Policy on the Offer and Acceptance Of Finders Fees or Completion Fees In Research Involving Human Subjects

Introduction

The Faculty of Medicine embraces the ethical principles, common standards, values and aspirations of the research community as expressed in national and international codes of research conduct.

The integrity and fiduciary nature of the physician-patient relationship, the confidentiality of information regarding the patient and the avoidance of any conflict of interest for physicians, trainees and other personnel associated with a study or trial involving human subjects, are among the guiding principles to the ethical conduct of clinical research and clinical trials.

This Policy addresses the issue of finders' fees and completion fees in research involving human subjects. In addition to this Policy, individuals should be familiar with and follow all Faculty Policies and Guidelines. Of particular relevance to this Policy are the Faculty of Medicine's "Principles and Responsibilities Regarding Conduct of Research and Faculty of Medicine" (PDF) and "Guidelines: Relationship between Physician Trainees, Postgraduate Training Programs and Industry". Also relevant is the Tri-Council Policy Statement "Ethical Conduct for Research Involving Humans", particularly Sections 4 and 7.

Definitions

Finders' fees. Money or other reward given by the sponsor (or by a physician) to a physician (or a group of physicians) in payment for identifying or recruiting a patient into a study or a trial. Finders' fees include bonus or milestone payments for successfully enrolling a particular number of patients or for successfully meeting a deadline in recruiting patients. [1]

Completion fees. Money or other reward given by the sponsor (or by a physician) to a physician (or a group of physicians) in payment for each patient's successful completion of the study or trial protocol. Completion fees include bonus or milestone payments for a particular number of patients successfully completing the study or trial or for successfully completing it within a specific timeframe. [2]

NOTE: These fees do not include compensation payments to a physician for the services he or she provides (e.g. for determining the eligibility of a patient consenting to be in the research or for services provided to a patient enrolled in a research study) or to the holdback sponsors maintain until trial completion. [A reminder: The patient (or his or her alternate decision- maker) must have provided consent to being a recruit for the study or trial and for the assessment to proceed.]

Guiding Principles

• Finders' fees and completion fees essentially constitute an inducement;
• A physician receiving such fees for patient recruitment or patient completion is in a conflict of interest since there is a divergence between the physician's private interests and his or her obligations to the patient.
• The conflict of interest is sufficiently direct and clear that the simple fact of disclosure of the finders' or completion fee to a Research Ethics Board and to patients is insufficient.

Policy Statement

• The Faculty of Medicine prohibits the offer or acceptance of finders' fees and completion fees;
• Faculty members, trainees or any other individuals are prohibited from knowingly assessing potential recruits to a study or a clinical trial when the recruitment by others includes the payment of a finder's fee.
• It is acceptable to assess potential recruits for a study or a clinical trial who have been referred by another individual, where permission of the recruit is obtained and no finder's fee has been or will be accepted by the referring individual.

[1] For example, at the start of a trial a finder's fee may be paid to a physician in exchange for recruiting trial patients. This fee is additional to and separate from the fee a physician receives as appropriate compensation for services rendered to or on behalf of trial patients. Finder's fees may take the form of other incentives such as monetary bonuses for identifying or recruiting a certain number of trial patients or for doing so within a certain time period. Sometimes, the finder's fee may take the form of a non-monetary reward (e.g., travel voucher).

[2] For example, at the end of a trial a completion fee may be paid to a physician in exchange for ach patient's successful completion of the trial or study protocol. This fee is additional to and separate from the fee a physician receives as appropriate compensation for services rendered to or on behalf of trial patients. Completion fees may take the form of other incentives such as monetary bonuses for a certain number of trial patients completing the study protocol or doing so within a certain time period. Sometimes, the completion fee may take the form of a non-monetary reward (e.g., travel voucher).

March 2003.