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BACKGROUND The conduct of research by clinicians is vital to maintain evidence-based practice and currency of clinician knowledge. However, the ability to conduct valid research is contingent on several factors including the knowledge of research ethics guidelines applicable within the researcher's location. AIMS To compare the actual and perceived knowledge of research ethics guidelines in a sample of healthcare clinicians in a public health service. METHODS A prospective cross-sectional design utilising an anonymous online survey. RESULTS Of the 432 valid responses, 8% were totally well calibrated on perceived and actual knowledge. A further 9% were totally miscalibrated on all items. The remaining 83% of respondents were variously miscalibrated on 1-4 items. The majority of miscalibrated responses represented overconfidence. CONCLUSIONS Clinicians are not as knowledgeable as they think about research ethics. This has implications for help-seeking behaviours within this population and highlights challenges for stakeholders in the provision of research support and education.

Research ethics is a fundamental part of the entire research. Patients with rheumatoid arthritis are sensitive group of research participants because their long-term health problems cause significant changes in their foot health. In foot health research, data are usually collected through a clinical assessment of the foot or questionnaires. However, there is limited evidence of the reported research ethics of empirical studies on foot health in patients with rheumatoid arthritis. Therefore this review aimed to analyze the reported research ethics of peer-reviewed empirical studies focusing on foot health in patients with rheumatoid arthritis as research participants. This systematic review used the Medline/PubMed, CINAHL, and Embase databases. A total of 1,653 records were identified, and 32 articles were included in the final analysis. Reporting research ethics in studies of patients with rheumatoid arthritis is fragmented, focusing predominantly on ethical approval and informed consent and lacking a broader discussion about research ethics.

Community engagement (patient and public involvement) is gaining prominence in health research worldwide. But there remains limited ethical guidance on how to share power with communities in health research priority setting, particularly that which has been informed by the perspectives of those being engaged. This article provides initial evidence about what they think are important ways to share power when setting health research projects’ topics and questions. Twenty-two people with lived experience, engagement practitioners, and members of the public who have been engaged in health research in the United Kingdom and Australia were interviewed. Thematic analysis identified 15 key ways to share power, many of which are relational. This study further demonstrates that tensions exist between certain ways of sharing power in health research priority setting. More research is needed to determine how to navigate those tensions.

Background: Alzheimer’s Disease and Related Dementias (ADRD) clinical trials require multidisciplinary expertise in medicine, biostatistics, trial design, biomarkers, ethics, and informatics. Objectives: To provide focused interactive training in ADRD clinical trials to a diverse cadre of investigators. Design: The Institute on Methods and Protocols for Advancement of Clinical Trials in ADRD (IMPACT-AD) is a novel multidisciplinary clinical trial training program funded by the National Institute on Aging and the Alzheimer’s Association with two educational tracks. The Professionals track includes individuals who fill a broad variety of roles including clinicians, study coordinators, psychometricians, and other study professionals who wish to further their knowledge and advance their careers in ADRD trials. The Fellowship track includes current and future principal investigators and focuses on the design, conduct and analysis of ADRD clinical trials. Setting: The 2020 inaugural iteration of IMPACT-AD was held via Zoom. Participants: Thirty-five trainees (15 Fellowship track; 20 Professionals track) were selected from 104 applications (34% acceptance rate). Most (n=25, 71%) identified as female. Fifteen (43%) were of a non-white race; six (18%) were of Hispanic ethnicity; eight (23%) indicated they were the first person in their family to attend college. Measurements: Participants completed daily evaluations as well as pre- and post-course assessments of learning. Results: Across topic areas, >90% of trainees evaluated their change in knowledge based on the lectures as “very much” or “somewhat increased.” The mean proportion correct responses in pre- and post-course assessments increased from 55% to 75% for the Professionals track and from 54% to 78% for the Fellowship track. Conclusions: IMPACT-AD successfully launched a new training opportunity amid a global pandemic that preliminarily achieved the goals of attracting a diverse cohort and providing meaningful training. The course is funded through 2025.

The governance of ethically acceptable research in higher education institutions has been under scrutiny over the past half a century. Concomitantly, recently, decision makers have required researchers to acknowledge the societal impact of their research, as well as anticipate and respond to ethical dimensions of this societal impact through responsible research and innovation principles. Using artificial intelligence population health research in the United Kingdom and Canada as a case study, we combine a mapping study of journal publications with 18 interviews with researchers to explore how the ethical dimensions associated with this societal impact are incorporated into research agendas. Researchers separated the ethical responsibility of their research with its societal impact. We discuss the implications for both researchers and actors across the Ethics Ecosystem.

Given the dearth of established safe and effective interventions to respond to COVID-19, there is an urgent ethical imperative to conduct meaningful clinical research. The good news is that interventions to be tested are not in short supply. Unfortunately, the human and material resources needed to conduct these trials are finite. It is essential that trials be robust and meet enrollment targets and that lower-quality studies not be permitted to displace higher-quality studies, delaying answers to critical questions. Yet, with few exceptions, existing research review bodies and processes are not designed to ensure these conditions are satisfied. To meet this challenge, we offer guidance for research institutions about how to ethically consolidate and prioritize COVID-19 clinical trials, while recognizing that consolidation and prioritization should also take place upstream (among manufacturers and funders) and at a higher level (e.g. nationally). In our proposed three-stage process, trials must first meet threshold criteria. Those that do are evaluated in a second stage to determine whether the institution has sufficient capacity to support all proposed trials. If it does not, the third stage entails evaluating studies against two additional sets of comparative prioritization criteria: those specific to the study and those that aim to advance diversification of an institution’s research portfolio. To implement these criteria fairly, we propose that research institutions form COVID-19 research prioritization committees. We briefly discuss some important attributes of these committees, drawing on the authors’ experiences at our respective institutions. Although we focus on clinical trials of COVID-19 therapeutics, our guidance should prove useful for other kinds of COVID-19 research, as well as non-pandemic research, which can raise similar challenges due to the scarcity of research resources.

