CIHR Procedure for Addressing Allegations of Non-compliance with Research Policies
July 22, 2004
ISBN 0-9736921-0-3
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Table of contents
Acronyms
Preamble
Definitions
- Openness and Accessibility
- Transparency and Accountability
- Due Process
- Continuous Learning
Decision Tree
Acronyms
ASAS Applicant Status Alert System
CCAC Canadian Council on Animal Care
CIHR Canadian Institutes of Health Research
EMC Executive Management Committee of CIHR
GC Governing Council of CIHR
MOU Memorandum of Understanding
NSERC Natural Sciences and Engineering Research Council
RIC Research Integrity Committee of CIHR
SCE Standing Committee on Ethics
SSHRC Social Sciences and Humanities Research Council
Preamble
The Canadian Institutes of Health Research (CIHR) is accountable to Canadians for how it invests public funds in health research. In return for CIHR's financial support, Institutions and researchers agree to abide by CIHR and/or Tri-Agency research policies. If CIHR becomes aware of an alleged breach of a research policy, it will take the steps outlined in this document to deal with the allegation and, if necessary, apply the financial sanctions available to it under its funding terms and conditions.
The Canadian Institutes of Health Research Act is the enabling legislation which establishes CIHR's mandate. Some aspects of this mandate include:
- promoting, assisting and undertaking research that meets the highest international standards of scientific excellence and ethics;
- fostering the discussion of ethical issues and the application of ethical principles to health research; and
- ensuring transparency and accountability to Canadians for the investment of the Government of Canada in health research.
This Procedure document is intended to be used as a guide in dealing effectively with allegations of non-compliance received by CIHR. CIHR's Standing Committee on Ethics (SCE) created a Sub-Committee on the Promotion of Research Integrity to assist CIHR in drafting this Procedure document. The SCE recognizes the need for this Procedure to evolve over time and is committed to championing its ongoing development.
This Procedure is founded on the following principles for upholding and promoting integrity in research:
- Openness and Accessibility
- Transparency and Accountability
- Due Process
- Continuous Learning
These principles are in keeping with CIHR's core values as stated in Investing in Canada's Future: CIHR's Blueprint for Health Research and Innovation - CIHR Strategic Plan 2003/04-2007/08:
Public Interest
- The public interest is of paramount importance in the creation and use of health knowledge through all research and related activities supported by CIHR.
Excellence
- In all aspects of the work undertaken by CIHR, including research, knowledge translation and organizational services, CIHR strives to meet the highest international standards of excellence.
Ethics
- CIHR believes that excellent research and good governance require the development and application of sound ethical principles.
Integrity
- CIHR upholds and promotes adherence to relevant research and organizational policies with utmost honesty, probity and professionalism.
Freedom of Inquiry
- CIHR recognizes that the primary purpose of all research in the public domain is the creation of new knowledge in an environment that embodies the principles of freedom of inquiry and unrestricted dissemination of research results.
Transparency and Accountability
- Decision-making processes should ensure that all decisions are fair, open, reputable and able to bear close public scrutiny. Honest and cost-effective accountability mechanisms will be in place for all aspects of the work undertaken by CIHR.
Collaboration
- CIHR values positive and mutually respectful relationships with partners and stakeholders who are committed to openness, responsibility and fairness and are mutually respectful of each other's priorities and objectives.
Evidence
- Funding priorities and policy making at CIHR must be based on the best available evidence.
Innovation
- CIHR values new ideas and creative approaches to addressing health and health system challenges in Canada and worldwide.
This Procedure is intended to be consistent with the Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards (MOU) and specifically, Schedule 8 of the MOU: Investigation and Resolution of Breaches of Agency Policies. (Currently, this Schedule is intended for review.)
CIHR commits to respecting the timelines provided in this document. In the event that circumstances do not permit strict adherence to these timelines, CIHR commits to taking the necessary action as soon as reasonably possible thereafter.
