Recent Breach Of Ethics In Healthcare Research

Recent Breaches of Ethics in Healthcare Research: A Critical Examination

Introduction:

The sanctity of human life and the pursuit of medical advancements are intrinsically linked. However, the drive for breakthroughs sometimes overshadows ethical considerations, leading to significant breaches in healthcare research. This article delves into recent examples of ethical lapses in healthcare research, analyzing their impact, exploring the underlying causes, and proposing solutions to prevent future occurrences. We'll examine specific cases, dissect the ethical principles violated, and discuss the urgent need for stronger oversight and greater transparency within the research community. Prepare to gain a comprehensive understanding of this critical issue and its implications for the future of medical innovation.


1. The Falsification of Data and Scientific Misconduct:

One of the most pervasive ethical breaches in healthcare research involves the deliberate falsification or fabrication of data. This can range from minor adjustments to outright invention of results to support a pre-determined conclusion. The consequences are devastating. Not only does it undermine the integrity of scientific findings, but it can also lead to the development and implementation of ineffective or even harmful treatments. Recent examples highlight the need for rigorous peer review processes, strengthened data verification protocols, and robust systems for detecting and addressing scientific misconduct. The pressure to publish, secure funding, and achieve career advancement often contributes to this problem, demanding a shift in research culture towards prioritizing integrity over ambition.

2. Informed Consent and Patient Vulnerability:

The principle of informed consent is paramount in ethical healthcare research. Patients must be fully informed about the nature of the research, potential risks and benefits, and their right to withdraw at any time without penalty. However, vulnerable populations, such as the elderly, children, individuals with cognitive impairments, or those from marginalized communities, are often at increased risk of exploitation. Recent breaches highlight instances where informed consent was inadequately obtained, or where vulnerable participants were pressured into participation without fully understanding the implications. This necessitates increased sensitivity to vulnerable populations and the development of tailored consent procedures that ensure genuine understanding and voluntary participation.

3. Conflicts of Interest and Industry Influence:

The influence of industry funding and conflicts of interest pose a significant threat to ethical research. Financial ties between researchers, pharmaceutical companies, and medical device manufacturers can compromise objectivity and lead to biased results. Recent cases have exposed instances where industry funding has skewed research outcomes, leading to the promotion of potentially harmful treatments or the suppression of unfavorable findings. Greater transparency regarding funding sources, stricter regulations on industry-sponsored research, and independent oversight are crucial to mitigating this risk and restoring public trust in scientific findings.

4. Data Privacy and Security Breaches:

The increasing reliance on electronic health records (EHRs) and big data analytics in healthcare research brings with it significant concerns regarding data privacy and security. Recent breaches have highlighted the vulnerability of patient data to hacking, unauthorized access, and misuse. The unauthorized disclosure of sensitive patient information not only violates ethical principles but also has profound legal and reputational consequences. Robust cybersecurity measures, stricter data protection regulations, and enhanced data anonymization techniques are essential to safeguarding patient privacy and maintaining ethical standards in data-driven healthcare research.

5. The Lack of Diversity and Inclusion in Research:

Ethical research demands inclusivity and representation of diverse populations. However, historical biases and systemic inequalities have resulted in underrepresentation of certain racial, ethnic, and socioeconomic groups in many research studies. This can lead to the development of treatments and interventions that are less effective or even harmful for specific populations. Recent calls for increased diversity and inclusivity in research emphasize the need for more equitable representation, tailored research designs, and community engagement to ensure that the benefits of medical advancements reach all segments of society.


6. The Role of Institutional Review Boards (IRBs):

Institutional Review Boards (IRBs) play a critical role in overseeing the ethical conduct of healthcare research. However, recent criticisms have questioned the effectiveness and consistency of IRB oversight. Concerns include inadequate staffing, insufficient training, and potential conflicts of interest among IRB members. Strengthening IRB oversight, enhancing training programs for IRB members, and improving transparency in IRB decision-making processes are vital to ensuring the ethical review of research protocols.

7. The Growing Importance of Transparency and Accountability:

Transparency and accountability are fundamental to maintaining ethical standards in healthcare research. Open access publication of research findings, clear disclosure of funding sources and potential conflicts of interest, and readily available mechanisms for reporting ethical violations are all crucial elements. Recent calls for increased transparency advocate for a culture of openness and accountability that fosters public trust and allows for independent scrutiny of research practices.


8. The Future of Ethical Healthcare Research:

Addressing the ethical challenges in healthcare research requires a multi-pronged approach. This includes strengthening regulations, enhancing oversight mechanisms, promoting a culture of ethical conduct within the research community, and fostering greater collaboration among researchers, ethicists, policymakers, and patient advocacy groups. Continuous education and training on ethical principles and best practices are crucial for all stakeholders involved in healthcare research. By prioritizing ethical considerations, we can ensure that medical advancements are pursued responsibly and equitably, benefiting all members of society.


