AJOB Empirical Bioethics

Nong, Paige; Creary, Melissa; Platt, Jodyn; Kardia, Sharon

doi: 10.1080/23294515.2022.2160506pmid: 36594825

Abstract Objective Analyze racial differences in comfort with medical research using an alternative to the traditional approach that treats white people as a raceless norm. Methods Quantitative analysis of survey responses (n = 1,570) from Black and white residents of the US to identify relationships between perceptions of research as a right or a risk, and comfort participating in medical research. Results A lower proportion of white respondents reported that medical experimentation occurred without patient consent (p < 0.001) and a higher proportion of white respondents reported that it should be their right to participate in medical research (p = 0.02). Belief in one’s right to participate was significantly predictive of comfort (b = 0.37, p < 0.001). Belief in experimentation without consent was significantly predictive of comfort for white respondents but not for Black respondents in multivariable analysis. Conclusions A rights-based orientation and less concern about the risks of medical research among white respondents demonstrate comparative advantage. Efforts to diversify medical research may perpetuate structural racism if they do not (1) critically engage with whiteness and its role in comfort with participation, and (2) identify and respond specifically to the needs of Black patients.

Notini, Lauren; Gaff, Clara; Savulescu, Julian; Vears, Danya F.

doi: 10.1080/23294515.2022.2160507pmid: 36595590

Abstract Background There is ongoing debate regarding whether and under which circumstances secondary findings (SF) should be offered in the pediatric context. Although studies have examined patient perspectives on receiving SF, little research has been conducted examining the experiences of clinicians offering SF to parents of newborns receiving genomic sequencing for a recently diagnosed medical condition. Methods To address this, we conducted qualitative interviews exploring the views and experiences of 12 clinicians who offered SF to parents of infants who had diagnostic exome sequencing (ES) to identify the cause of their hearing loss. Interviews explored clinicians’ accounts of parents’ choices and decision-making about receiving SF, their views on whether and when to offer SF, their experiences returning SF, and any ethical challenges they encountered. Interviews were audio-recorded, transcribed and analyzed using inductive content analysis. Results Clinicians reported parents who declined all SF often felt finding out about future conditions unrelated to their child’s hearing loss may be unhelpful, or even harmful, or were overwhelmed by their child’s diagnosis. Clinicians also reported that some parents chose SF because they felt obliged to, even if they did not want to receive them. They explained that while some parents experienced decision-making regarding SF as positive, for others, this process was challenging or distressing. While clinicians generally agreed SF should be offered, mainly to promote parental choice, most felt SF should be offered after disclosing diagnostic results, primarily to avoid overwhelming parents. Clinicians encountered several ethical challenges, including balancing parental autonomy with non-maleficence, wanting to report or not report certain SF, and questioning whether parents can make an autonomous choice regarding SF. Conclusions Our findings, which are novel as they relate to parents of young infants with a recent diagnosis of hearing loss, add new insights into clinicians’ and parents’ decision-making regarding SF in pediatrics.

Salter, Erica K.; Malone, Jay R.; Berg, Amanda; B. Friedrich, Annie; Hucker, Alexandra; King, Hillary; Antommaria, Armand H. Matheny

doi: 10.1080/23294515.2022.2160508pmid: 36576201

Abstract Objectives To characterize the prevalence and content of pediatric triage policies. Methods We surveyed and solicited policies from U.S. hospitals with pediatric intensive care units. Policies were analyzed using qualitative methods and coded by 2 investigators. Results Thirty-four of 120 institutions (28%) responded. Twenty-five (74%) were freestanding children’s hospitals and 9 (26%) were hospitals within a hospital. Nine (26%) had approved policies, 9 (26%) had draft policies, 5 (14%) were developing policies, and 7 (20%) did not have policies. Nineteen (68%) institutions shared their approved or draft policy. Eight (42%) of those policies included neonates. The polices identified 0 to 5 (median 2) factors to prioritize patients. The most common factors were short- (17, 90%) and long- (14, 74%) term predicted mortality. Pediatric scoring systems included Pediatric Logistic Organ Dysfunction-2 (12, 63%) and Score for Neonatal Acute Physiology and Perinatal Extensions-II (4, 21%). Thirteen (68%) policies described a formal algorithm. The most common tiebreakers were random/lottery (10, 71%) and life cycles (9, 64%). The majority (15, 79%) of policies specified the roles of triage team members and 13 (68%) precluded those participating in patient care from making triage decisions. Conclusions While many institutions still do not have pediatric triage policies, there appears to be a trend among those with policies to utilize a formal algorithm that focuses on short- and long-term predicted mortality and that incorporates age-appropriate scoring systems. Additional work is needed to expand access to pediatric-specific policies, to validate scoring systems, and to address health disparities.

