Download Responsible Conduct of Research

Deborah (Debbie) L. Smith, Ed.D.
Assistant Vice Chancellor for Research
UT Health Science Center
Office of Research Administration
910 Madison, Suite 823
Memphis, TN 38163
901 448-4823
[email protected]
Maggie Pyle, Ph.D.
Director
University of South Alabama
Office of Sponsored Programs
AD 200
Mobile, AL 36688
251 460-6456
[email protected]
“I never had a policy;
I have just tried to do my very best
each and every day.”
~Abraham Lincoln
Definition of Ethics
 A set of principles of right conduct; a
theory or system or moral values American Heritage Dictionary
 The principles of conduct governing an
individual or group (e.g., medical ethics)
- Merriam Webster’s Medical Dictionary
Kohlberg’s Stages of Moral Development
Kohlberg’s theories of moral development:
 Stage 1 - Obedience and Punishment Orientation
(early stages of childhood)
 Stage 2 - Individualism and Exchange/Deals
 Stage 3 - Good Interpersonal Relationships (usually teens)
 Stage 4 - Maintaining the Social Order/Rules
 Stage 5 - Social contract and individual rights
 Stage 6 - Universal Principles
Why do the right thing?
Stages of moral development
 Because something bad will happen if you do the wrong
thing (get fired, lose accreditation) or because something
good will happen if you do the right thing (get promoted,
receive accreditation) (Kohlberg’s Stage 1)
 Because you made a deal to do it (quid pro quo) (Kohlberg’s
Stage 2)
 Because “everyone else is doing it” or because other people
will not approve if you do the wrong thing (“Front Page of
Local Paper Test”) (Kohlberg’s Stage 3)
Why – cont’d
 Because it’s the law/rule; maintains the social order
(Kohlberg’s Stage 4)
 For the greater good of society, even if it may not conform
to norms or the individual’s own benefit (Kohlberg’s Stage
5)
 Because it is the right thing to do – applying universal
principles of justice regardless of who is concerned (no one
is “more equal” than others) – Kohlberg’s Stage 6)
**Most people are at stage 3 or 4; few ever get to stage 6
“Laws control the lesser man.
Right conduct controls the greater one.”
~ Chinese Proverb
Thought vs. Action
 Thinking at a specific moral stage
may not result in action that reflects
that stage.
 A person may KNOW that a thing is
“right” or “wrong” but that thinking
may not be consistent with the
person’s actions.
 “I know I shouldn’t do this, but . . .”
“A long habit of not thinking a thing wrong
gives it a superficial appearance of being
right.”
~ Thomas Paine
* “That’s the way we’ve always done it.”
Can People Learn to be Ethical?
 Kohlberg and others thought so.
 The IOM thought so. (IOM, 1989)
 Recent studies have shown that
university leaders believe so.
(Maldonado, et al.)
 Let’s HOPE so!
Moving up the Stages
 Stages are determined by interactions with others
(Kohlberg)
 Exposure to higher stages;
 Discussion, interchange;
 Challenges to thinking, leading to higher levels of
thinking
Ferguson’s Suggested Influences of
Character Development
 Heredity
 Early Childhood Experiences
 Modeling by important adults and older youth
 Peer Influence
 General physical and social environment
 Communications media
 What is taught in schools
 Specific situations and roles that elicit corresponding
behavior
Maslow’s Hierarchy of Needs
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Physiological Needs – food, water, shelter
Safety Needs
Love, Affection and Belongingness
Needs for Esteem – self-respect and respect from
others - overcome feelings of loneliness and alienation
 Needs for Self-Actualization – reaching potential
 Must have basic needs filled before
the individual can worry about
higher-level needs
~An individual’s need level may interfere with ethical
thinking, or cause a regression to a lower stage.
“The truth of the matter is that you always
know the right thing to do.
The hard part is doing it.”
~Norman Shwarzkopf
(U.S. General)
Increasing Scientific Misconduct
 The number of allegations of misconduct reported to ORI
rose by 50% from 2003-2006.
 ORI reported that 43% of closed cases in 2006 resulted in
misconduct findings, compared to 33% historically.
 Source: ORI Annual Report, May 2007
Examples of Questionable Behavior
 Industry Kick-backs – “takes two to tango”
 Effort Reporting - Individual and Institutional
responsibility
 Scientific Misconduct – Individual and Institutional
responsibility
 Fraud – Individual and Institutional
 Conflict of Interest – Individual and Institutional
Higher Ed’s Role: Teaching and Modeling
Personal Responsibility/Integrity
 Exhibiting higher stages of moral development enables
students to move to higher stages of moral development
through exposure and interaction
 Promoting a campus climate of integrity
should reach to all levels: faculty,
staff, students, (even high-level
administrators!) and encompass
all activities.
