Big data and artificial intelligence (“AI”) promise to transform virtually all aspects of biomedical research and health care (Matheny et al. 2019), through facilitation of drug development, diagno...

With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several factors that influence patient trust and potential institutional approaches to building trustworthiness. Drawing on (...) these findings, we suggest several considerations for research institutions seeking to cultivate long-term, trusting relationships with patients: Address the role of history and experience on trust, engage concerns about potential group harm, address cultural values and communication barriers, and integrate patient values and expectations into oversight and governance structures. (shrink)

No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)

The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards, to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to (...) highlight four contexts in which REC can be a valuable resource. REC assists: 1) investigators before and after the regulatory review; 2) investigators, IRBs, and other research administrators facing challenging and novel ethical issues; 3) IRBs and investigators with the increasing challenges of informed consent and risk/benefit analysis; and 4) in providing flexible and collaborative assistance to overcome study hurdles, mediate conflicts within a team, or directly engage with research participants. Institutions that have established, or plan to establish, REC services should work to raise the visibility of their service and engage in open communication with existing clinical ethics consult services as well as the IRB. While the IRB system remains the foundation for the ethical review of research, REC can be a valuable service for investigators, regulators, and research participants aligned with the goal of supporting ethical research. (shrink)

Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (shrink)

We conducted focus groups to assess patient attitudes toward research on medical practices in the context of usual care. We found that patients focus on the implications of this research for their relationship with and trust in their physicians. Patients view research on medical practices as separate from usual care, demanding dissemination of information and in most cases, individual consent. Patients expect information about this research to come through their physician, whom they rely on to identify and filter associated risks. (...) In general, patients support this research, but worry that participation in research involving randomization may undermine individualized care that acknowledges their unique medical histories. These findings suggest the need for public education on variation in practice among physicians and the need for a collaborative approach to the governance of research on medical practices that addresses core values of trust, transparency, and partnership. (shrink)

Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (shrink)

Digital contact tracing, in combination with widespread testing, has been a focal point for many plans to “reopen” economies while containing the spread of Covid‐19. Most digital contact tracing projects in the United States and Europe have prioritized privacy protections in the form of local storage of data on smartphones and the deidentification of information. However, in the prioritization of privacy in this narrow form, there is not sufficient attention given to weighing ethical trade‐offs within the context of a public (...) health pandemic or to the need to evaluate safety and effectiveness of software‐based technology applied to public health. (shrink)

In their forthcoming article, ‘What makes a medical intervention invasive?’ De Marco, Simons, and colleagues explore the meaning and usage of the term ‘invasive’ in medical contexts. They describe a ‘Standard Account’, drawn from dictionary definitions, which defines invasiveness as ‘incision of the skin or insertion of an object into the body’. They then highlight cases wherein invasiveness is employed in a manner that is inconsistent with this account (eg, in describing psychotherapy) to argue that the term invasiveness is often (...) used to explicitly or implicitly reference interventions that do not fall under the standard account. The authors offer an alternative ‘schematic’ definition of invasiveness, whereby medical interventions entail an underlying context-independent property of ‘basic invasiveness’ and may be understood both relative to each other and to a context-specific threshold of what is ‘invasive’.1 We propose that the meaning of terms such as ‘invasiveness’ is necessarily heterogeneous, and that what is implied by its usage will certainly depend on context, particularly in medical settings. Hence, the creation of a unifying definition is less critical than clarification of the implied and intended meanings of each instance of the term’s use. We further argue that interpreting the use of terms like ‘invasiveness’ in medical practice is complicated by the embedding of each use of this term in a different ‘language game’, whereby words and their meanings are understood by an in-group familiar with …. (shrink)

In their forthcoming article, Shavelson and colleagues (2023) identify a key ethical concern associated with medical aid-in-dying (MAiD) laws in the eleven US jurisdictions where the practice is le...

From its inception, genomics has been a speculative endeavor, fixated on a far-off horizon that would deliver on the promise of targeted diagnostics and individualized therapeutics (Fortun 2008). M...

McCradden et al. propose to close the “AI chasm” between algorithms and clinically meaningful application using the norms of evidence-based medicine and clinical research, with the rat...

