» Human Subjects Research & IRBs Where the World Finds Bioethics Fri, 24 Jun 2016 14:48:31 +0000 en-US hourly 1 First CRISPR Human Clinical Trial Gets a Green Light from the U.S. Fri, 24 Jun 2016 12:00:53 +0000 0 Despite Pressing Need, Survey Finds Most Americans Unlikely to Enroll in Clinical Trials Wed, 25 May 2016 13:47:36 +0000 0 Clinical Trials Infrastructure as a Quality Improvement Intervention in Low- and Middle-Income Countries Tue, 24 May 2016 20:25:28 +0000 0 The Potential for Infrastructure Benefits and the Responsiveness Requirement Tue, 24 May 2016 20:23:22 +0000 0 For cholesterol study volunteer, an unsettling discovery in a Science paper: herself Thu, 12 May 2016 12:14:13 +0000 0 “And Death Shall Be No More” Thu, 05 May 2016 15:59:58 +0000 by Craig Klugman, Ph.D.

Two years after John Donne’s death, the Holy Sonnets were published. In Sonnet 10, Donne speaks about the end of death: “Death, thou shalt die.” Although a metaphorical conceit referring to eternal life in heaven, the poem takes on new meaning in the age of regenerative medicine.

Since the 1968 ad hoc Harvard committee on defining death, brain death has been defined as the “irreversible loss of all functions of the brain, including the brainstem.” If a new project is successful that definition may have to be revised or deleted.…

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Ethics of research in usual care settings: Data on point Wed, 27 Apr 2016 17:26:18 +0000 0 Adrift in the gray zone: IRB perspectives on research in the learning health system Wed, 27 Apr 2016 17:24:41 +0000 0 The patient’s perspective on the need for informed consent for minimal risk studies: Development of a survey-based measure Wed, 27 Apr 2016 17:23:51 +0000 0 Patient and physician views about protocolized dialysis treatment in randomized trials and clinical care Wed, 27 Apr 2016 17:22:56 +0000 0 Alternative consent models for comparative effectiveness studies: Views of patients from two institutions Wed, 27 Apr 2016 17:21:34 +0000 0 Patients’ views concerning research on medical practices: Implications for consent Wed, 27 Apr 2016 17:20:02 +0000 0 BioethicsTV: “Heartbeat” tackles therapeutic misconception Fri, 08 Apr 2016 02:32:44 +0000 by Craig Klugman, Ph.D.

On episode 4 of Heartbeat, the heroine, Dr. Panttiere has received hospital funding to try an experimental cancer treatment on 5 patients. The intervention uses laparoscopic surgery to implant radioactive pellets directly into tumors. The show presents a good debate on the values of enrolling patients because the characters discuss the hope of more time versus providing patients with comfortable quality of life at the end of life. The side-by-side contrast is quite literal as the camera shows Panttiere sitting next to her paramour, Dr.…

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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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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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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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Day or Night: Ethics Depends on Time Fri, 01 Aug 2014 07:19:28 +0000 by Craig Klugman, Ph.D.

Is that shirt the cashier forget to ring up a bonus or do you point out the oversight? Do you report your peer for being an impaired physician or just look the other way when she drinks? Cut your $20 million pay as a CEO or “layoff” 10,000 workers?

When dealing with ethical issues like these your first step may be to watch the clock. A study published last year found that people are more moral in the afternoon than in the mornings.…

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AIN’T JUST THE MEAT IT IS ALSO THE MOTION: CONSENT MATTERS! Tue, 29 Jul 2014 17:18:43 +0000 “But look, you found the notice, didn’t you?”

“Yes,” said Arthur. “yes I did. It was on display in the bottom of a locked filing cabinet stuck in a disused lavatory with a sign on the door saying ‘Beware of the Leopard.'”

                           –Douglas Adams, The Hitchhiker’s Guide to the Galaxy

Any apologia for Facebook’s recent behavioral study has to address one issue head on: that of informed consent. Informed consent is the bedrock upon which the ethics of all biomedical and behavioral research on humans rests.…

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Did Facebook and PNAS violate human research protections in an unethical experiment? Thu, 10 Jul 2014 20:02:00 +0000 0 Enter the Corporate Congress: SCOTUS & FACEBOOK Wed, 02 Jul 2014 03:01:44 +0000 by Craig Klugman, Ph.D.

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. But after this week, any job candidate would be wise to ask their potential employer about his/her/its (in the case of corporations) religious beliefs.

