Hot Topics: Clinical Trials & Studies

Blog Posts (69)

October 16, 2018

Sunset on the RAC: When is it time to end special oversight of an emerging biotechnology?

by Jeffrey P. Kahn, Ph.D., M.P.H. and Anna C. Mastroianni, J.D., M.P.H.

National Institutes of Health Director (NIH) Francis S. Collins and Food and Drug Administration Commissioner Scott Gottlieb recently co-authoreda New England Journal of Medicinecommentary suggesting that special oversight of gene transfer research in humans was no longer necessary.…

October 1, 2018

Sloan Kettering Controversies: Trust is the Public Foundation of Medical Research

by Ann Mongoven, PhD, MPH

Recent controversies at Memorial Sloan Kettering Cancer Center raise ethical questions about medical research that deserve public attention.…

September 7, 2018

RACeing to Deregulate: Can We Afford Less Oversight of Gene Transfer Research?

by Craig Klugman, Ph.D.

 “As gene therapy continues to change, so must the federal framework set up to oversee it.”-Francis Collins & Scott Gottlieb

In one of his first acts of office, Trump ordered executive agencies to reduce regulations.…

July 11, 2018

Secret Twin Experiments & Bioethics.net 15 seconds of fame

by Craig Klugman, Ph.D.

On the advice of a family friend, I went to see the new documentary, Three Identical Strangers.

May 8, 2018

Speaking to the Media about Antimicrobial Resistance: A Deeper Description of How I Wear Many Hats as a Bioethicist

by Craig Klugman, Ph.D.

Last week, I was interviewed by an academic news serviceabout antimicrobial resistance (AMR) after a study reported that giving antibiotics to children in selected African towns led to a decreased mortality rate.  …

April 6, 2018

BioethicsTV (April 2-6): #ChicagoMed; #GreysAnatomy

by Craig Klugman, Ph.D.

Chicago Med (Season 3; Episode 14): Record checking; off label use; scope of practice; Grey’s Anatomy (Season 14; Episode 18): Experimental treatment; Saying goodbye

Chicago Med (Season 3; Episode 14): Record checking; off label use; scope of practice
Psychiatry resident Dr.…

February 21, 2018

Insider Report: NIH Alters Pre-Award Human Subjects Concerns Reporting; IRBs Not Told

by Craig Klugman, Ph.D.

On February 16, 2018, bioethics.net received an NIH memo sent to program officers on the same day.…

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).…

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Published Articles (19)

American Journal of Bioethics: Volume 18 Issue 11 - Nov 2018

Aligning Research Priorities to Improve Equity: A Challenge for Health Funders Alonzo L. Plough

American Journal of Bioethics: Volume 18 Issue 10 - Oct 2018

The One Health Approach to Zoonotic Emerging Infectious Diseases Ariadne Nichol & David Magnus

American Journal of Bioethics: Volume 18 Issue 10 - Oct 2018

A Radical Approach to Ebola: Saving Humans and Other Animals Sarah J. L. Edwards, Charles H. Norell, Phyllis Illari, Brendan Clarke & Carolyn P. Neuhaus

American Journal of Bioethics: Volume 18 Issue 7 - Jul 2018

On Gender and Reproductive Decision-Making in Uterine Transplantation Hilary Mabel, Ruth M. Farrell & Andreas G. Tzakis

AJOB Primary Research: Volume 9 Issue 2 - Jun 2018

To report or not to report: Exploring healthy volunteers' rationales for disclosing adverse events in Phase I drug trials Lisa McManus & Jill A. Fisher

American Journal of Bioethics: Volume 18 Issue 4 - Apr 2018

Ethical Guidance for Selecting Clinical Trials to Receive Limited Space in an Immunotherapy Production Facility Nancy S. Jecker, Aaron G. Wightman, Abby R. Rosenberg & Douglas S. Diekema

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

News (193)

December 11, 2018 9:15 am

What These Medical Journals Don’t Reveal: Top Doctors’ Ties to Industry (The New York Times)

The Sarah Cannon Research Institute, based in Nashville, received nearly $8 million in payments from drug companies on behalf of its president for clinical operations, Dr. Howard Burris, largely for research work. Dozens of his articles published in prestigious medical journals did not include the required disclosures of those payments and relationships.

December 6, 2018 9:00 am

If you’re single with cancer, you may get less aggressive treatment than a married person (The Washington Post)

If you are divorced, widowed or never married and develop cancer, watch out. You may get less aggressive treatment than your married friends.

