Hot Topics: Research Ethics

Blog Posts (40)

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.…

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.…

February 18, 2015

Precision Medicine Has Imprecise Ethics

by Craig Klugman, Ph.D.

How do physicians diagnose disease? First they go through a set of symptoms and then compile a list of differential diagnoses or what the underlying disease may be.…

January 12, 2015

“Post Publication peer review: Promise or Chaos?” Revisited

<p style="line-height: 19.0400009155273px;"><span style="line-height: 19.0400009155273px;">Late in 2013 I posted an entry to <a href="/BioethicsBlog/post.cfm/post-publication-peer-review-promise-or-chaos">this blog</a> which described PubPeer, the newly implemented system for post publication peer review. </span><span style="line-height: 19.0400009155273px;">In that blog I raised the question whether this is a good idea compared to other opportunities for post publication commentary such as letters to the editor or even new publications which would either support or challenge previously published research. The system has been going for a bit over a year now and I thought it would be appropriate to revisit the question of promise or chaos.</span></p> <p class="MsoNormal" style="line-height: 19.0400009155273px;"><span style="line-height: 19.0400009155273px;">One of my principal concerns related to the ability of anyone who met the qualifications to comment to jump in and comment. The necessary qualifications are quite easy to meet and quite arbitrary. Anyone who has been funded to do research by the National Institutes of Health (US) or the Wellcome Trust (UK) is considered qualified. I have no idea why someone funded by the National Science Foundation (US) or the National Research Council (Canada) is not qualified.  </span></p> <p><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 19.0400009155273px;">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><span style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 19.0400009155273px;"> </span></p>

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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 (352)

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.

November 4, 2014 3:50 pm

Human-subjects research: The ethics squad

Bioethicists are setting up consultancies for research — but some scientists question whether they are needed.

November 3, 2014 3:43 pm

White House to Cut Funding for Risky Biological Study

Prompted by controversy over dangerous research and recent laboratory accidents, the White House announced Friday that it would temporarily halt all new funding for experiments that seek to study certain infectious agents by making them more dangerous.

November 3, 2014 3:27 pm

Does Your Average Scientist Need an Ethicist on Call?

Bioethicists are setting up consultancies for research — but some scientists question whether they are a necessity.

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