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Gaceta Sanitaria Jun 2024
PubMed: 38944897
DOI: 10.1016/j.gaceta.2024.102412 -
Ethics & Human Research 2024A leading concern about single IRB (sIRB) review for multisite studies, as is now required by federal policies, is whether and how sIRBs consider local context in their... (Review)
Review
A leading concern about single IRB (sIRB) review for multisite studies, as is now required by federal policies, is whether and how sIRBs consider local context in their review. While several types of local context considerations have been proposed, there is no shared agreement among those charged with the ethics oversight of human subjects research as to the goals and content of local context review, nor the types of research studies for which sIRB review might be inappropriate. Through a scoping review of published scholarship, public comments, and federal guidance documents, we identified five assumed goals for local context review: protecting the rights and welfare of local participants; ensuring compliance with applicable laws and policies; assessing feasibility; promoting the quality of research; and promoting procedural justice. While a variety of content was proposed to be relevant, it was largely grouped into four domains: population/participant-level characteristics; investigator and research team characteristics; institution-level characteristics; and state and local laws. Proposed characteristics for exclusion from sIRB requirements reflected both protection- and efficiency-based concerns. These findings can inform ongoing efforts to assess the implications of policies mandating sIRB review, and when exceptions to those policies might be appropriate.
Topics: Humans; Ethics Committees, Research; Ethics, Research; Human Experimentation
PubMed: 38944885
DOI: 10.1002/eahr.500215 -
Ethics & Human Research 2024The use of patient-reported outcome measures (PROMs) is increasingly common in routine clinical practice. As tools to quantify symptoms and health status, PROMs play an...
The use of patient-reported outcome measures (PROMs) is increasingly common in routine clinical practice. As tools to quantify symptoms and health status, PROMs play an important role in focusing health care on outcomes that matter to patients. The uses of PROM data are myriad, ranging from clinical care to survey-based research and quality improvement. Discerning the boundaries between these use cases can be challenging for institutional review boards (IRBs). In this article, we provide a framework for classifying the three primary PROM use cases (clinical care, human subjects research, and quality improvement) and discuss the level of IRB oversight (if any) necessary for each. One of the most important considerations for IRB staff is whether PROMs are being used primarily for clinical care and thus do not constitute human subjects research. We discuss characteristics of PROMs implemented primarily for clinical care, focusing on: data platform; survey location; questionnaire length; patient interface; and clinician interface. We also discuss IRB oversight of projects involving the secondary use of PROM data that were collected during the course of clinical care, which span human subjects research and quality improvement. This framework provides practical guidance for IRB staff as well as clinicians who use PROMs as communication aids in routine clinical practice.
Topics: Humans; Ethics Committees, Research; Patient Reported Outcome Measures; Quality Improvement; Surveys and Questionnaires
PubMed: 38944884
DOI: 10.1002/eahr.500216 -
Ethics & Human Research 2024Online participant recruitment ("crowdsourcing") platforms are increasingly being used for research studies. While such platforms can rapidly provide access to large...
Online participant recruitment ("crowdsourcing") platforms are increasingly being used for research studies. While such platforms can rapidly provide access to large samples, there are concomitant concerns around data quality. Researchers have studied and demonstrated means to reduce the prevalence of low-quality data from crowdsourcing platforms, but approaches to doing so often involve rejecting work and/or denying payment to participants, which can pose ethical dilemmas. We write this essay as an associate professor and two institutional review board (IRB) directors to provide a perspective on the competing interests of participants/workers and researchers and to propose a checklist of steps that we believe may support workers' agency on the platform and lessen instances of unfair consequences to them while enabling researchers to definitively reject lower-quality work that might otherwise reduce the likelihood of their studies producing true results. We encourage further, explicit discussion of these issues among academics and among IRBs.
Topics: Crowdsourcing; Humans; Checklist; Patient Selection; Ethics, Research; Ethics Committees, Research; Research Personnel; Data Accuracy
PubMed: 38944883
DOI: 10.1002/eahr.500217 -
Ethics & Human Research 2024This article examines the ethics of research design and the initiation of a study (e.g., recruitment of participants) involving refugee participants. We aim to equip...
This article examines the ethics of research design and the initiation of a study (e.g., recruitment of participants) involving refugee participants. We aim to equip investigators and members of IRBs with a set of ethical considerations and pragmatic recommendations to address challenges in refugee-focused research as it is developed and prepared for IRB review. We discuss challenges including how refugees are being defined and identified; their vulnerabilities before, during, and following resettlement that impacts their research participation; recruitment; consent practices including assent and unaccompanied minors; and conflicts of interest. Ethical guidance and regulatory oversight provided by international bodies, federal governments, and IRBs are important for enforcing the protection of participants. We describe the need for additional ethical guidance and awareness, if not special protections for refugee populations as guided by the National Institutes of Health (NIH) Guiding Principles for Ethical Research.
Topics: Refugees; Humans; United States; National Institutes of Health (U.S.); Ethics, Research; Informed Consent; Ethics Committees, Research; North America; Conflict of Interest; Research Design; Patient Selection; Biomedical Research; Minors; Guidelines as Topic; Vulnerable Populations
PubMed: 38944882
DOI: 10.1002/eahr.500214 -
Ethics & Human Research 2024In an earlier essay, I advocated that translational bioethics uses the public's values, determined through social science, in its analysis of translational science...
In an earlier essay, I advocated that translational bioethics uses the public's values, determined through social science, in its analysis of translational science technologies. It may be unclear what those values might be, and whether such a translational ethics would necessarily conclude that cutting edge technologies should not be developed. In this essay, I show the public's values relevant to human brain organoids and argue that a translational bioethics analysis using these values would support continued organoid research.
