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Promoting Integrity in Research
Individual | Institutional |
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Handing Misconduct - InquiriesStudy of Inquiry Reports Not Submitted to ORI
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Jurisdiction | Reports |
Jurisdiction established | 9 |
Jurisdiction not established | 12 |
Allegation/No PHS funding | 1 |
PHS funding/No allegation | 1 |
No allegation/No PHS funding | 10 |
Total |
21 |
The allegations that came under PHS jurisdiction were
falsification, fabrication, fabrication/falsification, and plagiarism. The most frequent
type of allegation that did not meet the PHS definition of research misconduct was
authorship disputes. These disputes were presented frequently as plagiarism, but are not
considered by ORI to fall within the PHS definition of plagiarism. Disagreements over
order of authorship or over rights to publish or use ideas among collaborators would fall
within this category.5The other allegations - sloppy
research practices, protocol violations, patent disputes, sabotage of lab resources - may
have been viewed as meeting the definition under the "other practices" clause.
INVESTIGATION WARRANTED
Nine criteria were used to determine whether an inquiry
report contained sufficient information to determine whether an investigation was
warranted. (See Table 2.) Each criterion impacts on the conduct of a thorough, objective,
and competent inquiry. Expertise and conflicts of interest reflect the quality and
objectivity of the individuals conducting the inquiry. Interviewing the respondent,
whistleblower and witnesses and utilizing various data sources provide the information
needed to make the decision whether an investigation is warranted. The analysis provides
the interpretation of the data and logically links the data to the decision. Comments by
the respondent test the decision.
All criteria need not be met in all inquiries. An inquiry
into plagiarism may not require interviews of the whistleblower or witnesses and may not
require expertise in the discipline. A respondent may choose not to comment on the report
because no recommendation for an investigation was made. No one criterion constitutes a
necessary and sufficient condition upon which a decision may be made. The analysis of the
evidence probably comes closest to fulfilling that requirement.
The percentage of reports containing each criterion is
liberally estimated for it includes reports that explicitly addressed the criterion as
well as reports that partially addressed the criterion. The descriptions "partially
addressed" included information that was either redacted, or cited as an appendix or
attachment to the report but not submitted with the report. The absence of information in
the report about a criterion does not necessarily mean that the institution did not take
the appropriate action. It may have been documented elsewhere or not documented at all.
Table 2:Percentage of reports containing some
information on each criterion for evaluation whether an investigation was warranted.
Criterion | Percentage |
Appropriate expertise | 57 |
Addressed conflicts of interest | 29 |
Interview respondent | 81 |
Interview whistleblower | 62 |
Interview witnesses | 47 |
Cited sources of evidence | 81 |
Presented analysis of evidence | 48 |
Provided report to respondent for comment | 29 |
Attached respondent's comments to report | 24 |
Appropriate Expertise
Only 3 (14%) of the 21 reports provided enough information
to indicate that appropriate expertise was available during the inquiry. Appropriate
expertise may also have been utilized in nine (43%) inquiries, but redaction of the
disciplines of the committee members made a definitive determination impossible. Nine
(43%) other reports did not contain any indication that appropriate experts served on the
inquiry panel.
To determine whether inquiry committee members had
appropriate expertise, it was necessary for the report to contain information on the
discipline and research area of the respondent. Five (23%) reports identified the
respondent's area of research; two of these reports demonstrated a match with the
committee membership. Four (19%) reports did not state this information, and 12 (57%) did
not contain sufficient information to identify the discipline of the respondent.
Conflicts of Interest
Six (29%) of the reports discussed possible conflicts of
interest on the part of inquiry committee members. These reports either identified a
conflict and corrected it by substituting an appropriate committee member, or stated that
there were no conflicts. Fifteen (71%) reports did not address conflicts of interest or
whether steps were taken to protect against it.
Interview Respondent
Respondent interviews were reported most often. Thirteen
(62%) reports demonstrated that the respondents were interviewed. However, three
interviews were conducted by the respondent providing written responses to inquiry
committee questions. Interviews may have been reported in four (19%) other reports but
redactions made a definitive determination impossible. The remaining four (19%) reports
did not indicate the respondent was interviewed by any means.
Interview Whistleblower
Nine (43%) reports indicated that the whistleblower was
interviewed; interviews may have been reported in four (19%) other reports but redactions
made a definitive determination impossible. Eight (38%) reports did not indicate the
whistleblower was interviewed.
