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Ethics in research ppt by jiya

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This document provides an overview of ethics in research. It defines ethics and discusses key historical events that shaped modern research ethics like the Nazi experiments and the Nuremberg Code. The three primary ethical principles of beneficence, respect for human dignity, and justice are examined. Informed consent, risks/benefits analysis, and the role of institutional review boards in ensuring ethical research are covered. Challenges in vulnerable populations and qualitative/mixed methods research are also summarized.

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WELCOME
ETHICS IN RESEARCH PRESENTED BY JIYA G PANTHANALIL IST YEAR MSC NURSING NIMHANS, BANGALORE
INTRODUCTION • Research contributes to nursing knowledge • Research influence patient care standards • Professional nurses are obliged to ensure safe, robust and ethical research
DEFINITION • ETHICS-Greek word: ethos=custom or convention, or the spirit of community • Moral principles that govern a person’s behaviour or the conducting of an activity: Oxford dictionary (2014) • The branch of philosophy that deals with morality. Ethics is concerned with distinguishing between good and evil in the world, between right and wrong human actions, and between virtuous and non virtuous characteristics of people-The American Dictionary of Cultural Literacy (2005)
• Nursing ethics is defined as the principles of proper professional conduct concerning the rights and duties of nurses themselves, their patients, and their fellow practitioners, as well as their actions in the care of patients and in relations with their families- U S National Library of Medicine (2014)
WHAT ETHICS IS AND WHAT IT IS NOT WHAT ETHICS IS • About commitment to positive values • A communal activity, applying rational principles and universal standards to social life • About real power relations and responsible power sharing WHAT ETHICS IS NOT • About negative code of conduct, moral prohibitions, disciplinary rules • A private matter, nor about subjective feelings, personal attitudes and choices • Introspective self examination, or judging one’s or other’s moral state
WHAT ETHICS IS • About active participation in a moral community • Problem solving activity • An educational process WHAT ETHICS IS NOT • Personal reliance on experts, lawyers, philosophers or religious authorities • Interminable disputes, or insoluble dilemma • Occult processes
ETHICAL THEORIES • Deontology- duty is the basis of all action • Teleology- actions can only judged on the basis of consequences they produce Utilitarianism-central concern is ‘the general welfare rather than individual’s interest’
HISTORICAL EVENTS AND DEVELOPMENT OF CODE OF ETHICS
NAZI MEDICAL EXPERIMENTS (1933-1945)
• Atrocious, unethical activities implemented in Third Reich in Europe from 1933-1945 • Programs included sterilisation, euthanasia, and numerous medical experiments in Nazi concentration camps • Sterilised Jews whom Nazis considered as racial enemies
• Medical experiments involved exposing to high altitudes, freezing temperature, malaria, poisons, typhus fever, untested drugs and surgery without anaesthesia • Selection of subjects was racially based • Subjects had no opportunity to refuse the participation
NUREMBERG CODE- 1949
Mistreatment of human subjects in Nazi experiments led to the development of Nuremberg Code (1949) Nuremberg Code contains guidelines for • Voluntary consent • Withdrawal of subjects from study • Protection of subjects from physical and mental suffering, injury, disability, and death • The balance of benefits and risks in the study
DECLARATION OF HELSINKI (1964) • Greater care can be exercised to protect subjects from harm • Strong, independent justification for exposing a healthy volunteer to substantial risk of harm • Investigators must protect life and health of research subjects
TUSKEGEE SYPHILIS STUDY(1932)
• U S Public Health Service initiated the study in town of Tuskegee, Alabama • Research subjects were divided into two groups • One group of 400 men who had untreated syphilis • Control group of 200 men without syphilis
WILLOWBROOK STUDY (1950-1970)
• Research on hepatitis by Dr. Krugman at Willowbrook among mentally retarded children • Early subjects were fed extracts of stool from infected individuals • Later subjects received injections of purified virus • Parents were forced to give permission for the child to be a subject
