Academic Medical Centers and
Other Teaching Institutions
January 2013
Research Misconduct
John Dahlberg, PhD
Deputy Director, Office of Research Integrity (DHHS)
Rachel Nosowsky, JD
Acting Deputy General Counsel, University of California
Introduction
The Role of Legal Counsel in Research Misconduct Proceedings
Rachel Nosowsky, Acting Deputy General Counsel University of California
Background
Publicized cases starting in the mid-1970s and into
the early 1980s led to public concern that misconduct
was rampant and neither the government nor universities had any procedures to address it
Health Research Extension Act of 1985 required PHS awardees to
establish administrative processes to review allegations of scientific fraud
NIH issued “Policies and Procedures for Dealing with Possible
Misconduct in Science” in the Guide for Grants and Contractsshortly thereafter and later established an Office of Scientific Integrity
The PHS Office of Research Integrity enforces PHS regulations (last
updated in 2005)
All federal agencies that conduct or support research were
required as of December 2001 to adopt procedures conforming to a single standard issued by the White House Office of Science and Technology Policy (OSTP)
Rules Today Vary by Funding Agency and
Institution
General principles and framework established by OSTP:
http://ori.hhs.gov/federal-research-misconduct-policy
Each funding agency establishes its own rules, typically
following the OSTP framework – for example:
PHS Rules: http://ori.hhs.gov/
NSF Rules: http://www.nsf.gov/oig/misconscieng.jsp Some Other Agencies: http://ori.hhs.gov/federal-policies
Each institution that receives funds must establish
procedures and submit an assurance of compliance
Basics
The misconduct process is:
Quasi-judicial (similar in many ways to the medical staff peer
review process)
Subject to specific procedural requirements designed to assure
due process
Governed by procedural requirements dictated by a
combination of regulatory mandates and local institutional policies
Federal agencies exercise oversight but generally become
involved only if investigations are initiated and, most
intensely, when they conclude
Process Summary
(See supporting materials for details.)
Complaint/Allegation
(may be in any form)
Assessment - Is the allegation one of
misconduct? - What funding is involved?
- Is the allegation sufficiently credible and
specific?
Inquiry
-Reasonable basis (misconduct; funding) - Preliminary evidence indicates the allegation may have substance
Investigation -Preponderance standard applies - Burden on institution to prove misconduct Burden on respondent to prove affirmative defense
Before an Allegation is Made
Become knowledgeable about the regulations
that govern research performed
at your
institution
(state, nonprofit, and other funders
may have different rules)
Familiarize yourself with institutional policies
and practices
Assure the designated Research Integrity Officer,
Deciding Official,
and other research/research
compliance personnel
are knowledgeable
about the regulations and policies consistent
with their roles in the process
Role of Legal Counsel
During/After a Proceeding
Advise research administrators/compliance officials regarding
appropriate treatment of allegations
Manage communications and other interactions with counsel
for (complainants and) respondents; and participate in ORI communications as appropriate
Support RIO, inquirer/inquiry committee,
investigator/investigation committee in managing the misconduct process consistent with regulations and institutional policies – role is as legal advisor and not as a participant in the process
Review inquiry/investigation reports for legal sufficiency
Monitor for and coordinate with related legal issues/processes
implicated by proceeding (e.g., HRPP, animal welfare program, regulatory compliance, grants/contracts management,
John Dahlberg, PhD
Deputy Director
Office of Research Integrity
Today’s Topics
ORI’s mission and jurisdiction
Oversight review by the Division of
Investigative Oversight (DIO)
DIO Forensics and technical assistance:
strengthening institutional findings
Role of institutional counsel: partnering
with ORI
ORI’s Mission
Mission: To promote the integrity of
PHS-supported extramural and
intramural research programs
Respond effectively to allegations
of research misconduct
Promote research integrity
Definition of Research Misconduct
Fabrication is making up data or results
and recording or reporting them
Falsification is manipulating research
materials, equipment, or processes, or
changing or omitting data or results such
that the research is not accurately
Definition of Research Misconduct
Plagiarism is the appropriation of another
person’s ideas, processes, results, or
words without giving appropriate credit
Research misconduct does not include
honest error or differences of opinion
(42 CFR Part 93.103)
Proof of Research Misconduct
Requires
That there be a significant departure from
accepted practices of the relevant
research community,
and
The misconduct be committed
intentionally, knowingly, or recklessly;
and
The allegation be proven by a
preponderance of the evidence,
(42 CFR Part 93.104)
Additional ORI Activities
