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Ethics in Nursing Research NURS 3010

Ethics in Nursing Research NURS 3010. Principles and Issues Pauline Anderson-Johnson, MSc , BScN , RN 2011, edited Jascinth Lindo 2012 & 2013. Class Objectives. D iscuss the historical background that guaranteed the development of codes of ethics

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Ethics in Nursing Research NURS 3010

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  1. Ethics in Nursing ResearchNURS 3010 Principles and Issues Pauline Anderson-Johnson, MSc, BScN, RN 2011, edited Jascinth Lindo 2012 & 2013

  2. Class Objectives • Discuss the historical background that guaranteed the development of codes of ethics • Identify the 3 primary ethical principles of the Belmont Report and the important dimensions of each • Identify procedures for adhering to ethical principles and protecting human participants • Develop consent forms for use in research studies • Assess the ethical aspects of a research report • Define and use new terms

  3. Why Ethical Approval??? • Research - includes any social science, biomedical epidemiological activity that entails systematic collection or analysis of data with the intent to generate new knowledge, in which humans: • Are exposed to manipulation, intervention, observation, or other interaction with investigators either directly or thru alteration of their environment • Become individually identifiable thru investigators collection , preparation or use of biological material or medical or other records (Casebook on ethical issues in international health research, 2004)

  4. Historical Background • 1930s & 1940s – Germany - research on humans testing their endurance and reaction to disease and drugs – humans exposed to permanent physical harm and death, participants could not refuse to be part (Nazi medical experiments) • 1930-1972 – USA – medical treatment deliberately withheld in order to study the course of untreated disease – (Tuskegee Syphilis study, sponsored by US Public Health service)

  5. Historical Background • 1960’s – USA - injection of live cancer cells in elderly patients without their consent ( Jewish Chronic disease Hospital, Brooklyn) • 1960’s – USA – children infected with the hepatitis virus • 1980s – New Zealand – patients with carcinoma in situ were not given treatment in order to study the natural progression of the disease (Dr Herbert Green of National Women’s Hospital, Aukland) • Many more, maybe not as large or obvious

  6. Codes of Ethics Codes of Ethics have been developed in response to these violations of human rights • 1949 – Nuremburg code • 1964 – Declaration of Helsinki accepted by the World medical Assembly • 2000 – Declaration of Helsinki revised

  7. Codes of Ethics Many organizations or disciplines have established their own code of ethics • Nurses have developed their own Code • ANA – Ethical Guidelines in the Conduct , Dissemination and Implementation of Nursing Research • ICN – Code for Nurses • The Belmont Report – a model for many guidelines

  8. Code of Ethics The Belmont Report • Code of Ethics which was adopted by the National Commission for Protection of Human Subjects by the Federal Govt of the USA. • Used widely and many of the guidelines adopted

  9. Ethical Principles • THREE (3) primary ethical principles according to the Belmont Report 1. Beneficence 2. Respect for Human Dignity or Autonomy 3. Justice

  10. Ethical Principles - Beneficence • Researcher should: minimize harm and Maximize benefits • Dimensions • The right to protection from harm and discomfort (Nonmaleficence) • The right to protection from exploitation

  11. Ethical Principles – Beneficence • Dimensions • The right to protection from harm and discomfort (Nonmaleficence) • Researcher has a duty to avoid, prevent or minimize harm to participants • Should not be subjected to unnecessary risks of harm or discomfort • Participation must be essential to achieving scientifically and societally important aims • Harm can be – physical, emotional, social or financial (Polit & Beck, 2006)

  12. Ethical Principles – Beneficence • Dimensions • The right to protection from exploitation • What does this mean? • (Polit & Beck, 2006)

  13. Ethical Principles – Respect for Human Dignity • Includes: • the right to self determination • the right to full disclosure

  14. Ethical Principles - Respect for Human Dignity • Right to self determination • Right to voluntarily decide on participation – without prejudiced treatment • Right to ask questions • Freedom from coercion – explicit and implicit threats of penalty from failing to participate or excessive rewards as a benefit to participate

  15. Ethical Principles - Respect for Human Dignity • Right to full disclosure • Full disclosure is required for participants to make informed voluntary decisions • Researcher should describe the nature of the study fully, persons right to refuse, the risks and benefits. • Full disclosure may create bias • Deception

  16. Ethical Principles - Respect for Human Dignity • Full disclosure may cause bias • Bias – affect accuracy • Bias – affect recruitment of participants • Researchers may use: • Concealment • Deception

  17. Ethical Principle - Justice • The principle of justice is synonymous with fairness and equity and researchers are obliged to treat participants fairly and equitably before, during and after the research Study. (ABA, A. B. A. 2007)..

