Transcript MUSC College of Graduate Studies Postdoctoral Retreat on the Responsible Conduct of Research “Misconduct & Whistleblower Protection” Ed Krug BioE 101 876-2404 [email protected].

MUSC College of Graduate
Studies
Postdoctoral Retreat on the
Responsible Conduct of Research
“Misconduct & Whistleblower
Protection”
Ed Krug
BioE 101
876-2404
[email protected]
052512
Singapore Statement on Research Integrity
2010 (51 countries represented)
Common Principals of Research Integrity:
• Honesty in all aspects of research
• Accountability in the conduct of research
• Professional courtesy and fairness in
working with others
• Good stewardship of research on behalf of
others
http://www.singaporestatement.org
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•
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•
Failure to report all data
Fabrication of data to match number of reported
subjects
Falsification of data on study report forms
Failure to report all adverse events/reactions or
serious adverse events/reactions related to the
study
"A large percentage of allegations of misconduct
received by ORI involves clinical research.” John
Dahlberg, HHS Office of Research Integrity
Titus et al. Nature 453:980-982
Evolution of RCR Training
1981 Congressional Interest (Gore et al.) in response to
several high profile cases
1987 Health Research Extension Act - institutional processes
to review scientific fraud
1989 Office of Scientific Integrity established
1992 NAS Report
1993 OSI became ORI - moved from NIH to HHS
1995 Ryan Commission - established RCR educational
programs and whistleblowers protection
1999 HHS required RCR training of all research staff (repealed
in 2001 on technicality - regulation vs. policy)
2005 ORI initiated training program of institutional research
integrity officials
http://academicdepartments.musc.edu/uco/code
_conduct.htm
Expectations
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Integrity
Compliance
Confidentiality
Reporting possible violations
According to the US HHS Office of
Research Integrity …
”Research misconduct means fabrication, falsification, or
plagiarism in proposing, performing, or reviewing research,
or in reporting research results.
(a) Fabrication is making up data or results and recording
or reporting them.
(b) 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.
(c) Plagiarism is the appropriation of another person’s
ideas, processes, results, or words without giving
appropriate credit.
(d) Research misconduct does not include honest error or
differences of opinion."
http://ori.hhs.gov/
What do I do if I suspect misconduct?
A. Gawrylewski (2009) The Scientist 23:67.
Process for Addressing an Allegation of Research Misconduct:
1. Research Integrity Officer receives complaint.
2. Complainant interviewed by the inquiry committee.
3. Respondent notified in writing of the allegation and pertinent data records
sequestered.
4. Respondent interviewed by, and present evidence to, inquiry committee.
5. Deciding Official receives inquiry report and determines if an investigation
is warranted, and if so notifies PHS ORI within 30 days.
6. Complainant interviewed by the investigation committee.
7. Respondent interviewed by the investigation committee.
8. Any individuals pertinent to the investigation interviewed.
9. Investigation committee submits findings and recommendations to
Research Integrity Officer, who reports to the Deciding Official.
10. If misconduct has been found, the Deciding Official determines what
administrative actions are appropriate and reports to the PHS ORI.
11. The PHS ORI determines whether or not to accept the Deciding Officials
report. If the report is not acceptable, the investigation continues until the
PHS ORI is satisfied.
12. The PHS ORI may post findings of research misconduct on their website.
MUSC Confidential Hotline
800-296-0269
Report any activity reasonably believed in violation of
any law or regulation, any MUSC policy, or any Federal
or State healthcare requirement by means of the
Confidential Hotline: 1-800-296-0269
(toll free, available 24 hours, 7 days a week).
The Confidential Hotline is monitored by a third-party
vendor.
The Research Integrity Committee Investigates
Potential Research Misconduct
http://academicdepartments.musc.edu/research/ori/ric/
The PHS Office of Research Integrity Is a Great Resource
http://ori.hhs.gov
Principles of ORI Whistleblower’s Bill of Rights
1) whistleblowers are free to disclose lawfully whatever information
supports a reasonable belief of research misconduct as it is defined by
PHS policy,
2) institutions have a duty not to tolerate or engage in retaliation against
good-faith whistleblowers,
3) institutions have a duty to provide fair and objective procedures for
examining and resolving complaints, disputes and allegations of
research misconduct,
4) institutions have a duty to follow procedures that are not tainted by
partiality arising from personal or institutional conflict of interest or other
sources of bias,
5) institutions have a duty to elicit and evaluate fully and objectively
information about concerns raised by whistleblower,
6) institutions have a duty to handle cases involving alleged research
misconduct as expeditiously as possible without compromising
responsible resolutions, and
7) at the conclusion of proceedings, institutions have a responsibility to
credit promptly, in public or private as appropriate, those whose
allegations are substantiated.
http://ori.hhs.gov/misconduct/Guidelines_Whistleblower.shtml
US Dept. Health & Human Services Office
of Research Integrity
http://ori.dhhs.gov/education/
National Center for Professional &
Research Ethics
http://nationalethicscenter.org/
MUSC Office of Research Integrity
http://research.musc.edu/ori/index.html
Take home messages
The goal of training in the responsible
conduct of research is to promote a general
awareness of professional norms in
scientific research, as well as encourage a
life-long attention to the ethical
underpinnings from which they are derived.
It is much more than simply
following the rules!
Emotion can detect problems, but logic is a
much better approach to resolve them
Issues or Points of Conflict
• What are the situations in which the rights or obligations of
interested parties are in conflict?
Interested Parties
• Who other than those directly presented in the conflict have
an interest?
Consequences of Action
• Identify those that have the highest probability of occurring or
the greatest impact first
Obligations
• What are the responsibilities of each individual to other
interested parties?
• Are these grounded in moral considerations or are they a
rationalization?
Be cognizant of ASSUMPTIONS – then
validate, refute or modify as needed!
“The truth of the matter is that you always
know the right thing to do. The hard part is
doing it.” – General Norman Schwarzkopfdf
VS.
http://walt.foreignpolicy.com/files/in
tegrity51417692.jpg
http://nickshell1983.files.wordpress.com/2010/09/g0130
09blago1_cst_feed_20090129_16_28_37_1500h400w3
06.jpeg
• Research “norms” can
vary due to local culture
and are sometimes
questionable when
viewed in a larger
context
• True “research norms”
evolve over time
PI
staff &
trainees
department
or division
institution
community of practice
public/society
Successful teams are diverse
"Innovation provides the seeds for economic
growth, and for that innovation to happen
depends as much on collective difference as on
aggregate ability. If people think alike then no
matter how smart they are they most likely will
get stuck at the same locally optimal solutions.
Finding new and better solutions, innovating,
requires thinking differently. That ’ s why
diversity powers innovation.“
- Scott E. Page, Professor,
University of Michigan
If problems arise…
“May I speak with you confidentially?”
“Thank you for being able to speak with you
confidentially.”
MUSC Postdoctoral Retreat CITI RCR
Certification Requirement
Due by 11 PM Friday December 19, 2014
(80% minimum score to pass)
1. Go to www.musc.edu/cgi-bin/citi/login.cgi
2. Log in with your NetID and password
3. Select “Biomedical Responsible Conduct of Research
Course 1”
4. Email an electronic version of your certificate of
completion to me ([email protected])