Albany Medical Center
 Search
Home / Caring / Educating / Discovering / Find a Doctor / News / Give Now / Careers / About / Calendar / Directions / Contact
Topic: Research Integrity
April 17, 2014 | Posted By Zubin Master, PhD

One of my areas of research focus in bioethics is known as the responsible conduct of research (RCR) (a.k.a. research integrity). Research on research integrity covers a range of different norms and practices including authorship and publication ethics, research misconduct (fabrication, falsification and plagiarism), responsible mentorship, peer review, and RCR education among others. I have written on several of these topics in our AMBI blogs.

One of the topics I am interested in chatting about today is bias in the academic setting, but even more generally in the workplace. Much about research methodology aims to reduce or eliminate bias. For example, the experimental scientific method attempts to reduce bias by having proper controls, blinding researchers, and employing statistics so that we don’t over interpret our findings. Sociologists and other qualitative researchers may declare their biases when reporting research so the reader knows where the researcher is coming from. The entire concept of declaring conflicts of interest also aim to permit others to know what potential interest(s) the researcher may have which could bias their results. Moreover, the peer review process, which academia heavily relies on, aims to reduce bias in research. Peer review is not only used in the context of evaluating research, it also evaluates academic scholars for jobs, committee memberships, awards and scholarships, and other entitlements. One recent studydone by Drs. Daniele Fanelli and John Ioannidis showed the overestimation of effect sizes in behavioral research. Here the researchers performed a meta-analysis of meta-analyses (cleverly called meta meta-analysis) and found that researchers working in the behavioral, but not biomedical, sciences tended to exaggerate effects that were not supported by the data. Most interestingly, this exaggerated effect was heightened if the research had one or more US authors. While this sort of bias in the reporting of research may at first glance seem relatively benign, it actually has significant consequences because other researchers build on the results of previously published work and accumulatively, our social policies and clinical practices are based on evidence collected from such studies. Yet bias can come in all sorts of shapes and sizes in the academic and research context, some of which I think hits more personally to individual researchers.

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.

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.

January 27, 2014 | Posted By Michael McNichol and Zubin Master, PhD

Since the discovery of human embryonic stem cells in 1998, many promises have been made by individuals and groups about the potential of stem cell research to revolutionize the practice of regenerative medicine. Yet to date, very little has been seen in terms of novel therapies in the clinic. Because of the substantive economic investments made in stem cell research in order to realize the promise they can offer, greater efforts to translate stem cell research into medicines has ensued. However, many factors might impede the clinical translation of stem cell research. In this blog, we briefly highlight the ethical and scientific issues surrounding the successful translation and commercialization of stem cell research.

The process of clinical translation begins with preclinical research using in vitro systems and animal models to show proof-of-principle and demonstrate safety and efficacy of a potential therapeutic. For example, if a stem cell is to be transplanted into a patient to treat a degenerative disease, then the type of stem cell that is being used must show that it can successfully treat a similar disease in animals prior to testing the product in humans. There are many reasons for using appropriate animal models that mimic human diseases: low cost, reproductive cycle, number of offspring, genetic similarity, similarity in the manifestation of the disease in humans, and ease of handling. However, there are many limitations to animal models that do not result in direct translation in humans, meaning what may work in animals may not at the end of the day be effective in people. While we choose animals as models to mimic human disease, the biology of animals is still significantly different than humans and thus may simply not translate 100%. This issue is difficult to get around. 

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 31, 2013 | Posted By Zubin Master, PhD

Bioethics research is closely tied with policy. While discrepancies exist, I classify bioethics as an interdisciplinary field of study. As most interdisciplinary fields, one aim of bioethics is to develop practical solutions for real world problems in the biomedical and clinical sciences among other fields it impacts. Thus much of bioethics scholarship is closely intertwined and aims to inform health, social and science policy. Bioethics scholarship is also meaningful in attempting to raise awareness and educate researchers, practitioners, patients and the public on many areas of ethics in the health sciences. As a bioethics academic who has worked in both Canadian and U.S. institutions, I have enjoyed the benefit of examining policy and educational landscapes in both countries. Today, I want to specifically talk about research integrity policies, practices and education in Canada and compare it to the U.S.

What is research integrity?

