This study explores the ethical issues contained in warning letters (WLs) issued to institutional review boards (IRBs) by the United States Food and Drug Administration (FDA).The online FDA Warning Letter Index was reviewed for letters issued to IRBs in the United States under the violation categories "Institutional Review Board" and "IRB" for the period January 1997 through July 2004. The resultant letters were evaluated for violations in 4 regulatory themes: having and following written procedures for research review; documentation of research review; IRB membership and conflict of interest; and informed consent.Fifty-two (52) FDA WLs were issued to IRBs during this period. Hospital/medical centre IRBs received the most letters (n = 34), followed by university IRBs (n = 9) and private IRBs (n = 9). The most common regulatory violations were failure to have and follow adequate written procedures about how the review of research is conducted (50 WLs); failure to prepare and maintain adequate documentation of IRB activities (47 WLs); and failure to provide adequate continuing review of approved studies (36 WLs). Nineteen WLs were issued for consent form issues.Warning letters are informative with regard to clinical research regulations and research subject protection. The content of these letters consistently indicates weaknesses in review and documentation activities of audited IRBs, potentially signalling similar issues among IRBs across the United States. Our findings, in a setting of overburdened IRBs who, in general, passively monitor studies, raise concerns about study oversight and optimal protection of research subjects.
Authors and their institutions are vulnerable to predatory publishers due to the “publish or perish” research mentality. The author’s spam-filtered emails from journals were collected for 90 days and analysed for 8 stylistic components; the journal website was explored for publishing fees, research ethics policies, and physical address; the publisher’s physical address was cross-checked in corporate registries for validation; each journal was checked for indexing in Embase®, MEDLINE®, and the Directory of Open Access Journals (DOAJ). One hundred twenty email solicitations were received from 101 journals. Overall, 52 (43.3%) solicitations were from specialty medical journals (e.g., endocrinology, cardiology, orthopaedics); 23 (19.2%) were sent from general medicine journals. Flattery (77 emails) and grammar errors (761 total, x̅ 6.3/email) were common. Publication fees ranged from free to USD 5,000, with some journals requiring copyright transfer to the publisher yet charging authors and claiming to be open access. Most journals were found to be based in either India (75.3%) or Nigeria (17.8%); however, the physical address noted on the journal website was often deceptive (70.3%) or undisclosed (13.9%). Some of the journals had either no research ethics policy (n=7) or a policy that addressed only plagiarism (n=16). Guidance to detect predatory publishers is provided.
The postmortem issues raised by battery‐operated implants (BOI) are complex and issues of consent, setting (clinical vs research), and environmental risks have received little attention in bioethics literature. Analyzing the issues, the following are argued: (1) Patients receiving BOIs should sign a consent form that includes a requirement for postmortem explant of the device; (2) BOI consent forms should require the explanted devices be returned to their manufacturers for Returned Product Analysis; (3) Failure to explant and analyze devices from the research setting fails the research goal of generation of knowledge for the benefit of future patients; (4) Failure to explant and analyze devices from the clinical setting allows product defects to be potentially hidden from patients, families, clinicians, manufacturers, and regulatory agencies; (5) Bodies buried with BOIs potentially harm the environment; (6) Religious or philosophical objections to autopsy should not supersede the duty to explant and analyze BOIs; (7) The concepts herein for BOIs could potentially extend to non‐BOI if the device has failure modes that can lead to a potentially life‐threatening event or can cause permanent debilitating health issues, and the burial or cremation of the device poses environmental harm. In these situations, neither the patient (premortem) nor family (postmortem) should have the right to refuse explant. (PACE 2013; 36:7–10)
