Ms. Susan Zimmerman
Executive Director
Secretariat on Responsible Conduct of Research
350 Albert Street
Ottawa, ON K1A 1H5 Canada
[email protected]
April 1, 2016
Re: Request for Feedback on Proposed Changes to Tri-agency Framework: Responsible Conduct of
Research (RCR Framework)
In response to the request that institutions provide feedback to your office to support your five year
review of the RCR Framework, the University of Waterloo is pleased to offer the following observations
and recommendations. On behalf of the university, I have formulated input which addresses four key
aspects relevant to this five year audit:
•
•
•
•
the major benefits which have resulted from the RCR framework
opportunities which exist to further enhance the effectiveness of the RCR Framework
opportunities which exist to enhance the process used to conduct the five year audit
an assessment of the specific wording changes being contemplated (detailed in Appendix 1).
Thank you for this opportunity to contribute my thoughts and recommendations for change. I hope that
this input is useful to the federal secretariat as you consider how best to enhance the Tri-agency
Framework: Responsible Conduct of Research (2011).
Respectfully submitted,
Maureen Nummelin, Ph.D.
Chief Ethics Officer
University of Waterloo
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Benefits of the RCR Framework
Since first enacted in December 2011, our experience has shown that a number of aspects of the
Canadian RCR framework are beneficial:
I.
The emphasis of the Canadian RCR framework is on establishing a shared code of conduct to
facilitate the responsible conduct of research. This nuanced shift in how the Tri-agency
expectations have been framed as positive “professional competencies and expectations” is in
contrast to the more typical deficit model orientation adopted by other jurisdictions such as the
United States, which typically focus on defining “research misconduct”.
II.
An opportunity exists within the RCR Framework to implement institutionally specific
sanctions. While any violation of the RCR Framework is a breach, sanctions can be applied which
are proportional to the breach and in line with institutional past practice and organizational
cultures and norms.
III.
The requirement in the RCR Framework that institutions appoint a central point of contact to
oversee the processes may encourage people to come forward who might view the central
contact as a neutral third party. Over time, this “arm’s length” reporting and oversight role may
engender enhanced institutional consistency with respect to both the processes enacted and
the sanctions applied, particularly for those institutions which had previously utilized a more
decentralized approach to managing research integrity obligations.
IV.
The requirement that complainants report alleged breaches to a central point of contact may
foster a climate in which complainants are more likely to come forward if they would
otherwise have perceived themselves to be vulnerable in the context of the organizational
structure. Such complainants e.g., students, junior faculty, post-docs, may be reluctant to make
allegations in situations where they perceive significant power differentials to exist, particularly
if complaints were previously dealt with by line management e.g., faculty supervisors,
department Chairs, senior faculty or principal investigators.
V.
The notion of “breach” has been broadly defined within the RCR Framework and includes both
serious breaches such as falsification, fabrication or plagiarism (FFP) as well as less serious
breaches often referred to as questionable research practices (QRP). By adopting the concept
of a “breach” which includes both FFP and QRP, irresponsible behaviours are more likely to be
identified earlier in a researcher’s career or earlier in the research process. A highly cited metaanalysis suggests that less than 2% of researchers engage in FFP while up to 72% of researchers
admit to having engaged in QRP. Other research exists which suggests that those who engage in
QRP are eventually more likely to engage in FFP. The definition of breach which includes both
FFP and QRP is a more comprehensive response to a shared desire to enhance researcher
competencies and to elevate behavioural expectations.
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VI.
Institutions need to transparently deal with, and publicly report, proven allegations involving
the irresponsible conduct of research. This mandatory public reporting will enhance levels of
public trust. FFP are typically high profile situations and widely covered in the press. Mandatory
public reporting and institutional accountability to deal with breaches in a timely fashion using a
prescribed process will demonstrate to peer institutions, the public at large, and research
sponsors that all responsible allegations have been assiduously investigated. Public reporting
may also have a chilling effect on researchers who might otherwise be tempted to engage in FFP
or QRP since these institutional case histories will emphasize to other members of the
institution that disciplinary sanctions will be enacted should transgressions occur.
VII.
The two stage inquiry/investigation committee process is in line with the process used in most
jurisdictions and provides for sufficient opportunity to ensure the allegations have substance
using an informal process.
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Opportunities to Enhance the Effectiveness of the RCR Framework
Although there are clear benefits associated with the existing RCR Framework as noted above, our
experience has shown that additional structural changes would further enhance the effectiveness of
the process.