Administer the Assurance program
Correct or retract research publications
Protect the confidentiality of respondents,
complainants, and witnesses
Protect witnesses from retaliation
(42 CFR 93.300 (d))
Exclude/Debar dishonest investigators from PHS
and Federal agency funded research
Make public findings of misconduct so that
institutions and individuals will be aware of
wrongdoing
ORI lacks jurisdictions for many
types of inappropriate behavior:
some are referred to other agencies
Misuse of human or animal subjects
Misconduct and other complaints
involving FDA-regulated research
Financial mismanagement
Radiation or biosafety hazards
Conflict of interest
Other issues not within ORI’s
jurisdiction:
Honest error or honest differences in
interpretations or judgments of data
Authorship or credit disputes
Duplicate publication
Collaboration agreements or
research-related disputes among collaborators
Intellectual property
Handling Cases of Research Misconduct
Admin. action Allegation Assessment Inquiry Investigation DIO Review Recommendation and ORI determination(s) Settlement or charge letter Hearing Appeal ORI Administrative Law Judge (ALJ) Institution
ORI’s Role in Assisting Institutions
During Its Investigation
ORI’s goal is to provide procedural and technical
assistance whenever asked
ORI has held eleven “Boot Camps for RIOs”
since 2007 to provide intensive training to RIOs
and counsels in best practices
ORI staff are on call to help with issues as they
arise, and can provide technical assistance via
GoToMeeting sessions to help with forensic
issues
DIO Oversight: Forensics
During the 20 years that OSI/ORI have
existed, investigators have developed a
number of computer-assisted tools and
approaches to help strengthen institutional
findings.
The following slides will provide a few
Detection of Fabricated
Numbers
If sets of transcribed numbers are provided as
“raw data” rather than instrument printouts,
consider whether the numbers might have been
fabricated
.
Research by ORI and others shows that
insignificant (right-most) digits in numbers, if real,
e.g. from instruments, are uniformly distributed
while numbers made up by people often are
non-uniform
.Here is a DIO scan of a spreadsheet submitted by a respondent that was unaccompanied by an instrument printout. Under pressure, he subsequently provided
similar data that was accompanied by printouts from a scintillation counter.
ORI 4/05 23 Data Sets 4-11 Digit 0 1 2 3 4 5 6 7 8 9 F re q u e n c y 0 10 20 30 40 50 60 Right-most digit; p = 0.778 Second right-most (10s), p = 0.787
Data Sets 1-3 (no counter tapes)
Digit 0 1 2 3 4 5 6 7 8 9 F re q u e n c y 0 10 20 30 40 50 60 70 Right-most digit; p = < 0.00001 Second right-most (10s), p = <0.00001
the two right most positions for the data sets without
counter tapes (left) and those with counter tapes
(right). 0.0 10.0 20.0 30.0 40.0 50.0 60.0 70.0 80.0
1 2 3 4 5 6 7 8 9 10
2 Year Reporting Period ('89-90 to '07-08)
ORI 4/05 25
Screen shot from Photoshop
showing analysis under way – the small circle in the Color Picker is the brush size moved to a color
approximately matching the image’s background.
ORI 4/05 27
The result of removing most of the “scribbling.”
A Slippery Slope
The next few slides show how difficult it can be
to determine if a manipulation is appropriate,
possibly inappropriate, or obviously fraudulent.
Generally, ORI is reluctant to make findings of
misconduct when an image has been
“beautified” by altering background, or by reuse
of loading controls, when the actual data verifies
the factual findings claimed in the grant or
paper.
However, adding or removing important
elements of a figure can often be considered
evidence for intentional falsification.
Contrast Enhancement – detecting small differences in gray scale
Contrast Enhanced Original Data
Effect of Histogram Equalization: “SPLICED” DATA?
manipulation DOES NOT mean research misconduct
(shown with permission)
When a is Problem Found: Extend Visualization
Visualization shows the BANDS ARE TOO SIMILAR TO BE DIFFERENT
Embossed Original Data Published Data
Forensic Value of Background:
►
Harder to see since it has the least contrast
►
Overlooked since not of primary interest,
i.e., below the perceptual “radar screen”
Gradient Map – reveals similarities in background and bands Original Data Colorized Data
MORPHOLOGICAL
FEATURES OF
BANDS
False Colorization “Gradient Map” Reveals Mini-features 67 MW band 32 MW band LOWER BANDS SHOW NO SIMILARITY
Role of Institutional Counsel
Experienced RIOs have learned to rely on their
attorney(s) to:
Provide legal advice prior to and during review of
allegations of misconduct
Assisting with triaging complex complaints
Assisting with preparing committees for interviews Dealing with attorneys representing respondents (and
other witnesses)
Working with DIO to discuss possible settlements.
three-way agreements, and other legal concerns (e.g., parallel law suits in Federal or State court)
Reaching Voluntary
Agreements
Several years ago DIO was assigned responsibility for seeking
voluntary agreements with respondents
This typically involves an initial communication to the
respondent or her/his attorney to determine if there is any interest in an agreement.
