The October issue of Regulatory Affairs Focus, the monthly magazine of the Regulatory Affairs Professionals Society, may be a useful source of ideas for CME courses on medical ethics. The entire issue is devoted to examining several ethical issues that face the US healthcare system including the protection of human subjects in clinical trials, the promotion of prescription drugs, and end-of-life decisions. CME providers may also recognize themselves as sharing in the same kinds of ethical dilemmas as regulatory professionals.

"The challenge we face as regulatory professionals," writes issue editor Michael Daley, "is that sometimes we are considered the keepers of the 'ethical chalice,' and yet factions within our companies sometimes consider us the gatekeepers and 'program killers' because of the rules, regulations and guidelines that govern our profession and industry...With the pressures of profitability, approval time, promotional noise, and brand recognition, sometimes it can be challenging to stand the ground of an ethical course. But we--as regulatory professionals--and our corporate cultures must continue to be aware that doing the right thing will always be the best thing in the long run for our companies or clients."

In one article, Mark Yessian, with the HHS Office of the Inspector General, examines the challenges facing the protection of human subjects in medical research by focusing on Institutional Review Boards (IRBs), which have "the most singular and focused responsibility for protecting human subjects." Three years ago, Yessian was the chief author of an OIG report that concluded the nation's IRBs were in trouble. The report found that the way clinical research was conducted had changed dramatically since the IRB system was developed. In the late 1970s, most clinical trial research was conducted by individual investigators at academic medical centers. Today, most research trials are part of larger multi-center efforts with thousands of subjects. Individual IRBs often have little knowledge of what is happening at other sites, if problems have come up, or even if other IRBs request protocol changes.

In addition, the report found IRBs were reviewing too many projects too quickly and with too little expertise and training, conducting minimal continuing review and little evaluation of their effectiveness, and facing conflicts that threatened their independence, as research funding becomes a more and more important revenue source to their institutions.

Yessian outlines a number of steps that have been taken to improve the situation since the report was issued. "These steps are important and encouraging," he writes, "but underlying forces remain that can make it enormously difficult to generate sustained and deep-seated reform. These include the pressing societal interest in finding cures to diseases and rapid access to new therapies--even if those therapies are offered in Phase I experimental trial; the financial and competitive pressures that commercial sponsors face in seeking to bring new products to market; and the enduring quest of institutions and investigators to make scientific breakthroughs and, yes, to gain the prestige associated with their discoveries."

In another article, Karine Morin, secretary of the American Medical Association's Council on Ethical and Judicial Affairs, discusses the association's standards of ethical conduct in research. She notes medical research is having unprecedented growth, which is not likely to abate anytime soon. "The stakes have never been higher and the medical profession, as custodian of patients' welfare, will need to be ever so diligent in establishing ethical guidance to protect research participants. For this reason, investigators--and all others involved in the research enterprise--should be mindful of the AMA's Code of Medical Ethics." Morin provides an overview of the AMA obligations and guidelines.

Also in the October issue, John Murray, a member of Astra-Zeneca's promotional regulatory affairs department, looks at the ethical consideration in prescription drug promotion. "Direct-to-consumer broadcast advertising and the Internet are moving into areas where regulations implemented in a different era provide little guidance. As a result, regulatory professionals are often the ethical compass, bridging the gap between ... a somewhat archaic regulatory scheme [and] ethical principles."

Finally, Dr. David Fleming, an affiliated scholar with the Center for Clinical Bioethics at Georgetown University, provides a global perspective on healthcare decisions at the end of life. Dr. Fleming examines the way healthcare providers from different cultures promote and use advance care planning, respond to requests for assistance in dying, and address the notion of futility and limiting treatment for the terminally ill and other particularly vulnerable patients. He finds that although cultural differences do exist in how the best interest of the patient is interpreted and what actions should be taken, healthcare professionals from all cultures share a universal concern for patient welfare in making end-of-life decisions. He notes that over the past 30 years physicians and healthcare systems worldwide have identified the need to respect the wishes of the patient and promote palliative care at the end of life. But "the challenge is more acute for neonates and the elderly" and "a greater effort must be made to minimize inconsistencies in treatment and to more accurately respect the needs of those who cannot speak for themselves," Fleming writes.

To learn more about the Regulatory Affairs Professionals Society and its publications, call (301) 770-2920, or visit the website.