ChatGPT is an artificial intelligence (AI) chatbot that processes and generates natural language text, offering human-like responses to a wide range of questions and prompts. Five days after its re...

The papers by Nancy Kass, Ruth Faden, and colleagues describe an ethical imperative to study clinical care as it is being delivered. The goal of learning from each patient is attractive, but integrating research and clinical practice is not easy. The authors suggest that the bioethical framework in use for the past forty years to oversee clinical research may be as much an impediment to the development of a learning health care system as a means of protecting the interests of (...) patients. This framework draws a bright line between clinical research and clinical care activities, subjecting clinical research to institutional review and ongoing oversight while assuming that clinical care is conducted primarily in the interests of patients and not in need of additional ethical oversight. The authors identify five characteristics that have been used to distinguish the two activities, and they conclude that none succeed. The practical implications of this conclusion are left unspecified, however. Should ethical oversight simply be eliminated for these kinds of research activities on the grounds that oversight is not mandated for clinical care and the two cannot be distinguished? (shrink)

BackgroundAlthough the peer review process is believed to ensure scientific rigor, enhance research quality, and improve manuscript clarity, many investigators are concerned that the process is too slow, too expensive, too unreliable, and too static. In this feasibility study, we sought to survey corresponding authors of recently published clinical research studies on the speed and efficiency of the publication process.MethodsWeb-based survey of corresponding authors of a 20% random sample of clinical research studies in MEDLINE-indexed journals with Ovid MEDLINE entry dates (...) between December 1 and 15, 2016. Survey addressed perceived manuscript importance before first submission, approximate first submission and final acceptance dates, and total number of journal submissions, external peer reviews, external peer reviewers, and revisions requested, as well as whether authors would have considered publicly sharing their manuscript on an online platform instead of submitting to a peer-reviewed journal.ResultsOf 1780 surveys distributed, 27 corresponding authors opted out or requested that we stop emailing them and 149 emails failed (e.g., emails that bounced n = 64, returned with an away from office message n = 70, or were changed/incorrect n = 15), leaving 1604 respondents, of which 337 completed the survey (21.0%). Respondents and non-respondents were similar with respect to study type and publication journals’ impact factor, although non-respondent authors had more publications (p = 0.03). Among respondents, the median impact factor of the publications’ journal was 2.7 (interquartile range (IQR), 2.0–3.6) and corresponding authors’ median h-index and number of publications was 9 (IQR, 3–20) and 27 (IQR, 10–77), respectively. The median time from first submission to journal acceptance and publication was 5 months (IQR, 3–8) and 7 months (IQR, 5–12), respectively. Most respondents (62.0%, n = 209) rated the importance of their research as a 4 or 5 (5-point scale) prior to submission. Median number of journal submissions was 1 (IQR, 1–2), external peer reviews was 1 (IQR, 1–2), external peer reviewers was 3 (IQR, 2–4), and revisions requested was 1 (IQR, 1–1). Sharing manuscripts to a public online platform, instead of submitting to a peer-reviewed journal, would have been considered by 55.2% (n = 186) of respondents.ConclusionCorresponding authors have high perceptions of their research and reported requiring few manuscript submissions prior to journal acceptance, most commonly by lower impact factor journals. (shrink)