Topic: Responsible Conduct of Research
January 20, 2016 | Posted By Zubin Master, PhD

There have been dozens of papers in the past few years about our current biomedical science enterprise being unsustainable, starting with a prominent paper by Bruce Alberts, Marc Kirschner, Shirley Tilghman and Harold Varmus in 2014. They and others argue that the biomedical science environment is unstainable given its current growth and has led to a hypercompetitive environment where innovation has declined while possibly other factors have worsened such as authorship ethics, cutting corners, and the irreproducibility of results. There is tons of data from the NIH, NSF and academic researchers demonstrating the low rate of success in obtaining grants, longer post-docs, and less faculty level job opportunities, yet we continue to increase the number of students accepted into PhD programs. What are we going to do with the overflow of PhDs?

A recent article by Julie Gould in Nature writes about this topic. To summarize, she and others come up with several solutions of which I will discuss a few.

The first, and perhaps the most difficult for researchers and institutions to swallow, is simply reduce the number of PhDs (the entry rate). I and others have indicated that we need to decouple the labor from the training function of PhDs. Currently, PhDs and post-doctoral fellows are the labor backbone for the biomedical research workforce. Principal investigators (PIs) use PhDs as cheap labor to undertake research within their grants. The problem I think can be easily resolved if NIH was to set limits on the number of students which can be recruited for different types of NIH grants, or if academic institutions and graduate departments limit the number of PhDs they enroll. Yet there is really no appetite for such a policy shift and enormous resistance. Some argue that fewer PhD scientists could send a message that perhaps going into science is not the best vocation one can enter or that it may reduce scientific imagination overall. I’m not sure if this is a worthwhile reason to maintain the growing number of PhDs in biomedical science.

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.

November 5, 2015 | Posted By Zubin Master, PhD

Several months ago, I read an interesting article written by Sara Reardon and published in Nature titled “Uneven response to scientific fraud”. The Science and Nature journals are great at providing news surrounding scientific topics, including discussions on scientific fraud. In this article, the author discusses a case of misconduct, which is typical to other cases and certainly not the most egregious in terms of harming patients in a trial or a danger to public health. Yet despite this, the penalties this researcher received were quite harsh. And as I have written in previous blogs, it seemed no one else is to blame including research institutions.

On July 1, 2015, Dr. Dong-Pyou Han was sentenced to 57 months in prison for research misconduct. Dr. Han is a biomedical scientist who was let-go from Iowa State University for fabricating and falsifying data of a HIV vaccine research study where he spiked rabbit blood samples with human HIV antibodies which made it appear that the rabbits were developing immunity. In addition, he has also been fined 7.2 million dollars. Because Han’s research was supported by the U.S. National Institutes of Health (NIH), the investigation was performed at his home university with reports sent to the U.S. Office of Research Integrity (ORI). He admitted to misconduct and explained his actions by saying he tried to cover up a mix-up in samples he had made years ago. As such, ORI debarred him from funding for up to 3 years. In the article by Reardon, several experts of misconduct explained that receiving a 57 month prison sentence is quite rare. These experts also explained that ORI’s maximum debarment of 3 years is typical for such cases and stiffer penalties are used for those who have greatly impacted public health or harmed human participants in a clinical study. But Dr. Han’s case received higher profile than most because Iowa senator Mr. Charles Grassley wanted to make an example of him. Grassley felt that the penalty of losing a job and 3 years debarment for such a case was light compared to the public deception and the waste of millions of taxpayer dollars. While I would agree with the Senator, I am think that 57 months in prison is a bit over the top given the type of harm. But my contention is not really to talk about the penalty given to Dr. Han. Rather, I am interested in knowing why again, as is the case with almost all cases of research misconduct, a focus has been placed solely on the culprit and there is no blame or responsibility shifted to institutions.