Human genetic and genomic research can yield information that may be of clinical relevance to the individuals who participate as subjects of the research. It has been common practice among researchers to notify participants during the informed consent process that no individual results will be disclosed, “incidental” or otherwise. However, as genetic information obtained in research becomes orders of magnitude more voluminous, increasingly accessible online, and more informative, this precedent may no longer be appropriate. There is not yet consensus on (...) the responsibilities of researchers to disclose individual research results to research participants. Empirical research suggests that participants want to know individual research results. On the other hand, the increased resolution and power aforded by new genomic analyses may lead to fndings of statistical, but not necessarily clinical, signifcance. This paper addresses the issues to be considered in deciding whether and how to disclose “incidental” fndings or other fndings of clinical signifcance that arise in the course of human genomic and genetic research. What research results should be ofered, and what should not be ofered? For which research should individual results be ofered to research participants, when should they be ofered, how, and to whom? (shrink)

Peterson et al. (2023) identify important ethical issues that are relevant to psychedelic therapy and research in various clinical populations and contexts. This is certainly the case in palliative...

Human genetic and genomic research can yield information that may be of clinical relevance to the individuals who participate as subjects of the research. However, no consensus exists as yet on the responsibilities of researchers to disclose individual research results to participants in human subjects research. “Genetic and genomic research” on humans varies widely, including association studies, examination of allele frequencies, and studies of natural selection, human migration, and genetic variation. For the purposes of this article, it is defined broadly (...) to include analysis of DNA collected from humans that has implications for human health. This paper addresses both research results of individual research participants that may be an intended product of the research, as well as unanticipated, “incidental” findings. (shrink)

There are deep divides over the use of racial and ethnic categories in biomedical research and its application in both medical and non-medical contexts. On one side of a roughly described dividing line are practitioners who need to use every piece of information at their disposal to solve pressing, realworld problems in real time, such as making clinical diagnoses or identifying perpetrators of crime. On the other side are scientists and policy makers committed to meeting a scientific and social need (...) for accuracy and thus trying to avoid miscategorization.As Jay Cohn describes in this issue, medical practitioners in particular have used racial and ethnic categories to “enhance diagnostic and therapeutic precision.” He argues for retaining this practice. The plea, motivated by genuine concern for patients, is to avoid “throwing the baby out with the bathwater.” However, Cohn and others mischaracterize the nature of the debate. The argument is not about whether differences among populations exist, or even whether differences among “races” exist. (shrink)

The use of racial categories in biomedicine has had a long history in the United States. However, social hierarchy and discrimination, justified by purported scientific differences, has also plagued the history of racial categories. Because “race” has some correlation with biological and genetic characteristics, there has been a call not to “throw the baby out with the bathwater” by eliminating race as a research or clinical category. I argue that race is too undefined and fluid to be useful as a (...) proxy for biology or genetics. (shrink)

Recent experiments have been used to “edit” genomes of various plant, animal and other species, including humans, with unprecedented precision. Furthermore, editing the Cas9 endonuclease gene with a gene encoding the desired guide RNA into an organism, adjacent to an altered gene, could create a “gene drive” that could spread a trait through an entire population of organisms. These experiments represent advances along a spectrum of technological abilities that genetic engineers have been working on since the advent of recombinant DNA (...) techniques. The scientific and bioethics communities have built substantial literatures about the ethical and policy implications of genetic engineering, especially in the age of bioterrorism. However, recent CRISPr/Cas experiments have triggered a rehashing of previous policy discussions, suggesting that the scientific community requires guidance on how to think about social responsibility. We propose a framework to enable analysis of social responsibility, using two example.. (shrink)

Background Researchers engaged in the study of the ethical, legal, and social implications (ELSI) of genetics and genomics are often publicly funded and intend their work to be in the public interest. These features of U.S. ELSI research create an imperative for these scholars to demonstrate the public utility of their work and the expectation that they engage in research that has potential to inform policy or practice outcomes. In support of the fulfillment of this “translational mandate,” the Center for (...) ELSI Resources and Analysis (CERA), funded by the National Human Genome Research Institute (NHGRI), aims to facilitate community-informed, ELSI research results synthesis and dissemination. However, little is known about how ELSI research scholars define the goals of translation and imagine the intended users of their research findings.Methodology We distributed a Qualtrics survey to ELSI scholars that aimed to determine: (1) researchers’ expectations for their research findings in relation to policy or practice outcomes, (2) the stakeholder groups researchers believe could benefit from their research findings, and (3) the methods researchers use to foster the uptake of their findings by those stakeholders.Results Most ELSI researchers surveyed thought there were stakeholders that could benefit from their research findings, including health care professionals, at-risk individuals, patients, and their family members, policy-makers, and researchers/scientists, and expected their research findings to inform the creation or revision of laws, policies, or practice guidelines. Most researchers planned to disseminate findings directly to relevant stakeholders, with fewer expecting dissemination support from research funders, universities, or other entities.Conclusion The broad range of research topics, disciplines, and set of potential end users represented in ELSI reseach complicate the work of a knowledge broker. Nonetheless, the CERA can play an important role in disseminating ELSI results to relevant stakeholders. Further research should explore outreach mechanisms. (shrink)

