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Drugs of unproven benefit for COVID-19: a pharma perspective on ethical allocation of available therapies

Caplan, Arthur L; Waldstreicher, Joanne; Childers, Karla; Maree, Aran
PMCID:7598031
PMID: 32931482
ISSN: 1558-8238
CID: 4679152

Reactions to the National Academies/Royal Society Report on Heritable Human Genome Editing

Angrist, Misha; Barrangou, Rodolphe; Baylis, Françoise; Brokowski, Carolyn; Burgio, Gaetan; Caplan, Arthur; Chapman, Carolyn Riley; Church, George M; Cook-Deegan, Robert; Cwik, Bryan; Doudna, Jennifer A; Evans, John H; Greely, Henry T; Hercher, Laura; Hurlbut, J Benjamin; Hynes, Richard O; Ishii, Tetsuya; Kiani, Samira; Lee, LaTasha Hoskins; Levrier, Guillaume; Liu, David R; Lunshof, Jeantine E; Macintosh, Kerry Lynn; Mathews, Debra J H; Meslin, Eric M; Mills, Peter H R; Montoliu, Lluis; Musunuru, Kiran; Nicol, Dianne; O'Neill, Helen; Qiu, Renzong; Ranisch, Robert; Sherkow, Jacob S; Soni, Sheetal; Terry, Sharon; Topol, Eric; Williamson, Robert; Zhang, Feng; Davies, Kevin
In September 2020, a detailed report on Heritable Human Genome Editing was published. The report offers a translational pathway for the limited approval of germline editing under limited circumstances and assuming various criteria have been met. In this perspective, some three dozen experts from the fields of genome editing, medicine, bioethics, law, and related fields offer their candid reactions to the National Academies/Royal Society report, highlighting areas of support, omissions, disagreements, and priorities moving forward.
PMID: 33095048
ISSN: 2573-1602
CID: 4679172

The ethics of the unmentionable

Caplan, Arthur L
PMID: 32895297
ISSN: 1473-4257
CID: 4590182

Ethical considerations for protecting the options of subjects in primary epidemic vaccine trials

Caplan, Arthur L; Abraham, Jerrold L
PMID: 32943477
ISSN: 1473-4257
CID: 4651602

Posthumous assisted reproduction policies among a cohort of United States' in vitro fertilization clinics

Trawick, Emma; Sampson, Amani; Goldman, Kara; Campo-Engelstein, Lisa; Caplan, Arthur; Keefe, David L; Quinn, Gwendolyn P
Objective/UNASSIGNED:To assess the presence and content of policies toward posthumous assisted reproduction (PAR) using oocytes and embryos among Society for Assisted Reproductive Technology (SART) member clinics in the United States. Design/UNASSIGNED:Cross-sectional questionnaire-based study. Setting/UNASSIGNED:Not applicable. Patients/UNASSIGNED:A total of 62 SART member clinics. Interventions/UNASSIGNED:Questionnaire including multiple choice and open-ended questions. Main Outcome Measures/UNASSIGNED:Descriptive statistics regarding presence and content of policies regarding PAR using oocytes and embryos, consent document content regarding oocyte and embryo disposition, and eligibility of minors and those with terminal illness for fertility preservation. Results/UNASSIGNED:Of the 332 clinics contacted, 62 responded (response rate 18.7%). Respondents were distributed across the United States, and average volume of in vitro fertilization (IVF) cycles per year ranged from <250 to >1,500, but 71.2% (n = 42) reported a volume of <500. Nearly one-half (42.4%, n = 25) of clinics surveyed reported participating in any cases of posthumous reproduction during the past 5 years, and 6.8% (n = 4) reported participation in >5 cases. Participation in cases of posthumous reproduction was not significantly associated with practice type or IVF cycle volume among those surveyed. Only 59.6% (n = 34) of clinics surveyed had written policies regarding PAR using oocytes or embryos, whereas 36.8% (n = 21) reported they did not have a policy. Practice type, IVF cycle volume, fertility preservation volume, and prior participation in cases of PAR were not significantly associated with the presence of a policy among respondent clinics. Of those with a policy, 55.9% (n = 19) reported they had used that policy, 59.1% (n = 13) without a policy reported they had considered adopting one, and 63.6% (n = 14) reported they had received a request for PAR services. Only 47.2% (n = 25) of clinics surveyed specified that patients not expected to survive to use oocytes due to terminal illness are eligible for oocyte cryopreservation, whereas 45.3% (n = 24) did not specify. Conclusions/UNASSIGNED:Respondent clinics reported receiving an increasing number of requests for PAR services, but many also lacked PAR policies. Those with policies did not always follow ASRM recommendations. Given the low response rate, these data cannot be interpreted as representative of SART clinics overall. As PAR cases become more common, however, this study highlights poor reporting of PAR and institutional policies toward PAR, suggesting that SART clinics may not be equipped to systematically manage the complexities of PAR.
PMCID:8244314
PMID: 34223220
ISSN: 2666-3341
CID: 4932912

