Hot Topics: Human Subjects Research & IRBs

Blog Posts (29)

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.…

November 21, 2017

Attica Leprosy Study: Ethical Issues In What Little We Know

by Craig Klugman, Ph.D.

We are indebted to the inmates of the Attica Correctional Facility who participated in this study and to the warden and his administration for their help and co-operation.…

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.…

July 6, 2017

Rethinking the Belmont Report?

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.…

July 5, 2017

The Belmont Report: First Word or Last Word on the Foundations of Research Ethics?

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.…

July 3, 2017

Tune Ups to Belmont & Common Rule Need to Consider Community-Engaged Research

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 (34)

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

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

Beyond Consent: Building Trusting Relationships With Diverse Populations in Precision Medicine Research Stephanie A. Kraft, Mildred K. Cho, Katherine Gillespie, Meghan Halley, Nina Varsava, Kelly E. Ormond, Harold S. Luft, Benjamin S. Wilfond & Sandra Soo-Jin Lee

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

Building a Trustworthy Precision Health Research Enterprise David Magnus & Jason N. Batten

AJOB Primary Research: Volume 8 Issue 1 - Mar 2018

Understanding variations in secondary findings reporting practices across U.S. genome sequencing laboratories Sara L. Ackerman PhD, MPH & Barbara A. Koenig

AJOB Primary Research: Volume 8 Issue 1 - Mar 2018

A paradigm for understanding trust and mistrust in medical research: The Community VOICES study M. Smirnoff, I. Wilets, D. F. Ragin, R. Adams, J. Holohan, R. Rhodes, G. Winkel, E. M. Ricci, C. Clesca & L. D. Richardson

AJOB Primary Research: Volume 8 Issue 1 - Mar 2018

Would you be willing to zap your child's brain? Public perspectives on parental responsibilities and the ethics of enhancing children with transcranial direct current stimulation Katy Wagner, Hannah Maslen, Justin Oakley & Julian Savulescu

AJOB Primary Research: Volume 8 Issue 1 - Mar 2018

Children's perspectives on the benefits and burdens of research participation Claudia Barned, Jennifer Dobson, Alain Stintzi, David Mack & Kieran C. O'Doherty

American Journal of Bioethics: Volume 18 Issue 1 - Jan 2018

The Emergence of Clinical Research Ethics Consultation: Insights From a National Collaborative Kathryn M. Porter, Marion Danis, Holly A. Taylor, Mildred K. Cho, Benjamin S. Wilfond & on behalf of the Clinical Research Ethics Consultation Collaborative Repository Group

American Journal of Bioethics: Volume 17 Issue 12 - Dec 2017

Our Life Depends on This Drug: Competence, Inequity, and Voluntary Consent in Clinical Trials on Supervised Injectable Opioid Assisted Treatment Daniel Steel, Kirsten Marchand & Eugenia Oviedo-Joekes

AJOB Primary Research: Volume 8 Issue 4 - Dec 2017

Views of clinical trial participants on the readability and their understanding of informed consent documents Rita Somers, Cornelius Van Staden & Francois Steffens

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News (207)

May 1, 2017 9:00 am

Human vaccine data release jump-starts biotech’s bid for RNA drugs (Science)

The executive team at Moderna raised a cheer today after publishing their first early snapshot of human efficacy data that demonstrate their messenger RNA tech works — at least on the first try. The biotech tested their H10N8 flu vaccine on a small group of 31 subjects, looking at their response in two different measures. All demonstrated a sufficient immune response to fight off the virus in the first measure, and all but 3 in the second, for a total of 23 who received the vaccine.  None of the 8 subjects who received a placebo responded.

February 22, 2017 6:00 am

Artificial intelligence grows a nose (Science)

Now, 22 teams of computer scientists have unveiled a set of algorithms able to predict the odor of different molecules based on their chemical structure. It remains to be seen how broadly useful such programs will be, but one hope is that such algorithms may help fragrancemakers and food producers design new odorants with precisely tailored scents.

January 20, 2017 9:00 am

New Common Rule on the Federal Policy for the Protection of Human Subjects (Federal Register)

The departments and agencies listed in this document announce revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.

October 7, 2016 8:00 am

This 8-year-old is free of cancer — for now — after a ‘breakthrough’ treatment (Washington Post)

By the time 8-year-old Ava Christianson got to the National Institutes of Health this summer, she had lost several grueling rounds to leukemia and was bracing for the next one.

July 28, 2016 8:17 am

Europe overhauls rules for ‘first-in-human’ trials in wake of French disaster (Science)

The European Union is beefing up protections for volunteers in phase I clinical trials in the wake of a disastrous clinical study in Rennes, France, that resulted in the death of one volunteer and the hospitalization of five others. On 21 July, the European Medicines Agency (EMA) in London announced in a “concept paper” that it wants to improve strategies to identify and reduce risks in “first-in-human” (FIH) studies on healthy volunteers. EMA is asking for input from stakeholders.

July 8, 2016 8:51 am

President Obama’s 1-million-person health study kicks off with five recruitment centers (Science)

President Barack Obama’s ambitious 1-million-person personalized medicine study began to take shape this week with the announcement of four medical centers that will recruit volunteers starting this fall. A fifth center aims to sign up 350,000 participants by blasting the general public with ads coming soon to your web browser or mobile phone.

June 24, 2016 8:00 am

First CRISPR Human Clinical Trial Gets a Green Light from the U.S. (Scientific American)

CRISPR, the genome-editing technology that has taken biomedical science by storm, is finally nearing human trials.

May 25, 2016 9:47 am

Despite Pressing Need, Survey Finds Most Americans Unlikely to Enroll in Clinical Trials (Memorial Sloan Kettering Cancer Center)

The lack of participation in clinical research may be the Achilles’ heel of today’s cancer community. According to a new survey of more than 1,500 consumers and nearly 600 physicians conducted on behalf of Memorial Sloan Kettering Cancer Center (MSK), only 35 percent of Americans indicated that they were “likely” to enroll in a clinical trial. Other studies have shown that only 4 percent of cancer patients enroll in clinical trials nationally each year.

May 12, 2016 8:14 am

For cholesterol study volunteer, an unsettling discovery in a Science paper: herself (Science)

When I first meet Rita Woidislawsky at La Colombe, her favorite coffee shop steps from Philadelphia, Pennsylvania’s upscale Rittenhouse Square, she’s effusive and bracingly direct—hugging patrons she knows, waving to baristas, and quickly finding the one table that’s about to free up. She’s dressed in workout clothes and delights in looking younger than her 68 years, with curly hair and an Israeli accent that’s lingered since she emigrated in her late teens.

July 10, 2014 4:02 pm

Did Facebook and PNAS violate human research protections in an unethical experiment?

Whatever good and bad things about Facebook there are, however, there’s one thing that I never expected the company to be engaging in, and that’s unethical human subjects research.

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