1. ETHICAL CONSIDERATIONS IN THE CONDUCT OF HEALTH SCIENCES RESEARCH

2. WHAT IS ETHICAL RESEARCH
A research is ethical when the researcher
Carry out the research competently, rigorously and methodologically
Manage resources with respect and integrity
Acknowledge fairly those who contribute guidance and asssitance
Communicate results accurrately
Consider the consequences of the research for the field of study in particular and for the society in general

3. FUNDAMENTAL ETHICAL PRINCIPLES
Three Fundamental Ethical Principles
Respect for Persons
Beneficence
Justice

4. RIGHTS OF PERSONS Right to self determination Right to privacy
Right to anonymity and confidentiality
Right to fair treatment
Right to protection from discomfort and harm

5. RESPECT FOR PERSONS Based on the following convictions
Individuals are autonomous that is they have the right to self determination.
This implies that they have the right to
decide whether or not to participate in a study, without the risk of penalty or prejudicial treatment.
Right to withdraw from a study at any time
Right to refuse to give information
Right to ask for clarification about purpose of study

6. DIMINISHED AUTONOMY
Individuals with diminished autonomy cannot decide fro themselves. These includes children (minors), mentally ill persons, unconscious patients and institutionalized persons Where power relations are present the individual may become vulnerable for example, prisoners, students whose lecturer is the researcher In some communities in Africa, individuals are not regarded as autonomous In these conditions special attention will have to be given to protect the right of these individuals

7. BENEFICENCE
The researcher must secure the well being of the participant. Thus the research must provide benefits. Any research that does not provide benefit is unethical
Who benefits from research?
The individual and the society
However the individual participant may not benefit from the research directly or immediately. Even benefits to the society may be delayed

8. NON MALEFICENCE
The complement of the principles of beneficence is NON MALEFICENCE which means the research must first do no harm
To adhere to this principle the researcher must protect the participants from all forms of harm such as the following

9. Physical harm
Psychological harm from stigmatization, discrimination, stereotyping
Emotional harm such as anxiety, depression, worry, etc
Spiritual
Economic harm e.g insurance policy decline, or insurance premium raise as a cnsequence of the research, economic goods boycot etc
Reputational harm
Social harm
Legal harm

10. Thus the concept of risk benefit ratio
It is noted that research may introduce some harm in the process of obtaining benefits. Thus the principle of beneficence and non maleficence is futher clarified to include the following
First benefit
Then do no harm
Then minimise harm
Thus the concept of risk benefit ratio

11. What is the cost of the benefit
What is the cost of the benefit? Can the benefit be obtained through another methods that is less costly- RISK-BENEFIT RATIO
The duty of the researcher is to provide benefit and minimize harm

12. PRINCIPLE OF JUSTICE
The principle of justice refers to participants right to fair selection and treatment.
Fairness should be shown in selection of the study population, selection of the unit of enquiry.
Participants should not be selected because it convenient to do so or because the investigator wants them to benefit from a certain treatment

13. Justice should also be shown in sharing benefits of research especially when new drugs are discovered or the research leads to some economic benefits
Agreements for between participants in a research and the investigator should be respected. Agreements could be on compensation, puntuality, incentives, sharing of information or results etc

14. OPERATIONALIZING THE PRINCIPLES
Respect for persons
Privacy
Confidentiality
Anonymity
Consent
Beneficence and non maleficence
Assessing risk/benefit ratio
Justice

15. PRIVACY ISSUES
The investigator must respect the participants right to privacy
The participant has the right to determine in what circumstances research information is derived from him.
The participant has the right to determine the circumstances and extent to which information related to him is shared or not with other parties.

16. CONFIDENTIALITY
Confidentiality is the process of keeping the identities of participants in a study secret
In publishing the report of the study, investigators must ensure that the identities of the participants are kept secret.

17. Anonymity
The participant who agrees to research has the right to expect that the information collected from or about him remain anonymous. To be anonymous means to be nameless
To ensure anonymity the following can be done
Use number or code names for participants
Keep master list of code names in a safe place
Destroy the list of real names

18. Consent issues
The expression of personal autonomy implies that the individual freely decides to participate in a research process. To freely decide the individual must have the capacity to decide, be provided the information to decide and be free from every limitation that hinders that decision. Thus informed consent has three components
Information
Comprehension or understanding of the information
Choice of the individual (Consent or Dissent)

19. Information The information must be clear and documented
The information could be provided in the following forms
Written
Verbal
Taped
The choice of method depends on the careful
consideration of the individual participants
characteristics

20. Content of the information
Title of the research
Introduction to the research activities, researchers title and position, the purpose of the research, the selection of the paticipants and the population being studied, how the data will be collected, the risks involved in the study, the benefits, assurance of anonymity, confidentiality and privacy, voluntary nature of the participation, office of the researcher to answer any questions from the participants, name of contact peson
Signature for consent

21. Assessing risk-benefit ratio
Risk refers to the potential the the participants may be harmed during the research.
All research involves a certain amount of risk.
Benefits are the positive values that the research provides for example the the study’s potential contributions to knowledge, practicl value to the society and the benefit to the individual participant

22. The general rule is that the risk should not exceed the potential benefit to be gained by the study.

23. RESEARCH INTEGRITY
The researcher must demonstrate respect for the scientific community by protecting the integrity of scientific knowledge.
The researcher must be competent, rigorous accurrate and honest
The researcher must refrain from
Fabrication, falsification or forgery
Manipulation of design and methods
Selective retainment or manipulation of data
Plagiarism
Irresponsible collaboration