Hot Topics: Research Ethics

Blog Posts (25)

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 »
May 7, 2014

Philosopher Calls for End to Animal Experimentation (and more): Is there a “reasonable” conception of animal rights?

by J.S. Blumenthal-Barby, MA, PhD

According to Christine Korsgaard, one of the leading moral philosophers in the Western world and Arthur Kingsley Porter Professor of Philosophy at Harvard University, the answer is yes.…

April 2, 2014

Another Scandal Rocks the Stem Cell World

<p>The scientific and medical potential of stem cells hold so much promise that progress in this area is widely followed with intense interest. Since pluripotent stem cells are able to differentiate into any cell type they hold the promise of leading to therapies for a wide variety of diseases and disabilities which cause human suffering and end lives prematurely. This field of research and development has attracted the efforts of large numbers of the most brilliant and talented biomedical researchers in the entire world. This raises the vexing question of why some of these brilliant and talented researchers are doing some very stupid things.</p> <p class="MsoNormal">It seems like only yesterday (it was actually in 2004 and 2005) that Hwang Woo-Suk a renowned Korean veterinarian and researcher published the first reports in Science Magazine of the derivation of pluripotent stem cells from human embryos and subsequently the successful cloning of human embryonic stem cells. Hwang was a national hero. However these studies were recognized in 2006 as being the result of fraud.  I remember wondering then, just as I am wondering now, how someone could risk all that they had earned by committing such blatant fraud. How could they not realize that misconduct in such important work would be discovered and punished. I do not get it.</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>
April 1, 2014

Cute with a Good Story: Social Media Selects Experimental Subjects

by Craig Klugman, Ph.D.

For patients with a serious illness, accessing cutting edge drugs has just taken a new turn. In the past, a patient with cancer would undergo conventional treatments.…

March 16, 2014

Informed Consent Still Necessary for Research on Human Subjects

<p>Three eminent bioethicists have proposed, in an article published in the <a href="http://www.nejm.org/doi/pdf/10.1056/NEJMhle1313674">New England Journal of Medicine</a> last month, that some comparative effectiveness research should not require informed consent from patients. I do not agree, at least not yet. Drs. Faden, Beauchamp, and Kass have provided a thoughtful justification for their position. However the circumstances in which this new scenario would work does not yet exist.</p> <p class="MsoNormal">Let’s be more specific. These authors have been among those advocating what they term a learning healthcare system which blurs the line between clinical care and research but predicates both on a common set of research and clinical ethics principles.  Research and medical practice allows the system to learn and implement improvements. They lay down seven ethical principles to guide such a health care system. The first of these principles is to “respect the rights and dignity of patients.” It does not seem to me that you can meaningfully respect the rights and dignity of people and use them in clinical trials, even comparative effectiveness trials, without their permission. The seventh principle, “contribute to the common purpose of improving the quality and value of clinical care and health care systems” seems in some ways laudable but is dubious in the context of respect for rights. The first six principles define obligations of the participants in the health care system. This seventh principle describes an obligation on the patients to “participate in certain types of learning activities that will be integrated with their clinical care.” </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>
February 27, 2014

Multisite Ethics Review of Research Involving Humans

<p class="MsoNoSpacing">Before research involving humans can commence, the ethical aspects of the research study are reviewed by local ethics boards in the United States known as Institutional Review Boards (IRBs). IRBs review many factors surrounding the ethics of research involving humans, including whether the science is valid, there is a favorable benefit-to-risk ratio, participants are recruited fairly and have retained the right to withdraw from research, privacy is protected, and the informed consent process will be performed such that participants are fully informed and understand the nature of the study. IRBs are located within institutions that perform human research such as universities and colleges, research centers, government agencies, and others. IRBs consist of individuals with a diversity of scientific, clinical, ethics, and legal expertise. The advantage of performing ethics review at the local level is that IRB members know their community, including the prevalence of health issues and the average educational level allowing them to be able to effectively communicate with community members and ensure they can access beneficial research. As trust is an essential element to voluntary community participation, an absence of it might lead to decreased enrolment in clinical trials. Knowing that a body of experts has reviewed the ethical aspects of research is likely to promote trust between participants and the research institution.</p> <p class="MsoNoSpacing">While local review certainly has its advantages, more research is being performed at multiple institutions, such as large phase 3 and 4 clinical trials that can be performed at dozens of research sites across the country. Currently, this means that researchers will have to submit their protocol to every individual IRB for approval. Several studies surrounding multisite ethics review have been performed and many question whether a more efficient system cannot be developed. Below we discuss some of the issues with multisite ethics review and outline a few reform strategies.</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>

