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Best Practices: Conflict of Interest & Disclosure to Learners

One of the challenges many activity planners face is how to comply with the Standards for Commercial Support. While compliance is not necessarily difficult, it does require a great deal of attention to detail. By creating a standard procedure for handling conflict of interest (COI) and disclosure, planners can simplify their process for handling these key accreditation requirements.

Identification of Potential Conflicts of Interest

All persons who are in a position to control the content of an activity may have a COI. These "persons" include any faculty (presenters) and members of the planning committee. But there may be more people in control of the content of your activity. Any reviewers, editors, authors, etc. may have the opportunity to impact your activity. So the first step is to identify this group of people. And this must be done at the beginning of your planning process. You don't want to be halfway through the planning process and only then discover that one of your planners has a COI. And before you ask, yes, speakers/faculty can be identified later. When you make your list of persons in a position to control content, you can put a placeholder for your faculty. 

Now that you know who may be in control of the content of your activity, you need to make sure all of them complete some sort of COI disclosure form. Most organizations use an actual form (paper or online), but there is no requirement that it be a written process. If your organization and activities are small, this information could be collected by phone call. But there is some key language that is required.

Definition of a Commercial Interest

Whether printed on a paper or read aloud to someone who will verbally answer questions about their financial relationships, the ACCME's definition of a commercial interest must be included in your COI disclosure process.

A commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients (ACCME, Definition, 2019).

Hospitals, government organizations, labs, and many non-profits are not considered commercial interests. (A full list of organization types that do not fall under this definition is on the ACCME's website). It is always better, though, for individuals to over-disclose. It is not up to the individual completing the COI disclosure to determine what is relevant. My favorite example of this is the individual who let me know about their stock holdings in a company that makes garden sheds. It was easy for me to identify that relationship as not presenting a conflict, but I appreciate that presenter's thoroughness and honesty.

Relevant Financial Relationships

Again, whether you use a printed form or are reading the request aloud, you must also include an explanation of what a relevant financial relationship is.

The ACCME defines "'relevant' financial relationships" as financial relationships in any amount occurring within the past 12 months that create a conflict of interest (ACCME, Standard 2, 2019).

It was probably this part of the form that the person I mentioned above was focused on when they told me about their shares in the garden shed manufacturer. And, frankly, for the purposes of the individual completing the form, this is the important part. If they aren't sure if the relationship may create a conflict of interest, they should err on the side of caution and disclose the relationship. You can then make the call on whether a resolution needs to take place.

Another thing to note is that the financial relationships of a spouse are considered to be no different than the financial relationships of the individual in control of the content, so make sure to ask about a spouse's relationships, too.

So which ones are relevant? Look back at the definition of a commercial interest. What does each company produce, market, re-sell, or distribute? Does that have anything to do with your activity? Again, going back to my example, if that activity had been about safety regulations in outbuildings, then this relationship might have posed a potential COI. But the chances of that happening in our field are slim. More often what you'll see in our line of work is a relationship with a pharmaceutical company or medical device manufacturer. Does that company produce oncology drugs for your oncology-focused activity? You can be more specific, of course. Does a relationship with a company that makes a breast cancer treatment pose a potential COI in a presentation about colon cancer? There may be some relationships that you review and can immediately mark as non-conflicted. For everyone else, you'll need to take steps to resolve the conflict that relationship may present.

Resolution of Conflicts of Interest

You've identified everyone who is control of the content. You've collected descriptions of all of their financial relationships from the past 12 months. You've identified which of those relationships are relevant to your activity. Now you need to resolve any potential conflicts. This is why it is important to start your planning process with collecting COI disclosure forms. You need to resolve any planner conflicts before they can continue to participate in the activity.

I highly recommend referencing the ACCME's Flowchart for the Identification and Resolution of Personal Conflicts of Interest. It includes a detailed list on how potential COI can be resolved (in addition to being a handy one-page reminder of the best practices described in this post). Most planner conflicts can be managed by having that individual recuse themselves. And most faculty conflicts can by managed by a peer-review process. What matters is that a resolution process takes place and is documented. You want to be able to show that the activity you are presented was planned with as little bias as possible.

Unresolvable Relationships

There is one type of relationship that cannot be resolved. Employees of commercial interests have a financial relationship that inherently cannot be resolved. The only resolution is to remove that individual from the activity altogether. Now, if the employee is the spouse of the individual in control of the content of your activity, you can proceed with another form of resolution.

For example, a drug rep may be married to a physician. If the physician is going to be presenting at your activity, you can use a peer-review process to resolve this financial relationship. But if the drug rep was initially signed on to present at the activity, they will have to be replaced with someone who is not employed by a commercial interest.

Disclosure to Learners

Now that all of your potential COI has been resolved, all that is left is to let your learners know about it. You don't have to tell them about the whole process, but you do need to tell them about the relationships. There are three parts to remember to disclose: name, organization, and relationship.

Dr Smith owns stock in Happy Garden Sheds.

But that's not all. You need to disclose the lack of financial relationships, too. This can be done individually or as a group.

Dr Smith has no financial relationships to disclose. Dr Jones has no financial relationships to disclose. Dr Brown has no financial relationships to disclose

Or

Drs Smith, Jones, and Brown have no financial relationships to disclose.

But since you want to make sure that all of the planners, reviewers, etc. are included in your disclosure to learners, the easiest way is to use a blanket statement for this non-conflicted group.

All others involved in the planning or presentation of this activity have no financial relationships to disclose.

And as with everything else in this process, keep a record that this took place. While disclosure to learners doesn't need to happen in writing, a written disclosure to learners in a handout or slide is the easiest way for you as a planner to make sure that all of the required language is included and provided to learners at the start of the activity.

As you can see, it is the details that make most of the work, not the process. If you implement a process similar to this into your planning, you should have no problem showing your compliance with the Standards for Commercial Support related to independence and COI.

References

ACCME (2019). Definition of a Commercial Interest. Available at: https://www.accme.org/accreditation-rules/policies/definition-commercial-interest

ACCME (2017). Flowchart for the Identification and Resolution of Personal Conflicts of Interest. Available at: https://www.accme.org/sites/default/files/2019-09/829_20180705_ACCME_COI_Flowchart.pdf

ACCME (2019).Standard 2: Resolution of Personal Conflicts of Interest.Available at: https://www.accme.org/accreditation-rules/standards-for-commercial-support/standard-2-resolution-personal-conflicts

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