Understanding Ethical Challenges in Medical Education Research.

Rapidly advancing biomedical and electronic technologies, ongoing health disparities, and new online educational modalities are all changing medicine and medical education. As medical training continues to evolve, research is increasingly critical to help improve it, but medical education research can pose unique ethical challenges. As research participants, medical trainees may face several risks and in many ways constitute a vulnerable group. In this commentary, the author examines several of the ethical challenges involved in medical education research, including confidentiality and the risk of stigma; the need for equity, diversity, and inclusion; genetic testing of students; clustered randomized trials of training programs; and questions about quality improvement activities. The author offers guidance for navigating these ethical challenges, including the importance of engaging with institutional review boards. Academic medical institutions should educate and work closely with faculty to ensure that all research adheres to appropriate ethical guidelines and regulations and should provide instruction about the ethics of medical education research to establish a strong foundation for the future of the field. Research on medical education will become increasingly important. Given the potential sensitivity of the data collected in such research, investigators must understand and address potential ethical challenges as carefully as possible.

HIV prevention research and COVID-19: putting ethics guidance to the test.

BACKGROUND: Critical public health measures implemented to mitigate the spread of the novel coronavirus disease (COVID-19) pandemic have disrupted health research worldwide, including HIV prevention research. While general guidance has been issued for the responsible conduct of research in these challenging circumstances, the contours of the dueling COVID-19 and HIV/AIDS pandemics raise some critical ethical issues for HIV prevention research. In this paper, we use the recently updated HIV Prevention Trials Network (HPTN) Ethics Guidance Document (EGD) to situate and analyze key ethical challenges related to the conduct of HIV prevention research during the COVID-19 pandemic as well as identify potential areas for refinement of the guidance document based on this unprecedented state of affairs. MAIN BODY: Necessary actions taken for HIV prevention research studies due to the COVID-19 pandemic involve an array of ethical issues including those related to: (1) risk mitigation; (2) behavior change; (3) compounding vulnerability; (4) community engagement; (5) trial reopening; and 6) shifting research priorities. CONCLUSIONS: In the context of the dueling HIV and COVID-19 global pandemics, research teams and sponsors must be nimble in responding to the rapidly changing environment by being sensitive to the associated ethical issues. The HTPN EGD provides a rich set of tools to help identify, analyze and address many of these issues. At the same time, future refinements of the HPTN EGD and other research ethics guidance could be strengthened by providing explicit advice regarding the ethical issues associated with disrupted research and the reopening of studies. In addition, additional consideration should be given to appropriately balancing domains of risk (e.g., physical versus social), addressing the vulnerability of research staff and community partners, and responding to un-anticipatable ancillary care needs of participants and communities. Appropriately addressing these issues will necessitate conceptual work, which would benefit from the careful documentation of the actual ethical issues encountered in research, the strategies implemented to overcome them, and their success in doing so. Throughout all of these efforts, it is critical to remember that the HIV pandemic not be forgotten in the rush to deal with the COVID-19 pandemic.

Ethical Challenges Arising in the COVID-19 Pandemic: An Overview from the Association of Bioethics Program Directors (ABPD) Task Force.

The COVID-19 pandemic has raised a host of ethical challenges, but key among these has been the possibility that health care systems might need to ration scarce critical care resources. Rationing policies for pandemics differ by institution, health system, and applicable law. Most seem to agree that a patient's ability to benefit from treatment and to survive are first-order considerations. However, there is debate about what clinical measures should be used to make that determination and about other factors that might be ethically appropriate to consider. In this paper, we discuss resource allocation and several related ethical challenges to the healthcare system and society, including how to define benefit, how to handle informed consent, the special needs of pediatric patients, how to engage communities in these difficult decisions, and how to mitigate concerns of discrimination and the effects of structural inequities.

Correction: Evaluation of the cost and effectiveness of diverse recruitment methods for a genetic screening study.

The original version of this Article contained an error in the undergraduate degree awarded to the author Ian Halim, which was incorrectly given as BS. This has now been corrected to BA in both the PDF and HTML versions of the Article.