Article Outline: Recent Breaches of Ethics in Healthcare Research

Name: Ethical Lapses in Healthcare Research: A Critical Review

Introduction: Defining ethical breaches and their impact on healthcare research.
Chapter 1: Data Falsification and Scientific Misconduct. Examples, consequences, and preventive measures.
Chapter 2: Informed Consent Issues: Vulnerable populations and inadequate consent procedures.
Chapter 3: Conflicts of Interest: Industry influence and its impact on research objectivity.
Chapter 4: Data Privacy and Security: Breaches, consequences, and protective measures.
Chapter 5: Lack of Diversity and Inclusion: Unequal representation and its implications.
Chapter 6: The Role of IRBs: Effectiveness, limitations, and improvements.
Chapter 7: Transparency and Accountability: Open access, disclosure, and reporting mechanisms.
Conclusion: Recommendations for enhancing ethical practices in healthcare research.


(The detailed explanation of each chapter is provided above in the main article.)


FAQs:

1. What are some common ethical breaches in healthcare research? Common breaches include data falsification, inadequate informed consent, conflicts of interest, data privacy violations, and lack of diversity in research participants.

2. How can conflicts of interest affect research outcomes? Conflicts of interest can bias research findings, leading to the promotion of ineffective or harmful treatments.

3. What is the role of Institutional Review Boards (IRBs)? IRBs review research protocols to ensure they adhere to ethical standards and protect the rights and welfare of participants.

4. How can data privacy be protected in healthcare research? Data privacy can be protected through robust cybersecurity measures, data anonymization techniques, and adherence to data protection regulations.

5. What are the consequences of unethical research practices? Unethical research practices can lead to ineffective or harmful treatments, erosion of public trust, legal repercussions, and damage to the reputation of researchers and institutions.

6. How can we promote diversity and inclusion in healthcare research? Promoting diversity and inclusion requires actively recruiting participants from diverse backgrounds, developing culturally appropriate research designs, and engaging with communities to ensure equitable representation.

7. What is the importance of transparency in healthcare research? Transparency builds trust, allows for independent scrutiny of research methods and findings, and helps identify and address potential biases.

8. What measures can be taken to prevent future ethical breaches? Preventative measures include stronger regulations, enhanced oversight, ethical training for researchers, and fostering a culture of ethical conduct.

9. Where can I report ethical violations in healthcare research? Reporting mechanisms vary depending on the institution and the nature of the violation. Contact the relevant IRB, research ethics committee, or regulatory authority.


Related Articles:

1. The Tuskegee Syphilis Study: A Landmark Case of Unethical Research: This article examines the infamous Tuskegee experiment and its lasting impact on ethical guidelines.

2. The Willowbrook Hepatitis Studies: Exploiting Vulnerable Populations: This article discusses the unethical experimentation on children with intellectual disabilities at the Willowbrook State School.

3. The Nazi Medical Experiments: The Dark Side of Scientific Advancement: This article explores the horrific medical experiments conducted by Nazi doctors during World War II.

4. Data Security Breaches in Healthcare: Protecting Patient Privacy in the Digital Age: This article discusses the challenges and solutions related to data security in healthcare research.

5. Informed Consent in Clinical Trials: Challenges and Best Practices: This article examines the complexities of obtaining informed consent from diverse populations.

6. Industry Funding and Conflicts of Interest in Biomedical Research: This article analyzes the impact of industry funding on the objectivity of research findings.

7. The Role of Institutional Review Boards in Protecting Research Participants: This article discusses the importance of IRBs and their role in ensuring ethical research practices.

8. Promoting Diversity and Inclusion in Clinical Trials: This article explores strategies for increasing representation in clinical research.

9. Open Science and Data Sharing: Fostering Transparency in Healthcare Research: This article examines the benefits of open science practices and data sharing for advancing ethical research.


