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The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research
THE BELMONT REPORT ETHICAL PRINCIPLES AND GUIDELINES FOR THE PROTECTION OF HUMAN SUBJECTS OF RESEARCH The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research April 18, 1979 SUMMARY: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings. 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. -
Code Gray.Pub
Written by Christine Mitchell, RN, FAAN and Ben Achtenberg with a historical commentary by Susan Reverby, PhD and assistance from Joan Sawyer and Karen Wolf, RN, MS Contents INTRODUCTION ....................................................................................... 3 Background ............................................................................................3 Synopsis of the Film ..............................................................................3 Suggested Uses .......................................................................................4 Scheduling ..............................................................................................4 FILM AS A TOOL FOR DISCUSSION .......................................................4 WHAT IS NURSING ETHICS? ...................................................................5 GLOSSARY ...................................................................................................5 SOME GENERAL DISCUSSION QUESTIONS ........................................6 CASE 1: BENEFICENCE ............................................................................7 Description of the Case .........................................................................7 The Principle: Beneficence ...................................................................7 Questions for Discussion ......................................................................8 CASE 2: AUTONOMY ................................................................................9 Description -
Institutional Review Board (IRB)
Institutional IRB Essentials: Review All research team members need to complete the Board (IRB) Human Subjects Research course in CITI before the IRB application can be approved. This includes the Protecting the rights and welfare faculty advisor and students. CITI: of human subjects involved in www.citiprogram.org research activities You need to have final, written IRB approval before you begin. All consent forms and study materials must be approved by the IRB before being used. It’s fine if you’ve already started a literature review, but the IRB review and approval must be completed before you involve any human subjects in your research, including any study advertisement or subject recruitment. Office of Research Assurances (ORA) Morrill114 Hall, Room What is the Institutional Levels of review for IRB How long is the process? Review Board (IRB)? determination Providing that you (and your research team) have done your part in completing As Federally mandated, The University of • Full [convened] Committee Review- the Human Subjects Protection course Idaho IRB is an ethics committee greater than minimal risk through CITI and submitting all of the composed of scientists and non- • Expedited Review-no more than correct documents, then the IRB office scientists who serve as advocates for minimal risk can usually process Exempt reviews human subjects involved in research. • Exempt Review-less than “minimal within one business week and Expedited The IRB is charged with the risk” reviews within two to three business responsibility of reviewing and • Not Human Subjects Research weeks. If we need to contact you for overseeing human subjects research additional information or corrections, conducted by UI researchers. -
Ethical Role of the Manager
Ethical Role of the Manager In a broad construction of the ethical role of the manager, managing and leading can be said to be inherently ethics-laden tasks because every managerial decision affects either people or the natural environment in some way—and those effects or impacts need to be taken into consideration as decisions are made. A narrower construction of the ethical role of the manager is that managers should serve only the interests of the shareholder; that is, their sole ethical task is to meet the fiduciary obligation to maximize shareholder wealth that is embedded in the law, predominantly that of the United States, although this point of view is increasingly accepted in other parts of the world. Even in this narrow view, however, although not always recognized explicitly, ethics are at the core of management practice. The ethical role of managers is broadened beyond fiduciary responsibility when consideration is given to the multiple stakeholders who constitute the organization being managed and to nature, on which human civilization depends for its survival. Business decisions affect both stakeholders and nature; therefore, a logical conclusion is that those decisions have ethical content inherently and that managerial decisions, behaviors, and actions are therefore inherently ethical in nature. Whenever there are impacts due to a decision, behavior, or action that a leader or manager makes, there are ethical aspects to that decision or situation. While some skeptics claim that business ethics is an oxymoron, the reality is that decisions and actions have consequences, and that reality implies some degree of ethics, high or low. -
