Ethics in Research: - Vanderbilt School of Medicine

Ethics in Research:
A Retrospective on Research Integrity,
Research Misconduct, and Research Policy
Elizabeth Heitman, PhD
Vanderbilt University Medical Center
Center for Biomedical Ethics and Society

The transition from trainee to funded
faculty investigator is marked by
increasing levels of responsibility for
the policies and practices essential to
good research.

Where do policies on
“research ethics” come from?
• Federal government
• State and local government
• Professional organizations
• Institutions
• Laboratories and work groups

Most research policy comes from
federal efforts to promote
standards of ethics, health, and
safety in research.
NIH requires all funded institutions
and investigators to comply with a
host of policies governing ethics and
research integrity.

NIH funding to institutions is contingent on
compliance with these and other policies,
spelled out by institutional contract.
• Debarment and Suspension
• Drug-Free / Smoke-Free
Workplace
• Seat Belt Use
• Lobbying
• Financial Conflict of Interest
• Research Misconduct
• Data Management / Sharing
• Nondelinquency on Federal Debt
• Human Embryonic Stem Cell
Research
• Effort Reporting
• Human Subjects/ Required
Education on Protection of
Human Subjects
• Research on Fetal Tissue
• Recombinant DNA / Human
Gene Transfer Research
• Vertebrate Animals
• Inclusion of Women, Children,
and Minority Participants

Objectives
• Consider the development of federal and
institutional policies on research integrity
• Examine some historical revelations of scientific
misconduct and the discussion of research
integrity that led to many policies
• Consider the current dual emphasis on
individual and institutional integrity and their
meaning for postdoctoral fellows

Irony of Ethics in History
• Insight and reform come more often from
scandal and catastrophe than from reflection in
good times.
• Authoritative ethical standards for research have
typically been developed in response to
misconduct or scientific changes that pose
significant new risks.
• Ethical standards often come as external
regulation and institutional oversight; internal
professional debate is crucial but less visible.

Ethical ideals for research developed
alongside practical methodologies as the
scientific community became established.
• Honesty and truthfulness
• Objectivity and rationality
• Skepticism, self-criticism, and peer-review
review
• Openness, trust, and communalism
• Intellectual freedom and tolerance

Medical research pre-1920 was
governed by Hippocratic ethics
• Few doctors were trained in experimental
theory or scientific techniques
• Most experimentation was conducted by
physicians as part of therapy – both doctor
and patient saw experimentation as in the
patient’s s interest
• Emphasis on patient’s s welfare in the event of
a conflict between science and therapy

The growth of science and demand for
benefit stretched the unwritten norms
of biomedical research, creating
greater need for clearly articulated
standards.
• Development of new specialty fields
decreased common knowledge, identity,
and values among researchers.
• Heightened need for skepticism AND
trust among researchers

Researchers had little reason to articulate
their ethical norms until moral crises
forced them to spell out standards to
judge wrongdoing.
Today’s s formal statements and policies on
research ethics have been developed
largely in response to apparent violations of
unwritten professional expectations.

Ethical scandals and new technologies
forced researchers to articulate ethical
standards in several key areas:
• Human research
• Animal research
• Biological safety
• Scientific integrity
Formal standards also led to the creation of new
structures to oversee them.

Discovery of Nazi researchers’
abuse of human subjects led to
the 1949 Nuremberg Code, the
ethical standard by which Nazi
medical war crimes were judged.
Principle 1. “The voluntary consent of the
human subject is absolutely essential.”

Increased attention focused on defining
informed consent and researchers’ and
institutions’ responsibility to human
subjects:
• WMA Declaration of Helsinki - 1964
• Henry Beecher’s s exposé - 1966
• Creation of IRBs - 1966
• USPHS (Tuskegee) Syphilis Trial - 1972
• National Research Act - 1974
• Belmont Report - 1979
• Respect for persons, beneficence, justice

US regulation of animal research began in
response to a 1966 pet-napping scandal.
• The Laboratory Animal Welfare Act – 1966
• Prevention of theft of pets through recordkeeping
• Standards for housing and care
• Exclusion of birds and rodents – 1972
• PHS Policy on Humane Care and Use of Animals, with
institutional review – 1971
• Revisions mandated IACUC – 1986
• National Research Council’s Guide - 1996

Recombinant DNA research in the 1970s
raised new questions about risks of
unintended harms from new organisms.
• NAS moratorium on rDNA work – 1974
• Asilomar statement – 1975
• Containment to match risk
• Professional standards self-imposed
• Institutional Biosafety Committees (IBCs(
IBCs) ) to
review NIH-funded
rDNA protocols
• Expansion to broader ID research
• Biosecurity and dual-use use research post-9/11?