  recent breach of ethics in healthcare research: Registries for Evaluating Patient Outcomes Agency for Healthcare Research and Quality/AHRQ, 2014-04-01 This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
  recent breach of ethics in healthcare research: Beyond the HIPAA Privacy Rule Institute of Medicine, Board on Health Care Services, Board on Health Sciences Policy, Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule, 2009-03-24 In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
  recent breach of ethics in healthcare research: Assessing Genetic Risks Institute of Medicine, Committee on Assessing Genetic Risks, 1994-01-01 Raising hopes for disease treatment and prevention, but also the specter of discrimination and designer genes, genetic testing is potentially one of the most socially explosive developments of our time. This book presents a current assessment of this rapidly evolving field, offering principles for actions and research and recommendations on key issues in genetic testing and screening. Advantages of early genetic knowledge are balanced with issues associated with such knowledge: availability of treatment, privacy and discrimination, personal decision-making, public health objectives, cost, and more. Among the important issues covered: Quality control in genetic testing. Appropriate roles for public agencies, private health practitioners, and laboratories. Value-neutral education and counseling for persons considering testing. Use of test results in insurance, employment, and other settings.
  recent breach of ethics in healthcare research: The Belmont Report United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978
  recent breach of ethics in healthcare research: Artificial Intelligence in Healthcare Adam Bohr, Kaveh Memarzadeh, 2020-06-21 Artificial Intelligence (AI) in Healthcare is more than a comprehensive introduction to artificial intelligence as a tool in the generation and analysis of healthcare data. The book is split into two sections where the first section describes the current healthcare challenges and the rise of AI in this arena. The ten following chapters are written by specialists in each area, covering the whole healthcare ecosystem. First, the AI applications in drug design and drug development are presented followed by its applications in the field of cancer diagnostics, treatment and medical imaging. Subsequently, the application of AI in medical devices and surgery are covered as well as remote patient monitoring. Finally, the book dives into the topics of security, privacy, information sharing, health insurances and legal aspects of AI in healthcare. - Highlights different data techniques in healthcare data analysis, including machine learning and data mining - Illustrates different applications and challenges across the design, implementation and management of intelligent systems and healthcare data networks - Includes applications and case studies across all areas of AI in healthcare data
  recent breach of ethics in healthcare research: The Immortal Life of Henrietta Lacks Rebecca Skloot, 2010-02-02 #1 NEW YORK TIMES BESTSELLER • “The story of modern medicine and bioethics—and, indeed, race relations—is refracted beautifully, and movingly.”—Entertainment Weekly NOW A MAJOR MOTION PICTURE FROM HBO® STARRING OPRAH WINFREY AND ROSE BYRNE • ONE OF THE “MOST INFLUENTIAL” (CNN), “DEFINING” (LITHUB), AND “BEST” (THE PHILADELPHIA INQUIRER) BOOKS OF THE DECADE • ONE OF ESSENCE’S 50 MOST IMPACTFUL BLACK BOOKS OF THE PAST 50 YEARS • WINNER OF THE CHICAGO TRIBUNE HEARTLAND PRIZE FOR NONFICTION NAMED ONE OF THE BEST BOOKS OF THE YEAR BY The New York Times Book Review • Entertainment Weekly • O: The Oprah Magazine • NPR • Financial Times • New York • Independent (U.K.) • Times (U.K.) • Publishers Weekly • Library Journal • Kirkus Reviews • Booklist • Globe and Mail Her name was Henrietta Lacks, but scientists know her as HeLa. She was a poor Southern tobacco farmer who worked the same land as her slave ancestors, yet her cells—taken without her knowledge—became one of the most important tools in medicine: The first “immortal” human cells grown in culture, which are still alive today, though she has been dead for more than sixty years. HeLa cells were vital for developing the polio vaccine; uncovered secrets of cancer, viruses, and the atom bomb’s effects; helped lead to important advances like in vitro fertilization, cloning, and gene mapping; and have been bought and sold by the billions. Yet Henrietta Lacks remains virtually unknown, buried in an unmarked grave. Henrietta’s family did not learn of her “immortality” until more than twenty years after her death, when scientists investigating HeLa began using her husband and children in research without informed consent. And though the cells had launched a multimillion-dollar industry that sells human biological materials, her family never saw any of the profits. As Rebecca Skloot so brilliantly shows, the story of the Lacks family—past and present—is inextricably connected to the dark history of experimentation on African Americans, the birth of bioethics, and the legal battles over whether we control the stuff we are made of. Over the decade it took to uncover this story, Rebecca became enmeshed in the lives of the Lacks family—especially Henrietta’s daughter Deborah. Deborah was consumed with questions: Had scientists cloned her mother? Had they killed her to harvest her cells? And if her mother was so important to medicine, why couldn’t her children afford health insurance? Intimate in feeling, astonishing in scope, and impossible to put down, The Immortal Life of Henrietta Lacks captures the beauty and drama of scientific discovery, as well as its human consequences.
  recent breach of ethics in healthcare research: Clinical Ethics Albert R. Jonsen, Mark Siegler, William J. Winslade, 1992 Clinical Ethics introduces the four-topics method of approaching ethical problems (i.e., medical indications, patient preferences, quality of life, and contextual features). Each of the four chapters represents one of the topics. In each chapter, the authors discuss cases and provide comments and recommendations. The four-topics method is an organizational process by which clinicians can begin to understand the complexities involved in ethical cases and can proceed to find a solution for each case.
