Institutional Review Board (IRB)

Purpose

The College of San Mateo Institutional Review Board (IRB) is charged with reviewing non-exempt research and making recommendations on the ethical and safety status of the proposed research. The IRB serves to ensure that research conducted on human subjects, including both biological and social science inquiries, be ethical and not infringe upon the rights or jeopardize the welfare of the subjects. An IRB is solely about the protection of human subjects in research. The results of the consideration will be forwarded to the President via the Dean of Planning, Research and Institutional Effectiveness.

Membership

• Dean of Planning, Research, Innovation and Effectiveness (PRIE)
• District Research and Planning Councils

Procedures

The IRB reviews proposals for human subjects research to be conducted by employees or students of CSM as well as research projects occurring on the CSM campus, off-campus sites, or virtual classrooms. Exempt status criteria is available on this site for your review. 

To request review by the Institutional Review Board, please provide the following information to the Office of Planning, Research, and Institutional Effectiveness (PRIE):

1. Letter of Intent
• Identify who will be conducting the research
• Give a brief summary of the planned research including its purpose and intended outcomes
• The letter of intent should be no more than a few paragraphs in length
2. Surveys or interview questions
• Provide copies of survey or interview questions to be used in the research
3. Protocol or research plan
• Describe in more detail how the research will be conducted (such as the proposed participant populations, size of study, inclusion/exclusion criteria for participation, recruitment/data collection procedures, timelines, etc.)
• Describe any potential risks to participants
• Describe any anticipated benefits to participants
• Describe how confidentiality will be maintained
• Include any other relevant information that would allow independent determination of whether there is a risk to human subjects
4. Other committee approvals, if available
• Provide copies
• The Institutional Review Board will thoroughly review all information provided by the researcher. Upon conclusion of this review, the IRB will submit a recommendation to the College President. The outcome of the IRB process will be communicated in writing to the person(s) who submitted the research proposal for review.

Forms and Resources

• Elements of Informed Consent
• Sample Consent Form

Additional Information is available from the U.S. Department of Health and Human Services, Office of Human Research Protections (OHRP):

• Decision charts to assist in determining whether a project is human subjects research which must be reviewed by an IRB
• Guidance on Engagement of Institutions in Research

Exempt Status Criteria

At CSM, only non-exempt research is subject to administrative review by the IRB. To qualify for exempt status, the project must clearly meet one or more of the exemption criteria below. Any project may be submitted to the IRB for determination of whether it meets exemption criteria. The following exemption criteria is specified in the Code of Federal Regulations, Title 45, Part 46, Subpart A:

Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. 
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:  (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. 
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. 
4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. 
5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.  
6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Frequently Asked Questions

1. How long does the IRB process take?
   It depends on the time of year and the nature of the research proposal.  Proposals which qualify for exempt or expedited review are usually processed quickly. Proposals which require full IRB review can take a significant amount of time. Researchers are encouraged to submit proposals as early as possible to ensure enough time for review to occur prior to the desired start date for the research project.
2. I am a doctoral student who would like to conduct research involving students at CSM and have already received IRB approval from my home institution.  Do I need IRB approval from CSM?
   Yes. Please submit the IRB approval from your home institution along with your research proposal. The CSM IRB will review the information since you intend to conduct research involving students enrolled at CSM.
3. I believe my research is exempt. Do I still need IRB approval?
   Yes, it is necessary if your research involves human subjects. Please submit your project for review and allow the IRB to make the determination of exempt status