Reviewer about bioethics, Study notes of Bioethics

Download Reviewer about bioethics and more Study notes Bioethics in PDF only on Docsity! NCMA 218 Principles of Ethics and Research 1. Nuremberg code of 1947  Ethics principles for human experimentation resulting from Nazi doctors’ trial  Focus on human rights and welfare 10 principles of Nuremberg Code 1. Voluntary free informed consent 2. Good unprocurable by other means 3. Medically justified: prior animal trials, 4. Proper design 5. No unnecessary suffering or injury 6. No death or disability except if researcher is subjected to risks never exceed humanitarian purpose 7. Protection/safeguards in place 8. Qualified researcher 9. Participants can stop anytime 10. Researcher ready to stop anytime Declaration of Helsinki  Statement of ethical principles for medical research involving human participants, including identifiable human material and data; doctors doing medical research on patients  For all involved in medical research  Basis for Good Clinical Practice (GCP) GENERAL PRINCIPLES • Purpose: understand disease, improve interventions • Human participants necessary • Primacy of patient’s best interest: health, well-being, rights • Duty and responsibility of researcher even if with consent of participants • Subject to ethical standards: International and national guidelines cannot reduce Helsinki • Respect and protect participants • Minimize harm to environment • Qualified researcher • Fair access to research CLINICAL REVIEW AND EDUCATION • Access for under-represented • Physician justify using patients by potential value and ensure that research will not adversely affect health • Appropriate compensation and treatment for harm RISKS, BURDENS, AND BENEFITS • Pre-assess then monitor • Importance of objectives outweigh R/B for participants o Benefits outweigh risks for participants and groups affected and managed • Measures to minimize implemented • Once risks outweigh the benefits or if there is already a clear outcome: assess if research should be continued VULNERABLE GROUPS AND INDIVIDUALS • Increased likelihood of wrong and harm – Special protection • Responsive to their health needs • Cannot be done on non-vulnerable • Stand to benefit from result SCIENTIFIC REQUIREMENTS AND RESEARCH PROTOCOLS • Conform to accepted scientific principles • Respect animals • Complete protocol including addressed ethical considerations • Post-trial provisions indicated RESEARCH ETHICS COMMITTEES • Transparent, independent, and qualified • Follow norms • Approve protocol • Monitor study, approve amendments, and receive final report PRIVACY AND CONFIDENTIALITY • Protect INFORMED CONSENT 1. For capable: voluntary, informed • method of obtaining: caution of dependent relationships • if not written: documented and witnessed • option of being informed of general outcome and study results 2. For not capable: legally authorized representative; • consider vulnerable group • assent if capable, dissent respected •condition vulnerable characteristic for research; if circumstances prevent Free and Informed Consent, REC approval, proxy; ASAP Belmont Report 1976 The Belmont Report is a report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The report was issued on 30 September 1978[1] and published in the Federal Register on 18 April 1979. [2] The report took its name from the Belmont Conference Center where the document was drafted in part. The Belmont Conference Center, once a part of the Smithsonian Institution, is in Elkridge, Maryland, 10 miles south of Baltimore, and until the end of 2010 was operated by Howard Community College. [3] The Belmont Report [2] summarizes ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence, and justice. Three primary areas of application are also stated. They are informed consent, assessment of risks and benefits, and selection of subjects. According to Vollmer and Howard, the Belmont Report allows for a positive solution, which at times may be difficult to find, to future subjects who are not capable to make independent decisions. The three fundamental ethical principles for using any human subjects for research are: 1. Respect for persons: protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent. Researchers must be truthful and conduct no deception; 2. Beneficence: the philosophy of "Do no harm" while maximizing benefits for the research project and minimizing risks to the research subjects; and 3. Justice: ensuring reasonable, non- exploitative, and well-considered procedures are administered fairly — the fair distribution of costs and benefits to potential research participants — and equally. Ethical Issues Related to Evidenced Based Practice Evidence- Based medicine or evidence based practice, is the judicious use of the best current evidence in making decisions about the care of the individual patient. Evidence-base practice is a systematic inter connecting scientifically generated evidence with the tacit knowledge of the expert practitioner to achieve a change in a particular practice for the benefit of a well-defined client/patient group. Evidence-based nursing it is a process by which nurses make clinical decisions using the best available research evidence, their clinical expertise and patient preference Ethical issues Moral principles such as truth, fairness, and respecting autonomy lie at the heart of these ethical concerns. Evidence based practice focuses on searching and appraising available evidence on the advantages and disadvantages of various interventions. Ethical issues include:  Status of evidence- available evidence in health care areas consists mostly of expert opinions where despite important advance in research, only few have amassed sufficient data to enable research-based confidence in treatment interventions.  