Hot Topics: Human Subjects Research & IRBs

Blog Posts (13)

September 30, 2016

BioethicsTV: Community Research Consent and Competing for an Infant Heart

by Craig Klugman, Ph.D.

In the fall premiere of Code Black, military trauma surgeons are visiting the hospital on an annual pilgrimage to share what they have learned treating battlefield injuries.…

September 26, 2016

Response to “Do the EPA Studies Violate Do No Harm & Informed Consent”

by Nancy King, JD

I have just read your August 25 post on the EPA studies. While, I do not know that much about these particular exposure studies, I do know that EPA is taking the inquiry very seriously.…

August 25, 2016

Do the EPA Exposure Studies Violate Do No Harm and Informed Consent?

by Craig Klugman, Ph.D

A government agency recruits elderly and sick patients for an important research study. In a controlled environment, subjects are exposed to airborne pollutants at levels many times higher than found in the real world.…

May 5, 2016

“And Death Shall Be No More”

by Craig Klugman, Ph.D.

Two years after John Donne’s death, the Holy Sonnets were published. In Sonnet 10, Donne speaks about the end of death: “Death, thou shalt die.” Although a metaphorical conceit referring to eternal life in heaven, the poem takes on new meaning in the age of regenerative medicine.…

April 7, 2016

BioethicsTV: “Heartbeat” tackles therapeutic misconception

by Craig Klugman, Ph.D.

On episode 4 of Heartbeat, the heroine, Dr. Panttiere has received hospital funding to try an experimental cancer treatment on 5 patients.…

August 4, 2015

The Stanford Prison Experiment film: An Essential Teaching Tool

By Craig Klugman, Ph.D.

In teaching research ethics, there are a few “classic cases” that we offer students as examples of where human subject research went wrong: Tuskegee Study of Untreated Syphilis, the Nazi medical experiments, Willowbrook Hepatitis Experiments, human radiation experiments, and (now) the Guatemala syphilis study, among others.…

July 16, 2015

On the Origins of Research Ethics: China and the West

by Craig Klugman, Ph.D

When I was a graduate student, I was fortunate to be one of five students chosen by the China Medical Board to attend an international bioethics conference between the U.S.…

March 26, 2015

Research 2.0: Rise of the Citizen-Scientist and the Death of Privacy

by Craig Klugman, Ph.D.

On Monday I attended a symposium on inter-professional education. During a session on new technologies in medicine (telemedicine, wearables, and mobile devices) I brought up the question of preserving privacy.…

August 1, 2014

Day or Night: Ethics Depends on Time

by Craig Klugman, Ph.D.

Is that shirt the cashier forget to ring up a bonus or do you point out the oversight?…

July 29, 2014


“But look, you found the notice, didn’t you?”

“Yes,” said Arthur. “yes I did. It was on display in the bottom of a locked filing cabinet stuck in a disused lavatory with a sign on the door saying ‘Beware of the Leopard.'”

                           –Douglas Adams, The Hitchhiker’s Guide to the Galaxy

Any apologia for Facebook’s recent behavioral study has to address one issue head on: that of informed consent.…

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Published Articles (14)

AJOB Primary Research: Volume 7 Issue 3 - Jul 2016

Ethical challenges in designing and implementing health systems research: Experiences from the field Adnan Hyder & Carleigh Krubiner

AJOB Primary Research: Volume 7 Issue 3 - Jul 2016

Does promoting research advance planning in a general elderly population enhance completion of a research directive and proxies' predictive ability? a randomized controlled trial Gina Bravo, Lise Trottier, Marie-France Dubois, Marcel Arcand, Danièle Blanchette, Anne-Marie Boire-Lavigne, Maryse Guay, Paule Hottin, Julie Lane, Suzanne Bellemare & Karen Painter

American Journal of Bioethics: Volume 16 Issue 8 - Aug 2016

IRB and Research Regulatory Delays Within the Military Health System: Do They Really Matter? And If So, Why and for Whom? Michael C. Freed, Laura A. Novak, William D. S. Killgore, Sheila A. M. Rauch, Tracey P. Koehlmoos, J. P. Ginsberg, Janice L. Krupnick, Albert "Skip" Rizzo, Anne Andrews & Charles C. Engel

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

AJOB Primary Research: Volume 7 Issue 2 - May 2016

Ethics of research in usual care settings: Data on point Jeremy Sugarman

AJOB Primary Research: Volume 7 Issue 2 - May 2016

Adrift in the gray zone: IRB perspectives on research in the learning health system Sandra Soo-Jin Lee, Maureen Kelley, Mildred K. Cho, Stephanie Alessi Kraft, Cyan James, Melissa Constantine, Adrienne N. Meyer, Douglas Diekema, Alexander M. Capron, Benjamin S. Wilfond & David Magnus

AJOB Primary Research: Volume 7 Issue 2 - May 2016

The patient's perspective on the need for informed consent for minimal risk studies: Development of a survey-based measure Sherrie H. Kaplan, Adrijana Gombosev, Sheila Fireman, James Sabin, Lauren Heim, Lauren Shimelman, Rebecca Kaganov, Kathryn E. Osann, Thomas Tjoa & Susan S. Huang

AJOB Primary Research: Volume 7 Issue 2 - May 2016

Patient and physician views about protocolized dialysis treatment in randomized trials and clinical care Ashley Kraybill, Laura M. Dember, Steven Joffe, Jason Karlawish, Susan S. Ellenberg, Vanessa Madden & Scott D. Halpern

AJOB Primary Research: Volume 7 Issue 2 - May 2016

Alternative consent models for comparative effectiveness studies: Views of patients from two institutions Nancy Kass, Ruth Faden, Rachel E. Fabi, Stephanie Morain, Kristina Hallez, Danielle Whicher, Sean Tunis, Rachael Moloney, Donna Messner & James Pitcavage

News (204)

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.

April 2, 2014 2:17 pm

Guidance published on informing study participants about findings with potential health implications

In the course of a study involving human participants, it is possible that researchers may make a finding that has potential health or reproductive implications for an individual participant.

March 3, 2014 4:08 pm

Women Still Left Out of Medical Research: Report

Two decades after the passage of a landmark law mandating that women be represented in government-funded medical research, a new report reveals that the world of science is still ignoring women’s unique health issues far more than it should.

August 26, 2013 12:56 pm

Reporting to NIH on Race and Ethnicity of Clinical Research Participants

The inclusion of women, different racial and ethnic groups, and children is extremely important in clinical research to understand who is affected by a given disease or condition and to develop the appropriate treatments.

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