Athens, Ga. – Just as the ethical standards for medical research require that scientists be aware of the effects their research has on persons in the study, researchers from the University of Georgia and Armstrong Atlantic State University argue that attention to ethical issues should be a critical component of health care policy development.
In a recent paper published online in the Journal of Gerontological Nursing, Dr. Toni Miles, professor of epidemiology and director of the Institute of Gerontology at the UGA College of Public Health, and Dr. David Adams, associate professor of health sciences at Armstrong, propose that a formal ethics review process could help anticipate the unintended consequences of new health care policies, such as the Affordable Care Act.
In 1978, the Belmont Report was published by the United States Government to provide a succinct description of the ethical principles and guidelines to be followed for research involving human subjects. The document highlighted three general principles-respect for persons, beneficence and justice-and further refined the series of international biomedical codes created after revelations of horrific medical experiments performed by Nazi doctors during WWII.
“Before the Belmont Report, a researcher could do whatever they wanted to with their human subjects,” Miles said. “There was no commitment to treating patients in a humane fashion.”
Today, medical research involving human subjects must be reviewed and approved by an Institutional Review Board of experts and subjects must voluntarily give informed consent to participate in research trials, Miles explained.
“The next logical stage would be to apply this same lens to the development of health care policy, especially now that we find ourselves in the midst of a health care quality movement focused on cost. The Belmont Report provides a platform for this process,” she said.
Miles cited an example from the paper. “The Centers for Medicare and Medicaid Services have put policies in place that pay institutions for implementing measures that improve the quality of health care services to its beneficiaries,” she said.
One of these measures of quality is that patients over the age of 65 have a copy of their advance directive included in their chart. An advance directive, sometimes called a living will, is a legal document that expresses a person’s wishes for the type of care he or she would like to receive should he or she become unable to make such decisions.
“CMS likes this advance directive policy because it saves costs on health care delivery that some people don’t want. Hospitals like it because they are going to get paid better for including this documentation,” Miles said. “The question is does this policy pass a Belmont-style sniff test?”
In the article, Miles and Adams work through the application of the Belmont principles to current health care policies, like advanced directives. The first principle, respect for persons, requires that a policy respect personal autonomy or a person’s ability to make an informed, un-coerced decision. The second, beneficence, would assess a policy for its ethical obligation to secure the participant’s well-being or “do no harm.” Justice, the third Belmont principle, would ask if the benefits and burdens of a health care policy are fairly distributed.
“Sometimes a new policy has an unintended, perverse effect and harms rather than helps,” Miles said. “Medical researchers get help with this issue through the ethics review. Policy can influence the lives of so many people. There should be a process to help policy makers with this issue too.”
Miles also points to the eligibility criteria for Medicaid as an area where a formal ethical review could be informative in developing better health policy.
“Is it respectful, harmless, and just to limit access? For example, young males who are unemployed are not a mandatory service group under Medicaid,” Miles said. “Does this policy pass the Belmont criteria when you have a young man who cannot get a job because he has a chronic illness? Some people would argue, ‘No, it’s not fair and it certainly does not respect the rights of someone who is sick.'”