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LESSONS:
Introduction to Research Nuremberg Code Declaration of Helsinki Belmont Report Ethical Concerns in Research Evidence-Based Practice Ethico-Moral Obligations of the Nurse in Evidence-Based Practices INTRODUCTION TO RESEARCH (LESSON 1) What is research? ‒ Scientific methods are used to carefully study a certain issue or research problem. ‒ Involves Inductive(qualitative) and Deductive(quantitative) method. ‒ Earl Robert Babbie, an American sociologist, ‒ said, "Research is a systematic inquiry to describe, explain, predict, and control the observed phenomenon." ‒ It uses both intuitive and deductive reasoning. Phases in Research Where to get Human Samples from People for Research?
- Scientists work with a clinician who works in their specific area to get biological samples from people for research. (SampleSmart, 2021) If the researcher needs samples from people who have ovarian cancer, they will probably work with a gynecologic doctor, who treats people with this kind of cancer all the time. Many times, hospitals will require their clinicians to take part in or work with research projects as part of their job. This means that the doctors and nurses need to take part in research projects and clinical trials. By making these studies possible, authors are advancing science research, which will probably help patients in the future. Due to the low cost of getting the samples, this way of getting biospecimens is very popular in academic research.
- The researcher gets biospecimens from a business whose main job is to provide researchers with human biological samples. (SampleSmart, 2021) The idea of biobanks came about to make it easier for experts to get biospecimens. Biobanks can either get new biospecimens or collect and store samples that are okay to use for study, depending on the biobank. According to their main goal, these biobanks are meant to help science move forward and help create new tests and treatments for specific diseases.
- The researcher gets samples from people at a biobank that is connected to a university, hospital, or charity. (SampleSmart, 2021) These companies connect people with hospitals and doctors, and they also handle all the issues of ethics and safety. In order to make money, the companies offer the service of finding biospecimens. That's why the costs of getting samples this way are usually higher. This is the main way that life science companies get data. Are you Conducting Human Subjects Research? ‒ This is a complicated research with lots of rules ‒ Ethical guidelines for human genetic research in the Philippines (Jae Joseph Russell B. Rodriguez, 2022) Human research in the Philippines requires compliance with national ethical rules and guidelines
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‒ The Republic Act No. 10532, or the Philippine National Health Research System Act of 2013, Mandates that all health and health- related research should adhere to the guidelines of the Philippine Health Research Ethics Board (PHREB) (Philippine National Health Research System, 2013). ‒ Philippine Health Research Ethics Board (PHREB) Adopts the WHO definition of health “A state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity” Thus, studies involving human subjects conducted in the country, including human population genetic research, are within its purview, even if not necessarily medical in scope. “must undergo ethical review and clearance before implementation to ensure the safety, dignity, and well-being of research participants” Informed Consent in Research ‒ Researchers must obtain the voluntary, informed consent of individuals participating in their studies. ‒ A key principle of ethical human subjects study is getting informed consent. Researchers must make sure that people who want to take part in the study get information about it that is detailed enough to allow them to make an informed decision and presented in a way that makes it easy for them to choose not to participate. This includes providing detailed information about the: Purpose, Procedures, Risks, and benefits of the research, Ensuring that participants have the capacity to understand and make an informed decision. Why is Informed Consent important in a study? (National Human Genome, 2022) ‒ In the United States, the requirements for obtaining informed consent from research participants are stipulated by several regulations and policies. ‒ Informed Consent= “Common Rule.” 1930 – The origin of modern regulations for informed consent in the U.S., when Nazi physicians conducted horrific experiments on human subjects without their consent before and during WWII. A set of 10 ethical principles for physicians and researchers to follow when conducting experimentation on humans, one of which was informed consent. ‒ With limited exceptions, the Common Rule Mandates that researchers obtain informed consent for federally funded research that involves "a living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens." ‒ Not all research that involves human samples or data requires informed consent. ‒ According to the current definition of "human subject" in the Common Rule, Informed consent is not required for use of samples and data that do not identify the person/donor (such as those stored in biobanks and data repositories for future research use) or Informed consent is not required for use of samples and data from people who are deceased. Human Subjects Research ‒ Grants and Funding in the Philippines ‒ Stages of basic academic research among Philippine Indigenous cultural communities/ Indigenous peoples (ICC/IPs) (Jae Joseph Russell B. Rodriguez, 2022)
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‒ Several other documents further expanded upon the principles outlined in the Nuremberg Code, including the Declaration of Helsinki, the Belmont Report and the Common Rule. ‒ The goal has always been - and always will be to conduct ethical clinical trials and protect human subjects. CONCLUSION In any experiment/ research involving human experiments, the researcher must make sure that the individuals understand and consent to participate voluntarily. The outcome of the research should benefit the participants and researchers must be scientifically qualified. Participants are free to withdraw any time during the course of research, and researchers have the obligation to stop the study as soon as they observe that continuation could be fatal.
