Interactions Between the Faculty of Medicine and the Pharmaceutical, Biotechnology, Medical Device, and Hospital and Research Equipment and Supply Industries

1.1 This Policy applies to Faculty Members, Faculty Staff and Learners of the Faculty of Medicine, University of Ottawa. Industry representatives are also expected to adhere to this Policy in its interactions with the Faculty.

1.2. This Policy replaces any previous Faculty policies or statements about interactions between the Faculty and Industry.

For the purposes of this Policy,

2.1 Conflict of Interest (COI) may be actual, potential or perceived. A conflict of interest occurs when an individual has a significant financial, professional or other personal consideration with Industry that may compromise, or have the potential to compromise or the appearance of compromising, their professional judgment or integrity in clinical responsibilities, teaching, conducting or reporting research, or performing other obligations.

2.2 Faculty Members means all unionized and non-unionized academic staff of the Faculty of Medicine, including visiting professors, clinicians with academic appointments or administrative duties, and academic staff paid, in whole or in part, by another organization or working on a volunteer basis.  For clarity, Faculty members include, but are not limited to, members of APUO, scientists, clinicians with academic appointments whether paid or volunteer and clinicians with administrative appointments including Dean, Vice-Deans, Associate and Assistant Deans, Program Directors and Department Heads.

2.3 Faculty Staff means administrative or support staff employed by the Faculty of Medicine who are not Faculty Members.

2.4 Gift refers to items of any value given by Industry to Faculty Members, Faculty Staff or Learners for personal use and for which the recipient neither pays nor  provides services. This includes, but is not limited to, items such as pens, notepads, textbooks, electronic media, food and meals, gift certificates, tickets, devices, products or services, travel, hotel accommodations, entertainment or payments for attending a meeting.

2.5 Industry shall refer to for-profit enterprises, including: pharmaceutical, biotechnology, medical services, medical device, hospital and research equipment and supplies industries and businesses and those organizations which provide research and educational support for the above industries, such as medical communications companies; and including those related not-for-profit enterprises affiliated with a for-profit enterprise (such as industry or trade associations).

2.6  Learner means an individual registered at the University, whether on a full-time or part-time basis or as a special student and whether at the undergraduate, graduate or postdoctoral level, including medical students, residents, fellows and individuals attending the Faculty on a temporary basis as part of an elective or other program

3.1       The mission statement of the Faculty is as follows: “We explore, we learn, we care”. To accomplish this mission, the Faculty strives to develop, deliver and evaluate high quality educational programs; to conduct research and other scholarly enquiry into the basic and applied medical sciences; to plan for the development and delivery of health care services; and to help improve health status and service delivery to the Province of Ontario and the wider community. These activities may sometimes benefit from interaction with Industry representatives in a manner that advances the use of the best available evidence, so that medical advances and new technologies become broadly and appropriately used.   

3.2       It is recognized that there are many positive developments resulting from academic and industrial collaboration including new drugs, devices and procedures which ultimately leads to the improved health of people in our community. Interactions between the Faculty, its Faculty Members, Faculty Staff, Learners and Industry occur in a variety of contexts, including marketing of new pharmaceutical products, medical devices and/or equipment; on-site training for newly purchased devices; educational support of Learners, and continuing medical education; and research activities. Faculty Members, Faculty Staff, and Learners also participate in interactions with Industry off-campus and in scholarly publications. While the interaction with Industry can be beneficial, these interactions must be ethical and avoid Conflict of Interest situations that could lead to increased costs of healthcare, compromise of patient safety, bias, or affect the integrity of the Faculty’s education, training and research programs, or the reputation of either the Faculty Member, the Faculty or the University and its affiliated hospitals. Provision of direct and/or personal financial support or Gifts, even in modest amounts, can exert a subtle but measurable impact on a recipient’s behaviour.

4.1       It is the policy of the Faculty that clinical decision-making, education, and research activities be free from influence or perceived influence created by improper relationships with Industry or by the receipt of Gifts. The principles outlined in this policy shall guide all potential relationships or interactions between Industry and the Faculty, its Faculty Members, Faculty Staff and Learners.

