Promoting Scientific Integrity at Health Canada
Health Santé Zubin Master, Ph.D.
Canada Canada
Research Policy and Outreach Division, Science Policy Directorate, Strategic Policy Branch, Health Canada
Aim Health Canada’s Draft Scientific Integrity Framework 4) Mentoring in Research
• To develop a scientific integrity (SI) framework for Health Canada (HC) with the aim to mitigate the • The HC SI Framework has four components: • HC may be developing a guide to mentoring in scientific research
risks related to scientific misconduct. which will contain the characteristics of a good mentor i.e., availability,
(ii) Procedure understanding, enthusiasm and encouragement, listening, challenging
(i) SI Policy for Handling without intimidating, customizing to different needs, and others.
Background Misconduct
5) Breach of Loyalty
Illustration obtained from www.gifted.ucon.edu
Health Canada
Integrity in Non-Governmental Organizations • Premature reporting of scientific information may harm the health and safety of Canadians, cause
Scientific Integrity confusion or fear or waste people’s time.
• There is no specific legislation or policy that governs SI in Canada.
• For non-governmental research organizations, the Tri-Council Policy Statement: Integrity in Framework • The SI Policy may provide guidance on when researchers can openly discuss ideas and results
Research and Scholarship (TCPS-I)1 governs the ethical conduct of research and scholarship in all (iii) Mentorship (iv) SI and when they should refrain from such discussions.
disciplines with individuals in research institutions who receive federal funds from the tri-Agencies Guide Training
6) Consideration of Scientific Information During Decision-Making
(Natural Sciences and Engineering Research Council–NSERC; Social Sciences and Humanities
Research Council–SSHRC; and Canadian Institutes of Health Research–CIHR). • The SI Policy may contain a discussion on the use and delivery of scientific information based on
the HC Decision-Making Framework.
• Universities and research institutions who receive tri-Agency funds may have adopted the TCPS-I Approach and Methods
or have adapted the policy for their particular type of research. Moreover, various research Scientific Integrity Policy 7) Misinterpretation of Scientific Data During Regulatory Examination
institutions may also have established a procedure for handling allegations of misconduct. • Intentional misinterpretation of data is dishonest behavior and the SI Policy may contain
• Policies are developed to influence behavior
requirements to help ensure impartiality during regulatory examination including the declaration of
Canadian Research Integrity Committee (CRIC) • Issues that cause risk of scientific misconduct were identified:
conflicts of interest.
(i) through the analysis of case studies of scientific misconduct,
• The CRIC representing 16 major government and non-governmental organizations across Canada (ii) by performing an environmental scan of national and international governmental and non- 8) Good Faith Reporting & Protection Against Reprisal
was created to determine the value of a broad Canadian approach to address issues of SI and governmental policies and practices of scientific or research integrity, and • The SI Policy may contain provisions that make it a misconduct to report allegations of scientific
misconduct. (iii) by reviewing the academic literature on scientific and research integrity. misconduct dishonestly.
• In January 2007, the CRIC held a workshop which concluded that Canada did not have a common
• Identified issues that undermine scientific integrity were discussed with the Scientific Integrity • Moreover, the SI Policy may have requirements which protect those individuals against reprisal
system of governance of research integrity and identified a need to review definitions, policies,
Working Group at Health Canada and with Senior Management Board-Science. who reported an allegation of scientific misconduct in good faith.
procedures, and training practices.
• The CRIC awarded a contract to Hickling, Aurthurs, Low (HAL) through a competition process to • A mixture of instruments were used i.e., Mentorship Guide, training course, and policy.
survey the Canadian and international research integrity policies, procedures, and training practices • Several discussions and consultations were held and are ongoing to discuss the components of Procedure for Handling Scientific Misconduct
and a final report is expected to be delivered in May 2009. the SI Policy and the mechanism to handle allegations of scientific misconduct. • 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.
Integrity in Federal Science-Based Departments and Agencies Procedure for Handling Allegations of Scientific Misconduct • The DP serves a resource person both for the manager and for the employee.
• Although the Values and Ethics Code for the Public Service does speak about professional • Several procedures for handling misconduct from different organizations were examined i.e., • The SRC is designed to help the manager determine whether their was scientific misconduct.
conduct, there is no specific government-wide science or research integrity policy or code. NRC2, CFIA3, AAFC4, U.S. 42CFR936, the University of Toronto7.
• Some science-based Departments and Agencies i.e., National Research Council (NRC)2, • HC Human Resources (HR) and Legal Services Unit were consulted. Concern
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.
Results Notification
• Other Departments may govern specific aspects in the conduct of science i.e., Environment Scientific Integrity Policy
Stage 1:
Canada’s publication policy5. • The SI Policy should be broad to cover research, regulatory examination, and the use of scientific Prelim Assessment
• Several instances of misconduct have been reported in Canada and at present, HC does not have information at HC.