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 25, 2015 | Posted By Zubin Master, PhD

The newest science journal on the block with several unique twists is Research Ideas and Outcomes (RIO). RIO aims to publish a variety of outputs in the research cycle, not only the results of research. The journal will publish papers on ideas, proposals, methods, research results, and software. They also publish review articles, opinion pieces, data papers, software descriptions, workflows, data management plans, conference abstracts, single figure publications, project reports and much more. Their aim is to better use the efforts scientists spend on writing and evaluating research proposals and other products within the research cycle. RIO does have limits; they will not accept teaching lectures or materials, clinical trials, patient or other data that may be considered unethical, homeopathy, nuclear or bioweapons research, creationist or religiously motivated research, cryptozoology, and pseudoscience. The journal also has many other interesting aspects. While they are an open access journal, unlike others, they do not charge the typical high costs of thousands of dollars. The journal charges between 50 to a few hundred euros for most types of publications. Peer review is also optional and RIO relies on public scrutiny to promote transparent and public peer review. Expert driven peer review, typically done in most medical and science journals, however, can be done upon the author’s request. The typical review process for papers submitted to RIO includes several technical checks and an external pre-submission review from a colleague.

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 19, 2015 | Posted By Zubin Master, PhD

I love reading the news posts in Nature and Science that I receive in the journal’s eAlerts. This past month was most interesting because there were two news posts that I thought were actually a bit contradicting. The first one titled “Spending bills put NIH on track for the biggest raise in 12 years” was published in July of this year and explains how both houses of congress want to increase the National Institutes of Health’s (NIH) annual budget (Kaiser, 2015a). The Presidential branch wants to give the NIH a 1 billion dollar increase while just recently, a Senate panel approved a 2 billion increase. The article also goes onto say that certain programs have been given priority such as the Alzheimer’s research and others like the Agency for Healthcare Research and Quality will receive cuts. Needless to say, I am sure that biomedical and behavioral scientists throughout the country are probably ecstatic. But is this really a good thing?

The other news blurb I read was titled an “A for effort, C for impact from U.S. biomedical research, study concludes” also written by the same author (Kaiser, 2015b). In this article, Jocelyn Kaiser reports the results of a study by two research scientists Dr. Arturo Casadevall and Anthony Bowen who examined publications in the PubMed database and the number of authors, along with the approval of new drugs and their work was published in the journal Proceedings of the National Academy of Sciences (USA). The researchers compared publication outputs with the number of new molecules approved by the U.S. government. What they found was not too surprising. 

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.

January 27, 2015 | Posted By Zubin Master, PhD

Academic journal publishing is big business. More journals are popping up in almost every field especially with the open access movement dominating academic publishing. While editors of some high impact journals might reject papers outright, editors of most journals, especially open access journals, might be willing to send the paper out for peer review so long as it isn’t methodologically flawed (Arns, 2014). Some predatory open access journals likely provide far less scrutiny and may send seriously flawed or poorly written papers to reviewers – I can personally vouch for this happening for one open access journal in my field. With the rise of journals and the increased pressure for scientists to publish, the demand and strain on peer reviewers and the peer review system is growing.

There are certainly signs that peer review is placing demands on researchers. For example, my previous supervisor who is an expert in bioethics and health law once told me he receives a request to peer review an article every couple of days. Another researcher at Mt. Sinai Hospital at the University of Toronto in Canada mentioned that he receives 300 requests to review papers a year, each of which takes him 3-4 hours to complete (Diamandis, 2015). Many of my colleagues who are prolific researchers turn down peer reviews, trying to do only a few a year or pass it off to junior researchers. In a recent column of the journal Nature, Martijn Arns explains that the increased pressure to review and the reluctance of researchers to undertake peer review might mean that editors will assign papers to reviewers who might not have the appropriate expertise in a particular area. Peer reviewers who are not experts on the topic should not accept articles to review, or declare to editors what areas they can appropriately review. Certainly junior researchers or doctoral students may not be international experts on a topic, but junior researchers might do a better job of reviewing manuscripts by investing more time and giving fair consideration to an article. However, given the time involved and the sense of obligation to conduct peer review, some reviewers might cut corners and perform mediocre reviews.

