Policy 115 - Responsible Conduct of Research

Adoption

Date : Approved Senate 2014-2015.61 and Board of Governors 2015.60

Modifications
  • Date: 2020-02-18
    Instance of Approval: Senate
  • Date : 2020-02-24
    Instance of Approval: Board of Governors
     
Originating/Responsible Department : Office of the Vice-President, Research

RESPONSIBLE CONDUCT OF RESEARCH

PREAMBLE

The knowledge created through Research conducted by the University of Ottawa contributes to the intellectual, social, health and economic fabric of society. Our communities and society trust the integrity of our Researchers and have confidence in our institutional and individual compliance with the regulations, policies, practices and ethical norms which govern Research. The University of Ottawa recognizes its responsibility to provide an environment that supports and promotes the responsible conduct of research.

PURPOSE

1. The purpose of this Policy is to confirm the University of Ottawa’s continued commitment to the highest standards of integrity in all aspects of Research, including seeking funding, conducting Research and reporting the results.

APPLICATION AND SCOPE

2. Capitalized words and expressions used in this Policy have a corresponding meaning attributed to them as set out in the Definitions at Section 28 of this Policy and Section 42 of Procedure 29-2.

3. This Policy applies to all Members of the University Community engaged in Research under the University’s auspices or jurisdiction, regardless of the location of the Research.

4. This Policy does not replace, limit or supersede existing University of Ottawa collective agreement provisions or academic regulations.

5. A faculty may develop and adopt additional policies or procedures which must, at a minimum, meet and not conflict with the provisions of this Policy and of Procedure 29-2. The faculty council or the executive committee of the faculty shall be the depository of such additional policies and procedures. The faculty shall inform the Office of Research Ethics and Integrity of any such additional policies or procedures and shall ensure that they are publicly accessible.

6. Principal Investigators and Researchers, whose Primary Appointment is at a hospital or research institute affiliated with the University, shall be subject to the responsible conduct of research policy of such hospital or institute, except as indicated below for students. In the absence of such policy at the hospital or at the research institute, or if the hospital or research institute policy does not meet the standards of this Policy and Procedure 29-2, this Policy and Procedure 29-2 shall apply.

a) The Primary Appointment of students and Research Trainees working at a hospital or hospital-based research institute and whose work is being conducted in fulfillment of their academic programs such as thesis-related work shall be the University of Ottawa.

b) The Primary Appointment of students and Research Trainees working in an
employer-employee relationship at a hospital or hospital-based research institute to perform work outside of their academic programs shall be the hospital or hospital-based research institute.

POLICY

7. The University is committed to:

a) maintaining the highest standards of integrity in its research activities;

b) maintaining a research environment that promotes the responsible conduct of research and academic freedom;

c) fulfilling its responsibilities in upholding applicable legislation for the conduct of Research and the policies, rules, regulations and its contractual agreements with Research Sponsors and with the Agencies

8. The University recognizes its responsibility for promoting awareness and importance of responsible conduct of research.

9. The University has established minimum requirements for the responsible conduct of research and procedures for addressing Allegations as set out in Procedure 29-2 established under this Policy.

10. It is a collective responsibility of all Members of the University Community to promote a culture of high integrity standards in Research activities, to ensure responsible conduct of research and to abide by Applicable Laws for the conduct of Research and Research Sponsors’ Policies and/or Requirements.

11. Allegations of suspected Breaches of Responsible Conduct of Research, made in good faith, are a necessary and valuable service and individuals are expected to report in good faith any information pertaining to possible Breaches of Responsible Conduct of Research and to participate, as appropriate, in the Inquiry and/or Investigation to address such Allegations or Breaches.

12. The University provides and maintains a fair and timely process for reporting, investigating and addressing Allegations and determines consequences through collective agreement provisions or under Procedure 29-2 established under this Policy.

13. The University is committed to continuing its work with its affiliated hospitals and research institutes to harmonize the procedures for investigating and addressing Allegations.

14. The University will take appropriate preventative and corrective action, including academic sanctions, when a Breach of Responsible Conduct of Research occurs and will, where warranted, hold individuals responsible in accordance with applicable collective agreement provisions, terms of employment or other University Policies and Procedures.

