Perfect is a Dirty Word: Adventures in Disclosure and Conflict of Interest

Authors: Marci Fjelstad, MPH, MBA, CHCP, University of Utah, School of Medicine; Jack Dolcourt, MD, MEd, University of Utah, School of Medicine; Megan Swartz, CHCP, Cedars-Sinai; Letti Bresnahan, MBA, CHCP, University of Texas Health Sciences San Antonio

Editor: Erin Schwarz, Vivacity Consulting, LLC

Human beings can never obtain perfection and frankly, we are happier when we do not reach for this impossible goal. In the CE world, many of us live in fear of imperfection, especially when it relates to disclosures and conflicts of interest. Even when we have a good system for collecting and resolving conflicts in our CE, we sometimes miss things or make mistakes. 

Inspired by the work of patient safety professionals, where errors are expected, discussed and problem-solved together, the authors of this article began talking to each other about how we have tried to create a culture of safety, encouraging ourselves to share and problem-solve errors or near-misses in our disclosure process. By acknowledging when our disclosure or conflict of interest process maybe has not worked as intended or an error was made, we can identify weak areas in a system and find ways to address it.

Let’s Start the Healing

The authors of this article agreed; we are officially giving you, the reader, permission to open the door, share experiences and start the healing. Stop the blame and shame and focus on the “why” errors occur and how to prevent them. Take the pressure off and learn from mistakes, improve your program and sleep a little better at night.

This article includes case-based discussions of some sticky disclosure situations we found ourselves in, and provides some strategies to avoid future errors. We encourage you to ask, “what would I do” when you read about our experiences. 

First, a foundational question: why do we collect disclosure anyway? Not only is it an accreditation requirement but even if there was no ACCME (or similar accreditation body) mandate, we still believe that collecting disclosures would be important. Our credibility as CME providers rests on being an honest broker. Our learners rely on the assurance that CME certification means the content is valid and free from commercial influence. That is the most compelling reason we expend such time and energy on this process.

But, sometimes, fear gets in the way. One strategy to deal with the fear is to turn to our colleagues, share the issue and problem solve together (a community of practice). As stated by Cruess, in Medicine as a Community of Practice: Implications for Medical Education, “Communities of practice can guide the development of interventions to make medical education more effective and can help both learners and educators better cope with medical education's complexity.”[1]  Remember that perfect is not our goal. We strive for compliance with criteria; education not promotion. Let us agree that we will do the best we can, learn from our past and get it "right" as often as we can.   

Case Examples

What Would You Do #1: {Don’t need disclosures}

A new series at a healthcare institution has been planned. The planners have identified a professional practice gap in their organization in that there are no safe spaces where learners can discuss healthcare topics related to ethical issues and the controversial topics; this series aims to address this need. The planners expect that learners will acknowledge, recognize and contemplate when sometimes in medical scenarios there is a clear “wrong” answer without a “right” one. Complex topics will be tackled with facilitated discussion. Topic examples include informed consent in research, surrogate decision-making for patients with advanced illness and shared-decision making in serious illness.  

What would you do to collect disclosure? You might choose to collect disclosure from all those involved in the content. 

31 July figure 1

Or you might choose to not collect disclosures. Yes, you read that correctly. Referring to the ACCME’s flowchart for Identifying and Resolving Personal Conflicts of Interest, published February 22, 2017, you might review Step A (and its excellent tutorial) and determine that this content, focused on ethics in medicine, could not be related to products or business lines of a commercial interest. During your planning process, ask yourself if the content is related to the products or business lines of an ACCME-defined commercial interest. If it is not, there cannot be any relevant financial relationships and so there is no reason for you to collect disclosure. You still need to tell your learners there were no relevant financial relationships, but you know there are not any. 

Think of it like a Venn Diagram (see figure above). Your content cannot interact with a financial relationship, relevant or not, because it is just too far removed. As you are planning, think whether or not the content of an activity might fit this idea. (Remember: you must decide this during planning.)

What other areas of content beside ethics might fit this idea? The authors of this article brainstormed this question and we suggested these topics might apply (with the caveat that you would need to get details):

  • Faculty development
  • Statistics discussions
  • Research development process, methodology
  • Learning science, becoming better teachers
  • Mindfulness or wellness concepts
  • Anatomy or biology
  • How to take vital signs, enter data in EHRs, perform a physical exam

What content from your program might fit this scenario?

What Would You Do #2: {inaccurate information is provided}

Your office has been approached by several physicians, requesting accreditation for a large national conference they are planning. The agenda is three full days of content and filled with breakout sessions, evening sessions and keynote talks.

The content is clearly related to products of commercial interests and you begin the process of collecting, reviewing and resolving all conflicts of interest. All disclosures are obtained and you diligently review relationships, review presentations, resolve potential conflicts and breathe a sigh of relief. During the conference, you are informed that a speaker with well-known relationships with industry had stated “nothing to disclose” on your disclosure and in the program handouts. After the initial panic, you realize thankfully there is time before the presentation takes place, and you approach the speaker to question his disclosure. Dreading the awkwardness, you approach the faculty member in the Speaker Ready Room where he is uploading his talk. You ask if he or his spouse/partner has had any financial relationships with commercial interest (defined as any entity producing, marketing, re-selling or distributing healthcare goods or services consumed by, or used on, patients) in the last 12 months. He is completely unphased by the question and responds, “Oh Yes!” He tells you what they are and agrees to add a slide listing his relationships. You are able to resolve any potential conflicts on the spot by looking at his slides. CME crisis averted!