Introduction Managing patients who return home after commercial transplantation in a foreign country and those considering travel abroad, may create ethical dilemmas for donation and transplantation professionals. Research in the Netherlands suggests approximately 35% of transplant professionals are likely to encounter at least one returning transplant “tourist”,[1] however the prevalence of such experience internationally is unknown. Methods A working group of the Ethics Committee of The Transplantation Society (TTS) conducted a study investigating professional experience of ethical issues in donation and transplantation. Participants were recruited via email to participate in an anonymous survey in English or Spanish. Survey items addressed participant demographics and professional experience of ethical issues or concerns in specific domains of donation and transplantation practice. Invitations were sent to TTS members and to the leadership of national and regional transplantation professional societies, for dissemination among members and colleagues. Data were collected between January 27- May 1, 2016. Selected data pertaining to reported experience of issues relating to organ trade, transplant tourism and financial incentives for donation are presented in this paper. Results 864 respondents from 84 countries completed the survey (44% Europe; 20% North America; 12% Latin America; 9% Asia; 8% Middle East; 4% Australia and New Zealand; 2% Africa). 40% of respondents were physicians; surgeons (23%); donor or transplant coordinators (21%); other (16%). 33% of respondents (n = 281) reported personal experience of ethical issues relating to organ trading, transplant tourism or incentives for donation. Among nephrologist respondents, the proportion with such experience was 47% (n = 85). Of all respondents with such experience, 66% reported experience of ethical concerns in retrospective management of transplant travellers; 57% prospective management of patients considering travel abroad to purchase an organ; 44% management of foreign patients who travelled for the purpose of donation or transplantation; 35% management of living donor-recipient pairs where a commercial relationship is suspected. Conclusions At least one third of transplant professionals may experience ethical dilemmas related to management of patients who have traveled, or are considering travel abroad for commercial transplantation, or who may be involved in organ trafficking. Guidance tools are urgently needed to support clinicians in managing such ethical dilemmas. The Transplantation Society Ethics Committee. Declaration of Istanbul Custodian Group. Reference: 1. Ambagtsheer F, Van Balen LJ, Duijst‐Heesters WLJM, Massey EK, & Weimar W. Reporting organ trafficking networks: a survey‐based plea to breach the secrecy oath. American Journal of Transplantation. 2015;15: 1759–1767.
Background and Purpose: To characterize the global physician community’s opinions on the use of digital tools for COVID-19 public health surveillance and self-surveillance. Materials and Methods: Cross-sectional, random, stratified survey done on Sermo, a physician networking platform, between September 9 and 15, 2020. We aimed to sample 1000 physicians divided among the USA, EU, and rest of the world. The survey questioned physicians on the risk-benefit ratio of digital tools, as well as matters of data privacy and trust. Statistical Analysis Used: Descriptive statistics examined physicians’ characteristics and opinions by age group, gender, frontline status, and geographic region. ANOVA, t -test, and Chi-square tests with P < 0.05 were viewed as qualitatively different. As this was an exploratory study, we did not adjust for small cell sizes or multiplicity. We used JMP Pro 15 (SAS), as well as Protobi. Results: The survey was completed by 1004 physicians with a mean (standard deviation) age of 49.14 (12) years. Enthusiasm was highest for self-monitoring smartwatches (66%) and contact tracing apps (66%) and slightly lower (48-56%) for other tools. Trust was highest for health providers (68%) and lowest for technology companies (30%). Most respondents (69.8%) felt that loosening privacy standards to fight the pandemic would lead to misuse of privacy in the future. Conclusion: The survey provides foundational insights into how physicians think of surveillance.
Ethical issues associated with transfusion-free medicine and surgery have been around since the inception of the concept of this clinical practice. For clinicians, ethical concern and outright moral distress can arise in many situations. While the shared goal between doctor and patient might be transfusion-free clinical practices, the physician is always making mental calculations that attempt to balance the need for tissue oxygenation against the need for human blood transfusion. This chapter discusses various ethics matters, including professionalism in the practice of transfusion-free practice, informed consent, informed refusal, pediatric assent, organ transplantation, and research.
