Undue Inducement Research Articles

A Roadmap for Improving Medicare’s Application of Coverage With Evidence Development

The Centers for Medicare and Medicaid Services’ coverage with evidence development (CED) policy allows the agency to provide coverage for an item or service through a National Coverage Determination (NCD), conditional upon an agreement to collect evidence designed to address specific questions or uncertainties. The goals of this policy are to expedite beneficiary access to new items and services and to generate additional evidence on the impact of these items or services for Medicare beneficiaries. However, these goals have not been fully realized because of several issues with the way the policy has been implemented, including (1) a lack of clear criteria for when CED will be applied, (2) examples of CED data collection activities placing unnecessary burdens on clinicians and the potential for undue inducement on beneficiaries, and (3) a lack of clarity around the process and timeline for reconsidering and ending CED requirements. Additionally, there are cases in which the application of CED has failed to improve access to services for certain Medicare beneficiaries because no data collection activity was implemented in response to the CED requirement or because the NCD only allows the technology to be provided and studied in certain centers of excellence. We describe a roadmap for addressing these issues, which includes, for example, developing a framework to guide the application of coverage constraints in NCDs with CED requirements. Once these issues are addressed, the Centers for Medicare and Medicaid Services could consider expanding the use of CED to technologies that are not subject to NCDs.

An experimental test of whether financial incentives constitute undue inducement in decision-making

Around the world, laws limit the incentives that can be paid for transactions such as human research participation, egg donation or gestational surrogacy. A key reason is concerns about ‘undue inducement’—the influential but empirically untested hypothesis that incentives can cause harm by distorting individual decision-making. Here I present two experiments (n = 671 and n = 406), including one based on a highly visceral transaction (eating insects). Incentives caused biased information search—participants offered a higher incentive to comply more often sought encouragement to do so. However, I demonstrate theoretically that such behaviour does not prove that incentives have harmful effects; it is consistent with Bayesian rationality. Empirically, although a substantial minority of participants made bad decisions, incentives did not magnify them in a way that would suggest allowing a transaction but capping incentives. Under the conditions of this experiment, there was no evidence that higher incentives could undermine welfare for transactions that are permissible at low incentives.

Impact of financial compensation on enrollment and participation in a remote, mobile-app based research study.

There is no consensus on how to determine appropriate financial compensation for research recruitment. Selecting incentive amounts that are reasonable and respectful, without undue inducement, remains challenging. Previously, we demonstrated that incentive amount significantly impacts participants' willingness to complete various hypothetical research activities. Here we further explore this relationship in a mock decentralized study. Adult ResearchMatch volunteers were invited to join a prospective study where interested individuals were given an opportunity to view details for a study along with participation requirements, then offered a randomly generated compensation amount between $0 and $50 to enroll and participate. Individuals agreeing to participate were then asked to complete tasks using a remote mobile application (MyCap), for two weeks. Tasks included a weekly survey, a daily gratitude journal and daily phone tapping task. Willingness to participate was 85% across all incentive levels but not significantly impacted by amount. Task completion appeared to increase as a function of compensation until a plateau at $25. While participants described the study as low burden and reported that compensation was moderately important to their decision to join, only 31% completed all study tasks. While offering compensation in this study did not have a strong effect on enrollment rate, this work provides insight into participant motivation when joining and participating in studies employing mobile applications.

Ethical Considerations Regarding Financial Incentives in Plastic Surgery-Related Health Research.

Introduction: To recruit enough patients to achieve adequate statistical power in clinical research, investigators often rely on financial incentives. The use of these incentives, however, remains controversial as they may cause patients to overlook risks associated with research participation. This concern is amplified in the context of plastic surgery where aesthetic procedures are often more desirable and are not typically covered by public or private insurance plans. Despite this, the ethical debate regarding the use of incentives has largely been absent from plastic surgery journals; therefore, efforts to summarize the existing literature in the context of plastic surgery are necessary. Methods: A narrative review of the peer-reviewed published literature was performed to identify existing articles pertaining to financial incentives in plastic surgery-related health research. Results: While incentives have the potential to improve sample sizes and promote the recruitment of under-represented patient populations, undue inducement and biased recruitment are possible. At present, there exists a paucity of empirical evidence to substantiate this. Efforts should be taken by investigators and research ethics boards (REBs) to limit the potential negative impacts of monetary compensation. Investigators should place reasonable limits on the value of incentives as well as select models associated with lower risks of undue influence and enrollment bias. When financial remuneration is offered, additional care should be taken by investigators to ensure participants are adequately informed of the risks associated with research participation. Conclusion: Current best practice recommendations suggest that proposals submitted to REBs justify the incentives used. Information regarding incentives should also be included within study consent forms and communicated as part of the informed consent process.