No
a specific SI policy. • The scope of the policy should target researchers, regulators, and decision-makers at HC and will Within Scope of Policy
Outside Scope
of Policy
focus around scientific and research integrity, not professional conduct. Yes
Risks of Scientific Misconduct at Health Canada • The SI Policy is meant to (i) influence behavior through a series of either mandatory or non-
Stage 2: Stage 3: Stage 4: Stage Five
Health and safety of Canadians mandatory requirements and (ii) educate and prevent potential scientific misconduct. Fact Finding Review Committee Outcome Determin. Resolution
Appeal
Diminishes public trust in the conduct of science and health research at HC and in the scientific
enterprise more generally Issues that Potentially Undermine Scientific Integrity
Decreases trust amongst scientists at HC • Several issues related to the conduct of research and the use of science during regulatory
Discredits the scientist(s) involved and jeopardizes the reputation and credibility of HC and how it is examination and decision-making were identified:
managed
Misuse of public finds Research Integrity Issues Scientific Integrity Issues Minus Health Canada Research and Regulatory Consultations
Legal liability Fabrication, falsification, plagiarism (FFP) Research Integrity • Two HC consultations with researchers and regulators were conducted in April 2009 to discuss the
Associated administrative, legal, and financial costs Unfair authorship credit & poor publication Breach of loyalty SI Policy in addition to discussions with legal services, HR and unions.
practices Inappropriate consideration or delivery of
Failure to respect research subjects (human scientific information during decision-making
and animal) Misinterpretation of scientific data during
Next Steps
Spheres of Integrity Poor mentoring regulatory examination • Feedback from the HC consultations with researcher and regulators will be
• HC conducts research and uses science during regulatory examination and for policy Poor data management Reporting bad faith allegations and taken into consideration to further refine the SI Policy.
development. Inadequate peer review of research proposals inappropriate reprisal • Further consultations will be taken with legal, HR, and unions; Scientific
• Different policies within HC, for the federal public service, and guidelines from other organizations Integrity Working Group, specific units within HC.
have different impacts on different areas of HC business. • A draft SI Policy will be developed and reviewed by Senior Management
Policies include Tri- Covers integrity
Scientific Integrity Policy Boards at HC.
Council Policy related to the conduct 1) Fabrication, Falsification & Plagiarism (FFP) • A guide to mentorship and an educational strategy will be developed.
Statement for and presentation of
• The issues of poor peer review of research proposals and poor data
research involving research. • All of the national and international policies examined prohibit FFP as one of the most dishonest
humans. management practices which may undermine integrity will be dealt with later.
Research types of behaviors.
Integrity Covers research • SI Policy will define FFP & may prohibit FFP.
Both scientific and
integrity and includes
how science is References
professional integrity interpreted and used 2) Authorship and Publication Practices 1. Tri-Council Policy Statement: Integrity in Research and Scholarship. 2007.
include policies i.e., during policy • SI Policy may provide guidance on authorship credit, acknowledgements, republication of papers, http://www.nserc.ca/professors_e.asp?nav=profnav&lbi=p9&format=print
development or
Values and Ethics Scientific evaluation. and the disclosure of conflicts of interest in the peer review of research. 2. National Research Council. September 9, 2008. Proposed NRC Research Integrity Policy.
Code for the Public 3. Canadian Food Inspection Agency. February 26, 2008. Policy on the Responsible Conduct of Research and Development and
Servant or Our Code
Integrity
Related Scientific Activities in, and for, the Canadian Food Inspection Agency.
of Conduct, HC. Covers science & 3) Respect for Research Subjects 4. Agriculture Agri-Food Canada. November, 2006. Science Ethics Policy Framework. Pp. 1-27.
research integrity and
Professional includes other • Research involving human subjects must receive ethics review by the HC Research Ethics Board 5. Environment Canada. June 2008. The Environment Canada Publication Policy. Pp. 1-20.
Integrity 6. Code of Federal Regulations. Title 42 Public Health. Chapter 1 Public Health Service, Department of Health and Human
professional conduct (REB) according to the HC REB Administrative Policy and Procedures Manual8 prior to the Services. Part 93 Public Health Services Policies on Research Misconduct. Revised October 1, 2007. Pp. 587-615. UKRIO
in the workplace.
commencement of the research. 7. University of Toronto Governing Council. November 27, 2006. Framework to Address Allegations of Research Misconduct.
• Research involving non-human animals must recieve ethics review by the HC Animal Care http://www.research.utoronto.ca/policies/index.html
Committee (ACC) according to the HC Ottawa-ACC Policies and Procedures Manual9. 8. Health Canada. January 30, 2009. Health Canada’s Research Ethics Board Ethical Review of Research Involving Humans:
Administrative Policy and Procedures Manual. Pp. 1-82.
9. Health Canada. January 22, 2009. Health Canada Ottawa – Animal Care Committee Policies and Procedures. Pp. 1-9.