Client Autonomy- patient and family participation in planning and intervention (autonomy) is an important dimension of rehabilitation. This participation should also include decision making under difficult circumstances by the client when competing interests are decided.  Conflict of interest- May be represented when clinical trials are subjected to questions about the validity of their contributions. ETHICO-MORAL OBLIGATIONS OF THE NURSE IN EVIDENCE-BASED PRACTICES 1. Golden Rule 2. The principle of Totality – The whole is greater than its parts names of the people involved. All health-care professionals are responsible for documenting the care they provided or the actions taken. The system used should record all interactions with members of the health-care team, including clarification of orders, failed attempts to reach other team members, and the follow up action taken. 13. Client Education Educational interventions and related health teachings that provide comprehensive information to clients must be documented. It promotes clear communications on a daily basis, of the scope and 14. Documenting an Incident in the Health-care Record It is imperative that all incidents that occured with its corresponding pertinent data are documented in the client’s health record. Prescribed protocol on documenting these types of incidents are to be followed in order to provide clear resolutions. CONFIDENTIALITY Health care personnel are obligated to maintain confidentiality in dealing with all information pertaining to patient’s hospitalization an care provided to each one of them. Discretion in the access, retrieval, transmittal and storage of relevant documents and safe-keeping of all copies of valuable health records must be maintained at all times at all costs. Availability of various forms of technology must not change nor disregard this fundamental patient’s right to privacy of health information. ETHICAL AND LEGAL ASPECTS OF DOCUMENTATION Legal Implications of Documentation 1. The patient’s health-care record is an important legal document. 2. It must contain the following: • accountability and the provision of care/treatment • database used to resolve questions/concerns about care • chronological record of events involving patient care and hospital stay • nursing care rendered 3. It is intended to: • refresh the nurse of situations that are required to give evidence in court • reconstruct events • establish times and dates • resolve conflict in testimony, and • show that standard of care and reasonable and prudent care was provided. 4. Correcting errors in charting/documentation: Moral Decision-Making Principle of Moral Discernment Olson (2002) refers to the ability to discern what is morally right from morally wrong that requires moral reflectiveness on the meaning of good and bad. It refers to ability to draw conclusions from the discernment to develop convictions. Four Principles of Moral Discernment/Judgment  Principle of formal cooperation  Principle of Material cooperation  Principle of lesser evil  Principle of double effect Principle of well-formed conscience  Informed consent to medical treatment is fundamental in both ethics and law.  Patients have the right to receive information and ask questions about recommended treatments so that they can make well- considered decisions about care.  Successful communication in the patient- physician relationship fosters trust and supports shared decision making Strategies of Moral Decision-Making Process Ethical Dilemma  is a problem in the decision-making process between two possible options, neither of which is absolutely acceptable from an ethical perspective;  Approaches to solve an ethical dilemma were deduced:  Refute the paradox (dilemma): The situation must be carefully analyzed. In some cases, the existence of the dilemma can be logically refuted.  Value theory approach: Choose the alternative that offers the greater good or the lesser evil.  Find alternative solutions: In some cases, the problem can be reconsidered, and new alternative solutions may arise. PROCESS OF ETHICAL DECISION MAKING  Gather data and identify conflicting moral claims  Identify key participants  Determine moral perspective and phase of moral development of key participants  Determine desired outcomes  Identify options  Act on the choice  Evaluate outcomes of actions Gather data and identify conflicting moral claims  What makes this situation an ethical problem? Are there conflicting obligations, duties, principles, rights, loyalties, values or beliefs?  What are the issues?  What facts seem most important?  What emotions have an impact?  What are the gaps in information at this time? Identify key participants  Who is legitimately empowered to make this decision?  Who is affected and how?  