5.1       This Policy covers the following:

1. Gifts, meals and compensation
2. Drug and device samples
3. Access by Industry representatives to Faculty Members, Faculty Staff, and Learners
4. Industry support for educational programs
5. Industry-sponsored scholarships or other educational funds for Learners
6. Off-Campus Industry-sponsored meetings or activities
7. Industry support for research
8. Disclosure of relationships with Industry
9. Training
10. Reporting of non-compliance

GIFTS, MEALS AND COMPENSATION

5.1(a) Gifts

Faculty Members, Faculty Staff and Learners shall not accept Gifts for personal use from Industry representatives, regardless of the nature or value of the Gift. Gifts of educational materials directed at physicians or patients are permitted only if appropriate materials are not available from a public source (e.g., government agency, foundation, or disease-related association) or commercially available and are PAAB (Pharmaceutical Advertising Advisory Board) approved. This restriction also applies to product information that Industry representatives leave in or outside the room for participants to pick up after rounds. It also applies to collections of peer-reviewed scientific articles, since such collections may be highly selective and not representative of the literature.  Gifts to the Faculty, including, but not limited to, donations, grants, in-kind support, and other materials may be accepted by the Faculty, its offices, divisions, departments and research institutes provided terms and conditions of such a Gift are publicly disclosed and acceptance of such a Gift complies with applicable University policies and procedures on Gift acceptance.

5.1(b) Meals

Meals or other hospitality which are directly funded by Industry (i.e. paid for by Industry or their representative) and are provided to individuals may not be offered in any facility occupied and operated by the Faculty or owned by the University. This includes, but is not limited to, coffee, snacks, lunches or dinners. Faculty Members and Faculty Staff are expected to apply this principle when participating in any off-campus events solely sponsored by Industry which may or may not include meals. Specifically, Faculty Members and Faculty Staff shall not facilitate or condone the attendance of Learners at off campus events solely sponsored by Industry which may or may not include meals. Learners (but not graduate students) must only participate in off campus medical educational events that are accredited by a recognized College or Society (i.e. meals and hospitality provided by the physician organization sponsoring the event, not Industry directly).

5.1(c) Compensation

Compensation in exchange for listening to a sales talk, or attending a continuing medical education session or other activity in which the attendee has no other role is not permitted.

5.1.1    Arrangements with Industry whereby Faculty Members, Faculty Staff, or Learners are guaranteed the payment of an amount or other benefit without any duties (such as participation on scientific advisory boards that do not regularly meet and provide scientific advice) are considered Gifts and are not permitted. In order to avoid Gifts disguised as consulting contracts, speaking engagements or other arrangement for services, a contract must be signed by the Faculty Member prior to the event which provides specific tasks and deliverables with payment commensurate with such tasks and deliverables. This contract must be retained on file by the Faculty Member and disclosed as part of the Faculty Member’s annual “Conflict of Interest” disclosure to the Office of Professionalism or reappointment review as indicated in section 5.7.4 of this Policy. Faculty Members may accept appropriate compensation from Industry for work done (i.e. consultation and peer-training) at a rate up to that which is commensurate with their clinical/academic remuneration. Faculty Members must not participate in speaker bureaus for specific companies.

5.1.2 The Faculty may, subject to applicable collective agreements, require Faculty Members and Faculty Staff to change the terms of consulting agreements or request use of a standard contract template to ensure compliance with this Policy or University policies and procedures. If the terms cannot be followed, the Faculty may withhold its approval of such consulting activities.

