Transcript The Ethical Treatment of Human and Non

The Responsible Conduct of Research
Paul Braunschweiger Ph.D.
Professor of Radiation Oncology
Chair, University of Miami IACUC
Talking points
• What is RCR and why is it important
• New Guidelines, NSF, NIH.
• Intersection of RCR and Lab animal
welfare.
• Resources for teaching the RCR
NSF Mandate for RCR Education
• August 20, 2009 NSF implementation of Section 7009 of
the America Creating Opportunities to Meaningfully
Promote Excellence in Technology, Education, and
Science (COMPETES) Act (42 U.S.C. 1862o–1).
http://edocket.access.gpo.gov/2009/pdf/E9-19930.pdf
• Requires 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.’’
NSF Mandate for RCR Education
• January 4, 2010, NSF will require that, at the
time of proposal submission to NSF, a proposing
institution’s Authorized Organizational
Representative certify that the institution has a
plan to provide appropriate training and oversight
in the responsible and ethical conduct of
research to undergraduates, graduate students,
and postdoctoral researchers who will be
supported by NSF to conduct research.
NSF Mandate for RCR Education
• Content
– No specific recommendation.
– “Therefore, it is the responsibility of each institution to
determine both the content and the delivery method for the
training that will meet the institution’s particular needs for
RCR training in all areas at that institution for which NSF
provides support.”
• Delivery method
– No specific recommendations
– “It will be up to each institution to determine how best
to ensure effective and appropriate education in
responsible research practices.”
RCR 12-29-07
NIH Mandate
• Policy
– NIH requires that all trainees, fellows, participants, and
scholars receiving support through any NIH training, career
development award (individual or institutional), research
education grant, and dissertation research grant must
receive instruction in responsible conduct of research. This
policy will take effect with all new and renewal applications
submitted on or after January 25, 2010, and for all
continuation (Type 5) applications with deadlines on or after
January 1, 2011.
• National Institutes of Health (NIH), NOT-OD10-019, issued November 24, 2009.
NIH Mandate
• National Institutes of Health (NIH), NOTOD-10-019, November 24, 2009.
1. Develops principles on providing instruction in
responsible conduct of research.
2. Specific about who should participate, how often
instruction should occur, and the form that instruction
should take;
3. Addresses issues that have arisen as the practice of
biomedical, behavioral and clinical science has evolved
4. Provides guidance to applicants, peer reviewers and NIH
staff in determining how well specific plans for instruction
in responsible conduct of research compare with the best
practices.
RCR 12-29-07
NOT-OD-10-019, issued November 24, 2009.
Applicability
• This Notice applies to:
–
–
–
–
–
–
RCR 12-29-07
All NIH Institutional Research Training Grants,
Individual Fellowship Awards,
Career Development Awards (Institutional and Individual),
Research Education Grants,
Dissertation Research Grants,
Other grant programs with a training component that
requires instruction in responsible conduct of research as
noted in the Funding Opportunity Announcement.
NOT-OD-10-019, issued November 24, 2009.
Principles for the RCR
1. Responsible conduct of research is an essential
component of research training. Instruction in RCR is an
integral part of all research training programs. Its
evaluation will impact funding decisions.
2. Active involvement in the issues of responsible conduct of
research should occur throughout a scientist’s career.
– Instruction in responsible conduct of research should
therefore be appropriate to the career stage of the individuals
receiving training.
3. Individuals supported by individual funding opportunities
such as fellowships and career development awards are
encouraged to assume individual and personal
responsibility for their instruction in responsible conduct of
research.
RCR 12-29-07
NOT-OD-10-019, issued November 24, 2009.
Principles for the RCR
4. Research faculty of the institution should participate in
instruction in RCR in ways that allow them to serve as
effective role models for their trainees, fellows, and
scholars.
5. Instruction should include face-to-face discussions by
course participants and faculty; i.e., on-line instruction may
be a component of instruction in responsible conduct of
research but is not sufficient to meet the NIH requirement
for such instruction, except in special or unusual
circumstances.
6. Instruction in responsible conduct of research must be
carefully evaluated in all NIH grant applications for which it
is a required component.
RCR 12-29-07
5 Instructional Components
1. Format
–
–
RCR 12-29-07
Face-to-face discussions among the participating
trainees/fellows/scholars/participant.
