Ethics Of Human Subjects Research Research Articles

Data Ethics in Library Learning Analytics

Introduction: This study examines data handling and data ethics in library learning analytics research projects involving the use of data about students as library patrons, alongside a baseline evaluation of the benefits of library learning analytics to libraries practicing it. Methods: Citations were gathered via citation chain aggregation from the original Value of Academic Libraries report, then winnowed to projects with English-language artifacts documenting them, collection and/or analysis of library data about students, and a research question about the contribution of student library use to student success. Results and Discussion: Much of this research is reaching publication despite not employing best practices nor documenting respect for human-subjects research ethics, library-specific privacy and confidentiality ethics, and student data-privacy expectations. Very few projects create direct benefits to libraries. This result would not be possible without gaps or lapses in editorial processes, peer review, and upstream research guidance and ethics reviews. Conclusion: Ethics reforms are required at all stages of research and publication to prevent further unethical exploitation of patron data.

Ethics of ‘Counting Me In’: framing the implications of direct-to-patient genomics research

Count Me In (CMI) was launched in 2015 as a patient-driven research initiative aimed at accelerating the study of cancer genomics through direct participant engagement, electronic consent and open-access data...

Cultural Values and Beliefs of Selected Local Communities in Botswana: Implications for Human Subject Research Ethics Practice.

Calls have been made for researchers prospectively and continuously to engage study communities. If done, this typically occurs through a specific research study or collaboration. Rarely are community mores examined in-depth to understand implications for research ethics policy processes. We describe a qualitative study designed to understand local community values, beliefs, and practices that relate to research ethics in Botswana and explore how communities would want their interests represented. Through focus group discussions across two different selected ethnic communities and in-depth interviews with paramount chiefs, we highlight a range of community values and expectations that represent concrete behavioral representations of respect and trustworthiness. Communities are willing to engage in the process of enhancing research and research ethics policies and procedures. We invite future research and training that seek to connect local conceptualizations of substantive and procedural aspects of research ethics.

Pharmaceutical Companies, Human Rights, and the Alien Tort Statute.

On January 3, 2019, U.S. District Judge Theodore D. Chuang of the U.S. District Court of the District of Maryland took a crucial first step in redressing one of the worst human subjects research ethics violations in U.S. history.

Hans Jonas and the Ethics of Human Subjects Research.

In the 1960s, human experimentation and public funding of research increased significantly, and with the rise of the modern teaching hospital, the distinction between clinical care and experimentation became more and more blurred. Yet little in the way of meaningful government regulation existed in the United States prior to 1970. In 1966, Paul Freund, the president of the American Academy of Arts and Sciences, appointed an interdisciplinary working group to consult on the issues being raised by human experimentation. Contributions from the group were published in a 1969 issue of Daedalus titled Ethical Aspects of Experimentation with Human Subjects. In the lead essay, Hans Jonas challenged then-conventional understandings of the moral problems posed by research involving humans and argued for an alternative moral framework. To Jonas, it mattered whether the physician was trying to make the patient well rather than trying to find out how to improve the health of future patients.

On the Ethics of Human Subjects Research

On the Ethics of Human Subjects Research

Using Team-Based Learning to Teach Human Subjects Research Ethics

For health sciences students, understanding human subjects research ethics is essential for providing equitable healthcare. Active learning approaches were needed to engage students with the content and support transfer of knowledge to clinical practice. A team-based learning (TBL) module was developed and implemented in an evidence-based practice undergraduate nursing course across 3 semesters with 169 students to promote understanding and application of research ethics principles. Thematic analysis of student reflections showed five themes: change in attitude, learning/understanding, application of ethical principles, specific terminology, and specific examples. Faculty facilitators reported increased engagement, understanding, and application.

