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Enviado por Biblio on 11/2/2016 10:36:20 (17 Lecturas)

The Hasting Center Report > January-February 2016 (volume 46, number 1)

Confronting Biospecimen Exceptionalism in Proposed Revisions to the
Common Rule

We need better approaches to secondary research with biospecimens and data, but the proposed federal reforms do not have the solutions.
Holly Fernandez Lynch, Barbara E. Bierer, and I. Glenn Cohen
On September 8, 2015, the Department of Health and Human Services issued a Notice of Proposed Rule Making to revise the Federal Policy for the Protection of Human Subjects, widely known as the “Common Rule.” The NPRM proposes several changes to the current system, including a dramatic shift in the approach to secondary research using biospecimens and data. Under the current rules, it is relatively easy to use biospecimens and data for secondary research. This approach systematically facilitates secondary research with biospecimens and data, maximizing the capacity for substantial public benefit. However, it has been criticized as insufficiently protective of the privacy and autonomy interests of biospecimen and data sources. Thus, the NPRM proposes a more restrictive regime, although more so for biospecimens than data. Both the status quo and the NPRM’s proposal are critically flawed.

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Enviado por Biblio on 11/2/2016 10:35:48 (17 Lecturas)

The Hasting Center Report > January-February 2016 (volume 46, number 1)

Balancing Benefits and Risks of Immortal Data: Participants’ Views of Open Consent in the Personal Genome Project
Oscar A. Zarate, Julia Green Brody, Phil Brown, Moníca D. Ramírez-Andreotta, Laura Perovich, and Jacob Matz

An individual’s health, genetic, or environmental-exposure data, placed in an online repository, creates a valuable shared resource that can accelerate biomedical research and even open opportunities for crowd-sourcing discoveries by members of the public. But these data become “immortalized” in ways that may create lasting risk as well as benefit. Once shared on the Internet, the data are difficult or impossible to redact, and identities may be revealed by a process called data linkage, in which online data sets are matched to each other. Reidentification (re-ID), the process of associating an individual’s name with data that were considered deidentified, poses risks such as insurance or employment discrimination, social stigma, and breach of the promises often made in informed-consent documents. At the same time, re-ID poses risks to researchers and indeed to the future of science, should re-ID end up undermining the trust and participation of potential research participants.

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Enviado por Biblio on 11/2/2016 10:35:22 (15 Lecturas)

Virtual patients--what are we talking about? A framework to classify the meanings of the term in healthcare education.
(PMID:25638167 PMCID:PMC4318546)


Kononowicz AA , Zary N , Edelbring S , Corral J , Hege I

System enables identification of digital entities

The term "virtual patients" (VPs) has been used for many years in academic publications, but its meaning varies, leading to confusion. Our aim was to investigate and categorize the use of the term "virtual patient" and then classify its use in healthcare education.A literature review was conducted to determine all articles using the term "virtual patient" in the title or abstract. These articles were categorized into: Education, Clinical Procedures, Clinical Research and E-Health. All educational articles were further classified based on a framework published by Talbot et al. which was further developed using a deductive content analysis approach.536 articles published between 1991 and December 2013 were included in the study. From these, 330 were categorized as educational. Classifying these showed that 37% articles used VPs in the form of Interactive Patient Scenarios. VPs in form of High Fidelity Software Simulations (19%) and Virtual Standardized Patients (16%) were also frequent. Less frequent were other forms, such as VP Games. Analyzing the literature across time shows an overall trend towards the use of Interactive Patient Scenarios as the predominant form of VPs in healthcare education.The main form of educational VPs in the literature are Interactive Patient Scenarios despite rapid technical advances that would support more complex applications. The adapted classification provides a valuable model for VP developers and researchers in healthcare education to more clearly communicate the type of VP they are addressing avoiding misunderstandings.
ORCIDs linked to this article
Zary N , 0000-0001-8999-6999 , Karolinska Institutet

Enviado por Biblio on 11/2/2016 10:34:49 (18 Lecturas);dn=584762667411822;res=IELHEA

General practice ethics: Continuing medical education and the pharmaceutical industry

Australian Family Physician
Volume 44 Issue 11 (Nov 2015)

Mintzker, Yishai; Braunack-Mayer, Annette; Rogers, Wendy

Abstract: This is the fifth in a six-part series on general practice ethics. Cases from practice are used to trigger reflection on common ethical issues where the best course of action may not be immediately apparent. The case presented in the article is an illustrative compilation and not based on specific individuals.
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To cite this article: Mintzker, Yishai; Braunack-Mayer, Annette and Rogers, Wendy. General practice ethics: Continuing medical education and the pharmaceutical industry [online]. Australian Family Physician, Vol. 44, No. 11, Nov 2015: 846-848. Availability: <;dn=584762667411822;res=IELHEA> ISSN: 0300-8495. [cited 10 Feb 16].
Personal Author: Mintzker, Yishai; Braunack-Mayer, Annette; Rogers, Wendy; Source: Australian Family Physician, Vol. 44, No. 11, Nov 2015: 846-848 Document Type: Journal Article ISSN: 0300-8495 Subject: Physician and patient--Moral and ethical aspects; Patients--Attitudes; Physicians (General practice)--Attitudes; Pharmaceutical industry--Management; Peer Reviewed: Yes

Enviado por Biblio on 11/2/2016 10:34:10 (17 Lecturas)

The Hasting Center Report > January-February 2016 (volume 46, number 1)
Fever of the Tuskegee Study

Robert White

A commentary on “Fevered Decisions: Race, Ethics, and Clinical Vulnerability in the Malarial Treatment of Neurosyphilis, 1922-1953,” by Matthew Gambino in the July-August 2015 issue.

