Resources

U.S. Government Printing Office

1949

"The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision."

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

April 18, 1979

"The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the Commission that were held over a period of nearly four years. It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects."

Council for International Organizations of Medical Sciences

October, 2002

"The CIOMS guidelines have been developed and revised with the problems of conducting medical research in less developed countries particularly in mind. The proposed guidelines were first published in 1982, revised in 1993, and have now been published in a third version after a revision process lasting three years. Last month the Bulletin published just one guideline and accompanying commentary. There now follow all the guidelines, without commentary, but with an appendix detailing what should be in a protocol."

World Medical Association

2013

"The Declaration of Helsinki (DoH) is the World Medical Association’s (WMA) best-known policy statement. The first version was adopted in 1964 and has been amended seven times since, most recently at the General Assembly in October 2013. The current (2013) version is the only official one; all previous versions* have been replaced and should not be used or cited except for historical purposes."

U.S. Department of Health and Human Services

January 19, 2017

"The final rule is designed to more thoroughly address the broader types of research conducted or otherwise supported by all of the Common Rule departments and agencies such as behavioral and social science research. It also benefits from continuing efforts to harmonize human subjects policies across federal departments and agencies."

Amy L. Fairchild, Ronald Bayer

May 07, 1999

"While Tuskegee can stimulate productive reflection on questions of social justice, its reckless invocation risks derailing serious and sustained discussion of the dilemmas posed by research with vulnerable populations. Ironically, it can also make current research abuses pale in comparison to the historical syphilis study, thus minimizing their gravity. The abuse of Tuskegee has consequences not only for present discussion, but also for the past. It threatens to rob Tuskegee of its unique value and meaning. It misuses the memory of the 399 African American men whose most basic rights were violated for 40 years. In so doing, it diminishes the significance of their suffering."

Evelyne Shuster

November 13, 1997

"The Nuremberg Code has not been officially adopted in its entirety as law by any nation or as ethics by any major medical association. Nonetheless, its influence on global human-rights law and medical ethics has been profound. Its basic requirement of informed consent, for example, has been universally accepted and is articulated in international law in Article 7 of the United Nations International Covenant on Civil and Political Rights (1966). Informed consent, with specific reliance on the Nuremberg Code, is also the basis of the International Ethical Guidelines for Biomedical Research Involving Human Subjects, the most recent guidelines promulgated by the World Health Organization and the Council for International Organizations of Medical Sciences (1993)."

Jerry Menikoff, Julie Kaneshiro, and Ivor Pritchard

February 16, 2017

"The Common Rule — the set of federal regulations for ethical conduct of human-subjects research — has finally been updated. A long process of deliberation and discussion has resulted in a final rule that differs significantly from what was initially proposed."

Ezekiel J. Emanuel, MD, PhD; David Wendler, PhD; Christine Grady, PhD

May 24, 2000

"Many believe that informed consent makes clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects, we propose 7 requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies: (1) value—enhancements of health or knowledge must be derived from the research; (2) scientific validity—the research must be methodologically rigorous; (3) fair subject selection—scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects; (4) favorable risk-benefit ratio—within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks; (5) independent review—unaffiliated individuals must review the research and approve, amend, or terminate it; (6) informed consent—individuals should be informed about the research and provide their voluntary consent; and (7) respect for enrolled subjects—subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored. Fulfilling all 7 requirements is necessary and sufficient to make clinical research ethical. These requirements are universal, although they must be adapted to the health, economic, cultural, and technological conditions in which clinical research is conducted."

Ezekiel J. Emanuel, David Wendler, Jack Killen, Christine Grady

01 March 2004

"In recent years, there has been substantial debate about the ethics of research in developing countries. In general, the controversies have centered on 3 issues: first, the standard of care that should be used in research in developing countries; second, the “reasonable availability” of interventions that are proven to be useful during the course of research trials; and third, the quality of informed consent. The persistence of controversies on such issues reflects, in part, the fact that existing ethical guidelines can be interpreted in multiple ways, are sometimes contradictory, or rely on unstated, yet controversial, ethical principles. To provide unified and consistent ethical guidance, we apply a previously proposed ethical framework for clinical research within developed countries to developing countries, explicating a previously implicit requirement for collaboration. More importantly, we propose specific and practical benchmarks to guide researchers and research-ethics committees in assessing how well the enumerated ethical principles have been fulfilled in particular cases."

