Zubin Master

Mayo Clinic - Rochester · Biomedical Ethics Research Program

Misinformation among clinics advertising unproven stem cell interventions (SCIs) is pervasive and has resulted in patient and societal harms. Most bioethics commentaries have centered on advancing regulatory approaches to curtail the supply side of the market, but insufficient attention has been paid to considering strategies influencing patient de...

The rapidly evolving stem cell field puts much stress on developing educational resources. The ISSCR Education Committee has created a flexible stem cell syllabus rooted in core concepts to facilitate stem cell literacy. The free syllabus will be updated regularly to maintain accuracy and relevance.

Despite patient demand for stem cell therapies (SCTs) for musculoskeletal conditions, there remains limited research on why patients seek SCTs or their sources of information. We employ three questions into a consult intake form: (1) Why are you interested in stem cell treatment for your condition? (2) How did you find out about stem cell treatment...

Background For gravely ill patients who have no treatment options and who are ineligible for clinical trials, the US Food and Drug Administration (FDA) established the Expanded Access Program (EAP). Motivated by efforts to weaken FDA regulation and sold as providing greater access to experimental drugs, the federal Right to Try Act (RTT) was passed...

The two-bucket problem of unproven stem cell interventions (SCIs) continues to bifurcate good (ethical) from bad (unethical) practices in the translation of stem cell medicine in ways that divert attention from other salient and challenging questions. It causes scholars to focus narrowly on reprimanding bad actors through legal and regulatory appro...

Stem cell therapies occupy a unique place in the American public’s consciousness which has led to excessive enthusiasm over their potential to cure orthopedic conditions. Much has been written about direct-to-consumer marketing of cell therapies for a myriad of medical conditions. Far less has been studied on the attitudes that drive many patients...

Introduction Direct to consumer stem cell and regenerative interventions (SCRIs) for various medical conditions have increased in popularity due to unmet medical needs and the promise of SCRIs to meet those needs. These interventions may have varying levels of safety and efficacy data and many lack sufficient scientific data to be marketed. The dir...

The U.S. Food and Drug Administration (FDA) allows patients with serious illnesses to access investigational drugs for “compassionate use” outside of clinical trials through expanded access (EA) Programs. The federal Right-to-Try Act created an additional pathway for non-trial access to experimental drugs without institutional review board or FDA a...

Many sports medicine physicians are currently considering introducing regenerative medicine into their practice. Regenerative medicine and the subclassification of orthobiologics are a complicated topic and have produced widely varying opinions. Although there is concern by government regulators, clinicians, scientists, patient advocacy organizatio...

Objective: To explore the experiences, approaches, and challenges of physicians consulting patients about experimental stem cell and regenerative medicine interventions (SCRIs). Participants and methods: From August 21, 2018, through July 30, 2019, semistructured interviews of 25 specialists in cardiology, ophthalmology, orthopedics, pulmonology...

The unproven stem cell intervention (SCI) industry is a global health problem. Despite efforts of some nations, the industry continues to flourish. In this paper, we call for a global approach and the establishment of a World Health Organization (WHO) Expert Advisory Committee on Regenerative Medicine to tackle this issue and provide guidance. The...

e13603 Background: Over half of Americans report favoring access to experimental treatments even if they have yet to be proven either safe or effective, yet only 3-5% are enrolled in clinical trials and a fraction of a percent in expanded access. The Expanded Access (EA) program (aka “compassionate use”) and Right-to-Try (RTT) are parallel federal...

While much of the scholarly work on ethics relating to academic authorship examines the fair distribution of authorship credit, none has yet examined situations where a researcher contributes significantly to the project, but whose contributions do not make it into the final manuscript. Such a scenario is commonplace in collaborative research setti...

Background and Aims Premature commercialization of unproven stem cell interventions (SCIs) has received significant attention within the regenerative medicine community. Patients considering SCIs may encounter misinformation and seek out guidance from their physicians who are trusted brokers of health information. However, little is known about the...

The stem cell preservation industry has grown substantially with private businesses, public hospitals, and academic medical centers considering preserving induced pluripotent stem cells, mesenchymal stem cells, and other cell types of patients and the public in order to potentially use them for stem cell therapy should such an intervention exist in...

Background The federal Right-to-Try (RTT) Act created an alternate regulatory pathway for preapproval access to investigational drugs. A few studies have examined the experiences of physicians with Food and Drug Administration’s Expanded Access Programs (EAP), but no study has yet to examine their attitudes and experiences toward RTT. Methods This...

