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  IV-2.10- UNIVERSITY OF MARYLAND SYSTEM POLICY ON HUMAN SUBJECTS OF 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)
 
	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 
       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. Federal Wide Assurance 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 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 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 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. 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