Q: What is the IRB, and should I care?
A: 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).
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 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.
Q: What are the different categories of review?
A: 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
Q: What happens when I submit my application?
A: 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).
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. 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.
Q: What if I have questions?
A: 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.)