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ETHICAL ASPECTS OF HEALTH RESEARCH
Dr. Jayesh Patidarwww.drjayeshpatidar.blogspot.com
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 behaviourthe 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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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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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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– The principles of beneficence
– The principles of respect for human dignity
– The principles of justice
Ethical Principles in Research
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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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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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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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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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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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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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The principle of justice
This principle includes
The right to fair treatment
The right to privacy
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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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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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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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Informed consent
Meaning: It means that participants have adequateinformation regarding the research, are capable ofcomprehending the information, and have the power offree choice, enabling them to consent to or declineparticipation 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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Participant selection
Procedures
Potential risks or costs
Potential benefits
Confidentially pledge
Voluntary consent
Right to withdraw
Alternatives
Contact information
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Children
Mentally or emotionally disabled people
Physically disabled people
The terminally ill
Institutionalized people
Pregnant women
Vulnerable subjects
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External reviews and the protection ofhuman 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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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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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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Elements of a research critique
• Substantive dimensions
• Methodologic dimensions
• Interpretive dimensions
• Presentational and stylistic dimensions
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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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