Conflict of Interest: Recruitment of Subjects for Research Studies
Policy Number: #6-06
Policy Category: Practice
Approved by Council: September 2006
Publication Date: December 2006
College Contact: Physician Advisory Service
Conflict of Interest: Recruitment of Subjects for Research Studies
In recruiting their patients into a research study, physicians have a duty to manage existing and potential conflicts of interest. This policy articulates the College’s expectations in relation to conflicts of interest that may arise in the recruiting of subjects for research studies, including offers of compensation to physicians, and patient consent.
“Recruitment” refers to the physician soliciting or identifying patients from his or her practice for possible enrolment in a research study.1
“Compensation” includes both financial and non-financial rewards, gifts or benefits. Non-financial compensation includes non-cash gifts, benefits or rewards, such as objects, trips that are not directly relevant to the study, or academic benefits. Financial compensation includes, but is not limited to, loans, credits, and fees, including finder’s fees and completion fees.2
Compensation may also include any allocation received in exchange for clinical or administrative work required to process research subjects through a clinical research study, such as compensation for time spent reviewing patient eligibility, discussions with patients regarding their interest in participating, and submitting the required patient information to the investigator.
In all instances, physicians must act in the best interests of their patient. This includes avoiding or appropriately managing conflicts of interest.
What is a Conflict of Interest?
A conflict of interest is created any time a reasonable person could conclude the physician’s primary duty to act in the patient’s best interests may be affected or influenced by a competitive secondary interest. Conflicts of interest can be actual, potential or perceived. A perceived conflict of interest exists where a reasonable and informed person, having thought the situation through, would reasonably think that the referring physician may be adversely influenced by his or her other interests in deciding whether to make a referral.
A conflict of interest, whether actual, potential or perceived, can arise where the physician does or may receive compensation for recruiting patients to participate in a research study.3
When a physician is offered compensation for an activity or for knowledge obtained in the course of his or her professional duties, there is a danger that the physician will be placed in a conflict of interest, as the physician’s interests may diverge from those of his or her patients. This risk extends to physicians accepting compensation for recruiting patients to participate in a research study.
The College recognizes, however, that receiving compensation does not always place the physician in a conflict of interest, provided that the situation is managed in accordance with these guidelines.
Physicians may accept compensation for recruiting patients for participation in a research study only if:
- The study has been approved and will be monitored by a research ethics board (‘REB’) that is not affiliated with the sponsor;4
- Recruiting patients requires the physician to undertake activities beyond his or her normal practice activities; and
- The compensation provided is related to actual clinical or administrative services provided and is commensurate with those services. As a general guideline, compensation should be commensurate with expenses incurred and the reasonable income otherwise earnable for the time spent participating in the study (opportunity costs).5 Parameters such as time, expenditure and complexity of the work required may also be relevant considerations in determining what is an appropriate compensation amount.
Subject to the exception outlined below, physicians must obtain express consent from each patient before disclosing patient information6 to researchers.
To provide proper consent, a patient must have the capacity to consent and the consent must be provided voluntarily and without duress, coercion, fraud or misrepresentation.7 Patients must also be completely and honestly informed about the consequences (both clinical and otherwise) of having their information provided to researchers as part of the recruitment process.8
To that end, physicians must inform patients of the purpose for which the information is provided to researchers; and of the patient’s entitlement to withhold consent, without treatment repercussions.9 The College advises physicians that they should inform their patients of the nature of the benefit the physician will receive for recruiting the patient for participation in the research study.10 Physicians should also disclose any affiliations (e.g., with the pharmaceutical company or researcher) that may impact on the patient’s decision to provide consent.
Exception to Consent Requirement: Permitted Disclosure under PHIPA
If the researchers intend to contact patients, patient consent to the disclosure of personal health information is required.11
However, physicians may disclose patient information to researchers without patient consent, if:
- Researchers provide physicians with a written application for the information, a research plan, and a copy of the decision from the REB approving the research;
- The researcher enters into an agreement with the physician to comply with any conditions that the physician may impose related to the use, security, disclosure, return or disposal of the information;12 and
- The researcher will not be contacting the patient.
Physicians should only disclose personal health information where no other information will do, and should disclose as little personal health information as possible to meet the research needs.13
Physicians are never prohibited from seeking a patient’s consent, even where an exception to the consent requirements apply. The College advises physicians that, whenever possible, they should make every reasonable effort to obtain the patient’s consent before disclosing his or her information.14
If the physician is uncertain about whether this exception applies or whether the above guidelines have been satisfied, the College recommends contacting the College’s Physician Advisory Service, the Canadian Medical Protective Association (CMPA), or other insurance provider for guidance.
The College expects that physicians involved in recruitment activities will take the necessary steps to avoid being placed in a conflict of interest or appropriately manage conflicts of interest. In some instances, this may mean that the physician should decline some or all of the compensation offered, or choose not to be involved in the recruitment process. The College may consider non-compliance with this policy to be professional misconduct.
1Tasks associated with “recruitment” include reviewing the eligibility of a patient, discussion with the patient regarding his or her potential interest in participating in a trial, and submitting the required patient information for the study. It does not include any aspect of conducting the actual research study. Clinicians who are researchers/investigators should be mindful that they have additional obligations to potential and actual research subjects.
2The College has adopted the following definitions of finder’s fees and completion fees from the University of Toronto’s Policy on the Offer and Acceptance of Finder’s Fees or Completion Fees in Research Involving Human Subjects:
Finder’s Fees: money or other reward given by the sponsor or a physician to a physician or group of physicians in payment for identifying or recruiting a patient into a study or trial. Finder’s fees include bonus or milestone payments for successfully enrolling a particular number of patients or for successfully meeting a deadline in recruiting patients.
Completion Fees: money or other reward given by the sponsor or a physician to a physician or 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.
These fees do not include compensation payments to a physician for the services he or she provides or to the holdback sponsors maintain until trial completion. Consequently, finder’s fees and completion fees constitute inducement.
3Further expectations related to conflicts of interest generally are set out in the College’s Conflict of Interest policy.
4REB approval ensures that the study itself is ethical. Research Ethics Boards may or may not evaluate the compensation provided to physicians for referring patients.
5See the College’s policy MD Relations with Drug Companies, as adopted from the CMA Guidelines on the Relationship between Physicians and the Pharmaceutical Industry.
6For the purposes of this policy, patient information refers to ‘personal health information’ as it is defined in s. 4(1) of the Personal Health Information Protection Act (PHIPA), and includes (but is not limited to) information that relates to an individual’s physical or mental health, medical history, organ or tissue donation, substitute decision makers, health number, and payments or eligibility for health care. Under PHIPA, the patient’s express consent is required for providing his or her personal information outside of the patient’s “circle of care” (e.g., to researchers), except where otherwise directed by statute. Please see the College’s policy on Confidentiality of Personal Health Information for further discussion.
7Please refer to the College’s Consent to Medical Treatment policy for general discussion of consent.
8In addition, patients must be informed of any information required by REBs.
9Section 18(5) of PHIPA.
10Informing the patient of the “nature” of the benefit involves disclosing the type of benefit that may be received. It also includes disclosing the amount of any compensation the physician will receive, if the patient specifically requests this information.
11Section 44(6)(e) of PHIPA.
12Section 44(1) of PHIPA. Further details regarding statutory requirements can be found by consulting sections 44 (1) to (10) of the PHIPA, and sections 15, 16 and 17 of the Regulations enacted under PHIPA (O.Reg. 329/04, General).
13PHIPA ss. 30(1), 30(2).
14College Policy, Confidentiality of Personal Health Information, Permitted Disclosure under PHIPA.