Academics in every discipline including the fundamental and applied sciences (i.e., biomedical science, engineering), the social sciences, and humanities are self-governed professionals who conduct research upholding principles of research integrity. Research integrity (a.k.a. scientific integrity or the responsible conduct of research) captures a range of principles and practices governing ethical research. It includes practices such as research misconduct (commonly known as fabrication, falsification, and plagiarism), authorship and publication ethics, peer review, mentoring, conflicts of interest, research involving animals and humans and social responsibility. Yet beyond outlining principles and practices, there is a growing field of research on research integrity where scholars try and improve our understanding of the normative and practical aspects of research integrity. I’ve written about different topics within research integrity including what is conceptual bioethics research? and peer review in previous AMBI blogs.

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 3, 2013 | Posted By Zubin Master, PhD

This is part 2 of a blog written last month. In Part 1, I explained how open access (OA) journals work and some of the shortcomings of peer review. This was done to provide a background on a recently published study by staff at the leading journal Science. In this part, I will cover the specific experiment reported by Science and explain some of the limits of its design followed by an interesting and novel model of the non-profit OA journal BioéthiqueOnline.

Part 2: Open Access Journals, Peer Review, and Conflicts of Interest

Do OA Journals Perform Rigorous Peer Review?

Recently, John Bohannon of the Science group conducted an investigation where he submitted scientifically flawed papers using fake names and provided the names of research or academic institutions that didn’t exist to 304 OA journals (Science 342: 60-65, 2013). The idea was to create a scientific paper with major errors, so that “[a]ny reviewer with more than a high-school knowledge of chemistry and the ability to understand a basic data plot should have spotted the paper’s shortcomings immediately.” Bohannon created a database of molecules, lichens and cancer cell lines and ran them through a computer program to generate unique papers, but with a standard structure: “molecule X from lichen species Y inhibits the growth of cancer cell Z.” He also created fake authors from fictitious African institutions with the hope that using developing world authors would lessen suspicion by journal editors. The main flawed graph showed a dose-dependent decrease in cell growth yet despite rising concentrations, the effects on cells were modest. In addition, the anti-proliferative molecule was dissolved in a large amount of ethanol and because the control group was not treated with the same solution buffer, the anti-proliferative effects seen could simply be due to the cytotoxic effects of ethanol. In a second experiment, Bohannon attempted to show an “interactive effect” by adding the molecule with radiation, but the control cells were not exposed to any radiation. As the experiments had a tragically flawed design, the idea was that any peer reviewer should pick them up and the article should be rejected.

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 4, 2013 | Posted By Zubin Master, PhD

This blog will be written in two parts. It discusses some interesting results produced by the publisher Science in regards to the quality of peer review of open access (OA) journals. In this first part, I will provide a brief explanation of OA journals and how peer review works and cover some of the shortcomings of peer review. In the second part of this blog post, I will discuss the specific experiment reported by Science and explain some of the limits of its design and end off with an interesting and novel model of the OA journal BioéthiqueOnline.

Part 1: The Open Access Movement and Limits of Traditional Peer Review

There has been a rise in OA journals, which are scholarly journals that are available online and are free to access or can be heavily subsidized. There is variation in how OA journals function e.g., authors may self-archive and upload a copy of the paper to an institutional or central repository (e.g., PubMed Central), journals may provide free access after an embargo period typically 6-12 months, or all journal articles may be made available online but authors pay a fee to publish. This last model is one we will pay attention to for the purposes of this blog.

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 28, 2013 | Posted By Paul Burcher, MD, PhD

Two articles in the New York Times raise a disturbing question regarding the ethics of cancer treatment in this country.  The first on ovarian cancer treatment noted that despite significantly better survival data with intraperitoneal chemotherapy (IP) over intravenous chemotherapy (IV) for ovarian cancer, most oncologists were still using IV chemotherapy. The reason given is that IP chemotherapy is more difficult to give, and more labor intensive, but is not reimbursed at a higher rate.  That is, physicians are routinely withholding the more effective treatment for economic reasons.  Another recent article describes how oncologists tend to choose more expensive chemotherapy even when it is not more effective because they are paid a percentage of the drug’s cost. 

It is an often-repeated truism that physician behavior will follow economic incentives perfectly—if you wish to reduce physician procedures capitate patient care, if you wish to increase patient procedures, pay physicians on a fee-for-service basis.  While this has been empirically demonstrated, it is a bit hard to accept that this adage remains true even when physicians seems to be crossing the line into unethical behavior in order to follow the almighty dollar.  The IP chemotherapy issue is most troubling because it represents physicians giving care they know to be inferior because the better treatment costs more to deliver, and this reduces their own income.

