Tag: disclosure

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UK report on prenatal testing calls for ban on sex disclosure

A new report by the UK’s Nuffield Council on Bioethics, “Non-invasive prenatal testing: ethical issues”, has probably pleased no one by trying to steer a course between banning abortions for sex-selection and allowing abortions for the most common kind of foetal abnormalities.

NIPT is a major breakthrough. It uses a blood sample taken from the pregnant woman and can be done from 9 or 10 weeks of pregnancy. It analyses DNA from the placenta that circulates in the woman’s blood to estimate the chance that the fetus has Down’s, Edwards’ or Patau’s syndromes, as well as single-gene disorders like cystic fibrosis and achondroplasia. It can also determine its sex.

The test is currently available in the UK through private hospitals and clinics, and in some NHS (ie, public) hospitals. Last year, the UK Government announced that from 2018, the NHS will offer NIPT to pregnant women who have been found through initial screening to have at least a 1 in 150 likelihood of having a fetus with Down’s, Patau’s or Edwards’ syndromes.

The report says that NIPT should lead to fewer false results and fewer diagnostic tests, which carry a small risk of miscarriage. In the case of Down syndrome fetuses, 200 more would be identified (with 90% or more being aborted) and 17 fewer miscarriages of healthy foetuses because of invasive tests.

In addition, the Nuffield Council calls for a moratorium on the use of NIPT in sequencing the whole genome of fetuses; it wants a ban on its use in finding out the sex of the fetus because that would lead to sex-selective abortion.

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.

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In the Journals: February 2017 by Christine Sargent

American Ethnologist

Good ramps, bad ramps: Centralized design standards and disability access in urban Russian infrastructure

Cassandra Hartblay

Accessible design seeks to reconfigure the social by restructuring the material. As the idea moves globally, it becomes entwined in local logics of moral obligations between citizens and the state. Wheelchair users in the city of Petrozavodsk, in northwestern Russia, talk about inaccessible infrastructure as being embedded in moral relationships. In their stories, hierarchies of expertise diffuse responsibility for outcomes and devalue user knowledge. When accessible design elements are installed to meet minimum standards, they are “just for the check mark” and often do not “work.” Wheelchair ramps produce value for businesses or governments by representing an idea of access that circulates as a commodity. Failed accessible design draws attention to a moral field governing the responsibilities of actors to produce a “good” built environment, imbricated in teleologies of progress. [disability, design, infrastructure, access, ramps, postsocialism, Russia]

Self-governance, psychotherapy, and the subject of managed care: Internal Family Systems therapy and the multiple self in a US eating-disorders treatment center

Rebecca J. Lester

“The self” has seen a surprising resurgence in recent anthropological theorizing, revitalizing interest in whether and how it can be studied ethnographically. These issues are brought to the fore by a newly popular psychotherapy technique, Internal Family Systems therapy (IFS), as practiced in a US eating-disorders clinic. There, clinicians and clients negotiate tensions between this model’s understanding of a multiple, refracted self and managed-care companies’ insistence on personal responsibility. In considering the moral and pragmatic work of IFS in the clinic, a new critical anthropology of selfhood illuminates the vectors through which economic and political commitments become imbricated in the self.

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.

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User Beware: Privacy Settings just a Facade

Image via

By Brenda Curtis, Ph.D.

Social media platforms continue to improve and refine their privacy settings as the demand for advanced user protections increases. Although enabling catered privacy settings to online profiles allows users to indicate who they would like share personal information with, it does not necessarily protect them from the platforms – i.e. websites and apps – themselves. Since social media accounts provide users with a sense of control over personal data, users assume that their information is safe. However, no matter what settings or privacy protections are applied to personal profiles, users do not generally have control over the online platform itself. What this means is the website or app being used usually shares information from accounts with third parties like advertising agencies or other databases. This data sharing is widespread throughout the industry, but it is not generally known by the public. This is partly because the disclosure of this sharing is done in the social media platform’s “Terms and Conditions” Which are often skimmed over or ignored.

Aside from social media websites, there are several other websites and apps that access your personal information via this information sharing to create a single database for everyone in the country. This is generally called data aggregation. One such site that has been in the news recently is FamilyTreeNow.  FamilyTreeNow is explicitly a genealogy site, and compiles information from various legal online sources to create a database full of personal information for genealogical research. This site pairs information from public records such as police records and court documents with the information collected from social media and address databases to create a sometimes way too revealing profile.

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.