So, what happened? Is this person deliberately trying to withhold relevant information? Are they an evil mastermind, trying to subvert the CME system? We do not believe so. Context matters. Different people interpret “relevance” differently than the ACCME expectation, especially with faculty who present in varied and diverse settings. Relevance for one faculty engagement may not be relevant for another. So what to do? Well, there are a variety of strategies to consider:

  • Review and revise your disclosure form to be sure it is clear and concise
  • From the beginning and throughout planning, emphasize the importance of objective, non-promotional content
  • Use this as a teachable moment with this faculty member and planners to discuss all faculty, presentation topics and possible known financial relationships with course directors
  • Familiarize yourself with planners and faculty, their expertise and their relationships
  • If all else fails, consider withholding credit

Ultimately, we all share the same unequivocal goal, ensuring that we are an honest broker because our content is objective, valid and free of commercial influence. 

What Would You Do #3: {employees of commercial interests}

One of the most troublesome scenarios is when you receive a disclosure that indicates the person is an employee of an ACCME-defined commercial interest. It is even more complex when that person is also an employee in your healthcare organization and one of the top experts in their field. How do you tell an expert in your organization that they cannot participate in your CME activity? Unfortunately, the authors are experiencing this scenario more often, as the healthcare model continues to evolve at an extremely fast pace. Many healthcare organizations are not only delivering care but also are on the front line researching and developing drugs, devices, products and services to enhance the care of their patients. Medical professionals not only are dedicated to providing the best care for their patients but also are encouraged by their institutions to monetize research breakthroughs by creating start-up companies. This has led to an increasing number of experts who are employed by highly reputable medical organizations and also employee/owners of commercial interests.    

How do we balance our attendees’ need to learn from the experts with the ACCME’s requirements?  

Right now, there are three special-use cases where employees of ACCME-defined commercial interests may be in a position to control the content of accredited CME activities.

1. Employees of ACCME-defined commercial interests can control the content of accredited CME activities when the content of the CME activity is not related to the business lines or products of their employer.

2. Employees of ACCME-defined commercial interests can control the content of accredited CME activities (e.g., as planners, authors or speakers [including poster presentations]) when the content of the accredited CME activity is limited to basic science research (e.g., pre-clinical research, drug discovery) or the processes/methodologies of research, themselves unrelated to a specific disease or compound/drug. In these circumstances, the accredited provider must be able to demonstrate that it has implemented processes to ensure employees of ACCME-defined commercial interests have no control of CME activity content that is related to clinical applications of the research/discovery or clinical recommendations concerning the business lines or products of their employer.

3. Employees of ACCME-defined commercial interests can participate as technicians in accredited CME activities that teach the safe and proper use of medical devices. In this circumstance, the accredited provider must demonstrate that it implements processes to ensure that employees of ACCME-defined commercial interests have no control of CME activity content that is related to clinical recommendations concerning the business lines or products of their employer.

Source: Accreditation Council for Continuing Medical Education website

Once you have reviewed the special use cases, what steps would you follow next?

  1. Make a sad face and groan
  2. Go to Google and research the company
  3. Email or call the faculty member to confirm/clarify they are indeed an employee/owner
  4. Dial a “CME Friend” to see if they had a similar issue
  5. Contact the activity chair or planners with suggestions
  6. Document what you ultimately decide to do

If you cannot manage the conflict based on the three special-use cases and the above approach, you might be forced to replace the faculty member or change the topic on which they are presenting. Or you might not allow the person to be involved at all. Or you might move their talk to another time and space, separate from the accredited CME activity, and not offer credit.

None of these are great approaches and this one keeps us up at night. There is so much involved in this scenario: political pressures within our institutions; the CME imperative for unbiased education; collaboration between researchers and the care-team; and ultimately, excellence in patient care. The authors of this article hope the definition of an ACCME-defined commercial interest may be updated in the near future to better allow for these evolutionary changes in healthcare. In the meantime, we continue to disclose and work with employees of commercial interests when it is appropriate and compliant. We must have better ways to resolve these types of issues in the future. Our learners deserve to hear untainted information from the experts, and our patients deserve to be cared for by well-informed learners.

Conclusion: Points of Practice

Do not be afraid to share your dirty laundry. Find a friend or two or 20 and brainstorm, collaborate and discuss the challenges you are facing. Build a community of practice; we are stronger together.

Let go of the fear. Do not aim at ‘perfect’; aim for high quality education without bias.

Recognize the grey areas or times the disclosure process did not work as intended. Build a spirit of safety and improvement within your program so that you can learn from mistakes and do better next time.

[1] Cruess RL1, Cruess SR, Steinert Y., Medicine as a Community of Practice: Implications for Medical Education.

Acad Med. 2018 Feb;93(2):185-191. doi: 10.1097/ACM.0000000000001826.

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