JEWISH CHRONIC DISEASE HOSPITAL STUDY (1960)
• Study conducted to determine patients’ rejection responses to live cancer cells • Twenty two patients were injected with a suspension containing live cancer cells • Physician from Sloan-Kettering Institute for cancer research directed the study • Study conducted without the informed consent
IMPORTANCE OF ETHICS IN RESEARCH • Protects the vulnerable group and other study participants • Participants are safeguarded from exploitation • Establishes risk-benefit ratio for study subjects • Ensures fullest respect, dignity, privacy, disclosure and fair treatment for subject • Builds capability of subjects to accept or reject participation in study
ETHICAL PRINCIPLES The Belmont report articulates three primary ethical principles  Beneficence  Respect for human dignity  Justice
BENEFICENCE • Imposes duty on researchers to minimise harm and to maximise benefits The right to protect from harm and discomfort Freedom from exploitation Benefits from research
RISK BENEFIT RATIO MAJOR POTENTIAL BENEFITS TO PARTICIPANTS MAJOR POTENTIAL RISKS TO PARTICIPANTS •Access to an intervention that otherwise be unavailable to them •Comfort to discuss situation with a friendly person •Increased knowledge of themselves •Satisfaction in helping others •Monetary or material gains •Physical harm •Boredom ,fatigue,physical discomfort •Psychological or emotional discomfort •Social risks •Loss of privacy •Loss of time •Monetary costs
THE PRINCIPLE OF RESPECT FOR HUMAN DIGNITY • The right to self determination-Humans should be treated as autonomous agents, capable of controlling their own activities • The right to full disclosure-Researcher should fully describe the nature of study, subject’s right to refuse participation, researcher’s responsibility and risks and benefits
ISSUES RELATED TO PRINCIPLE OF RESPECT • Inability of individuals to make well informed judgements • Bias • Concealment • Deception
THE PRINCIPLE OF JUSTICE • The right to fair treatment • The right to privacy
INFORMED CONSENT
INFORMED CONSENT • Participants have adequate knowledge regarding research, have the power of choice, enabling to decline participation voluntarily. • Informed assent-the process where by minors may agree to participate in clinical trials.
VULNERABLE SUBJECTS
THERAPEUTIC MISCONCEPTION • Research subject misinterpret and enrol in the study thinking it to be routine medical care • Misinterpret the information and believes that research directly benefits him
POST TRIAL ACCESS • Holds special importance for clinical research • Pharmaceutical companies from developed countries collect data from developing countries • Most of these drugs would never be used by the communities from where the experimental data is collected
ETHICAL DILEMMAS
CODE OF ETHICS FOR DIFFERENT DISCIPLINES
1978 • Important Code of ethics adopted by National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research (U. S) 1992 • Guidelines for psychologists published by the American Psychological Association in Ethical principles of Psychologists and Code of Conduct 1995 • The American Nurses’ Association put forth a document entitled Ethical guidelines in the Conduct, Dissemination and Implementation of Nursing Research
CODE OF ETHICS FOR NURSES IN INDIA
INSTITUTIONAL REVIEW/INSTITUTIONAL ETHICAL COMMITTEE • Committee that reviews research to ensure that the investigator is conducting research ethically • Consists of at least five members from different background • IRB in hospitals composed of physicians, lawyers, clergy, community and lay persons and more recently nurses
LEVELS OF REVIEW BY IRB • Exempt from interview • Expedited interview • Complete review
RESEARCH MISCONDUCT FABRICATION FALSIFICATION PLAGIARISM
RESEARCH MISCONDUCT
PLAGIARISM CHECKER
ROLE OF PEER REVIEWERS, JOURNAL EDITORS, AND RESEARCHERS • Fraudulent- If there is documentation or testimony from co-authors that publication didnot reflect what had actually been done • Questionable- If no co-author could produce the original data or had personally observed or performed or participated in research publication
GUIDELINES FOR CRITIQUING ETHICAL ASPECTS OF STUDY • Was the study approved and monitored by IRB? • Were participants subjected to any physical harm or psychological distress? • Did the benefits outweigh potential risks?
