

https://calbaptist.box.com/s/zvgbnag1wrg4jn1rf3wi8d8hdvpllf3u

Per the handbook, after you email your complete application to irb@calbaptist.edu, 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 three weeks from the final submission date. Applications that require full board review are subject to the committee’s meeting schedule (approximately twice a month during the traditional academic year and as needed during summer months).

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. A checklist of required elements is included in the IRB handbook; your consent form should address each point as relevant to your research. Items should only be excluded if they are irrelevant (e.g., all research has potential risks and benefits—basic elements 3 and 4 in the checklist—not all research involves risks if the participant becomes pregnant during the study's tenure— additional element 1 in the checklist). Justification for the removal of an element of informed consent (alteration of consent) or for not collecting participants' signatures (waiver of documentation of consent) needs to be included in the application.
• Proofread all applications. Remember your audience is multidisciplinary; eliminate unnecessary jargon while maintaining technical accuracy. An IRB application is a professional submission; 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 so that someone who did not write it could conduct the study precisely as you intended. (Don’t worry; the IRB is confidential, and your application details will not be released.)
• Include all necessary documents.
• Remember that IRB review focuses on a fundamental 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.

Check the handbook. Although few people enjoy reading handbooks, the IRB handbook was explicitly written with you, a researcher, in mind. Please review the requirements in the handbook before creating your application. IRB proposals that include elements expressly prohibited in the handbook and cannot be approved. Please prepare before you engage with the IRB application by reading the IRB handbook. If you still have questions, please reach out to us at irb@calbaptist.edu. We are here to help! (Also, if you searched the IRB handbook for an answer and could not 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.)