Topics: Humans; Organoids; Brain; Translational Research, Biomedical; Decision Making; Bioethics; Social Values
PubMed: 38944881
DOI: 10.1002/eahr.500218 -
International Journal of Gynaecology... Jun 2024An arbitrary gestational age limit of viability cannot be set, and in clinical practice the focus should be on a periviability interval-the so-called "gray zone" of...
An arbitrary gestational age limit of viability cannot be set, and in clinical practice the focus should be on a periviability interval-the so-called "gray zone" of prognostic uncertainty. For cases within this interval, the most appropriate decision-making process remains debatable and periviability has emerged as one of the greatest challenges in bioethics. Universally recognized ethical principles may be interpreted differently due to socioeconomic, cultural, and religious aspects. In the case of periviability, there is considerable uncertainty over whether interventions result in a greater balance of clinical good over harm. Furthermore, the fetus or neonate is unable to exercise autonomy and the physicians and parents will act as patient surrogates. When parents and physicians disagree about the infant's best interest, a dialogue without paternalistic attitudes is essential, whereby physicians should only offer, but not recommend, perinatal interventions. Parental choice, based on thorough information, should be respected within the limits of what is medically feasible and appropriate. When disagreements between parents and physicians occur, how is consensus to be achieved? Professional guidelines can be helpful as a framework and starting point for discussion. In reality, however, guidelines only rarely draw categorical lines and in many cases remain vague and ambiguously worded. Local ethics committees can provide counseling and function as moderators during discussions, but ethics committees do not have decision precedence. Counseling assumes the most significant role in periviability discussions, taking into consideration the particular fetal and maternal characteristics, as well as parental values. Several caveats should be observed relative to counseling: message fragmentation or inconsistence should be minimized, prognosis should preferably be presented in a positive framing, and overreliance on statistics should be avoided. It is recommended that decisions regarding neonatal resuscitation in the periviability interval be made before birth and not conditional on the newborn's appearance at birth. Regardless of decision, it is important to assure pre- and postnatal coherence. The present article describes how individual physicians, centers, and countries differ in the approach to the decision to initiate or forgo intensive care in the periviability interval. It is impossible to provide a global consensus view and there can be no unifying ethical, moral, or practical strategy. Nevertheless, ethically justified, quality care comprises early involvement of the obstetric and neonatal team to enable a coherent, comprehensible, nonpaternalistic, and balanced plan of care. Ultimately, physicians will need to adjust the expectations to the local standards, local outcome data, and local neonatal support availability.
PubMed: 38944691
DOI: 10.1002/ijgo.15744 -
Soins. Gerontologie 2024The use of technical aids has a positive impact on the autonomy and quality of life of elderly or disabled people, and is also beneficial for the caregivers and...
The use of technical aids has a positive impact on the autonomy and quality of life of elderly or disabled people, and is also beneficial for the caregivers and professionals who support them. Nevertheless, there are still major obstacles to their use, notably a general lack of information on technical aids. This observation led us to produce a set of information tools to help people better understand these aids and how to use them.
Topics: Humans; Personal Autonomy; Aged; Disabled Persons
PubMed: 38944469
DOI: 10.1016/j.sger.2024.04.008 -
Journal of Industrial Microbiology &... Jun 2024Corynebacterium glutamicum ATCC 13032 is a promising microbial chassis for industrial production of valuable compounds, including aromatic amino acids derived from the...
Corynebacterium glutamicum ATCC 13032 is a promising microbial chassis for industrial production of valuable compounds, including aromatic amino acids derived from the shikimate pathway. In this work, we developed two whole-cell, transcription factor based fluorescent biosensors to track cis, cis-muconic acid (ccMA) and chorismate in C. glutamicum. Chorismate is a key intermediate in the shikimate pathway from which value-added chemicals can be produced, and a shunt from the shikimate pathway can divert carbon to ccMA, a high value chemical. We transferred a ccMA-inducible transcription factor, CatM, from Acinetobacter baylyi ADP1 into C. glutamicum and screened a promoter library to isolate variants with high sensitivity and dynamic range to ccMA by providing benzoate, which is converted to ccMA intracellularly. The biosensor also detected exogenously supplied ccMA, suggesting the presence of a putative ccMA transporter in C. glutamicum, though the external ccMA concentration threshold to elicit a response was 100-fold higher than the concentration of benzoate required to do so through intracellular ccMA production. We then developed a chorismate biosensor, in which a chorismate inducible promoter regulated by natively expressed QsuR was optimized to exhibit a dose-dependent response to exogenously supplemented quinate (a chorismate precursor). A chorismate-pyruvate lyase encoding gene, ubiC, was introduced into C. glutamicum to lower the intracellular chorismate pool, which resulted in loss of dose-dependence to quinate. Further, a knockout strain that blocked the conversion of quinate to chorismate, also resulted in absence of dose-dependence to quinate, validating that the chorismate biosensor is specific to intracellular chorismate pool. The ccMA and chorismate biosensors were dually inserted into C. glutamicum to simultaneously detect intracellularly produced chorismate and ccMA. Biosensors, such as those developed in this study, can be applied in C. glutamicum for multiplex sensing to expedite pathway design and optimization through metabolic engineering in this promising chassis organism.
PubMed: 38944415
DOI: 10.1093/jimb/kuae024 -
The American Journal of Medicine Jun 2024
PubMed: 38944230
DOI: 10.1016/j.amjmed.2024.06.015