Tag: research ethics

Bioethics Blogs

In the Journals – July 2017 by Danya Glabau

American Quarterly

Regina Kunzel

Among the central themes of the eclectic field of mad studies is a critique of psychiatric authority. Activists and academics, from a range of positions and perspectives, have questioned psychiatry’s normalizing impulses and have privileged mad-identified knowledges over expert ones. One of the most successful assaults on psychiatric authority was launched by gay activists in the 1960s and early 1970s, resulting in the removal of homosexuality from the American Psychiatric Association’s (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM) in 1973. But if that event marked an inspirational victory against psychiatric power, it was also, as Robert McRuer notes, “a distancing from disability.”1Revisiting this history through analytic lenses offered by disability and mad studies defamiliarizes familiar historical narratives and unsettles the critique of psychiatric authority, especially when countered by claims to health.

 

Conflicts over the value, meaning, and efficacy of vaccination as a preventive practice suggest that vaccination resistance stages disagreement within modern biological citizenship. This paper explores how immunity circulates in both vaccination controversy and biopolitical philosophies. Two positions—one characterized by somatic individualism, flexible bodies, reflexive approaches to knowledge, and the idea of the immune system as “the essential relation the body has with its vulnerability,” and another characterized by the immunitary paradigm, biosecurity, trust in expert systems, and vaccination—emerge. Understanding that oppositional relation can reframe public understanding of vaccine skepticism and public health responses to it.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Research Ethics Roundup: First Human Embryos Edited in US, Large Scale Wellness Studies, Seeing Pregnant Women as “Vulnerable” Research Subjects, Europe’s New Animal Research Transparency Efforts

This week’s Research Ethics Roundup looks at the first known US-based attempt of changing the DNA of embryos with CRISPR, the results of a large-scale wellness study, why researchers are challenging the notion that pregnant women are a “vulnerable” research population, and why European researchers are choosing to be transparent about their research with animals.

The post Research Ethics Roundup: First Human Embryos Edited in US, Large Scale Wellness Studies, Seeing Pregnant Women as “Vulnerable” Research Subjects, Europe’s New Animal Research Transparency Efforts appeared first on Ampersand.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

From PI to IRB Administrator: Lessons Learned

PRIM&R invited members of our Emerging Professionals Working Group (EPWG) to write about topics of relevance to their work and to the research ethics community. In this post, Sarah Luery describes her experience as a principal investigator (PI) and master’s student submitting to the IRB, and shares tips (now as an IRB Administrator) to demystify the IRB process.

The post From PI to IRB Administrator: Lessons Learned appeared first on Ampersand.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Can we trust research in science and medicine?

By Brian D. Earp  (@briandavidearp)

Readers of the Practical Ethics Blog might be interested in this series of short videos in which I discuss some of the major ongoing problems with research ethics and publication integrity in science and medicine. How much of the published literature is trustworthy? Why is peer review such a poor quality control mechanism? How can we judge whether someone is really an expert in a scientific area? What happens when empirical research get polarized? Most of these are short – just a few minutes. Links below:

Why most published research probably is false

The politicization of science and the problem of expertise

Science’s publication bias problem – why negative results are important

Getting beyond accusations of being either “pro-science” or “anti-science”

Are we all scientific experts now? When to be skeptical about scientific claims, and when to defer to experts

Predatory open access publishers and why peer review is broken

The future of scientific peer review

Sloppy science going on at the CDC and WHO

Dogmas in science – how do they form?

Please note: this post will be cross-published with the Journal of Medical Ethics Blog.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Can We Trust Research in Science and Medicine?

By Brian D. Earp  (@briandavidearp)

Readers of the JME Blog might be interested in this series of short videos in which I discuss some of the major ongoing problems with research ethics and publication integrity in science and medicine. How much of the published literature is trustworthy? Why is peer review such a poor quality control mechanism? How can we judge whether someone is really an expert in a scientific area? What happens when empirical research get polarized? Most of these are short – just a few minutes. Links below:

Why most published research probably is false

The politicization of science and the problem of expertise

Science’s publication bias problem – why negative results are important

Getting beyond accusations of being either “pro-science” or “anti-science”

Are we all scientific experts now? When to be skeptical about scientific claims, and when to defer to experts

Predatory open access publishers and why peer review is broken

The future of scientific peer review

Sloppy science going on at the CDC and WHO

Dogmas in science – how do they form?

Please note: this post will be cross-published with the Practical Ethics blog. 

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Authorship and Pets

The International Committee of Medical Journal Editors is an
influential group that, as expected, takes publication and authorship very
seriously.  They have issued the most
generally accepted definition of the criteria for authorship of scientific
publications. They list these criteria very clearly and unambiguously on their website.
These criteria are:

“The ICMJE
recommends that authorship be based on the following 4 criteria:

  Substantial
contributions to the conception or design of the work; or the acquisition,
analysis, or interpretation of data for the work; AND

  Drafting the
work or revising it critically for important intellectual content; AN

  Final
approval of the version to be published; AND

  Agreement to
be accountable for all aspects of the work in ensuring that questions related
to the accuracy or integrity of any part of the work are appropriately investigated and resolved. “

They go on to say “All those designated as authors
should meet all four criteria for authorship, and all who meet the four
criteria should be identified as authors.” There does not seem to leave much
doubt as to their meaning. The practise of guest authorship, including authors
with non-substantive contributions by virtue of their position was once common
but is now considered inappropriate. However, no simple set of guidelines can
address all possible circumstances. Which raises the point I am addressing in
this blog: What about pets?

