Ethical issues in oocyte banking for nonautologous use: an Ethics Committee opinion.

Ethical considerations for the banking of oocytes for nonautologous use are discussed.

Stopping exploitation: Properly remunerating healthcare workers for risk in the COVID-19 pandemic.

We argue that we should provide extra payment not only for extra time worked but also for the extra risks healthcare workers (and those working in healthcare settings) incur while caring for COVID-19 patients-and more generally when caring for patients poses them at significantly higher risks than normal. We argue that the extra payment is warranted regardless of whether healthcare workers have a professional obligation to provide such risky healthcare. Payment for risk would meet four essential ethical requirements. First, assuming healthcare workers do not have a professional obligation to take on themselves the risks, payments in the form of incentives would preserve autonomy in deciding what risks to take on oneself. Second, even assuming that healthcare workers do have a professional obligation to take on themselves the risks, payments for risk would create fair working conditions by avoiding exploitation. Third, payments for risk would make it more likely that public healthcare systems can discharge their institutional responsibility to provide healthcare in circumstances where healthcare workers may otherwise (perhaps legitimately) opt out. Fourth, payments for risk would guarantee an efficient healthcare system in pandemic situations. Finally, we address two likely objections that some might raise against our proposal, particularly with regard to incentives, namely that such payments or incentives can themselves be coercive and that they represent a form of undue inducement.

The Claims of Biospecimen Donors to Credit and Compensation.

The biorights movement argues that current treatment of biospecimen donors is unfair. To evaluate this claim, the present Science & Society article identifies the standards used to determine credit and compensation in research, and applies them to donors. This analysis suggests most donors deserve credit and, contrary to current practice, some deserve compensation.

Paying Participants in COVID-19 Trials.

Trials are in development and underway to examine potential interventions for treatment and prophylaxis of coronavirus disease 2019 (COVID-19). How should we think about offering payment to participants in these trials? Payment for research participation is ethically contentious even under ideal circumstances. Here, we review 3 functions of research payment-reimbursement, compensation, and incentive-and identify heightened and novel ethical concerns in the context of a global pandemic. We argue that COVID-19 trial participants should usually be offered reimbursement for research-related expenses, and compensation for their time and effort, as for other types of research under usual circumstances. Given increased risk of undue influence against pandemic background conditions, incentive payment should be avoided unless essential to recruitment and retention in important trials whose social value outweighs this risk. Where essential, however, incentives can be ethically permissible, so long as reasonable efforts are made to minimize the possibility of undue influence.

A general approach to compensation for losses incurred due to public health interventions in the infectious disease context.

This paper develops a general approach to how society should compensate for losses that individuals incur due to public health interventions aimed at controlling the spread of infectious diseases. The paper falls in three parts. The first part provides an initial introduction to the issues and briefly outlines five different kinds of public health interventions that will be used as test cases. They are all directed at individuals and aimed at controlling the spread of infectious diseases (1) isolation, (2) quarantine, (3) recommended voluntary social distancing, (4) changes in health care provision for asymptomatic carriers of multi-resistant microorganisms, and (5) vaccination. The interventions will be briefly described including the various risks, burdens and harms individuals who are subject to these interventions may incur. The second part briefly surveys current compensation mechanisms as far as any exist and argue that even where they exist they are clearly insufficient and do not provide adequate compensation. The third part will then develop a general framework for compensation for losses incurred due to public health interventions in the infectious disease context. This is the major analytical and constructive part of the paper. It first analyses pragmatic and ethical arguments supporting the existence of an obligation on the part of the state to compensate for such losses, and then considers whether this obligation can be defeated by (1) resource considerations, or (2) issues relating to personal responsibility.

Germline Genome Editing Research: What Are Gamete Donors (Not) Informed About in Consent Forms?