As one of the most compelling technologies for imaging the brain, functional MRI (fMRI) produces measurements and persuasive pictures of research subjects making cognitive judgments and even reasoning through difficult moral decisions. Even after centuries of studying the link between brain and behavior, this capability presents a number of novel significant questions. For example, what are the implications of biologizing human experience? How might neuroimaging disrupt the mysteries of human nature, spirituality, and personal identity? Rather than waiting for an ethical (...) agenda to emerge from some unpredictable combination of the concerns of ethicists and researchers, the attention of journalists, or after controversy is sparked by research that cannot be retracted, we queried key figures in bioethics and the humanities, neuroscience, media, industry, and patient advocacy in focus groups and interviews. We identified specific ethical, legal and social issues (ELSI) that highlight researcher obligations and the nonclinical impact of the technology at this new frontier. (shrink)

Without proper recognition of the dual pandemics of COVID-19 and racism that Asian Americans and other racial minorities in the United States are facing, we cannot successfully address structural b...

We examine the relation between earnings information content and the use of trust words, such as “character,” “ethics,” and “honest,” in the MD&A section of 10-K. We find that earnings announcements of firms using trust words have lower information content than earnings announcements of firms that do not use trust words. We also find that the value relevance of earnings is lower for firms using trust words than those not using trust words. Further, firms using trust words are more likely (...) to receive a comment letter from the SEC, pay higher audit fees, and have lower corporate social responsibility scores. Overall, our results suggest that firms that use trust words in the 10-K are associated with negative outcomes, and trust words are an inverse measure of trust. (shrink)

Background Machine learning (ML) is utilized increasingly in health care, and can pose harms to patients, clinicians, health systems, and the public. In response, regulators have proposed an approach that would shift more responsibility to ML developers for mitigating potential harms. To be effective, this approach requires ML developers to recognize, accept, and act on responsibility for mitigating harms. However, little is known regarding the perspectives of developers themselves regarding their obligations to mitigate harms.Methods We conducted 40 semi-structured interviews with (...) developers of ML predictive analytics applications for health care in the United States.Results Participants varied widely in their perspectives on personal responsibility and included examples of both moral engagement and disengagement, albeit in a variety of forms. While most (70%) of participants made a statement indicative of moral engagement, most of these statements reflected an awareness of moral issues, while only a subset of these included additional elements of engagement such as recognizing responsibility, alignment with personal values, addressing conflicts of interests, and opportunities for action. Further, we identified eight distinct categories of moral disengagement reflecting efforts to minimize potential harms or deflect personal responsibility for preventing or mitigating harms.Conclusions These findings suggest possible facilitators and barriers to the development of ethical ML that could act by encouraging moral engagement or discouraging moral disengagement. Regulatory approaches that depend on the ability of ML developers to recognize, accept, and act on responsibility for mitigating harms might have limited success without education and guidance for ML developers about the extent of their responsibilities and how to implement them. (shrink)

Volume 20, Issue 7, July 2020, Page 86-88.

Public investments in genomic and precision medicine have begun to yield clinically useful interventions, most recently, for example, two new, FDA-approved gene therapies for sickle cell disease (F...

Appeals to scrutinize the use of race and ethnicity as variables in genetics research notwithstanding, these variables continue to be inadequately explained and inconsistently used in research publications. In previous research, we found that published genetic research fails to follow suggestions offered for addressing this problem, such as explaining the basis on which these labels are assigned to populations. This study, an analysis of genetic research articles using race or ethnicity terms, explores possible features of journals that are associated with (...) improved reporting of race and ethnicity in genetic research. A journal’s expressed commitment to improving how race and ethnicity are used in genetic research, demonstrated by an editorial or in its instructions to authors, was the strongest predictor of following recommendations about reporting race and ethnicity. Journal impact factor had only a limited positive effect on attention to these issues, suggesting that editorial resources associated with higher impact factor journals are not sufficient to improve practices. Our findings reiterate that race and ethnicity variables are used inconsistently in genetic research, but also shed light on how journals might improve practices by highlighting the need for scientists to carefully scrutinize the use of these variables in their work. (shrink)

This paper reports our analysis of the ELSI Virtual Forum: 30 Years of the Genome: Integrating and Applying ELSI Research, an online meeting of scholars focused on the ethical, legal, and social implications (ELSI) of genetics and genomics.

