Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

Current legal standards of informed consent send the wrong message to physicians about their moral and legal expectations. A “transparency” model that sees consent as a conversation process can enhance good medical practice and patient autonomy without foreclosing appropriate judicial review.

The Office for Human Research Protections was correct in determining that the consent forms for the National Institutes of Health -sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP's actions. Disagreement focuses on three central issues: how risks and benefits should be described in informed consent documents; the meaning and application of the concept of “standard of care” in the context of research; and the proper role of OHRP. Examination of the consent forms (...) reveals that they failed to disclose the reasonably foreseeable risks of the experimental interventions in the study, as well as the potential for differences in the degree of risk between these interventions. Although the concept of “standard of care” may be helpful in determining the ethical acceptability of other aspects of research, such as clinical equipoise, it is not helpful in discussing consent requirements. (shrink)

Debate surrounding the SUPPORT study highlights the absence of consensus regarding what information should be disclosed to potential research participants. Some commentators endorse the view that clinical research should be subject to high disclosure standards, even when it is testing standard-of-care interventions. Others argue that trials assessing standard-of-care interventions need to disclose only the information that is disclosed in the clinical care setting. To resolve this debate, it is important to identify the ethical concerns raised by clinical research and determine (...) what consent process is needed to address them. (shrink)

The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) has been the focal point of many different criticisms regarding the ethics of the study ever since publication of the trial's findings in 2010 and 2012. In this article, we focus on a concern that the technical design and implementation details of the study were ethically flawed. While the federal Office Human Research Protections focused on the consent form, rather than on the study design and implementation, OHRP's critiques of the consent (...) form reveal views about the study design and implementation that we believe are fundamentally flawed. These criticisms about the design and implementation of SUPPORT, if generalized, become relevant concerns about these aspects of many comparative effectiveness research studies.Our analytical approach will be to use SUPPORT as a prime example of comparative effectiveness research and show why it challenges some prevailing assumptions about the riskiness of research. We will address five aspects of the study design and implementation: 1) randomization, 2) treatment by protocol, 3) choice of endpoints, 4) lack of a “standard care” control group, and 5) the use of altered oximeters. Examining these aspects will allow us to answer two specific central questions. The first is a methodological question with ethical implications: was the study designed in such a way as to answer the primary study question? The second question is whether the study design added or decreased risk to the babies enrolled in the study compared to babies who were not in the study. (shrink)

In this paper I argue for recognizing the moral duty to participate in research. I base my argument on the need for biomedical research and the fact that at some point studies require human participants, what I call collaborative necessity. In presenting my position, I argue against the widely accepted views of Han Jonas and all of those who have accepted his declarations without challenge. I go on to show why it is both just and fair to invite and encourage (...) people to participate in studies. It is just because research participation is the necessary means to achieve the broadly shared goals of preventing and curing disease and alleviating disease symptoms. Mutual love requires us to be willing to do for others what we would want them to do for us. It is fair because the approach treats similarly situated people in the same way. Research participation is morally required because failing to do one's part in the collaborative project of advancing biomedical science would be free-riding. People who exempt themselves from participation while eagerly accepting benefits from others doing their part are taking advantage of their compatriots and treating themselves as more deserving than others when they are not. (shrink)

Lantos and Feudtner argue that SUPPORT was an instance of CER and that CER differs from research involving unproven, experimental therapies because it exposes research subjects to the same risks patients regularly face in clinical practice. Like many defenders of SUPPORT, they formally acknowledge the study as research but want it to be thought of as clinical care. They develop an appealing argument, but it is misleading. Whatever doctors might have done in clinical practice, their choice of target range within (...) the study and for study participants was influenced by research aims. Just as in research involving unproven, experimental therapies, the care of patients in SUPPORT was altered for the goal of obtaining knowledge to help future patients. (shrink)

This Essay examines the elegantly simple idea that consent to medical treatment or participation in human research must be “informed” to be valid. It does so by using as a case study the controversial clinical research trial known as the Surfactant, Positive Pressure, and Oxygenation Randomized Trial. The Essay begins by charting, through case law and the adoption of the common rule, the evolution of duties to secure fully informed consent in both research and treatment. The Essay then utilizes the (...) SUPPORT study, which sought to pinpoint the level of saturated oxygen that should be provided to extremely low birth weight infants to demonstrate modern complexities and shortcomings of the duty to secure informed consent. This Essay shows how the duty is measured by foreseeability of risks and benefits in human research and why federal regulators believed the tradeoffs in risk and benefits from differing oxygen levels administered in the support study were foreseeable. It then explores the contours of the duty to secure informed consent when applied to researchers who also serve as treating physicians, highlighting how common law duties differ in jurisdictions that apply the professional standard and those that apply the patient-centered material risk standard. This Essay provides new insight into what the law must do to make real the notion that [e]very human being of adult years and sound mind has a right to determine what shall be done with his body.”. (shrink)