What is the level of competence of the person most affected in relation to the decision to be made?  What are the rights, duties, authority, context, and capabilities of participants? Determine moral perspective and phase of moral development of key participants  Do participants think in terms of duties and rights?  Do the parties involved exhibit similar or different moral perspectives?  Where is the common ground? The difference?  What principles are important to each person involved?  What emotions are evident within the interaction and with each person involved?  What is the level of moral development of the participants? Determine desired outcomes  How does each party describe the circumstances of the outcome?  What are the consequences of the desired outcomes?  What outcomes are unacceptable to one or all involved? Identify options  What options emerge through the assessment process?  How do the alternatives fit the lifestyle and values of the person(s) affected?  What are legal considerations of the various options?  What alternatives are unacceptable to one or all involved?  How are alternatives weighted, ranked, and prioritized? Act on the choice  Be empowered to make a difficult decision  Give yourself permission to set aside less acceptable alternatives  Be attentive to the emotions involved in this process. Evaluate outcomes of action  Has the ethical dilemma been resolved?  Have other dilemmas emerged related to the action?  How was the process affected those involved?  Are further actions required? MEANING AND SERVICE VALUE OF MEDICAL CARE Allocation of Health Resources Cost-effective limited resources for health should be allocated to maximize the health benefits for the population served. A cost-effectiveness analysis (CEA) of alternative health interventions measures their respective costs and benefits to determine their relative efficiency in the production of health. Costs are measured in monetary terms; benefits are measured in health improvements. By dividing costs by benefits, one can obtain a cost-to-effectiveness ratio for each health intervention, and interventions can be ranked by these ratios. Although a CEA is typically an economic analysis performed by health economists, it is also a measure of one ethical criterion for the evaluation of health programs. Cost- effectiveness is not merely an economic concern, because improving people's health and well-being is a moral concern, and an allocation of resources that is not cost-effective produces fewer benefits than would have been possible with a different allocation. Producing more rather than fewer benefits for people is one important ethical consideration in evaluating actions and social policies. Equity Is concerned with the distribution of benefits and costs to distinct individuals or groups. The maximization of benefits, which is associated with the general philosophical moral theory of utilitarianism or consequentialism, however, is routinely criticized for ignoring those considerations (Rawls 1971). Equity in health care distribution is complex and embodies several distinct moral concerns or issues that this chapter delineates. There is no generally accepted methodology comparable to CEA for determining how equitable a distribution is; nevertheless, allocations are unsatisfactory if equity considerations are ignored. Issues involving access to care  Access to Quality Care - Patients want to be able to access their healthcare when they want and need it.  Geographic and Manpower Shortage  Limited education  Poor infrastructures  Cost  Scientific evidence vs Cultural Practice BENEFITS AND CHALLENGES OF TECHNOLOGY  Reducing healthcare costs.  Predicting epidemics.  Avoiding preventable deaths.  Improving quality of life/quality care  Reducing healthcare waste.  Improving mobility/access  Developing new drugs and treatments.  Security e.g. data hacking/phishing  Volume of data in iCloud  Dangers with AI central data point  Impersonal patient-healthcare provider relationships  Connectivity  Cost  Fast and numerous changes Current technology: Issues and dilemma  Portability  Cost  Real-  Security  time events  Equity  Justice Lobbying/Advocating fort Ethical Issues Related to Health Care  Since the ethical foundation of lobbying is the vigorous public debate necessary for informed decision making, ethical dilemmas related to lobbying tend to arise when various behaviors by lobbyists and lawmakers undermine the fairness and transparency of that process and do not contribute to the common good  Ethical lobbyists embrace the rule of law and its underlying principles. Avoid conflicts of interest: If a potential conflict arises, ethical lobbyists disclose it immediately to both parties and recuse themselves until the matter is resolved. Code of Ethics for Nursing; Multiple Ethical Obligations; Nurse-Doctors Relations A. The History of Code of Ethics for Filipino Nurse’s 1922- The Code was formed 1982- PNA approved the COE October 1983- COE was published October 21, 1982- The final presentation of the documents. March 21, 1984- the PRC Board of Nursing adopted the ICN. BON Resolution no. 633 October 18, 1989- The amended Code of Ethics was approved by the BON in its resolution no. 1955 October 23, 2003- New COE was presented at the Assembly of Nursing Rep. during the 81st Foundation. Anniversary, 46th