5.2 DRUG AND DEVICE SAMPLES

5.2.1 The Faculty views the provision by Industry manufacturers of “free” samples, for example, of prescription drug or device products as a marketing practice designed to promote the use of these products and to gain access to prescribing professionals in an attempt to influence their behaviour. At the same time, the Faculty recognizes that this practice can assist some patients to quickly begin a course of treatment or to determine which therapeutic option is most beneficial for that patient.  While societal benefits may result from the availability of medications at the point of care, provision of samples is also accompanied by regulatory and security concerns, poses potential safety risks for patients, and encourages prescribing of new, high cost medications whose safety and efficacy may not be different from existing treatments. In this context, Faculty Members, Faculty Staff and Learners may only utilize pharmaceutical or device samples within the policies and procedures established by the affiliated healthcare facility and relevant provincial health authorities. In general, samples should be provided to a central bureau, e.g., ideally a hospital dispensary or organized clinic and not to individual Faculty Members or Learners. The clinic note should document the use of free samples and the reason for their use. The Faculty also recognizes that the contribution of these samples may be a valid in-kind contribution to a research program seeking peer-reviewed third party funding.

5.2.2    Drug samples and reagents provided to laboratories for research purposes may be accepted by Faculty Members, Faculty Staff or Learners provided there is clear written documentation kept by the person responsible for the research regarding the source and disposition of the samples/reagents.

5.3 ACCESS BY INDUSTRY REPRESENTATIVES TO FACULTY MEMBERS, SUPPORT STAFF AND LEARNERS

5.3.1    Faculty Members, Faculty Staff and Learners in the clinical setting or at health care facilities associated with the Faculty must abide by the policies and procedures established by such facilities and/or relevant provincial health authorities with regard to meeting with Industry representatives. In general, Industry representatives are permitted in non-patient care areas only by appointment. They may attend meetings or rounds only if permission has been granted by the health care facility, Department Head or delegated Division Head, and they have signed an agreement which prohibits their participation in discussions. Industry representatives are not permitted in patient care areas except to provide in-service training on devices or other equipment as requested by the health care facility, Department Head or delegated Division Head, and then only by appointment and, if applicable, with appropriate consent by the patient or surrogate. Documentation of permission must be retained by the health care facility, Department Head or delegated Division Head. Industry representatives must not pay for access to clinical areas under any circumstance. Industry representatives are prohibited from having any direct interactions with Learners unless they are supervised by a Faculty Member. However, independent interactions between Learners that are medical residents or graduate students and Industry representatives may be acceptable if their supervisor is of the opinion that the interactions are appropriate for the level of training and the Learner understands the requirement to apply the principles of the “Interactions with Industry” policy.

5.3.2 Commercial exhibits intended to showcase Industry products are not permitted on Faculty of Medicine premises unless specifically authorized by the Dean’s Office and may only be allowed elsewhere if they are directly related to an educational activity, and must comply with the Office of Continuing Professional Development’s “Policy on Continuing Medical Education and Industry”. Industry representatives may be permitted to demonstrate products/devices as part of education programs only when deemed necessary by the program committee organizing the event.

5.4 INDUSTRY SUPPORT FOR FACULTY EDUCATIONAL PROGRAMS

5.4.1 When accepted by the Faculty, Industry support for educational programs must be free of Conflict of Interest and must be provided in the form of an education grant.  Funds that are provided by educational groups or other entities that act as “intermediaries” for Industry (i.e. medical communications companies) must also be provided as education grants.

5.4.2 Funds from Industry for undergraduate medical educational activities may be provided to the Faculty through the Undergraduate Education Office, but must not be given directly to a Faculty Member, Faculty Staff or Learner. Education grants may cover expenses including, but not limited to, venue costs, speaker expenses and honoraria, modest food and beverages that are determined by the Undergraduate Education Office to be important for the program.

5.4.3 Funds from Industry for postgraduate medical educational activities may be provided to the Faculty, to a Department or Division within the Faculty, but must not be given directly to a Faculty Member, Faculty Staff or Learner. Education grants may cover expenses including, but not limited, to venue costs, speaker expenses and honoraria, modest food and beverages that are determined by the Department or Division to be important for the program.

