The Belmont Report and Innovative Clinical Research.


:A central pillar of the Belmont Report is that a bright line must be drawn between medical practice and biomedical research. That line may have been brighter 50 years ago. Today, the typical physician is likely to work for a corporation or health system that styles itself as a learning health system. Such systems increasingly emphasize the (research-like) use of data to measure quality, encourage efficiency, ensure safety, and guide a standardized approach to clinical care. While these activities are not considered research, they pose many of the same risks or conflicts of loyalty. In research, the doctor's fiduciary loyalty to the patient is compromised by a loyalty to the scientific process. In learning health systems, the doctor's loyalty is compromised by loyalty to the system and its metrics. In this world, it is not clear that research-as conceptualized by the Belmont Report, codified in the Common Rule, and overseen by IRBs-is a uniquely risky activity deserving of such uniquely strict oversight. Perhaps, instead, the divided loyalties and conflicts of interest faced by everyday clinicians working in learning health systems demand a protective framework similar to the one that we now have for the activities that we designate as "research." This article compares the risks of the various activities that might be called "research" and suggests a unified system of oversight for all of them.


Perspect Biol Med


Lantos JD




Has Abstract


2020-01-01 00:00:00














  • Diagnosis and Metaphor.

    abstract::Human beings rely on metaphor as a primary cognitive device for interpreting the world around them. Metaphors figure especially strongly in discourse around health, illness, and medicine. It is not just that patients use metaphors to describe their personal experience of being unwell, or that medical professionals emp...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章


    authors: Hanne M

    更新日期:2015-01-01 00:00:00

  • From the Great Barrier Reef to a "cure" for the flu: tall tales, but true.

    abstract::How we discovered that sea birds on the Great Barrier Reef are riddled with influenza viruses, and how one of these led to a new drug now being used in the battle against the flu. ...

    journal_title:Perspectives in biology and medicine

    pub_type: 历史文章,杂志文章


    authors: Laver WG

    更新日期:2004-10-01 00:00:00

  • Birth Narratives, Babies, and the Catholic Moral Imagination: Informing Influences on the Pope's Address.

    abstract::This commentary considers two informing influences on Pope Francis's support of perinatal hospice care for families facing diagnoses of serious fetal anomalies. Reflecting on the morally formative scriptural narrative of Mary's pregnancy and Jesus's birth and drawing upon an often-repeated idea of Pope Francis's papac...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章


    authors: Hardt J

    更新日期:2020-01-01 00:00:00

  • Toward a broader notion of community.

    abstract::Both leading scientific journals and the popular press now regularly report the convincing evidence of massive environmental degradation and decline. Yet despite the seriousness of the problems, despite their anthropogenic nature, and despite their profound implications for present and future population health, such t...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章


    authors: Levine BR

    更新日期:2007-01-01 00:00:00

  • Global Bioethics: A Story of Dreams and Doubts from Bengal.

    abstract::This article is concerned with the practice of bioethics outside of the Euro-American and Anglophone settings in which it was first formulated. In theoretical terms, the article considers the frictions that arise when global-scale projects such as bioethics are introduced into diverse social and cultural settings. Met...

    journal_title:Perspectives in biology and medicine

    pub_type: 传,历史文章,杂志文章


    authors: Simpson B

    更新日期:2018-01-01 00:00:00

  • The body, its emotions, the self, and consciousness.

    abstract::This article proposes a means for better understanding the self and consciousness. Data indicate that the basic "emotional brain" continually computes potential survival risk against reward to rank consequent "emotion scores" for all sensory inputs. These scores compete to yield winner-takes-all outcomes that determin...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章


    authors: Boyd GW

    更新日期:2012-07-01 00:00:00

  • Expectations and obligations: professionalism and medicine's social contract with society.

    abstract::As health care has become of great importance to both individual citizens and to society, it has become more important to understand medicine's relationship to the society it serves in order to have a basis for meaningful dialogue. During the past decade, individuals in the medical, legal, social sciences, and health ...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章,评审


    authors: Cruess RL,Cruess SR

    更新日期:2008-10-01 00:00:00

  • Conception control as a health practice: an emerging concept in government and medicine.

    abstract::The health aspects and benefits of conception control as a justification for U.S. government support of family planning are reviewed. The Family Planning Services Act of 1970 set a goal of serving 5 million indigent women by 1975. It is predicted that the program will far surpass that goal. 340 million dollars were...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章


    authors: Hellman LM

    更新日期:1973-04-01 00:00:00

  • A new curriculum to link the basic science of aging with geriatric practice.

