1. The Tri-council Framework On Responsible Conduct In Research A Panel Member And Researchers Perspective Marc F. Joanisse, Ph.D. U. Western Ontario Karen Wallace Secretariat on Responsible Conduct of Research

2. Governance of Responsible Conduct of Research in Canada Highlights of the Tri-Agency Framework: Responsible Conduct of Research Responsibilities of researchers, institutions and Agencies in the Responsible Conduct of Research (RCR) Overview

3. Governance of RCR in Canada Based on policy, not regulatory authority; enforced through funding Institutions are eligible to receive and administer Agency funding on condition that they comply with and enforce Agency policies Researchers must follow Agency policies as a condition of funding (set out in application/funding agreement)

4. Governance Structure Panel on Responsible Conduct of Research (PRCR) Secretariat on Responsible Conduct of Research (SRCR)

5. Volunteer, independent body Members appointed by Agency Presidents drawn from a range of disciplines and professional backgrounds, including institutional administrators experienced in addressing research integrity issues Advises the three Agency Presidents Panel on Responsible Conduct of Research (PRCR)

6. PRCR mandate Review institutional inquiry/investigation reports with all identifying information removed Recommend recourse to Agency Presidents for final decision Promote responsible conduct through education Provide advice to Agencies on responsibility matters Review Framework every five years Recommend revisions to Framework

7. Secretariat on Responsible Conduct of Research (SRCR) Formerly Secretariat on Research Ethics Responsible for human research ethics and responsible conduct of research on behalf of the Agencies Central point of contact for all matters related to RCR for all three federal research Agencies CIHR, NSERC, SSHRC

8. Secretariat on Responsible Conduct of Research (SRCR) Main RCR responsibilities include: Supporting Panel on Responsible Conduct of Research (PRCR) Promoting RCR through interpretation and education Following up with Institutions to make certain that investigations are conducted in a timely fashion and in accordance with their RCR policies Briefing PRCR and Agency Presidents on RCR files Directing allegations to appropriate bodies

9. RCR Framework: Highlights Foundation of Framework: Responsible Conduct of Research RCR is broader than the traditional definition of research integrity Scope of breaches broader than FFP Intentionality not relevant re breach, only relevant with respect to recourse Investigation committees must have at least one external member (not currently affiliated with the Institution) Especially re: expert assessment – important to avoid appearance of COI Inquiries and investigations now have timelines 2 months for an inquiry additional 5 months for an investigation

10. Scope of the Framework Applies to researchers holding Tri-Council funds And to institutions eligible to administer those funds

11. Establish and enforce Responsible Research policy Framework applies to all research conducted under the auspices or jurisdiction of the institution – regardless of source of funding So – institutions must address all allegations in accordance with the minimum requirements of the Framework Through initial inquiry And, if necessary, formal investigation Report to Agencies if Agency funding is involved Institutional Responsibilities

12. Institutional reporting requirements Institutions must report to the Secretariat: immediately when an allegation relates to activities funded by an Agency that may involve significant financial, health and safety, or other risks when the outcome of the inquiry is a confirmed breach and Agency funds are involved on the outcome of each investigation conducted related to Agency funds, regardless of the finding when the Secretariat is copied on an allegation (Institution to inform SRCR whether or not it is proceeding with an investigation) Institutions are not required to report to the Secretariat: on allegations that do not involve Agency funds on allegations involving Agency funds that are unsubstantiated following an inquiry (when the Secretariat was not copied on the allegation)

13. Verify that institutions have followed their own policies within Framework timelines Consider reports from institutions and determine whether to take recourse Disclose serious breaches (determination made by President) Main responsibilities of Agencies

14. Adapting institutional policies to comply with Framework June 2012 deadline – extended to end of 2012 Adding external members to investigation committees Cost; inconvenience; difficult to identify members Adherence to timelines 2 months for inquiries; additional 5 months for investigations Education Limited resources (human and material) Framework Implementation: Institutional Challenges