Publication of scientific paper is critical for modern science evolution, and professional advancement. However, it comes with many responsibilities. An author must be aware of good publication practices. While refraining from scientific misconduct or research frauds, authors should adhere to Good Publication Practices (GPP). Publications which draw conclusions from manipulated or fabricated data could prove detrimental to society and health care research. Good science can blossom only when research is conducted and documented with complete honesty and ethics. Unfortunately, publish or perish attitude has led to unethical practices in scientific research and publications. There is need to identify, acknowledge, and generate awareness among junior researchers or postgraduate students to curb scientific misconduct and adopt GPP. This article discusses various unethical publication practices in research. Also, the role and responsibilities of authors have been discussed with the purpose of maintaining the credibility and objectivity of publication.

Objective Trillions of dollars pass to physicians from industry-related businesses annually, leading to many opportunities for financial conflicts of interest. The Open Payments Database (OPD) was created to ensure transparency. We describe the industry relationships as reported in the OPD for presenters at the 2019 Society of Gynecologic Oncology (SGO) Annual Meeting and evaluate concordance between author disclosures of their financial interests and information provided by the OPD. Methods This is an observational, cross-sectional study. Disclosure data were collected from authors with oral and featured abstract presentations in the 2019 SGO annual conference. These disclosures were compared to data available for each author in the 2018 OPD, which included the amount and nature of industry payments. Results We examined the disclosures of 301 authors who met inclusion criteria. Of 161 authors who had disclosure statements on their presentations,147 reported “no disclosures,” and 14 disclosed industry relationships. The remaining 140 did not list any disclosure information. Sixty percent (184/301) of authors had industry relationships in the 2018 OPD, including 173 of 287 (60.3%) of authors who either reported no disclosures or did not have disclosure data available in their presentations. These transactions totaled over 43 million USD from 122 different companies, with most payments (46%) categorized as “Research or Associated Research.” Accurate disclosure reporting was associated with receiving higher payments or research payments, and being a presenting author. Conclusions Most authors at the SGO annual conference did not correctly disclose their industry relationships when compared with their entries in the OPD.

The SARS-CoV-2 pandemic has affected practically every aspect of life across the globe for the past year or more; the practice of clinical research not the least. Clinician scientists attempting to start or continue work both related and unrelated to the disease itself have faced ethical, oversight, or regulatory challenges. No aspect of the clinical trial enterprise was unaffected. These narratives detail some of the barriers encountered and how the investigators coped (or didn't cope). Common themes emerged, ranging from a need to contribute, which drove the researchers to frustration with real and perceived obstructions (both old and new). The narratives disclose common ethical issues related to research during a pandemic: issues both qualitatively and quantitatively different from other human subject research; challenges both new and novel, as well as those previously seen, but writ large in the face of the crisis. The narratives also offer words of advice from the trenches and speak to successes, both large and small, and to the value of teamwork and focus on a common goal.

Neuroimaging research regularly yields “incidental findings”: observations of potential clinical significance in healthy volunteers or patients, but which are unrelated to the purpose or variables of the study.

In 2010 Largent, Wendler and Emanuel proposed the ‘consent substitute model’ for emergency research with incapacitated participants. The model provides a means to enroll participants in emergency research without consent, if five conditions are met: (1) the research addresses the patients’ urgent medical needs (2) the risk‐benefit ratio is favorable (3) there are no known conflicts with patients’ values or interests (4) cumulative net risk is minimal and (5) consent is given as soon as possible. We review national and international ethics laws, regulations and guidelines to determine (a) whether they accord with the consent substitute model’s five conditions and (b) the level of congruence across these documents. We find that only one document meets all five conditions and that there is significant disparity among the documents, particularly between national and international ones. These differences may have stymied international collaboration in emergency research. We recommend that the two international documents used most, the International Council for Harmonisation’s Guideline for Good Clinical Practice and the World Medical Association’s Declaration of Helsinki, are revised to include more specific provisions on emergency medical research.

BACKGROUND: Adolescents in low- and middle-income countries (LMICs) have a high burden of HIV, increasing the importance of including adolescents in HIV research. Adolescence is a period of transition that introduces unique ethical challenges for HIV research. The aim of this paper is to describe the ethical-legal barriers to adolescent participation in HIV research studies and potential strategies for including adolescents in LMIC research studies. METHODS: We examined experiences from PATC3H, a research consortium focused on HIV prevention and treatment research in resource-constrained settings. The consortium includes studies in Brazil, Kenya, Mozambique, Nigeria, South Africa, Zambia, and Uganda. PATC3H researchers were asked to identify ethical and practical challenges for adolescent consent to research participation in these countries. We also used standardized scenarios to facilitate comparison of adolescent consent in these seven countries. Informed by our examination of PATC3H consortium experiences, we conducted a scoping review focused on solutions that could be used to enhance adolescent participation in LMIC HIV studies. FINDINGS: Our consortium experiences demonstrated many ethical challenges, including the following: inconsistent or absent guidance for the conditions under which adolescents can independently consent to research participation; guidelines that fail to account for the full array of adolescents’ lives; and substantial variation in how ethical review committees assess adolescent research studies. Our scoping review identified several potential consent-related strategies to expand adolescent access to HIV research, including waiving parental consent requirements, allowing adolescents to provide independent research consent, and clarifying surrogate decision-making processes. INTERPRETATION: While there are several ethical and practical challenges in adolescent consent to HIV research participation in LMICs, these challenges can be addressed by alternative consent strategies. Guidance on the ethics of adolescent HIV research is needed to increase adolescent participation in research.

