ETHICAL CONSIDERATIONS IN THE CONDUCT OF HEALTH SCIENCES RESEARCH

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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.

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

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)

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

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

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

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

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