Hot Topics: Research Ethics

Blog Posts (43)

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.…

July 27, 2015

Investigating Two Claims Against Planned Parenthood: Center of Medical Progress’s Secret Videos

by Craig Klugman, Ph.D.

Before you being reading, I have a disclaimer: Growing up, my mother worked for Planned Parenthood. As a nurse, she practiced in their clinics offering well women services, counseling, and contraception.…

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.…

June 3, 2015

Can Bioethics Panels Fix the Problems With the Availability of “Compassionate Use” Experimental Drugs?

<p class="MsoNoSpacing" style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;"><span style="line-height: 22.3999996185303px; font-size: 11.1999998092651px;">On May 7, 2015, <a href="http://www.med.nyu.edu/pophealth/faculty/caplaa01">The New York Times reported</a> that <a href="http://www.jnj.com">Johnson &amp; Johnson</a> (New Brunswick, New Jersey) </span><span style="line-height: 22.3999996185303px; font-size: 11.1999998092651px;">had asked Arthur Caplan, PhD, Professor of Bioethics at New York University School of Medicine </span><span style="line-height: 22.3999996185303px; font-size: 11.1999998092651px;">to create a new panel “that will <a href="http://www.nytimes.com/2015/05/07/business/company-creates-bioethics-panel-on-trial-drugs.html">make decisions about patients’ requests</a> for potentially lifesaving medicine, responding to an emotional debate over whether companies should allow desperately ill people to have access to the drugs before they are approved [by the FDA].” </span></p> <p class="MsoNormal" style="font-size: 11.1999998092651px; line-height: 22.3999996185303px;"><span style="font-size: 11.1999998092651px; line-height: 22.3999996185303px;">“</span><a style="font-size: 11.1999998092651px; line-height: 22.3999996185303px;" href="http://www.mayoclinic.org/healthy-lifestyle/consumer-health/expert-answers/compassionate-use/faq-20058036">Compassionate use</a><span style="font-size: 11.1999998092651px; line-height: 22.3999996185303px;">” experimental drugs have been available for some time. In the recent Ebola crisis, last year the FDA “allowed the makers of ZMapp, an experimental treatment, to be used on a handful of patients, but the company quickly exhausted its limited supply.” Of late, several states have enacted “</span><a style="font-size: 11.1999998092651px; line-height: 22.3999996185303px;" href="http://www.nytimes.com/2015/01/11/us/patients-seek-right-to-try-new-drugs.html">Right to Try</a><span style="font-size: 11.1999998092651px; line-height: 22.3999996185303px;">” statutes in an attempt to craft a legally-recognized right to early access to drugs still in clinical trials.</span></p> <p><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; line-height: 19.0400009155273px; font-size: 12px;">The Alden March Bioethics Institute offers a Master of Science in Bioethics, a 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="/Academic/bioethics/index.cfm">website</a>.</strong></p>
May 8, 2015

Cost of Compassionate Use is Simply Too High

by Craig Klugman, Ph.D.

Johnson & Johnson’s Janssen Pharmaceutical Company announced that it has contracted with New York University’s Division of Medical Ethics to assemble an external Compassionate-Use Advisory Committee (CompAC) to examine requests for investigational new drugs (INDs) outside of clinical trials.…

May 8, 2015

Use of Unproven Interventions is Never Obligatory

<p style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;"><span style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;">I recently read a paper written by my colleagues at Alden March Bioethics Institute entitled “</span><a style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;" href="/Academic/bioethics/documents/White%2C_Gelinas_%26_Shelton_New_Pub.pdf">In Particular Circumstances Attempting Unproven Interventions and Circumstances is Permissible and even Obligatory</a><span style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;">”. </span></p> <p class="MsoNormal" style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;"><span style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;">I do not entirely agree with my colleagues. I do not disagree that there are some very limited circumstances in which unproven interventions are warranted nearly all of which are in the research or compassionate use context. The recent Ebola crisis is an example of that where the use of monoclonal antibodies against the Ebola virus was consistent with theory and prior scientific precedent. However we must balance that against the harm done. The consumption of available ZMapp antibody in compassionate use likely precluded the opportunity to conduct clinical trials in a timely manner to determine if it actually did provide any benefit. Had it been used to prove efficacy it could have justified the investment necessary to prepare it large quantity and let future physicians and patients make informed decisions on its use. Moreover the manner in which the compassionate use was implemented, nearly exclusively available to US and European health care workers and barely any availability to Africans could hardly be considered just. During the next Ebola outbreak we may be faced with the same circumstances because we still do not really know its efficacy. There is now enough ZMaap available to conduct trials and these have been initiated but there may not be enough patients available to conduct them.</span></p> <p class="MsoNormal" style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;"><strong style="line-height: 19.0400009155273px; color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px;">The Alden March Bioethics Institute offers a Master of Science in Bioethics, a 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="text-decoration: underline; color: #000099;" href="/Academic/bioethics/index.cfm">website</a>.</strong><span style="line-height: 19.0400009155273px; color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px;"> </span><span style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;"> </span></p>
April 23, 2015