Faculty Roles and Role Models
 Roles:
 Teacher (staying current, fairness, student interaction)
 Researcher (competition for grants, incentives, data,
staff assistants, students, publication)
 Clinician/Service (perhaps) - patient interaction, charge
structure
 Mentor - quality time, examples
 Role Model
 Compliance - mandate or innate?
 Competition - fair or “all’s fair”?
 Collegiality - good of all or good for me?
Research Administrator Roles and Role Models
 Roles
 Policy Maker (proactive or reactive?)
 Policy Enforcer (consistent or depends on what’s at stake or who it
is?)
 Agency Liaison (working for good of all or getting what you want—
full disclosure or providing info to get the answer you want?)
 Faculty/Student/Institution Liaison/Advocate (doing what they
want or doing what’s right?)
 Information Provider (fudge the numbers?)
 Role Models
 Ethics Advocate – What’s the right thing, or what can we get by
with?
 Competition – What should we do, or what will it cost us if we don’t
do it? What is everybody else doing?
 Compliance – Doing the right thing or trying not to get caught?
 Job Security – Signing off because of political pressure?
Institutional Mission Statements
Mentioning Ethics/Integrity
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Princeton
Harvard (1997)
Marshall (Statement of Ethics)
NC-CH
Cornell
UTK
USA
Georgia Tech
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Source: Google
UTHSC Mission Statement
 The University of Tennessee Mission Statement: The mission of
The University of Tennessee is to provide the people of Tennessee with
access to quality higher education, economic development and
enhanced quality-of-life opportunities.
 UT Health Science Center Mission Statement: The Health Science
Center aims to improve human health through education, research,
clinical care and public service. . . . .
 UTK: . . . Provide a high quality educational experience to
undergraduate students in a diverse learning environment--promoting
the values and institutions of democracy that prepare students to lead
lives of personal integrity and civic responsibility in a global society
University of South Alabama Mission Statement
 The University mission actively embraces the functions of
teaching, research, public service, and health care through which
it vigorously pursues the preservation, discovery, communication
and the application of knowledge. As it grows and develops, the
University will focus its strengths to produce programs of
interdisciplinary excellence that address the special needs of the
people it serves. . . . The University’s environment must
encourage and foster the qualities expected of leaders, such as
integrity, service, stewardship, involvement and respect for
individuals, as well as an appreciation for diversity.
Your Institution’s Mission Statement
 What does it say?
 What does THAT say about your institution?
 Interest in economic development?
 Interest in political correctness?
 Interest in the greater good?
Institutional Policy:
Positive or Negative Focus?
 Responsible Conduct of Research – teaching proper
research procedures, integrity, ethical behavior
 Scientific Misconduct – policy spelling out what will
happen if personnel do not follow the rules
“The measure of a man’s real
character is what he would
do if he knew he never
would be found out.”
~ Thomas Babington Macaulay
(1800-1859) – former member of Parliament
What is it ?
What is the Institution’s responsibility?
RCR – The Institution’s Responsibility
Responsible Conduct of Research
Umbrella
covering all research areas
RCR – The Institution’s Responsibility
Responsible Conduct of Research
Basic Responsibilities
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Scientific Integrity
Data Acquisition, Management, Sharing, and Ownership
Publication Practices and Responsible Authorship
Peer Review
Mentor-Trainee Relationships
Collaborative Science
Research Involving Human and Animal Subjects
Conflict of Interest and Commitment
NIH Research Ethics Online Training Course
http://researchethics.od.nih.gov/
RCR – The Institution’s Responsibility
Norman’s Norms for Personal Conduct
 Honesty
 Objectivity
 Integrity
 Carefulness
 Openness
 Respect for Intellectual Property
 Confidentiality
 Responsible Publication
RCR – The Institution’s Responsibility
Norman’s Norms for Personal Conduct
 Responsible Mentoring
 Respect for Colleagues
 Social Responsibility
 Non-Discrimination
 Competence
Abbreviated list
http://www.niehs.nih.gov/research/resources/bio
ethics/whatis.cfm
Adapted from Shamoo A and Resnik D. 2003.
Responsible Conduct of Research (New York:
Oxford University Press).
RCR – The Institution’s Responsibility
Required Training in Responsible Conduct of Research
 NIH Training Grants
1989 – graduate students on training grants required to
receive RCR training
 NSF / America COMPETES Act
August 2007
SEC. 7009. <<NOTE: 42 USC 1862o-1.>> RESPONSIBLE CONDUCT OF RESEARCH.