This is followed by DIO forwarding a draft agreement with a
transmittal letter explaining the options available to the respondent.
Then the negotiations begin which can take considerable
effort and patience, but which nearly always lead to a settlement.
With a few notable exceptions, DIO has found attorneys
representing respondents to be helpful.
When ORI does not concur with
some or all of the institution’s
findings
For numerous reasons, such as a lack of
significance of the misconduct, insufficient legal
basis for ORI to justify a charge letter, or an
inability to identify who was responsible for what
was clearly misconduct, ORI may decline to
pursue certain findings. When this happens, we
provide the following language to assist
institutions (from a recent letter, with suitable
redactions):
This administrative decision is the result of a complex and thorough review process conducted by the Director, a panel of scientist-investigators, and legal counsel. In addition to❚❚❚❚’s report, ORI considers factors necessary to sustain a finding of research misconduct, including the significance of the misconduct, the weight of the evidence, and the allocation of Federal resources, among other considerations.
In choosing not to pursue findings of research misconduct, ORI recognizes the authority of UC to independently set its own standards and make determinations of when staff have failed to meet the norms of behavior expected at the institution. ORI’s administrative determination in this case does not diminish the authority of❚❚❚❚to draw its own conclusions about the scientific or professional misconduct by the Respondent. The Public Health Service Policies on Research Misconduct (42 CFR §93.319(a)) states that:
institutions may have internal standards of conduct different from the HHS standards for research misconduct under this part. Therefore, an institution may find conduct to be actionable under its standards even if this action does not meet this part's definition of research misconduct.
Consistent with Federal law and ORI policy, inquiries and investigations that result in no PHS finding of misconduct remain confidential for ORI. We ask that you respect this policy. We consider this matter closed with our acceptance of the institution’s report. Please notify Dr.❚❚❚❚❚❚, the respondent, as well as Dr.❚❚❚❚❚❚❚❚❚❚❚❚❚❚❚❚, the complainant, about ORI’s determination.
Some Lessons Learned:
Complainants
Complainants are critical to the identification of
misconduct, but should not be permitted to direct the review of allegations.
Complaints often fail to appreciate the difference
between something being false and being able to prove misconduct.
Some complainants will allege retaliation due to making
allegations (thus potentially becoming eligible for ORI assistance) when in fact many other issues led to disciplinary action.
Some Lessons Learned:
Aggressive Respondents
Many respondent (and their attorneys) will attempt to
delay the institution’s review; if successful, this can damage ORI’s capacity to make findings.
Delay tactics can include seeking TROs, suing the
institution and its officials (and ORI on occasion), claiming lack of due process by the RIO/committee, claiming to be ill, making counter allegations against others, and refusing to agree to interviews.
It is important to hold respondents to a reasonable
schedule, and ORI recommends considering using outside counsel to deal with particularly aggressive attorneys.
Some Lessons Learned:
Admissions – good and bad
DIO frequently receives calls to discuss possible settlements
based on an assessment or inquiry plus an admission (42 C.F.R. Part 93.316). These situations often lead to expedited closure via a three way agreement.
Settlements cannot be reached by the institution without
ORI’s approval, so contact DIO when such situations arise to discuss how best to proceed.
Many admissions are inadequate for ORI; they must admit to
acts of falsification, fabrication and/or plagiarism, identify specifically what was done and where reported, and not claim that there was no intent to deceive or that the acts were just errors.
Some Lessons Learned:
Harmonization
About one third of ORI’s cases involve clinical research, with
possible overlap with human subject issues (OHRP) and FDA regulated research.
ORI has found that if allegations go to the IRB rather than the
RIO, possible research misconduct is often not recognized.
In addition, the confidentiality requirements of ORI’s
regulation are not consistent with OHRP’s requirements that lead to rapid disclosures.
ORI is working with OHRP and the FDA to identify guidelines
on dealing with handling the complexities of concerns involving protection of human subjects while dealing with apparent research misconduct.
Some Lessons Learned:
Various
The importance of the RIO’s status within his/her
institution
Controlling inquiry committees to stop their review once
it becomes clear that an investigation is needed (new issues can be added as identified by the investigation committee).
Role of the institution’s deciding official
Problems resulting from separate disciplinary procedures
re-evaluating the misconduct findings.
