Tag: review

Bioethics Blogs

Final Rule, three months later

It’s been three months since the announcement of the new Common Rule. Some reactions so far:

Shweder and Nisbett hope for vast deregulation

On March 12, Richard A. Shweder and Richard E. Nisbett published an essay in the Chronicle of Higher Education celebrating the new final rule:

in January the federal government opened the door for universities to deregulate vast portions of research in the social sciences, law, and the humanities. This long-sought and welcome reform of the regulations requiring administrative oversight of federally funded human-subject research on college campuses limits the scope of institutional review board, or IRB, management by exempting low-risk research with human subjects from the board’s review.

In particular, they wrote that “the overhauled policy … holds that exempted research activities should be excused from board review with no requirement of IRB approval of the exemption.”

[Richard A. Shweder and Richard E. Nisbett, “Long-Sought Research Deregulation Is Upon Us. Don’t Squander the MomentChronicle of Higher Education, March 12, 2017.

Meyer asks, what’s new?

On March 16, Michelle N. Meyer tweeted a GIF showing that several of the provisions cheered by Shweder and Nisbett have been part of the regulations for decades. Indeed, since 2009, OHRP has grudgingly acknowledged that the Common Rule allows researchers to make exemption determinations. The problem has been persuading universities to take advantage of these longstanding provisions.

On the other hand, Meyer notes that the liberation of oral history is new, and that the exemption for “benign behavioral interventions” is, in her terms, “new & awesome.”

(GIF re-posted here with Meyer’s permission.)

Comments posted to the Chronicle website made similar points.

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

Paid Sick Days: The Better Way

Kelly Holloway describes how changes to business practices concerning sick days can be beneficial for workers’ health and the economy.

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Most employees understand the case in favour of paid sick days. If you do not have them, you probably have to choose between staying home sick and losing pay or going to work sick and putting other people’s health at risk. But the steadfast counter argument to the campaign for paid sick days is that businesses suffer, especially small businesses. And when businesses suffer, the economy suffers.

A newly formed alliance, the Better Way to Build the Economy Alliance, is challenging the argument that legislated paid sick days are bad for the economy. It is doing so by bringing together employers who feel that paid sick days are actually good for businesses. More than that, the alliance claims that decent working conditions and a better minimum wage are good for the economy. This alliance of businesses and community leaders is helping to prove that investments like paid sick days and better wages result in higher levels of employee productivity and customer satisfaction.

“In a small business, you know your employees, and it’s rare, rare, that someone will abuse a paid sick day,” says Paul Hayman from Five Walls Realty in Guelph. “In fact, in my experience most of the time you have to tell someone to go home because they’re feeling sick.”

Toronto, 2016. Photo Credit: Kelly Holloway

Hayman, along with other employers, is featured in the Better Way videos, launched earlier this month.

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

New Cochrane Review of Patient Decision Aids

There is now yet another new Cochrane review of the evidence on patient decision aids.  Here are the conclusions:

  • When people use decision aids, they improve their knowledge of the options (high-quality evidence) and feel better informed and more clear about what matters most to them (high-quality evidence). 
  • They probably have more accurate expectations of benefits and harms of options (moderate-quality evidence) and probably participate more in decision making (moderate-quality evidence). 
  • People who use decision aids may achieve decisions that are consistent with their informed values (evidence is not as strong; more research could change results). 
  • People and their clinicians were more likely to talk about the decision when using a decision aid. 
  • Decision aids have a variable effect on the option chosen, depending on the choice being considered. 
  • Decision aids do not worsen health outcomes, and people using them are not less satisfied. 
  • More research is needed to assess if people continue with the option they chose and also to assess what impact decision aids have on healthcare systems.

Source: bioethics.net, a blog maintained by the editorial staff of The American Journal of Bioethics.

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

Food Security & Nutrition in Timor-Leste

Q&A with Becky McLaren

 

Can you briefly describe the Timor-Leste project and your recent visit to the country?