15. A person may file or withdraw an Allegation pursuant to this Policy and its Procedure 29-2 without fear of reprisal or threat, except where paragraph 16 of this Policy applies.

16. Where the University has finally determined the Allegation is not made in good faith or is made with malice, the University will take appropriate preventative and corrective action, including academic sanctions, and will, where warranted, hold individuals responsible in accordance with applicable collective agreement provisions, terms of employment or other University Policies and Procedures.

CONFIDENTIALITY

17. Allegations will be treated in a confidential manner and in accordance with the provisions of any applicable collective agreement and having regard to applicable privacy legislation.

18. All individuals involved in an Allegation and the process for addressing such an Allegation must keep the matter confidential in order to safeguard individuals against unsubstantiated Allegations, to protect the rights of those involved in the Allegation and to preserve the integrity of the Inquiry and Investigation.

ACCOUNTABILITY

19. Throughout the process for addressing an Allegation, the Office of Research Ethics and Integrity shall be responsible for:

a) ensuring that the process for addressing an Allegation set out in Procedure 29-2 is dealt with in a timely manner and in accordance with Procedure 29-2

b) providing reports on the status and outcome of Inquiries and Investigations into an alleged Breach of Responsible Conduct of Research to the appropriate
bodies, including Research Sponsors, Agencies, the Secretariat on Responsible Conduct of Research or to the University’s Research Ethics Boards, as may be required, and having regard to confidentiality considerations and to applicable privacy legislation; and

c) preparing public statistical annual reports on confirmed findings of Breaches of Responsible Conduct of Research and action taken, subject to applicable privacy legislation.

20. The Office of the Vice-President, Research shall report to the Administrative Committee on all activities related to the promotion and implementation of Policy 115 - Responsible Conduct of Research and Procedure 29-2.

MPLEMENTATION AND REVIEW

21. The Vice-President, Research, is responsible for the implementation and review of this Policy and making recommendations for amendments to it for the final approval of the Senate and the Board of Governors.

22. The University, through its Administrative Committee and Senate Executive Committee, shall establish procedures relating to the implementation of this Policy including, without limitation, Procedure 29-2: Addressing Allegations of a Breach of Responsible Conduct of Research.

CONFLICT OF INTEREST

23. All parties involved in misconduct Allegations, Inquiries or Investigations shall reveal the presence of any and all potential, perceived or actual conflicts of interest. All parties involved in Inquiries or Investigations will have no potential, perceived or actual Conflicts of Interest.

24. If the person who would normally run an Inquiry or Investigation is in a Conflict of Interest, the Allegation should be addressed to the Director, Research Ethics and Integrity, who will consult the Vice-President, Research (or Provost and Vice-President, Academic Affairs, depending on the nature of the Allegation) so that a replacement can be chosen.

25. If the Allegation is made against the Director, Office of Research Ethics and Integrity or if the Director, Research and Integrity is in a Conflict of Interest, the Vice-President, Research will choose a replacement who will take on the duties of the Director, Office of Research Ethics and Integrity for the case.

26. If the Allegation is made against the Vice-President, Research or if the Vice-President, Research is in a Conflict of interest, a replacement will be chosen by the President.

27. If the Allegation is made against the President or if the President is in a Conflict of Interest, the Director, Office of Research Ethics and Integrity, acting through the Secretary-General, will consult the Chair of the Board of Governors to determine an appropriate course of action and process, consistent with the principles of this Policy.

DEFINITIONS

28. For the purposes of this Policy and Procedure 29-2 established under this Policy, the following words and expressions shall have the corresponding meaning as set out below and in Section 42 of Procedure 29-2. For the most part these definitions are based on the Tri-Agency Framework: Responsible Conduct of Research and do not replace or supersede existing definitions contained in applicable University of Ottawa collective agreement provisions:

Agency or Agencies: Refers to any one of the following or collectively as the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC) and the Social Sciences and Humanities Research Council of Canada (SSHRC).

Allegation: A declaration, statement, or assertion communicated in writing to the effect that there has been, or continues to be, a Breach of Responsible Conduct of Research, the validity of which has not been established.

