The Institutional Perspective
Mary Childs, Legal Counsel University of
Guelph, November 2013
If we knew what it was we were doing, it would not be called research, would it?
Albert Einstein
Mary Childs, Legal Counsel University of
Guelph, November 2013
 The need for policies……..
 Piltdown Man 1912
 – “missing link” between apes and man
found in Sussex, England….the “missing
link” had the skull of a modern man
and the jaw of an orangutan. The teeth
had been filed and the bones
chemically aged.
 Obviously, the researchers were
“missing” something as well.
Mary Childs, Legal Counsel University of
Guelph, November 2013
 1950-1970 – Project MKUltra
 CIA supported experiments which
included a number of illegal activities
including the surreptitous administration
of LSD and chemicals to unsuspecting test
subjects
 research undertaken at 80 institutions,
including 44 colleges and universities
including McGill
 Became associated with the widespread
destruction of most records, lack of
informed consent for thousands of
participants, the uncontrolled nature of
the experiments, and the lack of follow-up
data.
 Results included incontinence, amnesia,
paranoia and several deaths.
Precedents
Mary Childs, Legal Counsel University of
Guelph, November 2013
 Painting by numbers 1974
 William Summerlin, researcher at
Memorial Sloan-Kettering Cancer Center
in NYC
 claimed to have shown success with skin
transplants between genetically unrelated
animals by transplanting fur of black
mouse to white mouse
 It was discovered that a black marker had
more to do with black patches than
transplantation
Precedents
Mary Childs, Legal Counsel
University of Guelph, November 2013
 1998 Andrew Wakefield – conflict
of interest
 Medical researcher famous for his study
linking the Measles/ Mumps/Rubella
(MMR) vaccine to the onset of autism
 In addition to the findings of fabrication
and falsification, it was also revealed that
Wakefield planned to launch a financial
venture to provide new medical tests
associated with the study results.
Precedents
Mary Childs, Legal Counsel
University of Guelph, November 2013
 Hwang Woo-Suk, South Korean
veterinarian and research
 Published two papers in Science (2004
and 2005)reporting his ability to produce
human stem cell lines using cloned
embryos from patients suffering from
spinal-cord injury
 Data was fabricated or falsified. Human
eggs for the research were provided by
two of his research assistants
 2009 – after a three year trial, he was
found guilty of embezzling research funds
and illegally purchasing human eggs. He
received a two-year suspended jail
sentence and later moved to Libya.
Precedents
Mary Childs, Legal Counsel
University of Guelph, November 2013
 January 22, 2013 on-line article in
The Scientist, reporting on a study
published in mBio by Joan Bennett
et al of Rutgers University
 Study of 228 individuals found
guilty of research misconduct by
the Office or Research Integrity
(ORI) between 1994-2012
 88% of fraud committed by faculty
in the life sciences were by male
faculty and 60% of the misconduct
was conducted by senior research
personnel compared to students
and postdocs.
 One on-line comment to the article
indicated that women were just
more covert and manipulative
Mary Childs, Legal Counsel University of
Guelph, November 2013
Mary Childs, Legal Counsel University of
Guelph, November 2013
Mary Childs, Legal Counsel University of
Guelph, November 2013
 Introduction/Scope/Objectives
 Ensure funding decisions are based on
accurate and reliable information
 Ensure funds are used responsibly
 Promote and protect the quality,
accuracy and reliability of funded
research
 Promote fairness in the conduct of
research
 Body of the Agreement
 Responsibilities of the Researchers –
section 2
 Responsibilities of the Institution –
section 4
 Responsibilities of the Agencies – section
6
Mary Childs, Legal Counsel
University of Guelph, November 2013
1.
Promoting Research
Integrity (positive
obligation)
 High level of rigour
 Complete and accurate
records
 Referencing and obtaining
permission for use
 Authorship
 Acknowledging
contributions
 Managing conflict of
interest
Responsibilities
of the
Researcher –
5 categories
Mary Childs, Legal Counsel
University of Guelph, November 2013
2. Applying for and Holding
Funding
 Provide true and complete
info on application
 Certify not otherwise
ineligible
 Ensure others listed have
agreed to be included
3. Management of
awards/funding
 MOU on Roles and
Responsibilities in the
Mgmt of Federal Grants
and Awards
 Individual funding
agreements
Responsibilities
of the
Researcher….
Mary Childs, Legal Counsel
University of Guelph, November 2013
4.
Compliance with other
policies
 Include but not limited to 8
other policies or
guidelines…Ethical Conduct
of Research Involving
Humans, CCAC Policies and
Guidelines, Cdn
Environment Assessment
Act, Laboratory Biosafety
guidelines…..
5.
Responsibilities
of the
Researcher……
Rectifying a breach
 Obligation to be
proactive in rectifying
it
Mary Childs, Legal Counsel
University of Guelph, November 2013
1. Including but not limited
to …..
 Fabrication
 Falsification
 Destruction of research
records
 Plagiarism
 Redundant publications
 Invalid authorship
 Inadequate
acknowledgment
 Mismanagement of Conflict
of interest
Breaches by
Researchers –
4 categories
Mary Childs, Legal Counsel
University of Guelph, November 2013
2. Misrepresentation in an
application or related
document
3. Mismanagement of funds
4. Breaches of other policies
for certain types of research
 Role of Individs. re allegations
 “Responsible
allegations….should be
sent….”
Breaches by
Researchers…
Mary Childs, Legal Counsel
University of Guelph, November 2013
 Definition includes actual,
perceived and potential
 No absolute ban
 Identify, report and decide
 Activity to cease
 Activity to continue with
parameters
 Activity to continue with no
parameters
 Institutional definitions
Mary Childs, Legal Counsel
University of Guelph, November 2013
 Abide by MOU on Roles and
Responsibilities in Mgmt of
Federal Grants and awards
(“MOU”)*
 Promotion of responsible
conduct
 Obligation to develop and
administer policies to
address allegations of breach
 Reporting of allegations to
Agencies
 Promoting awareness and
education
 Breaches by the institution
 Addressed under MOU
Responsibilities
of
Institutions
Mary Childs, Legal Counsel
University of Guelph, November 2013
 Communicating, promoting,
reviewing…
 Process for Addressing
allegations
 Receiving allegations
 Review of Institutional
Reports
 Recourse
 Request correction of
research record, refuse
future applications,
terminate present
installments, seek refund,
other recourse under law
 Accountability and
Reporting
 Includes public disclosure
in cases of serious breach
Responsibilities
of the
Agencies
Mary Childs, Legal Counsel
University of Guelph, November 2013
I firmly believe that
you live and learn,
and if you don't learn
from past mistakes,
then you need to be
drug out and shot.
Mary Childs, Legal Counsel University of
Guelph, November 2013