5.4.4 Funds for continuing professional development including medical education activities may be provided by Industry in the form of an education grant to the Faculty of Medicine, to an individual Department or to the Office of Continuing Professional Development (“OCPD”), but must not be given directly to an individual Faculty Member, Faculty Staff or Learner. Education grants may cover expenses including, but not limited, to venue costs, speaker expenses and honoraria, modest food and beverages that are determined by the planning committee to be important for the program. Ideally, registration fees should be charged for education events for physicians which should reduce the funding needed from Industry. OCPD must accredit all Industry-funded CPD programs using the University or Faculty name or logos (except for rounds and journal clubs), and budgets for these programs must be registered with OCPD. Agreements governing grants supporting educational events must receive prior approval by the Office of Continuing Professional Development. Industry funding must be acknowledged using company names and logos only (no trade names of drugs or devices) on brochures and programs.

5.4.5    The content of all continuing professional development must be independently determined by the Faculty program planning group consisting of physicians and healthcare professionals representing the target audience. Industry sponsors of educational programs or their representatives may not determine the content or selection of speakers for educational programs nor participate in such decisions, and in the case of CPD activities, the organization of events must comply with policies of the OCPD and meet accreditation standards of the Royal College of Physicians and Surgeons and/or the College of Family Physicians of Canada.

5.5 INDUSTRY-SPONSORED SCHOLARSHIPS OR OTHER EDUCATIONAL FUNDS FOR LEARNERS

5.5.1    Direct use of Industry funds, in which the Industry can be identified, to support Learners to attend conferences or off-campus courses is not acceptable.

5.5.2    Industry support for scholarships and academic prizes must be free of any real or perceived Conflict of Interest, and must comply with the following requirements:

1. The Faculty of Medicine’s Department or Division must select the Learner(s) for participation or for receipt of prizes or awards at ceremonies and convocation;
2. Such prizes must be named for the achievements they recognize and not for the Industry that provided the funds, although the accompanying citations may identify the Industry organization;
3. The funds must be provided to the Department or Division and not directly to the Learner;
4. The presentation of the award must be made by a representative of the Department, not of Industry;
5. There is no implicit or explicit expectation that the recipient must provide something in return for receipt of the award.

5.6 OFF-CAMPUS INDUSTRY-SPONSORED MEETINGS OR ACTIVITIES (NOT COVERED IN SECTION 5.1(b) OR SECTION 5.4)

5.6.1 Faculty Members, Faculty Staff, and Learners may only participate in off-campus meetings or conferences developed by physician or scientific society/organizations which receive Industry support or funding (including, but not limited to, lecturing, organizing the meeting or moderating sessions), if they abide by the following requirements:

1. Any financial support is fully disclosed to participants by the meeting sponsor;
2. The content and funding of the meeting or session must be under the control of the physician or scientific society/organization (see sections 5.4.4 and 5.4.5);
3. The speaker(s) must provide a fair and balanced discussion of the current science and treatment options;
4. The speaker(s) must make clear that the content and comments reflect the individual views of the speaker(s) and not those of the Faculty;
5. Compensation is reasonable and limited to reimbursement of reasonable travel expenses and an honorarium proportional to the defined service and must be payable by the meeting’s organization or society and not Industry directly.

5.6.2 Faculty Members and Faculty Staff may participate in Industry sponsored meetings pertaining to the evaluation of materials including but not limited to new equipment and products as part of an institutional procurement process provided they follow the institution’s (university, hospital, research institute) policies regarding procurement of such materials.

5.6.3    To provide optimal care to patients, surgeons and physicians may require training on new devices and/or procedures.  Industry has dual interests in advancing their products/devices but also in ensuring that these products/devices are used properly to result in best outcomes.  When Industry provides training at no cost to a Faculty Member, they must adhere to the principles of disclosure, transparency and manage any Conflict of Interest.  Industry funded training may be provided when:

a)  There is appropriate justification for the need for training by the Faculty Member;

b)   There is a commitment from the Faculty Member’s institution/organization or Faculty Department/Division to support the device and/or procedure including but not limited to: investigation, evaluation, or a contract for purchase of the device/product and/or infrastructure to support the procedure;

c)   There is full disclosure to the Faculty Member’s supervisor or administrator that training is required and supported;

d)   There is no other source of the training that does not require Industry sponsorship;

e)   The Faculty Member is acting as a representative of the institution or organization in their role to undertake training.