While on-line courses can be a valuable supplement
to instruction in responsible conduct of research,
online instruction is not considered adequate as the
sole means of instruction.
NOT-OD-10-019, issued November 24, 2009.
Instructional Components
2. Subject Matter
• While there are no specific curricular requirements for instruction
in responsible conduct of research, the following topics have
been incorporated into most acceptable plans for such
instruction:
– Conflict of interest – personal, professional, and financial
– Human and non-human subjects welfare, and safe laboratory
practices
– Mentor/mentee responsibilities and relationships
– Collaborative research including collaborations with industry
– Peer review.
– Data acquisition and management.
– Research misconduct and reporting misconduct .
– Responsible authorship and publication.
– The scientist as a responsible member of society, contemporary
ethical issues in biomedical research, and the environmental and
societal impacts of scientific research
RCR 12-29-07
NOT-OD-10-019, issued November 24, 2009.
Instructional Components
3. Faculty Participation
– Training faculty and sponsors/mentors are highly encouraged
to contribute both to formal and informal instruction in
responsible conduct of research. Full faculty participation.
4. Duration of instruction
– “Substantive contact hours”. Acceptable programs generally involve
at least eight contact hours.
– Semester long program maybe better than a one day 8 hr workshop.
5. Frequency of instruction.
– “…at the undergraduate, post-baccalaureate, pre-doctoral,
postdoctoral, and faculty levels.”
– …. Instruction must be undertaken at least once during each career
stage, and at a frequency of no less than once every four years.
•
RCR 12-29-07
Grant applications must address all 5 components.
NOT-OD-10-019, issued November 24, 2009.
Peer review
• Applications lacking a plan for instruction in responsible
conduct of research will be considered incomplete and
may be delayed in the review process or not reviewed.
• Applications with a “Plan”
– Reviewers will specifically address the five Instructional
Components (Format, Subject Matter, Faculty
Participation, Duration and Frequency) .
– Review panel’s evaluation of the plan will not be a
factor in the determination of the impact/priority score.
– Plans and past record will be rated as ACCEPTABLE
or UNACCEPTABLE.
– Regardless of Priority Score, applications with
unacceptable plans will not be funded until the
applicant provides an acceptable, revised plan.
RCR 12-29-07
Compliance
•
•
•
RCR 12-29-07
NIH policy requires participation in and successful completion of
instruction in responsible conduct of research by individuals
supported by any NIH training/research education/fellowship
/career award.
It is expected that course attendance is monitored and that a
certificate or documentation of participation is available upon
course completion.
NIH does not require certification of compliance or submission of
documentation, but expects institutions to maintain records
sufficient to demonstrate that NIH-supported trainees, fellows,
and scholars have received the required instruction.
Resources
•
•
•
•
•
RCR 12-29-07
The NIH Research Training website
(http://grants.nih.gov/training/extramural.htm) includes additional
information on instruction in responsible conduct of research.
Office of Research Integrity (http://ori.hhs.gov/), links to
instructional materials, and examples of programs that have been
regarded as good models for instruction in responsible conduct of
research (http://bioethics.od.nih.gov/researchethics.html).
The National Academy Press has just published the 3rd. edition
of the classic, On Being a Scientist, and is available online at
http://books.nap.edu/catalog.php?record_id=12192.
The CITI Program www.citiprogram.org , On-line program in the
RCR. Text, case studies, video vignettes and quizzes in the nine
topic areas of RCR. Training data management.
Responsible Conduct of Research Education Committee
(RCREC) http://rcrec.org
What is the RCR
What is involved in RCR education
Integrity & Responsible Conduct of
Research
• Accepted practices for the RCR can vary from
discipline to discipline and even from
laboratory to laboratory.
• Some shared values for the RCR that bind all
researchers together:
– Honesty - conveying information truthfully and
honoring commitments.
– Accuracy- reporting findings precisely and
taking care to avoid errors.
– Efficiency -using resources wisely and avoiding
waste.
– Objectivity - letting the facts speak for
themselves and avoiding improper bias.
– Compliance with regulatory requirements to
document ethical behavior.
• Integrity in the Research
“Integrity” Fredric Terral 2007
"Integrity Protecting the Works of Man." John Quincy Adams Ward, 1903
Integrity in Research Enterprise
•
•
•
•
•
Starts with Institutional Commitment
Promoted and nurtured by the IACUC, IRB, IBC, CoIC, ESCRO
Promotes of scientifically valid data
Avoids or minimizes all COIs
Embraced by the investigators, staff and students as,
“The right thing to do”
Why Does Integrity Matter in
Research?
