Tag: empirical research

Bioethics Blogs

Event: St Cross Special Ethics Seminar: The role of therapeutic optimism in recruitment to a clinical trial: an empirical study, presented by Dr Nina Hallowell

On Thursday 12 May 2016, Dr Nina Hallowell delivered the first St Cross Special Ethics Seminar of Trinity Term.  The talk is available to listen to here http://media.philosophy.ox.ac.uk/uehiro/TT16_STX_Hallowell.mp3

Title:  The role of therapeutic optimism in recruitment to a clinical trial: an empirical study

Abstract: Hope, or therapeutic optimism, is an important aspect of the provision and experience of medical care. The role of therapeutic optimism in clinical research has been briefly discussed within the empirical and bioethics literature, but the concept, and whether it can be transferred from care to research and from patients to clinicians, has not been fully investigated. Interviews with clinical staff involved in a peripartum randomised placebo-controlled trial– the Got-it trial  – revealed that therapeutic optimism has an important role to play facilitating clinical staff engagement with trial work. In this paper I will unpack the concept of therapeutic optimism in trial settings, describe how it is sustained in practice and outline some of the ethical risks and benefits.

About the speaker: Nina Hallowell is a medical sociologist who has recently been appointed to a research post in Ethox Centre in NDPH; where she will be responsible for developing a programme of research on ethical issues arising in big data research.  She has over twenty years’ experience of undertaking empirical research on the ethical and social issues generated by genetic testing in clinical and research contexts and different stakeholders’ views and experiences of research participation, at Cambridge, Edinburgh and Newcastle Universities. Recently, she has been involved in researching clinical staffs’ experiences of delivering RCTs and the ways in which they manage some of the ethical dilemmas they encounter.

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

Where to Publish and Not to Publish in Bioethics

Guest Post by Stefan Eriksson & Gert Helgesson, Uppsala University

* Note: this is a cross-posting from The Ethics Blog, hosted by the Centre for Research Ethics & Bioethics (CRB) at Uppsala University. The link to the original article is here. Re-posted with permission of the authors.

Introduction

Allegedly, there are over 8,000 so-called predatory journals out there. Instead of supporting readers and science, these journals serve their own economic interests first and at best offer dubious merits for scholars. We believe that scholars working in any academic discipline have a professional interest and a responsibility to keep track of these journals. It is our job to warn the young or inexperienced of journals where a publication or editorship could be detrimental to their career. Even with the best of intent, researchers who publish in these journals inadvertently subject themselves to criticism. We have seen “predatory” publishing take off in a big way and noticed how colleagues start to turn up in the pages of some of these journals. This trend, referred to by some as the dark side of publishing, needs to be reversed.

People have for a number of years now turned to Jeffrey Beall, a librarian at the University of Colorado, who runs blacklists of “potential, possible, or probable” predatory publishers and journals. His lists are not, however, the final say on the matter, as it is impossible to judge reliably actors in every academic discipline. Moreover, since only questionable journals are listed, the good journals must be found elsewhere.

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

A New Edition of Journal of Empirical Research on Human Research Ethics Is Now Available

April 28, 2016

Journal of Empirical Research on Human Research Ethics (vol. 11, no. 1, 2016) is available online by subscription only.

Articles include:

  • “Self-Consent for HIV Prevention Research Involving Sexual and Gender Minority Youth: Reducing Barriers through Evidence-Based Ethics” by Celia B. Fisher, et al.
  • “Ethics of Online Assent: Comparing Strategies to Ensure Informed Assent among Youth” by Mark S. Friedman, et al.
  • “Participants and Study Decliners’ Perspectives about the Risks of Participating in a Clinical Trial of Whole Genome Sequencing” by Jill Oliver Robinson, et al.
  • “Phase 3 Oncology Clinical Trials in South Africa: Experimentation or Therapeutic Misconception?” by Tina Malan and Keymanthri Moodley

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

Where to publish and not to publish in bioethics

Allegedly, there are over 8.000 so called predatory journals out there. Instead of supporting readers and science, these journals serve their own economic interests first and at best offer dubious merits for scholars. We believe that scholars working in any academic discipline have a professional interest and a responsibility to keep track of these journals. It is our job to warn the young or inexperienced of journals where a publication or editorship could be detrimental to their career. Even with the best of intent, researchers who publish in these journals inadvertently subject themselves to criticism. We have seen “predatory” publishing take off in a big way and noticed how colleagues start to turn up in the pages of some of these journals. This trend, referred to by some as the dark side of publishing, needs to be reversed.