Douglas S Diekema

July 01, 2006

"Achieving proper balance between the social good that comes from performing research that involves children and offering the appropriate level of protection to children who participate in research is a significant challenge. As investigators design and implement research protocols, they should be aware of the ethical and legal requirements that govern research with human participants. This is especially true of research that involves children and other vulnerable groups. The welfare of children participating in research depends on knowledgeable, caring, and responsible investigators who place the well-being of the research participant above all other aspects of the research project. The purpose of this article is to provide a brief overview of the history of research involving children, to provide a basis for understanding the context within which the current federal regulations were written, and to provide an overview of the regulatory requirements that relate to research involving children. Good research is ethical research, and that requires investigators who take seriously the importance of participant welfare, meaningful informed consent, and respect for research participants."

Jay Katz

1993

"The doctrine of informed consent, borrowed from the law of torts, cannot be readily transplanted into therapeutics settings. The broader, as yet unrealized, idea of informed consent, which suggests that parties must make decisions jointly, should guide interactions between physcians and patients or investigators and subjects."

Franklin G Miller, David Wendler, Leora C Swartzman

September 6, 2005

"A common feature of research investigating the placebo effect is deception of research participants about the nature of the research. This use of deception is considered necessary to understanding the placebo effect, but has received little systematic ethical attention. In this article, we examine ethical issues relating to deception in research on the placebo effect, with a particular focus on experiments involving patients in clinical settings. We propose a method of informing participants about the use of deception that can reconcile the scientific need for deceptive research designs with the ethical requirements for clinical research."

Lizbeth A. Adams

"Topics addressed: What are the general ethical principles applied to research with human subjects? How do you design ethical research studies? What are the components of ethically valid informed consent for research? What are the regulatory requirements to administer informed consent? What does IRB review of research entail: full-board, expedited, and exempt reviews? Is deception of subjects allowed when doing research?"

Brendan Parent, Bruce Gelb, Stephen Latham, Ariane Lewis, Laura L Kimberly, Arthur L Caplan

September 28, 2019

"Over 115 000 people are waiting for life-saving organ transplants, of whom a small fraction will receive transplants and many others will die while waiting. Existing efforts to expand the number of available organs, including increasing the number of registered donors and procuring organs in uncontrolled environments, are crucial but unlikely to address the shortage in the near future and will not improve donor/recipient compatibility or organ quality. If successful, organ bioengineering can solve the shortage and improve functional outcomes. Studying manufactured organs in animal models has produced valuable data, but is not sufficient to understand viability in humans. Before risking manufactured organ experimentation in living humans, study of bioengineered organs in recently deceased humans would facilitate evaluation of the function of engineered tissues and the complex interactions between the host and the transplanted tissue. Although such studies do not pose risk to human subjects, they pose unique ethical challenges concerning the previous wishes of the deceased, rights of surviving family members, effective operation and fair distribution of medical services, and public transparency. This article investigates the ethical, legal and social considerations in performing engineered organ research on the recently deceased."

Consuelo H. Wilkins, Brandy M. Mapes, Rebecca N. Jerome, Victoria Villalta-Gil, Jill M. Pulley, and Paul A. Harris

March 2019

"There is growing public demand that research participants receive all of their results, regardless of whether clinical action is indicated. Instead of the standard practice of returning only actionable results, we propose a reconceptualization called “return of value” to encompass the varied ways in which research participants value specific results and more general information they receive beyond actionable results. Our proposal is supported by a national survey of a diverse sample, which found that receiving research results would be valuable to most (78.5 percent) and would make them more likely to trust researchers (70.3 percent). Respondents highly valued results revealing genetic effects on medication response and predicting disease risk, as well as information about nearby clinical trials and updates on how their data were used. The information most valued varied by education, race/ethnicity, and age. Policies are needed to enable return of information in ways that recognize participants’ differing informational needs and values."

Amina White

November 2015

"Although there has been long-standing reluctance to include pregnant women as clinical trial participants, increasing recognition of profound gaps in research on the safety and efficacy of drugs often prescribed to pregnant women calls into question the practice of routinely excluding them. This article presents compelling reasons for including pregnant women in clinical research, highlights certain regulatory barriers to the inclusion of pregnant women, and proposes that professional societies with expertise in obstetrics and maternal−fetal medicine can be instrumental in hastening the paradigm shift from the systematic exclusion of pregnant women in research to a one of responsible and fair inclusion."

