Journal of Gerontological Nursing

Public Policy 

The Application of Belmont Report Principles to Policy Development

David P. Adams, PhD, MPH, MSc; Toni P. Miles, MD, PhD

Abstract

Attention to ethical issues is a routine part of medical research. In this article, we propose that health policy development, like research, include a formal review of these issues. Ethical knowledge is a critical component of epistemology and inherent in development of laws and principles of justice. However, we cannot assume that new policies are subject to a formal ethics review. The Belmont Report of 1978 provides a platform for this process. Prior to the Belmont Report, there was no foundation defining this process in medical research. Based on this history, we propose that health care payment policy development include a formal assessment of risks and benefits using an approach that is familiar to all researchers. [Journal of Gerontological Nursing, 39(12), 16–21.]

Dr. Adams is Associate Professor, Department of Health Sciences, Armstrong Atlantic State University, Savannah, and Dr. Miles is Director, Institute of Gerontology, and Professor of Epidemiology, College of Public Health, University of Georgia, Athens, Georgia.

The authors have disclosed no potential conflicts of interest, financial or otherwise. The authors thank Eileen Sullivan-Marx, PhD, RN, FAAN, for review and comment on prior versions of this article.

Address correspondence to Toni P. Miles, MD, PhD, Director, Institute of Gerontology, 255 E. Hancock, Athens, GA 30602-5775; e-mail: tonimile@uga.edu.

Posted Online: November 07, 2013

Abstract

Attention to ethical issues is a routine part of medical research. In this article, we propose that health policy development, like research, include a formal review of these issues. Ethical knowledge is a critical component of epistemology and inherent in development of laws and principles of justice. However, we cannot assume that new policies are subject to a formal ethics review. The Belmont Report of 1978 provides a platform for this process. Prior to the Belmont Report, there was no foundation defining this process in medical research. Based on this history, we propose that health care payment policy development include a formal assessment of risks and benefits using an approach that is familiar to all researchers. [Journal of Gerontological Nursing, 39(12), 16–21.]

Dr. Adams is Associate Professor, Department of Health Sciences, Armstrong Atlantic State University, Savannah, and Dr. Miles is Director, Institute of Gerontology, and Professor of Epidemiology, College of Public Health, University of Georgia, Athens, Georgia.

The authors have disclosed no potential conflicts of interest, financial or otherwise. The authors thank Eileen Sullivan-Marx, PhD, RN, FAAN, for review and comment on prior versions of this article.

Address correspondence to Toni P. Miles, MD, PhD, Director, Institute of Gerontology, 255 E. Hancock, Athens, GA 30602-5775; e-mail: tonimile@uga.edu.

Posted Online: November 07, 2013

The roots of the Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research [National Commission for the Protection of Human Subjects], 1978) date from the mid-1940s. As Allied forces pushed into Nazi Germany in early 1945, they encountered the unspeakable: “extermination camps” that systematically executed more than 6 million people, the majority of whom were members of targeted religious, ethnic, and sociopolitical groups. Within these camps, Allied units found not only evidence of mass starvation and extermination but also evidence of macabre medical experiments. By late 1945, Allied investigators had begun to arrest hundreds whom they suspected of perpetrating these acts. They appeared before the Nuremberg Tribunal in 1948, and soon many faced death penalties (Baader, Lederer, Low, Schmaltz, & Scherwin, 2005; Kious, 2001; Turner, 2012).

The memory of these atrocities has haunted the postwar years. In their wake followed international biomedical codes such as the Helsinki Declaration, concerted efforts to prevent such horrors in the postwar world (Rickham, 1964). A further refinement of the Helsinki Declaration, The Belmont Report, appeared in the late 1970s. Its elegant simplicity, true to the spirit of the Nuremberg and Helsinki documents, provided a succinct statement of core bioethical principles (National Commission for the Protection of Human Subjects, 1978).

The Belmont Report highlights three general principles: respect for persons, beneficence, and justice. The first, respect for persons, suggests that individuals who participate in biomedical research remain autonomous, participating in a study only if they freely consent after being informed of all known risks and benefits. The second, beneficence, echoes the Hippocratic axiom, Primum no nocere (“First, do no harm”), always striving to maximize benefits and minimize risks. The third, justice, highlights two key questions: Who stands to benefit from or bear the burden of the research?, and How should one distribute the potential benefits and burdens of the research (National Commission for the Protection of Human Subjects, 1978)?