Evaluation of the cost and effectiveness of diverse recruitment methods for a genetic screening study.

PURPOSE: Recruitment of participants from diverse backgrounds is crucial to the generalizability of genetic research, but has proven challenging. We retrospectively evaluated recruitment methods used for a study on return of genetic results. METHODS: The costs of study design, development, and participant enrollment were calculated, and the characteristics of the participants enrolled through the seven recruitment methods were examined. RESULTS: A total of 1118 participants provided consent, a blood sample, and questionnaire data. The estimated cost across recruitment methods ranged from $579 to $1666 per participant and required a large recruitment team. Recruitment methods using flyers and staff networks were the most cost-efficient and resulted in the highest completion rate. Targeted sampling that emphasized the importance of Latino/a participation, utilization of translated materials, and in-person recruitments contributed to enrolling a demographically diverse sample. CONCLUSIONS: Although all methods were deployed in the same hospital or neighborhood and shared the same staff, each recruitment method was different in terms of cost and characteristics of the enrolled participants, suggesting the importance of carefully choosing the recruitment methods based on the desired composition of the final study sample. This analysis provides information about the effectiveness and cost of different methods to recruit adults for genetic research.

Reliance agreements and single IRB review of multisite research: Concerns of IRB members and staff.

The new National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was adopted primarily to simplify and speed the review of complex multisite clinical trials. However, speeding review requires overcoming a number of obstacles. Perhaps the most substantial obstacle is the time and effort needed to develop reliance agreements among the participating sites. We conducted 102 semistructured interviews with sIRB personnel, including directors, chairs, reviewers, and staff, from 20 IRBs that acted as sIRBs for multisite research, including 6 commercial/independent sIRBs, and 10 university-based academic and 4 federal sIRBs. Almost without exception, the interviewees agreed that reliance agreements were complex, difficult to develop, and time-consuming. A major problem for relying sites was that different agreements specified different responsibilities for the relying sites. Attitudes differed about whether these problems will be resolved as IRB staff and managers become more experienced with sIRBs. However it is clear that the process of developing reliance agreements must be simplified. Federal assistance in standardizing at least some sections of reliance agreements might reduce the difficulties involved.

Impediments to communication and relationships between infertility care providers and patients.

BACKGROUND: Infertility patients generally see provider-patient communication and relationships as important, but as often insufficient, raising critical questions regarding why these gaps persist, and how they might best be addressed. METHODS: Semi-structured interviews of approximately one hour each were conducted with 37 ART providers and patients (17 physicians, 10 other health providers, and 10 patients) and were thematically analyzed. RESULTS: Patients see clinicians' interactions as ranging widely from good to bad, related to several specific barriers and factors. Patients and providers may differ in their physical and emotional experiences, expectations concerning treatment outcomes and uncertainties, and time frames and finances, generating dynamic processes and tensions. Characteristics of particular providers, clinics and patients can also vary. Infertility patients tend to find only one outcome acceptable - a "take home baby" - rather than partial success, as is the case with many other diseases. Yet most IVF cycles fail. Many patients must pay considerable out-of-pocket expenses for infertility treatment, exacerbating disappointments and frustrations. Providers often work in competitive, entrepreneurial markets, and "hype" their potential success. After treatment failures, providers may feel guilty and withdraw from patients. Yet these behaviors can antagonize patients more than physicians realize, aggravating patient stresses. Several providers described how they understood patients' needs and perceptions more fully only after becoming infertility patients themselves. Interactions with not only physicians, but other providers (e.g., nurses and staff) can play key roles. Patients may be willing to understand these impediments, but providers often communicate these obstacles and reasons poorly or not at all, furthering tensions. CONCLUSIONS: These data, the first to examine several critical aspects of challenges that infertility providers and patients face in communication and relationships, suggest that several key dynamic processes and factors may be involved, and need to be addressed. While prior research has shown that infertility patients value, but often feel disappointed in relationships with clinicians, the present data highlight several specific impediments, and thus have critical implications for future practice, research, guidelines and education.

