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Topic: Research Ethics
April 3, 2014 | Posted By John Kaplan, PhD

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.

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.

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 website.

March 17, 2014 | Posted By John Kaplan, PhD

Three eminent bioethicists have proposed, in an article published in the New England Journal of Medicine 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.

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.” 

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 website.

February 27, 2014 | Posted By Aidan B. Ferguson, LCSW and Zubin Master, PhD

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.

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.

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 website.

December 16, 2013 | Posted By John Kaplan, PhD

Open post-publication scientific peer review is here. Almost. Now we need to ask whether or not that is a good thing. Some are trumpeting this as a game-changing innovation which will improve the quality of scientific publication. Others are concerned that scientific publication will become more like Twitter and Facebook.

The site Pubmed Commons allows one to comment on any Pubmed indexed publication. Although the system now permits access in a limited way for testing, it will be open to essentially all who have Pubmed indexed papers in the relatively near future. Just as there are sites to review movies, restaurants, and contractors one will soon be able to include their insights and feelings about scientific papers. The advocates of this system believe that post-publication will open the peer review system to all qualified and can allow science to be communicated in a more transparent and less biased manner.

Advocates of post-publication peer review have been very critical of conventional pre-publication peer review

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 website.

October 8, 2013 | Posted By John Kaplan, PhD

My last blog, written just a few weeks ago, discussed the case of two neurosurgeons who had purposely introduced bowel bacteria into the brains of patients with glioblastoma, a process they termed “probiotic intracranial therapy”. In that blog I expressed the opinion that the physicians had inappropriately exposed their patients to excessive risk and compared the incident to assault. In the brief time since then high risk research has been covered in both the biomedical literature and the popular press. We have also seen more news regarding treatments with bowel bacteria indicating that fecal bacteria may well have their place in medical treatment. Their place, however, is in the gut not the brain.

In the journal Lancet, David Shaw argues that Institutional Review Boards “should never reject a study because it poses too high a risk to participants.” Institutional Review Boards are the mechanisms that review research protocols designed to be conducted with human subjects. Among the charges to Institutional Review Boards is to evaluate the balance between the potential benefits and potential risks of a proposed research project. When assessing protocols of prospective therapies they need to identify that there is adequate reason, both theoretical and experimental, to think the therapy might work. They should also assure that the risks of the proposed study do not endanger the participants out of proportion to the potential benefits. These dangers were excessive in the well known Tuskegee syphilis studies and similar studies in Guatemala as well as the supposed research in the Nazi atrocities. This horrendous history drove many of the protections we now use to safeguard human research participants.

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 website.

September 13, 2013 | Posted By John Kaplan, PhD

Today one can read the news media and regularly encounter stories about research misconduct and other questionable conduct by researchers. Having spent a career as a researcher and research ethicist I seldom see reports which shock me. There are millions of researchers making millions of research reports and these things happen. However the story of two neurosurgeons from the University of California at Davis School of Medicine was so egregious that it shocked even me.  Dr. J. Paul Muizelaar and Dr. Rudolph J. Schot so blatantly disregarded the ethical underpinnings for the conduct of research on human subjects that their only defense was that their actions did not constitute research. Much of my information on this incident comes from the excellent articles reported by Marjie Lundstrom of the Sacramento Bee as well as the insights of their editorial staff.

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 website.

August 13, 2013 | Posted By Jane Jankowski, LMSW, MS

This past week brought the announcement of an agreement between the living relatives of Henrietta Lacks and the U.S. National Institute of Health (NIH) regarding use of genetic information derived from HeLa cells, NY Times. Henrietta Lacks was a patient at Johns Hopkins Hospital in Baltimore, Maryland in 1951 where she was treated for and ultimately died from, cervical cancer. During her hospitalization, cells were retrieved from her tumor without her knowledge or permission. It is these cells, named HeLa cells, which proved to have an unprecedented ability to grow in laboratory cultures and were the source of many important scientific advances in the 20th centuryWall Street Journal . Neither she nor her family ever received any financial compensation for the vast contribution HeLa cells have made to science and society and restitution is not part of the story this week. Privacy of genetic information derived from Henrietta’s cells is the family’s concern, and rightly so. Of note, the story of Henrietta Lacks, her family, and HeLa cells is now widely known with the publication of Rebecca Skloot’s book, “The Immortal Life of Henrietta Lacks” in 2010 – a recommended read for anyone regardless of prior interest or knowledge in biomedical ethics www.rebeccaskloot.com

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 website.

July 2, 2013 | Posted By Bruce D. White, DO, JD

Recall the June 7, 2013 New York Times article by Andrew Pollock titled “An Experimental Drug’s Bitter End”? The author reminds us again about how difficult it is for patients and those involved in their care to understand that new drug clinical trials are experiments and not therapeutic interventions.

The goals of researchers in conducting new drug clinical trials – experiments – are clearly not the same as the goals of a physician who prescribes an approved drug as a therapeutic modality. How better can we help patients and their families understand this primary goal of medical research? In clinical trials, when the experiment ends, the patient may worsen clinically, or the patient may get better clinically, and the improving patient probably will no longer have access to the perceived beneficial drug as a therapy option. Regardless, after sufficient data is collected – whether good or bad – the experiment ends.

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 website.

June 13, 2013 | Posted By Ricki Lewis, PhD

Earlier today, my “in” box began to fill with info from everyone I’ve ever met letting me know that the Supreme Court had ruled on the Myriad case about patenting the breast cancer genes BRCA1 and BRCA2. I also received a dozen pitches from PR people offering me all manner of instant interviews with lawyers, doctors, bioethicists, and health care analysts.

No one offered me an interview with a geneticist – a person who knows something about DNA. So being such a person myself, I decided to take a look at the decision. And I found errors – starting right smack in the opening paragraph.

“Scientists can extract DNA from cells to isolate specific segments for study. They can also synthetically create exons-only strands of nucleotides known as composite DNA (cDNA). cDNA contains only the exons that occur in DNA, omitting the intervening exons.”

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 website.

May 20, 2013 | Posted By Jane Jankowski, LMSW, MS

Helping individuals with mental retardation maximize their autonomy and enjoy fulfilling quality life experiences is often at the core of ethical arguments surrounding healthcare options for individuals with these disabilities. Having worked with adults with mental retardation I have known some who gave birth, some who got married, and many who were sexually active. There are ranges in function and comprehension in any population group, and the options ought to apply fairly with consideration for the patient’s preferences and best interests guiding decision making. I will argue that in some cases, sterilization promotes autonomy and ought to be considered an option for those with mental retardation as it is for those without any cognitive impairment.  The benefits are the same for person with mental retardation as for any individual – freedom to engage in sexual activity without the risk if unwanted pregnancy. Unlike the old sterilization policies which allowed procedures to be performed over the objections of patients and guardians, this elective procedure may be permissible if an appropriate consent process is in place and engages the patient and his or her support network in the conversation. 

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 website.

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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