Scientific authorship serves to identify and acknowledge individuals who “contribute significantly” to published research. However, specific authorship norms and practices often differ within and across disciplines, labs, and cultures. As a consequence, authorship disagreements are commonplace in team research. This study aims to better understand...

Authorship is commonly used as the basis for the measurement of research productivity. It influences career progression and rewards, making it a valued commodity in a competitive scientific environment. To better understand authorship practices amongst collaborative teams, this study surveyed authors on collaborative journal articles published betw...

Aim: To address the unmet needs of patients interested in regenerative medicine, Mayo Clinic created a Regenerative Medicine Consult Service (RMCS). We describe the service and patient satisfaction. Materials & methods: We analyzed RMCS databases through retrospective chart analysis and performed qualitative interviews with patients. Results: The a...

To the Editor Dr Sugarman and colleagues reported on the professional standards for informed consent for patients seeking stem cell interventions outside a clinical trial from the International Society for Stem Cell Research.¹ We agree that informed consent is the cornerstone of ethical clinical practice and that patients need accurate information...

In November 2018, the announcement that genetically edited human embryos had been used for reproductive purposes caused international uproar; many observers argued that editing the human germline was unethical, particularly given the early stage of the science and the absence of appropriate oversight. We provide an overview of the implications of t...

We conducted a cross-sectional survey of 1,540 researchers concerning their experiences with and attitudes towards the ethics of equal contribution (EC) designations in publications. Over half the respondents (58.3%) said they had been designated as an EC at least once. Although most respondents agreed that EC designations can be a useful way of pr...

A recent commentary argued for arbitration to resolve authorship disputes within academic research settings explaining that current mechanisms to resolve conflicts result in unclear outcomes and institutional power vested in senior investigators could compromise fairness. We argue here that arbitration is not a suitable means to resolve disputes am...

Canada's Assisted Human Reproduction Act is long overdue for Parliamentary review. We argue that the current regulation of research using human reproductive materials is not proportionate, not responsive to the uncertain threats posed to human and environmental health and safety, and is not considerate of diverse values in a democratic society. We...

More than 700 US clinics advertise unproven stem cell treatments.¹ Hematopoietic stem cell transplants to treat various hematologic disorders are evidence-based whereas most other stem cell interventions are investigational. This study examined the characteristics and scope of training of clinicians performing unproven stem cell procedures.

Providers capitalize on patient testimonials to market unproven stem cell treatments (SCTs). We evaluated 159 YouTube videos and found patients discussed health improvements (91.2%), praised providers (53.5%), and recommended SCTs (28.9%). In over a third of the videos, providers posed questions to patients, thereby directing narratives and making...

In this special issue, we solicited three commentators to discuss issues specific to the responsible conduct of research as it relates to the birth of gene-edited children. We explore the ethics of prevention and its ties to the responsible conduct of gene editing research to introduce three commentaries addressing: (1) the relevance of cultural an...

Purpose: CRISPR is often called one of the century's most important discoveries and is commonly discussed in terms of its momentous potential impacts. This study analyzed how CRISPR is discussed in the North American popular press, including how it is defined, and which benefits and risks/concerns are attributed to the technology. Methods: Using...

Numerous social, economic and academic pressures can have a negative impact on representations of biomedical research. We review several of the forces playing an increasingly pernicious role in how health and science information is interpreted, shared and used, drawing discussions towards the role of narrative. In turn, we explore how aspects of na...

While sexual and gender minorities are at increased risk for poor health outcomes, there is limited data regarding patient-provider interactions. In this study, we explored the perspectives of LGBTQ patients and their encounters with physicians in order to improve our understanding of patient-physician experiences. Using purposive selection of self...

The sale of unproven stem cell interventions (SCIs) by commercial entities has proliferated in highly developed countries, most notably in the USA. Yet, there have been few criminal prosecutions and regulatory enforcement actions against providers who have violated laws and best practice standards due to the lack of resources and legal ambiguity. W...

The field of regenerative medicine is widely viewed as having the potential to improve treatment options for a broad range of conditions. Stem cell research in particular has been celebrated for its considerable clinical promise. Although measured enthusiasm surrounding this area of research is warranted, it must be balanced by patience and set in...

Background: In biomedical research, there have been numerous scandals highlighting conflicts of interest (COIs) leading to significant bias in judgment and questionable practices. Academic institutions, journals, and funding agencies have developed and enforced policies to mitigate issues related to COI, especially surrounding financial interests....

