AMA House of Delegates
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Philip Cascade, MD, a Michigan radiologist and a delegate with the American College of Radiology. Photo by Peter Wynn Thompson

Ethics essential in writing practice guidelines, AMA house decides

Delegates adopt policy outlining how to manage and limit conflicts of interest during the development stage.

By Alicia Gallegos — Posted July 4, 2011

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Ethical principles should be used when developing medical practice guidelines to prevent conflicts of interest, according to policy adopted by the AMA House of Delegates.

Such guidelines should be created independent of any direct financial support from entities that have an interest in the recommendations being developed, the policy says. Ideally, individuals associated with content development should be free of conflicts not only during the development process but also for a defined period of time after guideline publication.

The policy also calls for those establishing medical guidelines to adopt formal procedures that decrease risks for improper influence. This includes:

  • Required disclosure of all potential conflicts of interest.
  • Clearly defined criteria for assessing the seriousness of conflicts.
  • Defined strategies for eliminating or mitigating the influence of conflicts in circumstances when someone's participation cannot be avoided.

The policy meets the Institute of Medicine's challenge for medical societies to harmonize and strategize policies in writing medical guidelines, said Norman Kahn, MD, executive vice president and CEO of the Council of Medical Specialty Societies.

Recent studies, such as an analysis in the March 28 Archives of Internal Medicine, show that many guideline panelists have financial conflicts. The study said more than half of those on cardiovascular guideline-writing panels from 2004 to 2008 had conflicts.

Also in March, an IOM panel proposed standards on how clinical guideline panels should manage and limit conflicts of interest. The IOM said panelists should disclose relevant current and planned commercial, institutional and intellectual activities and related services that generate a "substantial proportion of income."

Philip Cascade, MD, a Michigan radiologist and a delegate with the American College of Radiology, said the ACR believes the new AMA ethical recommendations are important. But the policy's call for an independent peer review is problematic, he said. "Is it practical? It's costly, and it takes time ... The report itself gives very little information" about how to go about conducting these reviews.

The guidelines help ensure that published guidelines are as credible and trustworthy as possible, said the adopted Board of Trustees report.

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ADDITIONAL INFORMATION

Meeting notes: Medical ethics

Issue: Patients who provide samples of blood, cells, tissue and DNA may not fully understand that their biological materials may be pooled and stored for future research. Would the development of a universal consent form for research that involves stored biological materials be the best approach to ensure consent?

Proposed action: The Council on Ethical and Judicial Affairs said a universal consent form is not needed, as AMA policy already appropriately addresses informed consent as it relates to biobanking. The council proposed reaffirming several existing policies in reference to this issue. [Adopted]

Issue: Two resolutions asked the AMA to support specific positions on stem cell research and research involving human cloning.

Proposed action: CEJA said existing AMA policy must be updated to reflect the state of research. This means doctors who do stem cell research should adhere to institutional review board requirements. Doctors also should ensure that research is carried out with appropriate oversight and informed consent. [Adopted]

Issue: Studies say terminally ill hospice patients have an extended lifespan and improved quality of life compared with other terminally ill patients. But political discussions and media portrayals depict end-of-life issues in a bad light.

Proposed action: The AMA should meet with stakeholders to lead and direct the national discussion on end-of-life issues. [Adopted]

Issue: A museum exhibit in Michigan showcasing human bodies has raised questions about the cadavers' origins and whether consent was received from their families.

Proposed action: The AMA should request that federal or international authorities investigate if the bodies in the Premier Exhibition Inc.'s Bodies Revealed exhibits were obtained through approved international human rights measures. [Adopted]

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External links

"Conflicts of Interest in Cardiovascular Clinical Practice Guidelines," Archives of Internal Medicine, March 28 (link)

"Clinical Practice Guidelines We Can Trust," consensus report, Institute of Medicine, March 23 (link)

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