BackgroundResearch ethics guidelines set a high bar for conducting research with vulnerable populations, often resulting in their exclusion from beneficial research. Our study aims to better characterise participants’ vulnerabilities, agency, resourcefulness and sources of support.MethodsWe undertook qualitative research around two clinical studies involving migrant women living along the Thai–Myanmar border. We conducted 32 in-depth interviews and 10 focus group discussions with research participants, families, researchers and key informants.ResultsWe found that being ‘undocumented’ is at the core of many structural vulnerabilities, reflecting political, economic, social and health needs. Although migrant women lead challenging lives, they have a support network that includes family, employers, community leaders, non-governmental organisations and research networks. Migrant women choose to participate in research to access quality healthcare, gain knowledge and obtain extra money. However, research has the potential to exacerbate existing vulnerabilities, such as the burdens of cross-border travel, foregoing work and being more visible as migrants.ConclusionsOur study confirms that research is important to provide evidence-based care and was viewed by participants as offering many benefits, but it also has hidden burdens. Migrant women exercised agency and resourcefulness when navigating challenges in their lives and research participation.

BACKGROUND: Clinical genomic implementation studies pose challenges for informed consent. Consent forms often include complex language and concepts, which can be a barrier to diverse enrollment, and these studies often blur traditional research-clinical boundaries. There is a move toward self-directed, web-based research enrollment, but more evidence is needed about how these enrollment approaches work in practice. In this study, we developed and evaluated a literacy-focused, web-based consent approach to support enrollment of diverse participants in an ongoing clinical genomic implementation study. METHODS: As part of the Cancer Health Assessments Reaching Many (CHARM) study, we developed a web-based consent approach that featured plain language, multimedia, and separate descriptions of clinical care and research activities. CHARM offered clinical exome sequencing to individuals at high risk of hereditary cancer. We interviewed CHARM participants about their reactions to the consent approach. We audio recorded, transcribed, and coded interviews using a deductively and inductively derived codebook. We reviewed coded excerpts as a team to identify overarching themes. RESULTS: We conducted 32 interviews, including 12 (38%) in Spanish. Most (69%) enrolled without assistance from study staff, usually on a mobile phone. Those who completed enrollment in one day spent an average of 12 minutes on the consent portion. Interviewees found the information simple to read but comprehensive, were neutral to positive about the multimedia support, and identified increased access to testing in the study as the key difference from clinical care. CONCLUSIONS: This study showed that interviewees found our literacy-focused, web-based consent approach acceptable; did not distinguish the consent materials from other online study processes; and valued getting access to testing in the study. Overall, conducting empirical bioethics research in an ongoing clinical trial was useful to demonstrate the acceptability of our novel consent approach but posed practical challenges.

Electronic institutional review board systems (eIRBs) have become an integral component in ensuring compliance with Human Research Protection Program (HRPP) and IRB requirements. Despite this, few of these systems are configured to administer the single IRB (sIRB) process mandated by the National Institutes of Health (NIH) for multisite research. We interviewed 103 sIRB administrators, chairs, members, and staff members about their experiences with sIRB multisite research review. We observed three main obstacles to adapting existing eIRB systems to accommodate the sIRB process: (1) Existing systems are not designed for sIRBs and are not configured to administer sIRB responsibilities, (2) they are not interoperable, and (3) resources to improve existing systems are lacking. Our findings suggest that IRBs that act as an sIRB will need major changes to their electronic systems in order to accommodate sIRB processes. These difficulties threaten both the ability of IRBs to focus on ethical rather than bureaucratic problems and the efficiency of multisite trials.

Researchers who desire to make positive changes for vulnerable populations often conduct problem-focused studies. Although problem-focused research is important, when such studies are not carefully designed, their results can contribute to a deficit discourse. A deficit discourse is a narrative that describes the person through a myopic lens of negativity characterized only by illness, death, depression, failure, or the like. Deficit discourse negatively affects how health care providers and society interact with vulnerable people. This article discusses deficit discourse in health care and strengths-based research: an ethical approach to working with vulnerable individuals in research settings and a strategy to overcome deficit discourse. Strengths-based research approaches balance risks with countermeasures that include areas that are positive and amenable to growth or intervention. Strengths-based research can be conducted using qualitative, quantitative, or mixed-methods methodology. Strengths-based research should be culturally relevant and population-specific, often including the individuals of study throughout the process. By modifying the research approach, critical problems can be identified and addressed while also emphasizing positive ways to empower individuals and improve their lives. Additionally, these changes better the way researchers and health care providers view and care for people while also challenging deficit discourses in society at large.

Research ethics review committees (RERCs) and Human Research Protection Programs (HRPPs) are responsible for protecting the rights and welfare of research participants while avoiding unnecessary inhibition of valuable research. Evaluating RERC/HRPP quality is vital to determining whether they are achieving these goals effectively and efficiently, as well as what adjustments might be necessary. Various tools, standards, and accreditation mechanisms have been developed in the United States and internationally to measure and promote RERC/HRPP quality.We systematically reviewed 10 quality assessment instruments, examining their overall approaches, factors considered relevant to quality, how they compare to each other, and what they leave out. For each tool, we counted the number of times each of 34 topics (divided into structure, process, and outcome categories) was mentioned. We generated lists of which topics are most and least mentioned for each tool, which are most prevalent across tools, and which are left unmentioned. We also conducted content analysis for the 10 most common topics.We found wide variability between instruments, common emphasis on process and structure with little attention to participant outcomes, and failure to identify clear priorities for assessment. The most frequently mentioned topics areOur analysis confirms that RERC/HRPP quality assessment instruments largely rely on surrogate measures of participant protection. To prioritize between these measures and preserve limited resources for evaluating the most important criteria, we recommend that instruments focus on elements relevant to participant outcomes, robust board deliberation, and procedures most likely to address participant risks. Validation of these approaches remains an essential next step.

