Ethical responsibilities of the Principal Investigator or Faculty Supervisor

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 guidelines defining research conducted “under the auspices” of the University of Waterloo. Typically this will be a faculty member holding an indefinite term appointment at Waterloo.

In the case of student research, the PI is known as a Faculty Supervisor (FS). The FS has the same responsibilities as a PI and serves in this capacity.

For some types of clinical trials regulated by Health Canada, the PI may be also known as the Qualified Investigator (QI). There may be restrictions placed on who may occupy the role as a qualified investigator such as a physician or dentist. In some cases, the QI may be a separate member of the research team who carries out very specific Health Canada mandated responsibilities and the PI may be a Waterloo faculty member with overall responsibility for the execution of the research.

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

A. Pre-approval Stage

The PI serves as the overall project manager and ensure ethical compliance with relevant guidelines and statutes.

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 (ORE) has developed a series of institutional guidelines and links to common agency and sponsor requirements to assist with this compliance obligation. In addition to ensuring the responsible conduct of research, TCPS 2 also details some specific ethical responsibilities of the PI listed below:

  • Formulate a strategy to work with multiple Research Ethics Boards (REBs) to address procedural inconsistencies or substantive disagreements.

The TCPS2 states that “When multiple REBs are involved, the principal investigators should work with their REBs to formulate a strategy to address procedural inconsistencies or substantive disagreements that may arise among the participating REBs” (Article 8.1). For example, the PI might work with institutions to develop a consistent format for the information and consent letter or to address differing institutional data security requirements.

  • Ensure ethical approval is obtained and address REB concerns and feedback  in a timely fashion.

All research involving human participants conducted under the auspices of Waterloo must be reviewed and given ethics clearance by a University of Waterloo Research Ethics Committee. However, not all data collection activities are considered to be research and not all interactions or data collection with or from people is considered to be research involving human participants. Please refer to the ORE guidelines for further clarification or contact the ORE to discuss your situation. Failure to obtain ethical review and clearance for research involving human participants in considered to be research misconduct.

  • Ensure appropriate training has been completed by team members.

The TCPS2 states that “Particular areas of concern are whether the principal investigator or others on the research team are sufficiently trained to provide the investigational therapy and whether there is any risk of a negative impact on participants’ mental health. REBs should be aware that it is possible that the principal investigators of surgical clinical trials need not, themselves, be a surgeon or technician trained in the procedure” (Article 11.1).

The need to ensure appropriate training is of particular concern for clinical research where technical competency may be an issue (e.g. delegation of controlled acts). However, there may be other types of training required as well in social science and humanities research. This training might arise from a need to effectively deal with vulnerable populations or to ensure that other concerns are sensitively addressed which may arise with specific participant populations (e.g., First Nations communities).

The PI must become familiar with Waterloo's 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 aware of their research integrity obligations.

B. Post-approval Stage

The PI is responsible for:

  • Ensuring the consent process as outlined the research ethics application (Form 101) is followed.

The TCPS2 states “The head of the research team, also known as the principal investigator, is responsible for ensuring that the consent process is followed. This person is also responsible for the actions of any member of the research team involved in the consent process” (Chapter 3, Introduction). This is an important obligation since obtaining consent may be a lengthy process and may also be out sourced in multi-site research protocols to members of the research team other than the PI. Regardless of who actually obtains consent, it is the responsibility of the PI to ensure that the approved protocol is followed.

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

When given ethics clearance to proceed, the research protocol must be carried out in accordance with the approved procedures. Any deviation from what has been approved, which might become necessary, must be approved via a modification request.

Annual reports and study completion reports are due in a timely fashion. Researchers will receive annual reminders from the ORE of the need to complete an annual report.

Any unanticipated event which negatively affects participants must be reported via an adverse event report within 24 hours of the event occurring. Any deviations from approved protocols must also be reported to the ORE and REC.