Addressing ethical challenges in HIV prevention research with people who inject drugs.

Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs (PWID). Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research evidence will be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: (1) Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? (2) Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? (3) When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? (4) Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world.

How much is a child worth? Providers' and patients' views and responses concerning ethical and policy challenges in paying for ART.

Infertility treatments remain expensive and in many countries are covered by little, if any, insurance, raising critical questions concerning how patients and providers view and make decisions regarding these challenges. In-depth semi-structured interviews of approximately 1 hour were conducted with 37 IVF providers and 10 patients (17 physicians, 10 other providers and 10 patients), and were systematically analyzed. These data suggest current insurance policies and legislation pose critical ethical and logistical challenges for both patients and providers. These individuals face multiple uncertainties about costs and insurance, related to unclear causes of fertility, treatment length, costs and outcomes, and odds that insurers will cover expenses. Insurers frequently decline to agree to reimbursement beforehand, and decide only afterwards, case-by-case, generating stress. Patients and providers thus may not be able to predict how best to allocate limited resources. Providers may advocate for patients, but are usually unsuccessful. Patients may adopt several strategies: e.g., moving/seeking treatment elsewhere, switching or feeling "stuck" in jobs because of insurance, seeking "free" medications, going into debt, or using funds intended for other purposes. Patients do not perceive and respond to resource limitations as fixed phenomena-i.e., patients do not see treatment simply as "affordable" or not. Rather, patients face quandaries of how much to keep spending-how much a child is worth-and are forced to make complex risk/benefit calculations. Couples can disagree, straining relationships. In sum, these data, the first to explore how providers and patients struggle, view, and make decisions regarding limited insurance and resources for infertility, raise several critical ethical and policy issues. These data suggest that individuals have difficulty translating profoundly life-altering, deeply personal quests for meaning and fulfillment into purely economic terms. These findings thus have important implications for future policy, practice, research, and patient and provider education.

Buying and selling human eggs: infertility providers' ethical and other concerns regarding egg donor agencies.

BACKGROUND: Egg donor agencies are increasingly being used as part of IVF in the US, but are essentially unregulated, posing critical ethical and policy questions concerning how providers view and use them, and what the implications might be. METHODS: Thirty-seven in-depth interviews of approximately 1 h were conducted - with 27 IVF providers and 10 patients. RESULTS: Clinicians vary in their views and interactions concerning egg donor agencies, ranging widely in whether and how often they use agencies. Agencies may offer egg recipients increased choices, but raise ethical and other concerns regarding respect for donors as individuals (e.g., adequacy of informed consent), potential harms, justice (e.g., concerns about possible eugenics - by encouraging and facilitating selection and marketing of facts for offspring), and donors constituting a vulnerable group. The quality of agencies appears to vary considerably, from acceptable to problematic. Agencies' medical and psychological screenings of donors can range, and be minimal. Not all agencies adequately track donors' prior numbers of donations, or share the relevant records with clinics. Clinics may find that potential donors have genetic mutations and medical problems about which they were unaware. Yet agencies and clinics do not provide care for such donors, generating stress. Dissemination of donors' personal data can potentially threaten confidentiality. Questions emerge of whether increased monitoring/oversight of agencies may be beneficial. CONCLUSIONS: These data, the first to examine providers' views and interactions regarding egg donor agencies, suggest wide variations in quality and use of agencies, and have critical implications for practice, policy, education and research. Given the potential limitations of the current model of self-regulation of agencies, the present data suggest needs to consider stronger professional guidelines or possible governmental regulations to establish, require and enforce higher standards for agencies to follow, regarding advertising to potential donors and recipients, arranging for appropriate informed consent concerning risks and benefits involved, and for quality control. Appropriate informed consent should be obtained from potential egg donors, including the fact that they may learn about mutations or medical problems about which they were unaware, but for which they will not receive treatment as part of this process. Enhancing understanding among the public-at-large about what egg donation entails may also be helpful.

Ethical and Psychosocial Considerations in Informing HIV-Exposed Uninfected Children That They Were Exposed to HIV and Antiretroviral Medications In Utero.

