Ethical aspects of health research nursing research

1. ETHICAL ASPECTS OF
HEALTH RESEARCH
Dr. Jayesh Patidar
www.drjayeshpatidar.blogspot.com

2. Ethics
Definition:
(It has several meanings is common use it
refers to).
It refers to,
a method of inquiry that helps people to
understand the morality of human behaviour
the practices or beliefs of a certain group and
the expected standards of moral behaviour of
a particular group as described in the groups’
formal code of professional ethics.
Bioethics is ethics as applied to life
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3. Contd…
 The need for ethical guidelines
 To protect the rights of the human beings
 Historical background
 The Nazi medical experiments of the
1930’s and 1940’s
 In USA Tuskegee syphilis study
 In Jewish chronic disease hospital,
Brooklyn
 1993, Atomic Energy commission, a US
Federal Agency.
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4. Ethical dilemmas in conducting research
 Does a new medication prolong life in
cancer patients?
Codes of ethics
 Nuremberg code
 Declaration of Helsinki -1964 by the World
Medical Assembly
 Belmont report
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5. – The principles of beneficence
– The principles of respect for human
dignity
– The principles of justice
Ethical Principles in Research
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6.  Freedom from harm
 Freedom from exploitation
 Benefits from research
 The risk /benefit ratio
 Major potential benefits to participants
 Access to an intervention
 Increased knowledge
 Escape from normal routine
 Share the information with others
 Chance to discuss their problems
 Direct monetary or material gains
The principle of beneficence
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7. Major potential costs to
participants
o Physical harm
o Physical discomfort, fatigue or
boredom
o Psychological or emotional distress
o Loss of privacy
o Loss of time
o Monetary costs
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8. The principle of respect for human dignity
 Respect for human dignity includes
 The right to self determination are the two
major elements
 The right to full disclosure on which
informed
consent is based
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9. The right to self determination
Meaning: The right to self determination
means that prospective participants have
the right to decide voluntarily on
 To participate in a study
 To terminate their participation
 To refuse to give information
 To ask for clarification
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10. The right to full disclosure
Meaning: Full disclosure means that the
research has fully described the nature of
the study
• The participant’s right to refuse
participation, > the researcher’s
responsibilities
• The likely risks and benefits
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11.  Inability to make well informed to certain individuals
 Researcher’s feeling on violation for the research to field
meaningful information.
 When full disclosure poses the risk of biased results
 The researchers sometimes use covert data collection or
concealment or use deception
Issues relating to the principle of respect
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12. The principle of justice
 This principle includes
 The right to fair treatment
 The right to privacy
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13.  The fair and non discriminatory selection of participants
 The non prejudicial treatment of individual
 The honoring of all agreements made between the
researcher and the participant
 Participants’ access to research personnel at any point
of time
 Participant’s access to appropriate professional
assistance
 Debriefing or clarifying issues
 Respectful and courteous treatment at all times
Features of fair treatment
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14. The right to privacy
This can occur either through
 Anonymity
 Confidentiality procedures
 Steps to be followed to safeguard the
participants
 Obtain identifying information only when needed
 Assign an identification number and attach this
rather than other identifiers
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15. Contd…
 Maintain any identifying information and lists of
ID numbers in a locked file
 Restrict access to identifying information
 Enter no identifying information onto computer
files
 Destroy identifying information as quickly as is
feasible
 Get the sign of all research personnel on the
pledge of confidentially
 Report research information in the aggregate
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16. Informed consent
Meaning: It means that participants have adequate
information regarding the research, are capable of
comprehending the information, and have the power of
free choice, enabling them to consent to or decline
participation in the research voluntarily.
 The content of informed consent
 Participant status
 Study purpose
 Type of data
 Nature of the commitment
 Sponsorship
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17. Contd…
 Participant selection
 Procedures
 Potential risks or costs
 Potential benefits
 Confidentially pledge
 Voluntary consent
 Right to withdraw
 Alternatives
 Contact information
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18.  Children
 Mentally or emotionally disabled people
 Physically disabled people
 The terminally ill
 Institutionalized people
 Pregnant women
Vulnerable subjects
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19. External reviews and the protection of
human rights
 Human subjects committees or research
advisory panel
 Institutional review board
 Research critique is not just a review or
summary of a study, rather it is a careful
critical appraisal of strengths and
limitations of piece of research
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20. Steps in critical appraisal
of an article
Purpose:
 To develop a balanced evaluation of the
study’s contribution to knowledge
 Guidelines to consider on research critique
 Be sure to comment on the study’s
strengths as well as its limitations.
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21. Contd…
 Give specific example of the study’s
strengths and limitations
 Try to justify your criticism
 Be as objective as possible
 Be sensitive in handling negative
comments
 Suggest realistic alternatives that the
researcher might want to consider
 Evaluate all aspects of the study
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22. Elements of a research critique
• Substantive dimensions
• Methodologic dimensions
• Interpretive dimensions
• Presentational and stylistic dimensions
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23. Steps
• Critiquing research problems research questions and
hypotheses
• Critiquing research literature reviews
• Critiquing research theatrical and conceptual frameworks
• Critiquing research designs
• Sampling designs
• Data collection procedures
• Critiquing data quality and analyses and interpretation
• Critiquing ethical aspects of a study
• Critiquing the presentation of a research report.
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