Transcript Is Teaching Ethics a Waste of Time?

The Responsible Conduct
of Research
Daniel R. Vasgird, PhD, CIP
Research Compliance Services
Office of Research Responsibility
University of Nebraska, Lincoln
(402) 472-1837
[email protected]
http://research.unl.edu/orr
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"For a scientist, integrity embodies
above all the individual's commitment
to intellectual honesty and personal
responsibility … For an institution,
[integrity] is a commitment to creating
an environment that promotes
responsible conduct by embracing
standards of excellence,
trustworthiness, and lawfulness…"
-Integrity in Scientific Research, The
National Academy of Sciences
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The Fundamental Proposition
Rules are just a small part of
the picture. The alpha and the
omega has to be integrity from
which all else will follow,
including compliance.
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“Ethics primarily concerns the
effects of our actions on others.”
Randy Cohen
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“The first step in the evolution
of ethics is a sense of solidarity
with other human beings.”
Albert Schweitzer
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ORCS Core Areas
(Red = Federal Regulations)
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Human research protections (IRB)
Animal research protections (IACUC)
Data acquisition, management, sharing,
and ownership
4) Mentor/trainee relationships
5) Publication practices and responsible
authorship
6) Peer review
7) Collaborative science
8) Research misconduct
9) Conflict of interest and commitment
10) Environmental health and safety liaison (IBC & RSC)
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11) Export Controls
ORCS Mission:
Foster a culture of integrity and
compliance within the University directed
at ensuring that participants in the
University of Nebraska, Lincoln research
enterprise internalize and pursue the goal
of self-directed responsible conduct of
research.
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FSGO Compliance Elements
(HHS & NSF)
• Implementing written policies and procedures;
• Designating a compliance officer and
compliance committee;
• Conducting effective training and education;
• Developing effective lines of communication;
• Conducting internal monitoring and auditing;
• Enforcing standards through well-publicized
disciplinary guidelines; and
• Responding promptly to detected problems.
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Organization & Governance of
Research at UNL
• Academic and research activity is
conducted through the faculties and
departments, under the direction of the
appropriate dean and the Vice
Chancellor for Research
• For cases of research misconduct,
graduate students involved in research
are subject to the same disciplinary
procedures as faculty or staff
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Robert K. Merton
Stated that the disinterested pursuit of
truth is the norm of science, expressed as:
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Universalism
Communalism
Disinterestedness
Organized skepticism
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Consequences of ambition
Perseverance and success,
but for some increased:
1. Risk for unintentional bias
2. Willingness to cut corners
3. Willingness to commit serious
misconduct
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The OSTP Definition of Misconduct
“Research misconduct is defined as
fabrication, falsification, or plagiarism in
proposing, performing, or reviewing
research, or in reporting research results…
Research misconduct does not include
honest error or differences of opinion.”
http://www.unl.edu/research/orr/misconduct.shtml
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CONFLICTS OF INTEREST
A conflict of interest is a situation in
which financial or other personal
considerations have the potential to
compromise or bias professional
judgment and objectivity.
http://www.unl.edu/research/orr/conflict.shtml
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Key Components of Regulations
 The institution, not the federal government or
the sponsor, has the primary responsibility to
develop its own internal policies and procedures.
 The institution is to designate an official to
review disclosure of significant financial interest
and manage conflicts of interest.
 Investigators must disclose any "significant
financial interest" to the institution.
 The institution must report to the federal
funders if it believes an investigator’s significant
financial interest could affect the research.
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Goals of Federal Regulations
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Manage
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Reduce
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Eliminate
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UNL Conflict of Interest Policy
• Annual conflict of interest disclosure and
reporting by faculty members, officers of
research, and officers of administration
• Research-specific conflict of interest
disclosure and reporting in sponsored
research supported by a business in
which key personnel has ANY financial
interest or holds executive position
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Human Research Protections
Program
National Research Act
In July 1974, the passage of the National
Research Act established the National
Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research
which established IRBs.