Designer Embryos: The Future is Now

by Craig Klugman, Ph.D.

Oh, wonder!
How many goodly creatures are there here!
How beauteous mankind is! O brave new world,
That has such people in ’t!

April 15, 2015

Are religious research subjects a vulnerable population?

by Craig Klugman, Ph.D.

A recent study in the journal Psychology Science found that when people are thinking about God, they are more likely to state a willingness to participate in nonmoral,° risky behaviors such as skydiving, substance abuse, and speeding.…

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Published Articles (162)

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

American Journal of Bioethics: Volume 14 Issue 12 - Dec 2014

Shared Vulnerabilities in Research Eric Chwang

American Journal of Bioethics: Volume 11 Issue 11 - Nov 2011

“You Don't Know Me, But …”: Access to Patient Data and Subject Recruitment in Human Subjects Research Toby Schonfeld, Joseph S. Brown, N. Jean Amoura & Bruce Gordon

American Journal of Bioethics: Volume 14 Issue 11 - Nov 2014

Ethical Justifications for Access to Unapproved Medical Interventions: An Argument for (Limited) Patient Obligations Mary Jean Walker, Wendy A. Rogers & Vikki Entwistle

American Journal of Bioethics: Volume 14 Issue 11 - Nov 2014

Compassion and Research in Compassionate Use David Magnus

American Journal of Bioethics: Volume 14 Issue 10 - Oct 2014

Case Study: Ethical Implications of Social Media in Health Care Research Holly A. Taylor, Ellen Kuwana & Benjamin S. Wilfond

American Journal of Bioethics: Volume 14 Issue 10 - Oct 2014

Case Study Introduction: Challenging Cases in Research Ethics

American Journal of Bioethics: Volume 14 Issue 9 - Sep 2014

On the Minimal Risk Threshold in Research With Children Ariella Binik

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News (355)

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.

July 17, 2015 7:53 pm

Video of Planned Parenthood executive discussing tissue, organ prices sparks abortion firestorm

Last summer, a Planned Parenthood executive dined with representatives of a biomedical company eager to learn how the organization gets fetal tissues and organs to researchers.

April 30, 2015 6:31 pm

Withholding results from clinical trials is unethical, says WHO

The movement to ensure that clinical trial results don’t end up in drawers has found an important global ally. Today, the World Health Organization (WHO) issued a call to make results from every clinical study publicly available within a year. Not doing so can harm patients and research subjects, waste time and money, and hold back medical science, WHO says.

March 30, 2015 6:57 pm

Grants help level the playing field for young moms in science

Thanks to a generous benefactor, young mothers doing laboratory research at the Massachusetts General Hospital in Boston can receive major grants to keep them from falling behind while they raise their children.

March 18, 2015 1:49 pm

Build it (an easy way to join research studies) and the volunteers will come

Just nine days after the launch of Stanford Medicine’s MyHeart Counts iPhone app, 27,836 people have consented to participate in this research study on cardiovascular health.
March 9, 2015 6:26 pm

Apple's ResearchKit to give scientists ready access to study subjects

Apple Inc on Monday released ResearchKit, an open-source software tool designed to give scientists a new way to gather information on patients by using their iPhones.

February 2, 2015 2:49 pm

The new scientific revolution: Reproducibility at last

Diederik Stapel, a professor of social psychology in the Netherlands, had been a rock-star scientist — regularly appearing on television and publishing in top journals. Among his striking discoveries was that people exposed to litter and abandoned objects are more likely to be bigoted.

November 19, 2014 4:35 pm

http://www.reuters.com/article/2014/11/19/us-health-trials-idUSKCN0J320C20141119

U.S. health officials on Wednesday proposed significantly expanding what researchers are required to report about clinical trials of drugs, devices, and other interventions, addressing concerns that data crucial to patients and physicians is kept secret.

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