Hot Topics: Clinical Trials & Studies

Blog Posts (62)

February 14, 2018

Is a Vitamin D placebo trial in children with asthma ethical?

by Craig Klugman, Ph.D.

In a 2017 article from India, researchers conducted a meta-analysis looking at vitamin D deficiency and asthma in children.…

January 25, 2018

Monkey See, Human Do: Cloning Macaque Monkeys with Fetal Cells

by Craig Klugman, Ph.D.

 “How afraid of human cloning should we be?”
Monkeys have been cloned, Paving the way for human cloning
Yes, They’ve Cloned Monkeys in China.

January 9, 2018

Blindness Cure Is Out of Sight

by Craig Klugman, Ph.D.

The FDA has approved the world’s first gene therapy: Luxturna (voretigene neparvovec; AAV2-hRPE65v2) is a one-time intervention that can treat an inherited retinal disease (RPE65-mediated inherited retinal dystrophy).…

January 5, 2018

BioethicsTV (December 29, 2017-January 5, 2018): Medical Research and Consent for Testing

by Craig Klugman, Ph.D.

Black Mirror (Seasons 4; Episode 6): Medical research

In this British series exploring the potential nightmares of modern technology, this episode looked at three stories of research ethics in medicine.…

November 1, 2017

Rand Paul is About to Legislate Peer-Review: Scientists Need Not Apply

by Craig Klugman, Ph.D.

Senator and former Presidential candidate Rand Paul introduced S. 1973, a bill that would change how scientific grant proposals are reviewed.…

October 13, 2017

BioethicsTV (October 9-13, 2017): Drinking on transplant list; big pharma in pandemics; mortality forces morality

The Good Doctor (Season 1; Episode 3): A Patient Takes A Drink While on the Transplant List

This week, a patient is finally at the top of the list for a heart transplant.…

September 6, 2017

Response to the Common Rule Special Issue: Attention to Health Disparities

by Nicolle K. Strand, JD, MBioethics, and Nora Jones, PhD

The article and commentaries on recent revisions to the Common Rule published in the July 2017 issue of AJOB are missing, we believe, a key perspective.…

August 4, 2017

The Age of Designed Babies Arrives

by Craig Klugman, Ph.D.

In the film Gattaca, a couple desiring to have a child visits their neighborhood geneticist:

Geneticist: You have specified hazel eyes, dark hair and fair skin.

July 19, 2017

Response to: “Rethinking the Belmont Report? Yes!”

by Phoebe Friesen, Lisa Kearns, Barbara Redman, and Arthur L. Caplan

Emily Caldes and Jennifer McCormick make several excellent points in their blog post “Rethinking the Belmont Report?…

July 7, 2017

The 2017 Common Rule and the Clinical Ethics of Prolixity

Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field.

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Published Articles (13)

AJOB Neuroscience: Volume 8 Issue 2 - Jun 2017

Staying in the Loop: Relational Agency and Identity in Next-Generation DBS for Psychiatry Sara Goering, Eran Klein, Darin D. Dougherty & Alik S. Widge

AJOB Primary Research: Volume 8 Issue 3 - Sep 2017

Moral conflict and competing duties in the initiation of a biomedical HIV prevention trial with minor adolescents Amelia S. Knopf , Amy Lewis Gilbert , Gregory D. Zimet, Bill G. Kapogiannis, Sybil G. Hosek, J. Dennis Fortenberry, Mary A. Ott & The Adolescent Medicine Trials Network for HIV/AIDS Interventions

American Journal of Bioethics: Volume 17 Issue 5 - May 2017

Ethical Issues in Fecal Microbiota Transplantation in Practice Yonghui Ma, Jiayu Liu, Catherine Rhodes, Yongzhan Nie & Faming Zhang

AJOB Primary Research: Volume 8 Issue 1 - Feb 2017

Decision making in pediatric oncology: Views of parents and physicians in two European countries Domnita O. Badarau, Katharina Ruhe, Thomas Kühne, Eva De Clercq, Anca Colita, Bernice S. Elger & Tenzin Wangmo

AJOB Primary Research: Volume 8 Issue 1 - Feb 2017

Better to know than to imagine: Including children in their health care Tenzin Wangmo, Eva De Clercq, Katharina M. Ruhe, Maja Beck-Popovic, Johannes Rischewski, Regula Angst, Marc Ansari & Bernice S. Elger

AJOB Neuroscience: Volume 7 Issue 2 - Apr 2016

Ethics of Decoded Neurofeedback in Clinical Research, Treatment, and Moral Enhancement Eisuke Nakazawa, Keiichiro Yamamoto, Koji Tachibana, Soichiro Toda, Yoshiyuki Takimoto & Akira Akabayashi