Rueben C. Warren, Camille A. Clare, Rachel Villanueva, Vivian W. Pinn

April 2020

"Much is written about the importance of human-subjects research and health care delivery. This Commentary addresses the ethical problematic of justifying the scientific merit of J. Marion Sims’ surgical abusive behavior on enslaved Black women. Sims violated principles of bioethics and public health ethics. Distinguishing between the goal of human-subjects research and that of health care delivery is essential for fully understanding bioethics and public health ethics, and the tragedy of Sims’ unethical behavior."

Krystal S. Tsosiea, Joseph M. Yracheta, Jessica A. Kolopenuk and Janis Geary

07 Apr 2021

"Inclusive research practices must consider the ways that inequitable relationships between Indigenous peoples and scientific fields continue to disproportionately structure the risks and benefits of precision medicine, otherwise they will perpetuate harms and fail to address Indigenous demands for governance of the research that affects them. As Lee accurately points out, a commitment to justice requires addressing inequities that go beyond the discrete gift exchange that overwhelms many discussions about specimen donation in precision medicine. Hence, meaningfully engaging Indigenous communities in precision medicine must also entail restructuring research ecosystems from an anti-colonial standpoint. The language of gifting dishonors all that has already been taken for the benefit of others."

Giselle Corbie-Smith, Mysha Wynn, Alan Richmond, Stuart Rennie, Melissa Green, Stephanie M. Hoover, Sable Watson-Hopper, Kyle Simone Nisbeth

June 21, 2018

"Increasingly, researchers seek to engage communities, patients, and stakeholders as partners in the process and products of health research. However, there is no existing stakeholder-driven ethical framework for such engaged scholarship. We employed an iterative, stakeholder-engaged method to develop a data-driven framework for the ethical review and conduct of engaged scholarship. We used consensus development conference methods and a modified Delphi survey to engage 240 community members, ethicists, and academic researchers. This multi-staged process produced a framework with 4 domains: vision of equitable and just research, relationship dynamics, community-informed risk/benefits assessment, and accountability. Within the framework, 4 cross-cutting considerations and 15 statements explicate the stakeholders’ priorities for the ethical review and conduct of engaged scholarship. Though the findings are promising, the study is limited in that it focuses on stakeholder perspectives, but does not actually evaluate or apply the findings in the field. The stakeholder-engaged framework provides a platform for further articulation of ethical practices and policy for engaged scholarship."

Jodi Halpern

11 August 2003

"Patients seek empathy from their physicians. Medical educators increasingly recognize this need. Yet in seeking to make empathy a reliable professional skill, doctors change the meaning of the term. Outside the field of medicine, empathy is a mode of understanding that specifically involves emotional resonance. In contrast, leading physician educators define empathy as a form of detached cognition. In contrast, this article argues that physicians' emotional attunement greatly serves the cognitive goal of understanding patients' emotions. This has important implications for teaching empathy."

Deena R. Levine, Erik Liederbach, Liza‐Marie Johnson, Erica C. Kaye, Holly Spraker‐Perlman, Belinda Mandrell, Michele Pritchard, April Sykes, Zhaohua Lu, Dave Wendler, Justin N. Baker

02 January 2019

"High‐quality communication is a central pillar of patient‐ and family‐centered care in oncology. Ineffective communication in the context of cancer care is a source of distress and dissatisfaction for patients and families, whereas skillful communication can lead to improved health outcomes, better compliance, and enhanced patient/family satisfaction with care. From diagnosis, beginning with the “day 1 talk,” the oncologist can lay the foundation for a therapeutic alliance by providing clear information about diagnosis, prognosis, and treatment. Clinicians can improve their effective communication beyond the imparting of information by utilizing nontechnical language, asking open‐ended questions, engaging in active listening, expressing empathy, responding to emotion, building trust, and making time and space for discussion."

Bruce D. White, Wayne N. Shelton, and Cassandra J. Rivais

31 May 2018

""Clinical ethics consultants” have been practicing in the United States for about 50 years. Most of the earliest consultants—the “pioneers”—were “outsiders” when they first appeared at patients' bedsides and in the clinic. However, if they were outsiders initially, they acclimated to the clinical setting and became “insiders” very quickly. Moreover, there was some tension between traditional academics and those doing applied ethics about whether there was sufficient “critical distance” for appropriate reflection about the complex medical ethics dilemmas of the day if one were involved in the decision making. Again, the pioneers deflected concerns by identifying and instituting safeguards to assure professional objectivity in clinical ethics consultation services. One might suggest that in moving inside and establishing normative practices, the pioneer clinical ethics consultants anticipated adoption of their routines and professionalization of the field."

