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Administration

Subject: Institutional Review Board (IRB)
Number: 5.15
Date: June 2023
Supercedes: March 2009

Purpose Statement:

The primary purpose of the Institutional Review Board (IRB) is to ensure that the College follows federal and other external constituents’ guidelines and standards for conducting research on human subjects. The establishment of the IRB is to ensure that any individuals who are defined as human subjects research, either directly or indirectly, at the College are protected. Not only does the establishment of this entity guard the rights of individuals, it also assures that proposals submitted for review are in compliance with federal regulations. The IRB seeks to guide researchers in the ethical treatment and protection of human subjects by carefully reviewing all research protocol submissions and through the use of informed consent documentation.

Policy:

45 CFR 46 provides the requirements to follow for the protection of human subjects and in compliance, º£½ÇÉçÇø requires researchers to submit proposals for studies involving human subjects to the College’s Institutional Review Board (IRB) for review and approval prior to commencing with the proposed study. Those researchers seeking to conduct research at the College or recruit the College’s students, faculty, or staff as research populations are not able to solicit research subject participation or begin data collection until they have obtained approval from the College’s IRB. To the extent necessary 45 CFR 46 is hereby incorporated by reference, including but not limited to the Definitions section in 45 CFR 46.102.

The IRB is registered with the United States Department of Health and Human Services Office for Human Research Protections (OHRP) and reviews proposals involving human subjects to ensure that the rights and welfare of research participants are protected. Furthermore, the IRB is responsible for ensuring that any risks to participants have been considered and minimized and that all human subjects choose to participate in research only after being provided with informed consent.

The IRB does not assume the role of evaluating the merits of a research proposal, its design, or the potential contribution of the research to scholarly literature. The IRB does have the responsibility to evaluate if research will be conducted in an ethical matter that complies with established standards. IRB approval of a study does not constitute sponsorship or endorsement of research.

This policy applies to all research activities involving human subjects. All individuals who propose to conduct human subjects research will need to prepare and submit an application to the Institutional Review Board for consideration. In addition, individuals who are submitting a proposal for the stated research will be required to complete an online educational training program which provides the legal and ethical regulations of human subjects’ research. Proof of participation in this training must be submitted to the IRB at the time of application and must remain valid for the course of the study.

This policy applies to researchers not affiliated with Montgomery County Community College who would like to conduct research involving human subjects at the College including students, faculty, staff, and administration. Approval of non-affiliated human subjects research at the college is subject to the IRB’s capacity based on the number of current research projects.

Any unanticipated problems involving risks to human subjects or others as well as any instance of non-compliance with this policy and related regulations must be reported to the IRB Chair within ten working days. Any major violations such as harm to subjects or breaches of confidentiality/privacy, must be reported within 48 hours to the IRB Chair. Violations will be reported to U.S. Department of Health and Human Services, Office for Human Research Protections as required by 45 CFR 46.

The IRB consists of a minimum of five members subject to qualifications of experience and expertise to include the Executive Director of Institutional Effectiveness, the Director of Analysis and Implementation, an administrator (note: a representative from Student Services if the research includes students), a faculty member with expertise in scientific research, a faculty member with expertise in social science research, and a member who is unaffiliated with the College. IRB members serve for a three-year, renewable term. The Executive Director of Institutional Effectiveness serves as the chair. All IRB members are required to undergo human subjects training and maintain a valid training certificate on-file with the Chair of the IRB and Human Resources. All training certificates will be shared with Finance as needed for insurance and liability purposes.

The IRB provides options for Exempt, Expedited, or Full Review for applications, in accordance with 45 CFR 46.

The IRB will:

1. Review those proposals which need to be discussed by the whole board. Exempt or expedited proposals need only be approved or denied by the IRB Chair, however, the Chair may consult with other IRB members as needed.
2. Insure that vulnerable populations, risks to individuals, and risks to the College are properly protected before granting approval for the research to begin.
3. Review copies of informed consent to be given to research participants where applicable.
4. Inform researchers in writing of the decision to approve or disapprove a proposed research activity, or conditionally approve the research protocol with modifications required to secure final IRB approval of the research activity.
5. Ensure that prior approved research projects continue to be updated for review.
6. Terminate and/or suspend projects when misconduct in research is reported and/or confirmed.

A researcher may appeal an IRB decision in writing and request reconsideration of their application. An appeal would require a review by the full IRB at an Institutional Review Board meeting. The IRB does not allow appeals of full IRB decisions, project suspensions, or project terminations, as the IRB has the final authority for approval of proposed research.

Definitions:

Human Subject—a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

Vulnerable Populations in Research – if fetuses (pregnant women), neonates, minors, or prisoners are the focus of the research, the research subjects are a vulnerable populations and additional protections are required.

Exempt from Review—Research exempt from IRB review includes: research conducted in established or commonly accepted education settings, involving normal educational practices; research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior; research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if subjects cannot be identified; evaluation of services; and taste and food quality evaluation.

Expedited Review Procedures—the IRB may use an expedited review procedure for research involving no more than minimal risk, and for minor changes in research already approved by the IRB.

Minimal Risk—the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life.

 

For more information or questions regarding the IRB, please contact irb@mc3.edu.

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Additional IRB Information:

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