A central tension in pediatric research ethics arises from our desire to protect children from harm while also allowing progress toward discoveries that could improve child health. A prime example of this tension is research on a controversial yet increasingly common practice: the use of cannabis by women to treat nausea and vomiting of pregnancy. Studies of cannabis use in pregnancy face a combination of ethical hurdles because of the inclusion of pregnant women and involvement of a schedule I controlled substance. Given the growing need for research on the safety and efficacy of cannabis for nausea and vomiting of pregnancy, we reflect on the multiple historical contexts that have contributed to the challenge of studying cannabis use during pregnancy and make a case for the ethical rationale for such research.

Covid-19 has been one of the worst public health calamities faced by humankind in over a century. As of July 23, 2020, there have been 15,633,159 confirmed cases and 635,422 deaths reported, worldwide (1). We are six months into the pandemic, and yet we know little about the disease. The role of medicines is far from optimal, and vaccines are still under trials. Therefore, we have little to defend ourselves against this novel virus.brbr.

Data-sharing helps advance scientific research and assures the benefits of research data are maximized. Previous work has highlighted ethical challenges, especially in low- and middle-income countrie (LMIC) countries. This study examined the views of researchers in a middle-income country, Thailand, regarding the most important data-sharing challenges. The target researchers worked in biomedical and related research. The survey was distributed to 38 academic and health-science institutes, 18 university hospitals, 84 nonuniversity hospitals, and 22 research institutes across Thailand; 229 researchers in clinical/basic and social/behavioral sciences, and pubxxlic health/policy participated. Thai researchers were less concerned with informed consent and the feasibility of conducting research and sharing data, focusing on the importance of safeguards when handling data, including transfer to others, and possible lack of control over subsequent data use. The respondents felt that researchers should decide what types of project data are shareable and which data are likely useful to the scientific community. They were more concerned with appropriate acknowledgment and protecting the legal rights of the primary data collectors and providers. Although they had concerns about data access conditions, they rated sharing sufficient data and metadata to reproduce the analysis of the primary outcomes as highly important. These results are important for future efforts of the LMIC countries to develop efficient data-sharing frameworks and establish institutional data access committees. They highlight the importance, for the sustainability and fairness of these efforts, to ensure that parties in LMIC countries receive appropriate credit and are involved in determining where/when/how their data may be used. publishedVersion

Recent calls for retraction of a large body of Chinese transplant research and of Dr Jiankui He’s gene editing research has led to renewed interest in the question of publication, retraction and use of unethical biomedical research. In Part 1 of this paper, we briefly review the now well-established consequentialist and deontological arguments for and against the use of unethical research. We argue that, while there are potentially compelling justifications for use under some circumstances, these justifications fail when unethical practices are ongoing—as in the case of research involving transplantations in which organs have been procured unethically from executed prisoners. Use of such research displays a lack of respect and concern for the victims and undermines efforts to deter unethical practices. Such use also creates moral taint and renders those who use the research complicit in continuing harm. In Part 2, we distinguish three dimensions of ‘non-use’ of unethical research: non-use of published unethical research, non-publication, and retraction and argue that all three types of non-use should be upheld in the case of Chinese transplant research. Publishers have responsibilities to not publish contemporary unethical biomedical research, and where this has occurred, to retract publications. Failure to retract the papers implicitly condones the research, while uptake of the research through citations rewards researchers and ongoing circulation of the data in the literature facilitates subsequent use by researchers, policymakers and clinicians.

Background: Surgical research is potentially invasive, high-risk, and costly. Research that advances medical dogma must justify both its ends and its means. Although ethical questions do not always have simple answers, it is critically important for the clinician, researcher, and patient to approach these dilemmas and surgical research in a thoughtful, conscientious manner. Methods: We present four ethical issues in surgical research and discuss the opposing viewpoints. These topics were presented and discussed at the 39th Annual Meeting of the Surgical Infection Society as pro–con debates. The presenters of each opinion developed a succinct summary of their respective reviews for this publication. Results: The key subjects for these pro–con debates were: (1) Should patients be enrolled for time-sensitive surgical infection research using an opt-out or an opt-in strategy? (2) Should patients who are being enrolled in a randomized controlled trial (RCT) comparing surgery with a non-operative intervention pay the costs of their treatment arm? (3) Should the scientific community embrace open access journals as the future of scientific publishing? (4) Should the majority of funding go to clinical or basic science research? Important points were illustrated in each of the pro–con presentations and illustrated the difficulties that are facing the performance and payment of infection research in the future. Conclusions: Surgical research is ethically complex, with conflicting demands between individual patients, society, and healthcare economics. At present, there are no clear answers to these and the many other ethical issues facing research in the future. Answers will only come from continued robust dialogue among all stakeholders in surgical research.

