Institutional Review Board
Welcome to the UMES Institutional Review Board (IRB) home page. The purpose of this site is to provide information on the function of the IRB, as well as directions and application materials needed for researchers to complete the application process. We hope you find the information provided helpful and convenient.
News and Notices
What is an IRB?
An Institutional Review Board (IRB) is a committee designated by an institution to review, approve the initiation of, and conduct periodic review of research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects.
After ethically questionable biomedical studies, such as the Tuskegee study in the 1930s, IRBs have been implemented around the world to prevent unethical treatment of human subjects. IRBs are currently regulated by the Food and Drug Administration and the National Institutes of Health's (NIH) Office for Human Research Protections (OHRP). The U.S. Department of Health and Human Services requires University IRBs.
The purpose of the IRB is to inform and protect human subjects used in research. The IRB acts as an advocate for the research subject. This means that the IRB, during its review of a research project and the informed consent, has the right and responsibility to ensure that the research subject is fully informed of the procedures involved in the study as well as the risks and alternative treatments that are available if participation in the study is refused
What is Research?
Research is defined by the U.S. Department of Health and Human Services as " a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. " (45 CFR 46)
When in doubt, contact the IRB Staff to help determine whether a particular project is "research" as defined by the University of Maryland Eastern Shore and by federal regulations.
University System of Maryland Policy on Human Subjects of Research
(Approved by the Board of Regents, April 25, 1991; Adapted from the University of Maryland College Park IRB website)
The policy of the University System of Maryland is to respect and protect the rights and welfare of individuals. In the conduct of research, actions of the University System of Maryland 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; The Belmont Report)." Actions of the University System of Maryland and its constituent institutions will also conform to applicable federal, state, and local laws and regulations.
In accordance with this policy, all University System of Maryland 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. Federalwide Assurance document, 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 the University System of Maryland auspices.
To carry out this policy the University System of Maryland 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.
The UMES IRB would like to sincerely thank the IRB Office at the University of Maryland College Park for their assistance in developing our website.