Hot Topics: Clinical Trials & Studies

Blog Posts (48)

March 31, 2017

BioethicsTV: Aggressive Treatment Chosen for Patients at the End of Life

by Craig Klugman, Ph.D.

This week’s Thursday night medical TV was all about end of life decision-making and delved into the questions of how much aggressive treatment is too much, what happens when physicians lose clinical distance, and who makes decisions for patients.…

February 16, 2017

The 2017 Common Rule and the Clinical Ethics of Prolixity

by Steven H. Miles, MD

Bioethicist Steven Miles suggest that making the new Common Rules regulations easy to read is as important as the content

The new Common Rule to protect human subjects has an extraordinarily large and diverse audience.…

February 3, 2017

A Solution In Search of A Problem: Streamlining the FDA

by Craig Klugman, Ph.D.

A professional association for regulatory affairs posted an article on Wednesday reporting Trump’s comments “calling for a massive overhaul of US Food and Drug Administration (FDA) regulations.” Trump issued an executive that called for reducing the number of federal regulations (for each new one created, two must be retired).…

January 19, 2017

New Common Rule Regs Mean New Training for IRB Members

by Craig Klugman, Ph.D.

Yesterday, the Department of Health & Human Services released the long-awaited, and debated, new Common Rule.…

January 13, 2017

BioethicsTV: Violating confidentialty, ethical decision-making, unapproved human experimentation

by Craig Klugman, Ph.D.

Chicago Med (Season 2; Episode 10): In this episode a heart patient returns from a previous episode when a heart is found for a transplant.…

January 10, 2017

Be Wary What You Research: You Might Get Sued

by Craig M. Klugman, Ph.D.

Peter Cohen, Clayton Bloszies, Caleb Yee and Roy Gerona published an article in the journal Drug Testing and Analysis in April 2015 explaining the results of their testing of supplements.…

January 6, 2017

BioethicsTV (January 2-6, 2017): Violating promises, coma v. PVS, transplant evaluation, and whether to abort

by Craig Klugman, Ph.D.

Pure Genius (Season1; Episode 10- 1/5). In this episode, Dr. Channarayapatra is working with a patient in lung failure.…

November 9, 2016

Bioethics faces a rocky but navigable road

by Arthur Caplan, Ph.D.

Academic bioethics has never been popular with Republicans.  Libertarians dislike academic bioethics because it seems too elitist and anti-free market. …

November 9, 2016

President Trump & A Republican Congress: What Might It Mean?

by Craig Klugman, Ph.D.

In a 2000 episode of The Simpsons, a flash forward shows Lisa being elected the first heterosexual female U.S.…

October 28, 2016

BIOETHICS TV 10/27 – Modern miracles, body hacking, and sex trafficking

by Craig Klugman, Ph.D.

Pure Genius (Seasons 1, Episode 1)

This new TV show might be the ethicists worst nightmare. The show opens with Dr.…

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Published Articles (10)

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

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

Informed Consent and Standard of Care: What Must Be Disclosed Ruth Macklin & Lois Shepherd

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

What Should Be Disclosed to Research Participants? David Wendler

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

The SUPPORT Controversy and the Debate Over Research Within the Standard of Care David Magnus

News (132)

April 24, 2017 9:00 am

CRISPR studies muddy results of older gene research (Nature)

Scientists face tough decisions when the latest gene-editing findings don’t match up with the results of other techniques.

April 18, 2017 1:08 pm

Exercise is contagious, especially if you’re a man (Science)

They found that as people in cities with nice weather went for especially long runs, their friends in unaffected cities would extend their own runs, increasing their running distance and time and burning more calories. That suggests that at least some of that extra exercise is thanks to social influence, the researchers write today in Nature Communications. Men appeared more susceptible than women: They were strongly affected by male friends and moderately affected by female friends, whereas women were moderately affected by other women and unaffected by men.

April 11, 2017 9:00 am

Congress and FDA nominee heap love on ‘adaptive trials’ (Science)

This week, as President Donald Trump’s nominee to head FDA, Gottlieb sat before Republican lawmakers hungry for promises of “shorter time frames” for drug and device approvals, and again expressed his zeal—repeatedly—for adaptive trial designs. If confirmed to be FDA’s head, as expected, Gottlieb suggested he’d promote wider use of the approach.

March 23, 2017 9:00 am

San people of Africa draft code of ethics for researchers (Science)

The San people of Southern Africa are among the closest living relatives of our hunting and gathering ancestors. Scientists have flocked to study their age-old rituals and ancient genetic fingerprints. Now, after more than a century of being scrutinized by science, the San are demanding something back. Earlier this month the group unveiled a code of ethics for researchers wishing to study their culture, genes, or heritage.

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.

February 7, 2017 9:00 am

USDA blacks out animal welfare information (Science)

The U.S. Department of Agriculture (USDA) today removed public access to tens of thousands of reports that document the numbers of animals kept by research labs, companies, zoos, circuses, and animal transporters—and whether those animals are being treated humanely under the Animal Welfare Act. Henceforth, those wanting access to the information will need to file a Freedom of Information Act request.

January 31, 2017 9:00 am

Vaccine initiative marks bold resolution (Science)

Clearly, private companies cannot be expected to invest on their own. But it is incumbent on governments to invest, and thus address this market failure, in partnership with pharma. It is therefore encouraging that there is now a solid plan to do just that: the Coalition for Epidemic Preparedness Innovations (CEPI), launched on 18 January at the World Economic Forum in Davos, Switzerland, aims to develop and take through early clinical trials vaccines against potential threats. It already has enough cash to work on three — MERS, Nipah-virus infection and Lassa fever.

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.

January 13, 2017 9:00 am

Successful Ebola vaccine will be fast-tracked for use (BBC News)

Trials conducted in Guinea, one of the West African countries most affected by an outbreak of Ebola that ended this year, show it offers 100% protection. The vaccine is now being fast-tracked for regulatory approval.

December 8, 2016 9:00 am

Genetically Modified Pigs Could Ease Organ Shortage (The Wall Street Journal)

The goal is to create pig islets that the human immune system won’t recognize as foreign, so they can be transplanted into people.

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