Hot Topics: Research Ethics

Blog Posts (50)

November 2, 2015

A Bioethicist on Mars

by Craig Klugman, Ph.D.

The film, The Martian, is an exciting Robinson Crusoe space adventure. Based on the book of the same name by Andrew Weir, the film stays fairly close to the original source.…

October 16, 2015

If I Were Running the Place

<p style="font-size: 11.2px; line-height: 19.04px;"><span style="font-size: 11.2px; line-height: 19.04px;">I have a riddle for you.  Start with six attorneys; add three management consultants, three financial executives/advisors and a couple of bankers. Sprinkle in, one each, clothing store chain CEO and entertainment retail chain CEO. Add executives from a supermarket chain, a construction company, and a paper products company. Fold in a hedge fund manager, real estate executive, and an accountant. Finish with a reputation management expert and exactly one educator and one physician. What have you got? Perhaps you have the membership of an exclusive club, perhaps a class reunion of an exclusive prep school. No not these.  I will not make you guess any more. What you have is the Board of Directors of a large academic medical center which includes a major teaching hospital and a medical school. This academic medical center educates medical students and physicians, graduate students in science and other health professions. This teaching hospital is a major health care provider in the state capital of a large northeastern state. The academic medical center is the leading biomedical research organization in the region.</span></p> <p style="font-size: 11.2px; line-height: 19.04px;">The Board of Directors is fully responsible for the governance of this large and complex organization. This organization has a mission to educate, to conduct biomedical research, and to provide patient care services. I was expecting to see that this list of directors would include expertise from renowned educators with national reputations. I was expecting to see a list containing outstanding biomedical researchers who discovered knowledge which made the world a better place. I was expecting leaders from the field of healthcare and medicine. But that is not what I found. I was surprised.</p> <p><span style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 19.04px;"><strong>The Alden March Bioethics Institute offers a Master of Science in Bioethics, a</strong> </span><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 19.04px;">Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our <a style="color: #000099; text-decoration: underline;" href="http://www.amc.edu/Academic/bioethics/index.cfm">website</a>.</strong></p>
October 12, 2015

Human Subjects Research “Vulnerability”

by J.S. Blumenthal-Barby, Ph.D., MA

Revisions are being suggested to the Federal Policy for the Protection of Human Subjects through the Notice of Proposed Rulemaking (NPRM).…

October 5, 2015

Your Biology is in My Technology

by Craig Klugman, Ph.D.

The PBS series Open Mind has been on television for nearly 60 years. The program “is a thoughtful excursion into the world of ideas.” The December 30 episode was an interview with Dr.

October 1, 2015

True Confessions: Keeping up with the literature

by Craig Klugman, Ph.D.

When I was a graduate student learning about the job of being an academic, my advisor gave me some good advice.…

September 10, 2015

Ashley Madison & Using Stolen Data

by Arthur L Caplan, PhD and Charles Seife, MS

This past August, the public was treated to gigabytes of data stolen from the Ashley Madison website, including detailed records on millions of people who had registered for their service.…

September 10, 2015

Don’t Miss this Opportunity to Shape Federal Policy!

by Ellen Fox, MD

Yesterday, the Federal Register published a long-awaited Notice of Proposed Rulemaking to “modernize, strengthen, and make more effective” the Federal Policy for the Protection of Human Subjects known as “the Common Rule.” The proposed changes are endorsed by 16 Federal agencies, plus several others that “intend to adopt the proposed rule” through a separate rulemaking.…

August 31, 2015

Hashtag Advocacy or Slacktivism: How Should We Evaluate the Impact of Social Media Campaigns for Public Health?

by Macey L. Henderson, J.D.

It takes more than a TV news story or a Twitter hashtag campaign to save lives.…

August 25, 2015

Reproducibility Project or Research Police?

<p style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;"><span style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;">One of the great things about scientific knowledge is that it is subject to confirmation or refutation by subsequent research. Science can be confirmed by other laboratories repeating the same studies and finding the same results. However this rarely occurs in the actual course of normally conducted science. In the course of doing science most scientists choose not to simply try to simply replicate the previous study. Rather they consider the findings in the previous study develop the next hypothesis and do a study to extend the findings. Now this seems to be changing.</span></p> <p style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;">In 2011 authors from Target Research, a component of Bayer Healthcare, published <a href="http://www.nature.com/nrd/journal/v10/n9/pdf/nrd3439-c1.pdf">correspondence in Nature</a> reported that surveys of their internal scientists found “that only in ~20–25% of the projects were the relevant published data completely in line with our in-house findings”. This figure has been widely quoted in the literature but has been transformed into only 20-25% of these research findings were reproducible. There are many problems with this statement and this argument. First it is predicated on the presumption that an appropriate standard for reproducibility is data being entirely “in line” with the work done by internal scientists at Bayer Healthcare. Moreover the studies at Bayer Healthcare, unlike the studies they sought to replicate, were not submitted to the scrutiny of external peer review. There is every reason to consider the possibilities that the fault lies with the replicating studies at Bayer or possibly they did not exactly replicate the studies. We are left to simply accept the word of Bayer without the normal standard of quality that derives from peer review.</p> <p style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;"><span style="color: #34405b; font-family: Arial, Helvetica, sans-serif; line-height: 19.0400009155273px; font-size: 12px;"><strong>The Alden March Bioethics Institute offers a Master of Science in Bioethics, a</strong> </span><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; line-height: 19.0400009155273px; font-size: 12px;">Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our <a style="color: #000099; text-decoration: underline;" href="http://www.amc.edu/Academic/bioethics/index.cfm">website</a>.</strong></p>
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.…