Health care quality is an important issue in contemporary care (McGlynn, 2008). Thorlby, Jorgensen, Siegel, and Ayanian (2011) noted that disparity in health care quality is one example where an ethics review of policy could be informative. As part of its payment restructuring policy, the Patient Protection and Affordable Care Act of 2010 (PPACA) requires health care organizations to examine their quality data for gaps between groups. Quality reviews of outcomes—mortality or treatment complications—ask a fundamental question: Can we reduce the number of deaths and complications by improving our practices? Providers are required to document these outcomes for racial, ethnic, gender, language, and disability groups. Is there evidence for systematic differences in quality? In U.S. history, health care delivery systems have never been required to look for evidence of inequality of care within their confines. Does analysis of outcomes lead to diminished health care disparities? By restructuring payment, the PPACA has laid a foundation for formal review of care delivery outcomes. Can this process be the foundation for ethics studies of PPACA policy?

Policies shaping health care quality represent convergence of evidence from three fronts. First, there is consistent evidence that minorities remain less likely to receive medical or surgical interventions (Smedley, 2008). Studies of cardiac medication or bypass surgeries are a classic example of this problem. Second, the Commonwealth Fund Health Plan Report Card found that quality measures clearly show disparities in care between racial and ethnic groups receiving care inside an institution (Nerenz et al., 2002). A final line of work on health care quality comes from the Institute of Medicine (IOM). To address health care disparities, the IOM (2009) recommended that Congress pass laws requiring measurement of quality. With the enactment of the PPACA, formal quality assessment in health care and payment policy are now linked. Will the linkage between quality measures and payment policy diminish health care disparities? What are the ethics of this approach (i.e., its risks and benefits) to vulnerable populations?

The communities of health disparities researchers may not fully understand the approach used by health care organizations to engage in health care quality review. To use these data, the researchers will need to become familiar with PPACA and the quality measures available through the Centers for Medicare & Medicaid Services (CMS). The Medicare database contains quality measures for a diverse sample. In addition to adults 65 and older, the data also include a younger group of patients served by the end-stage renal disease program.

Linking consumer assessment of health care and payment is a key tool for measuring quality in the PPACA. In her testimony before the Senate Committee on Finance in 2008, Dr. Elizabeth McGlynn (2008) of the RAND Corporation defined quality care “as occurring when the right care is delivered to the right person at the right time, every time” (p. 1). Such quality should address, at the least, issues of medication errors, patient safety, and cultural competence (Miles & Smith, 2013). For the first time, the U.S. Government Accountability Office will be required to analyze the impact of the PPACA’s Hospital Compare policy and explicitly report on the impact of health care quality among racial, ethnic, and socioeconomic groups. For analyses of ethics and policy, CMS data may be the place to start (Miles & Smith, 2013). Will this policy meet the standards for ethical conduct of health care policy according to the Belmont principles? In the sections below, we examine health care quality policy using the three core principles of Respect, Do No Harm, and Justice.

Respect for Persons

Respect for persons incorporates at least two ethical convictions: first, that an individual should be treated as an autonomous agent, and second, individuals with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy (National Commission for the Protection of Human Subjects, 1978). A bona fide application of the Belmont Report may allow policy makers to establish national, if not international, standards by which to collect and utilize race and ethnicity data. Policies should stress due protection of persons. If policy makers wish to hold health care organizations responsible for disparities in health care, common standards will be needed for organizations’ data measurement, analysis, and use to guide systematic analysis and robust investment in potential solutions to reduce and eliminate disparities (Thorlby et al., 2011)

The voice of the patient offers an important starting point from which to apply the dictum respect for persons (Miles & Smith, 2013). A number of surveys indicate that communication is a barrier in health care. The National Council on Aging survey of middle-aged adults with chronic conditions reported that 36% asked for an individualized program to learn how to take better care of their health in a way that works for them and their life (Miles & Smith, 2013). Another 30% stated that they needed help to understand steps they might take to improve their health. Such findings highlight a clear opportunity for clinicians to address communication issues. National Public Radio, Robert Wood Johnson Foundation, and the Harvard School of Public Health (2012) conducted a poll of sick Americans about their equality of medical care over the past year. Respondents defined as “sick” were those who had a serious illness, medical condition, injury, or disability requiring a great deal of medical care or who had been hospitalized overnight in the past 12 months. What do adults with severe illness say about the quality of their care? Two thirds of sick Americans thought that there was a serious problem with the quality of the nation’s health care. Sick Americans saw a wide range of issues that contribute to quality problems across the nation. These included problems related to insurance plan restrictions, lack of availability of quality services, and concerns about some aspects of the way care is provided. Approximately 8 in 10 Americans (78%) believed that people being unable to afford the tests or drugs they need is a problem. They were concerned about the influence of health insurance plans on treatment decisions (64%). Many expressed concerns about being able to get access to high-quality physicians and hospitals (61%). Many sick Americans had experienced situations where they believe the care provided was not appropriate.

