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Abstract

  1. Top of page
  2. Abstract
  3. Editorial

The Institute of Medicine has called on health care leaders to transform their health systems into “learning health care systems,” capable of studying and continuously improving their practices. Learning health care systems commit to carrying out numerous kinds of investigations, ranging from clinical effectiveness studies to quality improvement research and implementation science. There has been progress in realizing the IOM's vision, but also many challenges. One of these challenges has been lingering uncertainty about whether the data collection and monitoring central to learning health care systems is actually research and if so, what kind of ethical oversight it should have. This is not a new question. Yet so far, there has been no foundational analysis of the fit between the existing human subjects protection framework in use in the United States and the new kinds of data collection activities that are being, and increasingly will be, undertaken by learning health care systems. Two companion feature articles in this volume, by a team at Johns Hopkins, fill this void.


Editorial

  1. Top of page
  2. Abstract
  3. Editorial

Health care in the United States is nearly twice as expensive as in other advanced countries, yet the quality of care is no better, and on many indicators it is worse, particularly for minority communities. There are problems of both over- and underutilization and an unacceptably high number of medical errors.[1] In recognition of these problems, the Institute of Medicine has called on health care leaders to transform their health systems into “learning health care systems,” capable of studying and continuously improving their practices.[2] Learning health care systems commit to carrying out numerous kinds of investigations, ranging from clinical effectiveness studies to quality improvement research and implementation science. Regardless of the kind of study, the common element is the collection of patient data, information about provider behaviors, patterns of care delivery, and administrative data about the patients and clinicians within one's own system—all with the goal of building an evidence base to improve care.

There has been progress in realizing the IOM's vision, but also many challenges. One of them has been lingering uncertainty about whether the data collection and monitoring central to learning health care systems is actually research and if so, what kind of ethical oversight it should have.

This is not a new question. The Hastings Center Report published a special report in 2006 on how best to oversee quality improvement research,[3] and in 2011, Emily Largent and her colleagues asked Report readers to imagine a health system that would expect its members to agree to being studied, with a series of structures and processes to ensure appropriate ethical oversight.[4] Yet so far, there has been no foundational analysis of the fit between the existing human subjects protection framework in use in the United States and the new kinds of data collection activities that are being, and increasingly will be, undertaken by learning health care systems.

Two companion feature articles in this volume, by a team at Johns Hopkins, fill this void. In the first, Nancy Kass, Ruth Faden, and their colleagues argue that the traditional distinction between treatment and research that has been the bedrock of our human subjects protection framework for nearly four decades does not hold up in the changing landscape of a learning health care system, which by definition links treatment and research. Further, they argue that the existing framework is a serious impediment to undertaking the kinds of activities learning health care systems strive to carry out. The second feature article urges a new ethical foundation for determining the type and level of oversight needed. The authors assert that some activities that are clearly what many people might label “research” pose few risks or burdens and may not require consent, whereas some treatments pose substantial risks and should require more rigorous consent and oversight than is often the case. Therefore, they call for a new ethical framework, based on the level of risk and burden posed by any given data collection activity, not on whether an activity is likely to be seen as treatment or research.

Strikingly, one of the authors of these feature articles (Tom Beauchamp) was the principal architect of the Belmont Report.[5] Yet these papers call into question the research ethics framework the United States has relied upon since Belmont and publication of the Code of Federal Regulations, Title 45, Public Welfare, Part 46 (also known as the Common Rule), which governs human participation in research.[6]

The commentaries presented in this volume find both common cause with the Johns Hopkins’ authors and also offer important critiques. Christine Grady and David Wendler describe the Hopkins’ approach as “radical.” In particular, they caution that the Hopkins authors have postulated both too broad and too strong an obligation to conduct learning activities, which—if enacted in a manner consistent with how the obligation has been framed—would have “dramatic implications.” Emily Largent, Franklin Miller, and Steven Joffe agree with the importance of establishing learning health care systems and acknowledge that the current system may hamper some low-risk data collection activities. However, they believe that the research-treatment distinction is still useful and should not be abandoned. Jerry Menikoff, director of the Office for Human Research Protections, believes that the new ethical framework being offered by the Johns Hopkins team would require patient participation in interventional research trials and exempt too broad a swath of studies from the necessity of providing voluntary, informed consent.

Joe Selby and Harlan Krumholz characterize three main kinds of studies likely to be undertaken in learning health care systems. They agree that oversight can be simplified for observational studies using existing clinical data without the imposition of additional data collection requirements beyond what is necessary for clinical care, but that oversight remains critical for prospective observational studies, which may require some additional data collection but where clinical decisions remain with clinicians and patients, and interventional studies, where treatment condition is assigned.