  recent breach of ethics in healthcare research: Sharing Clinical Trial Data Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Responsible Sharing of Clinical Trial Data, 2015-04-20 Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
  recent breach of ethics in healthcare research: Responsibility in Health Care G.J. Agich, 2012-12-06 Medicine is a complex social institution which includes biomedical research, clinical practice, and the administration and organization of health care delivery. As such, it is amenable to analysis from a number of disciplines and directions. The present volume is composed of revised papers on the theme of Responsibility in Health Care presented at the Eleventh Trans Disciplinary Symposium on Philosophy and Medicine, which was held in Springfield, illinois on March 16-18, 1981. The collective focus of these essays is the clinical practice of medicine and the themes and issues related to questions of responsibility in that setting. Responsibility has three related dimensions which make it a suitable theme for an inquiry into clinical medicine: (a) an external dimension in legal and political analysis in which the State imposes penalties on individuals and groups and in which officials and governments are held accountable for policies; (b) an internal dimension in moral and ethical analysis in which individuals take into account the consequences of their actions and the criteria which bear upon their choices; and (c) a comprehensive dimension in social and cultural analysis in which values are ordered in the structure of a civilization ([8], p. 5). The title Responsibility in Health Care thus signifies a broad inquiry not only into the ethics of individual character and actions, but the moral foundations of the cultural, legal, political, and social context of health care generally.
  recent breach of ethics in healthcare research: Code of Ethics for Nurses with Interpretive Statements American Nurses Association, 2001 Pamphlet is a succinct statement of the ethical obligations and duties of individuals who enter the nursing profession, the profession's nonnegotiable ethical standard, and an expression of nursing's own understanding of its commitment to society. Provides a framework for nurses to use in ethical analysis and decision-making.
  recent breach of ethics in healthcare research: Casebook on Ethical Issues in International Health Research World Health Organization, 2009 I. Defining research--II. Issues in study design . -- III. Harm and benefit -- IV. Voluntary informed consent -- V. Standard of care -- VI. Obligations to participants and communities -- VII. Privacy and confidentiality -- VIII. Professional ethics.
  recent breach of ethics in healthcare research: Responsible Conduct of Research Adil E. Shamoo, David B. Resnik, 2009-02-12 Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today.
  recent breach of ethics in healthcare research: The Computer-Based Patient Record Committee on Improving the Patient Record, Institute of Medicine, 1997-10-28 Most industries have plunged into data automation, but health care organizations have lagged in moving patients' medical records from paper to computers. In its first edition, this book presented a blueprint for introducing the computer-based patient record (CPR). The revised edition adds new information to the original book. One section describes recent developments, including the creation of a computer-based patient record institute. An international chapter highlights what is new in this still-emerging technology. An expert committee explores the potential of machine-readable CPRs to improve diagnostic and care decisions, provide a database for policymaking, and much more, addressing these key questions: Who uses patient records? What technology is available and what further research is necessary to meet users' needs? What should government, medical organizations, and others do to make the transition to CPRs? The volume also explores such issues as privacy and confidentiality, costs, the need for training, legal barriers to CPRs, and other key topics.
  recent breach of ethics in healthcare research: Protecting Data Privacy in Health Services Research Institute of Medicine, Division of Health Care Services, Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection, 2001-01-13 The need for quality improvement and for cost saving are driving both individual choices and health system dynamics. The health services research that we need to support informed choices depends on access to data, but at the same time, individual privacy and patient-health care provider confidentiality must be protected.
  recent breach of ethics in healthcare research: Ethical Considerations for Research on Housing-Related Health Hazards Involving Children Institute of Medicine, National Research Council, Division of Behavioral and Social Sciences and Education, Board on Children, Youth, and Families, Committee on Ethical Issues in Housing-Related Health Hazard Research Involving Children, Youth, and Families, 2005-11-10 Ethical Considerations for Research on Housing-Related Health Hazards Involving Children explores the ethical issues posed when conducting research designed to identify, understand, or ameliorate housing-related health hazards among children. Such research involves children as subjects and is conducted in the home and in communities. It is often conducted with children in low-income families given the disproportionate prevalence of housing-related conditions such as lead poisoning, asthma, and fatal injuries among these children. This book emphasizes five key elements to address the particular ethical concerns raised by these characteristics: involving the affected community in the research and responding to their concerns; ensuring that parents understand the essential elements of the research; adopting uniform federal guidelines for such research by all sponsors (Subpart D of 45 CFR 46); providing guidance on key terms in the regulations; and viewing research oversight as a system with important roles for researchers, IRBs and their research institutions, sponsors and regulators of research, and the community.
