Institutional Review Board (IRB)

Columbia College Institutional Review Board (IRB) Procedures

Last Updated: November 1, 2024

The Institutional Review Board (IRB) works to protect the rights and welfare of human research subjects participating in research activities conducted under the auspices of the institution.

All human subjects research must be submitted to the IRB and receive notification of exemption or approval before any data collection may begin.

• Research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46.102(d)).
• Use of human subjects: is defined as collection of data through intervention or interaction with living individuals. This includes experimental research as well as data collected through interpersonal communication, including surveys, interviews, and focus groups. (45 CFR 46.102(f)).

If you are proposing research that will be funded in whole or part by grants from the federal government, please contact the IRB to discuss additional requirements. This should be done before submission of any grant proposals.

Activities that do NOT require IRB oversight include,

• Classroom activities solely to fulfill course requirements or to train students in the use of a particular method, technology, of device. Data collected in classroom activities without IRB oversight may not be published or shared outside the classroom.
• Internal data collection for departmental, school, or other administrative purposes (e.g., teaching evaluations, customer service surveys, etc) which will not be published or shared.
• Secondary data analysis of non-identifiable data that cannot be linked to the individual (e.g., use of national datasets with no identifiers).
• Archival research that does not involve collecting data through interaction with a living research subject.
• Textual research that does not involve collecting data through interaction with a living research subject (e.g., literary analysis, or content analysis of extant text or images).

If you have any questions about whether a planned activity could quality as human subjects research, please contact the IRB.

Procedures

1. Each proposed project must identify a Principal Investigator (PI). The PI is responsible for writing and submitting the research protocol to the IRB. The PI assumes the responsibility for the ethical conduct of the project and for the welfare of the human subjects.
   1. Eligible PIs include: Columbia College faculty, Columbia College adjunct faculty, Columbia College staff, or Columbia College administrators.
   2. External researchers should contact the Office of Research and Planning for more information.
   3. Students may not serve as Principal Investigators. Students may be listed as Co-Investigators, but must have an eligible Principal Investigator overseeing the project.

All investigators must complete training on the ethical conduct of research. This applies to anyone who will interact/intervene with participants or have access to identifiable data. Use the following Open Educational Resources (OERs) to review the principles of Responsible Conduct of Research (RCR). As part of the application process, you will be asked to certify that you completed the following material:

• https://ori.hhs.gov/ori-introduction-responsible-conduct-research Complete Chapter 1: Rules of the Road and Chapter 3: The Protection of Human Subjects. You are encouraged to review other material that is relevant to your research.

Other sources that may be of use to you:

• the federal regulations on research (often referred to as the “common rule” https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
• The Belmont Report and other historical documents on which current standards are built https://www.hhs.gov/ohrp/international/ethical-codes-and-research-standards/index.html

[Note: For longer-term planning, it may be worthwhile to look into setting up a training through the Vision Resource Center or offering workshops so that proof of attendance/completion can be provided]

2. The PI will complete the following form and submit it via email to the IRB. The IRB will contact the PI via email if additional information or clarification is needed.
3. The Lead of the IRB or another person appointed by the VP of Instruction will determine which of the following categories the research proposal falls under:
   1. Does not require IRB review: The project does not involve human subject research.
   2. Exempt from IRB review: The project does involve human subject research, but it meets all criteria as an exemption as defined by federal regulation. Only the IRB can determine that that a project is exempt from IRB review; this cannot be determined by the PI.
   3. Expedited Review: The project meets the criteria for an expedited category as defined by federal regulation. The proposal will be reviewed by the IRB Lead or by one or more experienced reviewers designated by the IRB Lead or the Vice President of Instruction.
   4. Full Board Review: The project involves more than minimal risk, uses vulnerable subject populations, or otherwise is not eligible in the exempt or expedited review. In this situation, the IRB Lead or the VPI will convene a committee of qualified reviewers.

4. After determination is made, the PI will be notified by email. Investigators cannot begin their research until notification of approval from the IRB has been received.
   1. Protocols determined to be exempt will receive a Notification of Exemption letter via email to the PI.
   2. Approved protocols will receive a Notification of Approval letter via email to the PI.
   3. If the protocol is rejected or requires changes, the PI will be notified by email and provided with an explanation. The PI is encouraged to discuss the outcome with the IRB Lead to discuss possible revisions to the project.

7. The PI must notify the IRB of any changes to the research protocol before implementing the changes.
8. The IRB will conduct continuing review of previously approved research at least once per year. Continuing review is not required for the following:
   1. Research that was approved on an expedited basis.
   2. Research that completed data collection and the only work remaining is data analysis.
9. The IRB will maintain copies of reviewed research proposals, correspondence with investigators, meeting minutes or other records related to determinations. Records will be retained for at least 3 years after the completion of the research.

What to submit

Email the following to the lead of the IRB (Michelle Sandhoff sandhoffm@yosemite.edu). You may submit this as one file or multiple files.

• Completed and signed IRB Application
• Templates of any recruiting material (e.g., flyers, emails, social media posts, etc)
• Data collection tools (e.g., survey or interview questions, anything participants will be asked to fill out, etc)
• If research involves an external site or organization, letter or email indicating permission from this site/organization to conduct this research.
• Consent form (including any translations to languages other than English)