Vikki A. Entwistle, Ian S. Watt

17 Jul 2013

"Health services internationally struggle to ensure health care is “person-centered” (or similar). In part, this is because there are many interpretations of “person-centered care” (and near synonyms), some of which seem unrealistic for some patients or situations and obscure the intrinsic value of patients’ experiences of health care delivery. The general concern behind calls for person-centered care is an ethical one: Patients should be “treated as persons.” We made novel use of insights from the capabilities approach to characterize person-centered care as care that recognizes and cultivates the capabilities associated with the concept of persons. This characterization unifies key features from previous characterisations and can render person-centered care applicable to diverse patients and situations. By tying person-centered care to intrinsically valuable capability outcomes, it incorporates a requirement for responsiveness to individuals and explains why person-centered care is required independently of any contribution it may make to health gain."

Paul S. Appelbaum and Thomas Grisso

December 22, 1988

"The right of patients to accept or refuse recommended treatment requires careful reassessment when their decision-making capacities are called into question. Patients must be informed appropriately about treatment decisions and be given an opportunity to demonstrate their highest level of mental functioning. The legal standards for competence include the four related skills of communicating a choice, understanding relevant information, appreciating the current situation and its consequences, and manipulating information rationally."

Donald Oken

April 1, 1961

"A questionnaire and interviews were used to study the policies of 219 physicians about "telling" cancer patients. Ninety per cent indicated a preference for not telling. Although clinical experience was cited by three-quarters as the major policy determinant, the data bear no relation to experience or age. Instead, inconsistencies, opinionatedness, and resistance to change and to research were found which indicated emotion-laden a priori personal judgments as the real determinants. Feared reactions to telling (e.g., suicide) could rarely be substantiated. Equally undocumented assumptions were given as justifications for telling. Underlying were feelings of pessimism and futility about cancer. The strong feelings mobilized by our deep and serious concerns for cancer patients, and our difficulties in helping them, stimulate denial mechanisms. These responses, unfortunately, operate as interferences to progress in cancer therapy."

L. J. Fallowfield, V. A. Jenkins, H. A. Beveridge

June 1, 2002

"Healthcare professionals often censor their information giving to patients in an attempt to protect them from potentially hurtful, sad or bad news. There is a commonly expressed belief that what people do not know does not harm them. Analysis of doctor and nurse/patient interactions reveals that this well-intentioned but misguided assumption about human behaviour is present at all stages of cancer care. Less than honest disclosure is seen from the moment that a patient reports symptoms, to the confirmation of diagnosis, during discussions about the therapeutic benefits of treatment, at relapse and terminal illness. This desire to shield patients from the reality of their situation usually creates even greater difficulties for patients, their relatives and friends and other members of the healthcare team. Although the motivation behind economy with the truth is often well meant, a conspiracy of silence usually results in a heightened state of fear, anxiety and confusion not one of calm and equanimity. Ambiguous or deliberately misleading information may afford short-term benefits while things continue to go well, but denies individuals and their families opportunities to reorganize and adapt their lives towards the attainment of more achievable goals, realistic hopes and aspirations. In this paper, some examples and consequences of accidental, deliberate, if well-meaning, attempts to disguise the truth from patients, taken verbatim from interviews, are given, together with cases of unintentional deception or misunderstandings created by the use of ambiguous language. We also provide evidence from research studies showing that although truth hurts, deceit may well hurt more. ‘I think the best physician is the one who has the providence to tell to the patients according to his knowledge the present situation, what has happened before, and what is going to happen in the future’ (Hippocrates)."

Lawrence J. Schneiderman, Nancy S. Jecker, Albert R. Jonsen

June 15, 1990

"The notion of medical futility has quantitative and qualitative roots that offer a practical approach to its definition and application. Applying these traditions to contemporary medical practice, we propose that when physicians conclude (either through personal experience, experiences shared with colleagues, or consideration of published empiric data) that in the last 100 cases a medical treatment has been useless, they should regard that treatment as futile. If a treatment merely preserves permanent unconsciousness or cannot end dependence on intensive medical care, the treatment should be considered futile. Unlike decision analysis, which defines the expected gain from a treatment by the joint product of probability of success and utility of outcome, our definition of futility treats probability and utility as independent thresholds. Futility should be distinguished from such concepts as theoretical impossibility, such expressions as "uncommon" or "rare," and emotional terms like "hopelessness." In judging futility, physicians must distinguish between an effect, which is limited to some part of the patient's body, and a benefit, which appreciably improves the person as a whole. Treatment that fails to provide the latter, whether or not it achieves the former, is "futile." Although exceptions and cautions should be borne in mind, we submit that physicians can judge a treatment to be futile and are entitled to withhold a procedure on this basis. In these cases, physicians should act in concert with other health care professionals, but need not obtain consent from patients or family members."