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HUMAN RESEARCH GONE AWRY
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Nazi Experiments (Nuremberg Code)
Milgram Obedience Experiments
Radiation Experiments
Wichita Jury Taping Study
Jewish Chronic Disease Cancer Study
Thalidomide Tragedy
Syphilis Experiment (PHS, Tuskegee)
Led to NRA (IRBs & Informed Consent)
• Jesse Gelsinger
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MAIN FUNCTION OF IRB REVIEW
TO ASSURE THAT:
• RISKS ARE MINIMIZED AND
REASONABLE IN RELATION TO
ANTICIPATED BENEFITS.
• THERE IS INFORMED CONSENT.
• RIGHTS AND WELFARE OF
SUBJECTS ARE MAINTAINED (i.e.,
Continuous).
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DRAMATURGICAL
FUNCTION
To become the subject as
much as possible
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Human Research Protections
Program
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IRB support
Process Overview
Training: CITI & In Person
AAHRPP
Electronic Submission
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THE ESSENTIAL DILEMMA
Human dignity and social justice in
an economically and politically
unbalanced world
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The major responsibility for insuring
ethical decision making in human
research rests with the IRBs in terms
of empowerment, flexibility and
discretion.
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IRBs have ethical
responsibility and legal
authority.
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IRB
Belmont Report
•Respect for Persons
•Beneficence
•Justice
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The research protection
system fundamentally
revolves around mutual
trust.
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RESEARCH
“RESEARCH” MEANS A
SYSTEMATIC INVESTIGATION
DESIGNED TO DEVELOP OR
CONTRIBUTE TO
GENERALIZEABLE
KNOWLEDGE. 46.102 (d)
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HUMAN SUBJECT
• “Human subject” means a living
individual about whom an
investigator…conducting research
obtains
(1) data through intervention or
interaction with the individual, or
(2) identifiable private information.
46.102(f)
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Reasonable Expectations
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AUTHORITY OF IRB
• Requirement of review
• Approve, disapprove or modify
• Conduct continuing review
• At any time and in person if desired
• Must be done at least once per year
• Observe/verify changes
• Suspend or terminate approval
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CRITERIA FOR APPROVAL OF
RESEARCH 45 CFR PART 46.111
To approve research, an IRB should
determine that all of the following
conditions exist:
1. Risks to subjects are minimized.
2. Risks are reasonable in relation to
anticipated benefits, if any, to subjects
and to advancement of knowledge.
3. Selection of subjects is equitable.
4. Informed consent will be sought.
5. Informed consent will be documented.
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CRITERIA FOR APPROVAL OF
RESEARCH 45 CFR PART 46.111
6. Where appropriate, research plan
makes adequate provision for
monitoring the data collected to insure
safety of subjects.
7. There are adequate provisions to protect
the privacy of subjects and to maintain
the confidentiality of data.
8. Where any of the subjects are likely to be
vulnerable to coercion or undue
influence, additional safeguards have
been included in the study to protect
subjects.
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Ensure that language and
readability are appropriate to
the subject.
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46.116 Consent - the Process
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Process of information exchange which
should include:
- written materials (CF, letters,
debriefs)
- verbal instructions
- questions & answers after reading ICF
with subject
- setting/timing (family/friends
consultation)
- agreement/documentation
- reaffirmation/re-consent
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ETHICS IN ETHNOGRAPHIC
RESEARCH
In a nutshell, researchers must make their research goals clear
to the members of the community where they undertake their
research and gain the informed consent of their consultants to
the research beforehand. It is also important to learn whether
the group would prefer to be named in the written report of
the research or given a pseudonym and to offer the results of
the research if informants would like to read it. Most of all,
researchers must be sure that the research does not harm or
exploit those among whom the research is done.
http://www.aaanet.org/committees/ethics/ethics.htm
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“One is apt to think of moral
failure as due to weakness of
character: more often it is due to
an inadequate ideal.”
Richard Livingstone
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