    abstract::There is a growing national awareness that the extraordinary extension of life expectancy in our society poses an impending crisis for our health-care system. This is due in large part to the scarcity of primary-care providers, especially geriatricians. To address these concerns, the Obama administration has considere...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章


    authors: Hamerman D

    更新日期:2009-07-01 00:00:00

  • The Research Optimist's Defense.

    abstract::Several studies suggest that clinical researchers are prone to overestimating the chance that scientific protocols will succeed, say, by confirming a treatment hypothesis or reaching recruitment targets. In this essay, we address the normative question of whether such "unrealistic optimism" is harmful in clinical rese...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章


    authors: Benjamin D,Kimmelman J

    更新日期:2016-01-01 00:00:00

  • When medical cure is not an unmitigated good.

    abstract::The impact of chronic illness on patients has been discussed extensively, but little attention has been paid to the reverse situation: the need for patients who have been chronically ill since childhood to adjust to health and normality in adulthood. Drawing upon the narratives of two adults with childhood onset disea...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章


    authors: Orfali K,Anderson-Shaw L

    更新日期:2005-04-01 00:00:00

  • Origins of the classical gene concept, 1900-1950: genetics, mechanistic, philosophy, and the capitalization of agriculture.

    abstract::In the period of "classical genetics" (roughly 1915-950), the common view of the gene was mechanistic--hat is, genes were seen as individual, atomistic units, as material components of the chromosomes. Although it was recognized early on that genes could interact and influence each other's expression, they were still ...

    journal_title:Perspectives in biology and medicine

    pub_type: 历史文章,杂志文章


    authors: Allen GE

    更新日期:2014-01-01 00:00:00

  • Synthetic biology: programming cells for biomedical applications.

    abstract::The emerging field of synthetic biology is a novel biological discipline at the interface between traditional biology, chemistry, and engineering sciences. Synthetic biology aims at the rational design of complex synthetic biological devices and systems with desired properties by combining compatible, modular biologic...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章,评审


    authors: Hörner M,Reischmann N,Weber W

    更新日期:2012-01-01 00:00:00

  • Alternatives to War Within Medicine: From Conscientious Objection to Nonviolent Conflict About Contested Medical Practices.

    abstract::When we figure medical practice as warfare, an individual clinician may be either a dutiful combatant or a conscientious objector. The rhetorical structure of this choice means that clinicians may exercise their consciences by loyally joining or disloyally exiting the medical ranks' battle against disease. But there a...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章


    authors: Nussbaum AM

    更新日期:2019-01-01 00:00:00

  • The placebo response: its putative role as a functional salutogenic mechanism of the central nervous system.

    abstract::The concept of placebo has evolved over time. Generally believed to be the basis of the premodern pharmacopoeia, the placebo has been adopted in practice as a harmless but unscientific approach towards alleviating symptoms. Currently, many medical scientists view placebos pejoratively as confounding elements in the an...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章


    authors: Kradin RL

    更新日期:2004-07-01 00:00:00

  • Three Problems with Big Data and Artificial Intelligence in Medicine.

    abstract::The rise of big data and artificial intelligence (AI) in health care has engendered considerable excitement, claiming to improve approaches to diagnosis, prognosis, and treatment. Amidst the enthusiasm, the philosophical assumptions that underlie the big data and AI movement in medicine are rarely examined. This essay...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章


    authors: Chin-Yee B,Upshur R

    更新日期:2019-01-01 00:00:00

  • Misconceiving medical leadership.

    abstract::Medical leadership and leadership education have recently emerged as subjects of an expanding though as yet uncritical literature. Considerable attention is being given to the development of courses and electives, together with some proposals for generalizing these offerings to all medical students and doctors. This a...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章


    authors: Parker M

    更新日期:2013-07-01 00:00:00

  • Putting concerns about nature in context: the case of agricultural biotechnology.

    abstract::Concerns about nature are playing increasingly prominent roles in a variety of social debates, including medical biotechnology, environmental protection, and agricultural biotechnology. These concerns are often simply rejected as incoherent: critics argue that there is no good account for how natural states of affairs...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章


    authors: Kaebnick GE

    更新日期:2007-10-01 00:00:00

  • Medicine in the age of " Ulysses ": James Joyce's portrait of life, medicine, and disease on a Dublin day a century ago.

    abstract::Over time, contemporary writing becomes part of the historical record. In medicine, it is an important learning tool, particularly for understanding the experience and context of disease and illness. Although a century has elapsed since the fictional events on a single day described in James Joyce's Ulysses, the work ...

    journal_title:Perspectives in biology and medicine

    pub_type: 传,历史文章,杂志文章


    authors: Shanahan F,Quigley EM

    更新日期:2006-04-01 00:00:00

  • Is the Pace of Biomedical Innovation Slowing?