Is communication an issue regarding respect for persons? Communication of potential risk and benefit is an evolving area of health care policy (Strunk, Townsend-Rocchiccioli, & Sandford, 2013). Can we improve the design of risk/benefit communication by applying the respect for persons principle? Researchers have experience developing informed consent. In health care delivery, this communication is consent for procedure. There is also a consenting process tied to release of data. In theory, each of these events gives patients an opportunity to say “No”: No, I do not want my data released. No, I do not want the treatment offered. When there is a difference of opinion between a provider and patient on treatment options, there is a tendency to frame it as a lack of knowledge or understanding of treatment value by the patient. Current health care policy requires notation in the medical record that a discussion of advanced directives has taken place. The Agency for Healthcare Research and Quality’s (2012) Healthcare Effectiveness Data and Information Set measures in the care of older adults promotes the idea that advanced care planning includes a discussion about preferences for resuscitation, life-sustaining treatment, and end-of-life care. Evidence of advanced care planning must include the presence of an advanced care plan in the medical record or documentation of an advanced care planning discussion with the provider and the date discussed. Does the policy honor both autonomy and protection? A Belmont Report–style analysis of the policy surrounding advanced directives could yield alternative approaches to the design of this policy.

First, Do No Harm

The second Belmont principle refers to the notion that ethical treatment makes an effort to secure the person’s well-being. This is beneficence. The term beneficence is often understood to include acts of kindness or charity that go beyond strict obligation. In the Belmont document, beneficence is understood in a stronger sense, as an obligation. Two general rules are complementary expressions of beneficent actions in this sense: (a) do not harm and (b) maximize possible benefits and minimize possible harms. Reconciliation between payment policy and beneficence presents the greatest challenge. Payment policy has its basis in the realm of legal, financial requirement. Payment carries with it an expectation of receipt of goods or services. Not delivering goods or services is clearly fraud. The obligations of beneficence affect both individual providers and the larger society, because they extend both to individual patient care and to the entire enterprise of health care delivery.

The current discussion surrounding PPACA’s Medicaid expansion policy is the best example of this principle. No one has yet framed the discussion as a Belmont analysis. By doing that, we would need to designate the preferred object of protection—individuals or the larger base of taxpayers. The following text illustrates this exercise. This is excerpted text from a meeting of the New Hampshire commission (Leubsdorf, 2013, para. 5–8):

Deb Fournier, policy analyst at the New Hampshire Fiscal Policy Institute, told the commission that expanding Medicaid would add about 60,000 mostly uninsured people to the program and provide a boost to the state’s economy. Among those, getting help would be uninsured “mid-life adults,” aged 45 to 64 and including many people with chronic conditions such as hypertension and diabetes, said Lynda Flowers, a senior strategic policy adviser on the health team at AARP’s Public Policy Institute. Sooner, she said, would be better than later.

“States that expand early tend to reap the most benefits because as you know, in the early years, the federal government will be covering 100 percent of the cost of this program. And it’s during those years, especially in the states that like to put these people into managed care, that you can really leverage contract requirements to get these people’s health status improved…so that hopefully, over time, they will be costing you less when the states have to start putting in some federal matching dollars,” Flowers said.

Lynda Flowers presents an argument that illustrates an act of kindness or charity beyond strict obligation form of beneficence. In the following commentary, Christie Herrera presents a beneficence argument, which casts the larger state populace in a role requiring protection. She makes the argument that NH can only undertake the expansion if it does not harm and maximize possible benefits and minimize possible harms. In her presentation, harm and benefit is defined by the impact of policy on cost of care. There is no reference to the harm or benefit of patients (Leubsdorf, 2013, para. 9):

“Christie Herrera, vice president of policy at the Florida-based Foundation for Government Accountability, highlighted various reasons for New Hampshire not to expand Medicaid, including the potential for federal budget cuts that would result in less aid than expected, the potential for increased federal deficit spending that would increase the national debt and the mixed records for Medicaid expansion experiments in Maine and Arizona.”

Justice

The third general principle of the Belmont Report is justice. Who should receive the benefits of health care and bear its burdens? This is a question of justice, in the sense of “fairness in distribution” or “what is deserved.” An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals should be treated equally. However, this statement requires explication. Who is equal and who is unequal? What considerations justify departure from equal distribution? Almost all commentators allow that distinctions based on experience, age, deprivation, competence, merit, and position do sometimes constitute criteria justifying differential treatment purposes. It is necessary, then, to explain in what respects people should be treated equally. There are several widely accepted formulations of just ways to distribute burdens and benefits. Each formulation mentions some relevant property based on which burdens and benefits should be distributed. These formulations are (a) to each person an equal share, (b) to each person according to individual need, (c) to each person according to individual effort, (d) to each person according to societal contribution, and (e) to each person according to merit.