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DECLARATION OF HELSINKI
(LESSON 3)
The Helsinki Declaration of 1964 issued guidelines on medical research. ‒ The Declaration of Helsinki was created in 1964 by the World Medical Association (WMA). The WMA was established seventeen years before in 1947, and was created to handle the growing concern of unethical medical practice which became more apparent during and after World War II. ‒ Therefore, the Declaration of Helsinki is an ethical guideline, rather than a document with international legal implications. The Declaration set the standard for ethical human experimentation conducted by researchers. ‒ The Declaration of Helsinki has been revised six times, in 1975, 1983, 1989, 1996, 2000, and 2008. The fifth revision, in 2000, caused considerable controversy regarding issues such as whether the document should be revised at all, the restating of Article 29 which dealt with placebo use, and what the medical community should be required to do to treat patients after they have undergone a medical trial. ‒ After this revision, the U.S. FDA refused to refer to the new version and instead continued using the document from 1989. In 2006, the U.S. FDA discontinued referring to the Declaration at all. Also, the European Commission only uses an older version from 1996. This lack of cohesion has weakened the Declaration of Helsinki’s influence over the years. However, it is still viewed as a pioneering effort to ensure that patients involved in clinical trials are treated with the fairness around the world. GUIDING PRINCIPLES Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration. Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured. BASIC HUMAN RIGHTS OF RESEARCH SUBJECTS
- Right to Informed Consent The Right to refuse and/or withdraw from participation
- Right to Privacy
- Right to Confidentiality or anonymity of data
- Right to be Protected from harm RISK, BURDENS, BENEFITS ‒ Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects. ‒ Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed VULNERABLE SUBJECTS ‒ Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. ‒ Subjects who are mentally ill or legally incompetent such as the unconscious, or are in unique situations, like fetuses, require special attention. Those who are mentally ill, mentally retarded, unconscious and minors are incapable of evaluating the risks involved and cannot be given consent in their own behalf. Consent of parents or guardians are required. ‒ Investigative studies regarding fetuses shall have the consent in the presence of a third person because of the possible danger or injury to it. ‒ The Philippine Constitution guarantees the protection of the life of the mother and the life of the unborn. ‒ Students are vulnerable as their participation or non-participation may affect their grades. Employees may participate because of the influence it may bring to their promotion, salary increases or bonuses. It must be explained to them that this is not so.