• Was any type of coercion or undue influence used to recruit participants? • Were the participants deceived in any way? • Were appropriate informed consent procedures used? • Were adequate steps taken to safeguard participant’s privacy?
• Were vulnerable groups involved in research? • Were groups omitted from the inquiry without a justifiable rationale?
ETHICAL CONCERNS IN QUALITATIVE RESEARCH • Distress • Misinterpretation • Identification • Inconvenience
• ETHICAL CONCERNS IN QUANTITATIVE RESEARCH Related to the stage of research • Formulating the research questions • Designing the study • Collecting data • Analysis • Reporting
ETHICAL CONCERNS IN MIXED METHOD RESEARCH • Identify and describe issues related to the protection of human subjects • Understand the ethical issues associated with quantitative and qualitative research • Be prepared to educate IRB reviewers about mixed method research
ETHICS IN RESEARCH-INDIAN SCENARIO Twelve general principles are- • Principle of essentiality • Principles of voluntariness, informed consent, and community agreement • Principle of non-exploitation • Principle of privacy and confidentiality • Principle of precaution and risk minimisation • Principle of professional competence
• Principle of accountability and transparency • Principle of the maximisation of public interest and of distributive justice • Principle of institutional arrangements • Principle of public domain • Principle of totality of responsibility • Principle of compliance
ETHICS IN NURSING RESEARCH – INDIAN SCENARIO • TYPES OF UNETHICAL PUBLICATIONS Plagiarism Authorship irregularities Publication irregularities Scientific fraud • ETHICAL ISSUES IN USING ANIMALS IN RESEARCH
STUDENTS’ ROLE IN ETHICS IN RESEARCH • Ethical clearance should be get done • Need to get approval from guides and co-guides • Unethical to publish including guide as co-author
INTERNET ETHICS • Development of internet over years led to use of internet based research. • Numerous approaches include web page content analysis, online focus groups, online interviews, analysis of e-conversations
CONCLUSION • If research is based on a robust design and in a safe and ethical manner, it can be of benefit to all • Professional codes, laws, regulations, and ethics committees can provide guidance but ultimate determinant rests with researcher’s value system and moral code
DISCUSSION
Ethics in research ppt by jiya

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Ethics in research ppt by jiya

  • 2. ETHICS IN RESEARCH PRESENTED BY JIYA G PANTHANALIL IST YEAR MSC NURSING NIMHANS, BANGALORE
  • 3. INTRODUCTION • Research contributes to nursing knowledge • Research influence patient care standards • Professional nurses are obliged to ensure safe, robust and ethical research
  • 4. DEFINITION • ETHICS-Greek word: ethos=custom or convention, or the spirit of community • Moral principles that govern a person’s behaviour or the conducting of an activity: Oxford dictionary (2014) • The branch of philosophy that deals with morality. Ethics is concerned with distinguishing between good and evil in the world, between right and wrong human actions, and between virtuous and non virtuous characteristics of people-The American Dictionary of Cultural Literacy (2005)
  • 5. • Nursing ethics is defined as the principles of proper professional conduct concerning the rights and duties of nurses themselves, their patients, and their fellow practitioners, as well as their actions in the care of patients and in relations with their families- U S National Library of Medicine (2014)
  • 6. WHAT ETHICS IS AND WHAT IT IS NOT WHAT ETHICS IS • About commitment to positive values • A communal activity, applying rational principles and universal standards to social life • About real power relations and responsible power sharing WHAT ETHICS IS NOT • About negative code of conduct, moral prohibitions, disciplinary rules • A private matter, nor about subjective feelings, personal attitudes and choices • Introspective self examination, or judging one’s or other’s moral state
  • 7. WHAT ETHICS IS • About active participation in a moral community • Problem solving activity • An educational process WHAT ETHICS IS NOT • Personal reliance on experts, lawyers, philosophers or religious authorities • Interminable disputes, or insoluble dilemma • Occult processes
