Investigator Conflict of Interest
Investigator Conflict of Interest
|Department||Applied Educational Research|
|Creation Date||May 25, 2011|
|Approval Date||May 25, 2011|
|Effective Date||May 25, 2011|
This policy pertains to all staff, faculty, students or external persons intending to participate in or carry out research at and/or in collaboration with the Michener Institute.
The purpose of this policy is to describe investigator conflicts of interest and define the process for identification, disclosure, management and documentation of conflicts of interest and associated actions.
Conflict of Interest: The incompatibility of two or more duties, responsibilities, or interests (personal or professional) of an individual or institution as they relate to the ethical conduct of research, such that one cannot be fulfilled without compromising another. (TCPS 2)
“Researchers shall disclose in research proposals they submit to the REB any real, potential, or perceived individual conflicts of interest, as well as any institutional conflicts of interest of which they are aware that may have an impact on their research.” (TCPS 2 Article 7.4)
This Policy applies to the Chair, investigators, members of the REB, Research Office and/or administration.
2.1.1 At all times, investigators will act honestly and conduct themselves in accordance with highest ethical standards (see Research Code of Conduct) in such a way as to bear close scrutiny;
2.1.2 Individual investigators’ actions should align with the principles of respect for persons and concern for the rights and welfare of participants when considered by an independent observer;
2.1.3 Investigators may request reconsideration or appeal any decisions made by the REB regarding their studies and decisions made about them (see Policy: REB Reconsiderations and Appeals);
2.1.4 Studies may be periodically randomly audited and reviewed for conflicts of interest.
2.2 Identification of Conflicts of Interest
2.2.1 Conflicts of Commitment
- when non-institutional commitments interfere, impede or compromise one’s ability to fulfill their institutional responsibilities;
- when institutional resources are used for non-institutional activities.
2.2.2 Conflicts of Interest
- Power imbalance (i.e. Dual role of investigator and associated obligations; Faculty responsibility to instruct and evaluate students fairly or unbiasedly is compromised; staff member is in a position of influence to affect decisions being made in the institution);
- Financial (i.e. investigator has the potential to personally profit from the outcome of his/her research).
2.3.1 All disclosed conflicts will be held in confidence and will only be available to those relevant and/or required by law to have access to such information;
2.3.2 Investigators must disclose any actual, perceived or potential conflicts of interest to the Chair of the REB prior to the study submission review;
2.3.3 When deemed necessary by the REB, conflicts of interest will be publicly declared.
2.4 Managing conflicts of interest
2.4.1 Manageable conflicts
- Project is permissible as disclosed with no further action;
- Project is permissible only if appropriately managed (i.e. disclosing conflict publicly, altering study protocol);
2.4.2 Unmanageable conflicts
iii. Project is not permissible; there is no means of mitigating the conflict.
2.5.1 The REB will document the investigator in conflict, their conflict and any actions taken to mitigate the conflict of interest;
2.5.2 Any and all conflict of interest documentation will be stored as per Documentation guidelines (see REB Policy-Documentation).
- Tri-Council Policy Statement (TCPS 2). Ethical Conduct for Research Involving Humans, Medical research Council of Canada 2010. Article 7.4.
- ICH Harmonized Tripartite Guideline. Good Clinical Practice: Consolidated Guideline (E6)1996.