 

The project is a strategic review of the food security and nutrition situation in Timor-Leste. We’re working with the World Food Programme, which has done similar work in other countries. We’re evaluating what’s been done in the past and what’s currently going on in order to make recommendations for future work. Our review is framed around the Sustainable Development Goals (SDGs), specifically SDG 2 which aims to end hunger worldwide by 2030.

 

Our recent trip was an opportunity to develop relationships with our different collaborators, including our main partner in the review, CEPAD; build an outline for the project’s next steps; and meet other stakeholders – government, international and local NGOs, and civil society organizations.

 

Can you tell us about some of the unique nutrition and food security challenges facing Timor-Leste?

 

Timor-Leste is a post-conflict country which is still in the window of peacebuilding and becoming more stable. The country was colonized by Portugal until 1975 and then occupied by Indonesia until the UN helped it achieve independence in 2002. There was a reemergence of conflict in 2006, and UN peacekeepers maintained a presence in Timor-Leste until 2012. At the present, the country has a unique opportunity to move beyond creating a stable government and into building food and nutrition security. The government has the chance to restructure the agriculture and food systems.

 

Timor-Leste also has serious nutrition challenges, with one of the highest stunting rates in the world.

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

Into the Unknown: Methodological and Ethical Issues in Phase I Trials

Tuesday, April 18, 2017
12:00 – 1:00pm
RI auditorium, Glen Site – E S1.1129

With the current push to transform Montréal into a hub for early phase research, there is a pressing need to explore the issues that researchers and research ethics boards (REB) encounter in Phase I trials.

In this two-part presentation, recent examples from healthy volunteer and oncology studies will be used to illustrate how protocol design and ethics review can be enhanced.

Source: STREAM: Studies of Translation, Ethics, and Medicine.

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

Housing Equity Week in Review

Lots of news from the past week in housing equity and law. Check out the latest in the field from the week of April 10-17, 2017: In his first television interview as Secretary of Housing and Urban Development, Ben Carson … Continue reading

Source: Bill of Health, examining the intersection of law and health care, biotech & bioethics.

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

Next Up: A Proposal for Values-Based Law Reform on Unilateral Withholding and Withdrawal of Potentially Life-Sustaining Treatment

Jocelyn Downie

The latest issue (54:3) of the Alberta Law Review is a special issue on health law.  


I plan to read several of the articles and already read this one:  “Next Up: A Proposal for Values-Based Law Reform on Unilateral Withholding and Withdrawal of Potentially Life-Sustaining Treatment.”


The unilateral withholding and withdrawal of potentially life-sustaining treatment presents a complex issue of law and public policy.  Jocelyn Downie, Lindy Willmott, and Ben White examine the current state of this practice and conclude that it is occurring, being challenged in the courts, and is treated differently in different jurisdictions. 


Downie, Willmott & White review the current state of the law in the United Kingdom, Australia, New Zealand, the United States, and Canada. The authors use Canada as a case study to outline a process for pursuing law reform. The authors propose a model for law and policy reform in this area that is both informed and shaped by the fundamental values of Canadian society.


Ultimately, the authors argue that physicians should NOT have unilateral authority to limit life-sustaining treatment.  Nicely, their vocabulary maps that in the 2015 ATS multi-society statement.  


I have had the pleasure of working with Downie, Willmott and White before and look forward to seeing them later this year in Halifax at the Second International Conference On End Of Life Law, Ethics, Policy, And Practice.

Source: bioethics.net, a blog maintained by the editorial staff of The American Journal of Bioethics.

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

Blinded by the Promise of Stem Cell Treatments

Alan F. Cruess cautions against the use of unproven stem cell ‘treatments.’

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Recently, many of you may have read about three patients who are blind after receiving stem cell ‘treatments.’  The patients were ‘treated’ at a Florida clinic for age-related macular degeneration. This common eye condition is the leading cause of vision loss among people over the age of 50. The clinic harvested stem cells from the patients using liposuction and then injected these stem cells into their eyes. Again, these three patients, are now all blind as a result of this unproven ‘treatment.’

