MUSC College of Graduate Studies Postdoctoral Retreat on the Responsible Conduct of Research...
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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
MUSC College of Graduate Studies Postdoctoral Retreat on the Responsible Conduct of Research “Misconduct & Whistleblower Protection” Ed Krug BioE 101 876-2404
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
Slide 2
Common Principals of Research Integrity: Honesty in all aspects
of researchHonesty in all aspects of research Accountability in the
conduct of researchAccountability in the conduct of research
Professional courtesy and fairness in working with
othersProfessional courtesy and fairness in working with others
Good stewardship of research on behalf of othersGood stewardship of
research on behalf of others Singapore Statement on Research
Integrity 2010 (51 countries represented)
http://www.singaporestatement.org
Slide 3
Common lapses in research integrity in human subjects research
Failure to report all data Failure to report all data Fabrication
of data to match number of reported subjects Fabrication of data to
match number of reported subjects Falsification of data on study
report forms Falsification of data on study report forms Failure to
report all adverse events/reactions or serious adverse
events/reactions related to the study Failure to report all adverse
events/reactions or serious adverse events/reactions related to the
study Titus et al. Nature 453:980-982 "A large percentage of
allegations of misconduct received by ORI involves clinical
research. John Dahlberg, HHS Office of Research Integrity
Slide 4
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required RCR training of all research staff (repealed in 2001 on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 Evolution of
RCR Training
Slide 5
MUSC Code of Conduct
http://academicdepartments.musc.edu/uco/code
_conduct.htmExpectations IntegrityIntegrity ComplianceCompliance
ConfidentialityConfidentiality Reporting possible
violationsReporting possible violations
Slide 6
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 persons ideas, processes, results, or
words without giving appropriate credit. (d) Research misconduct
does not include honest error or differences of opinion." According
to the US HHS Office of Research Integrity http://ori.hhs.gov/
Slide 7
A. Gawrylewski (2009) The Scientist 23:67. What do I do if I
suspect misconduct?
Slide 8
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
12.The PHS ORI may post findings of research misconduct on their
website.
Slide 9
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.
Slide 10
The Research Integrity Committee Investigates Potential
Research Misconduct
http://academicdepartments.musc.edu/research/ori/ric/
Slide 11
The PHS Office of Research Integrity Is a Great Resource
http://ori.hhs.gov
Slide 12
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. Principles of ORI Whistleblowers
Bill of Rights
http://ori.hhs.gov/misconduct/Guidelines_Whistleblower.shtml
Slide 13
http://ori.dhhs.gov/education/ National Center for Professional
& Research Ethics http://nationalethicscenter.org/ US Dept.
Health & Human Services Office of Research Integrity MUSC
Office of Research Integrity
http://research.musc.edu/ori/index.html
Slide 14
Take home messages
Slide 15
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!
Slide 16
Issues or Points of Conflict What are the situations in which
the rights or obligations of interested parties are in
conflict?What are the situations in which the rights or obligations
of interested parties are in conflict? Who other than those
directly presented in the conflict have an interest?Who other than
those directly presented in the conflict have an interest?
Interested Parties Consequences of Action Identify those that have
the highest probability of occurring or the greatest impact
firstIdentify 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?What are the responsibilities of each individual to other
interested parties? Are these grounded in moral considerations or
are they a rationalization?Are these grounded in moral
considerations or are they a rationalization? Emotion can detect
problems, but logic is a much better approach to resolve them
Slide 17
Be cognizant of ASSUMPTIONS then validate, refute or modify as
needed!
Slide 18
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 VS. The
truth of the matter is that you always know the right thing to do.
The hard part is doing it. General Norman Schwarzkopfdf
Slide 19
Research norms can vary due to local culture and are sometimes
questionable when viewed in a larger contextResearch norms can vary
due to local culture and are sometimes questionable when viewed in
a larger context True research norms evolve over timeTrue research
norms evolve over time Individual Integrity public/society
community of practice institution department or division staff
& trainees PI
Slide 20
"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. Thats why diversity powers
innovation. - Scott E. Page, Professor, University of Michigan
Successful teams are diverse
Slide 21
If problems arise May I speak with you confidentially? Thank
you for being able to speak with you confidentially.
Slide 22
MUSC Postdoctoral Retreat CITI RCR Certification Requirement
Due by 11 PM Friday December 19, 2014 (80% minimum score to pass)
1. Go to 1. Go to
www.musc.edu/cgi-bin/citi/login.cgiwww.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 () 4. Email an
electronic version of your certificate of completion to me
([email protected])[email protected]