Hot Topics: Human Subjects Research & IRBs

Blog Posts (35)

November 27, 2018

Birth of Twins from Embryo Editing Raise Ethical, Legal, and Social Issues

Updated November 28 at 8:30am EST

by Craig Klugman, Ph.D.

The film GATTACA turned 20 years old this year. The premise of that film is a society where DNA is viewed as predictive of everything: Your intelligence, physical abilities, your health, even how long you will live.…

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 26, 2018

War Against Science 3.0: The EPA, Doublespeak, and Obfuscation

by Craig Klugman, Ph.D.

Transparency is a good thing. In ethics courses, we teach that doctors should be transparent to their patients, being truthful and disclosing information.…

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.…

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Published Articles (38)

AJOB Primary Research: Volume 9 Issue 3 - Nov 2018

Reliance agreements and single IRB review of multisite research: Concerns of IRB members and staff Charles W. Lidz, Ekaterina Pivovarova, Paul Appelbaum, Deborah F. Stiles, Alexandra Murray & Robert L. Klitzman

AJOB Primary Research: Volume 9 Issue 3 - Nov 2018

Data and tissue research without patient consent: A qualitative study of the views of research ethics committees in New Zealand Angela Ballantyne & Andrew Moore

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

AJOB Primary Research: Volume 9 Issue 2 - Jun 2018

Patient perspectives on compensation for biospecimen donation Samuel C. Allen, Minisha Lohani, Kristopher A. Hendershot, Travis R. Deal, Taylor White, Margie D. Dixon & Rebecca D. Pentz

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

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News (210)

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 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 3, 2018 9:00 am

APPLE'S HEART STUDY IS THE BIGGEST EVER, BUT WITH A CATCH (Wired)

Here’s the thing: Even if the Apple Watch excels at detecting undiagnosed AF (a big if), using it to screen large numbers of asymptomatic people isn’t necessarily a good idea.

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.

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