Maximising impactful, locally relevant global mental health research conducted in low and middle income country settings: ethical considerations.

Background: Achieving ethical and meaningful mental health research in diverse global settings requires approaches to research design, conduct, and dissemination that prioritise a contextualised approach to impact and local relevance. Method: Through three case studies presented at the 2021 Global Forum on Bioethics in Research meeting on the ethical issues arising in research with people with mental health conditions, we consider the nuances to achieving ethical and meaningful mental health research in three diverse settings. The case studies include research with refugees Rwanda and Uganda; a neurodevelopmental cohort study in a low resource setting in India, and research with Syrian refugees displaced across the Middle East. Results: Key considerations highlighted across the case studies include how mental health is understood and experienced in diverse contexts to ensure respectful engagement with communities, and to inform the selection of contextually-appropriate and feasible research methods and tools to achieve meaningful data collection. Related to this is a need to consider how communities understand and engage with research to avoid therapeutic misconception, exacerbating stigma, or creating undue inducement for research participation, whilst also ensuring meaningful benefit for research participation. Central to achieving these is the meaningful integration of the views and perspectives of local stakeholders to inform research design, conduct, and legacy. The case studies foreground the potential tensions between meeting local community needs through the implementation of an intervention, and attaining standards of scientific rigor in research design and methods; and between adherence to procedural ethical requirements such as ethical review and documenting informed consent, and ethical practice through attention to the needs of the local research team. Conclusions: We conclude that engagement with how to achieve local relevance and social, practice, and academic impact offer productive ways for researchers to promote ethical research that prioritises values of solidarity, inclusion, and mutual respect.

Maximising impactful and locally relevant mental health research: ethical considerations

Background:Achieving ethical and meaningful mental health research in diverse global settings requires approaches to research design, conduct, and dissemination that prioritise a contextualised approach to impact and local relevance.Method:Through three case studies presented at the 2021 Global Forum on Bioethics in Research meeting on the ethical issues arising in research with people with mental health conditions, we consider the nuances to achieving ethical and meaningful mental health research in three diverse settings. The case studies include research with refugees Rwanda and Uganda; a neurodevelopmental cohort study in a low resource setting in India, and research with Syrian refugees displaced across the Middle East.Results:Key considerations highlighted across the case studies include how mental health is understood and experienced in diverse contexts to ensure respectful engagement with communities, and to inform the selection of contextually-appropriate and feasible research methods and tools to achieve meaningful data collection. Related to this is a need to consider how communities understand and engage with research to avoid therapeutic misconception, exacerbating stigma, or creating undue inducement for research participation, whilst also ensuring meaningful benefit for research participation. Central to achieving these is the meaningful integration of the views and perspectives of local stakeholders to inform research design, conduct, and legacy. The case studies foreground the potential tensions between meeting local community needs through the implementation of an intervention, and attaining standards of scientific rigor in research design and methods; and between adherence to procedural ethical requirements such as ethical review and documenting informed consent, and ethical practice through attention to the needs of the local research team.Conclusions:We conclude that engagement with how to achieve local relevance and social, practice, and academic impact offer productive ways for researchers to promote ethical research that prioritises values of solidarity, inclusion, and mutual respect.

Ethics of Buying DNA

DNA databases have significant commercial value. Direct-to-consumer genetic testing companies have built databanks using samples and information voluntarily provided by customers. As the price of genetic analysis falls, there is growing interest in building such databases by paying individuals for their DNA and personal data. This paper maps the ethical issues associated with private companies paying for DNA. We outline the benefits of building better genomic databases and describe possible concerns about crowding out, undue inducement, exploitation, and commodification. While certain objections deserve more empirical and philosophical investigation, we argue that none currently provide decisive reasons against using financial incentives to secure DNA samples.