Interview Witnesses
Witness interviews were represented the least. Seven (33%)
reports indicated that witnesses were interviewed; interviews may have been reported in
three (14%) reports but redactions made a definitive determination impossible. Eleven
(52%) reports contained no information on witness interviews. It is possible that there
were no witnesses to interview in some cases.
Cited Sources of Evidence
Seventeen (81%) reports provided a list of evidence sources
consulted including lab notebooks, interview summaries, grant applications, pre-published
manuscripts, published papers, correspondence, curriculum vitae, slides, computer files,
purchase orders, doctoral theses, personnel file documents, and fellowship applications.
However, these reports did not describe the evidence provided by these sources in detail.
Four (19%) reports provided no specific information on the sources of evidence reviewed.
Analysis of Evidence
The heart of the inquiry report is a reasoned analysis that
links the detailed evidence to the conclusion that an investigation is unwarranted. Ten
(48%) reports provided such an analysis. Eleven (52%) reports did not.
Provided Inquiry Report to Respondent
Five (24%) reports indicated a copy of the report was
provided to the respondent for comment. Sixteen (76%) reports did not include information
indicating whether the respondent was afforded the opportunity to comment. It appears that
many institutions may not provide the respondent with the report for comment because an
investigation is not recommended. However, reports frequently discuss other problems
uncovered by the inquiry that could affect the reputation and position of the respondent.
In some cases, the inquiry report may be given to the respondent by the institutional
official reviewing the inquiry committee report, and therefore, such action is not noted
in the report.
Respondent's Comments Attached to Report
Five (24%) reports included the respondent's comments.
Sixteen (76%) reports gave no indication whether the respondent had commented on the
report. The regulation does not require institutions to make the comments from the
respondent a part of the record. However, those comments are useful in evaluating whether
the inquiry was objective, thorough, and competent.
The number of criteria covered in a report ranged from none
to eight; none covered nine criteria. (See Table 3.) The number of combinations produced
by nine criteria is enormous, so it is difficult to stipulate what combination of criteria
must be covered in a report, particularly when the qualitative implementation of each
criterion is paramount. Nevertheless, reports limited to four or fewer criteria are not
likely to provide sufficient support for a decision on whether to investigate. Reports
covering five criteria are probably marginal
while those including six or more criteria
are most likely sufficient.
Using the scale cited in the above paragraph, the seven
reports (33%) covering four or fewer criteria were deficient; six (29%) reports containing
five criteria were marginal, and eight (38%) reports addressing six or more criteria were
sufficient especially if they included an analysis of the evidence.
Table 3: Number of reports by number of criteria evident in
a report for evaluating whether an investigation was warranted.
Criteria | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 |
Reports | 2 | 1 | 2 | 1 | 1 | 6 | 6 | 1 | 1 | 0 |
COMPLIANCE WITH REGULATION
Besides monitoring the conduct of inquiries to determine
whether they are thorough, objective and competent, ORI also is responsible for ensuring
institutional compliance with the regulation. Therefore, the inquiry reports were analyzed
from a compliance perspective to determine whether they contained information on the nine
regulatory provisions that must be implemented in an inquiry. (See Table 4.) The first
four provisions listed in the table are directly related to deciding whether an
investigation is warranted. The five other provisions are concerned with the length of the
inquiry and the protection of the respondent, whistleblower, and Federal funds.
As expected, the reports provided information on the
provisions related to the conduct of an inquiry, but contained no information on the
required efforts to protect respondents and whistleblowers or the imposition of interim
administrative actions to protect Federal funds. As with the provision on exceeding the
60-day standard, the provisions related to the respondent, whistleblower, and interim
administrative actions may not be implemented in all inquiries because the situation may
not require their implementation, but such situations could be noted in the report. The
compliance information may be missing because the regulation stipulates only that an
inquiry report must contain the evidence reviewed, summarize relevant interviews and
include the conclusions of the inquiry.
Table 4: Percentage of reports containing information on
each regulatory provision.
Provision | Percentage |
Appropriate expertise | 57 |
Address conflict of interest | 29 |
Permit respondent to comment on allegation | 81 |
Provided report to respondent for comment | 29 |
Maintain confidentiality | 19 |
Reasons for exceeding 60-days | 0 |
Restoring reputation of exonerated respondent | 0 |
Protecting position of whistleblower | 0 |
Interim administrative actions | 0 |
Maintain Confidentiality
Four (19%) reports contained information on the steps taken
to maintain confidentiality. Seventeen (81%) reports did not.
