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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