Promoting Scientific Integrity at Health Canada

Health Sant
Canada Canada

Zubin Master, Ph.D.

Research Policy and Outreach Division, Science Policy Directorate, Strategic Policy Branch, Health Canada

Aim

To develop a scientific integrity (SI) framework for Health Canada (HC) with the aim to mitigate the
risks related to scientific misconduct.

Health Canadas Draft Scientific Integrity Framework

The HC SI Framework has four components:

(i) SI Policy

Background

Health Canada
Scientific Integrity
Framework

Integrity in Non-Governmental Organizations

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 CouncilNSERC; Social Sciences and Humanities
Research CouncilSSHRC; and Canadian Institutes of Health ResearchCIHR).
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 2009.

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
Canadas publication policy5.
Several instances of misconduct have been reported in Canada and at present, HC does not have
a specific SI policy.

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

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.
Policies include TriCouncil 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.

Covers integrity
related to the conduct
and presentation of
research.

Research
Integrity

Scientific
Integrity
Professional
Integrity

Covers research
integrity and includes
how science is
interpreted and used
during policy
development or
evaluation.
Covers science &
research integrity and
includes other
professional conduct
in the workplace.

(ii) Procedure
for Handling
Misconduct

(iii) Mentorship
Guide

(iv) SI
Training

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.
Illustration obtained from
www.gifted.ucon.edu

5) Breach of Loyalty

Premature reporting of scientific information may harm the health and safety of Canadians, cause
confusion or fear or waste peoples 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.

Approach and Methods

7) Misinterpretation of Scientific Data During Regulatory Examination

Scientific Integrity Policy

(i)
(ii)

Policies are developed to influence behavior

Issues that cause risk of scientific misconduct were identified:
through the analysis of case studies of scientific misconduct,
by performing an environmental scan of national and international governmental and nongovernmental policies and practices of scientific or research integrity, and
(iii) by reviewing the academic literature on scientific and research integrity.
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.

Procedure for Handling Allegations of Scientific Misconduct

Several procedures for handling misconduct from different organizations were examined i.e.,
NRC2, CFIA3, AAFC4, U.S. 42CFR936, the University of Toronto7.
HC Human Resources (HR) and Legal Services Unit were consulted.

Results

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.

Procedure for Handling 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.
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.
Concern

Notification

Scientific Integrity Policy

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 nonmandatory requirements and (ii) educate and prevent potential scientific misconduct.

Stage 1:
Prelim Assessment
Within Scope of Policy

No

Outside Scope
of Policy

Yes

Stage 2:
Fact Finding

Stage 3:
Review Committee

Stage 4:
Outcome Determin.

Stage Five
Resolution

Appeal

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

Scientific Integrity Policy

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.

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.

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.

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.

Next Steps

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.

References
1. Tri-Council Policy Statement: Integrity in Research and Scholarship. 2007. http://www.nserc.ca/professors_e.asp?
nav=profnav&lbi=p9&format=print
2. National Research Council. September 9, 2008. Proposed NRC Research Integrity Policy.
3. Canadian Food Inspection Agency. February 26, 2008. 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, 2006. Science Ethics Policy Framework. Pp. 1-27.
5. Environment Canada. June 2008. The Environment Canada Publication Policy. Pp. 1-20.
6. 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, 2007. Pp. 587-615. UKRIO
7. University of Toronto Governing Council. November 27, 2006. Framework to Address Allegations of Research Misconduct.
http://www.research.utoronto.ca/policies/index.html
8. Health Canada. January 30, 2009. Health Canadas 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.