June 11, 2004
Chris B. Pascal, J.D.
Director, Office of Research Integrity
1011 Wooten Parkway, Suite 750
Rockville, MD 20852
Re: RIN #0940-AA04 - Public Health Service Policies on Research
Misconduct
Dear Dr. Pascal:
This statement from the Association of Independent Research
Institutes (AIRI) addresses the proposed revisions to the Public Health
Service (PHS) Policies on Research Misconduct (currently at 42 CFR part
50, Subpart A).
The Association of Independent Research Institutes is a nationwide
association of 89 non-profit independent research institutes conducting
peer-reviewed basic and applied research in the biomedical and
behavioral sciences. AIRI institutions are distinct from other
organizations involved in research -- such as universities, hospitals,
and for-profits -- in their organization, mission, and size. Independent
research institutes receive 11% of NIH extramural research grants.
AIRI has a history ensuring that allegations of research misconduct
are taken seriously and dealt with effectively. We have worked to
educate our membership about the importance of this issue through
workshops at our annual meeting and through providing drafts of sample
research misconduct policies to aid and encourage institutions to
develop their own responsible policies.
AIRI applauds the PHS Office of Research Integrity (ORI) efforts to
harmonize the PHS Policies on Research Misconduct with the Office of
Science and Technology Policy (OSTP) Federal Policy of Research
Misconduct. Creating seamless regulatory guidelines and processes
ensures a greater understanding of behavior that is considered
misconduct, and thus a more efficient and balanced resolution of
research misconduct cases.
However, AIRI is concerned that PHS oversteps the boundaries of its
regulatory jurisdiction in the proposed addition to General Policy and
Applicability at § 93.100 and 93.102. Specifically, at § 93.100 (b) we
find no regulatory justification for extension of power over allegations
of research misconduct in research and training that is not supported by
PHS. Additionally, at § 93.102 (a) and in the definition of
PHS-supported research at §93.223, we believe that it is outside the
scope of PHS authority to extend its governance to “activities related
to” PHS research and training. The vagueness of this policy and its
foreseeable broad interpretation goes well beyond PHS interests.
Further, the undue extension of PHS control over plagiarism in Section
93.102 to encompass “any research proposed, performed, reviewed, or
reported regardless of whether the user or reviewer receives PHS
support'' should be withdrawn.
AIRI believes that there is no compelling interest for PHS to force
regulatory compliance on research activities and training programs not
supported by PHS. PHS jurisdiction should be limited to those research
projects and training programs that it supports directly.
Thank you for this opportunity to comment on the proposed
regulations. AIRI is dedicated to the integrity of science and is
committed to upholding the highest standards of research conduct.
Sincerely,
Randall Main
President
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