This paper presents an overview of the key ethical questions of performing gene editing research on military service members. The recent technological advance in gene editing capabilities provided by CRISPR/Cas9 and their path towards first-in-human trials has reinvigorated the debate on human enhancement for non-medical purposes. Human performance...

Research involving human embryos and reproductive materials, including certain forms of stem cell and genetic research, is a fast-moving area of science with demonstrated clinical relevance. Canada's current governance framework for this field of research urgently requires review and reconsideration in view of emerging applications. Based on a work...

Regenerative medicine has attracted the interest of scientists, physicians, and patient communities, and as well as policy-makers and the broader public given related ethical, legal, and social implications. Here we examine past initiatives in the ethical, legal and social implications arena in regenerative medicine, and offer our views on actionab...

The direct-to-consumer marketing of unproven stem cell interventions (SCIs) is a serious public health concern. Regulations and education have had modest impact, indicating that different actors must play a role to stop this unfettered market. We consider the role of the biotech industry in tackling unproven SCIs. Grounded in the concept of corpora...

Non-invasive prenatal testing (NIPT) is an exciting technology with the potential to provide a variety of clinical benefits, including a reduction in miscarriages, via a decline in invasive testing. However, there is also concern that the economic and near-future clinical benefits of NIPT have been overstated and the potential limitations and harms...

Misunderstanding and disputes about authorship are commonplace among members of multi/interdisciplinary health research teams. If left unmanaged and unresolved, these conflicts can undermine knowledge sharing and collaboration, obscure accountability for research, and contribute to the incorrect attribution of credit. To mitigate these issues, cert...

Stem cell research is an exciting field with clinical potential and has been rapidly moving towards the goal of translating research into therapeutics. Like all scientific fields, there are many ethical, legal, and social issues (ELSI) associated with stem cell research and stem cell scientists, especially trainees, should be aware of them. In this...

Non-invasive prenatal testing (NIPT) is an exciting technology with the potential to provide a variety of clinical benefits, including a reduction in miscarriages, via a decline in invasive testing. However, there is also concern that the economic and near-future clinical benefits of NIPT have been overstated and the potential limitations and harms...

Integrity in writing letters of recommendation is important to academic research because it is an influential criterion used pervasively in peer review. While research in the integrity of recommendation letters has concentrated on contents of the letter, bias and reliability, few have questioned the process of letter writing. Here, I argue that let...

Table of contents I1 Proceedings of the 4th World Conference on Research Integrity Concurrent Sessions: 1. Countries' systems and policies to foster research integrity CS01.1 Second time around: Implementing and embedding a review of responsible conduct of research policy and practice in an Australian research-intensive university Susan Patricia O'...

Large scale, multisite clinical research trials have been increasing in frequency. As it stands currently, a research project performed at multiple institutions requires ethics review at each institution. While local (institutional) review may be necessary in some instances, repetitive reviews may require unnecessary changes and not serve to furthe...

Background: Although much is known scientifically about maternally and paternally mediated fetal harms, there has been little research examining how these harms are portrayed in the media. The objective of this study was to examine how maternal and paternal age-related harm is portrayed in contemporary U.S. newspapers. Methods: A content analysis w...

Large scale, multisite clinical research trials have been increasing in frequency. As it stands currently, a research project performed at multiple institutions requires ethics review at each institution. While local (institutional) review may be necessary in some instances, repetitive reviews may require unnecessary changes and not serve to furthe...

This commentary provides a review and critique of the book Research Misconduct Policy in Biomedicine: Beyond the Bad-Apple Approach by Professor Barbara Redman.

This article will cover the contemporary ethical issues surrounding stem cell research and how they serve to influence scientific practices in the field. Discussions of hype in stem cell research, personhood, and the moral status of the human embryo; the physical and social harms to women; the translation and commercialization challenges of stem ce...

This article begins by providing an overview of several historical tragedies in research involving humans and how they can serve to promote the awareness and development of ethical practices and policies. We highlight several norms specific for ethical clinical research and what they mean in terms of corresponding practices for researchers and ethi...

Given a decade of regulatory experience and the changing nature of research using human embryonic stem cells, it is time to reconsider whether the current practice of dual ethics reviews for stem cell research is still appropriate.

Background: The public’s understanding of science is delivered mostly through mass media, which in turn impacts how people think about and use scientific and medical technologies in their daily lives. Therefore, it is important to understand how the media represents preconception harm, how accurately the science is described, and who is responsible...