Background: The increased use of electronic health records (EHRs) has resulted in new opportunities for research, but also raises concerns regarding privacy, confidentiality, and patient awareness. Because public trust is essential to the success of the research enterprise, patient perspectives are essential to the development and implementation of ethical approaches to the research use of EHRs. Yet, little is known about patients' views and expectations regarding various approaches to seeking permission for research use of their EHR data. Methods: We conducted semi-structured interviews with 120 patients in four counties in diverse regions of the southeastern United States: Appalachia, the Mississippi Delta, and the Piedmont area of North Carolina. We asked participants to consider, from multiple stakeholder perspectives, the advantages and disadvantages of three approaches to notifying patients of, or obtaining permission for, research use of their EHR data; whether they believed it would be acceptable if their healthcare organization used each approach; and which approach would be most appropriate. Results: Nearly all participants said General Notification, Broad Permission, and Categorical Permission would each be acceptable approaches to notification of, or permission for, EHR research. Over half identified Broad Permission as the most appropriate approach. Across all of these discussions, major themes included the importance of clarity, simplicity, and usability of patient-facing materials, as well as the level of transparency, trustworthiness, and respect for patients the approach conveys. Conclusions: Our findings help to inform the development and implementation of ethical approaches to the research use of EHRs by identifying key patient considerations regarding various approaches to permission and suggesting potential actions for healthcare organizations and researchers.

Scientific societies play an important role in promoting and fostering research integrity. Through a comparative study between China and the United States based on information published over the internet, this article lays out some problems existing in Chinese scientific societies concerning the promotion of research integrity. Research integrity assumes only a minor presence in societies' policy texts, terms that are incorporated tend to be too general, and concrete action often remains superficial. To remedy these problems, this article makes five recommendations for scientific societies to put more emphasis on research integrity: (1) formulating more professional and specific norms; (2) launching dedicated columns or adding related articles in journals; (3) holding seminars and briefings; (4) setting up specialized committees; and (5) strengthening research integrity education. To supplement the realization of these goals, the article also suggests possible incentive measures.

Tribal Institutional Review Boards (TIRBs) in the United States assert their rights within sovereign nations by developing ethical research processes that align with tribal values to protect indigenous knowledge systems and their community from cultural appropriation, exploitation, misuse, and harm. We reviewed six TIRB applications and processes to gain a better understanding about their requirements and research ethics. We located 48 activated and deactivated TIRBs in a database, mapped them in relation to tribal reservation lands, and then conducted in-depth content analysis. Our analysis demonstrates the importance of building relationships, becoming fully acquainted with the TIRB’s operating environment before seeking research approval, and issues related to tribal data management practices.

Introduction: An important gap within modern medicine is the lack of enough comparative effectiveness research of marketed medicines. Low-risk pragmatic randomized controlled trials (pRCTs) are tho...

This article considers a case in which a prominent researcher repeatedly made protocol deviations year after year while the institutional review board and university leadership failed to adequately address his continuing noncompliance. This article argues that, in addition to reporting this researcher's pattern of noncompliance to the Office for Human Research Protections, as required by federal regulations, the university should implement a remedial action plan.

Public health institutions increasingly realize the importance of creating a culture in their organizations that values ethics. When developing strategies to strengthen ethics, institutions will have to take into account that while public health research projects typically undergo thorough ethics review, activities considered public health practice may not be subjected to similar oversight. This approach, based on a research-practice dichotomy, is increasingly being criticized as it does not adequately identify and manage ethically relevant risks to those affected by nonresearch activities. As a reaction, 3 major public health institutions (the World Health Organization, US Centers for Disease Control and Prevention, and Public Health Ontario) have implemented mechanisms for ethics review of public health practice activities. In this article, we describe and critically discuss the different modalities of the 3 approaches. We argue that although further evaluation is necessary to determine the effectiveness of the different approaches, public health institutions should strive to implement procedures to ensure that public health practice adheres to the highest ethical standards.

Controlled human infection model (CHIM) studies involve the intentional exposure of healthy research volunteers to infectious agents. These studies contribute to knowledge about the cause or development of disease and to the advancement of vaccine research. But they also raise ethical questions about the kinds of risks that should be permissible and whether limits should be imposed on research risks in CHIM studies. Two possible risk thresholds have been considered for CHIM studies. The first suggests constraining ethically permissible risks according to a minimal risk threshold and the second endorses a higher risk threshold that excludes irreversible or fatal infections. I argue that neither of these thresholds is persuasive and situate questions about risk thresholds in CHIM studies within a broader debate about permissible risks in research. I argue that risks in CHIM studies should be constrained according to limits on research risks that do not offer corresponding benefits in all studies rather than developing a unique risk threshold for CHIM studies. I then propose five recommendations for the ethical assessment of risk in CHIM studies.

Preprint artykułu, który ukazał się w czasopiśmie: Journal of Empirical Research on Human Research Ethics, 2021, pp.1-10, (wydawca: SAGE Publishing), Online First: 15.11.2021. The global COVID-19 pandemic and quarantine/distancing measures have forced researchers to cope with a new situation. This paper aimed to analyze how the pandemic and its associated constraints have affected social researchers’ approach to research ethics. Drawing on an online qualitative survey with 193 Polish social researchers conducted in April and May 2020, we distinguished three approaches: nothing has changed, opportunity-oriented, and precautionary. According to the first, the pandemic was not regarded as a situation that required additional reflection on ethical issues or changes in research approaches. By contrast, the other two were based on the assumption that the pandemic affected research project ethics. The difference was in the assessment of changes in the area of ethics. The pandemic presented an opportunity and a threat to the ethicality of research, respectively. We discuss the implications of all three approaches for research and education.