Eligibility policy for public health insurance is a topic that could be subjected to a Belmont-style analysis. In the United States, most adults obtain health insurance coverage in the workplace (Miles, 2012). Medicaid eligibility rules give preference to mandatory populations including older adults, those who are blind, disabled individuals, pregnant women, and children. These rules have their basis in 500 years of English Poor Laws (Quigley, n.d.). These laws recognize worthy and non-worthy poor individuals, and there are unintended consequence of these laws. Young men with chronic mental illness—bipolar disorder or schizophrenia—encounter barriers to health care as they transition from living with parents to living on their own. Before the PPACA, private health insurance plans ended dependent coverage at age 19. Without consistent health care, these individuals cannot obtain the treatment needed to remain stable and enter the workforce. Without a job, these men were unable to secure employer-sponsored health insurance. Medicaid eligibility rules in most states excluded unemployed, young men unless they were severely unstable. Each policy—dependent coverage and Medicaid eligibility—could be subjected to a Belmont analysis of aspects of justice. The analysis goes beyond the traditional focus on costs associated with coverage of this group.

Implications

For nurses and other clinicians caring for older adults, there are no formal pathways to assess the ethical impact of health care policy. The new emphasis on patient safety is a promising strategy (Ojeleye, Avery, Gupta, & Boyd, 2013; Powers, Edwards, & Carey, 2013). The drive to improve quality in health care is also a promising start on this road. Title III of the PPACA is dedicated to improving the quality of health care. Quality improvement should always begin with the patient’s evaluation of the experience. Too often, we discount or undervalue their rating. An application of Belmont Principles to policy could begin with a reflection on the idea “What would our patients say about this policy?”

Conclusion and Policy Recommendations

In this speculative article, we described a strategy for applying the principles of the Belmont Report to identify ethical issues surrounding new health care policy. Estimating size of the affected population is part of usual policy development. Financing—through taxes or user fees—is a companion concern. The Belmont Report defines three principles used by all researchers during the design of medical research. These are respect for persons, beneficence, and justice. Payment policies, in particular, are often at the heart of issues that go “wrong” after a policy is enacted. Health care fraud is facilitated by poorly designed payment policy. Barriers to care for severely ill individuals are created by payment policy. In public plans, cost controls are achieved through eligibility rules. Eligibility is a form of payment policy. A bona fide application of the Belmont Report may allow policy makers to establish national and international standards for payment policy. In the PPACA, measures of health care quality drive payment policy.

Quality is not just an adjective. It rests on a foundation of patient-centered care. Patient satisfaction is a significant component of quality measurement. Quality refers to the timing and appropriateness of care. Quality is an issue faced by all racial and ethnic groups. Chronic illness is the thread linking these groups in their experience with health care delivery (Westlake, Sethares, & Davidson, 2013). In spring 2012, National Public Radio, the Robert Wood Johnson Foundation, and Harvard School of Public Health (2012) surveyed a nationally representative sample of Americans with severe medical problems. “Sick” Americans are defined as those who said they had a serious illness, medical condition, injury, or disability requiring a lot of medical care or who had been hospitalized overnight in the past 12 months. Many sick Americans report quality problems, including instances when they believe they received the wrong care or when they were concerned about some aspects of their medical care. Some Americans who had been hospitalized overnight in the past 12 months also say they have experienced several quality-of-care problems, including getting an infection while in the hospital; getting the wrong diagnosis, treatment, or test; and not being able to see a nurse when needed.

It seems to policy developers that the obvious response is quality improvement. However, this is a complex undertaking. Manley (2000) calls it a negotiation. The PPACA rests payment policy on quality assessment. Is this an ethically sound approach? What is the potential for perverse incentives? By viewing payment policy through the lens of the Belmont Report, we can see the downside of any new policy. This review would be particularly important for any group served by public health insurance plans such as Medicaid and Medicare.

Just distribution of potential risks and benefits for payment strategies are vital. Such equity, however, should begin with a transparent process. A number of organizations have moved in this direction by posting their prices for procedures (Steinmetz & Emanuel, 2013). Title I of the PPACA (2010) contains a list of health care benefits that are required for insurances in the state exchanges. Title IV contains specific language about reduced health care disparities for preventive care services for older Americans. These examples illustrate an informal approach to payment policy. In the literature surrounding research ethics, some critics have expressed concern about the potential exploitation of underrepresented or vulnerable populations. Health care policy and the construction of public plans such as Medicaid should stress careful attention to socio-cultural, educational, regional, socioeconomic, and international differences that might exist among individuals as well as populations. Moreover, beneficence requires an ethic of minimal harm to individual and population levels alike. Policy should emphasize careful attention to the equitable maximization of good associated with selection of insurance benefit packages.

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10.3928/00989134-20131028-07

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