DHHS Policy Changes, November, 1999
The Department of Health and Human Services operates a collaborative
system for promoting integrity in biomedical and behavioral research supported
or conducted by agencies of the U.S. Public Health Service (PHS). The system
for preventing, detecting, and investigating scientific misconduct involves
cooperative efforts among individual scientists, research institutions,
and PHS agencies, especially the National Institutes of Health. The HHS
Office of Research Integrity (ORI) monitors the system.
Institutions which carry out research funded by DHHS must make assurances
that they have adopted appropriate policies and procedures for handling
allegations of scientific misconduct. These assurances are made with
each application for research funding, and are also supported by yearly
reports made by the Research Integrity Officer.
In 1996, the HHS Secretary convened the Review Group on Research Misconduct
and Research Integrity to examine the system under which the Department
handles allegations of research misconduct, which included a review of
the issues addressed by the Commission. In October 1999, the review group
issued its recommendations, which were accepted by the Secretary. Under
the proposals agreed to:
1. The Department will adopt through rulemaking a new definition
of research misconduct that focuses on improper behaviors related specifically
to the conduct of research. The definition, proposed by the National
Science and Technology Council, will also be adopted by other federal agencies
engaged in research [see box next section]
2. Institutions that administer PHS-supported grants will maintain
responsibility for conducting initial inquiries and investigations when
allegations of misconduct are made. However, when further fact finding
is required by the federal government, it will be carried out by the Office
of the Inspector General rather than the ORI, as previously was the case.
3. Inquiries and investigations into potential research misconduct will
be separated from the decision making process of determining if misconduct
occurred. The ORI will recommend findings and sanctions to the Assistant
Secretary for Health, who will make the final decisions regarding misconduct,
subject to appeal.
4. The Departmental Appeals Board (DAB) will continue to hear appeals
from individuals who contest findings of misconduct. Each DAB appeals panel
will include 2 scientists, and the appeals process will be streamlined
with clarified procedures and rules for conducting hearings.
5. The Department will require research institutions to provide training
in the responsible conduct of research to all staff engaged in research
or research training with PHS funds. This expands an existing NIH requirement
that applied only to research trainees.
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New Federal-Wide Rule Proposed
The Federal Office of Science and Technology Policy has issued a proposed
"Federal Policy on Research Misconduct To Protect the Integrity of the
Research Record" with a request for public comment which will be open until
December 13. This new rule will apply across all federal agencies.
It adopts a definition of scientific misconduct that is consonant with
the one recently adopted by HHS (see box) and also incorporates most of
the procedural changes included in the new HHS policy.
New Definition of Scientific Misconduct
From the proposed "Federal Policy on Research Misconduct To
Protect the Integrity of the Research Record"
Research misconduct is defined as fabrication,
falsification, or plagiarism in proposing, performing, or reviewing research,
or in reporting research results.
1. Fabrication is making up results
and recording or reporting them
2. Falsification is manipulating research
materials, equipment, or processes, or changing or omitting data or results
such that the research is not accurately represented in the research record.
The research record is defined as
the record of data or results that embody the facts resulting from scientific
inquiry, and includes, for example, laboratory records, both physical and
electronic, research proposals, progress reports, abstracts, theses, oral
presentations, internal reports, and journal articles.
3. Plagiarism is the appropriation of another
person's ideas, processes, results, or words without giving appropriate
credit, including those obtained through confidential review of others'
research proposals and manuscripts.
Research misconduct does not include honest error or honest
differences of opinion.
A finding of research misconduct requires that:
• There be a significant departure from accepted practices of the scientific
community for maintaining the integrity of the research record;
• The misconduct be committed intentionally, or knowingly, or in reckless
disregard of accepted practices; and
• The allegation be proven by a preponderance of evidence.
Other major points covered by the proposed policy are:
• Initial responsibility for investigation lies with the research
institution;
• Multiple phases of the investigation are required, including inquiry,
investigation and adjudication phases, with provisions for appeals;
• Separation of the phases, with adjudication decisions separated from
the inquiry and investigation processes;
• Institutional notification of the agency, which specifies the circumstances
in which the institution must notify the federal funding agency of a scientific
misconduct investigation;
• Safeguards for informants;
• Safeguards for the subject of the allegation;
• Objectivity and expertise of individuals to review allegations and
conduct investigations;
• Timeliness of the inquiry, investigation, adjudication, and appeal
phases;
• Confidentiality during inquiry and investigation.