Gert Helgesson, Professor of Medical Ethics, Karolinska InstitutetPeople have for a number of years now turned to Jeffrey Beall, a librarian at the University of Colorado, who runs blacklists of “potential, possible, or probable” predatory publishers and journals. His lists are not, however, the final say on the matter, as it is impossible to judge reliably actors in every academic discipline. Moreover, since only questionable journals are listed, the good journals must be found elsewhere. We are much obliged to his work but think that a response of gatekeeping needs also to be anchored in each discipline.

As a suitable response in bioethics, we have chosen the following approach: Below, we alphabetically list the recommended journals in our field that either have an impact over one, as calculated by Thomson Reuters over a five year period, and a good reputation (still no potentially predatory journal in bioethics have received such a high IF, but it might happen), or by our own experience have been found to be of high quality when engaging with them as authors, reviewers and/or readers (and agreed upon by all those involved as authors of this blog post or as reference persons for the lists).

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

Wynn Calls for Department-Level Review of Student Research

L. L. Wynn, an anthropologist at Macquarie University and a member of that university’s Human Research Ethics Committee, spoke to 40 teachers and administrators at 14 Australian universities. She finds that “opportunities for independent undergraduate human research are being eroded by expanding ethics bureaucracies” and that “the ethics review process [is] a significant obstacle to universities and teachers who wish to incorporate original human research into the curriculum.” (7) She calls for the devolution of ethics review to individual departments.

[L. L. Wynn, “The Impact of Ethics Review on a Research-Led University Curriculum Results of a Qualitative Study in Australia,” Journal of Empirical Research on Human Research Ethics, Published online before print, March 16, 2016, doi:10.1177/1556264616636234.]

Wynn’s informants tell her that ethics boards display “biomedical or clinical bias,” that they delay student work by months, that they discourage bold questions about sexuality and mental health, and instead steer students into “much more generic, low-risk research that may actually not be all that interesting.” (5)

As Wynn acknowledges, such complaints will be familiar to those who have read the existing literature on ethics review of the social sciences, including Wynn’s own 2011 article, “Ethnographers’ Experiences of Institutional Ethics Oversight: Results from a Quantitative and Qualitative Survey,” which it was my privilege to edit.

Her chief contribution here is not documenting the problem, but forcefully advocating for a solution: departmental-level review. She writes than Australian university psychology department, which has such a practice, serves as “the single best-practice case that I identified during this research.”

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

#BioethicsSoWhite

 

By Celia B. Fisher, Ph.D.

In a recent article in the American Journal of Bioethics Kayhan Parsi of the Loyola University of Chicago Stritch School of Medicine exhorted bioethicists to address racism in their work. What the article did not address is why in 2016 it has taken bioethics so long to recognize a problem existing for more than 50 years since the field’s nascence.

One answer to the question is that training programs in bioethics continue to be grounded in the philosophical tradition that sees justice fulfilled through applying universal moral principles across diverse stakeholders. Even John Rawls’ revolutionary call for justice arrived at through imagining one’s social position behind a “veil of ignorance” unintentionally supports racial blindness, when bioethicists are required to simply “imagine” rather than actually investigate the needs and values of ethic minority stakeholders.

A more profound problem is the field’s lack of attention to the decades of social science research documenting patient perspectives on how the U.S. medical establishment has disenfranchised racial minorities through explicit and implicit biases resulting in inadequate diagnoses and care, continued health disparities and medical distrust. Parsi and commentators suggest that a greater training presence in historically Black colleges and the “moral courage” of individual bioethicists will increase bioethicists’ attention to systemic racism.

A bolder and more effective solution would be to bridge the training chasm between traditional theoretically-driven case-based bioethics and empirical evidence by requiring training in social-behavioral science approaches to understanding how bioethics consultation can reduce or exacerbate systemic racism.

Training a new generation in empirical approaches to bioethics that gives voice to the experiences of racial minority communities will lead to ethical decision-making that reflects the values and merits the trust of racial minority patients.

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

Doing the right thing by transgender kids is not easy

A US$5.7 million study of the long-term outcomes of medical treatment for transgender youth begins recruiting in May. But knotty ethical questions remain unanswered.

The study will be located at four academic medical centres with dedicated transgender youth clinics and will include 280 young people with gender dysphoria in two age groups.

Younger children in early puberty will receive hormone blockers, called GnRH agonists, to suspend the process of puberty – preventing the development of undesired secondary sex characteristics.

Older adolescents will begin use of masculinizing or feminizing cross-sex hormones that allow them to go through the “right” puberty – consistent with their gender of identification.

Feelings about the ethics of gender dysphoria run high, although little is really known about the condition. “People are making declarations of knowledge that are their belief systems, that aren’t also backed up by empirical research,” Jack Drescher, a psychiatrist at the William Alanson White Institute in New York City, told Nature. In this case, a number of ethicists regard hormone treatment itself as unethical, while those directing the study assume that it is.

