Faculty Handbook - Part III Policies, Procedures and Services Protection of Human Subjects in Research
|History:||Issued -- December 11, 2006|
|Additional References:||Policies and Procedures for Human Research Protection|
|Responsible Official:||Associate Provost for Research
The Catholic University of America fosters a research environment that promotes the respect for the rights and welfare of individuals recruited for, or participating in, research conducted by or under the auspices of the University. In the review and conduct of research, actions by the University will be guided by the principles (i.e., respect for persons, beneficence, and justice) set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (often referred to as the Belmont Report) and will be performed in accordance with the Department of Health and Human Services (HHS) policy, and regulations at 45 CFR 46 (also known as the "Common Rule"). The actions of University will also conform to all other applicable federal, state, and local laws and regulations.
II. Designation of Institutional Official
The University will designate an Institutional Official who has overall responsibility for the University's human research protection program. The duties of the Institutional Official are as follows:
A. Be responsible for compliance with institutional policies and all applicable regulations for the protection of human subjects.
B. Be the signatory authority for the Federal-wide Assurance to the Office of Human Research Protections.
C. Provide support to the human research protections program within the means of the institution.
In the performance of these duties, the Institutional Official has the authority to delegate such activities as may be necessary in order to fulfill these duties.
III. Institutional Review Board
To conduct its responsibility effectively, the University maintains an Institutional Review Board (IRB) to review research protocols involving human subjects. The IRB is an autonomous administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the University. The IRB has the following authority:
A. To approve, require modifications to secure approval, or disapprove all research activities overseen and conducted under the auspices of the University;
B. To suspend or terminate approval of research not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to participants;
C. To observe, or have a third party observe, the consent process; and
D. To observe, or have a third party observe, the conduct of the research.
All IRB approved research studies are subject to ongoing review, which must be conducted at least once annually by the IRB. If approval by the IRB lapses, all research activity must stop unless the IRB finds that there is an over-riding safety concern or ethical issue involved such that it is in the best interests of individual participants to continue participating in the research interventions or interactions.
The IRB has jurisdiction over all human subject research conducted under the auspices of the institution, regardless of funding source. Research under the auspices of the institution includes research conducted at this institution, conducted by or under the direction of any employee or agent of this institution (including students) in connection with his or her institutional responsibilities, conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or involving the use of this institution's non-public information to identify or contact human subjects.
Appropriate officials at the University (The President, Provost, General Counsel, Vice Provost for Graduate Studies, or the Institutional Official) may review any research protocol and have the right to disapprove the implementation of a research protocol that has been approved by the IRB. However, no one at the University shall approve the implementation of any research protocol nor may it override the decision of the IRB concerning a research protocol that has been disapproved by the IRB.
All institutional and non-institutional performance sites for the University, domestic or foreign, will be obligated by this policy to conform to ethical principles which are at least equivalent to those of this institution or as may be determined by the Department of Health and Human Services (DHHS) Secretary.
The Institutional Official and the IRB shall adopt operating procedures to implement this policy. These procedures shall serve as the governing procedures for the conduct and review of all human research conducted under the auspices of the University.
formatting checked 9/18/13 - VAL