Reasons for Exceeding 60 Days
This requirement clearly applied to only the two (10%)
inquiries that lasted at least 2 years. The reports on these inquiries did not contain any
explanation for the time extension. Twelve (57%) inquiries were completed within the
60-day standard set by the regulation.6
The processing time for the remaining seven (33%) inquiries could not be
determined.
The results presented in Table 5 clearly show that the
inquiry reports did not contain sufficient information to determine whether the inquiries
complied with the regulation.
Table 5: Number of reports by number of regulatory
provisions addressed in the report.
Provisions | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 |
Reports | 4 | 6 | 5 | 5 | 1 | 0 | 0 | 0 | 0 |
REPORT LENGTH
Although the length of a report is not indicative of the
quality of the information contained therein, the study indicates that it is very
difficult to adequately present the detailed information required to demonstrate that the
decision not to proceed to an investigation was based on a thorough, objective and
competent inquiry in less than a 5-page report. Fifty-seven percent of the reports
analyzed in the study were less than 5 pages in length while 24 percent were 11 pages or
more. (See Table 6.)
Table 6: Number of inquiry reports by number of pages in a
report.
Number of Pages | Reports |
1-2 | 7 |
3-4 | 5 |
5-6 | 2 |
7-8 | 1 |
9-10 | 1 |
11 or more | 5 |
Total | 21 |
CONCLUSION
This study demonstrated that more than half of the reports
on inquiries that were not reported to ORI were significantly deficient. Fifty-seven
percent did not contain information establishing PHS jurisdiction. Thirty-three percent
contained information on no more than four of the nine criteria used to determine whether
an investigation was warranted and another 28 percent were marginal, covering only five
criteria. Seventy-one percent provided information on only three or fewer criteria for
determining compliance with the regulation. And finally, 57 percent of the reports did not
contain the detailed information required to justify the decision that an investigation is
unwarranted.
These findings suggest that more technical assistance should be provided in the following areas:
1 42 C.F.R. Part 50, Subpart A, § 50.103 (d)(6).
2Institutions are required to report the total number of inquires they conduct each year and indicate whether each inquiry resulted in an investigation.
3One inquiry report was not included in the study because the inquiry was terminated shortly after it began upon the death of the respondent.
442 C.F.R. Part 50, Subpart A.
5ORI provides its working definition of plagiarism in ORI Newsletter 1994; 3(1):3.
642 C.F.R. Part 50, Subpart A, § 50.103 (d)(1).
November 7, 1996
Dear
The Office of Research Integrity (ORI) is conducting a
retrospective study of institutional scientific misconduct inquiries that did not proceed
to an investigation to gain insight into the implementation of the Federal regulation (42
CFR Part 50, Subpart A) by institutions and identify what technical assistance and
educational efforts, if any, ORI may be able to offer to institutions with respect to the
conduct of inquiries and investigations.
We are requesting that you submit the final report and
documentation for the (inquiry or # inquiries) that you reported in the 1994 or 1995
Annual Report of Possible Research Misconduct for which no investigation was reported. The
study will compare the inquiry process actually employed by institutions with the
provisions of the Federal regulation.
In submitting the requested materials, the names of all
institutions and individuals should be redacted to protect the confidentiality of the
proceedings and the privacy of the individuals involved. The material should be submitted
in a plain envelope with no return address. A letter should be sent to ORI under separate
cover indicating your response to this request. If you prefer, ORI will do the redaction.
Study results will be reported as aggregated,
non-identifiable data in the ORI report which will be sent to each participating
institution. The report also will be generally available from ORI upon request, the
results will be published in the ORI Newsletter and the ORI Annual Report.
We would appreciated receiving the materials requested
above by December 15, 1996. Your cooperation with this study is greatly
appreciated. If you have any questions regarding the proposed study, please call me at
(301) 443-5300.
Sincerely,
Lawrence J. Rhoades, Ph.D.
Director
Division of Policy and Education
Interview summaries ____ | Purchase Orders ______ |
Lab notebooks _____ | Animal Use Records ______ |
Computer files _____ | Other Records (indicate) ______ |
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This page last was updated on August 23, 2006
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