I.
The process to be used to investigate alleged breaches, and the resources required to
support these investigations, should be aligned with the likelihood and magnitude of
harm which may ensue and should vary depending on the nature of the alleged breach.
Institutions should be provided with flexibility to investigate, resolve and report on
breaches using a mix of institutionally decentralized processes for minor breaches, and
nationally centralized processes which provide requisite levels of transparency and
accountability to the federal government for more serious breaches.
o The Canadian RCR framework mandates a “one size fits all process” regardless
of the severity of the breach, the likely impact of the breach on the public or
research record, or the nature of the stakeholders affected. For example,
because most FFP breaches have the potential to affect the academy, the
scientific record, levels of public trust, the willingness of the public to support
research, the possibility that time and money will be wasted, it is appropriate to
investigate FFP breaches utilizing a quasi-legalistic process involving a high
degree of transparency and strict timelines accompanied by a high degree of
public accountability and reporting.
However, it might be argued that for many QRP, alternate processes which are
less labour and resource intensive would be a more efficient use of limited
resources. Many QRP do not have the same potential to affect the scientific
record, erode public trust or cause significant waste of time and money. Some
instances of QRP, for example situations involving inadequate acknowledgment
or authorship disputes, are also unlikely to have the same deleterious impact on
the academy. In fact, it might be argued that QRP breaches which involve
disagreements about authorship or acknowledgment are a key part of the
research enterprise and that it is only by engaging in robust discussions of this
nature that researchers develop requisite competencies.
II.
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The RCR Framework should obligate all complainants to first attempt good faith efforts to
resolve QRP issues, where appropriate, using conventional mediation, conciliation or
other alternative dispute resolution methods before an allegation can be filed.
Filing an allegation under the RCR Framework offers an alternative to face to
face conflict resolution. The unintended consequence of this alternative may be
that researcher willingness or ability to resolve interpersonal disputes may be
diluted over time. In our experience, QRP breaches often result from a lack of
requisite professional training and development, poor mentorship and
supervision, a lack of clarity around institutional policy, a lack of awareness of
current international standards or best practices, or they may be the direct
result of a relationship which has soured. Most QRP are unlikely to be the result
of an intentional attempt to corrupt the research record and are often most
appropriately viewed through a performance management or professional
development lens.
III.
The broad definition of “breach” beyond traditional FFP has resulted in significant
increases in the volume of allegations made. The vast majority of these alleged breaches
involve QRP rather than FFP.
This means that relatively minor breaches consume a disproportionate amount
of limited organizational resource in order to conduct both the informal inquiry
and the formal investigation stage according to the mandated process i.e. to
mount a formal investigation committee, secure legal support for the
institution, ensure external members are involved, ensure appropriate reporting
occurs, manage the inevitable legal process issues which occur as soon as a
quasi-legalistic process has been initiated. This use of limited resources to
manage QRP is occurring at a time when institutional research support
allowance funding has not increased.
The current approach outlined in the RCR Framework includes a broad
definition of breach, a high degree of centralization both at institutional and
national levels, a high degree of transparency, tight time lines, mandated central
reporting to a federal agency, the mandatory inclusion of external parties on
investigation committees, a quasi-legalistic process utilizing legal standards and
tests, and high degrees of public accountability. This may not be the best use of
limited institutional resource for very minor breaches, nor the best way to
resolve interpersonal disputes.
IV.
For many research intensive universities, Tri-agency funding represents but one source of
all of the funding available to the institution.
However, the RCR Framework must be applied to all research and all sponsors,
regardless of the sponsor preferences or possible impact on the research or
researchers. Other sponsors may not agree with some aspects of the RCR
Framework, yet it has been imposed on them.
V.
The balance between the breadth of the definition of breach and the desired level of
transparency and accountability required from institutions should be reexamined from an
international perspective given the growing internationalization of the research
enterprise.
Some jurisdictions, such as the United States, have a very narrow definition of
research misconduct, limited scope for the application of the national policy
accompanied by a high degree of centralized reporting to a central agency,
transparency and accountability for some types of research, and a quasi-judicial
process with strict compliance requirements. Other jurisdictions, such as the
Scandinavian countries and Australia, have implemented a broader definition of
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breach/research misconduct in line with the Canadian definition, but this has
been accompanied by a more decentralized system with less centralized
reporting and transparency for minor breaches. The Canadian guideline is an
anomaly when viewed in an international context since it incorporates both a
very broad definition of breach as well as a high degree of centralized reporting,
high levels of transparency and high levels of accountability. However it does
not provide for institutional flexibility to deal with minor breaches using a less
legalistic and more performance management oriented process with less
national transparency and accountability.
