There are good practical reasons to use electronic consent (e-consent) in randomised trials, especially when conducting large-scale clinical trials to answer population-level health research questions. However, determining ethical reasons for e-consent is not so clear and depends on a proper understanding of what e-consent means when used in clinical trials and its ethical significance. Here we focus on four features of ethical significance which give rise to a range of ethical considerations relating to e-consent and merit further focused ethics research.

Regarding medico-legal malpractice suits, lawyers and insurers focus on informed consent documentation. Unfortunately, there is no standard protocol for obtaining informed consent for platelet-rich plasma (PRP) injections. The objective of the present study was to create a pre-designed, evidence-based informed consent form specifically for PRP injections. The current evidence on the medico-legal implications of PRP injections was accessed, as well as informed consent in general and specifically informed consent in PRP injections. Additionally, we interviewed orthopaedic surgeons and patients who had undergone PRP injections in the past year using a semi-structured approach. A legally valid and evidence-based informed consent form for PRP injections ensures rights, encouraging open communication and transparency between the patient and surgeon. Moreover, if a lawsuit arose, informed consent would be a critical document in surgeons\' defence and would withstand scrutiny from lawyers and the judiciary. An evidence-based informed consent form for PRP injections was elaborated and reviewed by a legal expert to ensure adherence to legal proprieties. The final form of the informed consent for PRP injection was administered for one year and validated at our institution.

Pragmatic clinical trials of standard-of-care interventions compare the relative merits of medical treatments already in use. Traditional research informed consent processes pose significant obstacles to these trials, raising the question of whether they may be conducted with alteration or waiver of informed consent. However, to even be eligible, such a trial in the United States must have no more than minimal research risk. We argue that standard-of-care pragmatic clinical trials can be designed to ensure that they are minimal research risk if the random assignment of an intervention in a pragmatic clinical trial can accommodate individualized, clinically motivated decision-making for each participant. Such a design will ensure that the patient-participants are not exposed to any risks beyond the clinical risks of the interventions, and thus, the trial will have minimal research risk. We explain the logic of this view by comparing three scenarios of standard-of-care pragmatic clinical trials: one with informed consent, one without informed consent, and one recently proposed design called Decision Architecture Randomization Trial. We then conclude by briefly showing that our proposal suggests a natural way to determine when to use an alteration versus a waiver of informed consent.

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In the well-known case of Henrietta Lacks, cells from her tumor were taken without consent and used more than 70 years ago to create the first immortal human cell line (\"HeLa\" cells). That event led to many scientific breakthroughs and to the debate about the ethics of consent and requirements for compensation. May 2024 saw two decisions by US federal courts-one related to Lacks-that could narrow the scope of research allowed on tissues obtained without consent and on nonidentified tissues, with implications for biomedicine.

OBJECTIVE: To evaluate current usage and barriers of e-consent implementation in neurosurgical practice. Electronic consent (e-consent) forms provide an alternative method for conducting the informed consent (IC) procedure. IC requires an ability to understand, retain, weigh up and communicate decisions regarding the proposed procedure. Currently, e-consent has shown promise as a method of improving IC, yet barriers to implementation exist.
METHODS: A comparative analysis regarding procedural and consent data was collected over six months in two neurosurgical centres with elective and emergency caseloads. These were evaluated for changes over time following e-consent introduction. Clinicians were surveyed for their experience using of e-consenting to understand the barriers to implementation.
RESULTS: Over half (55.6%) of neurosurgical procedures made use of e-consent for IC. Lower rates of e-consent were used in trauma related procedures (38.38%) as compared to elective procedures. This did not increase significantly over the study period. Positive clinician survey feedback indicated e-consenting reduces the time required to perform IC, with 50% of respondents strongly agreeing. Barriers to implementation were reported on free-text entry pertaining largely to difficulties in emergency situations due to form complexity. The inability to create and edit templates for personalised e-consent delivery was a further limitation.
CONCLUSIONS: Despite the advantages conferred by e-consent for the administration of IC in neurosurgical procedures, reflected in our survey data, there remains limited use of the technology. Limitations remain relating to ease of access and complexity of use in trauma scenarios.

OBJECTIVE: To explore parental perceptions of the consenting process and understanding of the study in a pilot randomised controlled trial wherein extremely premature infants (<29 weeks\' gestation) were recruited either antenatally or by 4 h of life.
METHODS: We prospectively surveyed parents who had consented, declined consent or were eligible infants in the Positioning Preterm Infants for Neuroprotection study, a low-risk intervention study in the first 72 h of life. Structured interview questions explored the process and acceptability of the consenting approach by the parents and their knowledge of the study. Additional comments made by the parents were transcribed verbatim.
RESULTS: Sixty-two parents participated in the surveys; of those, 41 had provided their consent, 8 declined consent and 13 were parents of missed eligible infants. Overall, most parents reported they understood the study well before providing their consent and approaching them for consenting did not create a burden for them. A verbal explanation of the study by the study team, especially by the medical practitioners, was viewed as beneficial. Where consent was obtained in the birthing unit (imminent births and within 4 h of birthing), it was suggested that the 4-h period for obtaining post-natal consent may be too short. A deferred consent with a follow-up opportunity for obtaining informed consent could be a suitable alternative.
CONCLUSIONS: Parents found the consenting process acceptable and indicated they had sufficient understanding of the study to provide an informed consent. Deferred consent should be explored for future, low-risk intervention studies as an alternative to prospective consent where extremely preterm infants need to be recruited in the immediate neonatal period.