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BELMONT REPORT
(LESSON 4)
National Research Act (Pub. L. 93-348) Enacted on July 12, 1974, establishing the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Commission was tasked with identifying ethical principles and developing guidelines for biomedical and behavioral research involving human subjects. 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. BELMONT REPORT ‒ Written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research ‒ Developed from discussions at the Belmont Conference Center in February 1976 and four years of monthly Commission deliberations. ‒ Identifies basic ethical principles and guidelines that address ethical issues arising from the conduct of research with human subjects PRIORITY: Welfare of Clients/Subjects ETHICAL PRINCIPLES AND GUIDELINES FOR RESEARCH INCLUDING HUMAN SUBJECTS Three principles, or general prescriptive judgments, that are relevant to research involving human subjects are identified in this statement. These three are comprehensive, however, and are stated at a level of generalization that should assist scientists, subjects, reviewers and interested citizens to understand the ethical issues inherent in research involving human subjects. These principles cannot always be applied so as to resolve beyond dispute particular ethical problems. The objective is to provide an analytical framework that will guide the resolution of ethical problems arising from research involving human subjects. BOUNDARIES BETWEEN PRACTICE AND RESEARCH a. PRACTICE ‒ Refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. ‒ The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals. b. RESEARCH ‒ Designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). ‒ It is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective. BASIC ETHICAL PRINCIPLES Respect for Persons (Informed Consent) Right to Full Disclosure Right to Self- Determination Beneficence Do no harm Risk-Benefit Assessment Justice Privacy/Confidentiality Fair Treatment RESPECT FOR PERSONS 2 ethical convictions:
- Individuals should be treated as autonomous agents
- Persons with diminished autonomy are entitled to protection 2 separate moral requirements:
- Requirement to acknowledge autonomy
- Requirement to protect those with diminished autonomy. The subjects have the RIGHT FOR FULL DISCLOSURE and RIGHT FOR SELF- DETERMINATION
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BENEFICENCE
‒ Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. ‒ The term "beneficence" is often understood to cover acts of kindness or charity that go beyond strict obligation. ‒ In this document, beneficence is understood in a stronger sense, as an obligation. 2 general rules:
- Do not harm
- Maximize possible benefits and minimize possible harms (risk-benefit assessments) JUSTICE ‒ There are several widely accepted formulations of just ways to distribute burdens and benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed. These formulations are:
- To each person an equal share
- To each person according to individual need
- To each person according to individual effort 4.To each person according to societal contribution 5. to each person according to merit APPLICATION INFORMED CONSENT ASSESSMENT OF RISKS AND BENEFITS **SELECTION OF SUBJECTS
- INFORMED CONSENT** ‒ Application of RESPECT FOR PERSONS ‒ Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied. 3 elements: Information, Comprehension and Voluntariness A. INFORMATION ‒ Items for disclosure intended to assure that subjects are given sufficient information: the research procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research. Additional items have been proposed, including how subjects are selected, the person responsible for the research, etc. ‒ In all cases of research involving incomplete disclosure (some features will not be revealed until the research is concluded), such research is justified only if it is clear that: 1. Incomplete disclosure is truly necessary to accomplish the goals of the research 2. There are no undisclosed risks to subjects that are more than minimal 3. There is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them. ‒ Information about risks should never be withheld for the purpose of eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the research. B. COMPREHENSION ‒ The manner and context in which information is conveyed is as important as the information itself. For example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or curtailing opportunities for questioning, all may adversely affect a subject's ability to make an informed choice. C. VOLUNTARINESS ‒ An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of: 1. COERCION - occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. 2. UNDUE INFLUENCE - occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. ‒ Inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable. ASSESSMENT OF RISKS AND BENEFITS ‒ Application of BENEFICENCE ‒ Requires a careful arrayal of relevant data, including, in some cases, alternative ways of obtaining the benefits sought in the research. 1. THE NATURE OF SCOPE OF RISKS AND BENEFITS RISK ‒ Refers to a possibility that harm may occur