The growing international market for unproven stem cell-based interventions advertised on a direct-to-consumer basis over the internet (“stem cell tourism”) is a source of concern because of the risks it presents to patients as well as their supporters, domestic health care systems, and the stem cell research field. Emerging responses such as publi...

Stem cell tourism describes the Internet-based industry where in patients receive unproven stem cell interventions. To better inform the public, several organizations provide educational material on stem cell therapies and tourism; however, an assessment of the currently available resources reveals a lack of comprehensive information, suggesting th...

Most bioethics studies have focused on capturing the views of patients and the general public on research ethics issues related to informed consent for biobanking and only a handful of studies have examined the perceptions of scientists. Capturing the opinions of scientists is important because they are intimately involved with biobanks as collecto...

Background Over the past two decades, the promotion of collaborative partnerships involving researchers from low and middle income countries with those from high income countries has been a major development in global health research. Ideally, these partnerships would lead to more equitable collaboration including the sharing of research responsibi...

http://ori.hhs.gov/images/ddblock/march_vol22_no2.pdf

This booklet is a starting point to help you distinguish between legitimate research or therapy and unproven stem cell interventions. It includes other good sources of information to help you get as informed as possible before you make such an important decision about your health. Stem cell research has the potential to treat many different diseas...

Patient advocacy groups could add a crucially important unified voice to the growing chorus of criticism over the practices of businesses that advertise inadequately tested stem cell interventions on a direct-to-consumer basis.

Understanding the perception of patients on research ethics issues related to biobanking is important to enrich ethical discourse and help inform policy. We examined the views of leukemia patients undergoing treatment in clinics located in the Princess Margaret Hospital in Toronto, Ontario, Canada. An initial written survey was provided to 100 pati...

Stakeholder survey: perspectives on biobanking and tissue sampling. General population/patient population questionnaire.

David Resnik and Zubin Master review current policies and initiatives for preventing and managing research misconduct in high-income countries, summarize some high profile cases of misconduct, and make suggestions on ways forward.

Stem cell tourism is a growing industry in which patients pursue unproven stem cell therapies for a wide variety of illnesses and conditions. It is a challenging market to regulate due to a number of factors including its international, online, direct-to-consumer approach. Calls to provide education and information to patients, their families, phys...

We agree with Greely (2013) that embryonic stem cell research oversight (ESCRO) committees have probably helped to promote ethics in stem cell research (SCR). In this commentary, we draw attention to a few issues that we suspect neither ESCROs nor any current form of governance of SCR is likely to fix. These issues cast a certain degree of social s...

Many scholars claim there is a consensus on broad consent for biobanking. We analyzed the literature in PubMed and found no evidence for consensus. Public perception studies report mixed findings on consent, but many biobanks adopt broad consent. A belief in consensus may stem from knowledge of biobank consent practices.

Research on research integrity is an important element in building a strong national research integrity framework. There is a lack of empirical evidence and conceptual research on research integrity in Canada. To further strengthen and develop our system of research integrity, we believe that greater support is needed to promote research on researc...

Social scientists have begun elucidating the variables that influence public trust in science, yet little is known about hype in biotechnology and its effects on public trust. Many scholars claim that hyping biotechnology results in a loss of public trust, and possibly public enthusiasm or support for science, because public expectations of the bio...

Multiple authorship is becoming increasingly common in bioethics research. There are well-established criteria for authorship in empirical bioethics research but not for conceptual research. It is important to develop criteria for authorship in conceptual publications to prevent undeserved authorship and uphold standards of fairness and accountabil...

Stem‐cell tourism exploits the hope of patients desperate for therapies and cures. Scientists have both a special responsibility and a unique role to play in addressing this problem.

Inappropriate authorship is a common problem in biomedical research and may be becoming one in bioethics, due to the increase in multiple authorship. This paper investigates the authorship policies of bioethics journals to determine whether they provide adequate guidance for researchers who submit articles for publication, which can help deter inap...

In the US, stem cell research is at a moral impasse-many see this research as ethically mandated due to its potential for ameliorating major diseases, while others see this research as ethically impermissible because it typically involves the destruction of embryos and use of ova from women. Because their creation does not require embryos or ova, i...

The responsible conduct of research in the biomedical and behavioral sciences has received significant attention since the late 1980s. However, very little has been written about the responsible conduct of bioethics research. Bioethics is an interdisciplinary field and brings together divergent ethical standards and practices which may be the sourc...