Jennifer Hawkins

April 2014

"Philosophers concerned with what would be good for a person sometimes consider a person’s past desires. Indeed, some theorists have argued by appeal to past desires that it is in the best interests of certain dementia patients to die. I reject this conclusion. I consider three different ways one might appeal to a person’s past desires in arguing for conclusions about the good of such patients, finding flaws with each. Of the views I reject, the most interesting one is the view that prudential value is, at least partly, concerned with the shape of a life as a whole."

Rebecca Dresser

December 1995

"When patients have progressive and incurable dementia, should their advance directives always be followed? Contra Dworkin, Dresser argues that when patients remain able to enjoy and participate in their lives, directives to hasten death should sometimes be disregarded"

Stephen R. Baldassarri, Ike Lee, Stephen R. Latham, and Gail D’Onofrio

June 2018

"We revisit a complex medical case5 that raises important legal, ethical, and philosophical questions regarding the provision of life-saving care in individuals with relapsing injection drug use. We will use this case to explore—from medical, legal, and ethical perspectives—the care of critically ill people who use injection drugs and have life-threating conditions. We focus on a specific question: Is futility an appropriate and useful standard by which to determine provision of care to such individuals? Our goal is to establish guidance for hospital and legal systems to ensure consistent delivery of high quality, compassionate care for individuals with relapsed opioid use disorder and drug addiction more generally. The case also raises important philosophical questions regarding the fair distribution of scarce healthcare resources and whether futility is an appropriate standard by which to determine action. We conclude that although futility has been historically utilized as a justification for withholding care in certain settings, it is not a useful standard to apply in cases involving people who use injection drugs for non-medical purposes."

Yolonda Wilson, Amina White, Akilah Jefferson, and Marion Danis

20 Feb 2019

"Intersectionality has become a significant intellectual approach for those thinking about the ways that race, gender, and other social identities converge in order to create unique forms of oppression. Although the initial work on intersectionality addressed the unique position of black women relative to both black men and white women, the concept has since been expanded to address a range of social identities. Here we consider how to apply some of the theoretical tools provided by intersectionality to the clinical context. We begin with a brief discussion of intersectionality and how it might be useful in a clinical context. We then discuss two clinical scenarios that highlight how we think considering intersectionality could lead to more successful patient–clinician interactions. Finally, we extrapolate general strategies for applying intersectionality to the clinical context before considering objections and replies."

Annette Dula and September Williams

01 February, 2005

"Several widely held assumptions shape end-of-life discussion in the United States. They are embedded in mainstream bioethics and biomedical discourse, debate, and discussion, as well as in the popular media. We have come to regard them as the conventional wisdom. Despite their apparent reasonableness, the assumptions are not held universally by all US citizens, particularly those of color. They hold contradictions that partially explain why fewer African Americans than whites complete advance directives, and why African Americans tend to desire aggressive care at the end of life. This article considers some of these assumptions. It then considers a case and an approach to care that seeks to resolve potential conflicts proactively."

Felicia Stokes

01 February, 2017

"This article explores the role of the nurse practitioner (NP) and raises the awareness of the potential for NPs to be called on to participate in physician-assisted death. This article identifies the ethical and legal dilemmas that NPs may face when dealing with patients who have requested physician-assisted death. The article further defines the ethical and legal responsibilities of the NP who cares for patients requesting physician-assisted death and provides recommendations if future legislation allows NP involvement in the physician-assisted death process."