This article provides pragmatic advice for organizations interested in creating a research ethics consultation service (RECS). A robust RECS has the potential to build capacity among investigators to identify and consider the ethical issues they encounter while conducting their research. Determining whether to establish an RECS should begin with an institutional-needs assessment that includes three key questions: What are the current resources available to research teams to navigate ethical concerns that arise from their research? Is there a demand or perceived need for more resources? Is there institutional support (financial and otherwise) to establish and maintain an RECS? If this results in the decision to establish the consultation service, relevant institutional stakeholders must be identified and consulted, and personnel with the requisite skills recruited. The next step is to establish an RECS and build the infrastructure to process and respond to requests. The RECS's long-term sustainability will depend on a stable source of funding and a mechanism to receive constructive feedback to ensure that the service is meeting the institutional needs it set out to address.

Background Engagement of people with lived experience and members of the public is an ethically and scientifically essential component of health research. Authentic engagement means they are involved as full partners in research projects. Yet engagement as partnership is uncommon in practice, especially during priority-setting for research projects. What is needed for agenda-setting to be shared by researchers and people with lived experience and/or members of the public (or organisations representing them)? At present, little ethical guidance exists on this matter, particularly that which has been informed by the perspectives of people with lived experience and members of the public. This article provides initial evidence about what they think are essential foundations and barriers to shared decision-making in health research priority-setting and health research more broadly. Methods An exploratory, qualitative study was conducted in 2019. 22 semi-structured interviews were performed with key informants from the UK and Australia. Results Three main types of foundations were thought to be essential to have in place before shared decision-making can occur in health research priority-setting: relational, environmental, and personal. Collectively, the three types of foundations addressed many (but not all) of the barriers to power sharing identified by interviewees. Conclusions Based on study findings, suggestions are made for what researchers, engagement practitioners, research institutions, and funders should do in their policy and practice to support meaningful engagement. Finally, key international research ethics guidelines on community engagement are considered in light of study findings.

In a cluster randomised trial (CRT), intact groups—such as communities, clinics or schools—are randomised to the study intervention or control conditions. The issue of informed consent in CRTs has been particularly challenging for researchers and research ethics committees. Some argue that cluster randomisation is a reason not to seek informed consent from research participants. In fact, systematic reviews have found that, relative to individually randomised trials, CRTs are associated with an increased likelihood of inadequate reporting of consent procedures and inappropriate use of waivers of consent. The objective of this paper is to clarify this confusion by providing a practical and useful framework to guide researchers and research ethics committees through consent issues in CRTs. In CRTs, it is the unit of intervention—not the unit of randomisation—that drives informed consent issues. We explicate a three-step framework for thinking through informed consent in CRTs: (1) identify research participants, (2) identify the study element(s) to which research participants are exposed, and (3) determine if a waiver of consent is appropriate for each study element. We then apply our framework to examples of CRTs of cluster-level, professional-level and individual-level interventions, and provide key lessons on informed consent for each type of CRT.

The past few years have witnessed several media-covered cases involving citizens actively engaging in the pursuit of experimental treatments for their medical conditions-or those of their loved ones-in the absence of established standards of therapy. This phenomenon is particularly observable in patients with rare genetic diseases, as the development of effective therapies for these disorders is hindered by the limited profitability and market value of pharmaceutical research. Sociotechnical trends at the cross-section of medicine and society are facilitating the involvement of patients and creating the digital infrastructure necessary to its sustainment. Such participant-led research (PLR) has the potential to promote the autonomy of research participants as drivers of discovery and to open novel non-canonical avenues of scientific research. At the same time, however, the extra-institutional, self-appointed, and, often, oversight-free nature of PLR raises ethical concern. This paper explores the complex ethical entanglement of PLR by critically appraising case studies and discussing the conditions for its moral justification. Furthermore, we propose a path forward to ensure the safe and effective implementation of PLR within the current research ecosystem in a manner that maximizes the benefits for both individual participants and society at large, while minimizing the risks.

Tissue samples may be collected from children in the course of their clinical care, or when they participate in research. Those samples may be stored in research biobanks. However, as the removal of tissue from children in Australia is regulated by State and Territory legislation, clinicians and researchers require an understanding of the regulatory framework. Removal of tissue from children for purposes not authorised under legislation can result in offences being committed. In addition, ethical issues arise from the collection and storage of children's tissue for research purposes. Tissue used for genomic research also brings additional risks to participants. This paper describes the current law, discusses its inadequacies and raises some of the key ethical issues that Australian researchers need to know. This paper focuses on the removal and use of paediatric tissue for research purposes only.

There is no doubt that COVID-19 will have a substantial impact on access to biologics and biosimilar uptake, as well as on the related ethical, legal, and social dimensions of prioritization decisions. This holds especially true for Denmark and European markets, where governments are expected to cover most of the pharmaceutical needs of their citizens and where the crisis has been leading to an important reduction of available resources. In this paper we make four key comments relating to (1) broader ethico-legal dimensions of prioritizations in Europe, (2) human rights law and (3) regulatory aspects of access, diversification, vulnerability and systemic trust, and (4) additional challenges posed by COVID-19.

Background Genomic research can reveal ‘unsolicited’ or ‘incidental’ findings that are of potential health or reproductive significance to participants. It is widely thought that researchers have a moral obligation, grounded in the duty of easy rescue, to return certain kinds of unsolicited findings to research participants. It is less widely thought that researchers have a moral obligation to actively look for health-related findings (for example, by conducting additional analyses to search for findings outside the scope of the research question). Main text This paper examines whether there is a moral obligation, grounded in the duty of easy rescue, to actively hunt for genomic secondary findings. We begin by showing how the duty to disclose individual research findings can be grounded in the duty of easy rescue. Next, we describe a parallel moral duty, also grounded in the duty of easy rescue, to actively hunt for such information. We then consider six possible objections to our argument, each of which we find unsuccessful. Some of these objections provide reason to limit the scope of the duty to look for secondary findings, but none provide reason to reject this duty outright. Conclusions We argue that under a certain range of circumstances, researchers are morally required to hunt for these kinds of secondary findings. Although these circumstances may not currently obtain, genomic researchers will likely acquire an obligation to hunt for secondary findings as the field of genomics continues to evolve.

