Institutional Review Board

Date: March 2009

Supersedes: n/a

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Purpose

The purpose of the Institutional Review Board (IRB) is to ensure that the College is in compliance with federal and other external constituents’ guidelines and standards for conducting research on human subjects at the College. The establishment of the IRB is to ensure that any individuals associated in research either directly or indirectly with the College are protected. Not only will the establishment of this entity guard the rights of individuals, it will also assure that proposals submitted for review are in compliance with federal regulations.

Policy

To assure the protection of human subjects and to comply with Federal law including the 45 CFR 46 statute, Montgomery County Community College 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.

The Institutional Review Board will be registered with the United States Department of Health and Human Services Office for Human Research Protections (OHRP).

Procedure

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 for Research 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.

The IRB consists of a minimum of five members to include the Director of Institutional Research and Assessment, a representative from Student Affairs, a faculty member with expertise in scientific research, a faculty member with expertise in social science research, and a member external to the College. The Director of Institutional Research and Assessment serves as the chair. IRB members are required to undergo human subjects training.

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

The IRB is responsible for:

1. Reviewing 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).
2. Insuring that vulnerable populations, risks to individuals, and risks to the College are properly protected before granting approval for the research to begin.
3. Reviewing copies of informed consent to be given to research participants where applicable.
4. Ensuring that prior approved research projects continue to be updated for review.
5. Terminating and/or suspending projects when misconduct in research is reported and/or confirmed.

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.

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.