Graham, S. Scott; Sharma, Nandini; Karnes, Martha S.; Majdik, Zoltan P.; Barbour, Joshua B.; Rousseau, Justin F.

doi: 10.1080/23294515.2022.2160509pmid: 36576202

Abstract Introduction Financial conflicts of interest (fCOI) present well documented risks to the integrity of biomedical research. However, few studies differentiate among fCOI types in their analyses, and those that do tend to use preexisting taxonomies for fCOI identification. Research on fCOI would benefit from an empirically-derived taxonomy of self-reported fCOI and data on fCOI type and payor prevalence. Methods We conducted a content analysis of 6,165 individual self-reported relationships from COI statements distributed across 378 articles indexed with PubMed. Two coders used an iterative coding process to identify and classify individual fCOI types and payors. Inter-rater reliability was κ = 0.935 for fCOI type and κ = 0.884 for payor identification. Results Our analysis identified 21 fCOI types, 9 of which occurred at prevalences greater than 1%. These included research funding (24.8%), speaking fees (20.8%), consulting fees (18.8%), advisory relationships (11%), industry employment (7.6%), unspecified fees (4.8%), travel fees (3.2%), stock holdings (3.1%), and patent ownership (1%). Reported fCOI were held with 1,077 unique payors, 22 of which were present in more than 1% of financial relationships. The ten most common payors included Pfizer (4%), Novartis (3.9%), MSD (3.8%), Bristol Myers Squibb (3.2%), AstraZeneca (3.1%), GSK (3%), Boehringer Ingelheim (2.9%), Roche (2.8%), Eli LIlly (2.5%), and AbbVie (2.4%). Conclusions These results provide novel multi-domain prevalence data on self-reported fCOI and payors in biomedical research. As such, they have the potential to catalyze future research that can assess the differential effects of various types of fCOI. Specifically, the data suggest that comparative analyses of the effects of different fCOI types are needed and that special attention should be paid to the diversity of payor types for research relationships.

Morrell, Walker; Gelinas, Luke; Zarin, Deborah; Bierer, Barbara E.

doi: 10.1080/23294515.2022.2160510pmid: 36599052

Abstract Background Ethical and scientific principles require that clinical trials address an important question and have the resources needed to complete the study. However, there are no clear standards for review that would ensure that these principles are upheld. Methods We conducted semi-structured interviews with a convenience sample of nineteen experts in clinical trial design, conduct, and/or oversight to elucidate current practice and identify areas of need with respect to ensuring the scientific value and feasibility of clinical trials prior to initiation and while ongoing. We used a priori and grounded theory to analyze the data and constant comparative method to induce higher order themes. Results Interviewees perceived determination of scientific value as the responsibility of the investigator and, secondarily, other parties who review or oversee research. Interviewees reported that ongoing trials are rarely reevaluated due to emerging evidence from external sources, evaluation is complex, and there would be value in the development of standards for monitoring and evaluating evidence systematically. Investigators, IRBs, and/or data monitoring committees (DMCs) could undertake these responsibilities. Feasibility assessments are performed but are typically inadequate; potential solutions are unclear. Conclusions There are three domains where current approaches are suboptimal and in which further guidance is needed. First, who has the responsibility for conducting scientific review, whether it be the investigator, IRB, and/or DMC is often unclear. Second, the standards for scientific review (e.g., appropriate search terms, data sources, and analytic plan) should be defined. Third, guidance is needed on the evaluation of ongoing studies in light of potentially new and evolving evidence, with particular reference to evidence from outside the trial itself.

Peabody Smith, Ally; Taiclet, Lauren; Ebadi, Hamasa; Levy, Lilyana; Weber, Megan; Caruso, Eugene M.; Pouratian, Nader; Feinsinger, Ashley

doi: 10.1080/23294515.2022.2123869pmid: 36137012

Abstract Background: Patients undergoing invasive neurosurgical procedures offer researchers unique opportunities to study the brain. Deep brain stimulation patients, for example, may participate in research during the surgical implantation of the stimulator device. Although this research raises many ethical concerns, little attention has been paid to basic studies, which offer no therapeutic benefits, and the value of patient-participant perspectives. Methods: Semi-structured interviews were conducted with fourteen individuals across two studies who participated in basic intraoperative research during their deep brain stimulator surgery. Interviews explored interpretations of risks and benefits, enrollment motivations, and experiences of participating in awake brain research. Reflexive thematic analysis was conducted. Results: Seven themes were identified from participant narratives, including robust attitudes of trust, high valuations of basic science research, impacts of the surgical context, and mixed experiences of participation. Conclusion: We argue that these narratives raise the potential for a translational misconception and motivate intraoperative re-consent procedures.