In 2011, the Department of Health and Human Services proposed changes to the regulations that govern human subjects protection in federally funded research. The proposed changes involve modifying inclusion standards for minimal-risk research and removing the necessity of review from certain categories of noninvasive research. All studies would instead be required to comply with privacy protections as initiated by the Health Information Portability and Accountability Act . We argue that relying on HIPAA to protect participants from participation-related risks in noninvasive (...) research is insufficient to protect the autonomy and psychological health of potential research participants. Instead, we suggest a streamlined review format for these categories of research. (shrink)

The US National Institute of Health’s Human Microbiome Project aims to use genomic techniques to understand the microbial communities that live on the human body. The emergent field of microbiome science brought together diverse disciplinary perspectives and technologies, thus facilitating the negotiation of differing values. Here, we describe how values are conceptualized and negotiated within microbiome research. Analyzing discussions from a series of interdisciplinary workshops conducted with microbiome researchers, we argue that negotiations of epistemic, social, and institutional values were inextricable (...) from the reflective and strategic category work that defined and organized the microbiome as an object of study and a potential future site of biomedical intervention. Negotiating the divergence or tension between emerging scientific and regulatory classifications also activated “values levers” and opened up reflective discussions of how classifications embody values and how these values might differ across domains. These data suggest that scholars at the intersections of science and technology studies, ethics, and policy could leverage such openings to identify and intervene in the ways that ethical/regulatory and scientific/technical practices are coproduced within unfolding research. (shrink)

In many jurisdictions, legal frameworks afford patients the opportunity to make prospective medical decisions or to create directives that contain a special provision forfeiting their own ability to object to those decisions at a future time point, should they lose decision‐making capacity. These agreements have been described with widely varying nomenclatures, including Ulysses Contracts, Odysseus Transfers, Psychiatric Advance Directives with Ulysses Clauses, and Powers of Attorney with Special Provisions. As a consequence of this terminological heterogeneity, it is challenging for healthcare (...) providers to understand the terms and uses of these agreements and for ethicists to engage with the nuances of clinical decision‐making with such unique provisions surrounding patient autonomy. In theory, prospective self‐binding agreements may safeguard patient's “authentic” wishes from future “inauthentic” changes of mind. In practice, it is unclear what may be comprised within these agreements or how—and to what effect—they are used. The primary focus of this integrative review is to curate the existing literature describing Ulysses Contracts (and analogous decisions) used in the clinical arena, in order to empirically synthesize their shared essence and provide insights into the traditional components of these agreements when used in practice, the requirements of their consent processes, and the outcomes of their utilization. (shrink)

Background: Biomedical research is influenced by many factors, including the involvement of stakeholder groups invested in research outcomes. Stakeholder involvement in research efforts raises questions of justice as stakeholders’ specific interests and motivations play a role in directing research resources that ultimately produce knowledge, shaping how different conditions (and affected individuals) are understood and treated by society. This issue is highly relevant to child psychiatry research where diagnostic criteria and treatment strategies are often controversial. Biological similarities and stakeholder differences between (...) attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) provide an opportunity to explore this issue by comparing research foci and stakeholder involvement in these conditions. Methods: A subset of ADHD and ASD research articles published between 1970 and 2010 were randomly selected from the PubMed database and coded for research focus, funding source(s), and author-reported conflicts of interest (COIs). Chi-squared analyses were performed to identify differences between and within ADHD and ASD research across time. Results: The proportion of ADHD research dedicated to basic, description, and treatment research was roughly similar and remained stable over time, while ASD research showed a significant increase in basic research over the past decade. Government was the primary research funder for both conditions, but for-profit funders were a notable presence in ADHD research, while joint funding efforts between nonprofit and government funders were a notable presence in ASD research. Lastly, COIs were noted more frequently in ADHD than in ASD research. Conclusions: Our study shows significant differences in research foci and funding sources between the conditions, and identifies the specific involvement of for-profit and nonprofit groups in ADHD and ASD, respectively. Our findings highlight the relationship between stakeholders outside the research community and research trajectories and suggest that examinations of these relationships must be included in broader considerations of biomedical research ethics. (shrink)

Bioethics is reexamining how to implement diversity, equity, inclusion, and justice concerns into scholarship. However, bioethicists should question the categories used to define diversity. The act of categorization is value laden, and classification systems confer power and benefits and generate harms. For example, what conditions count as disabilities? We should consider the equity implications of offering only “male” and “female” options for self‐identification in health records. However, we should also interrogate all ideas about categorization, including how categories are formed, why (...) they are formed, and who decides. Bioethicists cannot comprehend fully what equity and justice mean for underrepresented, underserved, or marginalized people until there is an understanding of how the boundaries of marginalization are created. (shrink)