5.7 INDUSTRY SUPPORT FOR RESEARCH

5.7.1 A prerequisite for the participation of Faculty Members, Faculty Staff and Learners in any research activity is that these activities are ethically conducted, socially responsible and scientifically valid and in accordance with the University’s Policy 115 on the Responsible Conduct of Research and its Procedure 29-2 on Addressing Allegations of a Breach of Responsible Conduct of Research.

5.7.2 All Faculty Members, Faculty Staff, Learners who participate in the design, conduct of analysis or reporting of Industry-funded or Industry co-sponsored research which is based at the University shall ensure that the budget includes all applicable overhead costs and that there is a signed multi-partner agreement that is satisfactory to the researcher, the Head of the Department in which the researcher holds his/her primary appointment, and the Industry partner. In the case of research conducted at affiliated institutions (i.e. the contract will be administered outside the University) research projects involving Industry must comply with the policies and procedures of the affiliated institution. These policies and procedures must be agreed to by the University. Those research projects involving the participation of humans or the use of their data must be also be approved by the appropriate University or Hospital Research Ethics Board.

5.7.3    Research grants from, or contracts with Industry must not be accepted or utilized to support research unless they are directed by academic staff and are carried out objectively for the purposes of the advancement of scientific knowledge, training of highly qualified personnel (HQP) or clinical efficacy. Faculty Members, Faculty Staff, and Learners shall not enter into research agreements with Industry that limit their right to publish or disclose results of the study or report adverse events that occur during the course of the study. The Faculty recognizes that as part of a formal research contract between the University and Industry there may be publication review or limited delays to enable the filing of intellectual property protection.

5.7.4    Because of the potential to influence judgment, remuneration of subjects for participating in Industry-funded research studies, including clinical research studies, must not constitute enticement. It may cover reasonable time and expenses and, for studies involving the participation of humans or the use of their data, must be approved by the appropriate University or Hospital Research Ethics Board. Remuneration of researchers must be disclosed in the annual “Conflict of Interest”, or re-appointment review.  Finder’s fees, whereby the sole activity performed by the Faculty Member or Faculty Staff or Learner is to submit the names of potential research subjects, are not acceptable.

5.7.5    All research funding received from Industry will be administered through special purpose project-specific research accounts at the University or at an affiliated institute, centre or teaching hospital. Statements disclosing all expenditures, transfers and transactions from these accounts will be provided to Department Heads on an annual basis.

5.8 DISCLOSURE OF RELATIONSHIPS WITH INDUSTRY

5.8.1 On an annual basis, Faculty Members and Faculty Staff will disclose, in writing, relationships with Industry to the Faculty of Medicine’s Office of Faculty Affairs.  Disclosures will be reviewed and if a significant unmanaged Conflict of Interest is identified, the disclosure will be forwarded to Department heads or supervisors. The written disclosure must specify the nature of the relationship with Industry, the work performed and total amount and type of compensation or other benefit received. Similarly, Faculty Members and Faculty Staff will verify annually that their reporting was accurate and complete. Management of unresolved Conflicts of Interest will be done in collaboration between the Faculty Member, the Office of Faculty Affairs and the Department head and/or supervisor.

NOTE: Those who are also members of an affiliated hospitals’  staff may provide disclosure through their respective research institutes (Ottawa Hospital Research Institute (OHRI), the Children’s Hospital of Eastern Ontario Research Institute (CHEORI), the University of Ottawa Heart Institute (OHIRI), the Bruyère Research Institute (BRI), the Montfort Research Institute (MRI), the Royal’s Institute of Mental Health Research (IMHR))  provided they consent and authorize their Institutes to disclose the information to the Office of Faculty Affairs; otherwise the disclosure must be made to the Office of Faculty Affairs.