By the mid 1970s, federal regulatory
bodies provided some policy and
oversight of biomedical science in :
• Human research
• Animal research
• Biological safety

Through the debates on the ethics
and risks of biomedical research in
the 1960s-1970s, 1970s, no one questioned
the quality of the science.
In the 1980s, revelations of “fraud” by
prominent researchers prompted
journalistic inquiry and Congressional
review.

High-profile Cases of Misconduct
• William Summerlin, , MD – 1975
• Robert Slutsky, , MD – 1985
• John Darsee, , MD – 1981
• Stephen Breuning, , PhD – 1983
• Thereza Imanishi-Kari, PhD and David
Baltimore, PhD – 1986
• Robert Gallo – 1991

Science writers explored fraud and error
in biomedical science in the early 1980s
• Betrayers of the Truth – 1982
• NY Times science writers’ William Broad &
Nicholas Wade
• False Prophets -1986 and 1989
• Virologist/ editor of Journal of Irreproducible
Results
They also looked for misconduct in
history, identifying prominent figures’
apparent wrongdoing.

Historical Cases of Self-Deception,
Error, and Misconduct
• Ptolemy – fabricated observations?
• Newton – falsified measurements ?
• Mendel – trimmed data to fit hypothesis?
• Pasteur – plagiarized?
• Carrel – self-deception?
• Burt – fabricated data and collaborators?
• Millikan – plagiarized student’s s work?
• Watson and Crick – plagiarized stolen work?

Seemingly limited attention from the
scientific community and research
institutions prompted formal
investigation by the U.S. House
Subcommittee on Oversight and
Investigations, chaired by Rep. John
Dingell in 1986.
Public outcry and criminal indictments for
misuse of federal funds resulted.

Congressional hearings with prominent
biomedical researchers, including David
Baltimore, led Congress to seek to
protect US taxpayers’ money through
increased federal control over research.
• NIH Office of Scientific Integrity - 1989
• DHHS Office of Scientific Integrity Review -1989
• Merged as Office of Research Integrity (ORI) - 1992

DHHS Definition of Misconduct - 1989
…fabrication, falsification, plagiarism, or other
practices that seriously deviate from those
that are commonly accepted within the
scientific community for proposing,
conducting, or reporting research. It does not
include honest error or honest differences in
interpretations or judgments of data.
(54 FR 32449, Aug. 8, 1989)

DHHS Required Misconduct Policy
Funded institutions were also
required to establish a mechanism
for the reporting and investigation of
suspicions of misconduct and, later,
the protection of whistleblowers.

Professional societies and government
agencies promoted education rather than
oversight as the key to scientific integrity.
• IOM called for “formal instruction in good research practices”
(1989)
• NIH required NRSA training grants to include “plans for
instruction in the responsible conduct of research” (1989)
• NAS called for “programs that foster faculty and student
awareness of ... the integrity of the research process” (1992)
• DHHS Commission on Research Integrity urged NIH to certify
that federally funded research institutions had an educational
program on RCR (1995)

DHHS/ORI announced all institutions must
provide RCR training to all engaged in PHS-
funded research or research training (2000)
• Data management
• Mentor/trainee responsibilities
• Publication and authorship
• Peer review
• Collaborative science
• Research with human beings
• Research involving animals
• Research misconduct
• Conflict of interest and commitment

Final 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
represented in the research record.
Plagiarism is the appropriation of another person's
ideas, processes, results, or words without giving
appropriate credit. (65 FR 76260-76264, 76264, Dec. 6, 2000)

Government regulation and institutional
oversight of human research continued to
grow throughout the 1990s:
• Common Rule (45 CFR 46) - 1991
• Revised standards for research with vulnerable
populations - 1993 & 1998
• Presidents’ Advisory Committee on Human
Radiation Experiments - 1994
• Clinton’s s Apology for the Syphilis Trial – 1997
• Suspensions at Duke et al. – 1999
• Mandated IRB training - 1999
• Reorganization of OPRR into OHRP – 2001

Congressional and professional criticism
prompted ORI to withdraw its universal
RCR educational policy in February 2001
Many institutions had already begun to expand their
training grant RCR programs to all researchers.
Many professional societies, research organizations,
and government agencies had already begun to
articulate standards and formal policies.
Some institutions implemented universal RCR training
for compliance standards “just in case”.