American Journal of Bioethics: Volume 16 Issue 6 - Jun 2016

Clinical Trials Infrastructure as a Quality Improvement Intervention in Low- and Middle-Income Countries Avram Denburg, Carlos Rodriguez-Galindo & Steven Joffe

American Journal of Bioethics: Volume 16 Issue 6 - Jun 2016

The Potential for Infrastructure Benefits and the Responsiveness Requirement David Wendler

American Journal of Bioethics: Volume 14 Issue 3 - Mar 2014

The Ethics of Advertising for Health Care Services Yael Schenker, Robert M. Arnold & Alex John London

American Journal of Bioethics: Volume 13 Issue 12 - Dec 2013

Quality Improvement Ethics: Lessons From the SUPPORT Study Benjamin S. Wilfond

News (152)

February 12, 2018 9:00 am

Brain Transcriptome Distinctions, Overlaps Characterized in Neuropsychiatric Conditions (GenomeWeb)

New research is defining the similarities and differences between brain gene expression profiles involved in neuropsychiatric conditions.

January 5, 2018 9:00 am

Gene editing staves off deafness in mice (Nature)

Technique to knock out mutant gene relies on fatty molecules to deliver CRISPR components to inner-ear cells.

December 19, 2017 9:00 am

Opioid Abuse May Be Curbed by New Vaccine (Genetic Engineering and Biotechnology News)

In preclinical studies, a vaccine has been shown to induce antibodies that bind to heroin and keep it from crossing the blood–brain barrier. The vaccine, a haptenic heroin surrogate, was conjugated to tetanus toxoid and mixed with liposomes containing monophosphoryl lipid A as an adjuvant. It reduced heroin-induced antinociception and locomotive behavioral changes following repeated subcutaneous and intravenous heroin challenges in mice and rats.

December 14, 2017 9:00 am

Gene therapy makes a big advance treating hemophilia B blood disorder (Washington Post)

Konduros, 53, who runs a bakery and cafe in southeastern Ontario, is one of 10 men in an early-stage trial sponsored by Spark Therapeutics. (The disorder is much more common in men than women.) On Wednesday, researchers reported that a single intravenous infusion of Spark’s novel gene therapy enabled patients to safely produce sufficient clotting factor to prevent dangerous bleeding episodes.

December 12, 2017 9:00 am

Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information) (Government of Canada)

Without access to detailed clinical data, health professionals and researchers are unable to perform independent analyses of the evidence underlying published research findings and Health Canada’s regulatory reviews. This approach limits transparency and misses opportunities to promote greater confidence in the oversight of drugs and medical devices. It is also out of step with Health Canada’s key regulatory partners, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration, which have increased clinical data transparency over the past 10 years.

October 6, 2017 9:00 am

Changes in the microbiota cause genetically modified Anopheles to spread in a population (Science)

In an alternative strategy, Wang et al.engineered mosquitoes’ gut bacteria. A strain of nonpathogenic bacteria, AS1, was both sexually and transgenerationally transmitted. The strain infected a laboratory population of mosquitoes and persisted for at least three generations. AS1 engineered to inhibit malaria parasite development in the midgut could do so without handicapping the mosquitoes.

October 2, 2017 9:00 am

Chinese scientists fix genetic disorder in cloned human embryos (Nature)

A team in China has taken a new approach to fixing disease genes in human embryos. The researchers created cloned embryos with a genetic mutation for a potentially fatal blood disorder, and then precisely corrected the DNA to show how the condition might be prevented at the earliest stages of development.

September 13, 2017 9:00 am

South Korean researchers lobby government to lift human-embryo restrictions (Nature)

More than a decade after a fraud scandal in stem-cell science rocked South Korea, scientists in the field are ramping up pressure on the government to relax the country’s strict regulations on human-embryo research — which many researchers label a ban.

September 7, 2017 9:00 am

Massive Ebola data site planned to combat outbreaks (Nature)

More than 11,000 people died when Ebola tore through West Africa between 2014 and 2016, and yet clinicians still lack data that would enable them to reliably identify the disease when a person first walks into a clinic. To fill that gap and others before the next outbreak hits, researchers are developing a platform to organize and share Ebola data that have so far been scattered beyond reach.

August 9, 2017 9:00 am

Memory-enhancing drug reverses effects of traumatic brain injury in mice (Science)

Whether caused by a car accident that slams your head into the dashboard or repeated blows to your cranium from high-contact sports, traumatic brain injury can be permanent. There are no drugs to reverse the cognitive decline and memory loss, and any surgical interventions must be carried out within hours to be effective, according to the current medical wisdom. But a compound previously used to enhance memory in mice may offer hope: Rodents who took it up to a month after a concussion had memory capabilities similar to those that had never been injured.

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