5.8.2    Prior to any educational activity such as lectures, seminars or workshops, Faculty Members, Faculty Staff, and speakers must disclose to the learning audience whether or not they have any relevant Conflict of Interest or other interest with Industry. If the Faculty Member, Faculty Staff, Learner or speaker has a Conflict of Interest or any other interest with Industry, the disclosure must be contained in their written presentation materials. The disclosure must include the name of the individual, the nature of the interest and the relationship between the individual and Industry or the interest in Industry. Information that an individual has no relevant financial relationship must also be disclosed in advance to the learning audience.

5.8.3 Faculty Members, Faculty Staff or Learners with supervisory responsibilities must disclose any Conflict(s) of Interest (as outlined in section 5.8.1) to those under their supervision and must ensure that the Conflict of Interest does not affect or appear to affect his or her supervision of the individual.

5.8.4 Faculty Members, Faculty Staff and Learners are prohibited from publishing articles or presentations or producing other forms of media under their names (ghost writing) that are written in whole or in part by Industry representatives.
In scholarly publications, individuals must disclose Conflicts of Interest, including their related financial interests in accordance with the requirements of the International Committee of Medical Journal Editors (http://www.icmje.org).

5.8.5 Faculty Members, Faculty Staff and Learners having a direct role in making decisions on equipment or drug procurement must disclose to the purchasing unit, prior to making any such decision, any Conflict of Interest that they or their immediate family have in companies that might substantially benefit from the decision. Such relationships could include equity ownership (excluding indirect ownership such as stock held through mutual funds), compensated positions on advisory boards, a paid consultancy, or other forms of compensated relationship. They must also disclose any research or educational interest they or their department have that might substantially benefit from the decision. The purchasing unit will decide whether the individual must excuse him/herself from the purchasing decision.

5.8.6 Faculty Members, Faculty Staff or Learners with positions of influence or fiduciary responsibilities in an Industry must not participate in research with humans involving a technology or product owned by or obligated to the Industry unless specifically disclosed and approved by a Hospital/Institutional Research Ethics Board. Faculty Members conducting research involving humans must inform participants that the researcher will, or will not, receive a fee for their participation and by whom the fee will be paid.  In addition, individuals may not conduct research with humans if they or their immediate family have a significant financial interest in an existing or potential product or a company that could be affected by the outcome of the research.

5.9 TRAINING OF FACULTY, STAFF, AND LEARNERS REGARDING INTERACTIONS WITH INDUSTRY

5.9.1 Faculty Members, Faculty Staff and Learners shall receive awareness training regarding interactions with Industry. The Faculty will develop appropriate educational materials and methods, and each Department within the Faculty will oversee such training and its quality.

5.10 REPORTING OF NON-COMPLIANCE

5.10.1 Faculty Members, Faculty Staff or Learners who are aware of contraventions of this Policy are expected to report such contraventions as a professionalism concern to the Department Head or to the Office of Professionalism, and the processes for addressing and remedying professionalism concerns set out in the Faculty of Medicine’s Professionalism Policy shall be followed. If Industry representatives do not respect this Policy, they will be managed through progressive warnings and restrictions on access to Faculty personnel, facilities and events.  Non-respect of this Policy may also constitute a Breach of Responsible Conduct of Research, as defined in Policy 115 h) Mismanagement of Conflict of Interest: Failure to appropriately manage any real, potential or perceived Conflict of Interest, in accordance with the Institution’s policy on Conflict of interest in research or with Research Sponsors’ Policies and/or Requirements.

6.1 This Policy will be reviewed every three (3) years.

RELATED UNIVERSITY OF OTTAWA POLICIES AND PROCEDURES

Policy 115, Procedure 29-2

Policy 48

Policy 70

SOURCE DOCUMENTS:

Association of American Medical Colleges

“Industry Funding of Medical Education: Report of an AAMC Task Force”

(April 2008; approved by AFMC 2009)

Canadian Medical Association

“Guidelines for Physicians in Interactions with Industry” (2007)

College of Physicians and Surgeons of Ontario

Physicians’ Relationships with Industry: Practice, Education and Research 2014

College of Family Physicians of Canada and Royal College of Physicians and Surgeons of Canada.