• Possible administrative actions for those found to have committed
scientific misconduct
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ORI PROVIDES WORKING DEFINITION OF PLAGIARISM
The following was prepared by the Office of Research Integrity to help
researchers distinguish between plagiarism and other issues of contention,
such as authorship disputes.
Although there is widespread agreement in the scientific community on
including plagiarism as a major element of the PHS definition of scientific
misconduct, there is some uncertainty about how the definition of plagiarism
itself is applied in ORI cases.
As a general working definition, ORI considers plagiarism to include
both the theft or misappropriation of intellectual property and the substantial
unattributed textual copying of another's work. It does not include authorship
or credit disputes.
The theft or misappropriation of intellectual property includes the
unauthorized use of ideas or unique methods obtained by a privileged communication,
such as a grant or manuscript review.
Substantial unattributed textual copying of another's work means the
unattributed verbatim or nearly verbatim copying of sentences and paragraphs
which materially mislead the ordinary reader regarding the contributions
of the author. ORI generally does not pursue the limited use of identical
or nearly-identical phrases which describe a commonly-used methodology
or previous research because ORI does not consider such use as substantially
misleading to the reader or of great significance.
Many allegations of plagiarism involve disputes among former collaborators
who participated jointly in the development or conduct of a research project,
but who subsequently went their separate ways and made independent use
of the jointly developed concepts, methods, descriptive language, or other
product of the joint effort. The ownership of the intellectual property
in many such situations is seldom clear, and the collaborative history
among the scientists often supports a presumption of implied consent to
use the products of the collaboration by any of the former collaborators.
For this reason, ORI considers many such disputes to be authorship or
credit disputes rather than plagiarism. Such disputes are referred to PHS
agencies and extramural institutions for resolution.
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New Bureau Policy
Under the new Bureau policy, responsibility for dealing with allegations
of scientific misconduct is assigned to a Bureau Research Integrity Officer
(RIO), assisted by an Associate Research Integrity Officer at each Bureau
affiliate. Persons who have concerns about possible scientific misconduct
may speak to one of these officers confidentially. When an allegation
of misconduct is brought, the Associate RIO and the RIO will confer as
to whether the alleged conduct falls within the definition of scientific
misconduct and whether there is reasonably sufficient evidence to warrant
further inquiry. If both conditions are met, a fact-finding inquiry will
be carried out, by a small committee appointed by the RIO. The inquiry
provides a preliminary review to separate serious allegations from frivolous,
unjustified, or clearly mistaken conclusions which are drawn from observations.
If the inquiry committee finds that a full investigation is warranted,
the Chief Operating Officer of the entity where the misconduct is alleged
to have taken place will appoint a committee to investigate and report
on the allegations. This report will be delivered to the Chief Operating
Officer, who will decide if sanctions are called for.
The policy includes safeguards from retaliation for persons who bring
complaints in good faith, and safeguards for persons accused of misconduct.
The policy also delineates when the Bureau is obliged to report to ORI
allegations that lead to inquiries or investigations. More....
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Who Are the Bureau Research Integrity Officers?
The Bureau Research Integrity Officer is Dr. Robert Weinstein.
He can be contacted at 312-633-3237
For Cook County Hospital, the Associate Research Integrity Officer is
Keith Dookeran, MD, at 312-633-8207
For Provident Hospital, the Associate Research Integrity Officer is
Clyniece Watson, MD, at 312-572-2684.
For Oak Forest Hospital, the Associate Research Integrity Officer is
Henry Andoh, MD at 708-633-4193
For the Ambulatory & Community Health Network, the Associate
Research Integrity Officer is Mildred Williamson at 312-747-7700.
For Cermak Health Services, the Associate Research Integrity Officer
is Jean Kiriazes at 773-869-6575.
For the Cook County Department of Public Health, the Associate Research
Integrity Officer is Steven M. Seweryn, at 708-492-2021.
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See also:
Bureau Scientific Misconduct Policy
What Does Debarment Mean?
Office
of Research Integrity (ORI)
