Ethics & Nursing Research

1. ETHICS AND RESEARCH
PROF.DR.CHINNA CHADAYAN.N
RN.RM., B.SC (N)., M.SC (N)., PH.D (N).,
PROFESSOR,
ADULT AND ELDERLY HEALTH NURSING DEPARTMENT,
ENAM NURSING COLLEGE – SAVAR,
BANGLADESH.
M.SC(N)
UNIT - 6
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2. DEFINITION
• 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 individuals, group, or community under study
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3. IMPORTANCE OF ETHICS IN NURSING
RESEARCH
1.Protect the vulnerable group and other study participants from harmful effects of the
experimental interventions.
2.Safeguard the participants from exploitation by researchers.
3.Establish the risk benefit ratio for the study subjects.
4.Ensure the fullest respect, dignity, privacy, disclose of information, and fair
treatment for study subjects.
5.Build the capability of subjects to accept or reject participation in study and to have
access to informed or written consent for participation in research study.
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4. ETHICAL PRINCIPLES FOR RESEARCH
PRINCIPLES
• Ethical Principles for Research is necessary for the conduct of research on human subjects –
• Declaration of Helsinki (1964)
Minimize risks and maximize benefits
Obtain informed consent, preferably in writing
Safeguard personal integrity of participants
Participants free to withdraw from study
Research considered to be harmful should be discontinued
• The Belmont Principles (1979)
1. Respect for Persons – right to self-determination
2. Beneficence - know the good that will occur and do no harm
3. Justice - treat subjects fairly 8/30/2023 4

5. 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 - action of hiding something or preventing
Deception - the action of deceiving someone / cheating
BENEFICENCE
• Imposes duty on researchers to minimize harm and to maximize benefits
The right to protect from harm and discomfort
Freedom from exploitation
Benefits from research
THE PRINCIPLE OF JUSTICE
The right to fair treatment
The right to privacy
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6. PROTECTION OF STUDY PARTICIPANTS
Principle Application
Respect for Persons
1. Treated as autonomous agents
2. Vulnerable persons should be
protected
Obtain informed consent
Give participants the opportunity to
choose what will happen to them.
Include:
1. Information
2. Voluntariness
3. comprehension
Beneficence
1. Participants should not be harmed
2. Benefits should be maximized and
harms minimized to participants
Conduct risk/benefit assessments
– should be done in a systematic manner.
Review of the study by Ethics Committee
Justice
Benefits and risks must be distributed
fairly
Selection of participants
– establish fair procedures for the
selection of participants.
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7. INFORMED / WRITTEN CONSENT
4 ELEMENTS OF INFORMED CONSENT IS A
CYCLIC PROCESS
AGREEMENT TO
PARTICIPATE
ESSENTIAL
INFORMATION
COMPREHENSIO
COMPETENT
SUBJECT
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8. THE CONSENT OFAN INFORMED CONSENT MUST INCLUDE THE FOLLOWING:
1.Title of study and name(s) of investigator(s)
2. Introduction and invitation to subjects.
3.Basics of subject selection.
4.Procedural process and any intervention involved in the study.
5.Expected time and nature of participants involvement in the study.
6.Type of data/information to be obtained for respondents.
7.Details of the potential discomfort or risk for participants in the study.
8.Mechanism to protect privacy and anonymity of participants.
9.Contact details to collect information and clarification about doubts.
10.Statement about voluntary participation of subjects and right of termination without any
penalty.
11.Description of the expected benefits of the research study.
12.Signature lines.
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9. OTHER ETHICAL PRINCIPLES
1. Principles of essentiality: By this principle the research involving the use of human participants is considered to be completely essential for the
proposed research.
2. Principles of voluntariness Whereby respect for the right of the participant to agree or not to agree to participate in research or to withdraw from
research at any time, is paramount. The informed consent process ensure that participants’ rights are safeguarded.
3. Principles of non-exploitation Whereby research participants are equitably selected so that the benefits and burdens of the research are distributed
fairy and without arbitrariness or discrimination. Sufficient safeguards to protect vulnerable groups to protect vulnerable groups should be present.
Principle of social responsibility Whereby the research is planned and conducted so as to avoid creation or deepening of social and historic divisions
or in anyway disturb social harmony in community relationship.
4. Principles of ensuring privacy and confidentiality By this principle the identity and records of the human participants of the research or experiment
are highest kept confidential and access is limited to only those who are authorized. This cannot be disclosed without the written consent of the
participants.
5. Principles of risk minimization By this principle caution and proper care is taken to ensure that the research participant are put to the minimum risk,
at all levels of research and appropriate care and compensation is given if any harm occurs.
6. Principles of professional competence Whereby the research is planned, conducted, evaluated and monitored throughout by persons who are competent
and have the appropriate and relevant qualification, experience and/ or training. Principle of maximization of benefit Whereby due care is taken to design
and conduct the research in such a way as to directly or indirectly maximize the benefits to the research participants and/or to the society.
7. Principles of institutional arrangements Whereby institutions where the research is being conducted have policies for appropriate research
governance and take the responsibility to facilitate research by providing required infrastructure, manpower, funds and training oppurtunities.
8. Principles of accountability and transparency Whereby the research plan and outcomes emanating from the research are brought into the public
domain through registries, reports and scientific and other publications while safeguarding the right to privacy of the participants. The research should
be conducted in a fair, honest impartial and transparent manner to guarantee accountability. Related records and data notes should be retained for the
required period for possible external scrutiny/audit.
9. Principles of totality of responsibility Whereby all stakeholders involved in research are responsible for their actions. The professional, social and
moral responsibilities compliant with ethical guidelines and related regulations are binding on all stakeholders directly or indirectly. Principle of
environmental protection Whereby researchers are accountable for ensuring protection of the environment and resources at all stages of the research,
in compliance with existing guidelines and regulations.
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10. PROTECTION OF HUMAN RIGHTS
The right to self-determination
–Violations – coercion, covert collection, deception, diminished autonomy
The right to privacy and dignity
–Violations – invasion of privacy – sharing information, collecting information
The right to anonymity and confidentiality –Violations - breech of confidentiality, lack of coding or
grouping, reporting so individual can be ID’d.
Right to fair treatment –Violations – unfair selection, unfair treatment during study
Right to protection from discomfort and harm –Violations – physical, psychological, social, or
economic discomfort or harm
Right to full disclosure –Violations – withholding information in the interest of protecting the validity
of the study
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11. RESEARCH MISCONDUCT
DEFINITION
• Research Misconduct is about the bad, wrong and what ought not to be done in the context of research
TYPES OF MISCONDUCT
1. Fabrication
2. Falsification
3. Plagiarism
4. Violation of ethical standards regarding human and animal experiments
5. Violation of local regulatory, national or institutional requirements
6. Ghostwriting
7. Unqualified authorship
8. Suppression of data or findings 8/30/2023 11

