Hot Topics: Research Ethics

Blog Posts (30)

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.…

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.…

June 18, 2014

Relevance of Case-Based Studies in Workshops on RCR for Diverse Audiences (Part I)

<p class="MsoNoSpacing">By sharing a recent experience in which I delivered a lecture and case at a responsible conduct of research (RCR) workshop for biomedical science trainees, I will comment on why I believe that pedagogy on the RCR, specifically for biomedical scientists, needs two essential ingredients: delivering knowledge/information and providing case-based learning. The art is to determine how much of each element is needed and how to most effectively deliver information on an RCR topic and ensure trainees get the most from the ethical analysis of cases.</p> <p class="MsoNoSpacing"><strong>Ethics Workshop: Responsible Research Conduct &amp; Misconduct in Stem Cell Research</strong></p> <p class="MsoNoSpacing">As part of Canada’s Stem Cell Network at <a href="http://www.stemcellnetwork.ca/">http://www.stemcellnetwork.ca</a>, I had the unique opportunity to organize and present an Ethics Workshop as part of the Network’s annual Till &amp; McCulloch Meetings in October 2013. The workshop was a lecture followed by an interactive ethical case using “The Lab: Avoiding Research Misconduct” video hosted by the Office of Research Integrity (ORI) at<a href="https://ori.hhs.gov/thelab">https://ori.hhs.gov/thelab</a>. The 50 to 60 workshop attendees were primarily master’s, doctoral, and post-doctoral trainees, and almost all were biomedical researchers working with stem cells. Most attendees had never heard of RCR. Thus, the goals of the workshop were modest and involved introducing attendees to the following: RCR, research misconduct (fabrication, falsification, and plagiarism), the RCR link to scientific retractions, issues of authorship and publication ethics, and Canada’s RCR framework.</p> <p class="MsoNoSpacing"><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>
June 16, 2014

Killing a Patient to Save Whose Life?

A New York Times article a few weeks ago highlighted a clinical trial that just started in Pittsburgh. The provocative title “Killing a Patient to Save His Life” summarizes the technique that will be used on patients who present in cardiac arrest from a penetrating injury (e.g. gunshot or stab wound.) It involves replacing blood with cold saline to induce hypothermia and decrease the body’s... // Read More »
June 2, 2014

When the Biased Look at the World they see Bias

<p>The essence of responsible conduct of research is to assure that science concerns itself with the identification and clarification of objective truth.  I have spent some time this past week trying to read a recent study by Fanelli and Ioannidis entitled “<a href="http://www.pnas.org/content/110/37/15031.full">US studies may overestimate effect sizes in softer research</a>” published in the <em>Proceedings of the National Academy of Science</em>. </p> <p> This is a statistical paper, written densely, but still mostly understandable even to a mere scientist such as myself. Many of you have probably heard of John Ioannidis. He has gained prominence by doing theoretical analysis of the studies of others and using his results to conclude that most biomedical research is wrong or at least biased. I may be wrong, or at least biased, but I have come to believe upon reading this work that Dr. Ioannidis is wrong and maybe biased as well.</p> <p><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="http://www.amc.edu/Academic/bioethics/index.cfm">website</a></strong></p>
June 2, 2014

International Research Ethics

More and more research funded by high-income countries (HICs, e.g. the US) is taking place in low- and middle-income countries (LMICs). For example, colleagues at my institution have received grants of over $64 million to do research in Ghana. A search of ClinicalTrials.gov shows that 20 of 29 open studies in Ghana involve women, children, and persons with HIV—all considered vulnerable populations. The obvious concern... // Read More »

View More Blog Entries

Published Articles (159)

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

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

Making Sense of the Undue Burden Interpretation of Minimal Risk David B. Resnik

American Journal of Bioethics: Volume 14 Issue 8 - Aug 2014

AJOB 2.0: Taking Bioethics to a New Level David Magnus, Kayhan Parsi & Richard Sharp

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

View More Articles

News (346)

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?

September 23, 2014 1:54 pm

U.S. agency moves to end sex bias in biomedical research

The U.S. National Institutes of Health began putting in place on Tuesday its new policy aimed at ending long-standing sex bias in biomedical research favoring male lab animals and cells in the pivotal studies that are done before human clinical trials.

September 10, 2014 2:49 pm

NIH issues finalized policy on genomic data sharing

The National Institutes of Health has issued a final NIH Genomic Data Sharing (GDS) policy to promote data sharing as a way to speed the translation of data into knowledge, products and procedures that improve health while protecting the privacy of research participants.

August 12, 2014 1:58 pm

Japan scientist in discredited stem-cell research dead in suicide

A Japanese researcher at the center of discredited research that was initially hailed as a potential breakthrough for stem-cell treatment, killed himself after months of stress and exhaustion, officials said on Tuesday.

August 11, 2014 1:56 pm

Scientists retract narcolepsy study linked to GSK vaccine

Scientists who believed they had started to decipher links between a GlaxoSmithKline H1N1 pandemic flu vaccine and the sleep disorder narcolepsy have retracted a study after saying they cannot replicate their findings.

View More News Items