View More Blog Entries

Published Articles (150)

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

American Journal of Bioethics: Volume 14 Issue 4 - Apr 2014

Is There an Ethical Obligation to Disclose Controversial Risk? A Question From the ACCORD Trial Joseph P. DeMarco, Paul J. Ford, Dana J. Patton & Douglas O. Stewart

American Journal of Bioethics: Volume 14 Issue 3 - Mar 2014

Ethics and Empiricism in the Formation of Professional Guidelines Mildred K. Cho

AJOB Primary Research: Volume 5 Issue 1 - Feb 2014

AJOB Empirical Bioethics: A Home for Empirical Bioethics Scholarship Chris Feudtner, Jeremy Sugarman, Barbara A. Koenig, Peter A. Ubel, Richard F. Ittenbach, Laura Weiss Roberts & Laurence B. McCullough

American Journal of Bioethics: Volume 14 Issue 2 - Feb 2014

Ethical Review of Health Systems Research in Low- and Middle-Income Countries: A Conceptual Exploration Adnan A. Hyder, Abbas Rattani, Carleigh Krubiner, Abdulgafoor M. Bachani & Nhan T. Tran

American Journal of Bioethics: Volume 14 Issue 2 - Feb 2014

Connecting Health Systems Research Ethics to a Broader Health Equity Agenda Bridget Pratt

American Journal of Bioethics: Volume 13 Issue 12 - Dec 2013

Quality Improvement Ethics: Lessons From the SUPPORT Study Benjamin S. Wilfond

American Journal of Bioethics: Volume 13 Issue 12 - Dec 2013

Informed Consent and Standard of Care: What Must Be Disclosed Ruth Macklin & Lois Shepherd

American Journal of Bioethics: Volume 13 Issue 12 - Dec 2013

What Should Be Disclosed to Research Participants? David Wendler

American Journal of Bioethics: Volume 13 Issue 12 - Dec 2013

The SUPPORT Controversy and the Debate Over Research Within the Standard of Care David Magnus

View More Articles

News (335)

July 10, 2014 4:02 pm

Did Facebook and PNAS violate human research protections in an unethical experiment?

Whatever good and bad things about Facebook there are, however, there’s one thing that I never expected the company to be engaging in, and that’s unethical human subjects research.

July 3, 2014 1:46 pm

'Breakthrough' stem cell study retracted

It was hailed as a fast, easy, inexpensive and uncontroversial way to produce stem cells.

July 2, 2014 3:36 pm

Everything We Know About Facebook's Secret Mood Manipulation Experiment

Facebook’s News Feed—the main list of status updates, messages, and photos you see when you open Facebook on your computer or phone—is not a perfect mirror of the world.

July 2, 2014 3:33 pm

Study finds vaccine side effects extremely rare

Serious complications related to vaccines are very rare, and there is no evidence that immunizations cause autism, according to an analysis of 67 research studies.

July 1, 2014 1:35 pm

Doctors Are Examining Your Genitals for No Reason

In total, gynecological screenings cost the U.S. $2.6 billion every year. And yet, a new study published in the Annals of Internal Medicine reports that there is no established medical justification for the annual procedure.

June 30, 2014 6:13 pm

Stem cells: Taking a stand against pseudoscience

Elena Cattaneo and Gilberto Corbellini are among the academics working to protect patients from questionable stem-cell therapies. Here, they share their experiences and opinions of the long, hard fight for evidence to prevail.

June 23, 2014 1:53 pm

Cancer-gene data sharing boosted

When the US diagnostics giant Myriad Genetics had its legal monopoly on breast-cancer gene testing eliminated one year ago, the company still retained an enormous edge over competitors.

June 4, 2014 2:07 pm

Japan researcher agrees to withdraw disputed stem cell paper

A Japanese researcher accused of fabricating scientific results originally hailed as a breakthrough in stem cell research has agreed to retract two papers, deepening doubts about her “game- changing” findings.

May 28, 2014 2:35 pm

Stanford’s Big Data in BioMedicine Conference Turns Two

With Silicon Valley blazing on as number one hot spot for high tech and the Bay Area claiming the same for biotech, it makes sense that Stanford, sitting there mid-peninsula basking in all that brilliance, should command a leading role in bioinformatics.

May 19, 2014 2:46 pm

‘Right to Try’ laws spur debate over dying patients’ access to experimental drugs

Colorado, Missouri and Louisiana are poised to become the first states in the nation to give terminally ill patients the right to try experimental drugs without the blessing of the Food and Drug Administration, setting the stage for what could be a lengthy battle over who should decide whether a drug is too risky to try.

View More News Items