Nurses Week Celebration, and the Annual National Convention of Nurses in Iloilo City July 14, 2004- The new COE for Filipino Nurses was finally promulgated. PRC-BON Resolution no.220. B. CODE OF ETHICS FOR REGISTERED NURSES (BOARD OF NURSING) Board Resolution No. 220, Series of 2004 approved last 14th day of July, 2004 CODE OF ETHICS FOR NURSES WHEREAS, the Board of Nursing (BON) has the power to promulgate a Code of Ethics for Registered Nurses in coordination and consultation with the accredited professional organization (Sec. 9, (g), Art III of (Republic Act) No. 9173, known as the “Philippine Nursing Act of 2002); WHEREAS, in the formulation of the Code of Ethics for Registered Nurses, the Code of Good Governance for the Professions in the Philippines was utilized as the principal basis thereof: All the principles under the said Code were adopted and integrated into the Code of Ethics as they apply to the nursing profession; do anything that will bring discredit to a colleague and to any member of other professions. g. respect the rights of their co-workers. ARTICLE V REGISTERED NURSES, SOCIETY, AND ENVIRONMENT SECTION 14. Ethical Principles 1. The preservation of life, respect for human rights, and promotion of healthy environment shall be a commitment of a Registered Nurse. 2. The establishment of linkages with the public in promoting local, national, and international efforts to meet health and social needs of the people as a contributing member of society is a noble concern of a Registered Nurse. SECTION 15. Guidelines to be observed: REGISTERED Nurses must a. be conscious of their obligations as citizens and, as such, be involved in community concerns. b. be equipped with knowledge of health resources within the community, and take active roles in primary health care. c. actively participate in programs, projects, and activities that respond to the problems of society. D .lead their lives in conformity with the principles of right conduct and proper decorum. e. project an image that will uplift the nursing profession at all times. ARTICLE VI REGISTERED NURSES AND THE PROFESSION SECTION 16. Ethical Principles: 1. Maintenance of loyalty to the nursing profession and preservation of its integrity are ideal. 2. Compliance with the by-laws of the accredited professional organization (PNA), and other professional organizations of which the Registered Nurse is a member is a lofty duty. 3. Commitment to continual learning and active participation in the development and growth of the profession are commendable obligations. 4. Contribution to the improvement of the socio-economic conditions and general welfare of nurses through appropriate legislation is a practice and a visionary mission. SECTION 17. Guidelines to be observed: Registered Nurses must a. be members of the Accredited Professional Organization (PNA). b. strictly adhere to the nursing standards. c. participate actively in the growth and development of the nursing profession. d. strive to secure equitable socio-economic and work conditions in nursing through appropriate legislation and other means. e. assert for the implementation of labor and work standards. ARTICLE VII ADMINISTRATIVE PENALITIES, REPEALING CLAUSE, AND EFFECTIVITY SECTION 18. The Certificate of Registration of Registered Nurse shall either be revoked or suspended for violation of any provisions of this Code pursuant to Sec. 23 (f), Art. IV of R. A. No. 9173 and Sec. 23 (f), Rule III of Board Res. No. 425, Series of 2003, the IRR. C.THE INTERNATIONAL COUNCIL OF NURSES (ICN) CODE OF ETHICS FOR NURSES An international code of ethics for nurses was first adopted by the International Council of Nurses (ICN) in 1953. It has been revised and reaffirmed at various times since, most recently with this review and revision completed in 2012. Nurses have four fundamental responsibilities: 1. To promote health 2. To prevent illness 3. To restore health 4. To alleviate suffering What exists in nursing? Is a respect for human rights These includes: Cultural rights The right to having a life and choice To have dignity To be treated with respect Nursing care is respectful of and unrestricted by considerations of: Gender and Age Color and Race Creed – set of beliefs Culture Disability or illness Social status Sexual orientation Nationality Politics The ICN Code of Ethics for Nurses has four principal elements that outline the standards of ethical conduct. 1. Nurses and people -Nurse’s primary professional responsibility is to people requiring nursing care. 2. Nurses and practice - Nurses carries personal responsibility and accountability for nursing practice - Maintaining competence by continual learning. 3. Nurses and the profession The nurse assumes the major role in: determining and implementing acceptable standards of clinical nursing practice, management, research and education. The nurse is active in: 1. Developing a core of research-based professional knowledge. 2. Developing and sustaining a core of professional values. 