UNASSIGNED: Implementation science presents ethical issues not well addressed by traditional research ethics frameworks. There is little empirical work examining how clinicians whose work is affected by implementation studies view these issues. Accordingly, we interviewed clinicians working at sites participating in an implementation study seeking to improve patient handoffs to the intensive care unit (ICU).
UNASSIGNED: We performed semi-structured interviews with 32 clinicians working at sites participating in an implementation study aiming to improve patient handoffs from the operating room to the ICU. We analyzed the interviews using an iterative coding process following a conventional content analysis approach.
UNASSIGNED: Clinicians\' greatest concern about involvement was possible damage to interpersonal relations with more senior clinicians. They were divided about whether informed consent from clinicians was necessary but were satisfied with the study\'s approach of sending out mass communications about the study. They did not think opting out of the implementation portion of the study was feasible but saw this inability to opt out as unproblematic because they equated the study with routine quality improvement. Those clinicians who helped launch the study at their sites recounted several different ways of doing so beyond simply facilitating access.
UNASSIGNED: The risks that clinicians identified stemmed more from their general status as employees than their specific work as clinicians. Implementation researchers should be attuned to the ethical ramifications of involving employees of varying ranks. Implementation researchers using hybrid designs should also be sensitive to the possibility that practitioners affected by a study will equate it with quality improvement and overlook its research component. Finally, the interactions that go into facilitating an implementation study are more various than the \"gatekeeping\" typically discussed by research ethicists. More research is needed on the ethics of the myriad interactions that are involved in making implementation studies happen.

OBJECTIVE: Nitrous oxide affects memory and recall. We aimed to determine if using nitrous oxide during labor affected patients\' ability to learn and recall the risks and benefits of neuraxial analgesia.
METHODS: Single-center, prospective cohort study.
METHODS: Labor and delivery unit in a large academic medical center.
METHODS: Nulliparous patients with spontaneous or planned induction of labor.
METHODS: Parturients chose whether to use nitrous oxide during labor. At the discussion for epidural consent, 4 risks were described: headache, infection, nerve damage, bleeding.
METHODS: Labor pain score, time from nitrous oxide discontinuation, and cervical dilation were documented at the discussion of epidural risks. Patients were assessed for unprompted recall and prompted recall of epidural risks on postpartum day 1 and unprompted recall at postpartum week 6. The number and proportion of patients who indicated each true risk (unprompted and prompted recall) or distractor (prompted recall only) were summarized by treatment group and results compared using Pearson χ2 tests.
RESULTS: Of the 403 enrolled patients, 294 (73%) did not use nitrous oxide, and 109 (27%) did. The 2 groups were similar except women who used nitrous oxide were more likely to be cared for by midwives and had higher pain scores at their epidural request. Scores for unprompted or prompted recall of epidural risks were not different between women who received or did not receive nitrous oxide. All 4 risks were recalled unprompted by only 3% in the nitrous oxide group and by 6% in the group not receiving nitrous oxide (P = .18).
CONCLUSIONS: The use of nitrous oxide for labor analgesia does not adversely influence a parturient\'s ability to recall the risks of epidural placement. Patients who receive nitrous oxide for labor analgesia should be considered eligible to provide consent for subsequent procedures.

Only a few physicians are willing to comprehensively concern themselves with how a legally watertight treatment documentation should be structured, in addition to their practical activities; however, the importance of the documentation cannot be emphasized enough, not only for a potential case of liability but also for the medical (further) treatment. This article therefore illustrates the legal foundations of the mandatory documentation and the most important questions associated with it for the practice, in particular on the content of the documentation, the timing of the documentation, the preservation of treatment documents and on the conduct in cases of an impending incident.
UNASSIGNED: Die wenigsten Mediziner setzen sich neben ihrer praktischen Tätigkeit gern umfassend damit auseinander, wie eine juristisch „wasserdichte“ Behandlungsdokumentation zu gestalten ist. Die Bedeutung der Dokumentation nicht nur für einen etwaigen Haftungsfall, sondern auch für die medizinische (Weiter‑)Behandlung kann jedoch nicht ausreichend hervorgehoben werden. Der Beitrag beleuchtet daher die rechtlichen Grundlagen der Dokumentationspflicht sowie die wichtigsten damit zusammenhängenden Fragen für die Praxis, insbesondere zum Inhalt der Dokumentation, zum Dokumentationszeitpunkt, zur Aufbewahrung der Behandlungsunterlagen und zum Verhalten bei einem sich abzeichnenden Zwischenfall.