The ethical anatomy of payment for research participants

In contrast to most publications on the ethics of paying research subjects, which start by identifying and analyzing major ethical concerns raised by the practice (in particular, risks of undue inducement and exploitation) and end with a set of—more or less well-justified—ethical recommendations for using payment schemes immune to these problems, this paper offers a systematic, principle-based ethical analysis of the practice. It argues that researchers have a prima facie moral obligation to offer payment to research subjects, which stems from the principle of social beneficence. This principle constitutes an ethical “spine” of the practice. Other ethical principles of research ethics (respect for autonomy, individual beneficence, and justice/fairness) make up an ethical “skeleton” of morally sound payment schemes by providing additional moral reasons for offering participants (1) recompense for reasonable expenses; and (2a) remuneration conceptualized as a reward for their valuable contribution, provided (i) it meets standards of equality, adequacy and non-exploitation, and (ii) it is not overly attractive (i.e., it does not constitute undue inducement for participation or retention, and does not encourage deceptive behaviors); or (2b) remuneration conceptualized as a market-driven price, provided (i) it is necessary and designed to help the study achieve its social and scientific goals, (ii) it does not reinforce wider social injustices and inequalities; (iii) it meets the requirement of non-exploitation; and (iv) it is not overly attractive. The principle of justice provides a strong ethical reason for not offering recompenses for lost wages (or loss of other reasonably expected profits).

Ethical guidelines and regulations in conducting clinical research in children: A critical appraisal

Conducting clinical research in children poses significant challenges with regard to several ethical issues, such as informed consent and protection from harm. Notwithstanding, children need to participate in research to address health issues that affect them but such research aims must be balanced with the safety and well-being of the participants. While being attentive to mitigating risks and providing the right support, researchers can ensure that children feel respected and can participate safely. The informed consent of parents or legal guardians should be obtained, preferably in writing, stating all the features of the research that may affect their willingness to allow the child to participate. Because of their vulnerabilities and the need to be protected from the risks associated with any kind of research, there has been increased global concern toward the involvement of children in research practice. As a general principle, although parents or guardians may be asked to consent on behalf of a child, depending on the child’s cognitive ability and the nature of the research, a refusal of assent or consent to participate should always over-rule the parent’s or guardian’s consent. To ensure proper ethical conduct of research in children, Institutional Review Boards (IRBs) or Research Ethics Committees (REC) will be required to provide ongoing monitoring of pediatric research, especially in the vulnerable population, since there may be a tendency for undue inducement or coercion, which could make parents/guardians consent to their children participating in a research and that exposes them to substantial risk. Similarly, it will be important to assess whether the approval of pediatric research, especially nonbeneficial research, should require a super majority, rather than the simple majority of IRB members required under current international regulation. This article provides an insight into the ethical guidelines and principles in conducting clinical research in children.

Enhancing COVID-19 vaccination coverage using financial incentives: arguments to help health providers counterbalance erroneous claims

Financial reimbursements after receiving the coronavirus disease 2019 (COVID-19) vaccine have been criticized in the literature. This strategy has been described as payment to receive the vaccines, undue inducement, and unethical. We are aware that healthcare workers who work in primary healthcare, prevention, and public health may encounter similar reasons from people who refuse vaccination against COVID-19. For this reason, we are compelled to clarify these claims and provide arguments for all healthcare workers who might be challenged by such reasoning. In this critical review, we discuss why the claims against financial incentives that have been presented in the literature are erroneous.