VI.
The fact that Canada has a guideline and not a statute provides flexibility for institutions
in deciding how to operationalize the requirements; however, this same flexibility also
creates the potential for institution to institution inconsistency in terms of how the
requirements have been interpreted and operationalized.
Most institutions have spent significant time and money developing what are
essentially similar processes, guidelines, training regimes and templates.
Additional templates or resources provided from the federal secretariat which
would clarify best practice standards and assist with consistent
operationalization of requirements would be helpful.
VII.
When assessing whether a breach has substance, institutions should be allowed to
consider, if appropriate, intentionality and honest mistake at the outset rather than the
current requirement which restricts institutions to only consider intentionality and honest
mistake as mitigating factors affecting the sanction to be applied.
While most cases of FFP are clearly intentional, the same cannot be said for
QRP. Holding an unintentional QRP breach to the same level of public scrutiny
and transparency as an intentional FFP seems to be a misallocation of limited
resources and results in out-of-proportion consequences.
.
VIII.
The need to have central reporting and investigation committees including external
members can damage reputations for relatively minor breaches or for early stage
researchers where the breach occurs due to lack of knowledge.
It may be argued that minor breaches which arise due to lack of understanding
may be best treated as performance management issues (unless they are
repeated or have serious implications). The need to centrally report all breaches
to a central authority diminishes the role of line management and lessens the
ability of line management to intervene for performance oriented issues.
Furthermore, researchers may be reluctant to report minor offenses since they
could result in significant public transparency and attract significant
consequences. As well, the one size fits all process means that faculty
supervisors lose the ability to reign in their own students. This lessens the
credibility of line managers and supervisors. Mistakes should be tolerated as
part of the learning process. If every mistake could potentially subject a
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researcher to public sanction and scrutiny, true learning may be diminished as
researcher efforts turn to damage control.
IX.
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Rather than penalizing those institutions who do not comply, the Tri-agencies might
examine whether or not incentives could be provided to organizations which have shown
strong progress in meeting RCR Framework obligations or in providing support to their
researchers and in enhancing the integrity of research conducted at their institution.
Although a significant new compliance obligation was imposed on universities
with the advent of the RCR Framework, the financial support provided to
institutions to meet these additional compliance obligations was not changed to
reflect the increased costs associated with these new obligations. The Triagencies should provide incentive in the research support fund (previously
called indirect cost allowance) to reward institutions who demonstrate
sustained superior effort in implementing the requisite infrastructure and
meeting their compliance obligations (Note: Wei Yang, President of the Chinese
National Academy of Science indicated that China is moving in this direction)
Opportunities Which Exist to Enhance the Audit Process
In addition to the focus on clarifying the wording within the RCR framework, a more comprehensive and
robust consultative process should be initiated to assess the costs and benefits associated with the new
RCR Framework. This consultative process should be initiated with all stakeholders, particularly
university presidents, vice presidents of research and provosts. legal staff, research integrity officers,
CAUT, faculty and staff associations, student associations, research administrators, complainants and
respondents in order to gather feedback on what the results to-date have been. Following this
consultation process a report should be prepared and made available to all stakeholders. For example,
there are a number of additional questions which would inform future changes to the RCR framework,
including items such as:
1. What activities and resources have been required at an institutional level to comply with
RCR requirements? What types of additional resources have been required e.g. IT? people?
policy?
2. What have been the major challenges you experienced to-date associated with meeting
compliance obligations?
3. Are the timelines proposed in the RCR Framework realistic given your experience to-date?
4. How much time has been required in order to conclude allegations which were found to
have substance? Did this vary depending on the nature of the allegation?
5. How many allegations have been received since 2011? How many dealt with FFP? How
many dealt with QRP? How do these numbers compare to the experience of the institution
prior to 2011?
6. What areas of the RCR Framework have been most challenging for you to interpret?
7. How have you met your training obligations? What challenges have been experienced?
8. How do you feel that the Canadian RCR framework differs from the obligations in place in
other jurisdictions in the world? Benefits? Disadvantages?