There are two types of age-related macular degeneration: ‘wet’ and ‘dry.’ In recent years, treatment of wet macular degeneration has been transformed by new drugs which can be very effective if they are applied early. Meanwhile, treatment of the more common dry macular degeneration remains elusive. As such, patients with dry macular degeneration may be desperate to prevent and reverse blindness and willing to try emerging regenerative therapies.

Some experimental stem cells treatments to prevent blindness are promising, and they are being studied worldwide in laboratories and highly regulated clinical trial settings. In these settings, the safety and efficacy of experimental treatments can be closely monitored. Yet, the safety and efficacy should be called into question when these so-called ‘treatments’ are marketed outside of the research context. This was the case at the Florida clinic.

Before subjecting oneself or a loved one to any new ‘treatment’ with stem cells patients should be informed about the risks and potential benefits of the proposed treatment.

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

United States commits to improve both physicians training and quality in palliative care

A system to prepare physicians to address this type of medical need that showed a significant improvement in the quality of life expected in patients with serious illnesses.

In 1998 in the United States, only 15% of hospitals with 50 beds or more had an official palliative care programme. By 2013, this percentage had risen to 67%, and today, 90% of hospitals with more than 300 beds now have this type of care. However, it appears that widespread training of physicians to address this type of medical need has not yet been realised.

Palliative care physicians training

For this reason, the United States wish to implement a system to prepare physicians, the Palliative Care and Hospice Education and Training Act, to improve both training and quality in palliative care. A budget of 49.1 US million dollars has been allocated to this end, which does not seem high for the improvement in the quality of life expected in patients with serious illnesses (See HERE).

Furthermore, a recent systematic review (See HERE) that evaluated the effects of palliative care on patients and caregivers using data from 12,731 patients (mean age 67 years) and 2,479 caregivers showed a significant improvement in patient quality of life in the 1 to 3 months after care began. However, no association was found between palliative care and survival.

The authors concluded that this meta-analysis shows a significant association between patient quality of life, although results were more inconsistent with respect to the caregivers, and no significant association was found between palliative care and patient survival.

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

VR and PTSD: Healing from trauma by confronting fears in virtual reality environments

By Katie Givens Kime
Image courtesy of Flikr

What are the ethical implications of therapeutically re-exposing patients to trauma via virtual reality technologies? Of the 2.7 million American veterans of the Iraq and Afghanistan wars, at least 20% suffer from depression and/or post-traumatic stress disorder (PTSD), and other studies peg that percentage even higher. As a chronic, debilitating mental illness, one PTSD symptom is hyperarousal, in which a person repeatedly re-experiences a trauma in the form of nightmares, panic attacks, and flashbacks.  One of the most long-trusted therapeutic approaches to PTSD is exposure therapy; now, virtual reality technology is increasingly being used to simulate exposure to traumatic events and to environments related to the traumatic event.


Image courtesy of Flikr

Last month’s Neuroethics and Neuroscience in the News event featured the recent research and observations of Barbara O. Rothbaum, who is the Paul A. Janssen Chair in Neuropsychopharmacology at the Emory University School of Medicine and Director of the Emory Veterans Program & Trauma and Anxiety Recovery Program. Rothbaum outlined the way in which exposure therapy (with or without the aid of virtual reality technology) is based on principles of learning and also discussed reliable findings with animals and phobic disorders (Foa & Kozak, 1986). The underlying premise of such therapy is that repeated and prolonged exposure to feared but realistically safe stimuli leads to habituation, and eventually to extinction.

The virtual reality exposure therapy (VRE) combat environments for “Virtual Vietnam” (developed by Georgia Tech and Emory Universities) includes a virtual Huey helicopter, a “fly” over the jungles of Vietnam, a “walk” in clearings near jungles and swamps, and other imaginal immersions in Vietnam-related stimuli.

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.