Some studies say that 80% of children under with gender dysphoria abandon the idea by the time they enter puberty. However, it appears that children who identify as transgender in adolescence seldom change. Therefore, denying them the ability to transition is unethical, bioethicist Simona Giordano of the University of Manchester, UK, told Nature. “Not treating adolescents is not being neutral,” she says. “It means exposing children to a lot of harm.”

However controversial Giordano’s view is, even more controversial is how to treat younger children.

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 Unbearable Whiteness of Bioethics: Exhorting Bioethicists to Address Racism

by Kayhan Parsi, Ph.D.

To be ignorant of what occurred before you were born is to remain always a child.” (Cicero)

Fight the Power” (Public Enemy)

Recently, our medical school hosted Dr. Linda Rae Murray to give a talk on structural racism and medicine. A former president of the American Public Health Association, Dr. Murray gave a powerful presentation on the history of racism in the United States and its lingering impact upon health disparities. In one of her more provocative slides, she graphically conveyed the long history of racism toward African Americans in the United States (before and after the founding of the republic). For 250 years, legalized slavery existed. After a brief period of Reconstruction, institutionalized racism persisted for another 75 years during the Jim Crow era. During the civil rights era of the 1950s and 1960s, civil rights legislation was finally passed. We have now been living for nearly 50 years in a post-civil-rights era (a mere fraction of the overall history recounted by Murray). Today, racial discrimination is clearly illegal. We even have a black President. Yet structural racism persists. Why is that?

Many factors are at play here. Our schools are de facto segregated based on where families live (as Danis, Wilson and White point out, “In some areas, there is more segregation than during the Jim Crow era”). One’s ZIP code has a profound impact upon health outcomes. And, as the authors also point out, “These patterns are not the result of chance.” This reflects the view of Paul Farmer, who argues that the social inequities of the world are not the product of accident or random events.

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

Watching the retractions

Retraction Watch is a website devoted to information about, well, retractions: when a scientific or scholarly journal withdraws an article which it had previously published, for one or another reason (fraud being the most damning). The site can interest bioethics workers for obvious reasons: not just that it is a watchdog for scientific integrity, but also that it is your one-stop-shop for accusations of potentially unethical scientific behavior.

Recently, the tables were turned: a bioethics article was retracted. In fact, it was an article that this blog mentioned back in 2015. Chattopadhyay et al.’s “Imperialism in bioethics: how policies of profit negate engagement of developing world bioethicists and undermine global bioethics” looked at online journal access, and concluded that a number of bioethics journals were inaccessible to middle- and low-income researchers via prominent open-access initiatives (WHO’s Hinari, Pub Med Central). These broad claims were factually incorrect. You could call this the predictable consequence of the ’empirical turn’ in bioethics: if you emulate empirical methods, and generate empirical data to support ethical arguments, you are open to retraction when the facts aren’t right. So be it.

The discussion and comments on the case in Retraction Watch are worth taking a look at. For my part, I sympathize with the general claim that those in developing countries face serious challenges entering the bioethical ‘conversation of mankind.’ The roots of the problem likely run deeper than open-access: if you don’t have good English, or access to computers, or computers with reliable internet, or there is no hint of ‘bioethics’ in your educational institutions, or a burning interest in bioethics makes you an economical trainwreck and so on.

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

In the Journals December 2015 – Catching up by Melanie Boeckmann

Happy New Year to all Somatosphere readers! Hopefully you were able to take a break and came back refreshed and ready to tackle your reading list. Not sure where to start? Start here with the In the Journals December recap. Owing to its length, the round-up is divided into two separate posts. Find the second half here.

American Anthropologist

Sick Healers: Chronic Affliction and the Authority of Experience at an Ethiopian Hospital

Anita Hannig

At fistula hospitals in Ethiopia, patients who are not cured of their incontinence are hired as “nurse aides” to perform essential nursing duties in the ward and operating theater. An array of tensions surrounds the work of these women, tensions that are emblematic of their chronic—but secret—patient status. If accidentally disclosed, the women’s ongoing illness episodes sabotage their ability to administer treatment, such as injections. In contrast to classic anthropological accounts of wounded healers and therapeutic narratives about the virtues of experience-based care, I argue in this article that illness experience can also have a profoundly delegitimizing effect. Rather than attributing these dynamics to the alleged stigma that surrounds obstetric fistula sufferers, I delineate the various challenges to clinical authority that are epitomized by the figure of the sick healer. Nurse aides’ experiences with obstetric fistula proved to be a liability precisely because these experiences had not been resolved. Their chronic injuries raised questions both about their medical training and the efficacy of surgery. Attending to these Ethiopian health practitioners can hone our grasp of the professional dilemmas posed by chronic afflictions and contribute to our understanding of available ideologies at play in the global practice of biomedicine.

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.