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Reflect, Reframe, Remember: Takeaways from AER16

This year’s Advancing Ethical Research (AER) Conference provided me with the depth of knowledge I was expecting, but also with a new perspective that I had not anticipated. Full disclosure: I went to this conference assuming the pre-conference program would be most applicable and useful to my job. The pre-conference that I attended, IRB201, was, indeed, amazing. I walked away having memorized the 45 CFR 46.111 criteria for IRB review and approval and the ability to apply them to a protocol (or at least a practice protocol). Over the last few weeks, this new skill has carried me far; it has substantially refined my pre-review process, allowing me to more thoroughly and efficiently deliver an IRB protocol to my IRB administrator for her review. As one of just four IRB staff members at my institution, anything that streamlines the process and decreases burden is welcomed, and my newfound efficiency has not gone unnoticed or unappreciated.

The post Reflect, Reframe, Remember: Takeaways from AER16 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.

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Professional Codes and Diagnosis at a Distance

This is the second part of my response to Trish Greenhalgh’s post on the propriety of medics, psychiatrists in particular, offering diagnoses of Donald Trump’s mental health.  In the last post, I concentrated on some of the problems associated with making such a diagnosis (or, on reflection, what might be better called a “quasi-diagnosis”).  In this, I’m going to concentrate on the professional regulation aspect.

Greenhalgh notes that, as a UK medic, she is bound by the GMC’s Duties of a Doctor guidance,

which – to my surprise – does not explicitly cover the question of a doctor’s duty towards a public figure who is not his or her patient.

[…]

My reading of the GMC guidance is that in extreme circumstances, even acknowledging the expectation of how doctors should normally behave, it may occasionally be justified to raise concerns about a public figure (for example, when the individual is relentlessly pursuing a course of action that places many lives at risk). Expressing clinical concern in such circumstances seems to involve a comparable ethical trade-off to the public interest disclosure advice (Duties of a Doctor paragraphs 53-56) that breach of patient confidentiality may be justified in order “to prevent a serious risk of harm to others.”

Well, to be honest, it’s not that much of a surprise to me that the GMC guidelines doesn’t stretch to public figures – but that’s a minor point.

The more interesting thing for me is what the relationship is between the practitioner and the GMC.  Greenhalgh ends her post by saying that she “wrote this blog to promote further debate on the topic and invite the GMC to clarify its position on 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.

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In the Journals – January 2017 by Anna Zogas

Welcome to a new year of Somatosphere’s In the Journals section! Here are some of the articles available in January 2017. Enjoy!

Medical Anthropology

Chronic Subjunctivity, or, How Physicians Use Diabetes and Insomnia to Manage Futures in the United States
Matthew Wolf-Meyer & Celina Callahan-Kapoor

Prognostication has become central to medical practice, offering clinicians and patients views of particular futures enabled by biomedical expertise and technologies. Drawing on research on diabetes care and sleep medicine in the United States, in this article we suggest that subjectivity is increasingly modeled on medical understandings of chronic illness. These chronic conceptions of the self and society instill in individuals an anxiety about future health outcomes that, in turn, motivate practices oriented at self-care to avoid negative health outcomes and particular medical futures. At its most extreme, these anxieties of self-care trouble conceptions of self and social belonging, particularly in the future tense, leading patients and clinicians to consider intergenerational and public health based on the threats that individual patients pose for others.

Decoding the Type 2 Diabetes Epidemic in Rural India (open access)
Matthew Little, Sally Humphries, Kirit Patel & Cate Dewey

Type 2 diabetes mellitus is an escalating public health problem in India, associated with genetic susceptibility, dietary shift, and rapid lifestyle changes. Historically a disease of the urban elite, quantitative studies have recently confirmed rising prevalence rates among marginalized populations in rural India. To analyze the role of cultural and sociopolitical factors in diabetes onset and management, we employed in-depth interviews and focus groups within a rural community of Tamil Nadu.

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.

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The Oxford Handbook of U.S. Health Law

The Oxford Handbook of U.S. Health Law is now available.

Part I An Overview of the Legal Governance of Healthcare

  • Relating Health Law to Health Policy: A Frictional Account – William M. Sage
  • The Relationship between Bioethics and U.S. Health Law: Past, Present, and Future – I. Glenn Cohen
  • What Health Reform Reveals about Health Law – Allison K. Hoffman
  • A View from a Friend and Neighbor: A Canadian Perspective on U.S. Healthcare and the Affordable Care Act – Colleen Flood and Bryan Thomas
  • Healthcare Federalism – Abigail R. Moncrieff and Joseph Lawless

Part II Caring and Receiving Care

A. Access to Healthcare

  • Accessing Hospitals and Health Professionals – Eleanor D. Kinney
  • Access to Health Insurance and Health Benefits – Timothy Stoltzfus Jost
  • Legal Battles against Discrimination in Healthcare – Dayna Bowen Matthew