Cayla R Teal and Richard L Street

18 November, 2008

"Increasing the cultural competence of physicians is one means of responding to demographic changes in the USA, as well as reducing health disparities. However, in spite of the development and implementation of cultural competence training programs, little is known about the ways cultural competence manifests itself in medical encounters. This paper will present a model of culturally competent communication that offers a framework of studying cultural competence 'in action.' First, we describe four critical elements of culturally competent communication in the medical encounter--communication repertoire, situational awareness, adaptability, and knowledge about core cultural issues. We present a model of culturally competent physician communication that integrates existing frameworks for cultural competence in patient care with models of effective patient-centered communication. The culturally competent communication model includes five communication skills that are depicted as elements of a set in which acquisition of more skills corresponds to increasing complexity and culturally competent communication. The culturally competent communication model utilizes each of the four critical elements to fully develop each skill and apply increasingly sophisticated, contextually appropriate communication behaviors to engage with culturally different patients in complex interactions. It is designed to foster maximum physician sensitivity to cultural variation in patients as the foundation of physician-communication competence in interacting with patients."

Leslie J. Blackhall, Gelya Frank, Sheila Murphy & Vicki Michel

March 2001

"After a survey of 800 seniors from four different ethnic groups showed that Korean-American and Mexican-American subjects were much less likely than their European-American and African-American counterparts to believe that a patient should be told the truth about the diagnosis and prognosis of a terminal illness, we undertook an ethnographic study to look more deeply at attitudes and experiences of these respondents. European-American and African-American respondents were more likely to view truth-telling as empowering, enabling the patient to make choices, while the Korean-American and Mexican-American respondents were more likely to see the truth-telling as cruel, and even harmful, to the patients. Further differences were noted in how the truth should be told and even in definitions of what constitutes “truth” and “telling”. Clinical and bioethics professionals should be aware of how their cultural and economic backgrounds influence the way they perceive ethical dilemmas and remember to make room for the diverse views of the populations they serve."

Clarence H. Braddock

"When physicians communicate with patients, being honest is an important way to foster trust and show respect for the patient. Patients place a great deal of trust in their physician, and may feel that trust is misplaced if they discover or perceive lack of honesty and candor by the physician. Yet there are situations in which the truth can be disclosed in too brutal a fashion, or may have a terrible impact on the occasional patient. The goal of this summary is to be able to discern the difference."

Jessica De Bord, Wylie Burke, and Denise M. Dudzinski

"The obligation of confidentiality prohibits the health care provider from disclosing information about the patient's case to others without permission and encourages the providers and health care systems to take precautions to ensure that only authorized access occurs. Appropriate care often requires that information about patients be discussed among members of a health care team; all team members have authorized access to confidential information about the patients they care for and assume the duty of protecting that information from others who do not have access. Electronic medical records can pose challenges to confidentiality. In accordance with the Health Information Portability and Accountability Act of 1997 (HIPAA), institutions are required to have policies to protect the privacy of patients’ electronic information, including procedures for computer access and security."

"One platform to enhance the production, sharing, and use of scholarship on the Ethical, Legal, and Social Implications of genetics and genomics."

Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing

12 July 2021

"The recent application of tools, such as CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats; Cas9 nuclease), to edit the human genome with the intention of treating or preventing disease and the gaps in our scientific understanding, in addition to some of the proposed applications of human genome editing, raise ethical issues that have highlighted the need for robust oversight in this area. In December 2018, WHO established a global, multidisciplinary expert advisory committee (the Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, hereafter called the Committee) to examine the scientific, ethical, social and legal challenges associated with human genome editing (somatic, germline and heritable). The governance framework on human genome editing, along with the recommendations of the Committee, form a set of two publications that provide advice and recommendations on appropriate institutional, national, regional and global governance mechanisms for human genome editing."

Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing

12 July 2021

"The Committee developed a governance framework that draws from good practices in the governance of emerging technologies and applied them specifically to human genome editing. The governance framework, which can be implemented in different contexts, is intended to help those tasked with strengthening oversight measures, regardless of whether this is at the institutional, national, regional or international level. The governance framework identifies values and principles that help explain why governance measures may be needed and how those charged with reviewing or strengthening governance measures may undertake such a task. It reviews a set of tools, institutions and processes and puts forward seven scenarios to demonstrate how the various components of the governance framework come together in practice. The governance framework identifies a number of considerations for the successful implementation of oversight and governance measures for human genome editing."

Georgetown University Kennedy Institute of Ethics Bioethics Research Library

"The Bioethics Research Library holds original documents from the earliest U.S. Presidential Commissions about bioethics as well as archived websites containing reports and transcripts from more recent Commissions. "

Georgetown University Kennedy Institute of Ethics Bioethics Research Library

"Since October 2009, the project staff (working in Georgetown libraries in Qatar and Washington) have identified more than 4,700 writings on Islamic perspectives on abortion, death and dying, genetics, health care delivery, human experimentation, organ transplantation, and reproductive technologies, primarily in English and Arabic."