Untangling the ethical intersection of epidemiology, human subjects research, and public health

PurposeMembers of the American College of Epidemiology (ACE) Ethics Committee identified current ethics and epidemiology topic areas to consider for further discussion, consultation, teaching opportunities, and conference presentation. This article reflects on the activities of the Committee at the ACE Annual Meeting in New Orleans, Louisiana, September 24–26, 2017. MethodsThe overall aim for the Ethics Committee was to engage members of the College and other audiences and highlight the evolution of ethics and epidemiology since the inception of the original Ethics Guidelines published by the ACE Ethics and Standards of Practice Committee in 2000. The Ethics Committee organized a symposium session at the 2017 Annual Meeting of ACE on the ethics of human subjects research as it relates to specialized areas of epidemiology and the intersecting role of public health. This article presents a summary and further discussion of that symposium session. ResultsThree topic areas were presented: an overview of ethics and epidemiology (E.S.P.), very high biomarker levels in environmental epidemiology research (S.M.P.), and the interface of epidemiology, human subjects research, and public health interventions (S.M.). This article begins by reviewing the foundations of epidemiology and public health and the well-known ethical principles of human subjects research. Then, it considers the ethical considerations in the use of population registry data in epidemiological research, environmental epidemiology, and epidemic surveillance and response. This article may form the basis of teaching of ethics principles related to epidemiology and public health and may serve as a companion piece to the original ACE Ethics Guidelines. ConclusionsResearchers are increasingly faced with ethical considerations in diverse, nontraditional, and specialized areas of epidemiology and public health. This article illustrates these challenges with real-world examples of clinical and population registry data, the study of environmental biomarkers, and Zika virus epidemic; it also reviews relevant ethical principles underpinning these examples and identifies where gaps in knowledge may exist.

Negative prompts aimed at maintaining eating independence.

Psychological abuse of older people is difficult to recognise; specifically, nursing home residents have been documented to be at higher risk of psychological abuse during daily care, such as during feeding. Healthcare professionals adopt positive and negative verbal prompts to maintain residents' eating independence; however, negative prompts' purposes and implications have never been discussed to date. To critically analyse negative verbal prompts given during mealtimes as forms of abuse of older individuals and violation of ethical principles. This is a secondary analysis of three cases of negative prompts that emerged in a large descriptive study based upon focus group methodology and involving 13 nursing homes and 54 healthcare professionals. This study included 3 out of 13 nursing homes caring for residents with moderate/severe functional dependence in self-feeding mainly due to dementia; in these nursing homes, we conducted three focus groups and 13 healthcare professionals participated. This study was conducted in accordance with the Human Subject Research Ethics Committee guidelines after being approved by the Review Board of the Trust. With the intent of maintaining self-feeding independence, negative verbal prompts have been reported as being used by nursing home teams. By critically analysing these negative prompts, it turned out they could trigger intimidation, depression and anxiety and thus could be considered as forms of abuse; moreover, negative prompts can threaten the ethical principles of (1) autonomy using a paternalist approach, (2) beneficence and non-maleficence as with the intent to act in the best interests of residents (to maintain self-feeding independence) they are harmed in their dignity and (3) justice, given that residents who received negative prompts are treated differently from those who received positive prompts. Eating should be a pleasant experience with a positive impact on physiological, psychological and social well-being. However, negative prompting can lead to abuse and violation of basic ethical principles, destroying the healthcare professional resident and relative relationships strongly dependent on trust. Negative verbal prompting must be avoided.

Paying Patients: Legal and Ethical Dimensions

This Article explores the implications for medical care of a debate that is more familiar in the law and ethics of human subjects research: whether people should be paid to receive or decline medical interventions, or to reach certain health objectives. It examines the legal and ethical issues such payments raise, and considers various actors who might make such payments, including governments, employers, insurers, care providers, and private parties. It argues for two interrelated conclusions: first, that these payments should not be subject to blanket normative condemnation, and, second, that payments made in different settings and contexts frequently share underlying commonalities, which suggests categorizing them according to these commonalities. We should move from a “siloed” legal and normative landscape, where discussions of payments to patients in one context are isolated from similar discussions in other contexts, to a landscape where payments are evaluated and categorized more systematically. The categories along which payments should be evaluated include who the payer is, what purpose the payment serves, and who the payment affects. In Part I, I identify and present four categories of payments to patients. These include value-based insurance designs in which insurers offer patients a share of the savings realized when they choose cheaper medications; providers paying patients to adhere to treatment regimens; and private parties paying others to make health decisions such as avoiding pregnancy. In Part II, I examine the normative issues raised by these payments. I argue that the risk of exploitation or undue psychological pressure is low, but that we should be more concerned about ways in which the payments might change relationships between payers and payees or might harm the interests of third parties. In developing this analysis, I draw on work in the ethics of human subjects research. In Part III, I use the ethical analysis developed in Part II to develop normative frameworks for the evaluation of payments to patients. These frameworks identify and differentiate the responsibilities of different actors in the health care system. In doing so, these frameworks draw from and build on theories of distributive fairness. They also draw from accounts of professional and business ethics that prescribe specific responsibilities for professionals. Finally, in Part IV, I examine how these normative frameworks would bear on the legal issues that payments to patients raise. These include whether the payments are subject to taxation or might affect recipients’ eligibility for need-based benefits; whether they are consistent with antidiscrimination law; and whether they violate anti-kickback statutes or regulations.

