Conflict of Interest (COI) Guidelines for Applications Undergoing Merit or Ethical Review

A conflict of interest (COI) may arise when an individual’s personal, professional, financial, or other interests interfere with, or is perceived as interfering with, their impartiality in meeting their obligations and responsibilities in the conduct of research including the ethical or merit review and submission process. These guidelines complement the University’s Policy 69 – Conflict of Interest.

Not all COIs are inherently bad. A COI may exist even if no unethical or improper act results from the COI.  While COIs can raise concerns about bias and one’s ability to be impartial, in certain situations individuals perceived to have a COI can bring valuable perspectives and expertise to the conduct, review, and discussions of the proposed research. The key to all COI is for individuals to be transparent by disclosing and mitigating, or managing, the COI which ensures the review and conduct of the research is done ethically. A COI should be disclosed regardless of the magnitude of the COI.

General categories of COI

1. Personal or Professional Gain

  • Individuals may derive professional or personal benefit from the research, and this benefit may be further supported or legitimized through the successful merit review or ethical approval of the research project
  • Individual benefits personally or professionally from the research not being conducted and therefore gains from the merit review or ethics application not being given clearance/approval

Example

  • A Committee/Board member contributed significantly to the experimental design of the study. 

2. Relationships

  • Individual assigned to review the application and is a member of a Committee/Board or ORE staff who has, or recently had, a personal relationship with an applicant named on an application undergoing merit or ethical review
  • Individual who is an applicant undergoing merit or ethical review has a personal relationship with a member of the Committee/Board or ORE staff member assigned to review the application

Examples

  • A Committee/Board member, including an ORE/animal facility staff member, is included in the review of an application where one or more of their relatives, close friends, or an individual with whom they have/had a personal or financial relationship, is an applicant/investigator.
  • A researcher (faculty, staff, or student) is a relative or close friend or has/had a personal relationship with one or more of the members on the Committee/Board who has been assigned as a delegated reviewer for that application.

3. Impartiality Concerns

  • Independent observers reasonably question an individual’s actions or decisions in relation to the research being conducted, reviews for merit or that of the ethics application, and are based on factors other than the validity of the science or teaching activity, welfare of the animals, or the rights of the human study participants.
  • A Committee/Board member or an ORE staff member feels for any reason they are unable to provide an impartial review of the applicant’s submission.

Examples

  • A Committee/Board member collaborated, published, or shared funding with one or more of the applicants/investigators within the last six (6) months, or have plans to do so in the immediate future (i.e., the next 6 months).
  • A Committee/Board member is closely professionally affiliated with one or more of the applicants by having been a supervisor or a trainee of one or more applicants within the last five (5) years.
     

4. Financial Interests

  • Individuals have a direct or indirect financial interest in the research being conducted (or not) and thus would benefit from a positive or negative decision regarding a merit or ethical review and a subsequent clearance/approval, or disapproval.

Example

  • A Committee/Board member can gain or lose financially or materially from the study protocol/ethics application being approved (or disapproved). This can be during the time the protocol is undergoing an ethics review as well as future financial or material benefits from the study being approved (or disapproved).

Responsibilities for declaring a COI

A COI can apply to any member of the: 

  • ORE/Animal facility staff, 
  • Clinical Research Ethics Board (CREB), 
  • Human Research Ethics Board (HREB) including members of the Department of Psychology Delegated Ethics Review Committee (DERC), 
  • Scientific and Pedagogical Review for animal use applications,  
  • Animal Care Committee (ACC), and
  • Researchers (faculty, staff, or students)

REB and ACC responsibilities 

A standing agenda item for every REB and ACC meeting is a COI declaration. This declaration applies to any of the items on the agenda for review, discussion, and decision. This includes the ethics applications submitted for that month’s meeting. Members of the REB and ACC must declare any real, perceived, or potential COI before the review of the item on the agenda. This COI is noted in the meeting minutes, and the members must recuse themselves from the review and subsequent discussion and decision. Recused members will not be given access to the application for review and will leave the room during the presentation of the application and discussion. Members must not share information about the proposed study/project or personal details of individuals or situations that led to the COI declaration. 

Membership includes the Chair and Vice-chair who must declare a COI if one exists. In the event the Chair declares a COI, the Vice-chair will assume the Chair’s responsibilities for the review and all subsequent amendments and renewals/continuing reviews. If both the Chair and Vice-chair declare a COI for the same application, another member will be asked to chair the review of that study/project.