  • 8. ETHICAL THEORIES • Deontology- duty is the basis of all action • Teleology- actions can only judged on the basis of consequences they produce Utilitarianism-central concern is ‘the general welfare rather than individual’s interest’
  • 9. HISTORICAL EVENTS AND DEVELOPMENT OF CODE OF ETHICS
  • 11. • Atrocious, unethical activities implemented in Third Reich in Europe from 1933-1945 • Programs included sterilisation, euthanasia, and numerous medical experiments in Nazi concentration camps • Sterilised Jews whom Nazis considered as racial enemies
  • 12. • Medical experiments involved exposing to high altitudes, freezing temperature, malaria, poisons, typhus fever, untested drugs and surgery without anaesthesia • Selection of subjects was racially based • Subjects had no opportunity to refuse the participation
  • 14. Mistreatment of human subjects in Nazi experiments led to the development of Nuremberg Code (1949) Nuremberg Code contains guidelines for • Voluntary consent • Withdrawal of subjects from study • Protection of subjects from physical and mental suffering, injury, disability, and death • The balance of benefits and risks in the study
  • 15. DECLARATION OF HELSINKI (1964) • Greater care can be exercised to protect subjects from harm • Strong, independent justification for exposing a healthy volunteer to substantial risk of harm • Investigators must protect life and health of research subjects
  • 17. • U S Public Health Service initiated the study in town of Tuskegee, Alabama • Research subjects were divided into two groups • One group of 400 men who had untreated syphilis • Control group of 200 men without syphilis
  • 19. • Research on hepatitis by Dr. Krugman at Willowbrook among mentally retarded children • Early subjects were fed extracts of stool from infected individuals • Later subjects received injections of purified virus • Parents were forced to give permission for the child to be a subject
  • 20. JEWISH CHRONIC DISEASE HOSPITAL STUDY (1960)
  • 21. • Study conducted to determine patients’ rejection responses to live cancer cells • Twenty two patients were injected with a suspension containing live cancer cells • Physician from Sloan-Kettering Institute for cancer research directed the study • Study conducted without the informed consent
  • 22. IMPORTANCE OF ETHICS IN RESEARCH • Protects the vulnerable group and other study participants • Participants are safeguarded from exploitation • Establishes risk-benefit ratio for study subjects • Ensures fullest respect, dignity, privacy, disclosure and fair treatment for subject • Builds capability of subjects to accept or reject participation in study
  • 23. ETHICAL PRINCIPLES The Belmont report articulates three primary ethical principles  Beneficence  Respect for human dignity  Justice
  • 24. BENEFICENCE • Imposes duty on researchers to minimise harm and to maximise benefits The right to protect from harm and discomfort Freedom from exploitation Benefits from research
  • 25. RISK BENEFIT RATIO MAJOR POTENTIAL BENEFITS TO PARTICIPANTS MAJOR POTENTIAL RISKS TO PARTICIPANTS •Access to an intervention that otherwise be unavailable to them •Comfort to discuss situation with a friendly person •Increased knowledge of themselves •Satisfaction in helping others •Monetary or material gains •Physical harm •Boredom ,fatigue,physical discomfort •Psychological or emotional discomfort •Social risks •Loss of privacy •Loss of time •Monetary costs
  • 26. THE PRINCIPLE OF RESPECT FOR HUMAN DIGNITY • The right to self determination-Humans should be treated as autonomous agents, capable of controlling their own activities • The right to full disclosure-Researcher should fully describe the nature of study, subject’s right to refuse participation, researcher’s responsibility and risks and benefits
  • 27. ISSUES RELATED TO PRINCIPLE OF RESPECT • Inability of individuals to make well informed judgements • Bias • Concealment • Deception
  • 28. THE PRINCIPLE OF JUSTICE • The right to fair treatment • The right to privacy
  • 30. INFORMED CONSENT • Participants have adequate knowledge regarding research, have the power of choice, enabling to decline participation voluntarily. • Informed assent-the process where by minors may agree to participate in clinical trials.
