1. ETHICAL ASPECTS OF HEALTH RESEARCH

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

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.

4. Ethical dilemmas in conducting research
Does a new medication prolong life in cancer patients?
Codes of ethics
Nuremberg code
Declaration of Helsinki by the World Medical Assembly
Belmont report

5. Ethical Principles in Research
The principles of beneficence
The principles of respect for human dignity
The principles of justice

6. The principle of beneficence
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

7. Major potential costs to participants
Physical harm
Physical discomfort, fatigue or boredom
Psychological or emotional distress
Loss of privacy
Loss of time
Monetary costs

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

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

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

11. Issues relating to the principle of respect
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

12. The principle of justice
This principle includes
The right to fair treatment
The right to privacy

13. Features of fair treatment
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

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

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

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

17. Contd… Participant selection Procedures Potential risks or costs
Potential benefits
Confidentially pledge
Voluntary consent
Right to withdraw
Alternatives
Contact information

18. Vulnerable subjects Children Mentally or emotionally disabled people
Physically disabled people
The terminally ill
Institutionalized people
Pregnant women

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

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.

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

22. Elements of a research critique
Substantive dimensions
Methodologic dimensions
Interpretive dimensions
Presentational and stylistic dimensions

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.

24. THANK YOU