Hot Topics: Human Subjects Research & IRBs

Blog Posts (10)

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

AIN’T JUST THE MEAT IT IS ALSO THE MOTION: CONSENT MATTERS!

“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.…

July 1, 2014

Enter the Corporate Congress: SCOTUS & FACEBOOK

by Craig Klugman, Ph.D.

PART 1: SCOTUS
One of the facts that hiring managers are taught is that you can never ask a potential employee about their religion (among other protected areas) unless the candidate brings it up.…

May 9, 2014

Why vampires stay young

by Craig Klugman, Ph.D.

In the world of fantasy, the vampire is known for its immortality. In most incarnations, the vampire lives forever in a youthful state by feeding on the blood of humans.…

November 15, 2013

Does Execution by Lethal Injection Violate the Ethics of Human Research?

by Arthur L. Caplan, PhD

The Governor of Ohio has been wrestling with the question of whether a prisoner soon to be executed can donate his organs. …

Published Articles (11)

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

AJOB Primary Research: Volume 7 Issue 2 - May 2016

Patients' views concerning research on medical practices: Implications for consent Kevin P. Weinfurt, Juli M. Bollinger, Kathleen M. Brelsford, Travis J. Crayton, Rachel J. Topazian, Nancy E. Kass, Laura M. Beskow & Jeremy Sugarman

American Journal of Bioethics: Volume 14 Issue 5 - May 2014

Fostering IRB Collaboration for Review of International Research Francis Barchi, Megan Kasimatis Singleton & Jon F. Merz

AJOB Primary Research: Volume 4 Issue 2 - Apr 2013

Views of IRBs Concerning Their Local Ecologies: Perceptions of Relationships, Systems, and Tensions Between IRBs and Their Institutions Robert Klitzman

News (200)

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.

March 20, 2013 5:51 pm

Stanford bioethicist speaks out about layers of stem cell regulations

Stanford bioethicist Hank Greely, JD, spoke out in an article in Nature exploring whether all these layers of approval are really still necessary.

March 7, 2013 12:19 pm

Time to ditch stand-alone stem cell oversight panels, experts say (Nature Medicine)

The vital role ESCROs have played in recent years can now be taken over by IRBs and IACUCs—both of which have existed at universities and research institutions for decades. Those two review bodies would only have to expand their remits slightly to cover hESC-specific considerations.

April 10, 2012 12:18 pm

'Benefits and burdens' of participating in clinical research trials (News-Medical)

In one of the first studies of its kind, University of Pennsylvania School of Nursing researchers have identified what cancer patients consider the “benefits and burdens” of participating in clinical research trials. From their findings, the researchers developed a model of the five elements of decision-making (physical, psychological, economic, familial, and social) that patients with cancer use to determine whether to participate or remain in a clinical trial.

January 18, 2012 12:00 am

Fines expose failings in policing of Indian drug trials

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