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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