Chapter 2 the Underlying Principles of Ethical Patient Care
Chapter 2 The Underlying Principles of Ethical Patient Care Medical ethics is based on a series of ethical principles that are particularly relevant to medical practice and patient care. The principles were first developed by Tom Beauchamp and James Childress in their 1979 book, Principles of Biomedical Ethics, now in its fifth edition. Since then they have become recognized and used by those who work in medical ethics, training medical students and residents, working as eth- ics consultants in health care institutions, and serving on hospital ethics committees. These principles are included in the “common morality,” so they will be accepted by most members of the society. They are derived from classical ethical theories and are presupposed by traditional codes of medical ethics. The principles of medical ethics make several contributions to patient care and decision making in the medical context. They offer a way to approach ethical dilemmas that arise in the course of practicing medicine, making difficult health care decisions, and interacting with patients and their families. The principles pro- vide a way to organize our thinking about ethical issues in patient care and a shared language for health care providers to discuss these issues. Finally, the principles call attention to aspects of a medical situation that might be overlooked, and remind us that medicine is, ultimately, an ethical enterprise. Beauchamp and Childress introduced four basic principles of medical ethics: Principles of 1) Beneficence, 2) Non-Maleficence, 3) Respect for Autonomy, and 4) Justice. In this book we have expanded the original list of four principles to include the Principle of Respect for Dignity and the Principle of Veracity to include elements of patient care and medical decision making that are not explicitly covered by the original four principles, such as emotions and relationships; privacy and bodily integrity; religious, social, and cultural differences; and the importance of good communication skills. -
Ethical Issues in Different Social Science Methods
In T.L. Beauchamp, R.R. Faden, RJ. Wallace, Jr., & L. Walters (Eds.), Ethical isaues in social Ethical Issues in Social Science Methods 41 scienc& research (pp. 40-98). Baltimore: Johns Hop)(ins University Press. 1982. tion against injury)-would be more appropriate to social research.' Another issue to which the present framework might contribute concerns the apprcpri ateness of government regulations for the control of social research. Should Ethical Issues in Different social research be subject to government regulation at all? Should at [east Social Science Methods certain types of research be specifically exempt from regulation? If govern ment regulations are indicated, should they take a form difTerent from those designed for biomedicllo\ research or should they be applied in differem ways? HERBERT C. KELMAN The framework may help us address such questions in a systematic way. In the discussion that follows, Jshall (I) present the framework and identify the ethical issues that it brings to the fore; (2) examine which of these issues arise for each of the different methods of social research that can be dis tinguished; and (3 }draw out some of the general impticalions suggested by lhis analysis. Before turning to this discussion, however, I shall summarize the Thc c~hical issues arising in social science research tend to vary as a func general approach to the problem of moral justification that underlies my tion of the particular research methods employed. Fer-example, certain genres enelysls.' of social-psychological experiments have created ethical concerns because they involve mlsrecresenrarion of the purpose of the research to the partici Approach to Moral Justification pants or because they subject participants to stressful experiences. -
Protecting Human Research Participants NIH Office of Extramural Research Introduction