  • 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, to ensure that they can report trial findings fairly and accurately, particularly with respect to both efficacy and safety” (Article 11.12). The PI is responsible for maintaining complete, up to date, and accurate records as part of their project management responsibilities. The institution 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.

  • Maintaining the ability to link coded information.

The TCPS2 states “Data and information collected should have direct identifiers removed and replaced with a code. Depending on access to the code, it may be possible to re-identify specific participants (e.g., the principal investigator retains a list that links the participants’ code names with their actual name so data can be re-linked if necessary)” (Chapter 5, Introduction). Technology is rapidly evolving and changing and data storage formats are changing as well. University policies for record retention and data storage and security, require that data be maintained in accessible formats. For some types of funded research, such as Health Canada, this may require data to be kept in an accessible format for up to 25 years. Please refer to sponsor requirements and to the Waterloo record retention and IST policies noted above for detailed requirements.

  • Monitoring safety data and report new information to all participating sites.

Specific data monitoring and security obligations exist for researchers involved with clinical research and clinical trials. The TCPS2 states “Typically, researchers in charge of a trial at a particular site are responsible for communicating new information to their REB, to participants and, in the case of multi-site research, to the principal investigator. In single-site clinical trials, such researchers will likely be the principal investigator (the leader of the trial who is responsible for its ethical conduct). In this chapter, the term "researcher" is used in the context of communication with REBs and participants, and the term “principal investigator” is used in the context of communication among researchers involved in a multi-site trial” (Article 11.6).

The TCPS2 also states “The appointment of a Data Safety Monitoring Board (DSMB) does not alter the responsibilities of researchers and REBs to monitor participant safety. In the context of multi-site trials, when new information at one site may be relevant to participant welfare and consent at other sites, principal investigators must ensure that this information is shared with researchers at each site, and researchers must ensure that the REB also receives these reports” (Article 11.8).

Moreover, “When principal investigators receive new information, from the sponsor or any other source related to the trial, they are responsible for communicating this new information to their own REB, as well as to local site researchers, who must then inform their local REBs. In the case of multi-site trials (also known as multi-jurisdictional trials), the roles and responsibilities of the principal investigator, researchers and sponsor may vary depending on the model of research ethics review in use (see Chapter 8)” (Article 11.8).

Social science and humanities researchers may also find that data they have collected is particularly sensitive (e.g., personal health data) and security of the data needs to be carefully considered. Please refer to the guideline on data security. As well, any new information which might adversely affect participants should be provided to them so the PI can ensure ongoing consent has been secured.

  • Regularly monitoring participant welfare at all sites.

Although this is of particular concern with clinical trials, the PI must report any adverse events or protocol deviations to the ORE using the prescribed forms within prescribed timelines. When unanticipated problems do occur, an assessment should be made as to whether or not this new information is material to the consent previously provided by other participants. If it is deemed to have the potential to materially affect the consent previously provided, the PI may be required to obtain ongoing consent. The TCPS2 states “In multi-site clinical trials, when new information arises at one site that may affect participant’s welfare or consent at other sites, the researcher in charge of that site shall promptly inform the principal investigator of the trial. The principal investigator shall inform researchers at all other sites of the trial. It is the responsibility of the researcher in charge of each site to ensure their REB receives this information in a timely fashion…" Also, "The welfare of participants must also be considered when a trial is unexpectedly discontinued. When a researcher, a sponsor or other body (institution, funding agency, regulatory body) stops or unblinds a clinical trial, or a part of a clinical trial, the principal investigator has an ethical and a regulatory responsibility to inform both clinical trial participants and the REB of the discontinuance or unblinding and the reasons for it. Any risks to participants that may arise from the closing of the trial must be communicated in writing to the REB and the participants, and the researcher shall indicate any measures that will be taken to mitigate these risks” (Article 11.8).

  • 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 DSMB” (Article 11.7).

  • Sometimes fulfilling 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).

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