Human Subjects Research Protection and Institutional Review Board
Columbia College maintains an Human Subjects Research Protection (HSRP) policy and administers its Institutional Review Board (IRB) based on the Common Rule (i.e., the Code of Federal Regulations 45 CFR Part 46 , and see Yosemite Community College District Policy 4-8074).
All actors intending to gather data at or through Columbia College are referred to as Investigators. The lead Investigator is the Principal Investigator. No Investigator should conduct research involving human participants at Columbia College without receiving prior approval from an IRB, no matter the inferred or intended level of participant risk. If the research project is supervised by another IRB, Investigators must still seek Columbia College administrative approval.
Columbia College does not currently maintain a standing IRB, and cannot fully assess HSRP risk independently, but may defer to an external IRB following Single Institutional Review Board (sIRB) guidance in the Common Rule.
Seeking approval: Investigators whose research is supervised by another IRB should contact the Director of College Research and Planning using the contact information to the left prior to conducting any research. The Director will request all existing IRB materials, including project proposals, final IRB applications, approval letters, consent forms and procedures, and research instrumentation. The Director will screen these materials in due diligence to protecting the rights and welfare of college community members, but with the intention of deferring to the existing IRB. If the Director finds that the assessed level of risk to potential research participants determined by the external IRB is consistent with the materials submitted, the Director will provide administrative approval. In some circumstances, the Director may recommend or require additional administrative approvals, for example in cases where the intended research participants are college employees and would participate during working hours, or where the proposed research might conflict with other District or College policies. The turnaround time on responding to such requests is roughly 2 to 3 weeks.
Frequently Asked Questions
What are the primary purposes of these guidelines? The primary purposes are to ensure as little risk possible to individual research participants, to provide an ethical standard of research involving human participants, and to maintain compliance with federal law.
When does it count as “research?” According to the Common Rule, research is “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to the generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes” (§46.102(l)). This is a broadly applicable definition that is not limited by rule-of-thumb distinctions like academic vs. non-academic research, or of classroom vs. non-classroom research.
What if I'm a college or district employee collecting information for internal evaluation? Typically this type of activity would not be considered as "research," and although it should be designed ethically and sensitively, it would not necessarily require the same type of review. At the same time, innovative on-site programs often lead to interesting results that might be shared outside of the institution, such as at a regional conference. In such cases, internal evaluations would be subject to the same considerations as other types of research.
What is a determination of risk to research participants? There is no such thing as a risk-free research study, but the most commonly anticipated level of risk for projects conducted at Columbia College is referred to as “minimal risk.” Minimal risk studies are those that might ask questions or gather information ranging from benign to sensitive topics, but which also provide a clear and forthright description of the study, often via an informed consent document which explains the purpose of the research and what to expect by participating in the research, explains how each participant’s personal information and responses will be protected, and explains participants’ own rights and responsibilities when deciding to participate. “Moderate” and “severe” risk studies are typically more invasive, and might involve more potential for personal harm. Studies designed to test different methods of behavioral intervention or medical treatment, for example, are commonly identified as higher risk studies, and require greater complexity in terms of mitigating risk to participants. Studies that involve sensitive populations, like children, persons living with cognitive limitations, and incarcerated persons, are also generally treated as higher risk even when the study content is benign because such persons might have less capacity to make informed decisions about their participation, or might be more subject to coercive participation.
If my study formally counts as "research" based on the definition above, but is pretty basic, can I determine its risk level on my own, or just skip the process? No, this determination must be made by an IRB.
Does a determination of minimal risk mean that my study is “exempt” from established ethical standards of practice, like providing an informed consent document? The term “exempt” is often applied to studies that are determined to be at minimal risk, but this is because they have been reviewed and met a threshold where such ethical standards have been met. The exemption status typically means that projects can be supervised directly by a designee of the IRB (e.g., the IRB Chair) and do not need an additional layer of review by a full Institutional Research Board (IRB), but it is also the case that the full IRB would remain apprised of the designee's activities.
- What if my study is supervised by another institution with its own IRB? This is quite common. A good example is a dissertation researcher supervised by the IRB at their home institution. This is referred to as cooperative research, or research where multiple institutions have a stake in mitigating participant-risk. The most recent version of the Common Rule allows that research studies can be supervised by a single IRB, and so Columbia College will broadly defer to the determination of risk made by the primary supervising institution. However, this does not release Columbia College from its responsibilities to protect the rights and welfare of its community members, nor does it release investigators from their requirement to receive approval from the college prior to beginning any research, as described above.