  recent breach of ethics in healthcare research: Patient Safety and Quality Ronda Hughes, 2008 Nurses play a vital role in improving the safety and quality of patient car -- not only in the hospital or ambulatory treatment facility, but also of community-based care and the care performed by family members. Nurses need know what proven techniques and interventions they can use to enhance patient outcomes. To address this need, the Agency for Healthcare Research and Quality (AHRQ), with additional funding from the Robert Wood Johnson Foundation, has prepared this comprehensive, 1,400-page, handbook for nurses on patient safety and quality -- Patient Safety and Quality: An Evidence-Based Handbook for Nurses. (AHRQ Publication No. 08-0043). - online AHRQ blurb, http://www.ahrq.gov/qual/nurseshdbk/
  recent breach of ethics in healthcare research: Ethical Conduct of Clinical Research Involving Children Institute of Medicine, Board on Health Sciences Policy, Committee on Clinical Research Involving Children, 2004-07-09 In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.
  recent breach of ethics in healthcare research: Medical Ethics Manual John Reynold Williams, 2005
  recent breach of ethics in healthcare research: Fostering Integrity in Research National Academies of Sciences, Engineering, and Medicine, Policy and Global Affairs, Committee on Science, Engineering, Medicine, and Public Policy, Committee on Responsible Science, 2018-01-13 The integrity of knowledge that emerges from research is based on individual and collective adherence to core values of objectivity, honesty, openness, fairness, accountability, and stewardship. Integrity in science means that the organizations in which research is conducted encourage those involved to exemplify these values in every step of the research process. Understanding the dynamics that support †or distort †practices that uphold the integrity of research by all participants ensures that the research enterprise advances knowledge. The 1992 report Responsible Science: Ensuring the Integrity of the Research Process evaluated issues related to scientific responsibility and the conduct of research. It provided a valuable service in describing and analyzing a very complicated set of issues, and has served as a crucial basis for thinking about research integrity for more than two decades. However, as experience has accumulated with various forms of research misconduct, detrimental research practices, and other forms of misconduct, as subsequent empirical research has revealed more about the nature of scientific misconduct, and because technological and social changes have altered the environment in which science is conducted, it is clear that the framework established more than two decades ago needs to be updated. Responsible Science served as a valuable benchmark to set the context for this most recent analysis and to help guide the committee's thought process. Fostering Integrity in Research identifies best practices in research and recommends practical options for discouraging and addressing research misconduct and detrimental research practices.
  recent breach of ethics in healthcare research: Public Health Ethics: Cases Spanning the Globe Drue H. Barrett, Leonard W. Ortmann, Angus Dawson, Carla Saenz, Andreas Reis, Gail Bolan, 2016-04-20 This Open Access book highlights the ethical issues and dilemmas that arise in the practice of public health. It is also a tool to support instruction, debate, and dialogue regarding public health ethics. Although the practice of public health has always included consideration of ethical issues, the field of public health ethics as a discipline is a relatively new and emerging area. There are few practical training resources for public health practitioners, especially resources which include discussion of realistic cases which are likely to arise in the practice of public health. This work discusses these issues on a case to case basis and helps create awareness and understanding of the ethics of public health care. The main audience for the casebook is public health practitioners, including front-line workers, field epidemiology trainers and trainees, managers, planners, and decision makers who have an interest in learning about how to integrate ethical analysis into their day to day public health practice. The casebook is also useful to schools of public health and public health students as well as to academic ethicists who can use the book to teach public health ethics and distinguish it from clinical and research ethics.
  recent breach of ethics in healthcare research: Moral Uncertainty William MacAskill, Krister Bykvist, Toby Ord, 2020 About the bookToby Ord try to fill this gap. They argue that there are distinctive norms that govern how one ought to make decisions and defend an information-sensitive account of how to make such decisions. They do so by developing an analogy between moral uncertainty and social choice, noting that different moral views provide different amounts of information regarding our reasons for action, and arguing that the correct account of decision-making under moral uncertainty must be sensitive to that. Moral Uncertainty also tackles the problem of how to make intertheoretic comparisons, and addresses the implications of their view for metaethics and practical ethics. Very often we are uncertain about what we ought, morally, to do. We do not know how to weigh the interests of animals against humans, how strong our duties are to improve the lives of distant strangers, or how to think about the ethics of bringing new people into existence. But we still need to act. So how should we make decisions in the face of such uncertainty? Though economists and philosophers have extensively studied the issue of decision-making in the face of uncertainty about matters of fact, the question of decision-making given fundamental moral uncertainty has been neglected. In Moral Uncertainty, philosophers William MacAskill, Krister Bykvist, and Toby Ord try to fill this gap. They argue that there are distinctive norms that govern how one ought to make decisions and defend an information-sensitive account of how to make such decisions. They do so by developing an analogy between moral uncertainty and social choice, noting that different moral views provide different amounts of information regarding our reasons for action, and arguing that the correct account of decision-making under moral uncertainty must be sensitive to that. Moral Uncertainty also tackles the problem of how to make intertheoretic comparisons, and addresses the implications of their view for metaethics and practical ethics.