Opportunity to discuss ethical issues during clinical learning experience.

Undergraduate nursing students have been documented to experience ethical distress during their clinical training and felt poorly supported in discussing the ethical issues they encountered. This study was aimed at exploring nursing students' perceived opportunity to discuss ethical issues that emerged during their clinical learning experience and associated factors. An Italian national cross-sectional study design was performed in 2015-2016. Participants were invited to answer a questionnaire composed of four sections regarding: (1) socio-demographic data, (2) previous clinical learning experiences, (3) current clinical learning experience quality and outcomes, and (4) the opportunity to discuss ethical issues with nurses in the last clinical learning experience (from 0 - 'never' to 3 - 'very much'). Participants were 9607 undergraduate nursing students who were attending 95 different three-year Italian baccalaureate nursing programmes, located at 27 universities in 15 Italian regions. This study was conducted in accordance with the Human Subject Research Ethics Committee guidelines after the research protocol was approved by an ethics committee. Overall, 4707 (49%) perceived to have discussed ethical issues 'much' or 'very much'; among the remaining, 3683 (38.3%) and 1217 (12.7%) students reported the perception of having discussed, respectively, 'enough' or 'never' ethical issues emerged in the clinical practice. At the multivariate logistic regression analysis explaining 38.1% of the overall variance, the factors promoting ethical discussion were mainly set at the clinical learning environment levels (i.e. increased learning opportunities, self-directed learning, safety and nursing care quality, quality of the tutorial strategies, competences learned and supervision by a clinical nurse). In contrast, being male was associated with a perception of less opportunity to discuss ethical issues. Nursing faculties should assess the clinical environment prerequisites of the settings as a context of student experience before deciding on their accreditation. Moreover, the nursing faculty and nurse managers should also enhance competence with regard to discussing ethical issues with students among clinical nurses by identifying factors that hinder this learning opportunity in daily practice.

Justification and authority in institutional review board decision letters

While ethnographic study has described the discussions that occur during human subjects research ethics review, investigators have minimal access to the interactions of ethics oversight committees. They instead receive letters stipulating changes to their proposed studies. Ethics committee letters are central to the practice of research ethics: they change the nature of research, alter the knowledge it produces, and in doing so construct what ethical research is and how it is pursued. However, these letters have rarely been objects of analysis. Accordingly, we conducted a qualitative analysis of letters written by American institutional review boards (IRBs) overseeing biomedical and health behavioral research. We sought to clarify how IRBs exercise their authority by assessing the frequency with which they provided reasons for their stipulations as well as the nature of these reasons. We found that IRBs frequently do not justify their stipulations; rather, they often leave ethical or regulatory concerns implicit or frame their comments as boilerplate language replacements, procedural instructions, or demands for missing information. When they do provide justifications, their rationales exhibit substantial variability in explicitness and clarity. These rhetorical tendencies indicate that the authority of IRBs is grounded primarily in their role as bureaucratic gatekeepers. We conclude by suggesting that greater attention to justification could help shift the basis of the IRB-researcher relationship from compliance to mutual accountability.

Where are human subjects in Big Data research? The emerging ethics divide

There are growing discontinuities between the research practices of data science and established tools of research ethics regulation. Some of the core commitments of existing research ethics regulations, such as the distinction between research and practice, cannot be cleanly exported from biomedical research to data science research. Such discontinuities have led some data science practitioners and researchers to move toward rejecting ethics regulations outright. These shifts occur at the same time as a proposal for major revisions to the Common Rule—the primary regulation governing human-subjects research in the USA—is under consideration for the first time in decades. We contextualize these revisions in long-running complaints about regulation of social science research and argue data science should be understood as continuous with social sciences in this regard. The proposed regulations are more flexible and scalable to the methods of non-biomedical research, yet problematically largely exclude data science methods from human-subjects regulation, particularly uses of public datasets. The ethical frameworks for Big Data research are highly contested and in flux, and the potential harms of data science research are unpredictable. We examine several contentious cases of research harms in data science, including the 2014 Facebook emotional contagion study and the 2016 use of geographical data techniques to identify the pseudonymous artist Banksy. To address disputes about application of human-subjects research ethics in data science, critical data studies should offer a historically nuanced theory of “data subjectivity” responsive to the epistemic methods, harms and benefits of data science and commerce.

