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I. Title of Regulation

Institutional Review Board (IRB)

II. Objective of Regulation

To establish responsibility for the Human Subjects Review Process.

III. Authority

Board Policy 5.0036, Institutional Review Board

IV. Regulation Statement

In accordance with Board Policy 5.0036, Brookdale Community College will establish and maintain an Institutional Review Board (IRB) for the protection of human subjects. The IRB shall have seven members (appointed by the Executive Vice President for Educational Services), with varying backgrounds, to promote complete and adequate review of human subjects research activities conducted by the institution. The membership should be sufficiently qualified through experience and expertise, and sensitive to such issues as race/ethnicity, gender, and cultural differences. The Executive Director of Planning, Assessment, and Research (PAR) and Registrar shall serve as ex officio members. The IRB is assigned the responsibility to review research projects sponsored by, or associated with, Brookdale Community College.

Specifically, that includes all proposed research projects that have either or both of the following characteristics:

1. The subjects of the research project will be College employees and/or students.
2. The research project will be conducted by College employees and/or students.

Projects with these characteristics will undergo human subjects review prior to their implementation and also may be subject to human subjects review during their implementation.

Unless “exempt” (defined in next section), all proposed human subjects research will be reviewed by the Executive Director of PAR. He or she serves as the sole human subjects reviewer for projects he or she deems to pose low-level risk to the subjects and to the College in accordance with the Federal Guidelines for Human Subjects Review (Title 45, 5.0036R, Page 2Code of Federal Regulations, Part 46).

When the Executive Director of PAR deems that a project has moderate or substantial risk, or costs, to the subjects or the College, it must be reviewed by the IRB. Appeals of Human Subjects review decisions rendered by the Executive Director of PAR or the IRB may be made to the Executive Vice President of Educational Services whose decisions will be final.

In accordance with the Federal Policy for the Protection of Human Subjects, the following kinds of research are among those exempt from the College Human Subjects review process:

1. Research in educational settings on instructional techniques, curricula, or classroom instructional techniques.

2. Research involving the use of educational tests, survey procedures, interview procedures, or observations of public behavior unless

a. the subject can be identified, and disclosure of the subject’s responses could put the individual at risk of criminal or civil liability or
b. the results could damage the subject’s financial standing, employability.

3. Student academic assessments conducted by the College or course instructors.

4. Research involving the use of existing data, documents, records, etc. if these sources are publicly available or if the information is recorded by the investigator in such a way that subjects cannot be identified directly or through identifiers linked to the subjects.

V. Responsibility for Implementation

Executive Vice President for Educational Services
Proposed Lodging by BOT: May 2009
Approved: BOT 6/11/09