» Research Ethics Where the World Finds Bioethics Sun, 07 Feb 2016 14:10:25 +0000 en-US hourly 1 French Drug Trial Disaster Leaves One Brain Dead, Five Injured Sat, 16 Jan 2016 23:21:37 +0000 0 ORI Names New Director Wed, 06 Jan 2016 18:29:32 +0000 0 Zafgen halts obesity drug trial after second patient death Mon, 07 Dec 2015 17:51:13 +0000 0 Adolescent research participants’ descriptions of medical research Wed, 02 Dec 2015 23:35:08 +0000 0 Treading the Line Between Sensational and Groundbreaking Science Tue, 01 Dec 2015 18:50:42 +0000 0 Bioethics team creates online repository of advice on ethical research practices Mon, 23 Nov 2015 18:58:49 +0000 0 Stanford scientists criticize NIH moratorium Fri, 13 Nov 2015 20:50:45 +0000 0 Coca-Cola Spends Millions Of Dollars Funding Research That—Surprise!—Says Soda Is Just Fine Thu, 12 Nov 2015 20:51:12 +0000 0 A Bioethicist on Mars Mon, 02 Nov 2015 07:18:08 +0000 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. Astronaut Mark Watney is stranded on Mars when he is impaled by a metal rod in the middle of a sudden and violent storm. Thought dead due to a malfunction of his suit, his fellow astronauts leave him and make an emergency evacuation to return to Earth.…

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Young People’s Experiences of Participation in Clinical Trials: Reasons for Taking Part Sun, 01 Nov 2015 22:45:56 +0000 0 Patient dies during Zafgen’s obesity drug trial Mon, 19 Oct 2015 20:14:03 +0000 0 If I Were Running the Place Fri, 16 Oct 2015 09:10:58 +0000 0 Human Subjects Research “Vulnerability” Tue, 13 Oct 2015 03:21:07 +0000 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). The changes being suggested are numerous (helpful summaries can be found here and here My aim is not to review those changes, but to point out a curious conceptualization of vulnerability affirmed in the NPRM.

Consider the following section (regarding conditions for IRB approval) of the original regulations:

46.111(b) – When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.…

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Your Biology is in My Technology Mon, 05 Oct 2015 22:48:12 +0000 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. Maria Freire, President of the Foundation for the National Institutes of Health. The host of this show, Alexander Heffner, asked AJOB and BIOETHICS.NET to share this interview, about which he said, “it’s among our most fascinating conversations.”

The conversation is about exploring is about the intersection of biology and technology, harnessing big data to learn about human health and find cures for human disease.…

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Placebo Effects and Informed Consent Thu, 01 Oct 2015 19:53:33 +0000 0 True Confessions: Keeping up with the literature Thu, 01 Oct 2015 08:47:03 +0000 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. He told me to teach my classes, minimize my service, write everyday, and keep up with the literature. Teaching innovative classes using technology and active learning takes more time than lectures and seminars did. I became a department chair, which automatically increased my service duties. I still write, nearly everyday. What I do not have time for is keeping up with the literature.…

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Ashley Madison & Using Stolen Data Thu, 10 Sep 2015 20:35:01 +0000 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. Their service, of course, is a dating site meant to facilitate extra-marital affairs. The message isn’t subtle, as anyone who’s got their upbeat jingle — “I’m looking for someone other than my wife!” — stuck in his head can attest.…

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Don’t Miss this Opportunity to Shape Federal Policy! Thu, 10 Sep 2015 17:14:16 +0000 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. This event is momentous for several reasons. First, there have been almost no changes to the Common Rule for over 30 years.…

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Broad Consent for Research With Biological Samples: Workshop Conclusions Tue, 01 Sep 2015 19:49:44 +0000 0 Patient Perspectives on the Learning Health System: The Importance of Trust and Shared Decision Making Tue, 01 Sep 2015 19:47:14 +0000 0 Prudentia Populo: Involving the Community in Biobank Governance Tue, 01 Sep 2015 19:43:41 +0000 0 Hashtag Advocacy or Slacktivism: How Should We Evaluate the Impact of Social Media Campaigns for Public Health? Mon, 31 Aug 2015 12:00:25 +0000 by Macey L. Henderson, J.D.

It takes more than a TV news story or a Twitter hashtag campaign to save lives. Last August’s viral ice bucket challenge did more than just improve public health awareness of an issue. Its now been reported to have made a real impact into research for a rare disease, not just for improved public education and awareness.

An estimated 5,000 persons receive a diagnosis of Amyotrophic Lateral Sclerosis (ALS) each year in the United States, with an estimated prevalence of 12,000 cases according to the Centers for Disease Control and Prevention (CDC).…

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Reproducibility Project or Research Police? Tue, 25 Aug 2015 04:08:24 +0000 0 Ben Carson Conducted Research on Fetal Tissue — And Defends It Fri, 14 Aug 2015 17:53:23 +0000 0 Evolving Challenges and Research-Needs Concerning Ebola Thu, 13 Aug 2015 17:57:41 +0000 0 Children and Clinical Research: Ethical Issues Wed, 12 Aug 2015 17:53:30 +0000 0 The Stanford Prison Experiment film: An Essential Teaching Tool Tue, 04 Aug 2015 11:00:11 +0000 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. When discussing social science examples, the two studies that are usually taught at Milgram’s obedience studies and Zimbardo’s Stanford Prison Experiment.

