Aim Zubin Master, Ph.D. To develop a scientific integrity (SI) framework for Health Canada (HC) with the aim to mitigate the risks related to scientific misconduct. Health Santé Canada Health Canada Scientific Integrity Framework (iv) SI Training Next Steps Promoting Scientific Integrity at Health Canada There is no specific legislation or policy that governs SI in Canada. For non-governmental research organizations, the Tri-Council Policy Statement: Integrity in Research and Scholarship (TCPS-I) 1 governs the ethical conduct of research and scholarship in all disciplines with individuals in research institutions who receive federal funds from the tri-Agencies (Natural Sciences and Engineering Research Council–NSERC; Social Sciences and Humanities Research Council–SSHRC; and Canadian Institutes of Health Research–CIHR). Research Policy and Outreach Division, Science Policy Directorate, Strategic Policy Branch, Health Canada References Background 1.Tri-Council Policy Statement: Integrity in Research and Scholarship National Research Council. September 9, Proposed NRC Research Integrity Policy. 3.Canadian Food Inspection Agency. February 26, Policy on the Responsible Conduct of Research and Development and Related Scientific Activities in, and for, the Canadian Food Inspection Agency. 4.Agriculture Agri-Food Canada. November, Science Ethics Policy Framework. Pp Environment Canada. June The Environment Canada Publication Policy. Pp Code of Federal Regulations. Title 42 Public Health. Chapter 1 Public Health Service, Department of Health and Human Services. Part 93 Public Health Services Policies on Research Misconduct. Revised October 1, Pp UKRIO 7.University of Toronto Governing Council. November 27, Framework to Address Allegations of Research Misconduct. 8.Health Canada. January 30, Health Canada’s Research Ethics Board Ethical Review of Research Involving Humans: Administrative Policy and Procedures Manual. Pp Health Canada. January 22, Health Canada Ottawa – Animal Care Committee Policies and Procedures. Pp Integrity in Non-Governmental Organizations Universities and research institutions who receive tri-Agency funds may have adopted the TCPS-I or have adapted the policy for their particular type of research. Moreover, various research institutions may also have established a procedure for handling allegations of misconduct. Canadian Research Integrity Committee (CRIC) The CRIC representing 16 major government and non-governmental organizations across Canada was created to determine the value of a broad Canadian approach to address issues of SI and misconduct. In January 2007, the CRIC held a workshop which concluded that Canada did not have a common system of governance of research integrity and identified a need to review definitions, policies, procedures, and training practices. The CRIC awarded a contract to Hickling, Aurthurs, Low (HAL) through a competition process to survey the Canadian and international research integrity policies, procedures, and training practices and a final report is expected to be delivered in May Integrity in Federal Science-Based Departments and Agencies Although the Values and Ethics Code for the Public Service does speak about professional conduct, there is no specific government-wide science or research integrity policy or code. Some science-based Departments and Agencies i.e., National Research Council (NRC) 2, Canadian Food Inspection Agency (CFIA) 3, and Agriculture Agri-Food Canada (AAFC) 4 have specific research integrity policies and common mechanisms to handle allegations of research misconduct. Other Departments may govern specific aspects in the conduct of science i.e., Environment Canada’s publication policy 5. Several instances of misconduct have been reported in Canada and at present, HC does not have a specific SI policy. Spheres of Integrity HC conducts research and uses science during regulatory examination and for policy development. Different policies within HC, for the federal public service, and guidelines from other organizations have different impacts on different areas of HC business. Professional Integrity Scientific Integrity Research Integrity Covers science & research integrity and includes other professional conduct in the workplace. Covers integrity related to the conduct and presentation of research. Covers research integrity and includes how science is interpreted and used during policy development or evaluation. Policies include Tri- Council Policy Statement for research involving humans. Both scientific and professional integrity include policies i.e., Values and Ethics Code for the Public Servant or Our Code of Conduct, HC. Risks of Scientific Misconduct at Health Canada  Health and safety of Canadians  Diminishes public trust in the conduct of science and health research at HC and in the scientific enterprise more generally  Decreases trust amongst scientists at HC  Discredits the scientist(s) involved and jeopardizes the reputation and credibility of HC and how it is managed  Misuse of public finds  Legal liability  Associated administrative, legal, and financial costs Health Canada’s Draft Scientific Integrity Framework The HC SI Framework has four components: (i) SI Policy (ii) Procedure for Handling Misconduct Policies are developed to influence behavior Issues that cause risk of scientific misconduct were identified: (i) through the analysis of case studies of scientific misconduct, (ii) by performing an environmental scan of national and international governmental and non- governmental policies and practices of scientific or research integrity, and (iii) by reviewing the academic literature on scientific and research integrity. Approach and Methods