The potential for using germline genome editing (GGE) in humans has garnered a lot of attention, both for its scientific possibilities as well as for the ethical, legal, and social challenges it ignites. The ethical debate has focused primarily on the suggestions of using GGE to establish a pregnancy (i.e., to offer it in a clinical setting), which is, to date, illegal in many jurisdictions. The use of GGE in research (where a pregnancy would not be established) has received much less attention, despite the fact that it raises serious ethical and social issues as well. Herein, we report on the analysis of informed consent forms for egg and sperm donation used in a widely publicized study where genome editing was used to correct a disease-causing genetic mutation in human embryos. Importantly, embryos were created using eggs and sperm obtained specifically for these experiments. The analysis indicates deficiencies in how the forms addressed various issues, including limited and potentially misleading information about the sensitive nature of the study, the lack of an explicit mention of genomic sequencing, as well as the poor readability of the forms. Furthermore, the arguably high compensation of U.S.$5,000 for egg donors raises questions about undue inducement to participate in research. Moreover, since the procurement of eggs involves serious health risks, it may be questioned whether research requiring such a procedure should be pursued. If such experiments are continued, donors should be informed about all relevant aspects in order to make informed decisions about participating.

The Declaration of Helsinki on Medical Research involving Human Subjects: A Review of Seventh Revision.

The pinnacle of success achieved by the medical science and the benefits accrued to the patients have become possible through the medical research where human participants in the research are exposed to hazards inherent to the experiments. To protect the human subjects and to maintain high ethical standards, the World Medical Association has adopted "The Declaration of Helsinki" in 1964. After two years of consultation with the experts throughout the world, the seventh revision of the Declaration was adopted on 19th October 2013 in Brazil. The aim of this article is to review the seventh revision of the Declaration of Helsinki in relation to medical research involving human subjects and highlight the amendments made in the latest revision which are relevant to clinical research in human subjects. The latest revision has made four substantial changes on the existing Declaration, whch include dealing with the compensation of the trial-related injuries, approval of use of placebos in the clinical trials, protection of vulnerable groups and the post-trial provisions. The implications of these amendments in the clinical research are highlighted. Keywords: Consent; Declaration of Helsinki; ethics; experimental medicine; research; seventh revision.

Compensation models in emergency medicine: An ethical perspective.

There is considerable diversity in compensation models in the specialty of Emergency Medicine (EM). We review different compensation models and examine moral consequences possibly associated with the use of various models. The article will consider how different models may promote or undermine health care's quadruple aim of providing quality care, improving population health, reducing health care costs, and improving the work-life balance of health care professionals. It will also assess how different models may promote or undermine the basic bioethical principles of beneficence, non-maleficence, respect for autonomy, and justice.

Undisclosed Financial Conflicts of Interest of Authors of Clinical Drug Trials Published in Influential Medical Journals: A Cohort Study.

The International Committee of Medical Journal Editors requires authors to disclose all financial conflicts of interest (COI) that can be perceived as influencing the related trials. Undisclosed financial COI may influence the perception of the authors' scientific impartiality and erode the public trust in the reported results. Data regarding completeness of COI disclosure in high-impact-factor general medicine journals are limited. We compared payments disclosed by US-based physicians who were first or last authors of clinical drug trials published between August 2016 and August 2018 in the New England Journal of Medicine, JAMA, and Lancet, to payments reported by industry to the Centers for Medicare & Medicaid Services Open Payments Database. Of 247 included authors, 198 (80%) have not disclosed some or all received payments. The median undisclosed sum was $8409 (US Dollars) (interquartile range [IQR] $123 to $44,890). Most authors (n=170, 69%) have received more than $10,000 per year (median $120,403, IQR $58,905 to $242,014). The median undisclosed sum for these authors was $26,530 (IQR $7462 to $71,562). Median undisclosed sums for authors of papers from studies performed with and without industry funding were $20,899 (IQR $4191 to $59,883) and $149 (IQR $0 to $3276), respectively. In 10 (8%) of 125 industry-funded trials, the first or last author had not disclosed personal payments from the study sponsor (median $9741, IQR $4508 to $101,484). These findings could raise concerns about the authors' equipoise toward the trial results and influence the public perception of the credibility of reported data. Health care professionals, reviewers, and journal editors should demand more transparent reporting of financial COI.

Mapping French Laypeople's Views Regarding Living Organ Donation.