Effectiveness and Ethics of Incentives for Research Participation

Incentivizing research participation is controversial and variably regulated because of uncertainty regarding whether financial incentives serve as undue inducements by diminishing peoples' sensitivity to research risks or unjust inducements by preferentially increasing enrollment among underserved individuals. To determine whether incentives improve enrollment in real randomized clinical trials (RCTs) or serve as undue or unjust inducements. Two RCTs of incentives that were embedded in 2 parent RCTs, 1 comparing smoking cessation interventions (conducted at smoking cessation clinics in 2 health systems) and 1 evaluating an ambulation intervention (conducted across wards of the Hospital of the University of Pennsylvania) included all persons eligible for the parent trials who did not have prior knowledge of the incentives trials. Recruitment occurred from September 2017 to August 2019 for the smoking trial and January 2018 through May 2019 for the ambulation trial; data were analyzed from January 2020 to July 2020. Patients were randomly assigned to incentives of $0, $200, or $500 for participating in the smoking cessation trial and $0, $100, or $300 for the ambulation trial. The primary outcome of each incentive trial was the proportion of people assigned to each recruitment strategy that consented to participate. Each trial was powered to test the hypotheses that incentives served neither as undue inducements (based on the interaction between incentive size and perceived research risk, as measured using a 10-point scale, on the primary outcome), nor unjust inducements (based on the interaction between incentive size and participants' self-reported income). Noninferiority methods were used to test whether the data were compatible with these 2 effects of incentives and superiority methods to compare the primary and other secondary outcomes. There were a total of 654 participants (327 women [50.0%]; mean [SD] age, 50.6 [12.1] years; 394 Black/African American [60.2%], 214 White [32.7%], and 24 multiracial individuals [3.7%]) in the smoking trial, and 642 participants (364 women [56.7%]; mean [SD] age, 46.7 [15.6] years; 224 Black/African American [34.9%], 335 White [52.2%], and 5 multiracial individuals [0.8%]) in the ambulation trial. Incentives significantly increased consent rates among those in the smoking trial in 47 of 216 (21.8%), 78 of 217 (35.9%), and 104 of 221 (47.1%) in the $0, $200, and $500 groups, respectively (adjusted odds ratio [aOR] for each increase in incentive, 1.70; 95% CI, 1.34-2.17; P < .001). Incentives did not increase consent among those in the ambulation trial: 98 of 216 (45.4%), 102 of 212 (48.1%), and 92 of 214 (43.0%) in the $0, $100, and $300 groups, respectively (aOR, 0.88; 95% CI, 0.64-1.22; P = .45). In neither trial was there evidence of undue or unjust inducement (upper confidence limits of ORs for undue inducement, 1.15 and 0.99; P < .001 showing noninferiority; upper confidence limits of ORs for unjust inducement, 1.21 and 1.26; P = .01 and P < .001, respectively). There were no significant effects of incentive size on the secondary outcomes in either trial, including time spent reviewing the risk sections of consent forms, perceived research risks, trial understanding, perceived coercion, or therapeutic misconceptions. In these 2 randomized clinical trials, financial incentives increased trial enrollment in 1 of 2 trials and did not produce undue or unjust inducement or other unintended consequences in either trial. ClinicalTrials.gov Identifier: NCT02697799.

Review of “Freezing Fertility Oocyte Cryopreservation and the Gender Politics of Aging”

Reviewer: Skye A. Miner, National Institutes of Health Department of Bioethics, Bethesda, MD, USA Lucy van de Wiel expands the concept of reproductive aging in her book Freezing Fertility by examining how oocyte cryopreservation (OC) creates a postfertile condition, being neither fully fertile nor infertile. This cultural analysis critically reimagines what fertility means once preservation becomes “commonplace,” an accepted way of anticipating infertility (16). Thus, Freezing Fertility asks us to think about frozen eggs outside of individual means of empowerment or undue inducement but rather as a technology that provides a redefinition of fertility—one that destabilizes national boundaries, kinship structures, and gendered organizations of time. The argument that OC has allowed for the neoliberal postponement of fertility, making the individual solely responsible for not reproducing during her “fertile time,” is not new. However, Freezing Fertility goes beyond investigating the societal pressures that have led to delayed childbearing—educational attainment, establishment of...

A scoping review of genetics and genomics research ethics policies and guidelines for Africa

BackgroundGenetics and genomics research (GGR) is increasingly being conducted around the world; yet, researchers and research oversight entities in many countries have struggled with ethical challenges. A range of ethics and regulatory issues need to be addressed through comprehensive policy frameworks that integrate with local environments. While important efforts have been made to enhance understanding and awareness of ethical dimensions of GGR in Africa, including through the H3Africa initiative, there remains a need for in-depth policy review, at a country-level, to inform and stimulate local policy development and revision on the continent.MethodsTo identify and characterize existing ethics-related guidelines and laws applicable to GGR across much of Africa, we conducted a scoping review of English language policy documents identified through databases, repositories, and web searches. Thirty-six documents were included and coded using a framework that contained a range of themes across five analytical categories: (1) respect, (2) beneficence, (3) justice, (4) independent oversight, and (5) bans and prohibitions. Data analysis software (NVivo 12) was used to organize, code, and tabulate information according to document characteristics and topics. Illustrative examples of policy requirements were selected for inclusion.ResultsDocuments that met inclusion criteria spanned 20 years; published between 1996 and 2018, with the majority (58%) published after 2009. About two-thirds were denoted as “guidelines,” and slightly more than half were non-exclusive to GGR. Very few (six) country-level documents identified were specific to GGR. Requirements related to the principle of “respect” appeared most often across all documents, relative to other principles and processes. The most commonly stated ban was on reproductive cloning. Other prohibitions applied to germline editing, undue inducements in research, sample use for commercial purposes, employee mandatory DNA testing, fetal sex selection, stem cell use, eugenics, and research without public health benefits.ConclusionsEnforceable policies that are indispensable to the ethical conduct and review of GGR are either deficient or missing in many African countries. Existing international, GGR-specific ethics guidelines can be used to inform GGR policy development at a country-level, in conjunction with insight from country specific ethics committees and other local stakeholders.