  18. Veracity • Veracity involves the concepts of truth about the research study and the absence of deception. • Individuals have the right to be told the truth and not to be deceived about any aspect of the research. • All aspects of a research project require explanation by the researcher, who must make every effort to ensure the participants understand the implications throughout the study. • The principle of veracity is linked with respect for autonomy (Gillon, 1994).

  19. Fidelity and Confidentiality • Fidelity involves the concept of trust (ICN, 1996). Participants place trust in researchers • and this necessitates a commitment to protect them. The researcher must ensure that the • participants have an understanding of the risks, and thus foster a trusting relationship. • The researcher is responsible for ensuring confidentiality and privacy of the research • participants and the data obtained from them. Personal information obtained by the

  20. Review Class exercise • Explain the THREE (3) primary ethical principles according to the Belmont Report • Describe two historical events which have shaped the discussion regarding medical and research ethics and state the year they occurred

  21. Protection of Study Participants Principle Application • Respect for Persons • Treated as autonomous agents • Vulnerable persons should be protected • Beneficence • Participants should not be harmed • Benefits should be maximized and harms minimized to participants • Justice • Benefits and risks must be distributed fairly • Obtain informed consent • Give participants the opportunity to choose what will happen to them. Include: • Information • Voluntariness • comprehension • Conduct risk/benefit assessments – should be done in a systematic manner. Review of the study by Ethics Committee. • Selection of participants – establish fair procedures for the selection of participants

  22. (i)Informed consent Central to this process is that individuals have the right to decide for themselves (principle of Respect for persons) This means: Adequate information has been given to participants They understand the information – simple language They have the power to make a free choice They can consent voluntarily This process is documented by means of a Informed Consent Form

  23. Consent Form • Should be divided into sections • Should exclude medical/nursing jargon – should be clear and readable • Should include the following info: • Title of the study • Persons engaged in the study (PI, Co.I, RA) • Invitation to participate (You are invited to participate in the ….) and explain the purpose of the study

  24. Consent Form • Reason the person is being asked to participate • Explain clearly the purpose of the study • Detailed description of the procedures (describe what will happen in the study, amt of time required, if hospitalization is required, if blood will be taken or any lab procedures will be done, how long it will take, instruments to be used, etc)

  25. Consent Form 7. Potential risks to the subjects (psychological, social, physical). Explain likely severity and steps taken to protect them • Potential benefits of the study (desired benefits to society and individuals) • Economic considerations (any additional cost to persons as a result of participating) • Confidentiality considerations • Freedom of persons to ask questions and withdraw from the study at any time without penalty

  26. (ii)Ethics Committee Major responsibility of com’t’e or IRB • Review research proposals at convened meetings to ensure that ethical guidelines are followed • Ensures no violation of human participant • The committee will include scientists, research experts, lay persons, lawyers, ministers of religion • Review procedures of selection, protection, voluntary consent, confidentiality

  27. (iii)Risk/Benefit assessments Used to assess the ethical aspects of the study by reviewer • Determine if the benefits of participating are in line with the physical, emotional and financial cost • (see doc with major benefits and risks – p92) • Determine if risks to participants are commensurate with the benefits to society and the profession • Minimal risk – those anticipated; ordinary risks encountered in daily life or during routine tests

  28. Right to anonymity and confidentiality • Freedom for coercion and deception • Voluntary participation Privacy and dignity Rights of individuals Freedom from injury Informed consent Institutional review board /Ethics committees Source: ANA guidelines for protecting human rights

  29. Ethical Dilemma • NB: research that violates ethical principles are most times not done to harm the subjects but is due to a conviction that new and beneficial knowledge will be gained • The right of the participant and the demands of the research are put in direct conflict = ethical dilemma

  30. References ABA, A. B. A. (2007). Guidance to nurses and midwives regarding ethical conduct of nursing and midwifery research. Polit, D.F., & Beck, C.T. (2010). Essentials of nursing research: Appraising the evidence for Nursing practice. Philadelphia: Lippincott, Williams & Wilkins. (Chap 5) Gerrish, K., & Lacey, A. (2010). (Eds.), The research process in Nursing. UK: Wiley-Blackwell. (Chap 8) James A Fain. (1999). Reading, understanding, and applying nursing research: A text and workbook. Philadelphia, FA Davis Co. http://www.emro.who.int/publications/pdf/healthresearchers_guide.pdf (chap 3.1)

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