An important paper
on atomic behaviour published in Physical Reviews by Jack Hetherington and
F.D.C. Willard is the object of this question.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Authorship and Pets

The International Committee of Medical Journal Editors is an
influential group that, as expected, takes publication and authorship very
seriously.  They have issued the most
generally accepted definition of the criteria for authorship of scientific
publications. They list these criteria very clearly and unambiguously on their website.
These criteria are:

“The ICMJE
recommends that authorship be based on the following 4 criteria:

  •            Substantial
    contributions to the conception or design of the work; or the acquisition,
    analysis, or interpretation of data for the work; AND

  •          Drafting the
    work or revising it critically for important intellectual content; AND
  •           Final
    approval of the version to be published; AND
  •          Agreement to
    be accountable for all aspects of the work in ensuring that questions related
    to the accuracy or integrity of any part of the work are appropriately
    investigated and resolved. “
  • They go on to say “All those designated as authors
    should meet all four criteria for authorship, and all who meet the four
    criteria should be identified as authors.” There does not seem to leave much
    doubt as to their meaning. The practise of guest authorship, including authors
    with non-substantive contributions by virtue of their position was once common
    but is now considered inappropriate. However, no simple set of guidelines can
    address all possible circumstances. Which raises the point I am addressing in
    this blog: What about pets?

    An important paper
    on atomic behaviour published in Physical Reviews by Jack Hetherington and
    F.D.C.

    The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

    Bioethics News

    Excluding Pregnant Women From Clinical Studies Because They’re Classed As ‘Vulnerable’ Is ‘Harmful’

    July 20, 2017

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    Excluding mums-to-be from clinical studies is unfair and could be potentially harmful, researchers have said.

    Pregnant women are often ruled out of participating in clinical trials because they’re classified as a “vulnerable” group, and this creates a knowledge void around the impact of drugs taken during pregnancy and “unfairly excludes” them from taking part in clinical studies, concluded researchers writing in the ‘Journal of Medical Ethics’.

    “There is a desperate need to shift the paradigm to protect pregnant women through research, not just from research,” the researchers wrote.

    … Read More

    See Also – Commentary: Pregnant women should not be categorised as a ‘vulnerable population’ in biomedical research studies: ending a vicious cycle of ‘vulnerability’

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    The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

    Bioethics News

    Exclusion of Mothers-To-Be From Clinical Studies Unfair and Potentially Harmful

    July 18, 2017

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    In fact, pregnant women’s vulnerability boils down to the lack of research carried out in this group, and it’s a dilemma that can only be overcome by including mums-to-be in clinical studies, they say.

    “Our study once and for all demonstrates that there is no indication that pregnant women are vulnerable because of informed consent, susceptibility to coercion, or vulnerability of the fetus,” they write.

    “The only reason why pregnant women are potentially vulnerable in clinical research is to the extent that they are increasingly exposed to higher risks due to a lack of scientific knowledge which might render them vulnerable as research subjects,” they continue.

    “Only a joint effort to promote fair inclusion by funding agencies, authorities, researchers, methodologists, pharmacologists, guideline committees and [research ethics committees] can successfully reduce pregnant women’s vulnerability,” they conclude.

    In a linked Commentary, Drs Carleigh Krubiner and Ruth Faden, of the Berman Institute for Bioethics at Johns Hopkins University, Baltimore, argue that the designation of pregnant women as ‘vulnerable’ “is inappropriate and disrespectful.”

    And rather than protecting them, it has had the opposite effect, and created a great deal of uncertainty and anxiety.

    … Read More

    Vulnerability of pregnant women in clinical research, Journal of Medical Ethics (2017). DOI: 10.1136/medethics-2016-103955

    Commentary: Pregnant women should not be categorised as a ‘vulnerable population’ in biomedical research studies: ending a vicious cycle of ‘vulnerability’ Journal of Medical Ethics (2017). DOI: 10.1136/medethics-2017-104446

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    The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

    Bioethics Blogs

    The Zika Vaccine Research Agenda & Pregnant Women

    The Ethics Working Group on ZIKV Research & Pregnancy provides recommendations to ensure that pregnant women are responsibly and equitably included in the Zika virus vaccine research and development agenda.

    __________________________________________

    Zika virus vaccine development is proceeding rapidly, with a number of vaccine candidates already moving into Phase II clinical trials. These are trials that are designed to look for evidence of efficacy.

    As the public health community races to develop Zika virus vaccines, now is a critical time to ensure that research and development efforts adequately address the needs of pregnant women and their offspring. To this end, the Ethics Working Group on ZIKV Research & Pregnancy, an interdisciplinary group of international experts in vaccinology, maternal and child health, public health and ethics, has developed Ethics Guidance for including the needs and interests of pregnant women and their offspring in the Zika virus vaccine research and development agenda: Pregnant Women & the Zika Virus Vaccine Research Agenda: Ethics Guidance on Priorities, Inclusion, and Evidence Generation.

    A vial of the NIAID Zika Virus Investigational DNA Vaccine, taken at the NIAID Vaccine Research Center’s Pilot Plant in Frederick, Maryland. Credit: NIAID

    This Ethics Guidance argues that global concern about the devastating effects of Zika virus infection in pregnancy for normal fetal development, pregnant women and their offspring is not enough. Pregnant women and their babies should also be front and center in Zika virus vaccine development.

    Unless specific actions recommended by the Working Group are taken soon, pregnant women and their offspring will not be able to share fairly in the benefits of whichever vaccines prove efficacious.

    The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.