Treatment-research overlap demands paradigm shift in ethical oversight
medwireNews: As we come to learn more from healthcare, the traditionally distinct medical fields of treatment and research are becoming increasingly difficult to tell apart - so much so that the current framework for human subject protection is no longer applicable, argues a team of John Hopkins (Baltimore, Maryland) bioethicists in a Hastings Center Report.
This disconnect, according to authors Nancy Kass and colleagues, is impeding the activities that a learning healthcare system aims to achieve. "[O]ur system of oversight relies too heavily on the research-practice distinction to identify which activities warrant ethical review and to determine when patients are at risk and in need of oversight protection," they write.
Healthcare's increasing dependence on the collection, aggregation, and analysis of patient-level data to compare the effectiveness of various strategies and ultimately improve quality "provides an opportunity to rethink what matters morally in protecting the rights and interests of patients," say the authors.
Today's oversight, according to the article, saps limited resources and distracts hospital institutional review boards from quality oversight that is truly needed.
Commenting on appropriate oversight in a separate article, the authors call for a new ethical framework that hinges on the level of risk and burden created by any mode of data collection rather than having a treatment-research dichotomy act as the deciding factor.
Even further, the authors pose the patient protection framework as a matter of duty for the medical establishment to conduct learning activities and patients to contribute to such activities. "Just as health professionals and organizations have an obligation to learn," they write, "patients have an obligation to contribute to, participate in, and otherwise facilitate learning."
The bioethicists envision a learning healthcare system that "rejects the moral relevance of the traditional distinction between research and practice," and instead adopts policies and practices that link the "rights and dignity of patients [with] the common purpose of improving… clinical care and the healthcare system."
Disclosing this link to patients would keep them aware of how health care systems learn while allowing for transparency about risks and benefits as well as the confidentiality of their medical information when transmitted to other institutions.
The authors concede that the goals they presented in their article are "lofty" and likely to stir debate. In one of several accompanying commentaries, for example, the Hopkin's approach was described as "radical" by Christine Grady and David Wendler (National Institutes of Health Clinical Center, Maryland), who disagree with the call for a healthcare system designed to maximize learning activities.
By Peter Sergo, medwireNews Reporter