12. • FABRICATION
• Making up fake facts to support purpose of research, arguments, conclusions, etc •
• Making up fake references to support arguments, discussions, etc
• Making up results and research data
• FABRICATION Photo manipulation to distort their meaning
• Adding shapes or color to original image
• Splicing together different images to represent a single experiment
• Changing colour, brightness and contrast of only a part of the image
• Removing part of original image to give a different perspective
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13. • FALSIFICATION •
• Manipulation of research materials, equipment, or processes or changing or omitting
data or results such that research is not accurately reported
• Wrongly modify or misquote statements from well respected references
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14. • PLAGIARISM
• The use of another person’s ideas, processes, results, or words without giving appropriate
credit
– Using other’s ideas and results and reporting or publishing as if investigator has done all the
work under which the data was obtained
– Reproducing Tables, Figures or Plates of others without giving credit, acknowledgement or
permission
CITATION PLAGIARISM
• A minor form is copying whole sentences or paragraphs from references or literature although
credit is given
SELF-PLAGIARISM Salami publication
• Multiple publications of the same content with different titles and/or indifferent journals
• Includes publishing the same article in a different language without stating the initial source of
publication 8/30/2023 14

15. • ETHICAL VIOLATIONS
Failure to adhere to international standards and requirements for research involving human
and animal subjects
Failure to obtain ethical approval from the relevant authorities or committees
• REGULATORY VIOLATIONS
Failure to obtain approval or adhere to local regulatory, national and institutional
requirements for research
E. g. failure to get approval to conduct release of living modified organisms
E. g. failure to obtain approval to import and test experimental drug
E. g. failure to obtain institutional approval to conduct research
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16. GHOSTWRITING
 Someone other than the named author(s) writes the manuscript for publication. Writer is not involved in
the research and researcher(s) not involved in the writing.
 often done to mask incompetence of author(s)
 may mask influence or contributions of sponsors such as drug companies
 Usually involves element of financial fraud
• UNQUALIFIED AUTHORSHIP
Conferring authorship to those who have not made substantial contribution to the research.
– Senior researchers or heads of department who demands to be included
– Junior researchers include senior researchers, without their knowledge, as authors to increase chances
of acceptance for publication
– Senior researchers agree to be included as authors so as to include chances of acceptance for
publication 8/30/2023 16

17. SUPPRESSION OF DATA OR FINDINGS
• This is the failure to publish significant findings due to the results being adverse to
the interests of the researcher, institution, or sponsor
• Includes selective dissemination of data or findings
• Suppression of data and findings itself may not be a misconduct unless there is a
deliberate intention to deceive
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18. AVOIDANCE OF (ACCUSATION OF) MISCONDUCT
• Keep research records sufficient to reconstruct work done
• – Verify that work has been done
• – Avoids repeating what is already done
• – Verify who had contributed to the work
• Know or comply with relevant regulations
• Encourage open communications
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19. • If in doubt, ASK
• If you are guilty of misconduct, STOP, admit it, and take corrective actions
• If you witness misconduct, ACT
• Mentoring
• – Experienced researchers should guide those new to research
• – Experienced researchers should approach mentoring not as a burden but as an honor
• – Inexperienced researchers should seek guidance from those with experience; seeking
guidance should not be seen as a sign of ignorance but rather as a positive move to increase
knowledge One can always seek new information alone but good mentors make the journey
shorter and more rewarding
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