What is an IRB? § 46. 102
An Institutional Review Board (IRB) is a committee designated by an institution and established in accordance with Title 45 to review, approve the initiation of, and conduct periodic reviews of research involving human subjects. The primary purpose of such review is to ensure the protection of the rights and welfare of human subjects.
After ethically questionable biomedical studies, such as the Tuskegee study in the 1930s, IRBs were implemented to prevent unethical treatment of human subjects. IRBs follow established regulations put forth by the Department of Health & Human Services, the Food and Drug Administration, and/or the Department of Justice.
Office for Human Research Protections maintains regulatory oversight of human subjects research which falls under Title 45. OHRP also provides clarifications, guidance, educational programs, and educational materials relative to human subjects research.
The IRB has the authority to review, approve require modifications, disapprove, and terminate studies that involve human subjects.
Additional information can be found HERE
What is Research?
Research is defined as ” a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge... ” (45 CFR 46).
University System of Maryland Policy on Human Subjects of Research
Human Subject Research
“(Approved by the Board of Regents April 25, 1991; Amended by the Board on June 23, 2006; Amended by the Board on December 12, 2008; Amended by the Board on April 12, 2013)
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). 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 that 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 accordance with procedures outlined in recognized documents, e.g. Federal Wide Assurance (FWA) and/or applicable regulations and policies including other policies adopted by the System or an institution.
OFFICIALS OF THE SYSTEM OR AN INSTITUTION MAY NOT APPROVE RESEARCH INVOLVING HUMAN SUBJECTS THAT HAS NOT BEEN APPROVED BY AN IRB.
HOWEVER, OFFICIALS OF AN INSTITUTION MAY DISAPPROVE RESEARCH THAT HAS BEEN APPROVED BY AN IRB; IRB APPROVAL IS NOT THE ONLY APPROVAL
REQUIRED FOR THE CONDUCT OF HUMAN SUBJECTS RESEARCH.
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 that 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 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 System of Maryland 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.
An institution may rely upon an external IRB for review and approval of research if (a) the institution’s responsible official, identified in its FWA, approves the use of the external IRB and (b)the external IRB meets federal standards, as determined by the responsible official.
NO OFFICIAL OF THE SYSTEM OR A CONSTITUENT INSTITUTION SHALL TAKE ANY ACTION INTENDED TO INFLUENCE OR COERCE AN IRB, OR ANY OF ITS
MEMBERS, TO APPROVE SPECIFIC RESEARCH.
Replacement for: BOR VII-5.00″