Who one works for is increasingly determining not only what health care coverage you have but also what laws you have to follow and what legal protections you have.…

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Why vampires stay young Fri, 09 May 2014 04:42:19 +0000 by Craig Klugman, Ph.D.

In the world of fantasy, the vampire is known for its immortality. In most incarnations, the vampire lives forever in a youthful state by feeding on the blood of humans. Now it turns out that science may have proven that the blood of the young keeps you young.

At least, if you’re a mouse. Three papers published in the last week (two in Science and one in Nature Medicine) showed that giving blood from young mice to older mice reduced many of the signs of aging.…

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Fostering IRB Collaboration for Review of International Research Thu, 01 May 2014 17:53:32 +0000 0 Guidance published on informing study participants about findings with potential health implications Wed, 02 Apr 2014 18:17:26 +0000 0 Women Still Left Out of Medical Research: Report Mon, 03 Mar 2014 21:08:33 +0000 0 Does Execution by Lethal Injection Violate the Ethics of Human Research? Fri, 15 Nov 2013 06:14:27 +0000 by Arthur L. Caplan, PhD

The Governor of Ohio has been wrestling with the question of whether a prisoner soon to be executed can donate his organs.  Ronald Phillips, 40, is scheduled to be executed in the next few days for the 1993 rape and murder of 3-year-old Sheila Marie Evans.  He says he would like to donate his heart and kidney to his family members who may need them.  In fact, execution by electrocution, gassing and lethal injection in an execution chamber do not go well with organ donation. …

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Reporting to NIH on Race and Ethnicity of Clinical Research Participants Mon, 26 Aug 2013 16:56:36 +0000 0 Views of IRBs Concerning Their Local Ecologies: Perceptions of Relationships, Systems, and Tensions Between IRBs and Their Institutions Fri, 19 Apr 2013 17:15:52 +0000 0 Stanford bioethicist speaks out about layers of stem cell regulations Wed, 20 Mar 2013 21:51:04 +0000 0 Time to ditch stand-alone stem cell oversight panels, experts say Thu, 07 Mar 2013 18:19:50 +0000 0 ‘Benefits and burdens’ of participating in clinical research trials Tue, 10 Apr 2012 17:18:11 +0000 0 Protecting Patient Privacy Redux: Response to Open Peer Commentaries on You Don’t Know Me, But: Access to Patient Data and Subject Recruitment in Human Subjects Research Fri, 17 Feb 2012 01:12:45 +0000 0 Fines expose failings in policing of Indian drug trials Wed, 18 Jan 2012 06:00:00 +0000 0 Citizens for Responsible Care and Research Mon, 25 Oct 2010 04:00:00 +0000 1 EPA Reverses Controversial ?Human Guinea Pig? Rule Wed, 23 Jun 2010 05:00:00 +0000 0 Concern Over Foreign Trials for Drugs Sold in U.S. Tue, 22 Jun 2010 05:00:00 +0000 0 Consent Form Gobbledygook: Are Medical Research Subjects Adequately Informed? Mon, 21 Jun 2010 05:00:00 +0000 0 Physicians group accuses CIA of testing torture techniques on detainees Tue, 08 Jun 2010 05:00:00 +0000 0 Council Bars Doctor Who Liked Vaccine With Autism Thu, 27 May 2010 05:00:00 +0000 0 The Moral Life of Babies Sun, 09 May 2010 05:00:00 +0000 0 My Name Is Jesse. But I am not a boy. Inside my parents’ failed experiment with gender neutrality. Tue, 13 Apr 2010 05:00:00 +0000 0 Patient Records ‘Open to Prying Eyes’ Mon, 29 Mar 2010 05:00:00 +0000 0 Senator Moves to Block Medical Ghostwriting Thu, 20 Aug 2009 05:00:00 +0000 0 Swine flu vaccine tests underway Mon, 10 Aug 2009 05:00:00 +0000 0 Television Viewing Linked to Blood Pressure Increases in Children Thu, 06 Aug 2009 05:00:00 +0000 0 Lack of Study Volunteers May Hobble Cancer Fight Mon, 03 Aug 2009 05:00:00 +0000 0 Minorities Needed for Research Trials – Rochester Leads the Way Mon, 27 Jul 2009 05:00:00 +0000 0 NCI tackles trial enrollment Fri, 24 Jul 2009 05:00:00 +0000 0 Setback for Huntington’s disease therapy Tue, 21 Jul 2009 05:00:00 +0000 0 The Belmont Report Fri, 19 Jun 2009 04:00:00 +0000 0 Office for Human Research Protections (OHRP) Fri, 19 Jun 2009 04:00:00 +0000 0