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 22, 2013 | Posted By Zubin Master, PhD

The responsible conduct of research (RCR) (a.k.a. as research integrity) captures a range of ethical norms and practices which include research misconduct (generally defined as fabrication, falsification and plagiarism), authorship and publication ethics, the ethics of peer review, proper data management, mentoring, conflicts of interest, animal ethics, and the ethics of research involving humans. In some cases, topics such as animal ethics and the ethics of research involving humans are subfields of their own due to the extensive scholarship devoted to them. RCR has received considerable attention in many nations. For example, students and faculty may be required to receive education and training in RCR, several scholars study and perform research on research integrity, and many countries have developed policies to govern research integrity (Resnik and Master, 2013; Master, 2012). Yet most educational initiatives and research on research integrity center on the natural and applied sciences including, biomedical science, clinical research, engineering, and psychology. Fewer research integrity policies, education, and research is devoted to philosophy or law, or for multi or interdisciplinary fields such as bioethics.

I have previously argued that bioethicists need to pay closer attention to issues of research integrity. Why is this important? I define bioethics as an interdisciplinary field where scholars from philosophy, law, science, medicine, social science, nursing and anthropology come together to work on a common set of normative questions using a range of methods and theoretical lenses. By focusing efforts towards understanding research integrity practice, we will better understand the epistemic dimensions of our field, enhance integrity in bioethics scholarship, and be able to evaluate bioethicists more fairly. In turn, these efforts are likely to promote greater trust in bioethics by other academic scholars, among bioethicists, and the general public. Yet the field of bioethics has not paid close enough attention as it relates to research integrity issues of its own scholarship. Let’s focus on authorship as an example since this is one area that has most recently received some attention.

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 20, 2012 | Posted By Zubin Master, PhD

Last month, I discussed a research integrity case making international headlines of an iPS cell study conducted by a researcher Hisashi Moriguchi who had allegedly falsified or fabricated data, provided false institutional affiliation, plagiarized work, and had questionable publication practices. In this post, I want to outline a few of the lessons we can learn from this case.

I think Péter Kakuk said it best when he wrote that the Hwang cloning scandal “might shed light on the often neglected benefits of the 'social control of science'".  As a trained scientist, I can say that I used to believe that many of the safeguards felt more like impediments to research progress. As a bioethics researcher, I still feel there are kinks in the system of ethical oversight and there is evidence to support this view. However, I also believe that the ethical safeguards are in place to promote the responsible conduct of research and ensure that research is performed by upholding the utmost standards of integrity. In every issue of Nature or Science there is some report of research misconduct or misbehavior. There have been studies done in the US and many other nations about the frequency of misconduct. Yet despite such reports, I feel many scientists still believe there are too many research hurdles only to catch a few bad apples. This view needs to shift.

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 16, 2012 | Posted By Zubin Master, PhD

This blog will have two parts. In this first entry, I present will discuss a recent case of stem cell fraud and the subsequent blog entry will discuss possible lessons to learn appearing next month.

The tale begins when Woo-Suk Hwang, a once celebrated hero of South Korea, claimed to have made the first, patient-specific human embryonic stem cell (hES) line through a technique called somatic cell nuclear transfer (commonly referred to as research or therapeutic cloning). This study was soon after proven to be fraudulent. Not to get into too many details, but this technique requires obtaining ova from women providers, enucleating its genetic material, and placing the nucleus from a somatic cell and parthenogenically activating the egg. This initiates embryonic development and at about day 3-4 of development (where the embryo is at the blastocyst stage), hES cells can be isolated from the inner cell mass of blastocysts. This incredible feat in stem cell research was published in Science in 2004 and another study in 2005. In 2006, Hwang was discredited for fabricating results and after an investigation, he was convicted for embezzlement and bioethical allegations. He embezzled approximately 830 million won (US $700,000) of government funds and apparently used 2,200 eggs obtained from his female postgraduate students and junior researchers. All wasted!

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.

SEARCH BIOETHICS TODAY
SUBSCRIBE TO BIOETHICS TODAY
ABOUT BIOETHICS TODAY
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.
TOPICS