Introduction: To address ethical concerns about the of future research authorization, biobanks employing a broad model of consent can design ongoing communication with contributors. Notifying contributors at the time of sample distribution provides one form of communication to supplement broad consent. However, little is known about how community-informed governance might anticipate contributor responses and inform communication efforts. Objective: We explored the attitudes of members of a three-site Community Advisory Board (CAB) network. CAB members responded to a hypothetical proposal for notifying biobank contributors at the time of sample distribution to researchers utilizing the biobank. Methods: We used regularly scheduled CAB meetings to facilitate 3 large-group and 6 small-group discussions. Discussions were audio-recorded, transcribed, and analyzed for thematic content using descriptive thematic analysis. Results: The results challenged our expectation of general support for the proposed communications. While CAB members identified some advantages, they were concerned about several potential harms to biobank contributors and the biobank. The CABs understood biobank communication in terms of an ongoing relationship with the biobank and a personal contribution to research. Conclusion:Our findings contribute to the emerging literature on community engagement in biobanking. Additional communication with biobank contributors can serve a variety of value-based objectives to supplement broad consent. Design of communication efforts by biobanks can be improved by CAB members’ anticipation of the unintended consequences of additional contact with contributors. CAB members’ holistic interpretation of communication efforts suggests that biobank leadership considers all communication options as part of a more comprehensive communications strategy.

We explore conceptions of responsibility and integrity in global health research and practice as it is being carried out in the academic setting. Our specific motivation derives from the recent publication of a study by a clinical research team involving the delivery of mental health care services in a Ghanaian prayer camp. The study was controversial on account of the prayer camp's history of human rights abuses and therefore was met with several high-profile critiques. We offer a more charitable evaluation of the Joining Forces study. Our analysis has three primary goals. First, we respond to criticism suggesting that the Joining Forces research team needed to maintain some form of morally "clean hands" in relation to the human rights abuses at Mount Horeb prayer camp. We argue that, for academic global health practitioners working under severe resource constraints, what is reasonable and responsible to pursue is a complex proposition without a one-size-fits-all ethical answer. Second, we offer an explanation for why the Joining Forces study team designed the project as they did in spite of their obvious vulnerability to ethical concern. We argue that the Joining Forces study was a morally risky, but ethically earnest effort to reach a neglected patient population and promote behavior change in prayer camp staff. Third, we identify an open ethical question born of the researchers' commitment to pragmatism that, to our knowledge, has not been previously addressed in published discussion of the Joining Forces project. Namely, was the incomplete disclosure of information to prayer camp staff defensible? We close with a broader reflection on the notion of moral integrity in the pursuit of the salutary aims of global health.

Recent events encompassing social injustices, healthcare disparities, and police brutality against Black citizens highlight the continued need to strive toward unbiased and inclusive practices in all realms of the world. Our voices as cell biologists are powerful tools that can be used to combat inequities in the scientific landscape. In this inaugural Voices essay, we discuss how exclusion and inclusion events have contributed to our scientific journeys and how scientists can work to create an inclusive environment for our trainees and colleagues. As underrepresented minority scientists in the early and late stages of our scientific training, we frame the trainee experience to provide insight from unique perspectives. This essay also provides actionable items that the cell biology community can implement to promote inclusivity. We anticipate that initiating an open dialogue focused on diversity and inclusion will promote growth in the field of cell biology and enable scientists to assess and assume their role in creating welcoming environments. We believe that scientists at all stages in their careers can make meaningful and habitual contributions to supporting inclusivity in cell biology, thereby creating a future where diversity, equity, and inclusion are expected, not requested.

The goal of the current study was to examine novice researchers' views about online ethics education and to identify the instructional design components that may foster ethical practice. Applying the mixed methods approach, data were collected via a survey and semi-structured interviews among M.Sc. and Ph.D. students in science and engineering. The findings point to the need for rethinking the way conventional online ethics courses are developed and delivered; encouraging students to build confidence in learning from distance, engaging them in online active and interactive experiences, and providing them with personalized support and adaptive guidance. The novice researchers identified the synergistic integration of collaborative, case-based, and contextual learning, as the instructional design components that may foster not only ethical knowledge but also ethical practice in a fully online course.

BackgroundThere is a concern that the apparent effectiveness of interventions tested in clinical trials may not be an accurate reflection of their actual effectiveness in usual practice. Pragmatic randomized controlled trials (RCTs) are designed with the intent of addressing this discrepancy. While pragmatic RCTs may increase the relevance of research findings to practice they may also raise new ethical concerns (even while reducing others). To explore this question, we interviewed key stakeholders with the aim of identifying potential ethical challenges in the design and conduct of pragmatic RCTs with a view to developing future guidance on these issues.MethodsInterviews were conducted with clinical investigators, methodologists, patient partners, ethicists, and other knowledge users (e.g., regulators). Interviews covered experiences with pragmatic RCTs, ethical issues relevant to pragmatic RCTs, and perspectives on the appropriate oversight of pragmatic RCTs. Interviews were coded inductively by two coders. Interim and final analyses were presented to the broader team for comment and discussion before the analytic framework was finalized.ResultsWe conducted 45 interviews between April and September 2018. Interviewees represented a range of disciplines and jurisdictions as well as varying content expertise. Issues of importance in pragmatic RCTs were (1) identification of relevant risks from trial participation and determination of what constitutes minimal risk; (2) determining when alterations to traditional informed consent approaches are appropriate; (3) the distinction between research, quality improvement, and practice; (4) the potential for broader populations to be affected by the trial and what protections they might be owed; (5) the broader range of trial stakeholders in pragmatic RCTs, and determining their roles and responsibilities; and (6) determining what constitutes “usual care” and implications for trial reporting.ConclusionsOur findings suggest both the need to discuss familiar ethical topics in new ways and that there are new ethical issues in pragmatic RCTs that need greater attention. Addressing the highlighted issues and developing guidance will require multidisciplinary input, including patient and community members, within a broader and more comprehensive analysis that extends beyond consent and attends to the identified considerations relating to risk and stakeholder roles and responsibilities.