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Enviado por Biblio on 11/2/2016 10:33:19 (16 Lecturas)

The Hasting Center Report > January-February 2016 (volume 46, number 1)

Whatever Happened to Human Experimentation?

Carl Elliott

Several years ago, the University of Minnesota hosted a lecture by Alan Milstein, a Philadelphia attorney specializing in clinical trial litigation. Milstein, who does not mince words, insisted on calling research studies “experiments.” “Don’t call it a study,” Milstein said. “Don’t call it a clinical trial. Call it what it is. It’s an experiment.” Milstein’s comments made me wonder: when was the last time I heard an ongoing research study described as a “human experiment”? The phrase is now almost always associated with abuses. Asking a prospective subject to sign up for a medical experiment would probably get roughly the same response as asking him or her to sign up for a police interrogation.

It wasn’t always this way. In the early days of American bioethics, scholars used the word “experimentation” in the same neutral way that they later began to use “research study” and “clinical trial.”

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Enviado por Biblio on 11/2/2016 10:32:53 (16 Lecturas)

The Hasting Center Report > January-February 2016 (volume 46, number 1)

The Promise and Perils of Open Medical Data
State and federal legislatures have important roles to play in the open-data movement, by building public trust and protecting public welfare.

Sharona Hoffman

Not long ago I visited the Personal Genome Project’s website. The PGP describes its mission as “creating public genome, health, and trait data.” In the “Participant Profiles” section, I found several entries that disclosed the names of individuals along with their date of birth, sex, weight, height, blood type, race, health conditions, medications, allergies, medical procedures, and more. Other profiles did not feature names but provided all of the other details. I had no special access to this information. It is available to absolutely anyone with Internet access. The PGP is part of a trend known as “open data.” Many government and private entities have launched initiatives to compile very large data resources (also known as “big data”) and to make them available to the public. President Obama himself has endorsed open data by issuing a May 2013 executive order directing that, to the extent permitted by law, the federal government must release its data to the public in forms that make it easy to locate, access, and use.

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Enviado por Biblio on 11/2/2016 10:32:23 (16 Lecturas)

The Hasting Center Report > January-February 2016 (volume 46, number 1)

What’s Wrong with Evidence-Based Medicine?
Listening to patients’ stories is essential to proper diagnosis and treatment.

Joseph J. Fins

Medicine in the last decades of the twentieth century was ripe for a data sweep that would bring systematic analysis to treatment strategies that seemingly had stood the test of time but were actually unvalidated. Coalescing under the banner of evidence-based medicine, this process has helped to standardize care, minimize error, and promote patient safety. But with this advancement, something of the art of medicine has been lost.

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Enviado por Biblio on 10/2/2016 12:22:52 (24 Lecturas)

Ethics & Behavior
Volume 26, Issue 2, 2016
The Ethical Implications of Using Genetic Information in Personnel The Ethical Implications of Using Genetic Information in Personnel Selection

Brent B. Clarka*, Chet E. Barneya & Tyler Reddingtona
pages 144-162

Publishing models and article dates explained
Accepted author version posted online: 13 Jan 2015
Published online: 13 Jan 2015

Biology, during the last decade in particular, is making substantial headway into our social theories of business and behavior. While the social sciences rush to keep up with the advancement of knowledge, we highlight the need for an ethics discussion to also keep pace. Although the implications to theory are important, our focus is on how new knowledge has the capacity to alter the formulation and practice of business policy, which we believe is potentially profound. Furthermore, the ethicality of a set of issues can depend heavily on one’s perspective, and differing views may not always be compatible. With this in mind, we discuss the ways in which one area of emerging biological knowledge—behavioral genetics—invites a rethinking of the nuances of four long-standing topic areas of business ethics surrounding personnel selection; and we do so from two perspectives—that of the employer and of the job seeker. The four ethical topics are (a) the static (mostly) nature of genetic information that is out of an individual’s control, (b) faking and lying during selection processes, (c) privacy, and (d) stigmatization of minority groups.

Enviado por Biblio on 10/2/2016 12:22:22 (21 Lecturas)

Evolution: rationalism versus creationism
Charles Susanne


The actual neo-Darwinian concepts of human evolution conceive this evolution as a bush, unpredictable and at random. At the beginning of the 20th century, most of the biologists conceived evolution as a linear process oriented to progress, even if Darwin already presented evolution as a bush. It is this point of view, of a process in one dimension, that some Catholics, for instance, still see human evolution. One accepts with more difficulty that human evolution constitutes, as for all animal species, a bush where numerous abortive branches are present. The evolution does not correspond to any creator myths of the different religions: these myths are parts of the memes, from which the "reproductive success" is regularly decreasing, they keep only some allegoric value.

Palabras clave

evolution; creationism; religions

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