Definitions
Throughout this Procedure:
"Applicant Status Alert System" (ASAS) is the system used by CIHR to alert relevant CIHR staff members involved in the receipt and processing of grant applications, of a researcher's / institution's ineligibility for funding and the period of ineligibility.
"Institution" means any entity that receives or administers CIHR funding, and includes institutions not affiliated with universities, such as community hospitals.
"Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards (MOU)" refers to the agreement between NSERC, SSHRC, CIHR and the funded institutions. The MOU, together with related Schedules, describes the basic requirements for obtaining and maintaining institutional eligibility to administer agency funds.1
"Non-compliance" means any departure from relevant research policies, whether deliberate or inadvertent, and in particular those that relate to:
- Breach of research ethics
- Misconduct in research or scholarship
- Financial Mismanagement of public funds
Schedule 8 of the MOU entitled Investigation and Resolution of Breaches of Agency Policies, identifies three levels of non-compliance, to be dealt with as follows:
Level 1 - If the Agency and the Institution consider the alleged compliance issue to be minor, the Agency or Agencies and the Institution will work informally to investigate and, if necessary, to correct the problem. Relevant Research Administration officials will be advised, but senior officials of the Institution will generally not be involved in the case. It is anticipated that details of cases of this kind will not be shared with the other funding Agencies.
Level 2 - If the Institution or the Agency considers a compliance issue to be serious and a breach is confirmed, relevant Research Administration officials will review the documentation and establish a realistic schedule for resolving the situation. The Agency or the Agencies may demand that the Institution implement corrective measures, such as appointing a consultant to assist in the development and implementation of a remedial plan.
Level 3 - Should the matter not be resolved at Level 2 or be particularly serious or sensitive, it will be referred to senior-level officials from both the Institution and the Agency or Agencies for further action.
"Procedure" means the principles and related processes set out in this document.
"Research policies" include, but are not limited to:
- Tri-Council Policy Statement on Ethical Conduct of Research involving Humans
- Tri-Council Policy Statement on Integrity in Research & Scholarship
- Human Pluripotent Stem Cell Research: Guidelines for CIHR-Funded Research
- CIHR Grants and Awards Guides
- CCAC Policies and Guidelines on the Care and Use of Experimental Animals
- Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards and related Schedules (MOU).
"Sanctions" imposed by CIHR may include, but are not limited to:
In relation to individual researchers may include, but are not limited to, (as per the terms of the Tri-Council Policy Statement on Integrity in Research & Scholarship):
- Refusing to consider future applications for a defined time period;
- Withdrawing remaining instalments of the grant or award;
- Seeking a refund of all or part of the funds already paid as a grant or award for the research or scholarship involved.
Reporting cases of possible illegal conduct to the appropriate authorities.
In relation to institutions may include, but are not limited to, (as per the terms of Schedule 8 of the MOU) :
- Temporarily suspending funding to specific programs or projects until satisfactory corrective measures are in place;
- Declaring an institution ineligible to continue receiving Agency funds; or,
- Reporting cases of possible illegal conduct to the appropriate authorities.
1 Note, MOU Schedule 2 includes institutional responsibilities to develop policies or guidelines that, at a minimum, meet the requirements set out in the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans and CIHR's Guidelines on Human Pluripotent Stem Cell Research, and to apply those policies or guidelines to all research conducted under the auspices of the Institution, regardless of the source of funding.
I. Openness and Accessibility
Principle
CIHR is committed to an open process that is readily accessible to any person who wishes to bring forward an allegation of non-compliance.
Process
- This Procedure shall be made publicly available on CIHR's website, in public documents and through relevant listserves, as appropriate. It shall be provided to staff, institutions, researchers, research participants and the general public upon request.
- CIHR shall appoint a designated Ethics Policy Officer who will be responsible for receiving allegations of non-compliance with relevant funding policies.
- It shall be the Ethics Policy Officer's responsibility to communicate directly with the source of the allegation and to facilitate his/her access to CIHR.
- The Ethics Policy Officer's name, address, e-mail address, telephone and fax numbers will be made publicly available, together with the Procedure itself, as per (1) above.