  • 32. THERAPEUTIC MISCONCEPTION • Research subject misinterpret and enrol in the study thinking it to be routine medical care • Misinterpret the information and believes that research directly benefits him
  • 33. POST TRIAL ACCESS • Holds special importance for clinical research • Pharmaceutical companies from developed countries collect data from developing countries • Most of these drugs would never be used by the communities from where the experimental data is collected
  • 35. CODE OF ETHICS FOR DIFFERENT DISCIPLINES
  • 36. 1978 • Important Code of ethics adopted by National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research (U. S) 1992 • Guidelines for psychologists published by the American Psychological Association in Ethical principles of Psychologists and Code of Conduct 1995 • The American Nurses’ Association put forth a document entitled Ethical guidelines in the Conduct, Dissemination and Implementation of Nursing Research
  • 37. CODE OF ETHICS FOR NURSES IN INDIA
  • 38. INSTITUTIONAL REVIEW/INSTITUTIONAL ETHICAL COMMITTEE • Committee that reviews research to ensure that the investigator is conducting research ethically • Consists of at least five members from different background • IRB in hospitals composed of physicians, lawyers, clergy, community and lay persons and more recently nurses
  • 39. LEVELS OF REVIEW BY IRB • Exempt from interview • Expedited interview • Complete review
  • 40. RESEARCH MISCONDUCT FABRICATION FALSIFICATION PLAGIARISM
  • 43. ROLE OF PEER REVIEWERS, JOURNAL EDITORS, AND RESEARCHERS • Fraudulent- If there is documentation or testimony from co-authors that publication didnot reflect what had actually been done • Questionable- If no co-author could produce the original data or had personally observed or performed or participated in research publication
  • 44. GUIDELINES FOR CRITIQUING ETHICAL ASPECTS OF STUDY • Was the study approved and monitored by IRB? • Were participants subjected to any physical harm or psychological distress? • Did the benefits outweigh potential risks?
  • 45. • Was any type of coercion or undue influence used to recruit participants? • Were the participants deceived in any way? • Were appropriate informed consent procedures used? • Were adequate steps taken to safeguard participant’s privacy?
  • 46. • Were vulnerable groups involved in research? • Were groups omitted from the inquiry without a justifiable rationale?
  • 47. ETHICAL CONCERNS IN QUALITATIVE RESEARCH • Distress • Misinterpretation • Identification • Inconvenience
  • 48. • ETHICAL CONCERNS IN QUANTITATIVE RESEARCH Related to the stage of research • Formulating the research questions • Designing the study • Collecting data • Analysis • Reporting
  • 49. ETHICAL CONCERNS IN MIXED METHOD RESEARCH • Identify and describe issues related to the protection of human subjects • Understand the ethical issues associated with quantitative and qualitative research • Be prepared to educate IRB reviewers about mixed method research
  • 50. ETHICS IN RESEARCH-INDIAN SCENARIO Twelve general principles are- • Principle of essentiality • Principles of voluntariness, informed consent, and community agreement • Principle of non-exploitation • Principle of privacy and confidentiality • Principle of precaution and risk minimisation • Principle of professional competence
  • 51. • Principle of accountability and transparency • Principle of the maximisation of public interest and of distributive justice • Principle of institutional arrangements • Principle of public domain • Principle of totality of responsibility • Principle of compliance
  • 52. ETHICS IN NURSING RESEARCH – INDIAN SCENARIO • TYPES OF UNETHICAL PUBLICATIONS Plagiarism Authorship irregularities Publication irregularities Scientific fraud • ETHICAL ISSUES IN USING ANIMALS IN RESEARCH
  • 53. STUDENTS’ ROLE IN ETHICS IN RESEARCH • Ethical clearance should be get done • Need to get approval from guides and co-guides • Unethical to publish including guide as co-author
  • 54. INTERNET ETHICS • Development of internet over years led to use of internet based research. • Numerous approaches include web page content analysis, online focus groups, online interviews, analysis of e-conversations
  • 55. CONCLUSION • If research is based on a robust design and in a safe and ethical manner, it can be of benefit to all • Professional codes, laws, regulations, and ethics committees can provide guidance but ultimate determinant rests with researcher’s value system and moral code