BACKGROUND: French laypeople's views on living organ donation (LOD) were examined. METHODS: From 2010 to 2014, 327 adults (including 21 nurses) judged the acceptability of LOD in 60 realistic scenarios composed of all combinations of 5 factors: 1. type of organ; 2. whether it could have been obtained from a cadaver; 3. donor-recipient relationship; 4. donor's level of autonomy; 5. financial compensation; and 6. patients' level of responsibility for their illness. In all scenarios, the patients were in need of a kidney or liver transplantation. The ratings were subjected to cluster analysis and analyses of variance. RESULTS: Five qualitatively different positions were found that were termed Free Market (22%), Pragmatism (15%), Altruism (48%), Always Acceptable (7%), and Undetermined (8%). Nurses comprised the majority (90%) of the members of the altruism cluster. Younger and more-educated people were, more frequently than older and less-educated people, members either of the pragmatism or of the free market cluster. CONCLUSIONS: Half of French adults support the altruism model of LOD. A substantial minority, however, mostly young and more educated people, support alternative models allowing the introduction of financial incentives.

The Quest for Compensation for Research-Related Injury in the United States: A New Proposal.

In the U.S., there is no requirement for research sponsors to compensate human research subjects who experience injuries as a result of their participation. In this article, we review the moral justifications that compel the establishment of a better research-related injury compensation system. We explore how other countries and certain institutions within the U.S. have adopted various systems of compensation. The existence of these systems demonstrates both that the U.S. lags behind other nations in its protection of human research subjects and that the establishment of a compensation system is both practical and feasible. We then examine factors which have prevented the U.S. from establishing its own compensation system. We consider possible alternatives for the U.S. by examining the advantages and disadvantages of both established and proposed systems. We offer a new proposal that addresses the justice concerns which compel the establishment of a national compensation system, distributes the burdens of such a system on multiple stakeholders that benefit from research, and has the additional advantage of minimizing the administrative and logistical challenges associated with initiating such a system.

Is Payment for Egg Donation an Undue Inducement?

Should egg donors be paid? A negative answer might be offered on the ground that payment for egg donation is coercive. But is this viewpoint tenable? Is the offer of payment for egg donation really coercive? Even if not coercive, might payment for egg donation nonetheless be seen as exploitative? And if so why? The central argument of this paper focuses on the question whether the offer of payment for egg donation is an exploitative inducement and therefore an undue inducement. Another question raised in this paper is whether, given that it is commodifying, payment for egg donation constitutes a failure to recognize the giftedness and true value of human life.

Financial Conflicts of Interest Among Authors of Urology Clinical Practice Guidelines.

BACKGROUND: Recent studies have highlighted the presence of disclosed and undisclosed financial conflicts of interest among authors of clinical practice guidelines. OBJECTIVE: We sought to determine to what extent urology guideline authors receive and report industry payments in accordance with the Physician Payment Sunshine Act. DESIGN, SETTING, AND PARTICIPANTS: We selected the 13 urology guidelines that were published by the American Urological Association (AUA) after disclosure was mandated by the Physician Payment Sunshine Act. Payments received by guideline authors were searched independently by two investigators using the Open Payments database. OUTCOME MEASURES AND STATISTICAL ANALYSIS: Our primary outcome measure was the number of authors receiving payments from industry, stratified by amount thresholds. Our secondary outcome measure was the number of authors with accurate conflict of interest disclosure statements. RESULTS AND LIMITATIONS: We identified a total of 54 author disclosures. Thirty-two authors (59.3%) received at least one payment from industry. Twenty (37.0%) received >$10 000 and six (11.1%) received >$50 000. Median total payments were $578 (interquartile range $0-19 228). Twenty (37.0%) disclosure statements were inaccurate. Via Dollars for Docs, we identified $74 195.13 paid for drugs and devices directly related to guideline recommendations. We were limited in our ability to determine when authors began working on guideline panels, as this information was not provided, and by the lack of specificity in Dollars for Docs. CONCLUSIONS: Many of the AUA guideline authors received payments from industry, some in excess of $50 000. A significant portion of disclosure statements were inaccurate, indicating a need for more stringent enforcement of the AUA disclosure policy. PATIENT SUMMARY: Pharmaceutical company payments to doctors have been shown to influence how doctors treat patients. If these doctors are charged with making clinical recommendations to other doctors, in the form of clinical practice guidelines, the issue of industry payments becomes more severe. We found that many urologists on guideline panels receive money from industry and that a significant portion did not disclose all payments received.