II. Transparency and Accountability
Principle
The protection and promotion of research integrity is a responsibility that must be shared across the organization. CIHR is committed to ensuring that clear lines of accountability are established at each level of the organization, as necessary, to implement this Procedure.
Decision-making processes involved in this Procedure shall strive to be fair, open, reportable and able to bear close public scrutiny.
Process
- CIHR shall form a Research Integrity Committee (RIC) composed of the following members:
- Director, Ethics
- Director, Knowledge Creation or Research Translation Programs
- Chief Information Officer
- Director, Finance and Administration
- Director, CIHR Institute
- Researcher
- Institution Administrator
- Layperson
- External ethics expert
- Member of CIHR's Standing Committee on Ethics (SCE)*
- A roster with the name of three volunteers for each of the following positions will be maintained in order to ensure availability of a volunteer to participate in each of the RIC meetings:
- Researcher
- Institution Administrator
- Layperson
- External ethics exper
- The RIC may also consult with other staff or external members for advice as needed on a case-by-case basis. These consultations will respect the confidentiality of all parties involved, in accordance with the principle of Due Process, below.
- A quorum shall consist of half of the RIC members plus one. The Chair of the RIC or his/her designate and at least one external member who is not an employee of CIHR must be in attendance at each RIC meeting.
- RIC shall meet as required to review allegations of non-compliance and to decide on the most appropriate course of action. RIC's review of allegations shall be conducted in accordance with this Procedure.
- The Director of Ethics shall serve as Chair of RIC and shall sign correspondence on behalf of RIC.
- The Director of Ethics, as Chair of RIC, shall provide a regular summary report to CIHR's Executive Management Committee (EMC) (composed of the President, the VP Service and Operations, VP Knowledge Translation and Partnerships, and VP Corporate Affairs), on the nature, status and resolution of complaints received. The report will also include a brief summary on cases that RIC decided not to pursue and the reasons for those decisions.
- EMC shall, where appropriate, inform CIHR's Governing Council (GC) of particularly serious cases.
- The Ethics Policy Officer will document and record statistical data with respect to:
- the number of allegations received by the RIC in any given year; the general nature of the allegations received;
- the number of allegations that were not pursued and the general reasons why;
- the number that were pursued and investigated;
- the number that were resolved with a brief categorization of the outcomes; and
- the number of allegations that remain outstanding.
- In keeping with the Principle of Openness and Accessibility, these statistical data shall be posted on CIHR's website and updated on a semi-annual basis.
* SCE membership on RIC will be reassessed after 6 months,
given operational nature of RIC's work
III. Due Process
Principle
CIHR is committed to the principle of due process for all parties concerned (i.e. the person bringing the allegation, the person subject to the allegation, the institution involved, and other parties). Through the implementation of this Procedure, CIHR will address allegations of non-compliance with fairness and in a timely fashion.
Process
- Usually allegations of non-compliance shall be submitted in writing to the Ethics Policy Officer by the person(s) making the allegation. Allegations sent from anonymous sources or via a third party may be considered, but only if all relevant facts are publicly available or otherwise independently verifiable.
- Where an allegation of non-compliance is received or instigated by any person at CIHR, it shall be referred to the Ethics Policy Officer.
- Allegations received by the Ethics Policy Officer shall be placed in confidential files with restricted access. The names of the parties involved shall be disclosed to relevant CIHR staff and relevant CIHR decision-makers only on a strict "need to know basis".
- The Ethics Policy Officer shall issue an acknowledgement of receipt to the source of the allegation within 3 working days of receiving his or her allegation.
- The Ethics Policy Officer shall contact the source of the allegation to obtain any further details required prior to referring the allegation to RIC members.
- The Ethics Policy Officer shall refer the allegation to RIC members for consideration at the next meeting to be held within 30 days.
- The RIC shall review the allegation and decide on an appropriate course of action, which may include:
- not pursuing the allegation any further;
- referring the matter for investigation; or
- undertaking to resolve the matter directly with the institution, where the allegation is about an institution.