We build on what is known about the potential long-term health effects of perinatal antiretroviral medication exposure to examine ethical and psychosocial issues associated with disclosure by applying lessons from other health conditions, theories of child and adolescent development and rights, and the relevant literature and legal contexts. We present 2 cases to highlight potential issues; apply a bioethical framework that includes principles of autonomy, beneficence, nonmaleficence, and justice; and explore other factors, including the current uncertainty about these exposures' possible long-term health risks. This ethical framework can help clinicians and researchers consider and balance relevant concerns in deciding whether to inform offspring of HIV and related exposures.

Reviewing HIV-Related Research in Emerging Economies: The Role of Government Reviewing Agencies.

Little research has explored the possible effects of government institutions in emerging economies on ethical reviews of multinational research. We conducted semi-structured, in-depth telephone interviews with 15 researchers, Research Ethics Committees (RECs) personnel, and a government agency member involved in multinational HIV Prevention Trials Network (HPTN) research in emerging economies. Ministries of Health (MOH) or other government agencies often play pivotal roles as facilitators or barriers in the research ethics approval process. Government agency RECs reviewing protocols may face particular challenges, as they can lack resources, be poorly organized, have inconsistent review processes and limited expertise, and use differing definitions of national interests, including upholding national reputation and avoiding potential exploitation and stigma of the country's population. The MOH/governmental review body may be affected by power dynamics and politics in study reviews; may consider issues both related and unrelated to research ethics as understood elsewhere; and may prioritize particular diseases, treatments, or interventions over other topics/types of research. Poor communication and deeply-rooted tensions may exist between sponsor and host countries, impeding optimal interactions and reviews. Investigators must understand and plan for the potential effects of governmental agencies on multinational collaborative research, including preserving adequate time for agency review, and contacting these agencies beforehand to address issues that may arise. Better understanding of these issues can aid and advance appropriate global scientific collaboration.

Typologies of Altruistic and Financial Motivations for Research Participation.

Questions arise concerning participants' motives in risky studies, such as HIV vaccine trials (HVTs). We interviewed in-depth 20 gay/bisexual men. Participants described both altruistic and nonaltruistic motives. Altruistic motivations emerged primarily, with nine typologies: (a) cultural, (b) community related, (c) familial, (d) religious, (e) professional, (f) political (e.g., HIV activism), (g) moral (e.g., making up for past wrongs), (h) existential (e.g., providing sense of meaning), and (i) other psychological (e.g., emotional gratification). Views of compensation varied: not a factor (55%), added incentive (25%), main motivator, but in conjunction with altruism (15%), and primary motivator (5%). HVT participants thus often have both altruistic and financial motives, and related typologies emerged. These findings have critical implications for studies on HIV, other conditions, and research ethics.

Linguistic and Cultural Challenges in Communication and Translation in US-Sponsored HIV Prevention Research in Emerging Economies.

Linguistic and cultural differences can impede comprehension among potential research participants during the informed consent process, but how researchers and IRBs respond to these challenges in practice is unclear. We conducted in-depth interviews with 15 researchers, research ethics committee (REC) chairs and members from 8 different countries with emerging economies, involved in HIV-related research sponsored by HIV Prevention Trials Network (HPTN), regarding the ethical and regulatory challenges they face in this regard. In the interviews, problems with translating study materials often arose as major concerns. Four sets of challenges were identified concerning linguistic and cultural translations of informed consent documents and other study materials, related to the: (1) context, (2) process, (3) content and (4) translation of these documents. Host country contextual issues included low literacy rates, education (e.g., documents may need to be written below 5th grade reading level), and experiences with research, and different views of written documentation. Certain terms and concepts may not exist in other languages, or have additional connotations that back translations do not always reveal. Challenges arise because of not only the content of word-for-word, literal translation, but the linguistic form of the language, such as tone (e.g., appropriate forms of politeness vs. legalese, seen as harsh), syntax, manner of questions posed, and the concept of the consent); and the contexts of use affect meaning. Problems also emerged in bilateral communications--US IRBs may misunderstand local practices, or communicate insufficiently the reasons for their decisions to foreign RECs. In sum, these data highlight several challenges that have received little, if any, attention in past literature on translation of informed consent and study materials, and have crucial implications for improving practice, education, research and policy, suggesting several strategies, including needs for broader open-source multilingual lexicons, and more awareness of the complexities involved.

