The Institutional Perspective

1. Tri-Agency Framework: Responsible Conduct of Research – Building an Environment of Research Integrity The Institutional Perspective Mary Childs, Legal Counsel University of Guelph, November 2013

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. The Framework Mary Childs, Legal Counsel University of Guelph, November 2013

10. Good people do not need laws to tell them to act responsibly, while bad people will find a way around the laws.Plato Mary Childs, Legal Counsel University of Guelph, November 2013

11. 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

12. 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

13. 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

14. 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….. • Rectifying a breach • Obligation to be proactive in rectifying it Responsibilities of the Researcher…… Mary Childs, Legal Counsel University of Guelph, November 2013

15. 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

16. 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

17. 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

18. 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

19. 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

20. R. 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. Mary Childs, Legal Counsel University of Guelph, November 2013