Writing separate commentaries from their respective vantage points within the Veterans Health Administration, Tom Puglisi and Joel Kupersmith offer lessons from the VHA experience. The VHA has been a leader in system-wide continuous quality improvement and has worked out an approach to ethical oversight of quality initiatives—what it calls “non-research health care operations”—that is different from the system in place for research oversight and does not require IRB review. This independent form of accountability has facilitated the conduct of quality assessments, program evaluations, and other forms of learning activities. Moreover, the VHA has been able to put this alternative method of oversight into place for quality initiatives, even as it abides by the Common Rule for activities it classifies as research.

Like the VHA, Richard Platt, Claudia Grossmann, and Harry Selker, who are members of the IOM's Clinical Effectiveness Research Innovation Collaborative, propose a risk-based system of oversight that could proceed now, without changes to the Common Rule. They agree with the Faden team, and with VHA practice, that IRBs need not be involved and that consent is not necessary for a range of activities that do not confer more than minimal risk, such as the random allocation of hospitals or clinics to diverse but accepted care practices.

By inviting these commentaries, we aimed to provoke a national conversation about how to design ethical oversight that would adequately protect patients and clinicians without impeding the kinds of data collection activities essential to learning health care systems. Like the Johns Hopkins group, we believe there is not just an opportunity, but a moral imperative to mount clinical effectiveness studies, patient-centered outcomes research, quality improvement research, and implementation science. Transforming to learning health care systems is the ethical thing to do because systems that do not aim to study what they do and make improvements on the basis of what they learn inadvertently harm patients, maintain disparities, and waste resources.[7]

In short, our goal has been to stimulate more research on care both within health care systems and across them.[8] And we have reason for optimism. In February 2012, the two of us identified health care leaders from seventy academic medical centers whose chief executive and chief medical officers were committing financial and human resources to building the necessary infrastructure to become learning health care systems. We convened these leaders at an all-day meeting jointly sponsored by the Association of American Medical Colleges and the IOM. Since then, the AAMC has continued to facilitate dialogue within and across most of these institutions through what has come to be called the Research on Care Community.[9] New transdisciplinary teams are bringing research methodologists together with physicians, nurses, economists, social scientists, decision scientists, and systems engineers to ensure that people with the right skills are in place to carry out a wide range of studies, capable of improving patient outcomes, eliminating health disparities, reducing medical error, and increasing the efficiency and value of health care services. If these efforts and ones like them emerging across the country are to be successful, and pending any changes to the Common Rule or forthcoming guidance, heath care systems themselves will have to decide what kinds of ethical oversight are best. We hope the articles in this special supplement will help light the way.

  • 1
    Institute of Medicine, Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care, Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care, B.D. Smedley, A.Y. Stith, and A.R. Nelson, eds. (Washington, D.C.: National Academies Press, 2003); E.A. McGlynn et al., “The Quality of Health Care Delivered to Adults in the United States,” New England Journal of Medicine 348 (2003): 2635–45; Institute of Medicine, Committee on Quality of Health Care in America, To Err Is Human: Building a Safer Health System, L.T. Kohn, J.M. Corrigan, and M.S. Donaldson, eds. (Washington, D.C.: National Academies Press, 2000).
  • 2
    Institute of Medicine, IOM Roundtable on Evidence-Based Medicine, The Learning Healthcare System: Workshop Summary, L. Olsen, D. Aisner, and J.M. McGinnis, eds. (Washington, D.C.: National Academies Press, 2007); C. Grossmann, W.A. Goolsby, L. Olsen, and J.M. McGinnis for the Institute of Medicine, Committee on the Learning Health Care System in America, Engineering a Learning Healthcare System: A Look at the Future. Workshop Summary, (Washington, D.C.: National Academies Press, 2011).
  • 3
    M.A. Baily et al., “The Ethics of Using QI Methods to Improve Health Care Quality and Safety,” Hastings Center Report Special Report 36, no. 4 (2006): S1S40; M.A. Baily, “Harming through Protection?” New England Journal of Medicine 358 (2008): 768–69.
  • 4
    E.A. Largent, S. Joffe, and F.G. Miller, “Can Research and Care Be Ethically Integrated?Hastings Center Report 41, no. 4 (2011): 3746.
  • 5
    The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Washington, D.C.: Department of Health, Education, and Welfare, Publication OS 78–0012, 1978).
  • 6
    U.S. Department of Health and Human Services, Code of Federal Regulations, Title 45, Public Welfare, Part 46.102(d) (45 CFR 46.102[d]), 2009 Revision, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html/.
  • 7
    M.Z. Solomon, “The Ethical Urgency of Advancing Implementation Science,” American Journal of Bioethics 10, no. 8 (2010): 3132.
  • 8
    A.C. Bonham and M.Z. Solomon, “Moving Comparative Effectiveness Research into Practice: Implementation Science and the Role of Academic Medicine,” Health Affairs 29, no. 1 (2010): 1901905; E.C. Rich, A.C. Bonham, and D.G. Kirch, “The Implications of Comparative Effectiveness Research for Academic Medicine,” Academic Medicine 86, no. 6 (2011): 684–88.
  • 9
    The Research on Care Community, https://www.aamc.org/initiatives/rocc/.