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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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