    abstract::The pace of biomedical innovation is important because it determines the rate of progress in medicine and allied disciplines. A review of the history of medical advances reveals that the three decades from 1950 to 1980 were a particularly innovative time. Subsequent decades have seen fewer seminal advances, despite co...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章


    authors: Casadevall A

    更新日期:2018-01-01 00:00:00

  • "Meaning-making" in language and biology.

    abstract::The linguistic metaphor in biology adheres to a representational theory that seeks similarities between pre-given domains. The point of departure of this paper is the generative and nonrepresentational conception of metaphor. This paper argues that by adopting the nonrepresentational conception of metaphor, meaning-ma...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章,评审


    authors: Neuman Y

    更新日期:2005-07-01 00:00:00

  • The Etiological Stance: Explaining Illness Occurrence.

    abstract::Kelly, Kelly, and Russo (2014) recently proposed to integrate biological, behavioral, and social mechanisms into "mixed mechanisms" situated in the individual's "lifeworld" when considering illness causation. This article suggests considering terminological discrepancies, replacing the pathogenetic with an etiological...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章


    authors: Dammann O

    更新日期:2017-01-01 00:00:00

  • Coronary heart disease (CHD)--one or several diseases? Changes in the prevalence and features of CHD.

    abstract::In retrospect, mortality from coronary heart disease (CHD) in the 20th century followed an epidemic pattern: mortality rates increased dramatically from 1920 until about 1960, remained roughly constant for almost a decade, and have been decreasing since the late 1960s. CHD has traditionally been conceived of as a sing...

    journal_title:Perspectives in biology and medicine

    pub_type: 历史文章,杂志文章


    authors: Azambuja MI,Levins R

    更新日期:2007-04-01 00:00:00

  • Confidentiality, electronic health records, and the clinician.

    abstract::The advent of electronic health records (EHRs) to improve access and enable research in the everyday clinical world has simultaneously made medical information much more vulnerable to illicit, non-beneficent uses. This wealth of identified, aggregated data has and will attract attacks by domestic governments for surve...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章


    authors: Graves S

    更新日期:2013-01-01 00:00:00

  • Clinical Trials Without Consent?

    abstract::Fifty years after Beecher's landmark article, an old question is being debated anew: is it ethical to conduct clinical research without consent? This paper provides a systematic analysis of this question. First, it describes five clinical trials that have either been conducted (or proposed) without the subjects provid...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章


    authors: Kim SY

    更新日期:2016-01-01 00:00:00

  • Flexner at 100: a brief view from Oxford.

    abstract::Of all the principles set out by Flexner in 1910, the most fundamental, that of academic and scientific excellence, is more relevant to medical education in the United Kingdom today than ever before. To realize this, undergraduate medical education (UGME) at Oxford has evolved to incorporate the tutorial method of tea...

    journal_title:Perspectives in biology and medicine

    pub_type: 传,历史文章,杂志文章


    authors: Fleming KA

    更新日期:2011-01-01 00:00:00

  • High-tech brains: a history of technology-based analogies and models of nerve and brain function.

    abstract::This article reviews some of the technological devices and ideas which have been used over the years to answer the question, how does the brain work? It describes some of the early technology-based analogies and models of nerve fibers, and then discusses other analogies and models of the brain based on mechanical and ...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章,评审


    authors: Kirkland KL

    更新日期:2002-04-01 00:00:00

  • The living dead: fiction, horror, and bioethics.

    abstract::Popular fiction responds to, and may exacerbate, public anxieties in ways that more highbrow literary texts may not. Robin Cook's 1977 novel Coma exemplifies the ways in which medical thrillers participate in the public discourse about health care. Written shortly after the medical establishment promoted "irreversible...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章


    authors: Belling C

    更新日期:2010-07-01 00:00:00

  • Conceiving wholeness: women, motherhood, and ovarian transplantation, 1902 and 2004.

    abstract::Scholars have shown that organ transplantation may transform ideas about one's body, with recipients feeling that they are receiving not just a body part but also a part of the donor's identity. This article focuses on a different way in which organ transplantation shapes recipient identity: the idea of becoming whole...

    journal_title:Perspectives in biology and medicine

    pub_type: 历史文章,杂志文章


    authors: Rodriguez SB,Campo-Engelstein L

    更新日期:2011-07-01 00:00:00

  • Torture in Abu Ghraib.

    abstract::Iraqi detainees subjected to torture and mistreatment at Abu Ghraib prison may continue to suffer from significant physical and psychological consequences of their abuse. This article reports two cases of Iraqi individuals allegedly tortured at Abu Ghraib. Detailed forensic evaluations were conducted approximately one...

    journal_title:Perspectives in biology and medicine

    pub_type: 杂志文章


    authors: Keller AS

    更新日期:2006-10-01 00:00:00