unit 1 m.sc nursing research

3. INTRODUCTION
ETHICS
Is a greek word from ethos = custom or convention, or the spirit of
community.
Ethics refers to the rules of conduct of carrying out research ethical
issues are present at all stages of research essential part of the research
process.
Ethics is the study of proper action, research ethics concerns the
responsibility of researchers to be honest and respectful to all individuals
who may be affected by their research studies or their reports of the studies’
results.

4. DEFINITION
ETHICS
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)
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. DEFINITION
ETHICS
According to oxford dictionary, ethics are moral principles that govern
a person's behavior or the conducting of an activity.

6. IMPORTANCE
•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

7. APPROACHES
DEONTOLOGY
• Duty is the
basis of all
action.
TELOLOGY
• Actions can only
judged on the
basis of
consequences
they produce.
UTILITARIANISM
• Central concern
is ‘the general
welfare rather
than individual’s
interest’.

8. ETHICAL PRINCIPLES GUIDING RESEARCH
The belmont report articulates three primary ethical principles
•Beneficence
•respect for human dignity
•justice

9. ETHICAL PRINCIPLES GUIDING RESEARCH
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

10. ETHICAL PRINCIPLES GUIDING RESEARCH
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.

11. ETHICAL PRINCIPLES GUIDING RESEARCH
JUSTICE:
•The right to fair treatment
•The right to privacy

12. HISTORICAL EVENTS AND DEVELOPMENT OF
CODE OF ETHICS
•NAZI MEDICAL EXPERIMENTS (1933-1945)
•NUREMBERG CODE- [1949]
•DECLARATION OF HELSINKI (1964)
•TUSKEGEE SYPHILIS STUDY(1932)
•WILLOWBROOK STUDY (1950-1970)
•JEWISH CHRONIC DISEASE HOSPITAL STUDY (1960)

13. NAZI MEDICAL EXPERIMENTS (1933-1945)

14. NAZI MEDICAL EXPERIMENTS (1933-1945)
Atrocious, unethical activities implemented in third reich in
europe from 1933-1945
Programs included:
•Sterilisation.
•Euthanasia.
•numerous medical experiments in nazi concentration camps.
•sterilised jews whom nazis considered as racial enemies.

15. NAZI MEDICAL EXPERIMENTS (1933-1945)
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

16. NUREMBERG CODE- [1949]

17. 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

18. DECLARATION OF HELSINKI (1964)

19. DECLARATION OF HELSINKI (1964)
Declaration of helsinki, formal statement of ethical principles published by
the world medical association (WMA) to guide the protection of human
participants in medical research. The declaration of helsinki was adopted
in 1964 by the 18th WMA general assembly, at helsinki.
•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

20. TUSKEGEE SYPHILIS STUDY(1932)

21. TUSKEGEE SYPHILIS STUDY(1932)
The study begins in 1932, the public health service, working with
the tuskegee institute, began a study to record the natural history of syphilis
in hopes of justifying treatment programs for blacks. It was called the
“tuskegee study of untreated syphilis in the negro male.”
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.
The tuskegee study raised a host of ethical issues such as informed
consent, racism, paternalism, unfair subject selection in research,
maleficence, truth-telling and justice, among others.

22. WILLOWBROOK STUDY (1950-1970)

23. 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.

24. JEWISH CHRONIC DISEASE HOSPITAL STUDY (1960)

25. 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.

26. INFORMED CONSENT
Participants have adequate knowledge regarding
research, have the power of choice, enabling to decline
participation voluntarily.

27. VULNERABLE SUBJECTS

28. 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.

29. 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.

30. ETHICAL DILEMMAS
Ethical dilemmas are situations in which there is a
difficult choice to be made between two or more options,
neither of which resolves the situation in a manner that is
consistent with accepted ethical guidelines.

31. CODE OF ETHICS FOR DIFFERENT DISCIPLINES

32. 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

33. RESEARCH MISCONDUCT
FABRICATION
FALSIFICATION
PLAGARISM

34. 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

35. 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?

36. ETHICAL CONCERNS IN QUALITATIVE
RESEARCH
•Distress
•Misinterpretation
•Identification
•Inconvenience

37. ETHICAL CONCERNS IN QUANTITATIVE RESEARCH
•Formulating the research questions
•Designing the study
•Collecting data
•Analysis
•Reporting

38. 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.

39. ETHICS IN RESEARCH-INDIAN SCENARIO
Twelve general principles are-
1. principle of essentiality
2. principles of voluntariness, informed consent, and community agreement
3. principle of non-exploitation
4. principle of privacy and confidentiality
5. principle of precaution and risk minimisation
6. principle of professional competence
7. Principle of accountability and transparency

40. ETHICS IN RESEARCH-INDIAN SCENARIO
Twelve general principles are-
8. principle of the maximisation of public interest and of distributive justice
9. principle of institutional arrangements
10.principle of public domain
11.principle of totality of responsibility
12.principle of compliance

41. ETHICS IN RESEARCH-INDIAN SCENARIO
Types of unethical publications
 Plagiarism
authorship irregularities
publication irregularities
scientific fraud

42. 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

43. 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-onversations.