We’ve often heard about studies showing that married adults are more likely to survive cancer than singles. But buried in those same studies is another finding that hasn’t made the headlines. When surgery or radiotherapy is the treatment of choice, patients with spouses are more likely to get it.

November 30, 2018 9:00 am

‘Landmark study’ shows brain cells revamp their DNA, perhaps sparking Alzheimer’s disease (Science)

Unlike most cells in our bodies, the neurons in our brain can scramble their genes, scientists have discovered. This genome tampering may expand the brain’s protein repertoire, but it may also promote Alzheimer’s disease, their study suggests.

“It’s potentially one of the biggest discoveries in molecular biology in years,” says Geoffrey Faulkner, a molecular biologist at the University of Queensland in Brisbane, Australia, who wasn’t connected to the research. “It is a landmark study,” agrees clinical neurologist Christos Proukakis of University College London.

November 29, 2018 9:15 am

Who owns your medical data? Most likely not you. (The Washington Post)

Do you think you own your own medical data? Your hospital and doctor records, lab and radiology tests, genetic information, even the actual tissue removed during a biopsy or other surgical procedure? Well, you don’t.

It’s a good bet that the fine print of the consent form you signed before your latest test or operation said that all the data or tissue samples belong to the doctor or institution performing it. They can study it, sell it or do whatever they want with it, without notifying or compensating you, although the data must be depersonalized in their best effort to make sure you are anonymous.

November 27, 2018 9:15 am

Task Force Calls for Offering PrEP to All at High Risk for H.I.V. (The New York Times)

An influential government task force has drafted a recommendationthat would for the first time urge doctors to offer a daily prophylactic pill to patients who are at risk for contracting H.I.V. The recommendation would include all men and women whose sexual behavior, sex partners or drug use place them at high risk of contracting the virus that causes AIDS.

November 26, 2018 12:42 pm

Chinese researcher claims first gene-edited babies (AP News)

A Chinese researcher claims that he helped make the world’s first genetically edited babies — twin girls born this month whose DNA he said he altered with a powerful new tool capable of rewriting the very blueprint of life.

If true, it would be a profound leap of science and ethics.

A U.S. scientist said he took part in the work in China, but this kind of gene editing is banned in the United States because the DNA changes can pass to future generations and it risks harming other genes.

November 21, 2018 9:51 am

How Do Wishes Granted To Very Sick Kids Affect Their Health? (National Public Radio)

The children granted wishes were substantially less likely to visit the emergency department or to have an unplanned hospital admission within two years as compared with children who hadn’t received wishes. (Researchers matched the children’s personal and disease characteristics in the study.)

“My hypothesis is that these kids, when they come back, are more engaged with their families and medical providers, and perhaps they’re more adherent to their treatment plan,” says the study’s lead author Dr. Anup D. Patel, section chief of neurology at Nationwide Children’s Hospital and an associate professor of pediatrics at Ohio State University College of Medicine in Columbus.

November 15, 2018 9:00 am

What if the Placebo Effect Isn’t a Trick? (The New York Times)

But as ubiquitous as the phenomenon is, and as plentiful the studies that demonstrate it, the placebo effect has yet to become part of the doctor’s standard armamentarium — and not only because it has a reputation as “fake medicine” doled out by the unscrupulous to the credulous. It also has, so far, resisted a full understanding, its mechanisms shrouded in mystery. Without a clear knowledge of how it works, doctors can’t know when to deploy it, or how.

November 13, 2018 9:00 am

Genetics research 'biased towards studying white Europeans' (The Guardian)

People from minority ethnic backgrounds are set to lose out on medical benefits of genetics research due to an overwhelming bias towards studying white European populations, a leading scientist has warned.

Prof David Curtis, a geneticist and psychiatrist at University College London, has called on funding bodies to do more to address the emerging issue that genetic tests developed using samples from white Europeans can give meaningless results when applied to other ethnic groups. The problem could intensify as the clinical applications of genetics expand over the next decade.

November 9, 2018 1:00 pm

23andMe’s genetic test for how you’ll react to medication is ahead of its time (The Verge)

The doctor still isn’t supposed to suggest changing medication until they have you genetically tested again by an independent lab. “It seems to me that if a patient has an interest in their pharmacogenetic profile that could impact medication decisions, they’re probably better off just asking the physician about what testing can be done

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