When do I need to disclose?
- When preparing a talk or presentation, a verbal and in-writing disclosure statement is required regardless of whether or not research or speaker funding was received
- When there is a financial relationship to a medical device or pharmaceutical company, or any other commercial organization may directly benefit from the talk or presentation.
What are examples of financial relationships that I may need to disclose?
- Acting as a paid consultant with a pharmaceutical company or medical device company
- Paid membership on an Advisory Board that has an affiliation with your presentation topic or research
- Investment in a commercial interest.
- Holding a patent on a drug, product, or device.
- Membership on a speaker’s bureau.
- Receiving research grants from a commercial organization
- Receiving travel grants from a commercial organization.
Can I accept an honorarium for a slide deck that is an evidence-based presentation developed by pharma?
- You could accept the honorarium as a speaker delivering a presentation as reimbursement of your time; however, participating in this context of education when you have not developed the content of the presentation is considered ghostwriting, and not considered an acceptable practice.
How do I eliminate COI?
- Refuse individual gifts (meals) when you have provided no service in receipt of the gift.
- Plan education that involves pooled funding (unrestricted educational grants) for educational events
- Do not allow the use of your name when you have not created the presentation content. This is considered ghostwriting.
- Disclose any financial relationships that you have with commercial entities at the beginning of a presentation. Being transparent allows the audience to consider any undue external influence while listening to the presentation. Additionally, one may want to consider including in their presentation evidence of multiple drug interventions options to alleviate any bias towards one pharmaceutical company.
What does the COI with commercial entities policy not allow?
- Clinical teachers inviting learners to attend a non-accredited pharma dinner sponsored event or any pharma-sponsored social events.
- Faculty or staff arranging non-curricular educational events with commercial entities for students and residents.
- Pharma representatives and medical equipment representatives approaching and interacting with students and residents directly without a clinical faculty member present. Having a clinical faculty member present allows for teachable moments with the students and residents about the ethical and professional issues of physician– commercial entity relationships and interactions.
- Pharma representatives actively participating in educational presentation discussions. Pharma reps can attend but cannot participate in or contribute to the discussion, and must be free of any visible identity of drug promotion.
What difference does it make if events use unrestricted grants or educational pooling of funds?
Unrestricted grants and pooling of funds, such as securing several sources of funds, to run an educational event(s) eliminates the undue external influence of one industry or company over another. Unrestricted grants also allow full responsibility of organizers (participants) to take ownership in the selection of topics based on their clinical practice and personal learning needs, develop their own curriculum, and select their choice of speakers. The pooling of funds does allow for meals and other amenities to be part of the educational event, as there is no undue external influence present.
Can educational programs use industry educational material?
Industry can be a valuable source of educational material for students and residents. Industry educational material should be reviewed and approved for use by the faculty and program for its appropriateness in content in aligning with curricular objectives, ensuring that the material is peer-reviewed and that it does not endorse specific products. Any material developed by industry must be clearly labeled as such.
As a practising physician/health professional and a NOSM clinical faculty member, if I wish to assist with recruiting sponsorships or assisting in fundraising for my community hospital, do I need to seek approval from the NOSM Advancement Office?
No, is the simple answer. For fundraising or events seeking sponsorship that are not related to NOSM, you do not need to seek approval from the NOSM Advancement Office. You should, however, note the importance of abiding by the conflict of interest policy of the organization or institution that you are working with in soliciting those funds.
As a practising physician/health professional and a NOSM clinical faculty member, if I wish to assist with recruiting sponsorships or assisting in fundraising for an event or purpose that is a collaborative effort between my organization and NOSM, do I need to seek approval from the NOSM Advancement Office?
It would be helpful for you to seek the wording in the agreement that your organization currently holds with NOSM. In many of the current collaborative agreements between NOSM and its affiliated teaching hospitals/institutions, there is guidance on the joint relations of fundraising by informing the other of its fundraising plans and priorities where it is anticipated they might impact upon the other through the Joint Relations Committee.
In submitting a research ethics application, why do I need to disclose all financial relationships, and for how long back do I need to report?
Disclosure is the basic requirement. Researchers must disclose their financial interests to REBs, to the research subjects, in publications, and in all presentations of their findings. It may be helpful for you to review the evidence-based and validated tool of a “financial checklist” as a measure that you have covered all disclosures. Rochon, P. et al (2010). Financial conflicts of interest checklist 2010 for clinical research studies. Open Medicine, 4(1):e70
How many years back do I need to disclose my financial relationships?
Five years is the acceptable practice.
Can I accept samples from pharmaceutical companies?
Samples can only be accepted for use by patients. Personal use of samples, or use by friends or family, is not permitted. Samples must be stored under proper conditions. If samples are given to patients then proper recordkeeping must be ensured, which includes recording the name of the drug, quantity given, and ensuring that the expiry date has not passed.
Does conflict of interest with the pharmaceutical industry only apply to physicians?
No. All health professionals (e.g., nurses, nurse practitioners, pharmacists, dietitians, etc.) need to be aware of any undue external influences and abide by their professional association guidelines, policies within their practice environment, and their teaching roles with academic institutions.
As a health professional and clinical teacher holding a NOSM faculty appointment, to whom do I annually disclose my financial relationship of over $5,000.00?
At annual reviews, faculty should convey financial relationships over $5,000.00 to the Associate Dean, Faculty Affairs or designate.
For further information, please email firstname.lastname@example.org.