IV210 - USM

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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)
 
 
       The policy of the University of Maryland System is to
  respect and protect the rights and welfare of individuals.  In
  the conduct of research, actions of the University of Maryland
  System 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 of Maryland System and its constituent
  institutions will also conform to applicable federal, state, and
  local laws and regulations.
 
       In accordance with this policy, all University of Maryland
  System research activities which involve human subjects,
  regardless of the level of risk forseen, 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. Multiple Project Assurance document,
  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 of Maryland System or its constituent
  institutions and to any such activity performed elsewhere by
  faculty, students, or employees under University of Maryland
  System auspices.
  
       To carry out this policy the University of Maryland System
  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
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