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ETHICAL CONCERNS IN RESEARCH
(LESSON 5)
Ethics in nursing research can be defined as the act of moral principles that the researcher has to follow while conducting nursing research to ensure the rights and welfare of the individuals. ETHICAL PRINCIPLES IN RESEARCH
1. BENEFICENCE ‒ Promoting good or doing good ‒ One of the most fundamental ethical principle 2. RIGHT TO FREEDOM FROM HARM ANF DISCOMFORT ‒ Researchers have the obligation to avoid or minimize harm in studies with humans Physical harm Social harm Emotional harm Financial harm 3. RESPECT FOR HUMAN DIGNITY ‒ Includes “right to self- determination” and “right to full disclosure” Autonomy A patient/participant has the right to make decision about his/her care 3.1 RIGHT TO FULL DISCLOSURE ‒ The researcher has fully described the nature of the study. ‒ Self-determination and Right to full disclosure are the 2 major elements of INFORMED CONSENT 4. JUSTICE ‒ The right to fair treatment and their right to privacy ‒ The risks and benefits should be equally divided Participants should not be chosen based on gender, religion, wealth, or any other differentiator. ‒ Human subjects are essential to the conduct of research intended to improve human health. As such, the relationship between investigators and human subjects is critical and should be based on honesty, trust, and respect. **BASIC HUMAN RIGHTS OF RESEARCH SUBJECTS
- RIGHT TO INFORMED CONSENT** ‒ Recognition of self-determination and thorough comprehension of the proposed participation are the two components of self- determination. ‒ The subjects must understand the risks involved, the benefits anticipated, time and energy requirements and any anticipated loss. 2. RIGHT TO REFUSE OR WITHDRAW FROM PARTICIPATION ‒ There shall be neither recrimination for refusal nor for withdrawing from participation ‒ Refusal to participate can be minimized, if at the onset the subject has been given careful and honest opinion on what is to be done. 3. RIGHT TO PRIVACY ‒ The subject has the right to decide the time, the extent and circumstances he/she will willingly share his/her presence, thoughts, and behaviors with others. 4. RIGHT TO CONFIDENTIALITY OR ANONYMITY OF DATA ‒ Data shall not be used other than the specific purpose for which the subject gave consent and shall not be made public or available to others. 5. RIGHT TO BE PROTECTED FROM HARM ‒ There shall be appropriate balance between potential benefits of the research and the risks assumed by the subjects. ‒ Referral to counselling shall be included in the study protocol if necessary. IMPORTANCE OF ETHICS IN NURSING RESEARCH Protect the vulnerable groups and other study participants from harmful events. Safeguard the participants from exploitation from researchers. Establish the risk-benefit ratio for the study subjects. Ensure the fullest respect, dignity, privacy, disclose of information, and fair treatment for study subjects. Build the capability of subjects to accept or reject participation in the study.
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EVIDENCE-BASED PRACTICE
(LESSON 6)
‒ Combination of scientific evidence, patient preferences, and clinician expertise when making decisions for patient care. ‒ It leads to the “development of best practices to meet the need of clients efficiently and effectively” (Carter, Mastro, Vose, Rivera, & Larson, 2017) 3 MAIN COMPONENTS OF EVIDENCE- BASED PRACTICE
- Utilize the best external evidence
- Draw on individual clinical expertise
- Consider patient values and expectations EVIDENCE-BASED PRACTICE Levels of evidence in healthcare research can be grouped into four categories according to how credible the information is: Randomized controlled trials Evidence from cohort, case-control, or observational studies Expert opinions that are supported by experience, studies, or reports Personal experience “Five A’s of evidence based practice” in health science, these steps include Ask: Formulate answerable clinical questions about a patient, problem, intervention, or outcome. Acquire: Search for relevant evidence to answer questions. Appraise: Determine whether or not the evidence is high- quality and valuable. Apply: Make clinical decisions utilizing the best available evidence. Assess: Evaluate the outcome of applying the evidence to the patient’s situation. ADVANTAGES OF EVIDENCE-BASED PRACTICE IN NURSING Improves patient outcomes through superior care Maximizes providers’ time and reduces cost Adds new contributions to the science of nursing ETHICAL CONCERNS ON EBP (ALLMARK, 2015) Some types of knowledge are not included in EBP EBP downgrades or discounts types of knowledge that are used by practitioners and which are important for good practice; these include Experience, intuition and anecdote (Barker 2000; Bax 2008; Milton 2007; Tonelli 1998) Patient would be better served by an experienced practitioner rather than one well-versed in recent research evidence EBP runs counter