What are the ethical responsibilities of the Principal Investigator?

The Principal investigator (PI) is defined as “The leader of a research team who is responsible for the conduct of the research, and for the actions of any member of the research team” (TCPS 2nd edition, glossary).

At the University of Waterloo, a PI is appointed in accordance with the guideline document defining research conducted “under the auspices” of the University of Waterloo. Typically this will be a faculty member holding an indefinite term appointment at the University of Waterloo.

For some types of animal research funded by Health Canada, the PI may be also known as the qualified investigator (QI); however, there may be restrictions placed on who may occupy the role as a qualified investigator (e.g., physician, dentist). As a result, in some cases the QI may be a separate member of the research team who carries out very specific Health Canada mandates responsibilities and the PI may be a University of Waterloo faculty member with overall responsibility for the execution of the research.

In some jurisdictions Research Ethics Boards, or Research Ethics Committees (REC) or the Animal Care Committee (ACC), are required to ensure that the PI has the appropriate training and background to carry out the research and are required to ask for proof of credentials and experience. In specific situations, both the PI and QI may be required to submit proof of their credentials and licenses, and a current CV to the REC or ACC for review in accordance with requirements under various statutes.

A.   Pre-approval Stage:

The PI serves as the overall project manager and ensures ethical compliance with relevant guidelines and statutes, primarily those from the Canadian Council on Animal Care (CCAC) and the University of Waterloo.

Although ultimately responsible for the research itself and the actions of the research team, the PI must ensure full compliance with University of Waterloo and Tri-agency Research Integrity requirements. The Office of Research Ethics has developed a series of institutional guidelines and links to common agency and sponsor requirements to assist with this compliance obligation.

Investigators from two or more institutions may choose to undertake a collaborative project in which the animal-based work is to be divided between the animal facilities of the various institutions. For these projects, the ACC of each institution involved must receive a written animal use protocol detailing the animal-based work to be undertaken within the facilities for which it is responsible. This protocol must also provide a brief description of the project as a whole. Any interactions between the institutions relative to the animal-based work (e.g., transfer of animals from one institution to another, special requirements to ensure the health and welfare of the transferred animals, etc.) must be understood and accepted by the ACCs of each of the institutions involved.

Clear and direct communication between ACCs is strongly recommended to facilitate the process and to ensure that CCAC guidelines and policies are applied and animal care and use is appropriately overseen throughout all phases of a collaborative project.

The ACC of the home institution of the PI should normally take the lead in providing an ethical review of the most comprehensive protocol, and should coordinate and address questions and comments from the other ACCs involved.

  • Ensure approval for AUPP is obtained and address ACC concerns and feedback in a timely fashion.

All research involving animals conducted under the auspices of the University of Waterloo must be ethically approved by the ACC.  However, not all data collection activities are considered to be “research” and not all interactions or data collection with or from animals is considered to be “research involving animals which requires ACC approval”. Please refer to the ORE guidelines for further clarification or contact the ORE to discuss your situation. Failure to obtain ethical approval for research involving animals is considered to be research misconduct.

  • Ensure appropriate training has been completed by team members.

The need to ensure appropriate training is of particular concern for animal research where technical competency may be an issue (e.g., animal handling and surgery). However, there may be other types of training required as well. This training might arise from a need to effectively deal with specific techniques listed in the AUPP.                                        

The PI is reminded of University of Waterloo research integrity obligations and the need to ensure that all members of the research team are aware of research integrity obligations. Training is available from the ORE to assist the PI in ensuring that all members of the team are fully able to execute the protocol safety and effectively.

B. Post-approval Stage:

The PI is responsible for:

  • Keeping the ORE and ACC apprised of the status of the research, and any problems which might occur, in a timely fashion.

After ethics approval has been received from the ACC, the research protocol must be carried out in accordance with the approved procedures. Any anticipated deviation from what has been approved, which might become necessary, must be approved via a modification request.

Any unanticipated event which occurs which negatively affects animals must be reported via an incident report within 24 hours of the event occurring. Any deviations from approved protocols must also be reported to the ORE and ACC using the appropriate form. Appropriate forms are available via Sharepoint.  Any incident or deviations should be reported to the Animal Health Technicians (AHTs) and the Animal Research Co-ordinator as soon as possible. 

