Welcome to the College of Marin IRB webpage. All research conducted at COM involving students or employees or using COM data must be approved by the College’s Institutional Review Board (IRB). The procedures and the stated policies support compliance with FERPA and HIPPA regulations and the U.S. Department of Health and Human Services (DHHS) Title 45 Code of Federal Regulations Part 46 (Protection of Human Subjects). COM's IRB is registered with the DHHS Office for Human Research Protections (OHRP) (#IRB00013155) and has an approved federalwide assurance (#FWA00031547).
COM’s IRB serves to ensure the welfare, rights, and privacy of human subjects involved in research studies. Human subjects include students taking COM classes or participating in activities on COM premises, or faculty and staff employed by the Marin Community College District (MCCD). The IRB verifies that:
- Your research complies with Federal regulations, specifically the CFR45 and the Common Rule for the Protection of Human Subjects (Belmont Report);
- The rights and welfare of human subjects are protected;
- Risks of participating in the research have been considered and minimized;
- The potential for benefits of participating in the research has been identified and maximized;
- All human subjects are volunteers who choose to participate in research only after being provided with legally effective informed consent;
- Your research demonstrates a clear benefit to community colleges, and;
- Your research is aligned with the College's mission, vision, and statement of values.
College of Marin has the right to decline participation in any research study.
The IRB does not evaluate the soundness or quality of the proposed research, nor does IRB approval of a study indicate COM’s endorsement or sponsorship of the study.
The following provides an overview of the COM/MCCD procedures and guidelines for Human Subjects research.
(1) All research involving or pertaining to students or employees conducted by individuals or groups outside the Marin Community College District (MCCD) is subject to COM IRB review regardless of status (exempt or expedited) or approval by an Institutional Review Board from another institution or agency. If an external investigator's institution or agency has an IRB, the research must be reviewed and approved by that IRB prior to COM IRB approval.
(2) COM employees who are seeking to conduct research and/or use existing data and information for publication or public presentation purposes (including doctoral dissertations or master's degree theses, and in some cases, sabbatical research) must go through the COM IRB review process in order to gain approval prior to conducting research. COM employees should not access data or information for their research even though the access may be available through the employee's work responsibility.
(3) There are three types of reviews: Exempt, Expedited, and Full Review.
Exempt petitions are reviewed by the IRB Chair and either forwarded to Committee members with a recommendation to approve, or returned to the investigator with recommended revisions. Projects determined not to meet exempt criteria are returned to the investigator for revision.
To qualify for exempt review, a research project must clearly meet one or more of the exemption criteria specified in the Code of Federal Regulations, Part 46, Subpart A: §46.104 Exempt research.
Expedited reviews are conducted by at least two reviewers. To qualify for review at the exempt level, the proposal must have received prior IRB approval or exempt status at another organization or institution.
Research using human subjects that does not fit into either the expedited or exempt categories are required to be reviewed by the full IRB. All IRB members must review petitions subject to full review. Full review is required when proposed research poses a greater risk to participants, such as medical interventions.
Not Human Subjects Research
Research projects using de-identified individual-level COM data may be considered "not human subjects research," but still must be approved by the IRB. To request a determination of "not human subjects research," please fill out this 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
(4) All investigators must submit the following:
SECTION A: PROPOSAL FORM [LINK]
SECTION B: INVESTIGATOR AND INSTITUTIONAL INFORMATION
SECTION C: INVESTIGATOR COMPLIANCE ATTESTATION
- A copy of the signed human subjects IRB approval letter from the external investigator’s institution or agency
- A copy of all Informed Consent forms and/or procedures that meet 45 CFR § 46.116
- A copy of each research data collection instrument including questionnaires, interview guides, survey instruments, and testing instruments
- A copy of all recruitment materials including content for email notifications
- A copy of your certificate indicating you have completed recent training for research involving human subjects.
Proposals and accompanying materials should be submitted electronically to firstname.lastname@example.org. If you have any questions about conducting research at COM, please contact the office of Planning, Research, and Institutional Effectiveness (PRIE) at email@example.com or (415) 485-9514.
IRB Submission Deadline and Review Dates
Members of the COM IRB
The IRB is composed of five members from diverse backgrounds to ensure a comprehensive and adequate review of research activities. Currently, the COM IRB Committee is comprised of two faculty members from varying disciplines, two college administrators, and one staff member. In the case of a full IRB review, non-voting individuals with relevant subject matter competence may be invited to assist in the review of issues that require expertise in addition to that of the current IRB members. All members of the IRB have received training on the policies and procedures involving ethical human subjects research.
Holley Shafer, M.A., Chair
Planning, Research & Institutional Effectiveness, Non-scientist
Dr. Antonino Cucchiara, Member
Physics/Astronomy Faculty, Scientist
Dr. Marco Gonzalez, Member
Sociology Faculty, Scientist
Jon Horinek, Member
Dean of Enrollment Services, Non-scientist
Alina Varona, Member
Dean of Career Education, Non-scientist
Vacant, External/Community Member