  recent breach of ethics in healthcare research: International Ethical Guidelines for Health-Related Research Involving Humans Council for International Organizations of Medical Sciences (CIOMS), 2017-01-31 In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research.--Page 4 de la couverture.
  recent breach of ethics in healthcare research: Ethics in Scientific Research Cortney Weinbaum, Carlos Ignacio Gutierrez, 2019-06-05 Scientific research ethics vary by discipline and by country, and this analysis sought to understand those variations. The authors reviewed literature and conducted interviews to provide researchers, government officials, and others who create, modify, and enforce ethics in scientific research around the world with an understanding of how ethics are created, monitored, and enforced across scientific disciplines and across international borders.
  recent breach of ethics in healthcare research: Tri-council Policy Statement , 2014 This document is a joint policy of Canada's three federal research agencies, the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada. This updated version replaces the TCPS 2 (2010) as the official human research ethics policy of these agencies.
  recent breach of ethics in healthcare research: The Electronic Health Record Eike-Henner W. Kluge, 2020-02-28 The Electronic Health Record: Ethical Considerations analyses the ethical issues that surround the construction, maintenance, storage, use, linkage, manipulation and communication of electronic health records. Its purpose is to provide ethical guidance to formulate and implement policies at the local, national and global level, and to provide the basis for global certification in health information ethics. Electronic health records (EHRs) are increasingly replacing the use of paper-based records in the delivery of health care. They are integral to providing eHealth, telehealth, mHealth and pHealth - all of which are increasingly replacing direct and personal physician-patient interaction - as well as in the developing field of artificial intelligence and expert systems in health care. The book supplements considerations that are raised by national and international regulations dealing with electronic records in general, for instance the General Data Protection Regulation of the European Union. This book is a valuable resource for physicians, health care administrators and workers, IT service providers and several members of biomedical field who are interested in learning more about how to ethically manage health data.
  recent breach of ethics in healthcare research: Hippocratic Writings Hippocrates, 2005-05-26 This work is a sampling of the Hippocratic Corpus, a collection of ancient Greek medical works. At the beginning, and interspersed throughout, there are discussions on the philosophy of being a physician. There is a large section about how to treat limb fractures, and the section called The Nature of Man describes the physiological theories of the time. The book ends with a discussion of embryology and a brief anatomical description of the heart.
  recent breach of ethics in healthcare research: Science and Babies Institute of Medicine, Suzanne Wymelenberg, 1990-02-01 By all indicators, the reproductive health of Americans has been deteriorating since 1980. Our nation is troubled by rates of teen pregnancies and newborn deaths that are worse than almost all others in the Western world. Science and Babies is a straightforward presentation of the major reproductive issues we face that suggests answers for the public. The book discusses how the clash of opinions on sex and family planning prevents us from making a national commitment to reproductive health; why people in the United States have fewer contraceptive choices than those in many other countries; what we need to do to improve social and medical services for teens and people living in poverty; how couples should shop for a fertility service and make consumer-wise decisions; and what we can expect in the futureâ€featuring interesting accounts of potential scientific advances.
  recent breach of ethics in healthcare research: Evolution of Translational Omics Institute of Medicine, Board on Health Sciences Policy, Board on Health Care Services, Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials, 2012-09-13 Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.
  recent breach of ethics in healthcare research: Improving Access to and Confidentiality of Research Data National Research Council, Commission on Behavioral and Social Sciences and Education, Committee on National Statistics, 2000-09-11 Improving Access to and Confidentiality of Research Data summarizes a workshop convened by the Committee on National Statistics (CNSTAT) to promote discussion about methods for advancing the often conflicting goals of exploiting the research potential of microdata and maintaining acceptable levels of confidentiality. This report outlines essential themes of the access versus confidentiality debate that emerged during the workshop. Among these themes are the tradeoffs and tensions between the needs of researchers and other data users on the one hand and confidentiality requirements on the other; the relative advantages and costs of data perturbation techniques (applied to facilitate public release) versus restricted access as tools for improving security; and the need to quantify disclosure risksâ€both absolute and relativeâ€created by researchers and research data, as well as by other data users and other types of data.
  recent breach of ethics in healthcare research: Research Ethics for Students in the Social Sciences Jaap Bos, 2020-10-16 This open access textbook offers a practical guide into research ethics for undergraduate students in the social sciences. A step-by-step approach of the most viable issues, in-depth discussions of case histories and a variety of didactical tools will aid the student to grasp the issues at hand and help him or her develop strategies to deal with them. This book addresses problems and questions that any bachelor student in the social sciences should be aware of, including plagiarism, data fabrication and other types of fraud, data augmentation, various forms of research bias, but also peer pressure, issues with confidentiality and questions regarding conflicts of interest. Cheating, ‘free riding’, and broader issues that relate to the place of the social sciences in society are also included. The book concludes with a step-by-step approach designed to coach a student through a research application process.
