Respect for free and informed consent Respect for vulnerable persons Respect for privacy and confidentiality Respect for justice and inclusiveness Balancing harms and benefits Minimizing harm Maximizing benefit Respect for human dignity Human dignity is the recognition that human beings possess a special value intrinsic to their humanity and as such are worthy of respect simply because they are human beings. Cardinal principle of research which protects the multiple and interdependence interests of the person from physical, psychological and cultural integrity. Has 2 essential components: 1. selection and achievement of morally acceptable ends 2. morally acceptable means to those ends. There is need to define acceptable ends in terms of benefits of research for subjects, associated groups and for the advancement of knowledge. There is also need to find ethically appropriate means to conduct the research. Respect for free and informed consent Individuals are presumed to have capacity and right to make free and informed decisions. This is the process of communication between researcher and participant that leads to agreement or permission for research. This can be done with the issuing of a consent form issued by the researcher to the participant which is then signed as an evidence of consent. All material information should be given to a participant before they can given their consent. Also called substantial understanding, autonomous action, Violations include controlling influences, Coercion and manipulation Respect for vulnerable persons
Ethical obligations towards vulnerable persons
Diminished competence Diminished decision-making capacity Entitled to special protection, special procedures to protect their interests Entitlement (based on grounds of human dignity, caring, solidarity, fairness) to special protection against abuse, exploitation, discrimination These individuals may include children and institutionalized persons Respect for privacy and confidentiality
In many cultures are considered fundamental to human dignity
Standards protect the access, control and dissemination of personal information This helps to protect mental and/or psychological integrity The study should therefore be in consonant with values underlying privacy, confidentiality with anonymity respected Respect for justice and inclusiveness
Justice connotes fairness and equity
Procedural justice Involves the application process which shows fair methods, standards and procedures for reviewing research protocol. Distributive justice This implies that no segment of the population should be burdened with harms of the research Avoids exploitation of vulnerable individuals for the advancement of knowledge. Balancing harms and benefits
Balance critical to ethics of human research
Foreseeable harms should not outweigh anticipated benefits Harms-benefits analysis affects welfare and rights of subjects Such concerns are particularly evident in the biomedical and health research Minimizing harm Duty to avoid, prevent or minimize harm No unnecessary risk of harm Participation must be essential to achieving scientifically and societally important aims that cannot be realized without the participation of human subjects The principle of minimizing harm requires smallest number of human subjects that will ensure valid data Maximizing benefit
Principle imposes a duty to benefit others
The duty to maximize net benefits Produce benefits for subjects themselves, other individuals Produce benefits for society as a whole and for the advancement of knowledge (usually the primary benefit) Ethics approval boards in Zimbabwe
Ministry of Health and Child Care (MOHCC)
Medical Research Council of Zimbabwe (MRCZ) Research Council of Zimbabwe (RCZ) Medicines Control Authority of Zimbabwe (MCAZ) Joint Research Ethics Council of Zimbabwe (JREC)