Scientific Integrity Policy (iii) Mentorship Guide Identified issues that undermine scientific integrity were discussed with the Scientific Integrity Working Group at Health Canada and with Senior Management Board-Science. A mixture of instruments were used i.e., Mentorship Guide, training course, and policy. Several discussions and consultations were held and are ongoing to discuss the components of the SI Policy and the mechanism to handle allegations of scientific misconduct. Results Scientific Integrity Policy Procedure for Handling Allegations of Scientific Misconduct Several procedures for handling misconduct from different organizations were examined i.e., NRC 2, CFIA 3, AAFC 4, U.S. 42CFR93 6, the University of Toronto 7. HC Human Resources (HR) and Legal Services Unit were consulted. The SI Policy should be broad to cover research, regulatory examination, and the use of scientific information at HC. The scope of the policy should target researchers, regulators, and decision-makers at HC and will focus around scientific and research integrity, not professional conduct. The SI Policy is meant to (i) influence behavior through a series of either mandatory or non- mandatory requirements and (ii) educate and prevent potential scientific misconduct. Issues that Potentially Undermine Scientific Integrity Several issues related to the conduct of research and the use of science during regulatory examination and decision-making were identified: Research Integrity Issues  Fabrication, falsification, plagiarism (FFP)  Unfair authorship credit & poor publication practices  Failure to respect research subjects (human and animal)  Poor mentoring  Poor data management  Inadequate peer review of research proposals Scientific Integrity Issues Minus Research Integrity  Breach of loyalty  Inappropriate consideration or delivery of scientific information during decision-making  Misinterpretation of scientific data during regulatory examination  Reporting bad faith allegations and inappropriate reprisal 1) Fabrication, Falsification & Plagiarism (FFP) All of the national and international policies examined prohibit FFP as one of the most dishonest types of behaviors. SI Policy will define FFP & may prohibit FFP. Scientific Integrity Policy 3) Respect for Research Subjects Research involving human subjects must receive ethics review by the HC Research Ethics Board (REB) according to the HC REB Administrative Policy and Procedures Manual 8 prior to the commencement of the research. Research involving non-human animals must recieve ethics review by the HC Animal Care Committee (ACC) according to the HC Ottawa-ACC Policies and Procedures Manual 9. Illustration obtained from 4) Mentoring in Research HC may be developing a guide to mentoring in scientific research which will contain the characteristics of a good mentor i.e., availability, understanding, enthusiasm and encouragement, listening, challenging without intimidating, customizing to different needs, and others. 5) Breach of Loyalty Premature reporting of scientific information may harm the health and safety of Canadians, cause confusion or fear or waste people’s time. The SI Policy may provide guidance on when researchers can openly discuss ideas and results and when they should refrain from such discussions. 6) Consideration of Scientific Information During Decision-Making The SI Policy may contain a discussion on the use and delivery of scientific information based on the HC Decision-Making Framework. 7) Misinterpretation of Scientific Data During Regulatory Examination Intentional misinterpretation of data is dishonest behavior and the SI Policy may contain requirements to help ensure impartiality during regulatory examination including the declaration of conflicts of interest. 8) Good Faith Reporting & Protection Against Reprisal The SI Policy may contain provisions that make it a misconduct to report allegations of scientific misconduct dishonestly. Moreover, the SI Policy may have requirements which protect those individuals against reprisal who reported an allegation of scientific misconduct in good faith. Notification Appeal Stage Five Resolution Concern Outside Scope of Policy Within Scope of Policy Stage 1: Prelim Assessment Stage 2: Fact Finding Stage 3: Review Committee Stage 4: Outcome Determin. Yes No 2) Authorship and Publication Practices SI Policy may provide guidance on authorship credit, acknowledgements, republication of papers, and the disclosure of conflicts of interest in the peer review of research. Procedure for Handling Scientific Misconduct Feedback from the HC consultations with researcher and regulators will be taken into consideration to further refine the SI Policy. Further consultations will be taken with legal, HR, and unions; Scientific Integrity Working Group, specific units within HC. A draft SI Policy will be developed and reviewed by Senior Management Boards at HC. A guide to mentorship and an educational strategy will be developed. The issues of poor peer review of research proposals and poor data management practices which may undermine integrity will be dealt with later. Health Canada Research and Regulatory Consultations Two HC consultations with researchers and regulators were conducted in April 2009 to discuss the SI Policy in addition to discussions with legal services, HR and unions. The procedure for handling allegations of scientific misconduct is similar to other HR processes with the exception of having a 1) Designated Person-DP and 2) Scientific Review Committee-SRC. The DP serves a resource person both for the manager and for the employee. The SRC is designed to help the manager determine whether their was scientific misconduct.