  recent breach of ethics in healthcare research: Pain Management and the Opioid Epidemic National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse, 2017-09-28 Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
  recent breach of ethics in healthcare research: Autonomy, Rationality, and Contemporary Bioethics Jonathan Pugh, 2020 Personal autonomy is often lauded as a key value in contemporary Western bioethics, and the claim that there is an important relationship between autonomy and rationality is often treated as an uncontroversial claim in this sphere. Yet, there is also considerable disagreement about how we should cash out the relationship between rationality and autonomy. In particular, it is unclear whether a rationalist view of autonomy can be compatible with legal judgments that enshrine a patient's right to refuse medical treatment, regardless of whether . . . the reasons for making the choice are rational, irrational, unknown or even non-existent. In this book, I bring recent philosophical work on the nature of rationality to bear on the question of how we should understand autonomy in contemporary bioethics. In doing so, I develop a new framework for thinking about the concept, one that is grounded in an understanding of the different roles that rational beliefs and rational desires have to play in personal autonomy. Furthermore, the account outlined here allows for a deeper understanding of different form of controlling influence, and the relationship between our freedom to act, and our capacity to decide autonomously. I contrast my rationalist with other prominent accounts of autonomy in bioethics, and outline the revisionary implications it has for various practical questions in bioethics in which autonomy is a salient concern, including questions about the nature of informed consent and decision-making capacity.
  recent breach of ethics in healthcare research: The Plutonium Files Eileen Welsome, 2010-10-20 When the vast wartime factories of the Manhattan Project began producing plutonium in quantities never before seen on earth, scientists working on the top-secret bomb-building program grew apprehensive. Fearful that plutonium might cause a cancer epidemic among workers and desperate to learn more about what it could do to the human body, the Manhattan Project's medical doctors embarked upon an experiment in which eighteen unsuspecting patients in hospital wards throughout the country were secretly injected with the cancer-causing substance. Most of these patients would go to their graves without ever knowing what had been done to them. Now, in The Plutonium Files, Pulitzer Prize-winning reporter Eileen Welsome reveals for the first time the breadth of the extraordinary fifty-year cover-up surrounding the plutonium injections, as well as the deceitful nature of thousands of other experiments conducted on American citizens in the postwar years. Welsome's remarkable investigation spans the 1930s to the 1990s and draws upon hundreds of newly declassified documents and other primary sources to disclose this shadowy chapter in American history. She gives a voice to such innocents as Helen Hutchison, a young woman who entered a prenatal clinic in Nashville for a routine checkup and was instead given a radioactive cocktail to drink; Gordon Shattuck, one of several boys at a state school for the developmentally disabled in Massachusetts who was fed radioactive oatmeal for breakfast; and Maude Jacobs, a Cincinnati woman suffering from cancer and subjected to an experimental radiation treatment designed to help military planners learn how to win a nuclear war. Welsome also tells the stories of the scientists themselves, many of whom learned the ways of secrecy on the Manhattan Project. Among them are Stafford Warren, a grand figure whose bravado masked a cunning intelligence; Joseph Hamilton, who felt he was immune to the dangers of radiation only to suffer later from a fatal leukemia; and physician Louis Hempelmann, one of the most enthusiastic supporters of the plan to inject humans with potentially carcinogenic doses of plutonium. Hidden discussions of fifty years past are reconstructed here, wherein trusted government officials debated the ethical and legal implications of the experiments, demolishing forever the argument that these studies took place in a less enlightened era. Powered by her groundbreaking reportage and singular narrative gifts, Eileen Welsome has created a work of profound humanity as well as major historical significance. From the Hardcover edition.
  recent breach of ethics in healthcare research: Principles of Biomedical Ethics James F. Childress, 1983
  recent breach of ethics in healthcare research: Ethics in Mental Health Research James M. DuBois, 2008 Research holds a key to preventing and effectively treating mental disorders, including ADHD, depression, schizophrenia, and substance abuse. Yet even as research holds out promise, mental health researchers face numerous ethical challenges. Responsible for ensuring participants are able and willing to grant consent, researchers must also constantly protect privacy and confidentiality. But for so many situations, the appropriate decisions are not so clear. An individual with cognitive deficits may have difficulty understanding a research study and granting informed consent, but nevertheless wants to participate. Many studies gather private information about medical records or illegal behaviors that could lead to emotional, social, or legal harm if shared, yet state laws and institutional review boards may require researchers to breach confidentiality in specific situations. Moreover, mental health consumers and other vulnerable research participants are frequently familiar with historical cases of abuse of human subjects, and may be mistrustful of researchers or fear exploitation. At the same time, researchers are often frustrated when they feel that advocates or institutional review boards erect barriers to research, even while failing to enhance the ethical treatment of participants. Ethical research is rarely simply about avoiding bad activities, and more frequently about how to pursue good research when multiple values and commitments conflict. Ethics in Mental Health Research explores how ethical issues arise in mental health research, and offers concrete guidance to researchers who seek to comply with federal regulations while conducting research that is at once ethical and scientifically credible. Case studies used throughout illustrate a variety of situations and effective problem-solving strategies. This book is essential reading for mental health researchers, IRB members, and research advocates.