to patient-centered care By insisting that all practice is based on up- to-date research evidence where it is available, patient-centered care, which requires case-specific knowledge and intuition, is undermined Patients lose choice They are constrained to have what the evidence tells them to, a phenomenon that has been described as evidence- based paternalism (Rysavy 2013; Slowther et al. 2004; Liberati 2004). Practitioners lose choice They can no longer make choices that fit individual patients but which run counter to the guidelines of EBP (Loewy 2007; Kerridge et al. 1998; Gupta 2004b; Gupta 2003; Gupta 2014; Gupta 2004a). "Testable by RCT" is not the same as "most effective” EBP pyramid can lead practitioners to prefer treatments that are testable by RCT but which may in fact be less effective than others which are not. Practitioners might be pushed towards undertaking trials that are ethically dubious in order to meet the randomization requirement. Equipoise The state in which the practice community is genuinely unsure as to whether one treatment is superior to another
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ETHICO-MORAL OBLIGATIONS OF THE
NURSE IN EVIDENCE-BASED
PRACTICES
(LESSON 7)
Review of Definitions: MORALITY AND ETHICS Morality ‒ Refers to “traditions or beliefs about right and wrong conduct” and is influenced by social and cultural practices. It is what a person has been taught within society and her or his own culture. Ethics ‒ Is “the study of social morality.” It is how a person makes judgments between right and wrong. WHAT IS EVIDENCE-BASED PRACTICE? ‒ Evidenced-based practice (EBP) is applying or translating research findings in our daily patient care practices and clinical decision-making. ‒ EBP also involves integrating the best available evidence with clinical knowledge and expertise, while considering patients’ unique needs and personal preferences. If used consistently, optimal patient outcomes are more likely to be achieved. ‒ Using EBP means abandoning outdated care delivery practices and choosing effective, scientifically validated methods to meet individual patient needs. Health care providers who use EBP must be skilled at discerning the value of research for their specific patient population. BEFORE THERE WAS EVIDENCE... ‒ As health care providers, delivery of patient care should stimulate questions about the evidence behind our daily practice. ‒ For instance, there was a time when neutropenic patients were placed in strict isolation to protect them from developing life-threatening infections. Research findings were evaluated for best evidence and it was noted that using strict isolation precautions did not result in more favorable patient outcomes when compared to proper handwashing procedures coupled with standard precautions—and it seemed that we unnecessarily subjected patients to the negative psychological effects caused by extreme isolation. ‒ As clinicians, we sometimes follow outdated policies or practices without questioning their relevance, accuracy, or the evidence that supports their continued use. WHAT IS ETHICO-MORAL RESPONSIBILITY OF NURSES? The ethical principles that nurses must adhere to are the principles of: Justice Beneficence Non-maleficence Accountability Fidelity Autonomy Veracity WHAT IS A MORAL OBLIGATION IN NURSING? ‒ “The nurse’s primary commitment is to the recipient of nursing and health care services...” (ANA, 2015, p.5); ‒ However, in certain situations the risks of harm may outweigh a nurse’s moral obligation or duty to care for a given patient. HOW CAN YOU ENSURE AN ETHICO- MORAL NURSING PRACTICE? ‒ Organize an ethics committee or identify ethical champions in everyday life. Develop ethics-friendly policies and procedures. ‒ Provide continuing education and training in ethical decision making ‒ Promote open discussions among staff nurses and managers regarding ethical patient care. BENEFITS OF EVIDENCE-BASED PRACTICE IN NURSING Besides keeping health care practices relevant and current, evidence-based practice in nursing offers a range of other benefits to the nurse and the patients: ‒ Promotes positive patient outcomes ‒ Reduces health care costs by preventing complications ‒ Contributes to the growth of the science of nursing ‒ Allows for incorporation of new technologies into health care practice Increases nurse autonomy and confidence in decision-making ‒ Ensures relevancy of nursing practice with new interventions and care protocols ‒ Provides scientifically supported research to help make well- informed decisions
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‒ Fosters shared decision-making with patients in care planning Enhances critical thinking ‒ Encourages lifelong learning CONCLUSION When you use the principles of evidence-based practice in nursing to make decisions about your patient's care, it results in better outcomes, higher satisfaction, and reduced costs. Implementing this method promotes lifelong learning and lets you strive for continuous quality improvement in your clinical care and nursing practice to achieve nursing excellence.