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 27, 2014 | Posted By Zubin Master, PhD

In a recent paper published in BMC Medical Ethics, my co-authors and I argued that there are unique issues in authorship in the context of global health research (GHR).Global health places priority on improving and ensuring equity in health worldwide. GHR is often multi/interdisciplinaryand involves large collaborative networks. Our analysis of authorship GHR applies to situations where researchers from high income countries (HICs) partner with those in low and middle-income countries (LMICs). First, let’s start by illustrating an example of a GHR research project. Let’s say that researchers wanted to study the genetics of a tropical disease. They wrote and succeeded in obtaining a U.S. National Institutes of Health funded grant. HIC researchers may bring to the collaboration scientific expertise, access to genomics/proteomic technologies, and may have been the main PI on the grant. LMIC researchers may be from a nation affected with the disease and can also provide scientific expertise, insight into local perceptions and realities, and access to the study population – the latter especially being difficult for HIC researchers given possible issues surrounding trust. Together, the team may gather epidemiological genetic data relevant to international public health interventions and also help address local needs and interests.

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 2, 2014 | Posted By Zubin Master, PhD

Scientist Yoshiki Sasai, age 52, committed suicide and was found dead on August 5, 2014. Sasai was deputy director of the Center for Developmental Biology (CDB) at RIKEN in Kobe, Japan, and coauthor on two recently retracted Nature papers about an easier way to make induced pluripotent stem cells. The papers were retracted due to duplication and manipulation of images done by the main researcher and lead author on the two papers – Haruko Obokata. Although cleared of any direct involvement, Sasai was under immense pressure and heavily scrutinized by the media, public and peers. This involved speculation about Sasai’s intentions to orchestrate a media frenzy, and for being overly ambitious and motivated to win future grants overlooking the integrity of the science.

According to colleagues at RIKEN, Sasai was receiving counseling since the scandal broke headlines and he was also hospitalized for about a month in March (1). He was found hanging in a stairwell of a neighboring building and beside him were three letters addressed to CDB management, his laboratory, and Obokata. On August 12, Kazuhiro Nakamura, the family lawyer explained the contents of Sasai’s suicide note left for the family. Sasai was “worn out by the unjust bashing in the mass media and the responsibility he felt towards RIKEN and his laboratory” (2). But unsubstantiated claims in the media were not the only source of stress for Sasai. The speculation in tabloids might have also influenced how RIKEN and other colleagues behaved towards Sasai. In June, a report released by an independent RIKEN reform committee criticized CDB leaders for hyping the science and did not interview Sasai about such accusations. Their final recommendation was to dismantle CDB. According to the family lawyer, this was a tremendous shock for Sasai (2).

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 10, 2014 | Posted By Zubin Master, PhD

Both parts I and II of this blog were originally published as a commentary in the Office of Research Integrity’s Newsletter (http://ori.hhs.gov/newsletters) Volume 22, Number 2, March 2014 and has been reproduced with permission for the AMBI blog.

In Part I, published last month, I discussed my experience organizing and developing a responsible conduct of research (RCR) workshop for stem cell scientists that was held at the Till and McCulloch Meeting in October 2013 as part of Canada’s Stem Cell Network at http://www.stemcellnetwork.ca. In Part 2, I discuss the importance of developing RCR pedagogy that includes both lecture and informational components, and provides ethical cases such that students have a rich understanding of normative, policy, and practical aspects to different RCR topics.

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 19, 2014 | Posted By Zubin Master, PhD

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.

Ethics Workshop: Responsible Research Conduct & Misconduct in Stem Cell Research

As part of Canada’s Stem Cell Network at http://www.stemcellnetwork.ca, I had the unique opportunity to organize and present an Ethics Workshop as part of the Network’s annual Till & 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) athttps://ori.hhs.gov/thelab. 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.

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 16, 2014 | Posted By Zubin Master, PhD

Last month, I discussed bias in academia and more specifically in the workplace. Just to recap, there are several studies that show bias in peer review and bias or favoritism in the workplace. Much of the bias may be unconscious or what is considered “hidden bias” and is not shown overtly. In this month’s blog, I propose three steps to reduce bias in the workplace.

The solutions proposed here are geared towards academic work environments at the departmental level in one of the three settings: 1) professors or research scientists running a lab or a research group who supervise research assistants, students, fellows and staff; 2) department directors/heads; and 3) members and chairs of committees charged with the selection of candidates for awards, prizes, and positions. While I am not applying these steps to the peer review of grants or publications, some of the points may be helpful to reduce bias in peer review processes.

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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