National Standard for Support of Accredited CPD Activities

The Ottawa Hospital

Corporate Policy and Procedure Manual, Policy No. ADM 00362, Respectful Behaviour in the Workplace. (2006/11/24/revision 2016/09/08)

Corporate Policy and Procedure Manual, Policy No. 00365, Gifts. (2008/10/08/revision 2013/05/01)

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans

SECTION 1: Honoraria and expense reimbursement for Industry-sponsored Continuing Education

1.1 For speaking engagements that require overnight travel, the provided honoraria shall not exceed $3,000 per day plus reimbursement of reasonable out-of-pocket expenses documented with receipts. Exceptions would require prior written approval by the head of OCME, VP Medical Affairs of the Health Care Facility, CEO or appropriate Director of the affiliated research institute, Department Head, or Division Head.

1.2 For speaking engagements that do not require overnight travel, the provided honoraria shall not exceed $1,500 per day plus reimbursement of reasonable out-of-pocket expenses documented with receipts.

1.3 For the development of enduring materials, the provided honoraria shall not exceed $1,500 per day plus reimbursement of reasonable out-of-pocket expenses documented with receipts.

1.4 For the review of enduring materials, the provided honoraria shall not exceed $1,000 per day plus reimbursement of reasonable out-of-pocket expenses documented with receipts.

1.5 Fees exceeding the above guideline must be approved in advance by the Department Head.

SECTION 2: Compensation for acting as a consultant to Industry

2.1 Compensation for consulting work shall not exceed $3,000 per day plus reimbursement of reasonable out-of-pocket expenses documented with receipts.

2.2 Fees exceeding the above guideline must be approved in advance by the Department Head.

SECTION 3: Compensation for work-related to Industry-sponsored research

3.1 Compensation to an investigator for administrative activities required to initiate a clinical research study (including budgeting, ethics submission, etc.) shall not exceed $1,500 per day.

3.2 Compensation for attendance at a clinical investigators’ meeting shall not exceed $1,500 per day plus reimbursement of reasonable out-of-pocket expenses documented with receipts.

3.3 Payments for study-related procedures, examinations or follow-up visits required by protocol may not exceed the Ontario tariff for these services.

3.4 Payments for research-related services required for the conduct of a study not covered by Ontario Health tariffs (including letters, reports, etc.) may not exceed $750 per patient per year enrolled in the study.

3.5 Fees exceeding or in addition to the above guideline must be approved in advance by the Department Head.

SECTION 4: Cumulative Total (or Total Annual) Compensation from Industry

4.1 Where a Faculty member receives a total of more than $10,000 for services to Industry during a calendar year, the member shall inform the Department Head of the total. This must be reported prior to completing the annual conflict of interest statement or annual reappointment review.

4.2 Where the total exceeds $20,000 during a calendar year, the member shall also inform the Dean.

1. Fleischman W, Agrawal S, King M, et al.  Association between payments from manufacturers of pharmaceuticals to physicians and regional prescribing:  cross sectional ecological study.  BMJ 2016;354:i4189
2. Fickweiler F, Fickweiler W, Urbach E.  Interactions between physicians and the pharmaceutical Industry generally and sales representatives specifically and their association with physicians’ attitudes and prescribing habits: a systematic review.  BMJ Open 2017; 7: e016408
3. DeJong C, Aguilar T, Tseng CW, Lin GA, Boscardin WJ, Dudley RA.  Pharmaceutical industry-sponsored meals and physician prescribing patterns for medicare beneficiaries.  JAMA Intern Med 2016 Aug 1:176(8):1114-1122
4. Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L.  Industry sponsorship and research outcome.  Cochrane Database Syst Rev.  2017 Feb 16;2:MR000033