The Director shall require that each institution that applies for financial assistance from
the Foundation for science and engineering research or education describe in its grant
proposal a plan to provide appropriate training and oversight in the responsible and
ethical conduct of research to undergraduate students, graduate students, and
postdoctoral researchers participating in the proposed research project.
RCR – The Institution’s Responsibility
Responsible Conduct of Research
Where can I get training?
 NIH Research Ethics Online Training Course
http://researchethics.od.nih.gov/
 NIH Research Conduct and Ethics Instruction Materials
http://www1.od.nih.gov/oir/sourcebook/ResEthicsCases/cases-toc.htm
 NIEHS: What is Ethics in Research & Why is It Important?
http://www.niehs.nih.gov/research/resources/bioethics/whatis.cfm?
RCR – The Institution’s Responsibility
Institutional Compliance Culture
 Be a Good Citizen:
 Do the right thing because it is the right thing to do
 Discuss, communicate, report RCR incidents because it is the right thing to do
RCR – The Institution’s Responsibility
Institutional Compliance Culture
 Why do the right thing?
The vast majority of faculty are good citizens
Only a tiny fraction of faculty are poor citizens
 What motivates Institutional Responsibility to Teach Ethics/RCR?
Maintaining the Public Trust
Balancing Public Perception of Research Integrity
Meeting Federal Requirements
RCR – The Institution’s Responsibility
Creating An Institutional Compliance Environment
 Provide leadership in support of responsible conduct of research;
 Encourage respect for everyone involved in the research enterprise;
 Promote productive interactions between trainees and mentors;
 Advocate adherence to the rules regarding all aspects of the conduct of
research, especially research involving human participants and animals;
 Anticipate, reveal & mange individual and institutional conflicts of interest;
RCR – The Institution’s Responsibility
Creating An Institutional Compliance Environment
 Arrange timely and thorough inquiries and investigators of allegations of
scientific misconduct and apply appropriate administrative sanctions;
 Offer educational opportunities pertaining to integrity in the conduct of
research,
 Monitor and evaluate the institutional environment supporting integrity in the
conduct of research and use this knowledge for continuous quality
improvement.
Source: IOM Report on Integrity in Scientific Research: Creating an Environment That Promotes
Responsible Conduct
RCR – The Institution’s Responsibility
Promoting Responsible Conduct of Research
Causes of Misconduct : Are people simply Bad Apples
or just succumbing to Intense Pressures?
Why do people not report RCR incidents?
Effects of Training: Will it decrease misconduct?
RCR – The Institution’s Responsibility
What Could Happen to Norman
Verbal or Written Reprimands
Loss of signature authority
Oversight restrictions
Suspension
Loss of employment
Debarment / Excluded Parties
http://www.epls.gov/
 Prison Term
 Deportation
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Resources
 AAUP Resources on Professional Ethics
http://www.aaup.org/AAUP/issues/ethics/resethics.htm
 Crain, W. (1985). Theories of Development. Prentice-Hall, pp. 118-136.
 DHHS ORI website
http://ori.hhs.gov/education/index.shtml
 Dictionary.com
 Quotegarden.com
 www.myfavoritezine/ezine/dictionary/quotes
 Huitt, W. (2004) Moral and character development. Educational Psychology Interactive.
Valdosta, GA: Valdosta State University.
 Maldonado, et al. “Ethical Learning and the University: Listening to the Voices of
Leaders.” Paper presented at the Annual Meeting of the American Educational Research
Association (Chicago, Il., April 9-13, 2007).
Resources
 NCURA Compliance Neighborhood
http://www.ncura.edu
 Office of Research Integrity. Responsible Conduct of Research (RCR) Education.
http://ori.dhhs.gov/policies/RCR_Policy.shtml
 Office of Research Integrity. Annual Report 2006. Department of Health and Human
Services. May, 2007.
http://ori.dhhs.gov/documents/annual_reports/ori_annual_report_2006.pdf
 Shamoo A and Resnik D. 2003. Responsible Conduct of Research (New York: Oxford
University Press).
 Simons, J. A.; Irwin, D. B.; Drinnien, B.A. The Search for Understanding. West
Publishing Company, New York, 1987.
http://honolulu.hawaii.edu/intranet/committees/FacDevCom/guidebk/teachtip/maslow
.htm
“If you have integrity, nothing else matters.
If you don’t have integrity, nothing else matters.”
~Alan K. Simpson
(former U.S. Senator)