Members who have a prior and known COI should bring it to the attention of the ORE staff as soon as possible and preferably before a scheduled monthly meeting. If the COI is identified at the time the meeting is held, the member must declare the COI prior to the other members proceeding with the review and discussion of the related agenda item.  

If a member is unclear or uncertain if they have a COI, the member will bring the COI forward for discussion with the other committee members. This discussion should be conducted in the absence of the member who is bringing the possible COI disclosure forward. Through consensus, the members will decide if the member who disclosed a potential COI should recuse themselves from the review, discussion, and decision about the application or remain. 

To determine the appropriate action, the committee will focus on aspects of the COI that may reasonably impact either the protection of human participants or the ethical use of animals within the application. The committee members may take steps to eliminate or mitigate the conflict if applicable. These actions may include disclosing the COI to ensure other members are aware, informing participants about the COI, or taking further measures to eliminate or mitigate the conflict. COI training is available for faculty, staff, and students. 

ORE/Animal Facility or Safety Office staff member

A staff member who may provide consultative advice or guidance in the preparation of a merit review or ethics application is not deemed to be in a COI with a study/project or a researcher (faculty, staff, or student). As reviewers of ethics applications, whether it be a pre-review or as a delegated ethics reviewer, the ORE/Animal facility and Safety Office staff are university employees and, in the terms of their employment, are not expected to gain personal or professional benefits from a merit review or an ethical review of proposed studies/projects. These staff are performing their duties in accordance with their employment terms and should not be considered a study/project investigator. Thus, ORE/Animal facility and Safety Office staff should only be named on an ethics application on rare occasions. 

Staff members who do experience a real or perceived COI should disclose this to their supervisor as soon as possible. The supervisor will then recuse the staff member from handling the merit or delegated review and reassign the review to another staff member. 

Reviews for scientific or pedagogical merit 

The Manager of the ACC handles all scientific and pedagogical merit reviews that are needed prior to an ethics application being reviewed. This process is detailed in ACC016 – Review Process for Scientific Merit and Pedagogical Merit. Managing COI for scientific and pedagogical merit means the Manager and Chair of the Merit Review must ensure the reviewers are able to conduct an independent peer review of the proposed study/project and have the appropriate expertise to comment on the merit of the proposed work.

Merit reviewers must not:

  • be the current Chair, Vice-chair or a member of the ACC,
  • be from the same immediate Waterloo department as the Principal Investigator (PI),
  • have a potential COI with the applicant(s) including a scientific or personal difference or in a position to gain or lose financially from the outcome of the proposed study,
  • be closely professionally affiliated with the applicant(s) within the last five (5) years such as:
    • be a supervisor or a trainee of one or more applicants, or
    • collaborated, published, or shared funding with one or more of the applicants. 

Researcher 

Researchers (including faculty, staff, and students) must identify and manage COI to maintain public confidence and trust while maintaining the independence and integrity of the research process. This COI may be internal to Waterloo such as a COI with the Chair or Vice-chair of the REB/ACC or an ORE staff member or it may be external to Waterloo such as a COI because of a relationship with a for-profit company or a not-for-profit organization. 

Researchers are not prohibited from establishing relationships and collaborations with external groups, however relationships whether they are personal, professional, and/or financial must be declared including those of their immediate family members or other close relationships. This declaration of COI ensures there are means in place to mitigate or manage the COI allowing for objective conduct of the study/project.

Researchers shall disclose any real or perceived COI by completing and submitting with the ethics application the COI disclosure form as per Policy 69 – Conflict of Interest. This includes:

  • when submitting an initial/new ethics application for review,
  • with submission of an amendment or a renewal/continuing ethics review,
  • whenever a COI arises throughout the life of the study/project, such as changes in personal or professional responsibilities or financial circumstances.
     

Questions

Questions regarding a real or perceived COI can be sent to the Office of Research Ethics. 

If for any reason, a researcher is unable to accept the ethics review feedback and the REB/ACC decision to deny or not give ethical clearance for the proposed study/project, they are to proceed through the appropriate appeals process per the REB/ACC Terms of Reference. 
 

Resources

Adapted from Lakehead University’s Conflict of Interest Guidelines and Procedures

October 2025