Annual renewals are due in a timely fashion. Researchers will receive annual reminders from the ORE of the need to complete a renewal form. The maximum period of time during which an AUPP can be active is four years. After that period of time the PI must submit a new AUPP application.

  • Regularly monitor animal welfare at all sites.

The University of Waterloo has initiated a post-approval monitoring (PAM) process per CCAC's Terms of Reference for Animal Care Committees (2006). At the University of Waterloo the PAM process includes the annual renewal process and any modification requests, as well as a review of the progress of a study at specific time points following initial ethics approval.

The PI (or their delegate) is expected to meet with the AHT for their area to facilitate completion of a PAM form. The ORE advises AHTs when this process is due for any given AUPP. AHTs provide an oral report at each ACC meeting based on PAM forms completed during the previous four week period. The ACC will make recommendations for any follow up action.

C.  Post-Approval Project Management

Researchers are reminded that:

“The CCAC is an autonomous and independent body, created in 1968 to oversee the ethical use of animals in science in Canada. The CCAC is registered as a non-profit organization, and is financed primarily by the Canadian Institutes of Health Research (CIHR) and the Natural Sciences and Engineering Research Council of Canada (NSERC), with additional contributions from federal science‑based departments and agencies and private institutions participating in its programs. It is governed by a Council of representatives from 22 national organizations which are permanent member organizations and up to three limited term member organizations” (Who We Are, 2014).

As a result, animal researchers are obligated to fulfil project management responsibilities identified by the Tri-agency framework: Responsible Conduct of Research and University of Waterloo policies. Although these broader project management responsibilities are not explicitly detailed in the CCAC guidelines, these obligations include specific activities which are more fully described in the TCPS2 guideline. (Note: Although this guideline  applies specifically to research with human participants it does provide a sense for the best practices and Tri-agency project management expectations for all Tri-agency funded research).

  • Ensuring original data is accessible to facilitate accurate reporting

The TCPS2 states “Contracts should also ensure that principal investigators have the necessary access to original trial data, and the opportunity to analyze them” (Article 11.12). 

As with human research, the animal protocol PI is responsible for maintaining complete, up to date and accurate records as part of their project management responsibilities.  As is the case with research involving humans, University of Waterloo animal researchers and the PI must be able to prove to sponsors and funding agencies, in the event of an audit, that data has been collected and secured in accordance with the approved protocol.

  • Receiving safety reports and act on this information

The TCPS2 states “In accordance with Articles 11.7 and 11.8 and Articles 6.15 and 6.16, REBs can expect to receive safety reports and new information, including, but not limited to, unanticipated issues, changes to the research design and newly discovered risks. The reports are usually submitted by the local site researcher, who may also be the principal investigator, or by an established safety monitoring body, such as a Data Safety Monitoring Board (DSMB)” (Article 11.7).

As with human research, animal research PIs are also responsible for advising the ACC if new information or data emerges which suggests new risks for either the animals or the researchers. The PI should also ensure that the required safety training has been completed by members of their teams.

  • Sometimes fulfil sponsor responsibilities

The TCPS2 states “Trials may also have sponsors who can be a source of new information. Sponsors may be the principal investigator (investigator-initiated trials), a research institution or another type of organization (e.g., private company, not-for-profit association)” (Article 11.8).

Although most animal research at University of Waterloo occurs at a single site (i.e., University of Waterloo facility) animal researchers who serve as the PI on multi-site animal research protocols for which University of Waterloo is the sponsor may have additional responsibilities. Should this be the case, please consult with Leslie Copp to discuss the negotiation of a multi-site contract and the additional sponsor oriented responsibilities which may arise.

There are also a number of other University of Waterloo specific operational responsibilities which the PI should manage to fulfil daily project management responsibilities:

  • Communicating all protocol requirements to AHTs to ensure appropriate arrangements can be made (i.e,. housing, food & bedding, animal ordering, treatment and procedures)
  • Advising the AHTs of requirements for breeding colonies
  • Ensuring all members of the research team abide by the rules and procedures that govern the use of the facilities
  • Timely and complete reporting to ORE on an annual basis of animal usage numbers
  • Ensuring that all members of the team follow approved SOPs which are available on Sharepoint. Contact the Office of Research Ethics for access.

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