Effects of ethics education on moral sensitivity of nursing students.

While nursing ethics education is commonly provided for undergraduate nursing students in most nursing colleges, consensus on the content and teaching modules for these ethics courses have still not been established. This study aimed to examine the effects of nursing ethics education on the moral sensitivity and critical thinking disposition of nursing students in Korea. A one-group pre- and post-test design was used. Moral sensitivity was measured using the Korean version of the Moral Sensitivity Questionnaire. Critical thinking disposition was measured using the Critical Thinking Disposition Questionnaire. Participants and research context: Participants were 70 undergraduate nursing students who were attending a university located in Seoul, Korea. The nursing ethics education was provided 7 times, from September to December 2010, and comprised 90-min sessions each week. Ethical considerations: This study was conducted in accordance with the Human Subject Research Ethics Committee guidelines. After the education, the levels for the patient-oriented care, a sub-domain of moral sensitivity, and inquisitiveness, a sub-domain of critical thinking disposition, significantly improved. There were no changes in overall scores for moral sensitivity and critical thinking disposition. There were significant positive correlations between moral sensitivity and critical thinking disposition both pre- and post-intervention. These results reflect the need for ongoing efforts to develop innovative content, structure, and instructional methods for undergraduate nursing ethics education programs.

Confronting ethical permissibility in animal research: rejecting a common assumption and extending a principle of justice

A common assumption in the selection of nonhuman animal subjects for research and the approval of research is that, if the risks of a procedure are too great for humans, and if there is a so-called scientific necessity, then it is permissible to use nonhuman animal subjects. I reject the common assumption as neglecting the central ethical issue of the permissibility of using nonhuman animal subjects and as being inconsistent with the principle of justice used in human subjects research ethics. This principle requires that certain classes of individuals not be subjected to a disproportionate share of the burdens or risks of research. I argue for an extension of this principle to nonhuman animal research and show that a prima facie violation of the principle occurs because nonhuman animals bear an overwhelmingly disproportionate share of the risks of research without sufficient justification or reciprocal benefit.

Rethinking Research Ethics: The Case of Postmarketing Trials

Human subjects research ethics needs to directly address threats to the evidence base of the medical information economy.

The Fetus as a Patient and the Ethics of Human Subjects Research: Response to Commentaries on “An Ethically Justified Framework for Clinical Investigation to Benefit Pregnant and Fetal Patients”

The Fetus as a Patient and the Ethics of Human Subjects Research: Response to Commentaries on “An Ethically Justified Framework for Clinical Investigation to Benefit Pregnant and Fetal Patients”

A Case Study in Unethical Transgressive Bioethics: “Letter of Concern from Bioethicists” About the Prenatal Administration of Dexamethasone

On February 3, 2010, a “Letter of Concern from Bioethicists,” organized by fetaldex.org, was sent to report suspected violations of the ethics of human subjects research in the off-label use of dexamethasone during pregnancy by Dr. Maria New. Copies of this letter were submitted to the FDA Office of Pediatric Therapeutics, the Department of Health and Human Services (DHHS) Office for Human Research Protections, and three universities where Dr. New has held or holds appointments. We provide a critical appraisal of the Letter of Concern and show that it makes false claims, misrepresents scientific publications and websites, fails to meet standards of evidence-based reasoning, makes undocumented claims, treats as settled matters what are, instead, ongoing controversies, offers “mere opinion” as a substitute for argument, and makes contradictory claims. The Letter of Concern is a case study in unethical transgressive bioethics. We call on fetaldex.org to withdraw the letter and for co-signatories to withdraw their approval of it.

University of Arizona College of Medicine: Tucson and Phoenix

University of Arizona College of Medicine: Tucson and Phoenix

USA–China Agricultural Injury Research Training

In 2004, an epidemiologic study of 200 000 farm families yielded an annual estimate of 592 000 injury deaths and 3 490 000 permanent disabled individuals in rural areas of...