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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 nur...
DEFINITION 
• ETHICS-Greek word: ethos=custom or convention, or the 
spirit of community 
• Moral principles that govern a...
• Nursing ethics is defined as the principles of 
proper professional conduct concerning the rights 
and duties of nurses ...
WHAT ETHICS IS AND WHAT IT 
IS NOT 
WHAT ETHICS IS 
• About commitment to 
positive values 
• A communal activity, applyin...
WHAT ETHICS IS 
• About active participation 
in a moral community 
• Problem solving activity 
• An educational process 
...
ETHICAL THEORIES 
• Deontology- duty is the basis of all action 
• Teleology- actions can only judged on the 
basis of con...
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...
• Medical experiments involved exposing to high 
altitudes, freezing temperature, malaria, poisons, 
typhus fever, unteste...
NUREMBERG CODE- 1949
Mistreatment of human subjects in Nazi 
experiments led to the development of Nuremberg 
Code (1949) 
Nuremberg Code con...
DECLARATION OF 
HELSINKI (1964) 
• Greater care can be exercised 
to protect subjects from harm 
• Strong, independent 
ju...
TUSKEGEE SYPHILIS 
STUDY(1932)
• U S Public Health Service initiated the 
study in town of Tuskegee, Alabama 
• Research subjects were divided into two 
...
WILLOWBROOK STUDY (1950-1970)
• Research on hepatitis by Dr. Krugman at 
Willowbrook among mentally retarded 
children 
• Early subjects were fed extrac...
JEWISH CHRONIC DISEASE 
HOSPITAL STUDY (1960)
• Study conducted to determine patients’ 
rejection responses to live cancer cells 
• Twenty two patients were injected wi...
IMPORTANCE OF ETHICS IN 
RESEARCH 
• Protects the vulnerable group and other study 
participants 
• Participants are safeg...
ETHICAL PRINCIPLES 
The Belmont report articulates three primary 
ethical principles 
 Beneficence 
 Respect for human d...
BENEFICENCE 
• Imposes duty on researchers to 
minimise harm and to maximise 
benefits 
The right to protect from harm an...
RISK BENEFIT RATIO 
MAJOR POTENTIAL 
BENEFITS TO 
PARTICIPANTS 
MAJOR POTENTIAL RISKS 
TO PARTICIPANTS 
•Access to an inte...
THE PRINCIPLE OF RESPECT FOR 
HUMAN DIGNITY 
• The right to self determination-Humans should be 
treated as autonomous age...
ISSUES RELATED TO PRINCIPLE OF 
RESPECT 
• Inability of individuals to make well 
informed judgements 
• Bias 
• Concealme...
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 decli...
VULNERABLE SUBJECTS
THERAPEUTIC 
MISCONCEPTION 
• Research subject misinterpret and enrol in 
the study thinking it to be routine medical 
car...
POST TRIAL ACCESS 
• Holds special importance for clinical 
research 
• Pharmaceutical companies from developed 
countries...
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 B...
CODE OF ETHICS FOR 
NURSES IN INDIA
INSTITUTIONAL 
REVIEW/INSTITUTIONAL ETHICAL 
COMMITTEE 
• Committee that reviews research to ensure 
that the investigator...
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-a...
GUIDELINES FOR 
CRITIQUING ETHICAL 
ASPECTS OF STUDY 
• Was the study approved 
and monitored by IRB? 
• Were participants...
• Was any type of coercion 
or undue influence used to 
recruit participants? 
• Were the participants 
deceived in any wa...
• 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 
•...
ETHICAL CONCERNS IN 
MIXED METHOD 
RESEARCH 
• Identify and describe issues 
related to the protection of 
human subjects ...
ETHICS IN RESEARCH-INDIAN 
SCENARIO 
Twelve general principles are- 
• Principle of essentiality 
• Principles of voluntar...
• Principle of accountability and 
transparency 
• Principle of the maximisation of public 
interest and of distributive j...
ETHICS IN NURSING RESEARCH – 
INDIAN SCENARIO 
• TYPES OF UNETHICAL PUBLICATIONS 
Plagiarism 
Authorship irregularities ...
STUDENTS’ ROLE IN ETHICS 
IN RESEARCH 
• Ethical clearance should be 
get done 
• Need to get approval from 
guides and co...
INTERNET ETHICS 
• Development of internet over 
years led to use of internet 
based research. 
• Numerous approaches 
inc...
CONCLUSION 
• If research is based on 
a robust design and in 
a safe and ethical 
manner, it can be of 
benefit to all 
•...
DISCUSSION
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Ethics in research ppt by jiya

  1. 1. WELCOME
  2. 2. ETHICS IN RESEARCH PRESENTED BY JIYA G PANTHANALIL IST YEAR MSC NURSING NIMHANS, BANGALORE
  3. 3. INTRODUCTION • Research contributes to nursing knowledge • Research influence patient care standards • Professional nurses are obliged to ensure safe, robust and ethical research
  4. 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. 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. 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. 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. 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. 9. HISTORICAL EVENTS AND DEVELOPMENT OF CODE OF ETHICS
  10. 10. NAZI MEDICAL EXPERIMENTS (1933-1945)
  11. 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. 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
  13. 13. NUREMBERG CODE- 1949
  14. 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. 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
  16. 16. TUSKEGEE SYPHILIS STUDY(1932)
  17. 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
  18. 18. WILLOWBROOK STUDY (1950-1970)
  19. 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. 20. JEWISH CHRONIC DISEASE HOSPITAL STUDY (1960)
  21. 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. 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. 23. ETHICAL PRINCIPLES The Belmont report articulates three primary ethical principles  Beneficence  Respect for human dignity  Justice
  24. 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. 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. 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. 27. ISSUES RELATED TO PRINCIPLE OF RESPECT • Inability of individuals to make well informed judgements • Bias • Concealment • Deception
  28. 28. THE PRINCIPLE OF JUSTICE • The right to fair treatment • The right to privacy
  29. 29. INFORMED CONSENT
  30. 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.
  31. 31. VULNERABLE SUBJECTS
  32. 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. 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
  34. 34. ETHICAL DILEMMAS
  35. 35. CODE OF ETHICS FOR DIFFERENT DISCIPLINES
  36. 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. 37. CODE OF ETHICS FOR NURSES IN INDIA
  38. 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. 39. LEVELS OF REVIEW BY IRB • Exempt from interview • Expedited interview • Complete review
  40. 40. RESEARCH MISCONDUCT FABRICATION FALSIFICATION PLAGIARISM
  41. 41. RESEARCH MISCONDUCT
  42. 42. PLAGIARISM CHECKER
  43. 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. 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. 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. 46. • Were vulnerable groups involved in research? • Were groups omitted from the inquiry without a justifiable rationale?
  47. 47. ETHICAL CONCERNS IN QUALITATIVE RESEARCH • Distress • Misinterpretation • Identification • Inconvenience
  48. 48. • ETHICAL CONCERNS IN QUANTITATIVE RESEARCH Related to the stage of research • Formulating the research questions • Designing the study • Collecting data • Analysis • Reporting
  49. 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. 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. 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. 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. 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. 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. 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
  56. 56. DISCUSSION
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