•
•
•
•
•
Puts subjects at risk.
Injures careers
Wastes Resources
Wastes Time
Undermines the Public Trust.
The Public Trust
• The “Public” supports most of the research in the
US.
• Sponsored research is a privilege and not an
entitlement.
• Society Trusts investigators to conduct research
ethically and responsibly.
• Violation of the public’s trust, brings Regulation.
The Public Trust
• New Regulations are not the result of good or ethical
behavior.
• Federal Regulations specifically require
– Accountability
– Documentation of ethical behavior
• Regulatory requirements to document are designed to:
– Help investigators conduct research responsibly.
– Preserve the Public Trust in research.
• Without the Public’s Trust there is no
research
Betrayal of the Public Trust Brings
Regulation
• 1984 Univ. Penn. Head Trauma Study.
– PETA and ALF alleges inhumane research practices.
– Videos
– NIH investigated. Research activities not conducted
according the existing policies.
•
•
•
•
Lack of adequate anesthesia and analgesia.
Lack of sterile technique.
Lack of supervision by PI.
Lack of training of laboratory personnel.
– NIH Shut down the project.
• Research Project permanently shut down.
RCR 12-29-07
Consequences of betrayal of the
Public Trust
•
•
•
•
•
•
•
•
•
Puts subjects at risk
Federal inquiry / intervention
Institutional embarrassment
Fines
Wasted resources
Personal embarrassment
Loss of funding, Loss of livelihood
Fines
Justification and / or vindication for
groups with anti-research agenda.
A.L.F.
RCR 12-29-07
The Foundation of Ethical
Research Practices is
Research Ethics Education
Promoting integrity in the
Research Enterprise
• Teaching the Responsible Conduct of
Research
– Books, Journal articles
– Classroom experience
– Seminars and conferences
• Professional Societies
– Web based courses and tutorials.
– Mentoring
RCR 12-29-07
The Responsible Conduct of
Research
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
RCR 12-29-07
Research Misconduct.
Data Acquisition and Management.
Responsible Authorship.
Conflicts of Interest.
Responsible Peer Review.
Human Subjects Protection.
Lab Animal Welfare.
Mentoring.
Responsible Collaborative Research.
Financial responsibility.
Environmental ethics.
Data Acquisition and Management
study design
• Humane endpoints
– Minimizing Pain and distress
• Statistically justified sample size determinations.
• Data security –
– Photography and video in animal experimentation.
• Data acquisition and usage,
– Data obtained from studies where unapproved
procedures have been used.
• Pilot studies
– When does a pilot study cease being a pilot study.
RCR 12-29-07
Responsible Authorship
• Who on the research team deserves to be listed
in the byline of the paper and who should be an
author.
• According to the ICMJE
– Design of the experiments.
– Writing and/or editing the paper
– Approval of the manuscript before submission to the
journal.
• Which can can be ethically published.
• Publishing negative data
RCR 12-29-07
Mentoring
The social fabric of science
Excellent approach to teaching
research ethics and lab animal welfare.
The Ideal Mentor
• “The truly complete mentor." This is "a
single individual who is able to serve as an
advisor/guide, developer of talent/coach,
opener of doors/advocate, role model,
interpreter of organizational or professional
rules, protector, rule setter/boss - and
carries on all of these functions on a long
term basis."
Ideal mentoring may require input from more than one person!
Silen, "In Search of the Complete Mentor," in Mentations, Volume 5-Fall
1998,at http://www.hms.harvard.edu/dcp/mentations/fall_98/searchofmentor.html
Mentoring
• Most mentors are not well trained.
• Confusion, Res. Advisors vs. Mentors.
• Trainees often learn unethical practices
and short cuts from the mentor / research
advisor.
• Taking short cuts can get the students
and fellows in trouble with the IACUC.
RCR 12-29-07
Conflicts of Interest and
Commitment
Conflicts of Interest and Commitment
• 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.
– The appearance of a conflict of interest is one in which a reasonable
person would think that the professional's judgment is likely to be
compromised.
– A CoI exists whether or not decisions are affected by a personal
interest.
– A potential CoI involves a situation that may develop into an actual
conflict of interest.
