An Institutional Review Board is a committee designated by an institution to review, approve the initiation of, and conduct periodic review of research involving human subjects. Human subjects research also includes research that only involves the analysis of identifiable private information on living individuals. The primary purpose of an IRB review is to help assure the protection of the rights and welfare of human subjects. Investigators also share the responsibility for protecting human subjects.  The ethical principals described in the Belmont Report provide the foundation for the Federal regulations.

University of Maryland System Policy on Human Subjects of Research 

(Approved by the Board of Regents, April 25, 1991) 

The policy of the University of Maryland System is to respect and protect the rights and welfare of individuals. In the conduct of research, actions of the University of Maryland System and its constituent institutions will be guided, to the extent that they are applicable, by principles as set forth in such nationally accepted documents as the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Ethical Principles and Guidelines for the Protection of Human Subjects of Research (April 18, 1979). Actions of the University of Maryland System and its constituent institutions will also conform to applicable federal, state, and local laws and regulations. 

In accordance with this policy, all University of Maryland System research activities which involve human subjects, regardless of the level of risk foreseen, require review and approval, prior to the initiation of the activity. An Institutional Review Board (IRB) shall have jurisdiction over all reviews and approvals in accord with procedures set forth in recognized documents, e.g. Multiple Project Assurance document, [see Footnote] and/or applicable regulations and policies including other policies adopted by the System or an institution. Those research activities in which human subjects may be exposed to more than minimal risk must be reviewed at a convened meeting of an IRB; other research activities may be reviewed in the manner determined by the IRB under its procedures. An individual is considered to be at more than minimal risk if exposed to the possibility of harm -- physical, psychological, social, legal, or other -- as a consequence of participation as a human subject in any research activity which departs from the performance of routine physical or psychological examinations and tests, or which departs from established and accepted procedures necessary to meet the individual's needs, or which increases the probability or magnitude of risks ordinarily encountered in daily life. 

This policy applies to all research activities and to all educational development, training, and improvement or other related activities containing a research and development component. Furthermore, it applies to any such activity performed on the premises of the University of Maryland System or its constituent institutions and to any such activity performed elsewhere by faculty, students, or employees under University of Maryland System auspices. 

To carry out this policy the University of Maryland System institutions will maintain a sufficient number of IRBs with appropriate membership to provide for adequate reviews. The IRBs will have the authority to approve, to require modification as a condition of approval, and to disapprove proposed activities that are covered by this policy. Furthermore, the IRBs will have the authority to determine whether or not any activity is covered by the policy and whether it requires review by an IRB. 

Footnote:  The Multiple Project Assurance was replace with a Federalwide Assurance

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