Protecting Human Research Participants NIH Office of Extramural Research Introduction Research with human subjects can occasionally result in a dilemma for investigators. When the goals of the research are designed to make major contributions to a field, such as improving the understanding of a disease process or determining the efficacy of an intervention, investigators may perceive the outcomes of their studies to be more important than providing protections for individual participants in the research. Although it is understandable to focus on goals, our society values the rights and welfare of individuals. It is not considered ethical behavior to use individuals solely as means to an end. The importance of demonstrating respect for research participants is reflected in the principles used to define ethical research and the regulations, policies, and guidance that describe the implementation of those principles. Who? This course is intended for use by individuals involved in the design and/or conduct of National Institutes of Health (NIH) funded human subjects research. What? This course is designed to prepare investigators involved in the design and/or conduct of research involving human subjects to understand their obligations to protect the rights and welfare of subjects in research. The course material presents basic concepts, principles, and issues related to the protection of research participants. Why? As a part of NIH's commitment to the protection of human subjects and its response to Federal mandates for increased emphasis on protection for human subjects in research, the NIH Office of Extramural Research released a policy on Required Education in the Protection of Human Research Participants in June 2000. -
Autonomy in Research: Respect for Persons and Informed Consent
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike License. Your use of this material constitutes acceptance of that license and the conditions of use of materials on this site. Copyright 2006, The Johns Hopkins University and Holly Taylor. All rights reserved. Use of these materials permitted only in accordance with license rights granted. Materials provided “AS IS”; no representations or warranties provided. User assumes all responsibility for use, and all liability related thereto, and must independently review all materials for accuracy and efficacy. May contain materials owned by others. User is responsible for obtaining permissions for use from third parties as needed. Ethical Analysis Holly Taylor, MPH, PhD Johns Hopkins University Ethical Analysis Topics to be covered – Introduction to ethics – Framework for ethical analysis – Supplementing the framework 3 Section A Introduction to Ethics Normative Ethical Theory Person(s) Actions Consequences Continued 5 Normative Ethical Theory Virtue theory Consequentialist theory Non-consequentialist theory 6 Virtue Theory (Aristotle) Focus on person Cultivation of virtuous traits Image Source: www.epistemelinks.com Continued 7 Virtue Theory (Aristotle) “A just person—that is a person with the virtue of fairness—not only has the disposition to act fairly, but when so acting has a morally appropriate desire to do so. The person characteristically has a moral concern and reservation about acting in a way that would be unfair (p. 214).” Source: Beauchamp, -
Revised Ethical Guidelines in Indian Biobanking
Revised Ethical Guidelines In Indian Biobanking: Do We Need To Downregulate the Proposed Frameworks? Juhi Tayal1, Anurag Mehta2 and Alok Kumar1 1 Biorepository, Department of Research, Rajiv Gandhi Cancer Institute and Research Centre, India 2 Department of Laboratory Sciences and Molecular Diagnostics, RGCI&RC, India 1,2 Sec-5,Rohini, New Delhi, India-110085 Email: [email protected]/ [email protected] BACKGROUND Guideline for Indian Biobanks ABSTRACT • Clinical biobanks are gaining popularity in India and are also revolutionizing research. Indian • Biomedical research in India has revolutionized with the changing times. This Council for Medical Research(ICMR),Council for Scientific and Industrial Research (CSIR) and paradigm shift has not only bought greater complexities but also greater Department of Biotechnology (DBT) are the major agencies supporting research in India. The ICMR responsibilities for policy makers ,researchers and stakeholders. The is the national organization and also the apex body for developing ethical frameworks and guidelines advancement is not limited to basic research or clinical research ,it has now and also enforcing them. The ICMR issued the Policy Statement on Ethical Considerations Involved taken a foothold into Digital imaging and Artificial intelligence platforms as in Research on Human Subjects in 1980. Due to rapid advancement in biomedical sciences new well. ethical dimensions have emerged and nesseciated the updation of these guidelines time and again in • The aim of policy makers worldover was to safeguard four basic ethical 2000,2003, 2013 and very recently in 2017. The revision has introduced many new sections and principles for research involving human subjects: respect for persons, also revamped the existing sections .A new Section 11 was dedicated to Biological materials, beneficence, non-maleficence and justice. -
Trust As a Principle for Ethical Decision-Making in Research with Human Subjects by David B
