Tips on Complying with the Updated Standards for Commercial Support

Kopelow Takes Your Questions

When Murray Kopelow, MD, chief executive, Accreditation Council for CME, opened up his session at the Alliance for CME annual conference for questions, attendees rushed to the microphones with their specific concerns. Here are some of the audience members' burning questions, and Kopelow's replies.

QUESTION: Do the planning committee disclosures have to be disclosed to the learner?

ANSWER: Yes, if they control the content.

Q: If a person who controls content divests himself from the relationship, do you still have to disclose the conflict?

A: If the conflict is gone, it's resolved, but you still have to disclose it if it's within the 12-month period.

Q: Do faculty have to disclose all relationships, or just relevant ones?

A: In section 2.1 of the updated Standards, it states that “all relevant financial relationships with any commercial interest” must be disclosed to the provider. That means the relationship is present and relevant to the content.

Q: Can you give examples of safeguards for controlling commercial bias?

A: There are things you can do to prevent commercial bias, such as peer and content review to ensure the data's validity. Some people we have talked with who have highly motivated teachers who also are at high risk for bias, instruct them that they need to use evidence-based medicine when they get to areas with bias potential. Others have people on a panel to question the faculty member on that area. Also, when the difference in knowledge between the faculty and learners is greatest, the learners are less likely to perceive bias. Specialty societies for years have handled this by using monitors who are trained to look for bias.

Q: Some specialty societies could overdo disclosure to the point where it impacts the program. How much disclosure is too much?

A: I think the Alliance does a good job in their program book. It says that if there's nothing listed after a faculty name, the person has nothing to disclose. If a faculty member has nothing to disclose, we don't need to see that statement over and over again. But if 80 percent of your faculty have blank spaces below their names — which implies they have nothing to disclose — and we find out those areas are blank because they didn't turn in their disclosure forms, that's a different story.

Q: How should we deal with a course director who has a conflict of interest?

A: Take the scenario written about in The New York Times several years ago. Faculty for an activity about stents owned the company that made the stents, and they controlled the content. It's a clear case of conflict of interest. Someone else should be the chair. You also can use external evaluation and peer review to add a layer of decision-making if you have someone with a conflict who is that involved in the control of the content.

Q: What if the situation is not that obvious — he's a consultant to the pharma company, but is the best person to have for a particular activity. Is disclosing enough?

A: What the audience might perceive as just disclosure really could be much more — you made sure that the faculty picked are the best for the job, that the content is evidence-based, etc.

Q: Why all the articles criticizing CME when many of us are already doing a lot of what the updated Standards ask?

A: Because 30 percent of our accredited providers are not in compliance with disclosure. We have not yet measured content validation or the presence of bias.