15. Assistance from the Agencies Advice from Secretariat Interpretations of the Framework Informal discussions re: investigations Educational resources (free) Basic RCR webinars Interactive on-line RCR tutorial (winter 2014 launch)

16. Researchers Framework provides guidance on what is acceptable conduct Emphasis not on wrongdoing, but on responsible behaviour Independent Panel promotes fairness and consistency Institutions clearer procedures and timelines Public greater transparency Fostering an Environment of Responsible Conduct

17. Promote research integrity Manage Agency funds responsibly Comply with Agency policies Provide true and accurate information to the Agencies Researcher Responsibilities

18. Breaches Include Fabrication, Falsification Destruction of research records Plagiarism, Redundant publication Invalid authorship, Inadequate acknowledgment Failure to manage conflicts of interest

19. Misrepresentation of data –E.g., falsification in grant applications, progress reports Mismanagement/misuse of funds Non-compliance of Agency policies –E.g., human ethics, animal care And…

20. Typically directed to the Respondents institution But could also be directed to Secretariat Either way, Institution performs the inquiry Allegations of Misconduct

21. 1.Institutional Investigation –An initial inquiry determines if an investigation is warranted –Investigation examines validity of allegation –Arms length committee investigates, reports findings to Secretariat How Are Allegations of Breaches Handled?

22. 2.Institution reports outcome to Secretariat –In a timely manner (see policies) –Report is only required if Agency funds are involved 3.PRCR meets to discuss outcome of institution report –Anonymized/redacted –Recommends recourse to the relevant Tri- Council President(s) Allegations cont.

23. Institution-level recourse is independent of PRCR decision/recourse. PRCR decision focuses on use of Agency funds –Research not falling under Tri-Council funding is outside its scope Scope of Decisions/Recourse

24. Letter of concern Funding ineligibility for a defined period Terminate/seek refund of funds already paid Ineligibility to serve on agency committees Request researcher correct research record Other recourse possible by law Potential Agency Recourse

25. Launch an independent investigation –Always the Institutions responsibility Recommend institution-level recourse –Recourse is only what can be implemented at the Tri-Council level –Institutions can provide own recourse if warranted Respond to allegations concerning activities not funded through Tri-council What the Panel Cant Do

26. Issue a letter of concern Declare the researcher ineligible to apply for funding for a defined time period or indefinitely Terminate remaining instalments of the grant or award Seek a refund of all or part of the funds already paid Declare the researcher ineligible to serve on agency committees (e.g., peer review, advisory boards) Request that the researcher correct the research record Other recourse available by law Possible Recourse to Researchers

27. A postdoctoral fellow applies for NSERC funding, listing a publication as in press that is in fact not accepted for publication. A peer reviewer notices that this publications doesnt appear to exist. Is this a problem? How big? Case Study #1

28. Yes – its a breach of policy. At time of application the individual accepts to comply with the Framework. –Even small embellishments represent a significant breach Sample recourse: Applicant is declared ineligible to hold funding for 2 years. Case Study #1 (cont.)

29. Following publication of a study in a journal, a PI discovers some of the reported data was likely falsified by a lab member. PI fails to report the breach to the Institution in a timely manner. Institution discovers the breach when they read about it in Retraction Watch website. Case Study #2

30. Both the PI and lab member are potential respondents in an investigation –PI appears to have known about the breach and fail to report it. Institution recommends recourse for both, individuals –But must also communicate findings with Secretariat since study was Tri-Council funded Case Study #2 Cont.

31. Lab member is deemed ineligible to hold Tri-Council funds or sit on an Agency peer review panel for life PI is deemed ineligible for 2 years Institution must repay remaining portion of the award Case Study 2: Recourse

32. Questions? SECRETARIAT ON RESPONSIBLE CONDUCT OF RESEARCH Tel.: 613 996-0072 secretariat@rcr.ethics.gc.ca www.rcr.ethics.gc.ca