9. What do you feel the major impacts for your organization have been?
10. What do you feel the major benefits have been?
11. Do you feel that the benefits associated with implementing and administering the RCR
framework outweigh the costs?
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Appendix 1
Comments on the Proposed Wording Changes:
2.1.2.b
In addition to the agencies mentioned, ethics boards and other agencies, such as Health Canada,
may also require specific types of record keeping beyond those obligations contained in funding
agreements or institutional policies.
2.1.2.d
Define the phrase “substantial contribution” or provide examples of criteria which might be
used to determine when someone has made a substantial contribution. As well, consider
whether or not the obligation for authors and contributors to negotiate fairly might be expressly
included. It would be helpful to specifically incorporate a reference to external international
best practice guidelines such as those offered by ARRIVE, COPE or ICJME. Consider the extent to
which the guideline should obligate those involved with an authorship dispute to first attempt
good faith efforts to resolve the dispute before initiating a breach.
2.2 b.
In keeping with the positive orientation of the RCR framework, this obligation would be better
expressed in a positive manner i.e. applicants certify that they are eligible to apply for and hold
…
3.1.1 g
The previous inclusion of the notion that contributions should be recognized in relation to their
proportional contribution was helpful. Order of authorship is often conferred based on relative
and proportional contributions. Eliminating the notion of proportional recognition of authorship
is unhelpful.
3.2
The current definition of a responsible allegation is:
Responsible allegation: A substantially novel allegation made in good faith, confidentially and
without malice, that is based on facts which have not been the subject of a previous allegation,
and which falls within one or more breaches set out in Section 3 of this Policy.
The current wording suggests that in order for a breach to be a responsible allegation, all of the
conditions outlined in the definition must be satisfied i.e. must be substantially novel, must be
made in good faith, must be made confidentially, must be made without malice and must align
with one or more breaches outlined in the policy. However we question whether or not the
requirement that an allegation be made confidentially should be a required condition. For
example a complaint might still be significantly substantive but should not be dismissed simply
because the complainant has publicly complained about the situation or discussed it publicly.
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As well, the requirement that a breach be specifically mentioned in article 3 appears to be
contradictory. The RCR framework does not provide an exhaustive and exclusionary list of
breaches:
3.1 Breaches of Agency Policies
Breaches of Agency policies include, but are not limited to, the following:
As a result, the definition of a responsible allegation should provide for the possibility that the
institution might determine that a breach has occurred which is not specifically listed in article 3
of the RCR framework.
4.3.3.b
It is difficult for complainants to come forward in situations where they perceive that a
significant power differential exists without an institutional whistleblower policy. As well, in
provinces such as Ontario where the provincial Ombudsman has responsibility for the MUSH
sector, a failure to deal with perceived injustices within the institution can lead to significant
adverse public relations impacts. As a result, institutions without formal whistleblower policies
are at risk, particularly if the whistleblower policy or equivalent dispute resolution mechanisms
are not effectively enforced. These institutions might find that they receive a disproportionate
number of anonymous allegations when compared to institutions with an effective
whistleblower policy. If the institution disallows anonymous allegations at the investigation
committee stage, as is currently allowed, substantive allegations might not proceed beyond
informal inquiries.
4.4 d
In all aspects of the RCR framework, it would be helpful to provide forms, templates and sample
processes to assist with compliance activities of the type which might be provided were this a
statute supported by regulations rather than a guideline. At present, institutions across Canada
have all been inventing their own processes in splendid isolation. While a guideline affords
flexibility to institutions, having sample forms, templates and training from the federal
secretariat would offer a much needed “place to start”.
Definitions:
Breach – this definition of breach should specifically reference both the behaviour and
performance requirements as specified in articles 2 and 3 of the RCR Framework. The definition
should also make it clear that articles 2 and 3 do not provide a complete and exhaustive list of
what might be considered to be a breach. The proposed wording is very general and broad.
Providing key categories to be considered at each stage in the research, such as those outlined
in 2.1.2, would be helpful. A supplemental resource which would define specific behavioural
requirements at each stage or phase of the research would also be helpful.
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An additional useful differentiation might be to include criteria which would differentiate
between performance deficiencies which fall within this framework and those which do not for
breaches which are not specifically contemplated within the framework, e.g. creating a hostile
work environment which interferes with another researcher’s ability to conduct research.
It would also be helpful to include some criteria which might be used to determine the point at
which an ethical protocol deviation turns into the irresponsible conduct of research.
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