Many believe that informed consent makes clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects, we propose 7 requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies: (1) value-enhancements of health or knowledge must be derived from the research; (2) scientific validity-the research must be methodologically rigorous; (3) fair subject selection-scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects; (4) favorable risk-benefit ratio-within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks; (5) independent review-unaffiliated individuals must review the research and approve, amend, or terminate it; (6) informed consent-individuals should be informed about the research and provide their voluntary consent; and (7) respect for enrolled subjects-subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored. Fulfilling all 7 requirements is necessary and sufficient to make clinical research ethical. These requirements are universal, although they must be adapted to the health, economic, cultural, and technological conditions in which clinical research is conducted. JAMA. 2000;283:2701-2711.

/pdf/what-makes-clinical-research-ethical-1aaoil4fbl.pdf

What Makes Clinical Research Ethical

The theory of emerging adulthood has been proposed as a way of conceptualizing the developmental characteristics of young people between the ages of 18 and 25. Here, the theory is applied to explaining the high rates of substance use in this age group. Specifically, five developmentally distinctive features of emerging adulthood are proposed: the age of identity explorations, the age of instability, the age of self-focus, the age of feeling in-between, and the age of possibilities. Then, each of these features is applied to an explanation of drug use in emerging adulthood.

/pdf/the-developmental-context-of-substance-use-in-emerging-4uotgpun3a.pdf

The Developmental Context of Substance use in Emerging Adulthood

accademiche [38]. Ada [45]. Adrian [45]. African [56]. Age [39, 49, 61]. Al [23]. Al-Rawi [23]. Aldous [68]. Alex [15]. Allure [46]. America [60, 66]. American [49, 69, 61, 52]. ancienne [25]. Andreas [28]. Angela [42]. Animals [16]. Ann [26]. Anna [19, 47]. Annotated [46]. Annotations [28]. Anti [37]. Anti-Copernican [37]. Antibiotic [64]. Anxiety [51]. Apocalyptic [61]. Archaeology [26]. Ark [36]. Artisan [32]. Asylum [48]. Atri [54]. Audra [65]. Australia [41]. Authorship [15]. Axelle [29].

/pdf/a-complete-bibliography-of-publications-in-isis-2000-2009-1nklqbzyfs.pdf

A Complete Bibliography of Publications in Isis, 2000{2009

The prion hypothesis posits that a misfolded form of prion protein (PrP) is responsible for the infectivity of prion disease. Using recombinant murine PrP purified from Escherichia coli, we created a recombinant prion with the attributes of the pathogenic PrP isoform: aggregated, protease-resistant, and self-perpetuating. After intracerebral injection of the recombinant prion, wild-type mice developed neurological signs in ~130 days and reached the terminal stage of disease in ~150 days. Characterization of diseased mice revealed classic neuropathology of prion disease, the presence of protease-resistant PrP, and the capability of serially transmitting the disease; these findings confirmed that the mice succumbed to prion disease. Thus, as postulated by the prion hypothesis, the infectivity in mammalian prion disease results from an altered conformation of PrP.

/pdf/generating-a-prion-with-bacterially-expressed-recombinant-4dq6gfpksw.pdf

Generating a Prion with Bacterially Expressed Recombinant Prion Protein

The Nuremberg Code 1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by . . .

Fifty Years Later: The Significance of the Nuremberg Code

The Pursuit of Perfection: The Promise and Perils of Medical Enhancement

The Perfect Storm of Enhancement@@@The Pursuit of Perfection: The Promise and Perils of Medical Enhancement

n 1882 Koch discovered the tubercle bacillus and transformed both the medical and the social history of I tuberculosis and the experiences of those who contracted it. For the first time, the absence or presence of the bacillus made it possible to define, in Koch’s terms, “the boundaries of the diseases to be understood as tuberculosis.’’I And for the first time the sick became subject to oversight and discrimination. Prior to Koch’s discovery, tuberculosis, or as it was then called, consumption, was considered a hereditary and non-contagious disease, albeit a very deadly and persistent one. Over the first half of the nineteenth century, it was responsible for one out of every five deaths. It crossed all boundaries of geography, social class, age, and sex affecting residents in rural as well as urban areas, the prosperous as well as the poor, the young even more notably than the old, females more often than males? Physicians assumed a familial predisposition existed (as in the case of insanity); following the precepts of humoral medicine, they postulated that the disease originated in “irritations” whose sources were to be found in the interaction of an inherited constitution with a particular lifestyle and environment. The sick were to counter the irritants and thereby reverse the debilitating course of the disease by following aregimen known as “constitutional treatment.” They had to change diet (to a “mild’y and “unstimulating” one), change routine (to a regimen of “gentle exercise”) and residence (go to a mild or dry ~ l i m a t e ) . ~ The belief that the disease was hereditary placed it beyond the concerns of the public health officials who first organized departments of health in the mid-nineteenth century. Known as sanitarians, these officials located the causal elements and transmission of disease in foul-smelling or “miasmatic” conditions. To rid the cities of noxious odors and filth, they promoted massive engineering projects, including the construction of water supply and sewerage systems, and initiated the more efficient disposal of garbage and dead animals. But the sanitarians were engineers, not social engineers, leaving people outside their ken. Beginning in 1870, mortality from consumption, which had remained stable for decades, began a marked decline. Over the next several decades this downward shift became more pronounced. At the same time, however, one particular group, the urban poor, living in the tenement house districts, became increasingly susceptible to the disease. In New York, for example, the citywide death rate from consumption in 1870 was 428 per 100,000; by 1890 it had dropped to 390. But when the 1890 mortality rate was examined district by district, critical distinctions emerged. Dr. John Billings, the country’s leading statistician, reported that in a “beautiful residential section” on the Upper West Side, the death rate from tuberculosis was 49 per 100,000, but in the crowded tenement sections of lower Manhattan it was 776 per 100,000. In 1900, the citywide mortality had declined still further to 256 per 100,000, but in the poorest and most crowded districts, it hovered

Seek and hide: public health departments and persons with tuberculosis, 1890-1940.

Health advocacy organizations (HAOs) are influential stakeholders in health policy. Although their advocacy tends to closely correspond with the pharmaceutical industry's marketing aims, the financial relationships between HAOs and the pharmaceutical industry have rarely been analyzed.We used Eli Lilly and Company's grant registry to examine its grant-giving policies. We also examined HAO Web sites to determine their grant-disclosure patterns. Only 25% of HAOs that received Lilly grants acknowledged Lilly's contributions on their Web sites, and only 10% acknowledged Lilly as a grant event sponsor. No HAO disclosed the exact amount of a Lilly grant.As highly trusted organizations, HAOs should disclose all corporate grants, including the purpose and the amount. Absent this disclosure, legislators, regulators, and the public cannot evaluate possible conflicts of interest or biases in HAO advocacy.

https://ajph.aphapublications.org/doi/pdfplus/10.2105/AJPH.2010.300027

Health advocacy organizations and the pharmaceutical industry: an analysis of disclosure practices.

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The Pursuit of Perfection: The Promise and Perils of Medical Enhancement

The Perfect Storm of Enhancement@@@The Pursuit of Perfection: The Promise and Perils of Medical Enhancement

Seek and hide: public health departments and persons with tuberculosis, 1890-1940.

Health advocacy organizations and the pharmaceutical industry: an analysis of disclosure practices.