  recent breach of ethics in healthcare research: Care, Compassion and Recognition Carlo Leget, Chris Gastmans, Marian Verkerk, 2011 Since Carol Gilligan's In a Different Voice (1982) the ethics of care has developed as a movement of allied thinkers, in different continents, who have a shared concern and who reflect on similar topics. This shared concern is that care can only be revalued and take its societal place if existing asymmetrical power relations are unveiled, and if the dignity of care givers and care receivers is better guaranteed, socially, politically and personally. In this first volume of a new series leading care ethicists from Europe and the United States focus on the moral significance of two concepts in the debate that ask for further reflection. In discussion with the work of Axel Honneth on recognition and the work of Emmanuel Housset on compassion a contribution is made to a reconsideration of recognition and compassion from an ethics of care perspective. This volume contains contributions by Andries Baart, Estelle Ferrarese, Chris Gastmans, Mieke Grypdonck, Emmanuel Housset, Carlo Leget, Hilde Lindemann, Axel Liegeois, Christa Schnabl, Joan C. Tronto, Annelies van Heijst, Linus Vanlaere, Frans Vosman and Margaret Urban Walker.
  recent breach of ethics in healthcare research: Healthcare Research Ethics and Law Hazel Biggs, 2009-10-16 The book explores and explains the relationship between law and ethics in the context of medically related research in order to provide a practical guide to understanding for members of research ethics committees (RECs), professionals involved with medical research and those with an academic interest in the subject. Healthcare Research Ethics and Law sets out the law as it relates to the functions of Research Ethics Committees (RECs) within the context of the process of ethical review and aims to be accessible and readily understood by REC members. Each chapter begins by locating the material within the practical context of ethical review and then provides a more theoretical and analytical discussion detailing how the theory and practice fit together. The key legal issues of confidentiality, consent and negligence are addressed in detail, alongside practical guidance as to how and when liability may be incurred in these areas. In addition, the practical and legal implications of the implementation of European Directive 2001/20/EC, the Human Tissue Act 2004 and the Mental Capacity Act 2005 are considered alongside a discussion of their socio-political background and relevance for medical research in the UK.
  recent breach of ethics in healthcare research: Big Data, Health Law, and Bioethics I. Glenn Cohen, Holly Fernandez Lynch, Effy Vayena, Urs Gasser, 2018-03-08 When data from all aspects of our lives can be relevant to our health - from our habits at the grocery store and our Google searches to our FitBit data and our medical records - can we really differentiate between big data and health big data? Will health big data be used for good, such as to improve drug safety, or ill, as in insurance discrimination? Will it disrupt health care (and the health care system) as we know it? Will it be possible to protect our health privacy? What barriers will there be to collecting and utilizing health big data? What role should law play, and what ethical concerns may arise? This timely, groundbreaking volume explores these questions and more from a variety of perspectives, examining how law promotes or discourages the use of big data in the health care sphere, and also what we can learn from other sectors.
  recent breach of ethics in healthcare research: The Primacy of Caring Patricia E. Benner, Judith Wrubel, 1989 The Primacy of Caring is unique and remarkable, not only because it eludes classification within the curricular and practice arenas of professional nursing, but also because it offers a totally new view of stress, coping, and caring. The authors define and describe the essence of nursing practice, and make visible and powerful the hidden expertise of that practice.
  recent breach of ethics in healthcare research: Handbook of Research Ethics and Scientific Integrity Ron Iphofen, 2020-04-02 This handbook is a ‘one-stop shop’ for current information, issues and challenges in the fields of research ethics and scientific integrity. It provides a comprehensive coverage of research and integrity issues, both within researchers’ ‘home’ discipline and in relation to similar concerns in other disciplines. The handbook covers common elements shared by disciplines and research professions, such as consent, privacy, data management, fraud, and plagiarism. The handbook also includes contributions and perspectives from academics from various disciplines, treating issues specific to their fields. Readers are able to quickly source the most comprehensive and up-to-date information, protagonists, issues and challenges in the field. Experienced researchers keen to assess their own perspectives, as well as novice researchers aiming to establish the field, will equally find the handbook of interest and practical benefit. It saves them a great deal of time in sourcing the disparate available material in these fields and it is the first ‘port of call’ for a wide range of researchers, research advisors, funding agencies and research reviewers.The most important feature is the handbook’s ability to provide practical advice and guidance to researchers in a wide range of disciplines and professions to help them ‘think through’ their approach to difficult questions related to the principles, values and standards they need to bring to their research practice.