As an undergraduate at Stanford, my Psychology 101 teacher was Philip Zimbardo.…

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Investigating Two Claims Against Planned Parenthood: Center of Medical Progress’s Secret Videos Mon, 27 Jul 2015 22:00:39 +0000 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. After many years, she went on to direct their clinic’s in vitro fertilization program. I also heard the word “Planned Parenthood” stated with a quick northeastern accent. Said that way, as a child, I thought the place was called “Plant Parenthood” and wondered what plants had to do with women’s health.…

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Video of Planned Parenthood executive discussing tissue, organ prices sparks abortion firestorm Fri, 17 Jul 2015 23:53:07 +0000 0 On the Origins of Research Ethics: China and the West Thu, 16 Jul 2015 07:23:16 +0000 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. and China in Beijing. We listened to talks on the philosophical bases of ethics in each country and culture. The U.S. laid its philosophical history on the doorsteps of the ancient Greek traditions such as Plato and Aristotle as well as later European thinkers such as Kant, Mill, and Bentham.…

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Can Bioethics Panels Fix the Problems With the Availability of “Compassionate Use” Experimental Drugs? Thu, 04 Jun 2015 02:06:47 +0000 0 Cost of Compassionate Use is Simply Too High Fri, 08 May 2015 21:01:23 +0000 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. Arthur Caplan will lead this group, which will be composed of bioethicists, physicians, and patient advocates. The goal of this group is to provide recommendations on which patients should be given compassionate use access to experimental drugs.…

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Use of Unproven Interventions is Never Obligatory Fri, 08 May 2015 08:05:30 +0000 0 Withholding results from clinical trials is unethical, says WHO Thu, 30 Apr 2015 22:31:17 +0000 0 Designer Embryos: The Future is Now Thu, 23 Apr 2015 07:30:13 +0000 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! (Shakespeare, The Tempest, Act 5, Scene 1.

Nature News on Wednesday reported a group of Chinese researchers have successful genetically engineered a human embryo.

Researchers used “non-viable” embryos from fertility clinics. These embryos had an extra set of chromosome, having been fertilized by two sperm and containing three nuclei. Such embryos were chosen because of the impossibility of them gestating into a human being.…

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Are religious research subjects a vulnerable population? Wed, 15 Apr 2015 19:28:11 +0000 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. To reach their conclusion, the researchers asked online participants to undertake a short writing task. Half of the participants were asked to incorporate words that reminded them of God and half did not.

The participants then took one of several scenario tests where they were asked their willingness to participate in risky behaviors.…

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Examining the Ethics of Clinical Use of Unproven Interventions Outside of Clinical Trials During the Ebola Epidemic Wed, 01 Apr 2015 20:12:44 +0000 0 Selecting the Right Tool For the Job Wed, 01 Apr 2015 20:11:06 +0000 0 Grants help level the playing field for young moms in science Mon, 30 Mar 2015 22:57:03 +0000 0 Research 2.0: Rise of the Citizen-Scientist and the Death of Privacy Thu, 26 Mar 2015 07:34:05 +0000 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. The foundation sponsoring the event replied to me, “There is no such thing as privacy. It’s dead.” For someone who works in bioethics, serves on an IRB, and was formerly a journalist, this notion is scary. Perhaps, I have simply been in denial. After all, I use a mobile phone that tracks my position, synchs with the cloud, and provides much convenience.…

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Build it (an easy way to join research studies) and the volunteers will come Wed, 18 Mar 2015 17:49:56 +0000 0 Apple’s ResearchKit to give scientists ready access to study subjects Mon, 09 Mar 2015 22:26:40 +0000 0 The Social Determinants of Health: Why Should We Care? Sun, 01 Mar 2015 19:40:41 +0000 0 Precision Medicine Has Imprecise Ethics Wed, 18 Feb 2015 06:59:03 +0000 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. Then the doctor performs tests to rule out some diagnoses and advance others. In essence, though, diseases are classified according to their affect on the body—their symptology. What if instead of by symptoms, diseases were classified by their molecular function? Instead of being diagnosed with Type II Diabetes one might be diagnosed by whether there is a death of beta cells (i.e.…

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The new scientific revolution: Reproducibility at last Mon, 02 Feb 2015 19:49:36 +0000 0 “Post Publication peer review: Promise or Chaos?” Revisited Mon, 12 Jan 2015 05:01:18 +0000 0 Shared Vulnerabilities in Research Mon, 01 Dec 2014 21:05:15 +0000 0 Scientific Research: Critiquing the Critics Wed, 26 Nov 2014 10:11:04 +0000 0 Wed, 19 Nov 2014 21:35:21 +0000 0 Human-subjects research: The ethics squad Tue, 04 Nov 2014 20:50:53 +0000 0