– A CoI is not considered misconduct in research, since the definition for
misconduct is currently limited to F.F&P.
– A CoI could lead to misconduct.
Conflicts of Interest and
Commitment.
• Tangible conflicts of Interest
– Investigator has a financial stake in the
outcome of an experiment or trial.
• CoIs require management strategies
– Disclosure by the investigator,
– CoIs managed by the institution,
– Reported to the Feds.
WHAT DO THESE 4 PHYSICIANS
HAVE IN COMMON
Dr.
Charles
Nemeroff
Emory University
Took >$500K in unreported
consulting income from Glaxo.
Gov. Funded research on
Glaxo drugs
Harvard University
$4 million in unreported
consulting revenues from
Pharmaceutical Industry.
Promoted antipsychotic drugs
in children
GOV. GRANTS
Conflicts of Interest and
Commitment.
• Conflicts of commitment.
– Using institutional time for consulting.
– Using institutional resources for personal gain.
– Using graduate students/fellows for work on company
projects.
• Other intangible conflicts of interest.
– Personnel and professional.
• IACUC, IRB, ESCRO.
• Personal relationships. Good and Bad.
– Conflicts of conscience
• Religious beliefs.
• Philosophical differences (e.g., status of animals.)
CoI in Animal Research
Program
Understanding and Managing the Conflict of Interest
• The Public’s Interests
– Society demands medical advances.
– Society understands that animals as subjects:
• Can not understand the research.
• Can not consent to participate in what may cause them
harm, pain or death.
– Society demands documentation that animal research is
ethically designed and conducted.
Understanding and Managing the Conflict of Interest
•
• The investigator Interests
– Get the data, publish the papers, get the grants, support their
labs, get promoted, get a raise, buy the new boat.
• The Interests of the Veterinarians
– Animal welfare Vs. Helping investigators get their work done.
– Veterinarians as co-investigators, coauthor.
• Institutional interests
– Institutions want the grants, patents and indirect costs.
– IOs need to be willing to deal with problematic faculty
regardless of the grant suppport.
The IACUC specifically empowered by the Federal Regulations and UM Policy to manage the
tensions and conflicts.
The IACUC and Conflict Management
• IACUC has the oversight responsibility for all
animal use at the Organization.
– Manages interests of the “Public” vs other competing
interests.
– Makes sure the investigators consider the interests of the
animals.
– Reviews animal activities for sound experimental design
and the 3Rs.
– Insures the veterinary program is not unduly influenced by
the organization.
– Insures that institutions commit appropriate funding to
support the mission of the Animal Use Program.
– Independently investigates non-compliance.
• Can suspend activities that are not being conducted ethically
and put animals at risk.
The IACUC and Conflict
Management
• IACUC Reports the good, the bad and ugly to:
– Institutional Official
– OLAW and USDA
– Follow - up
• IACUC appointed by highest institutional authority.
– Protect the University’s interests
– Manage the CoI
– Maintain the Public’s trust
Research Ethics Education
CITI Program
•
•
•
•
•
Human Subjects Protection
Good Clinical Practice.
Lab Animal Welfare.
Responsible Conduct of Research.
Bio-safety and Bio-security
– [email protected]
– 305 243-7970
CITI Laboratory Animal
Welfare Program
Investigators
IACUC Members
Lab Animal Welfare Course
Site Usage
2009
2008
sites
311
271
CRs
49,566
40,908
CR per month % increase
4,506
32%
3,409
LAW Courses 2009
Basic Courses
Working with the IACUC
Working with the VA IACUC
Essentials for IACUC Members
Working With Animals In Biomedical Research - Refresher
Course
LAW Courses Completed
2009
Model Specific Courses
Working with Mice in Research
Working with Rats in Research Settings
Reducing Pain and Distress in Laboratory Mice and Rats
Aseptic surgery
Working with Swine in Research Settings
Working with Rabbits in Research Settings
Working with Amphibians in Research Settings
Working with Nonhuman Primates in Research Settings
Working with Dogs in Research
Working with Guinea Pigs in Research Settings
Working with Hamsters in Research Settings
Working with Cats in Research Settings
Working with Gerbils in Research Settings
www.citiprogram.org
JosephonWright
3,“ 1734
- August
29,
1797),
“An Experiment
a Bird in(September
The Air Pump
by Joseph
Wright
(1734-1797)
British National Gallery- London