Medical Imaging and Privacy in the Era of Artificial Intelligence: Myth, Fallacy, and the Future

Lotan, E; Tschider, C; Sodickson, D K; Caplan, A; Bruno, M; Zhang, B; Lui, Yvonne W
PMID: 32360449
ISSN: 1558-349x
CID: 4439052

The danger of DIY vaccines [Editorial]

Caplan, Arthur L; Bateman-House, Alison
PMID: 32855312
ISSN: 1095-9203
CID: 4614502

Ventilator Triage Policies During the COVID-19 Pandemic at U.S. Hospitals Associated With Members of the Association of Bioethics Program Directors

Matheny Antommaria, Armand H; Gibb, Tyler S; McGuire, Amy L; Wolpe, Paul Root; Wynia, Matthew K; Applewhite, Megan K; Caplan, Arthur; Diekema, Douglas S; Hester, D Micah; Lehmann, Lisa Soleymani; McLeod-Sordjan, Renee; Schiff, Tamar; Tabor, Holly K; Wieten, Sarah E; Eberl, Jason T
Background/UNASSIGNED:The coronavirus disease 2019 pandemic has or threatens to overwhelm health care systems. Many institutions are developing ventilator triage policies. Objective/UNASSIGNED:To characterize the development of ventilator triage policies and compare policy content. Design/UNASSIGNED:Survey and mixed-methods content analysis. Setting/UNASSIGNED:North American hospitals associated with members of the Association of Bioethics Program Directors. Participants/UNASSIGNED:Program directors. Measurements/UNASSIGNED:Characteristics of institutions and policies, including triage criteria and triage committee membership. Results/UNASSIGNED:Sixty-seven program directors responded (response rate, 91.8%); 36 (53.7%) hospitals did not yet have a policy, and 7 (10.4%) hospitals' policies could not be shared. The 29 institutions providing policies were relatively evenly distributed among the 4 U.S. geographic regions (range, 5 to 9 policies per region). Among the 26 unique policies analyzed, 3 (11.3%) were produced by state health departments. The most frequently cited triage criteria were benefit (25 policies [96.2%]), need (14 [53.8%]), age (13 [50.0%]), conservation of resources (10 [38.5%]), and lottery (9 [34.6%]). Twenty-one (80.8%) policies use scoring systems, and 20 of these (95.2%) use a version of the Sequential Organ Failure Assessment score. Among the policies that specify the triage team's composition (23 [88.5%]), all require or recommend a physician member, 20 (87.0%) a nurse, 16 (69.6%) an ethicist, 8 (34.8%) a chaplain, and 8 (34.8%) a respiratory therapist. Thirteen (50.0% of all policies) require or recommend those making triage decisions not be involved in direct patient care, but only 2 (7.7%) require that their decisions be blinded to ethically irrelevant considerations. Limitation/UNASSIGNED:The results may not be generalizable to institutions without academic bioethics programs. Conclusion/UNASSIGNED:Over one half of respondents did not have ventilator triage policies. Policies have substantial heterogeneity, and many omit guidance on fair implementation.
PMCID:7207244
PMID: 32330224
ISSN: 1539-3704
CID: 4436812

It's Not Easy Bein' Fair [Comment]

Ferguson, Kyle; Caplan, Arthur
PMID: 32716783
ISSN: 1536-0075
CID: 4542882

Adverse Consequences of Rushing a SARS-CoV-2 Vaccine: Implications for Public Trust

Trogen, Brit; Oshinsky, David; Caplan, Arthur
PMID: 32453392
ISSN: 1538-3598
CID: 4464692