Kamakahi vs ASRM and the future of compensation for human eggs.

A recent lawsuit that alleges that the American Society for Reproductive Medicine (ASRM) engages in price-fixing by capping the amount of compensation paid for human oocytes has several critical ethical and policy implications that have received relatively little attention. ASRM has argued that ceilings on donor compensation prevent enticement, exploitation, and oocyte commodification. Critics counter that low donor compensation decreases supply, because fewer women are then interested in donating, which then increases prices for the service that physicians, not donors, accrue, and that ethical goals can be better achieved through enhanced informed consent, hiring egg donor advocates, and better counseling and screening. Yet, if compensation caps are removed, questions emerge concerning what the oocyte market would then look like. Informed consent is an imperfect process. Beyond the legal and economic questions of whether ASRM violates the Sherman Anti-trust Act also lie crucial questions of whether human eggs should be viewed as other products. We argue that human eggs differ from other factory-produced goods and should command moral respect. Although eggs (or embryos) are not equivalent to human beings, they deserve special consideration, because of their potential for human life, and thus have a different moral status. ASRM's current guidelines appear to address, even if imperfectly, ethical challenges that are related to egg procurement for infertility treatment. Given public concerns about oocyte commodification and ASRM's wariness of government regulations, existing guidelines may represent a compromise by aiding patients who seek eggs, while simultaneously trying to avoid undue influence, exploitation, and eugenics. Although the ultimate outcome of this lawsuit remains unclear, policy makers, providers, lawyers, judges, and others should attend seriously to these issues. Alternatives to current ASRM guidelines may be possible (eg, raising the current caps to, say, $12,000 or $15,000, potentially increasing donation, while still avoiding certain ethical difficulties) and warrant close consideration. These complex conflicting ethical issues deserve more attention than they have received because they affect key aspects of clinical practice and the lives of countless patients.

Creating and selling embryos for "donation": ethical challenges.

The commercial creation and sale of embryos has begun, which poses a series of ethical questions that have received little scholarly attention. Some of the concerns that arise are similar to those posed by the sale of gametes, while other issues differ markedly. Questions emerge, first, regarding the rights of the unborn children and their ability to know their biological parents. Companies that create human embryos de novo may wish to keep gamete providers anonymous. Many of these offspring thus will never learn that their parents are not their biologic parents. Yet, such disclosures, regarding not only one but both of these biologic parents, may be important for these individuals; and a lack of this knowledge may impede their physical and psychological health. Second, questions surface regarding the fees that providers should charge for embryos and whether these amounts should vary based on the traits of 1 or both of the gamete donors. Some prospective parents may seek specific traits in a baby (eg, height or eye/hair coloring), which prompts the creation of embryos from 2 gamete donors who possess these characteristics. Third, ownership of embryos created without an advanced directive by patients poses dilemmas (eg, disposition of any remaining embryos). Fourth, guidelines do not yet exist to limit the number of embryos sold from each pair of gamete donors. Hence, unbeknownst to each other, full siblings could potentially meet, get married, and procreate. This discussion has several critical implications for future practice and professional education and policy. Patients with diseases associated with genetic tests may well ask obstetricians, gynecologists, and other physicians about these techniques and practices. Clinicians can refer such patients to assisted reproductive technology specialists; however, familiarity with the basic aspects of the issues and complexities involved could aid these providers and their patients Several of these issues can be addressed relatively easily through guidelines from professional associations (eg, limiting the number of embryos sold from each pair of gamete donors). Because creation and sales of embryos will likely spread, consideration of appropriate responses is critical to establish standards of care to help the future offspring, and ensure ongoing public trust.