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.

Promoting Ethical Payment in Human Infection Challenge Studies

To prepare for potential human infection challenge studies (HICS) involving SARS-CoV-2, we convened a multidisciplinary working group to address ethical questions regarding whether and how much SARS-CoV-2 HICS participants should be paid. Because the goals of paying HICS participants, as well as the relevant ethical concerns, are the same as those arising for other types of clinical research, the same basic framework for ethical payment can apply. This framework divides payment into reimbursement, compensation, and incentives, focusing on fairness and promoting adequate recruitment and retention as counterweights to concerns about undue inducement. Within the basic framework, several factors are especially salient for HICS, and for SARS-CoV-2 HICS in particular, including the nature of participant confinement, anticipated discomfort, risks and uncertainty, participant motivations, and trust. These factors are reflected in a payment worksheet created to help sponsors, researchers, and ethics reviewers systematically develop and assess ethically justifiable payment amounts.

Conducting community-based pediatric research in rural India: Experience from vadu rural health program.

This paper describes unique challenges faced during conduct of community research studies in rural population of Maharashtra at Vadu Rural Health Program, Pune, India. Some of the ethical issues faced include difficulty in comprehending the informed consent by rural families with low education levels and ensuring adequate compensation for study participation without undue inducement, ensuring large number of recruitments during early infancy, ensuring adherence to intervention by care-providers, retention of participants especially in studies having long follow-ups and regulatory compliance for serious adverse event reports are major operational challenges. The delays faced in approvals from the Health Ministry Screening Committee and lack of specific regulatory guidance on community-based conduct of studies pose challenges in terms of study timelines and operational aspect of these studies. Provision of study-related information during prestudy visits, designing patient information sheets in simple language, involving the decision-making member of the family, adequate time for families for decision-making are certain measures that have been useful for effective informed consent administration. Collaboration with accredited social health activists and auxillary nurse midwives for line-listing of pregnancies and births and regular conduction of prestudy visits or community sensitization meetings have been useful for the recruitment of large number of study participants during infancy. Strategies such as provision of universal immunization, selection of field research assistants from the local population, regular home visits, and provision of medical care has been helpful in retention of the study participants. Networking with local health facilities and local government bodies has helped in the provision of medical care to the study participants and in the management of serious adverse events. Our experience can provide important learnings to other investigators from developing countries working in the domain of child health.

The Effectiveness and Ethics of Incentives for Research Participation: Two Embedded Randomized Recruitment Trials

Background: Using financial incentives to improve research participation is controversial and variably regulated due to uncertainty regarding whether incentives serve as undue inducements by blunting peoples’ sensitivity to research risks, or unjust inducements by preferentially increasing enrollment among disadvantaged persons. Methods: Patients were randomly assigned to incentives of $0, $200, or $500 for participating in a trial comparing smoking cessation interventions, and to $0, $100, or $300 for participating in a trial evaluating an ambulation intervention. Each incentive trial was powered to rule out interactions between incentive size and perceived research risk (undue inducement), and between incentive size and income (unjust inducement), on the primary outcome of consenting to the parent trial. Findings: Incentives significantly increased enrollment among 654 patients in the smoking cessation trial (adjusted odds ratio (OR) for each increase in incentive = 1.70, 95% confidence interval (CI) = 1.34 – 2.17; p < 0.001), but not among 642 patients in the ambulation trial (adjusted OR = 0.88, 95% CI = 0.64 – 1.22; p = 0.45). In both trials, undue and unjust inducement were ruled out (upper confidence limits of ORs for undue inducement = 1.15 and 0.99, both p < 0.001; upper confidence limits of ORs for unjust inducement = 1.21 and 1.26, p = 0.011 and p < 0.001, respectively). In both trials, larger incentives were associated with more time spent reviewing consent forms (both p < 0.005). Incentives were not associated with perceived research risks, trial understanding, perceptions of coercion, or therapeutic misconceptions in either trial. Interpretation: Financial incentives increased trial enrollment in one of two trials, and did not produce undue or unjust inducement or other unintended consequences in either trial. Trial Registration: ClinicalTrials.gov number, NCT02697799. Funding Statement: National Cancer Institute. Declaration of Interests: We declare no competing interests. Ethics Approval Statement: Approved by IRBs at the University of Pennsylvania and Northwestern University, using a waiver of the requirement for informed consent. The trials were also guided by an Ethics Advisory Board and overseen by a Data and Safety Monitoring Board (DSMB).