- The RIC may decide not to pursue the allegation any further if:
- it reasonably believes that the allegation is without merit;
- the allegation is considered to be outside the mandate of CIHR (for example,
when neither the researcher nor the institution in question is funded by CIHR); or
- the allegation is impossible to pursue without further information which cannot be obtained either because the source is anonymous and the facts are not publicly available nor otherwise independently verifiable, or because the source refuses, or is unable, to provide such further information.
- If the RIC decides not to pursue the allegation further, it should inform the source of the allegation of its decision within 30 days of the decision of the RIC. Whenever possible, the source of the allegation should be referred to another organization that may be in a position to assist him/her.
- Where the RIC determines that an investigation is warranted, RIC may refer the matter to the relevant institution or most appropriate body for investigation, in compliance with the provisions of the federal Privacy Act (R.S. 1985, c. P-21 ) to which CIHR is subject.
- Accordingly, RIC must obtain consent from the source of the allegation prior to sending any documentation to the institution which contains personal information about him or her. Where the source does not consent to disclosure of personal information about them, RIC must remove personal information from the documentation before sending it to the institution. RIC must make it clear to the source of the allegation that in some cases the necessary removal of personal information may impede an institution's ability to carry out a thorough investigation of the matter.
- All investigations undertaken by the Institutions must conform to these procedures and must be conducted in accordance with Schedule 8 - "Investigations and Resolution of Breaches of Agency Policies" of the Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards, ("MOU") .
- Upon being informed of the findings of the investigation, RIC shall reconvene within 30 days to consider the findings.
- Where the case involves Level 1 non-compliance as defined in the MOU Schedule 8, RIC may determine an appropriate response on behalf of CIHR. In such cases, RIC shall inform the researcher and the institution of its response to the report of findings within 30 days.
III. Due Process (continued)
- For all Level 2 and Level 3 cases, as defined in the MOU Schedule 8, RIC shall provide its recommendations to EMC for decision and action. As appropriate, the matter should be referred to GC for information and/or final decision.
- If either CIHR or the institution believes that mediation may be useful, a mediator, chosen by agreement of both parties, will be appointed. The mediator's role will be to assist in finding a mutually satisfactory resolution to the outstanding issue(s) by making a non-binding recommendation for the consideration of both parties.
- The outcome of all Level 2 and 3 cases shall be communicated to the researcher and the institution.
- Where the sanction imposed by CIHR precludes a researcher/institution from applying for funding by CIHR, the ASAS will be activated to alert the relevant staff members of a researcher's/institution's ineligibility and the period of ineligibility.
IV. Continuous Learning
Principle
CIHR and its staff are committed to learning from their experience in handling cases of non-compliance and to improving this Procedure in the future. Hence, this Procedure is intended to be a living document and should be reviewed on a regular basis to ensure that it continues to respond to allegations of non-compliance in a fair and timely manner.
Process
- RIC shall prepare a report on an annual basis which summarizes the key lessons learned from the allegations of non-compliance it reviewed. The report may include an anonymized summary of facts from difficult cases (e.g. case studies) to illustrate the challenges faced when applying this Procedure in practice. In keeping with the Principle of Openness and Accessibility, this annual report shall be posted on the CIHR website.
- The Director of Ethics, as Chair of RIC, shall present this annual report to CIHR's SCE so that it can consider how the Procedure may be improved to better address challenges in the future.
- This Procedure shall be subject to a review two years after it is first adopted and every three years thereafter to ensure that it continues to respond to allegations of non-compliance in a fair and timely manner. Revisions to the Procedure must be approved by GC, on advice of its SCE.
Contact Information:
For further information and/or assistance please contact:
Ethics Policy Officer
Ethics Office, Canadian Institutes of Health Research (CIHR)
160 Elgin Street, 9th Floor
Address Locator 4809A
Ottawa, ON K1A 0W9
Phone: (613) 954-1383
Fax: (613) 946-0885
Email: ethics@cihr.gc.ca
Decision Tree