IOM’s s 2002 report “Integrity in Scientific
Research” defined integrity at two levels:
Individual integrity = commitment to intellectual
honesty and personal responsibility that
characterizes responsible conduct in research
Institutional integrity = creation of an environment
that promotes responsible conduct and fosters
integrity through structures, processes, policies,
and procedures

Individual-level level Integrity
• Intellectual honesty
• Accuracy in representing one’s s contributions
• Fairness in peer review
• Collegiality in communications and sharing of
resources
• Transparency in real or potential conflicts of interest
• Protection of human subjects in research
• Humane use of animals
• Adherence to the mutual responsibilities of team
members

Policies Supporting Institutional Integrity
• Research Misconduct
• Debarment and Suspension
• Financial Conflict of Interest
• Data Management and Sharing
• Protection of Human Participants
• Vertebrate Animals
• Recombinant DNA /Human Gene Transfer
Research
• Mentoring
• Appointment, Promotion and Tenure

Where Do We Stand?
• Debate has helped to articulate areas of
concern for researchers and institutions
• Statements of standards of practice and
formal professional guidelines being
developed
• Emphasis on education for new trainees,
clarification for practicing researchers
• Emphasis on compliance confuses ethics

Obstacles to Institutional Integrity
• Good policy does not ensure good practice
• Compliance is necessary but not sufficient
• Compliance generally concerns minimum standards,
not model behavior
• Standards for compliance may conflict
• Standards for compliance may not fit new situations
• Emphasis on compliance alone may breed cynicism

Obstacles to Institutional Integrity
• Good policy does not ensure good practice
• Compliance is necessary but not sufficient
• Compliance generally concerns minimum standards,
not model behavior
• Standards for compliance may conflict
• Standards for compliance may not fit new situations
• Emphasis on compliance alone may breed cynicism

The Research Environment and
Organizational Context of Research
• Normal Misbehaviors: Scientists Talk
About the Ethics of Research – Raymond
De Vries, Melissa S. Anderson, Brian C. Martinson,
JERHRE 2006; 1: 43-50.
• Scientists Perception of Organizational
Justice and Self-Reported Misbehaviors
– Brian C. Martinson, Melissa S. Anderson, A.
Lauren Crain, Raymond De Vries, JERHRE 2006; 1:
51-66.

• Meaning of data
“Normal Misbehaviors”
• Keeping notes
• Cooking and cleaning
• Rules of science
• Whose rules, when
• Details and big picture
• Life with colleagues
• Oversight is hard on relationships
• Competition and corruption
• Pressures of production
• Getting funding do to work to get funding
• More competition

The Research Environment and
Organizational Context of Research
• Policy focus on FFP fails to address more
prevalent “normal misbehavior” that is harmful
but harder to track.
• Normal misbehavior allows scientists to deal with
uncertainties on the frontier of knowledge.
• Normal misbehavior illustrates “pinch points”
where policy and social structures of science and
research institutions create strain.
• Ordinary and extraordinary misbehavior need
attention.

The Research Environment and
Organizational Context of Research
• Organizational justice affects both dramatic and
normal misbehavior.
• Mid career and junior researchers perceive
unfairness in the rules and processes of research,
and their research institution and environments.
• Ordinary and extraordinary misbehavior more
likely among researchers who perceive unfairness
– misbehavior is often an attempt to level the
playing field.
• Perception and reality are not distinguishable.

Organizational culture is crucial to
institutional integrity.
Institutional integrity equates excellent
research with integrity as well as with
productivity.
“We do good work” – “This is a good place to work”

THE POLITICS OF SCIENTIFIC
MISCONDUCT AND FRAUD
When: Tuesday, March 20, 2007
Where: University of Vienna
Dept. of Political Science .
Conference Room, 2nd Floor
Universitätsstrasse
tsstrasse 7
1010 Vienna, Austria