Applicable Laws: An expression to encompass all of the laws, regulations, professional or disciplinary standards or guidelines, relating to Research or to investigating or addressing a Breach of Responsible Conduct of Research. Examples include the Tri-Agency Framework: Responsible Conduct of Research; the Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans (TCPS 2); Canadian Council on Animal Care Policies and Guidelines; Agency policies related to the Canadian Environmental Assessment Act; Licenses for Research in the field; Laboratory Biosafety
Guidelines; Controlled Goods Program; Canadian Nuclear Safety Commission (CNSC) Regulations; and Canada’s Food and Drugs Act; access to information and protection of privacy laws.

Breach of Responsible Conduct of Research: An expression used to encompass the following non-exhaustive list of actions, which does not include honest differences of opinion, in the carrying out of Research or scholarly activity:

a) Fabrication: Making up data, source material, methodologies or findings,
including graphs and images.

b) Falsification: Manipulating, changing, or omitting data, source material,
methodologies or findings, including graphs and images, without acknowledgement and which results in inaccurate findings or conclusions.

c) Destruction of research records: The destruction of one’s own or another’s Research Data or records to specifically avoid the detection of wrongdoing or in contravention of applicable funding agreements, University policies and/or laws, regulations and professional or disciplinary standards.

d) Plagiarism: Presenting and using another’s published or unpublished work, including theories, concepts, data, source material, methodologies or findings, including graphs and images, as one’s own, without appropriate referencing and, if required, without permission.

e) Redundant publications: The re-publication of one’s own previously published work or part thereof, or data, in the same or another language, without
adequate justification or acknowledgment of the source.

f) Invalid authorship: Inaccurate attribution of authorship, including attribution of authorship to persons other than those who have contributed sufficiently to take responsibility for the intellectual content, or agreeing to be listed as author to a publication for which one made little or no material contribution.

g) Inadequate acknowledgement: Failure to appropriately recognize contributions of others in a manner consistent with their respective contributions and authorship policies of relevant publications.

h) Mismanagement of Conflict of Interest: Failure to appropriately manage
any real, potential or perceived Conflict of Interest, in accordance with the Institution’s policy on Conflict of interest in research or with Research Sponsors’ Policies and/or Requirements.

i) Misrepresentation in a funding application or related documents:

(i) Providing incomplete, inaccurate or false information in a grant or award application or related document, such as a letter of support or a progress report, including misrepresenting one's credentials, qualifications and/or research contributions;

(ii) Applying for and/or holding an NSERC, SSHRC or CIHR award when
deemed ineligible by NSERC, SSHRC, CIHR or any other research or research funding organization world-wide for reasons of Breach of Responsible Conduct of Research policies such as ethics, integrity or financial management policies.

(iii) Listing of co-applicants, collaborators or partners without their agreement.

j) Mismanagement of Grants or Award Funds: Using grant or award funds
for purposes inconsistent with the University or Research Sponsor policies;
misappropriating grants and award funds; contravening Research Sponsor financial policies; or providing incomplete, inaccurate or false information on documentation for expenditures from grant or award accounts.

k) Breaches of policy and regulatory requirements:

(i) Failing to meet University Policies or Procedures, Applicable Laws, or
Research Sponsors’ policies, rules, regulations, or contractual agreements or to comply with relevant policies, laws or regulations including, without limitation;


a. the Tri-Agency Framework: Responsible Conduct of Research;
b. 2nd edition of Tri-Council Policy Statement: Ethical Conduct of
Research Involving Humans (TCPS 2);
c. Canadian Council on Animal Care Policies and Guidelines;
d. Agency policies related to the Canadian Environmental Assessment Act;
e. Licenses for research in the field;
f. Laboratory Biosafety Guidelines;
g. Controlled Goods Program;
h. Canadian Nuclear Safety Commission (CNSC) Regulations;
i. Canada’s Food and Drugs Act;
j. access to information and protection of privacy laws.

(ii) Failing to obtain appropriate approvals, permits or certifications before
conducting research activities.

