Hot Topics: Research Ethics

Blog Posts (35)

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>
November 26, 2014

Scientific Research: Critiquing the Critics

<p class="MsoNormal" style="line-height: 19.0400009155273px;"><span style="line-height: 19.0400009155273px;">When I was a young scientist (quite some time ago) there was a joke that seemed to be circulating about how our older established colleagues conducted science. This was a somewhat cynical exercise motivated, at least in part, by professional jealousy. The joke went on to say that one could establish a fact by writing two papers. In the first paper the author speculates that something might be true. In the second paper the author says that the previously speculated thing is true, and references the paper containing the original speculation. In fact I have rarely seen this actually done. But as I write blog I have <a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001747">an example</a> sitting in front of me on my desk.</span><span style="line-height: 19.0400009155273px;"> It is especially intriguing that this paper was written by an individual who maintains that “<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.0020124">most published research findings are false</a>”.</span></p> <p class="MsoNormal" style="line-height: 19.0400009155273px;">The paper in question was published just last month with the rather presumptuous title: “How to make more published research true”.  This, of course, is a statement predicated on the presumption that much published research is false. Indeed the author says in the <a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.0020124">first paragraph</a>, referring to scientific research, that “Many new proposed associations and/or effects are false or grossly exaggerated” and <a href="http://ovidsp.tx.ovid.com/sp-3.13.1a/ovidweb.cgi?WebLinkFrameset=1&amp;S=AHIBFPDHNADDAJGMNCLKIFOBKEKBAA00&amp;returnUrl=ovidweb.cgi%3f%26TOC%3dS.sh.22.23.27.31%257c2%257c50%26FORMAT%3dtoc%26FIELDS%3dTOC%26S%3dAHIBFPDHNADDAJGMNCLKIFOBKEKBAA00&amp;directlink=http%3a%2f%2fgraphics.tx.ovid.com%2fovftpdfs%2fFPDDNCOBIFGMNA00%2ffs047%2fovft%2flive%2fgv024%2f00001648%2f00001648-200809000-00002.pdf&amp;filename=Why+Most+Discovered+True+Associations+Are+Inflated.&amp;PDFIdLinkField=%2ffs047%2fovft%2flive%2fgv024%2f00001648%2f00001648-200809000-00002&amp;link_from=S.sh.22.23.27.31%7c2&amp;pdf_key=B&amp;pdf_index=S.sh.22.23.27.31&amp;D=ovft">refers to</a> two previously published papers both single author papers by him.</p> <p class="MsoNormal" style="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="http://www.amc.edu/Academic/bioethics/index.cfm">website</a>.</strong></p>
November 2, 2014

Is it Ethical to give Ebola-Sufferers a Placebo?

<p style="line-height: 19.0400009155273px;"><span style="line-height: 19.0400009155273px;">Recently prominent bioethicists have voiced disagreement over whether it could be ethical to test experimental Ebola vaccines in placebo-controlled randomized trials.  Such trials would involve taking a group of people currently infected with Ebola and randomizing half of them to an arm that receives the experimental vaccine (plus, let us assume, the best current standard of care for Ebola), and the other half of them to an arm that receives a placebo instead of the vaccine (plus the same standard of care).  </span></p> <p style="line-height: 19.0400009155273px;">The main worry with these trials is that it is unethical to give Ebola-sufferers a placebo when an experimental vaccine is available that holds the prospect of benefit. (The prospect of benefit is typically inferred from success in trials with animals; at least one experimental vaccine, ZMapp, has showed <a href="http://www.nature.com/nature/journal/vnfv/ncurrent/abs/nature13777.html">notable efficacy</a> at preventing deadly disease in macaque monkeys inoculated with a virulent strain of Ebola.)  As a prominent group of bioethicists <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)61734-7/fulltext">recently pointed out</a>, conventional care for Ebola “does not much affect clinical outcomes,” resulting in a mortality rate as high as 70%.  “When conventional care means such a high probability of death,” they continue, “it is problematic to insist on randomizing patients to [a placebo arm] when the intervention arm holds out at least the possibility of benefit.”  Moreover, they insist, “none of us would consent to be randomized in such circumstances.” </p> <p style="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="http://www.amc.edu/Academic/bioethics/index.cfm">website</a>.</strong></p>
August 8, 2014

Ebola Outbreak Highlights Questions about Experimental Drug Treatment

<p class="MsoNormal">Questions regarding the availability and utilization of experimental drugs for treatment of disease have moved to the forefront following the apparently successful use of an <a href="http://www.cnn.com/2014/08/04/health/experimental-ebola-serum/index.html?hpt=hp_t1">experimental treatment</a> used for two American health workers treating the Ebola outbreak in West Africa. </p> <p class="MsoNormal">The questions that have been raised include both who such drugs should be made available to and under what circumstances they should be made available. An additional consideration is what processes should be put into place to assure that these decisions are made properly to allow patients with valid cases to obtain access while protecting ill people from inappropriate risks and suffering. An additional question which I will not delve into here is who pays for them. Health insurance does not pay for experimental treatments so someone else must. First I should clarify exactly what I mean by an experimental drug. I am referring to drugs that have a scientific rationale for their use and some scientific basis for believing they might work. I do not include cockamamie ideas with no reasonable basis simply because somebody thinks they should be used. I have <a href="/BioethicsBlog/post.cfm/hubris-and-biomedical-research ">previously written</a> about physicians who chose to use unreasonable treatments.</p> <p class="MsoNormal"><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 20px;">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> </p>
August 7, 2014

The Ethics of Ebola and Scarce and Experimental Drugs

by: J.S. Blumenthal-Barby

Yesterday I was contacted by the L.A. Times to answer a simple question: Should we give people access to the experimental Ebola drug, ZMapp?…

August 4, 2014

Do OkCupid and Facebook experiment on vulnerable populations?

by Keisha Ray, Ph.D.

A few months ago Facebook announced that some Facebook users were a part of a 2012 experiment.…

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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 (350)

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.

October 28, 2014 1:43 pm

The Ethics of Experimenting on Yourself

Ethicists have long worried about protecting patients from the researchers who experiment on them. But today, with more patients contributing to experiments and sometimes running their own—in what’s known as citizen science—ethicists are asking: Do patients need to be protected from themselves?

September 30, 2014 2:27 pm

Videos explain concepts of clinical research

When a doctor asks a patient if he or she would like to be randomized into an arm of a standard-of-care treatment study, does the patient really understand the question?

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