Vol. 14, No. 6, June 2018 “Happy Trials to You” Trust as a Principle for Ethical Decision-Making in Research with Human Subjects By David B. Resnik Research with human subjects is a highly regulated activity in the U.S. and many other countries. A regulation known as the Common Rule governs research supported by 16 federal agencies (Department of Homeland Security et al. 2017). Regulations adopted by the Food and Drug Administration (FDA) apply to research that supports applications for FDA-regulated products, such as drugs, biologics and medical devices (Food and Drug Administration 2017a, 2017b). Federal agencies, such as the FDA and the Office of Human Research Protections, also provide guidance for applying the FDA regulations and Common Rule, respectively (Resnik 2018). Additionally, some states, such as California, have adopted their own regulations pertaining to research with human subjects (State of California 1978). Despite this high degree of government oversight, ethical dilemmas continue to arise in research with human subjects, in part because the regulations do not cover every situation and are subject to interpretation (Klitzman 2015, Resnik 2018). For example, while the regulations require additional protections for subjects who are vulnerable to coercion or exploitation, they only include special provisions for certain classes of vulnerable subjects, such as children, pregnant women, and prisoners, and are silent on the protections needed for mentally disabled adults, students and employees (Resnik 2018). Although the regulations require that risks to subjects be minimized and be reasonable in relation to benefits, they do not clearly define “risks” and “benefits,” which often leads to controversies concerning the approval of risky studies involving healthy volunteers or children (Wendler 2010, Wertheimer 2011, Resnik 2018). -
Frequently Asked Questions About the IRB
Frequently Asked Questions about the IRB Researchers often have questions about what the IRB is, what it does, and why their research must be reviewed by the IRB. This page contains a list of the most commonly-asked questions about this topic. What is human subjects research? Federal regulations define human subjects research as a systematic investigation designed to develop generalizable knowledge, and which involves the collection of data from or about living human beings. Why does research on human subjects need a special review process? There have been many research projects that were conducted despite being unethical, hazardous, or even cruel. These projects caused severe harm to -- or even killed -- the people who served as their subjects. Some of the more notorious unethical research projects include: The Tuskegee Syphilis Study (1932 to 1972) used indigent and poorly educated Black sharecroppers in Alabama to track the natural history of untreated syphilis infections. The participants did not have any meaningful understanding of their illness and did not understand that they were participating in research that was specifically designed to track the course of the disease, rather than cure it. The Willowbrook Hepatitis Study (1950s), in which retarded children institutionalized at the Willowbrook State School in New York were infected with hepatitis to track the transmission and spread of the disease. Atrocities committed upon the inmates of Nazi concentration camps during World War II by Dr. Josef Mengele and others under the guise of medical research. The testing of ionizing radionuclides on children and young adults without their knowledge or consent by the United States Atomic Energy Commission and Department of Energy during the Cold War. -
Chapter 2 Ethical Decision-Making Guidelines and Tools
CHAPTER 2 Ethical Decision-Making Guidelines and Tools Jacqueline J. Glover, PhD © kentoh/Shutterstock © kentoh/Shutterstock Learning Objectives Scenario 2-A Decision Making After completing this chapter, the reader should for an Adolescent be able to: ■■ Define ethics. MT is a 16-year-old young man with terminal ■■ Identify the importance of studying ethics brain cancer. At the age of 10 he was diag- for the health information management nosed with acute leukemia. After three years (HIM) professional. of intense treatment, MT was in remission. ■■ Identify ethical concepts, including rele- After two years of remission, during which vant values, principles, virtues, approaches, he was doing very well in school and loved and theories. playing soccer, MT began having severe headaches. Unfortunately, his magnetic reso- ■■ Apply a process of ethical decision making nance imaging (MRI) scan showed a large to HIM scenarios. mass requiring immediate workup. The tis- sue biopsy of the intracranial mass showed a uniformly fatal tumor, likely related to his previous leukemia treatment. No additional Introduction intervention was recommended by the team, Ethics is the formal process of intentionally and and they wanted to refer him to hospice. critically analyzing, with clarity and consistency, MT’s parents had heard stories in the basis for one’s moral judgments. It is impor- the media about unprecedented recov- tant for HIM professionals to engage in this ery of children with terminal diagnoses. process, because they are accountable for their A national search of experimental proto- actions as professionals, not just personally as cols for brain tumors revealed two centers individuals.