105.0 IV-2.10- UNIVERSITY OF MARYLAND SYSTEM POLICY ON HUMAN SUBJECTS OF RESEARCH
 
 
  (Approved by the Board of Regents, April 25, 1991)
 
 
       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.  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.
 
 
 
  Replacement for:  BOR VII-5.00