SOP 105c - Conflicts of Interest - Organization

1.0 PURPOSE

This standard operating procedure (SOP) describes potential Conflicts of Interest (COI) in the relationship between the organization establishing the Research Ethics Board (REB) and the REB itself, and the requirements and procedures for disclosure and for managing potential COI within this relationship.

2.0 SCOPE

The SOP pertains to REBs that review human participant research in compliance with applicable regulations and guidelines.

3.0 RESPONSIBILITIES

All REB members and REB Office Personnel are responsible for ensuring that the requirements of this SOP are met.

4.0 DEFINITIONS

See Glossary of Terms.

5.0 PROCEDURE

Organizational policies should address the roles, responsibilities, and processes for identifying, eliminating, minimizing or otherwise managing COI relevant to research, including disclosure to REBs. Management of COI includes but is not limited to, prevention, evaluation, disclosure and the application of appropriate remedies as defined by the organization.

The REB must be fair and impartial, immune from pressure by the sponsor, the parent organization and the Researchers whose research is submitted for review. In the interest of public trust and the integrity of the ethics review, the REB must act independently from its parent organization and avoid or manage real or apparent COI. The organization must respect the REB's autonomy and ensure that it has the appropriate financial and administrative independence to fulfill its primary duties.

The standard that should guide decisions about determining COIs is whether an independent observer could reasonably question whether the REB actions or decisions could be based on factors other than the rights, welfare, and safety of the research participants.

5.1    Disclosure of Conflict of Interest

5.1.1    All organizational employees must be familiar with the COI Policy and must complete a Disclosure of COI Form(s) (if applicable) at the time of hire and annually after that or as per organizational policy.

5.1.2    Before engaging in any of the professional activities listed in the COI Policy, employees must seek the approval of the appropriate Organizational Official to ensure that no conflict exists in doing so.

5.1.3    REB members shall be apprised of the organizational structure, emphasizing the independent nature of the relationship between the REB and the organization. The actions of the REB members relating to their responsibilities to protect human research participants shall not be measured or evaluated in terms of organizational or financial goals.

5.1.4    REB meetings are closed to employees of the organization unless they are REB members, REB Office Personnel, permitted as observers, or invited by the REB to provide information, and only after signed confidentiality agreements are in place.

5.1.5    Organizational senior administrators shall not serve as REB members nor observe REB meetings when their presence may influence REB deliberations on the advisement of the REB Chair.

5.2    Management of Conflicts of Interest

5.2.1    The REB Chair or designee must be notified if an organizational COI relating to the REB is declared or discovered.

5.2.2    The REB Chair or designee must be notified immediately if any organizational employee attempts to, or appears to attempt to, influence the research ethics review process or to obtain preferential treatment.

5.2.3    The REB Chair or designee will review the available information to determine if a COI exists and to determine those aspects of the COI that might reasonably affect human participant protection.

5.2.4    The REB Chair or designee may require a management plan, including actions to eliminate or mitigate the COI. Required actions may include, but are not limited to:

• Divestiture or termination of relevant economic interest.
• Recusal of REB Office Personnel whose job status or compensation is impacted by research that the REB reviews.
• If organizational staff members are involved, inform the appropriate responsible organizational management personnel to develop and implement a management plan for remediation.

5.2.5    If the REB Chair or designee is unable to satisfactorily manage the COI, or if there are unresolved concerns about any undue influence on the REB, the REB Chair or designee will bring this to the appropriate Organizational Officials for determination of the appropriate course of action.

5.2.6    If the REB Chair or designee cannot bring the matter to the appropriate Organizational Officials because of an emergent situation or competing COI with the organization, the REB Chair or designee may escalate the issue to the board authority.

6.0 REFERENCES

See References.