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Published Articles (169)

AJOB Primary Research: Volume 7 Issue 1 - Dec 2015

Adolescent research participants' descriptions of medical research Christine Grady, Isabella Nogues, Lori Wiener, Benjamin S. Wilfond MD & David Wendler

American Journal of Bioethics: Volume 15 Issue 12 - Dec 2015

Treading the Line Between Sensational and Groundbreaking Science Christopher Scott

American Journal of Bioethics: Volume 15 Issue 11 - Nov 2015

Young People's Experiences of Participation in Clinical Trials: Reasons for Taking Part Malou Luchtenberg, Els Maeckelberghe, Louise Locock, Lesley Powell & A.A. Eduard Verhagen

American Journal of Bioethics: Volume 15 Issue 10 - Oct 2015

Placebo Effects and Informed Consent Mark Alfano

American Journal of Bioethics: Volume 15 Issue 9 - Sep 2015

Broad Consent for Research With Biological Samples: Workshop Conclusions Christine Grady, Lisa Eckstein, Ben Berkman, Dan Brock, Robert Cook-Deegan, Stephanie M. Fullerton, Hank Greely, Mats G. Hansson, Sara Hull, Scott Kim, Bernie Lo, Rebecca Pentz, Laura Rodriguez, Carol Weil, Benjamin S. Wilfond & David Wendler

American Journal of Bioethics: Volume 15 Issue 9 - Sep 2015

Patient Perspectives on the Learning Health System: The Importance of Trust and Shared Decision Making Maureen Kelley, Cyan James, Stephanie Alessi Kraft, Diane Korngiebel, Isabelle Wijangco, Emily Rosenthal, Steven Joffe, Mildred K. Cho, Benjamin Wilfond & Sandra Soo-Jin Lee

American Journal of Bioethics: Volume 15 Issue 9 - Sep 2015

Prudentia Populo: Involving the Community in Biobank Governance Megan A. Allyse, Jennifer B. McCormick & Richard R. Sharp

American Journal of Bioethics: Volume 15 Issue 4 - Apr 2015

Examining the Ethics of Clinical Use of Unproven Interventions Outside of Clinical Trials During the Ebola Epidemic Seema K. Shah, David Wendler & Marion Danis

American Journal of Bioethics: Volume 15 Issue 4 - Apr 2015

Selecting the Right Tool For the Job Arthur L. Caplan, Carolyn Plunkett & Bruce Levin

American Journal of Bioethics: Volume 15 Issue 3 - Mar 2015

The Social Determinants of Health: Why Should We Care? Adina Preda & Kristin Voigt

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News (362)

January 16, 2016 6:21 pm

French Drug Trial Disaster Leaves One Brain Dead, Five Injured

One person has been left brain dead and five others are in serious condition after taking part in the clinical trial of an experimental painkiller made by Portuguese drug company Bial, the French Health Ministry said on Friday.

January 6, 2016 1:29 pm

ORI Names New Director

More than a year and a half after its last director resigned, the Department of Health and Human Service’s (HHS) Office of Research Integrity (ORI) is getting a new leader, according to The Report on Research Compliance, which broke the news last week (December 3).

December 7, 2015 12:51 pm

Zafgen halts obesity drug trial after second patient death

Zafgen Inc said the U.S. Food and Drug Administration was putting a late-stage study testing its experimental obesity drug on complete hold after a second patient died during the trial.

November 23, 2015 1:58 pm

Bioethics team creates online repository of advice on ethical research practices

Standardized ethics consultation templates will enable bioethicists to share best practices in a centralized, privacy-protected repository.

November 13, 2015 3:50 pm

Stanford scientists criticize NIH moratorium

A group of seven Stanford scientists spoke out last week against the National Institute of Health’s decision to suspend funding for a specific type of stem cell research. They argued that the moratorium will discourage work with tremendous potential to advance medicine.

November 12, 2015 3:51 pm

Coca-Cola Spends Millions Of Dollars Funding Research That—Surprise!—Says Soda Is Just Fine

Last week, the University of Colorado announced that it would return a $1 million gift from Coca-Cola—news that came after a New York Times article in August revealed that the soda company funded a group of scientists called the Global Energy Balance Network that downplayed the relationship between soda and obesity, emphasizing instead the importance of exercise.

October 19, 2015 4:14 pm

Patient dies during Zafgen's obesity drug trial

Zafgen Inc said a patient died during a late-stage trial testing the company’s drug to treat Prader-Willi syndrome, a rare genetic disorder that leads to obesity.

August 14, 2015 1:53 pm

Ben Carson Conducted Research on Fetal Tissue — And Defends It

The discovery of Carson’s past involvement in fetal tissue donation comes on the heels of a piece in the latest issue of the NEJM on the importance of fetal tissue research by R. Alta Charo, JD.

August 13, 2015 1:57 pm

Evolving Challenges and Research-Needs Concerning Ebola

Publication by Robert Klitzman, M.D., Pofessor of Psychiatry and Director of the Masters of Bioethics Program at Columbia University, New York, NY.

August 12, 2015 1:53 pm

Children and Clinical Research: Ethical Issues

The report contains a number of recommendations on how to increase the involvement of children in research.

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