To report or not to report: Exploring healthy volunteers' rationales for disclosing adverse events in Phase I drug trials.

BACKGROUND: Phase I trials test the safety and tolerability of investigational drugs and often use healthy volunteers as research participants. Adverse events (AEs) are collected in part through participants' self-reports of any symptoms they experience during the trial. In some cases, experiencing AEs can result in trial participation being terminated. Because of the economic incentives underlying their motivation to participate, there is concern that healthy volunteers routinely fail to report AEs and thereby jeopardize the validity of the trial results. METHODS: We interviewed 131 U.S. healthy volunteers about their experiences with AEs, including their rationales for reporting or failing to report symptoms. RESULTS: We found that participants have three primary rationales for their AE reporting behavior: economic, health-oriented, and data integrity. Participants often make decisions about whether to report AEs on a case-by-case basis, evaluating what effects reporting or not reporting might have on the compensation they receive from the trial, the risk to their health, and the results of the particular clinical trial. Participants' interpretations of clinic policies, staff behaviors, and personal or vicarious experiences with reporting AEs also shape reporting decisions. CONCLUSIONS: Our findings demonstrate that participants' reporting behavior is more complex than previous portraits of healthy volunteers have suggested. Rather than finding participants who were so focused on the financial compensation that they were willing to subvert trial results, our study indicates that participants are willing in most cases to forgo their full compensation if they believe not reporting their symptoms jeopardizes their own safety or the validity of the research.

Patient perspectives on compensation for biospecimen donation.

BACKGROUND: The purpose of this study was to determine whether biospecimen donors believe they should receive compensation. This is the first study to report biospecimen donors' views on compensation and can potentially improve informed consent and recruitment practices. METHODS: Researchers asked patients undergoing surgical removal of tissue to donate biological materials to a biobank; the request was made at their presurgical appointment or in the preoperative clinic of the Emory University Hospital. We interviewed 126 biospecimen donors within 30 days post surgery regarding their perspective on compensation for biospecimen donation. RESULTS: In response to the question "Should you be paid for your participation in the tissue bank?," 95 (95/126, 75%) participants answered "No." Of these, 55 (55/95, 58%) indicated that donating biological materials should be about altruism, not gaining a monetary reward. Only 11 (11/126, 9%) participants unequivocally believed they should receive compensation, while 14 (14/126, 11%) felt entitled to compensation only under specific circumstances. Eleven (11/14) "Depends" participants indicated that donors should only be compensated when researchers perform for-profit research. Responses varied by race and income level, with whites more likely to not feel entitled to compensation and higher income participants more likely to respond "Depends." CONCLUSIONS: The majority of biospecimen donors stated they should not be paid for tissue bank participation. However, a minority believe they should be paid for donating tissue if the tissue is used in revenue-generating projects. These results provide some support for the current biobanking practice of not providing compensation.

Conflicts of Interest in Clinical Guidelines: Lack of Authors and Disclosures in the AAOMS White Papers.

PURPOSE: The purpose of this study was to evaluate current state of authorship, financial disclosures, and conflicts of interest in position papers published by the American Association of Oral and Maxillofacial Surgeons (AAOMS). MATERIALS AND METHODS: This is a cross-sectional review of the position papers published by the AAOMS from 2013 to 2017. Primary outcome variables include position papers published by the AAOMS. Secondary outcome variables include declaration of authorship, financial disclosures, and financial payments. The Open Payments Database for financial disclosures was reviewed for the year the position paper was published and the immediate preceding year. RESULTS: Ten position papers were published by the AAOMS from 2013 to 2017. Of the 10 papers, authorship was listed in 3, and none explicitly addressed the presence or absence of financial disclosures or conflicts of interest. Contributors to 3 of the 3 authored papers were found at review of the Open Payments Database to have received industry funding in the year the position paper was published and the immediate preceding year. The remuneration ranged from less than $1,000 to $554,006.02. CONCLUSION: Position papers published by the AAOMS lack standardization for authorship and statements on potential financial disclosure. The authors suggest full disclosures of authorship and authors' conflicts of interest should be stated on all position papers to provide transparency to the process.