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1992.06.03 :  Office of Research Integrity

Contact: Bill Grigg (202) 245-6867
June 3, 1992

       The Public Health Service announced today that it is
establishing an Office of Research Integrity to administer the
PHS program to deal with allegations of research misconduct in
PHS-funded research.
       James Mason, M.D., HHS assistant secretary for health and
head of the U.S. Public Health Service, said, "Scientific
misconduct is rare, but we are determined to address PHS
responsibilities justly and effectively when allegations occur. 
The new office will be responsible for handling misconduct
allegations in a manner that assures fairness to all parties and,
in particular, provides necessary protections, including the
opportunity for a hearing, to the accused scientist."  
       The plan for the new organization was developed in
partnership with the National Institutes of Health, and involves
combining NIH's existing Office of Scientific Integrity and an
existing PHS-level office, the Office of Scientific Integrity
Review, into a single office reporting to Dr. Mason at the PHS
level.
       A major feature of the new organization is an opportunity
for a scientist to request an independent hearing if the PHS
proposes to make a finding of research misconduct.  Such hearings
will be conducted by a panel appointed by the HHS Departmental
Appeals Board, which reports to the secretary and is independent
of the PHS.
       This reorganization establishes a clear separation of the
investigative and adjudicative functions, an essential feature
for assuring an objective and fair process.  The hearings will
provide an accused scientist access to evidence presented by the
PHS, the right to be represented by an attorney throughout the
proceedings, to question any witnesses presented by the PHS, and
to present witnesses and evidence in rebuttal of the charges.
       Dr. Mason also said, "The new organization and the new
policies that will flow from it will not change the fundamental
principle that outside institutions receiving PHS research funds,
such as universities and medical schools, have the primary
responsibility for addressing allegations of research
misconduct."  When PHS funds are involved in a research
misconduct investigation, the institution must report its
findings to the PHS.  In most circumstances the PHS will not
conduct its own investigation, and will rely on the institution's
findings.
       The Office of Research Integrity will have responsibility
for dealing with allegations of research misconduct in all
research supported or performed by PHS agencies.  These include
NIH, the Alcohol, Drug Abuse and Mental Health Administration,
the Centers for Disease Control, the Agency for Health Care
Policy and Research, and the Food and Drug Administration. 
However,  because of its special responsibilities as a regulatory
agency and its extensive investigative capacity, FDA will
continue to conduct its own investigations of alleged misconduct
in FDA regulatory research under its bio-research monitoring
program.
       The new organization will continue the existing Public
Health Service Advisory Committee on Research Integrity, an 11-
member panel of non-government experts in science, science and
academic administration, law and ethics.  The advisory committee
will continue to meet regularly and to provide advice to the
secretary and to Dr. Mason on research integrity policy matters.
       Dr. Mason named as interim ORI director, J. Michael
McGinnis, M.D., currently deputy assistant secretary for health
and director of the PHS Office of Disease Prevention and Health
Promotion.  
Dr. McGinnis has degrees in political science, medicine and
public policy from Berkeley, UCLA and Harvard.  His recognitions
include the government-wide Profile in Excellence Award and
Arthur Flemming Award, and the Distinguished Service Medal of the
U.S. Public Health Service.

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