Faculty Bibliography

OBJECTIVE:To evaluate the availability of information regarding patient access to investigational treatments through clinical trials and non-trial pre-approval access pathways from a sample of patient advocacy organization (PAO) websites in the United States. RESULTS:We systematically analyzed the content of 118 randomly selected PAO websites to assess whether they contained information on clinical trials and non-trial pathways-e.g., the U.S. Food and Drug Administration (FDA) expanded access (EA) program and right to try-over the course of two months from February to March 2019. A majority (81%, n = 96) of PAOs provided a link to ClinicalTrials.gov, and 73% (n = 86) had their own clinical trial finder or list of relevant trials. 23% (n = 27) mentioned EA, with 8% (n = 9) providing specific resources for FDA's EA program. 8% (n = 10) provided a statement on the passage of the federal right to try law. A majority of PAO websites contained information on clinical trials, but a minority discussed non-trial pre-approval access. The lack of information on the latter highlights an area in need of improvement.

Objective: Posthumous assisted reproduction (PAR) raises complicated ethical and legal issues. ASRM recommends that assisted reproductive technology (ART) and fertility preservation (FP) programs develop written policies regarding cases of PAR, though little is known about adoption of such policies and how they have been implemented. Our objective was to assess the presence and content of policies toward PAR using oocytes and embryos amongSociety for Assisted Reproductive Technology (SART) member clinics in the U.S.
Design(s): Cross-sectional questionnaire-based study.
Material(s) and Method(s): Our study consists of three phases of communication: email-, postal mail-, and phone-based survey. We report on the first phase of anonymous email survey responses. Surveys were emailed to ASRM-member medical directors of all SART member clinics (n=332) during March and April 2019 using a modified Dillman Method; contact information was acquired from SART and ASRM membership data. The survey included 23 multiple-choice and 3 opened-ended questions assessing practice characteristics (practice type, location, IVF cycle volume), presence of a clinic policy towards PAR, and the content of such policy. Descriptive data are presented as %, with Fisher's exact test used where appropriate, and thematic content analysis was applied to open-ended responses.
Result(s): The first phase of the study received 39 clinic responses (12% response rate). Respondents were distributed across the U.S.; average volume of IVF cycles per year ranged from < 250 to > 1500. More than one-third (35.9%, n=14) of clinics reported participating in any cases of PAR over the past five years, and 5.1% (n=2) reported participation in more than five cases. Participation in cases of PAR was not significantly associated with practice type or IVF cycle volume (p>0.05). 57.9% (n=22) had written policies towards PAR using oocytes or embryos, while 36.8% (n=14) reported they did not have a policy. Practice type, IVF cycle volume, FP volume, and prior participation in cases of PAR were not significantly associated with the presence of a policy (p>0.05). Of those with a policy, 52.4% (n=11) reported they had used that policy, 66.7% (n=10) without a policy reported they had considered adopting one, and 60.0% (n=9) reported they had received a request for PAR services. Only 44% (n=15) of clinics specified that patients not expected to survive to use oocytes due to terminal illness were eligible for oocyte cryopreservation, while 50.0% (n=17) did not specify. Open-ended comments suggested need for case-by-case appraisal and firm consent polices regarding gamete disposition.
Conclusion(s): Our preliminary results suggest that SART programs are receiving an increasing number of requests for PAR services, but many SART programs lack PAR policies, and those with policies do not always follow ASRM recommendations. As PAR cases become more common, clinics should be equipped to manage the complexities of PAR. More data are needed as this study continues, and future research is needed to understand barriers to the creation and implementation of these increasingly needed policies.
Copyright

OBJECTIVE:To assess the fulfilment of authors' and editors' individual disclosure of potential conflicts of interest in a group of highly influential medicine journals across a variety of specialties. DESIGN/METHODS:Cross-sectional analysis. SETTING AND PARTICIPANTS/METHODS:Top-ranked five journals as per 2017 Journal Citation Report impact factor of 26 medical, surgery and imaging specialties. INTERVENTIONS/METHODS:Observational analysis. PRIMARY AND SECONDARY OUTCOME MEASURES/UNASSIGNED:Percentage of journals requiring disclosure of authors' and editors' individual potential conflicts of interest (CoI). Journals that were listed as followers of the International Committee of Medical Journal Editors (ICMJE) Recommendations, members of the Committee on Publication Ethics (COPE) and linked to a third party (ie, college, professional association/society, public institution). RESULTS:Although 99% (129/130) of journals required author's CoI disclosure, only 12% (16/130) reported individual editors' potential CoIs. Forty-five per cent (58/130) of journals were followers of the ICMJE Recommendations, and 73% (95/130) were COPE members. Most (69%; 90/130) were linked to a college, professional society/association or public institution. Only one journal did not have policies on individual authors' and editors' CoI disclosure. CONCLUSION/CONCLUSIONS:Very few high-impact medical journals disclosed their editorial teams' individual potential CoIs-conversely, almost all required disclosure of authors' individual CoIs. Journal followers of the ICMJE Recommendations should regularly disclose the editors' individual CoIs, as this is the only legitimate way to ask the same transparency of authors.

Facial transplantation is emerging as a therapeutic option for self-inflicted gunshot wounds. The self-inflicted nature of this injury raises questions about the appropriate role of self-harm in determining patient eligibility. Potential candidates for facial transplantation undergo extensive psychosocial screening. The presence of a self-inflicted gunshot wound warrants special attention to ensure that a patient is prepared to undergo a demanding procedure that poses significant risk, as well as stringent lifelong management. Herein, we explore the ethics of considering mechanism of injury in the patient selection process, referring to the precedent set forth in solid organ transplantation. We also consider the available evidence regarding outcomes of individuals transplanted for self-inflicted mechanisms of injury in both solid organ and facial transplantation. We conclude that while the presence of a self-inflicted gunshot wound is significant in the overall evaluation of the candidate, it does not on its own warrant exclusion from consideration for a facial transplantation.