Georgetown University Kennedy Institute of Ethics Bioethics Research Library

"The Collection now contains over 1,500 books covering Jewish ethics and related subjects, including Holocaust studies."

Georgetown University Kennedy Institute of Ethics Bioethics Research Library

"The Bioethics Research Library is home to the Shigeo Morioka Asian Bioethics Collection. This book collection is named in Mr. Morioka’s honor in recognition of both his gifts and his long support of the study of bioethics in Asia."

Andrew Garrison

September 3, 2003

"Medical ethicists have traditionally referred to beneficence, nonmaleficence, respect for autonomy, and justice as fundamental principles of medical ethics.1 In some cases, however, adherence to these principles produces competing ethical obligations. Such is the dilemma when a patient with early Huntington disease (HD) forbids her physician to disclose this diagnosis to her daughter. The daughter is a patient of the same physician; she has a 50% chance of inheriting the HD mutation, which inevitably causes the disease."

Saul J. Weiner

November 2006

"Mr. Rangston is a substitute janitor at a junior high school in Gary, Indiana. Because he is only employed part time, he is not eligible for insurance benefits. He does not qualify for Medicaid or, at 53 years old, for Medicare. He comes into a student-run free health clinic on Chicago’s West side after a long commute from Gary. A year earlier, he had been referred to the clinic by a county public hospital. He had been diagnosed and treated for chronic recurrent prostatitis on multiple previous visits to the free health clinic, and on the current visit he reports having pain in his pelvic region and upon urination. He is sexually active but refrains from sex with his girlfriend when his symptoms flair up for fear of transmiting an infection. During a recent visit to the clinic, Mr. Rangston tested negative for sexually transmitted infections, had a negative urine dip, no glucose in his urine, normal prostate specific antigen (PSA) levels and an enlarged prostate but no nodules. He has traveled to the clinic almost monthly during the past year and has kept all scheduled appointments but one. His health literacy appears high according to a triage volunteer who read his medical history, and he is conscientious about choosing healthy behaviors."

Saul J. Weiner

February 2021

"This article examines the care of a Spanish-speaking woman with end-stage renal disease who returns repeatedly to the emergency department with complications related to missing hemodialysis. Her life circumstances suggest that she has been making difficult but rational decisions in an untenable situation, which is then readily resolved with the assistance of her care team. The case illustrates the pernicious effect of judgmentalism on patients from poor and marginalized communities, which exacerbates health inequity and illuminates the ethical importance of contextualizing patients’ care."

Melissa Lavoie and Angela S. Guarda

April 2021

"Use of force in the care of patients with severe anorexia nervosa is controversial but can be justified when the disorder becomes life-threatening. This commentary examines the role of force in compassionate care of an adolescent patient hospitalized with extreme anorexia nervosa and suggests strategies for reaching consensus, minimizing harm, and maximizing the chance of a therapeutic outcome when forced intervention is a compassionate thing to do."

U.S. Presidential Commission for the Study of Bioethical Issues

September 30, 2016

"You are a public health professional at a local health department in the United States, and the local school board has contacted you and your colleagues for advice on what they should do to best protect children and families. The community has many families who have immigrated to your town from the affected countries in western Africa and some who have recently visited their home countries. Media attention has focused on the epidemic, including some misinformation about how EVD is transmitted, and generated public pressure to be very cautious. Parents and teachers from the school district have expressed concern about the wellbeing of their children and families. Although there have been no EVD cases in your community, there have been a couple of scares that have caused widespread fear."

U.S. Presidential Commission for the Study of Bioethical Issues

September 30, 2016

"Some western African countries are experiencing an ongoing epidemic of the Ebola virus disease (EVD), a hemorrhagic fever. Several persons traveling from affected countries to the United States have been diagnosed with EVD after they arrived in the United States. While political and public health officials at the national level are considering a ban on travel from the affected countries, the city health department where you work is busy with local concerns about the outbreak. Your city is home to a large community of immigrants from the affected countries, and you and your colleagues have been receiving calls from anxious members of the public asking what the health department is doing to protect the local residents from contracting EVD. Members of the press also have been asking questions about the department’s response plan. Since the city has not had a case of the disease, the department has not yet issued a media statement about its proposed response."