Ethical Payment to Participants in Human Infection Challenge Studies, with a Focus on SARS-CoV-2: Report and Recommendations

To prepare for potential human infection challenge studies (HICS) involving SARS-CoV-2, this report offers an expert analysis of ethical approaches to paying research participants in these studies, as well as HICS more broadly. The report first provides an overarching ethical framework for research payment that divides payment into reimbursement, compensation, and incentive, focusing on fairness and promoting adequate recruitment and retention as counterweights to ethical concerns about undue inducement. It then describes variables relevant to applying this framework to any type of study, including the prospect of direct medical benefit, early participant withdrawal, study setting and location, pandemic circumstances, study budget, and participant perspectives. We conclude that there is no need for a unique payment framework specific to HICS or SARS-CoV-2 HICS, but that there may be features of particular relevance to ethical payment for these studies. Participants have varied motivations for enrolling in HICS, including financial considerations, altruism, and other interests, but undue inducement does not seem to be a significant problem based on available evidence. Payment in these studies should reflect the nature of participant confinement, anticipated discomfort from induced infection, risks and uncertainty, participant motivations, and the need to recruit from certain populations, as relevant. Where HICS involve significant risks and highly contingent social value, special review confirming the ethical permissibility of these studies can help promote confidence in the ethical permissibility of offers of payment to participate in them. We do not propose specific payment amounts for potential SARS-CoV-2 HICS, as these will be highly variable based on the relevant factors described in the report. Instead, we note that it is reasonable to start from payments offered in other similar studies, while adopting a systematic approach based on the ethical framework herein, as reflected in a pragmatic payment worksheet describing goals, coverage, factors to consider, and potential benchmarks.

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.

新冠瘟疫蔓延時的「知情同意」原則

LANGUAGE NOTE | Document text in Chinese; abstract also in English.本文就此次爆發的心冠病毒疸疫，探討中國在對抗疫情過程中所帶出的幾個倫理議題，尤其是如何把握傳染病突發處理中「知情同意」的倫理原則。根據世界衛生組織的規定，「知情同意」意指有行為能力的個體根據充分的相關信息採取行動的主動權，這個行動不能受到強制或謗導。然而在疫情突發時期，知情同意所涵蓋的諸如知情、能力、自願等原則在公共衛生受到挑戰之時也會受到一定的限制。如何在個人自主、個人權利與公共衛生、公共利益之間找到平衡？如何在最低限度的道德言語中找到共同的道德原則，這是疫情中值得探討的倫理議題。本文從世衛《傳染爆發倫理問題指南》出發，對其具 體的倫理原則進行分析，並將其原則放在此次爆發的疫情情境中加以説明，刨析這些原則在具體操作上的困境。作者最後試圖從儒家倫理學的角度闡述如何在東方的「家長主義式干預」和西方的「個體自主式不干預」中找到平衡點，如何在保護公民權利與保證公共衛生中找到平衡點。This paper addresses the question of informed consent during the COVID-19 pandemic. Informed consent is “the process in which a competent individual authorizes a course of action based on sufficient relevant information, without coercion or undue inducement” (WHO, 2016). However, informed consent based on disclosure, capacity, and voluntariness has been seriously challenged during the public health crisis we are facing today. How should we resolve the ethical conflict between individual autonomy and individual rights and public health and public good? How should we attain social consensus through “the minimum grammar” of common morality? In this paper, I first introduce the WHO’s “Guidance for Managing Ethical Issues in Infectious Disease Outbreaks” (2016) and its seven basic principles: justice, beneficence, utility, respect for persons, liberty, reciprocity, and solidarity. I then explain how those principles could face challenges in implementation during the pandemic, as there will always be tensions between individual rights, state interference, and health paternalism. Finally, I explore from a Confucian perspective the possibility of seeking the “middle point” between paternalism and individual autonomy, and between civil liberties and public health.DOWNLOAD HISTORY | This article has been downloaded 26 times in Digital Commons before migrating into this platform.