B. Legal Issues in Information Exchange

  • Health Information Law – Frank Pasquale
  • The Promise of Informed Consent – Robin Fretwell Wilson 
  • Communicating Loyalty: Advocacy and Disclosure of Conflicts in Treatment and Research Relationships – Robert Gatter 
  • Medical Privacy and Security – Sharona Hoffman

C. Ethics and Law of Treatments

  • New, Experimental, and Life-Saving Therapies – B. Jessie Hill
  • Mental Health and Other Behavioral Health Services – John V. Jacobi
  • Assisted Reproductive Technologies and Abortion – Judith Daar
  • Conscientious Refusals of Care – Elizabeth Sepper
  • Disability and Health Law – Leslie Francis, Anita Silvers, and Michael Ashley Stein
  • Autonomy and Its Limits in End-of-Life Law – Rebecca Dresser

D. Recourse for Injury

  • Medical Malpractice Liability: Of Modest Expansions and Tightening Standards – Barry R.

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.

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The privacy debate over research with your blood and tissue

Many people don’t realize that their leftover tissue, blood or other samples – otherwise known as “biospecimens” – taken during a visit to the doctor or hospital might be stripped of identifying information and used in research without their consent.

This makes some people uncomfortable.

So when the federal government decided to revise its “Common Rule” regulations governing federally funded research involving humans for the first time in decades, the draft revision included a proposal to require consent for all research with biospecimens, whether they have identifying information accompanying them or not. The original regulations required a person’s consent for research with biospecimens only if they had information with them that made them identifiable.

But when the updated Common Rule was released on Jan. 18, there was no change to this part of the regulation.

Human research regulations need to keep up with major advances in technology. They also need to balance enabling scientific progress with attempting to ensure safety and privacy for human participants in research.

So why wasn’t the proposal requiring consent for all biospecimen research adopted, and how do the new regulations recognize people’s concern in what happens to pieces of themselves in the future?

Research with nonidentified biospecimens doesn’t require consent.
Blood vials via www.shutterstock.com

Why we need human biospecimens for research

Exciting new research projects, like the Precision Medicine Initiative (PMI), aim to personalize medical interventions and therapies for things like cancer care.

But knowing how to personalize treatment requires comparing data from thousands of biospecimens to discover the relationship between genetic variation, health behaviors and medical outcomes.

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.

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A social scientist’s guide to the Final Rule

On 18 January 2017, sixteen federal agencies announced revisions to the Federal Policy for the Protection of Human Subjects. As I noted earlier, this marks a huge victory for historians, who have spent the last 20 years working to end the inappropriate interference of IRBs with oral history research.

In addition, the final rule includes several provisions of note to scholars in the humanities and social sciences. Here are some of them; I don’t claim it is a complete list.

No biospecimens overhaul; less controversy

The final rule “does not adopt the proposal to require that research involving nonidentified biospecimens be subject to the Common Rule, and that consent would need to be obtained in order to conduct such research.” This was the target of the greatest criticism from groups like the National Academies of Sciences, Engineering, and Medicine and SACHRP. So while this change has little direct bearing on the work of social scientists and scholars in the humanities, it will likely reduce the controversy surrounding the regulatory reform as a whole.

The abandonment of the biospecimens proposal could also reduce opposition to reform by conservatives. The House Freedom Caucus opposed a new Common Rule on the grounds that it would cost $13.334 billion over 10 years. This figure seems to have been drawn from the NPRM’s quantified costs of $13.342 billion (using a 3 percent discount rate), and ignored the NPRM’s quantified benefits of $2.6 billion. If all the Freedom Caucus cares about is money, it may like the final rule a lot more.

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.

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New Common Rule Regs Mean New Training for IRB Members

by Craig Klugman, Ph.D.

Yesterday, the Department of Health & Human Services released the long-awaited, and debated, new Common Rule. Many of the proposals that were released in earlier versions for public comment did not make their way into the rule. All IRB members will also need to undergo training to incorporate the new rules into their reviews. Most of the changes have a deadline of 1 year (January 2018) for enactment.

Though many experts in research ethics will be writing on this in great detail, I offer a brief synopsis of the changes here. However, keep in mind that the incoming administration has suggested they may rollback all executive orders made by the Obama administration in its last few months, if not during the entire Obama presidency. Thus, it is possible that these rule changes are rolled back very quickly.

Who is covered?

The new rules maintain that only federally funded clinical trials must be reviewed by an IRB.

New Definitions

For the first time, the rules adopt a definition of Clinical Trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.” The new rules also offer separate definitions of “identifiable biospecimen” and “identifiable private information,” whereas previously, both were defined together.

Some definitions were tweaked (e.g. “private information”) and others remain unchanged (e.g. “human subject”).

Biobanking specimens and information

One of the most controversial proposed changes was that of having to gain subject consent for use of banked specimens.

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.