4. Nurses and co-workers The nurse sustains a collaborative and respectful relationship with c0-workers in nursing and other fields. The nurse takes appropriate action to safeguard individuals, families, and communities when their health is endangered by a co-worker or any other person. - The nurse takes appropriate action to support and guide co-workers to advance ethical conduct. SUGGESTIONS FOR USE of the ICN Code of Ethics for Nurses The ICN Code of ethics for Nurses is a guide for action based on social values and needs. It will have meaning only as a living document if applied to the realities of nursing and health care in a changing society. To achieve its purpose the Code must be understood, internalized and used by nurses in all aspects of their work. It must be available to students and nurses throughout their study and work lives. D. Professional Boundaries and Ethico-Moral Obligations for Nurses as Specified by the ANA Code of Ethics for Nurses with Interpretive Statements (2001) Clinical Practice Boundaries Respecting patients’ dignity Right to self-determination Delegating tasks appropriately Practicing good judgment Accepting accountability in practice Alleviating suffering Being attentive to patients’ interests Working within the nurse practice acts and nursing standards of practice Professional Practice Boundaries Maintaining authenticity in all relationships with others such as nurse-to-nurse relationships, nurse-physician relationships, nurse-to-patient relationships, and multidisciplinary collaboration. Addressing and evaluating issues of impaired practice; fraternizing inappropriately with patients or others; Accepting inappropriate gifts from patients and families; Confidentiality and privacy violations; and unhealthy, unsafe, illegal, or unethical environments. Self-Care and Self-Development Boundaries and Obligations Participating in self-care activities to maintain and promote moral self-respect, Professional growth and competence, wholeness of character in nurses’ actions and in relationships with others, and preservation of integrity. Advancing knowledge and research through professionalism, practice, education, and administrative contributions. E. NURSE- PHYSICIAN RELATIONSHIP WHAT IS A HEALTH CARE PROFESSIONAL RELATIONSHIP? As a social being, the human person trends to relate with others. In establishing relationship, he uses language which may take variety of forms such as spoken or written words, gestures, signs, and other. Communication or interaction is essential to any human relationship. The relationship among people in health care milieu is professional. Meaning, it is established in connection with the performance of work as an occupation that is meant to cater the health care needs of the client. The interaction between health care practitioners themselves and their clients ought to enhance their professional relationship. Since the HCP-client relationship is therapeutic, the interaction must also be therapeutic. This interaction is processive in nature and character. It may develop even at a more meaningful level transcending what is merely mechanical into commitment and accountability with love, trust, concern, and care for each other. Ten Steps to Improving Physician-Nurse Relationships Tips for Nurses: 1. Always have the chart in hand when calling a physician. 2. Adopt the SBAR tool as a standard of communication especially telephone conversations. 3. Don’t begin telephone conversations with “I’m sorry to bother you....” 4.Be prepared for rounds. Anticipate late night problems ahead of time. 5.Use the progress notes to briefly communicate your key concerns/interventions. 6.Confront physicians whose behaviors are degrading by speaking to them in private. State the behavior and its effect. Ask manager for support if needed. 7.Take the time to thank and acknowledge those physicians with whom you have a good working relationship. 8.Don’t complain about a doctor to other staff. If you have a problem, speak to the physician in private. 9.Raise your awareness. Identify those physician behaviors which belittle or diminish you (one- word answers, no eye contact, interrupting, raised voice, etc.) 10.Further your education by pursuing a BSN or MSN degree Tips for Physicians: 1.It makes a world of difference to address a nurse by her/his name. If unsure, don’t hesitate to ask –the mere question denotes recognition. 2.Be a leader, not a commander –recognize that your role enables you to create an atmosphere where nurses feel comfortable sharing patient concerns and asking questions without feeling inferior. 3.Be considerate of the nurse- patient interaction when walking into a patient’s room. 4.Discuss the plan of care for complicated patients directly with the nurse–it takes less than 2 minutes to engage the RN and provides an opportunity for education. 5. Participate in joint educational and celebratory events. The ROI (Return on Investment) far exceeds the time/cost –the benefits are tremendous. 6.If you have a problem with a patient’s care, speak to the nurse involved first; then the charge nurse. 7.Invite nurses to round with you. Create a welcoming atmosphere. 8.Recognize the difference in education. Volunteer to give at least two minutes in services a year to staff on your area of expertise or concern. 9.Recognize the nurse’s role at the sharp end: a critical member of the team. 10.Compliment nurses who are doing a great job in public and in private. Code of Ethics for the Filipino Nurses Nurses and the People 1. Values, customs, and spiritual beliefs held by individuals shall be respected.