Conflict of Interest: A Conflict of Interest may arise when activities or situations place an individual in a real, potential or perceived conflict between the duties or responsibilities related to research, and personal, institutional or other interests. These interests include, but are not limited to, business, commercial or financial interests pertaining to the individual, his/her family members, friends, or former, current or prospective professional associates.

Inquiry: The process of reviewing an Allegation to determine 1) whether the
Allegation is responsible, 2) the particular policy or requirements of responsible conduct of research that may have been breached, and 3) whether an Investigation is warranted.

Investigation: A systematic process of examining an Allegation, collecting and examining the evidence related to the Allegation, and making a decision as to whether a Breach of Responsible Conduct of Research has occurred.

Member(s) of the University Community: An expression to encompass all University individuals that may be engaged in Research, including but not limited to:

a) employees, including all unionized and non-unionized academic and
administrative staff as well as those whose salary is paid through sources other than the University’s operating funds, such as grants, research grants and external contracts;

b) students, meaning individuals registered at the University, whether full time or part time and including special students, at the undergraduate or graduate level;

c) clinicians and physicians with an academic appointment, adjunct and emeritus professors, post-doctoral or clinical fellows, Research Trainees, medical residents, visitors, including visiting students and volunteers.

Primary Appointment: The lead institution (University or affiliated research hospital) responsible for the appointment and personnel costs of the Principal Investigator or Researcher. For under graduate and graduate students whose work is being conducted in fulfillment of their academic programs such as thesis-related work, the PrimaryAppointment shall be at the University of Ottawa.

Principal Investigator: The person who has ultimate responsibility for a research project. In the case of a project funded by an external or internal grant or contract, the Principal Investigator is the holder of the grant or contract. In the case of a project that is not funded, the Principal Investigator is the initiator of the Research project. The Principal Investigator is usually the supervisor of the Research Team and is usually a faculty member.

Research: An undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation.

Research Sponsor: The funding agency, foundation, organization or individual, or other entity, public or private, international, national, provincial or foreign, providing funding to the University and Member of the University community for Research.

Research Sponsors’ Policies and/or Requirements: An expression to encompass all of the policies, rules, directives, guidelines, regulations, processes, funding agreements with the University and contractual requirements established by Research Sponsors or Agencies, related to applying for and managing research funds, performing Research, disseminating Research results and the investigation of an Allegation. Examples of such policies and requirements include the 2nd edition of Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans (TCPS 2), The Tri-Agency Framework:
Responsible Conduct of Research and the Agreement on the Administration of Agency Grants and Awards by Research Institutions.

Research Trainee: Any undergraduate or graduate student, post-doctoral fellow or clinical fellow engaged in a research project, including visiting students and fellows.

Researcher: Anyone who conducts research activities.

Secretariat on Responsible Conduct of Research (or “SRCR”): The body responsible for providing substantive and administrative support for the Agencies with respect to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd edition (TCPS 2), and the Tri-Agency Framework: Responsible Conduct of Research (the Framework).

University Policies and Procedures: An expression to encompass the University’s administrative policies and administrative procedures and academic regulations.

RELATED DOCUMENTS

Agency documents
• Tri-Council Agreement on the Administration of Agency Grants and Awards by Research Institutions (2017)
• Tri-Agency Framework: Responsible Conduct of Research (2016)
• Tri-Council Policy Statement: Ethical conduct for Research Involving Humans, second ed. (2018)

University of Ottawa documents
Policy 29: Invention and Technology Transfer
Policy 31: Animals Used in Research and Teaching at the University Of Ottawa
Policy 48: Grants and Contracts Administered by the University
Policy 70: Conflict of Interest - Members of Staff
Policy 92: Financial Fraud • Academic regulation I-14 - Academic fraud
APUO collective agreement
o Article 10: Professional ethics
o Article 39: Disciplinary Measures
APTPUO Collective Agreement
o Article 2.6 Ethical Behaviour
o Article 6: Discipline and Discharge

Other
• The United States Public Health Service (PHS) regulation, "Public Health Service Policies on Research Misconduct,":42 CFR 93
http://ori.hhs.gov/sites/default/files/42_cfr_parts_50_and_93_2005.pdf  
 

 

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