BACKGROUND Laboratory medicine, like other areas of medicine, is obliged to adhere to high ethical standards. There are particular ethical issues that are unique to laboratory medicine and other areas in which ethical issues uniquely impact laboratory practice. Despite this, there is variability in ethics education within the profession. This review provides a foundation for the study of ethics within laboratory medicine. CONTENT The Belmont Report identifies 3 core principles in biomedical ethics: respect for persons (including autonomy), beneficence (and its corollary nonmalfeasance), and justice. These core principles must be adhered to in laboratory medicine. Informed consent is vital to maintain patient autonomy. However, balancing patient autonomy with the desire for beneficence can sometimes be difficult when patients refuse testing or treatment. The use of leftover or banked samples is fundamental to the ability to do research, create reference intervals, and develop new tests, but it creates problems with consent. Advances in genetic testing have created unique ethical issues regarding privacy, incidental findings, and informed consent. As in other professions, the emergence of highly contagious and deadly infectious diseases poses a difficult ethical dilemma of helping patients while protecting healthcare workers. CONCLUSIONS Although many clinical laboratorians do not see or treat patients, they must be held accountable to the highest ethical and professional behavior. Recognition and understanding of ethical issues are essential to ethical practice of laboratory medicine.

Assessment of safety is an integral part of real-time monitoring in clinical trials. In HIV prevention research, safety of investigational products and trial participation has been expanded to include monitoring for 'social harms', generally defined as negative consequences of trial participation that may manifest in social, psychological, or physical ways. Further research on social harms within HIV prevention research is needed to understand the potential safety risks for women and advance the implementation of prevention methods in real-world contexts.Secondary analysis of quantitative data from three randomized, double-blind, placebo-controlled trials of microbicide candidates in sub-Saharan Africa was conducted. Additionally, we assessed data from two prospective cohort studies that included participants who became HIV-positive or pregnant during parent trials.Social harms reporting was low across the largest and most recent microbicide studies. Social harm incidence per 100 person-years ranged from 1.10 (95% CI 0.78-1.52) to 3.25 (95% CI 2.83-3.74) in the phased trials. Reporting differed by dosing mechanism (e.g. vaginal gel, oral tablet, ring) and study, most likely as a function of measurement differences. Social harms were most frequently associated with male partners, rather than, for example, experiences of stigma in the community.Measurement and screening for social harms is an important component of conducting ethical research of novel HIV prevention methods. To date, social harm incidence reported in microbicide trials has been relatively low (4% per 100 person-years), and the majority have been partner-related events. However, any incidence of social harm within the context of HIV prevention is important to capture and understand for the safety of individuals, and for the successful impact of prevention methods in a real-world context.

There has been a recent increase in debates on the ethics of social media research, passive sensor data collection, and big data analytics. However, little evidence exists to describe how people experience and understand these applications of technology. This study aimed to passively collect data from mobile phone sensors, lapel cameras, and Bluetooth beacons to assess people’s understanding and acceptance of these technologies. Seven households were purposefully sampled and data collected for 10 days. The study generated 48 hr of audio data and 30,000 images. After participant review, the data were destroyed and in-depth interviews conducted. Participants found the data collected acceptable and reported willingness to participate in similar studies. Key risks included that the camera could capture nudity and sex acts, but family review of footage before sharing helped reduce concerns. The Emanuel et al. ethics framework was found to accommodate the concerns and perspectives of study participants.

As calls for transparency in human subjects research grow, investigators conducting Alzheimer’s disease (AD) biomarker research are increasingly required to consider their ethical obligations regarding the return of AD biomarker test results to research participants. When disclosing these test results to potentially vulnerable participants, investigators may face unique challenges to identify adverse events, particularly psychological events. The purpose of this paper is to describe our research team’s experience with developing and implementing a process for enhanced adverse event monitoring following the return of amyloid-β (Aβ) imaging results to research participants with mild cognitive impairment (MCI). Ethical and logistical considerations are presented along with preliminary findings from an ongoing randomized controlled trial of Aβ imaging results disclosure in MCI. Following receipt of amyloid imaging results, participants underwent 14 days of adverse event monitoring using ecological momentary assessment (EMA), a strategy to capture health, behaviors, and mood as they occur in participants’ natural settings in real time. EMA telephone calls were placed at random during waking hours to screen for mood changes. Investigators were alerted for positive depression, anxiety, suicidal ideation screenings, or for two days of failed call attempts. Preliminary feasibility of twenty-four participants with MCI who participated in EMA mood assessments was successfully completed 83% (SD = 0.4) of the time over 14 days with no alerts for anxiety or depression screening items. EMA, when used with standard adverse event monitoring, is a promising and novel approach to maximize early detection of negative psychological reactions following AD biomarker results disclosed in research settings.