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Mary Childs, Legal Counsel University of Guelph, November 2013
The Institutional Perspective
Tri-Agency Framework:
Responsible Conduct of Research – Building
an Environment of Research Integrity
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.
Precedents
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
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
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
Research on Research
Misconduct
Mary Childs, Legal Counsel University of Guelph, November 2013
The Framework
Mary Childs, Legal Counsel University of Guelph, November 2013
Good people do not need laws to tell them to act responsibly, while bad people will find a way around the laws.
Plato
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
Parts of the Contract
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 included3. 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. Rectifying a breach Obligation to be
proactive in rectifying it
Responsibilities of the
Researcher……
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 document3. Mismanagement of funds4. 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
Conflict of Interest
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
Mary Childs, Legal Counsel University of Guelph, November 2013
Click icon to add pictureR. Lee Emery
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.