Abstract Advances in science and technology have created a plethora of medical therapies in various forms including drugs, devices, and equipment. Many of these therapies are not curative, however, and patients sometimes find themselves being more burdened than benefited by them. These situations result in ethical dilemmas for which the bioethicist is sometimes consulted to resolve. Using philosophical principles of maximizing good, minimizing harm, being just, and respecting the values of others, the bioethicist counsels patients, families, and hospital personnel, sometimes functioning as advocate, arbitrator, negotiator, mediator, and teacher. Keywords: Bioethicistethicsapplied philosophyconsultationmedicine
A Case of Deception? PB, a middle-aged man, has suffered from Crohn's proctitis, an autoimmune disorder, for most of his life. To treat it, he undergoes a nonemergent colostomy and proctectomy; he had also undergone several bowel resections at other hospitals prior to this with no complications. Before surgery, he meets twice with the surgeon to discuss surgical risks such as heavy bleeding. Preoperatively, his hemoglobin is 10.2 g/dL. However, twenty-four hours after surgery, his hemoglobin drops to 5.1 g/dL, prompting the doctor to recommend transfusion. PB refuses, saying he is a Jehovah's Witness. Jehovah's Witnesses typically refuse blood transfusion based on their interpretation of the Bible verse, "You are to abstain from . . . blood" (Acts 15:9). Up until PB's refusal, neither the surgeon nor the anesthesiologist was aware that he was a Jehovah's Witness. Based on this surprising revelation, the surgeon requests a bioethics consult to find out how to proceed. The bioethicist reviews PB's chart and finds that the hospital admitting clerk had noted his religion as "Jehovah's Witness" on the registration form. The bioethicist then interviews PB and his wife. They provide the bioethicist with a copy of PB's advance directive. This document states that PB will refuse blood transfusions in all situations, but PB did not give it to the surgeon or preoperative staff before surgery. Did PB have a responsibility to provide information about his religious beliefs that would be relevant to his treatment to all hospital staff and make sure it was understood? commentary Katrina A. Bramstedt (bio) According to the American Medical Association, the practice of medicine is fundamentally a moral activity. Informed consent and therapeutic doctor-patient relationships rely on honesty between both parties. Lack of honesty on behalf of either party can create the potential for devastating consequences, yet often, discourse on this topic focuses on how the doctor communicates with the patient, not the patient with the doctor. In this case, even though the surgeon had multiple conversations with PB before surgery, PB never mentioned that he was a Jehovah's Witness and would refuse transfusion. Knowing these risks, it is somewhat surprising that PB did not choose a "bloodless surgery center" for his operation; however, he may have intentionally deceived the surgeon in order to be sure the surgeon would not decline to operate. Because the surgeon and anesthesiologist were unaware of PB's faith, they might have given him a blood transfusion during surgery. Was PB gambling with his faith, denying the risk because of the improved quality of life that the surgery would give him? Could his failure to disclose his faith to the surgeon be a way of passively creating an opportunity to receive an intraoperative transfusion that might save his life? Jehovah's Witnesses believe transfusions inadvertently received are not battery, and the patients receiving them are not subject to spiritual retribution. Considering PB's history of multiple surgeries without transfusion, he might have believed his risk of bleeding was low. The ethical problem with all these scenarios is that the surgeon is removed from the equation. That is, in nonemergency situations (as in this case), the surgeon retains the right to choose which operations he will perform, even if the patient has sought him out. Surgeons and anesthesiologists may elect to withdraw from cases in which a patient's religion constrains their personal practice of medicine. In the case described, the surgeon was shielded from information that was pertinent to PB's health care values and treatment planning. That planning could potentially benefit PB's surgical outcome and quality of life and prevent possibly catastrophic consequences should something go wrong. The preoperative consultations between PB and his surgeon could also have presented an opportunity to discuss "bloodless surgery centers," and for the surgeon to possibly provide referrals. By not disclosing his religious beliefs to the surgeon during their two conversations, PB was not being truthful about his medical concerns and failed to build a trusting relationship with his doctor. The surgeon is responsible for obtaining informed consent from the patient; however, this is only possible when the patient is truthful...
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