Ethics Flashcards
Define the term research
Research refers to a class of activity designed to develop or contribute to generalizable knowledge.
Define research involving human paticipants based on WHO
‘any social science, biomedical, behavioural, or epidemiological activity that entails systematic collection or analysis of data with the intent to generate new knowledge, in which human beings are involved
Research involving human participants includes:
i. Studies of a physiological, biochemical or pathological process, in healthy participants or patients.
ii. Studies of the response to a specific physical, chemical or psychological intervention in healthy participants or patients.
iii. Controlled trials of diagnostic, preventive or therapeutic measures in larger groups of persons.
iv. Studies designed to determine the consequences of specific preventive or therapeutic measures for individuals and communities.
v. Studies concerning human health-related behaviour in a variety of circumstances and environments.
Importance of research
a) Progress in medical care and disease prevention depends upon an understanding of physiological and pathological processes or epidemiological findings, and requires at some time research involving human participants.
b) The collection, analysis and interpretation of information obtained from research involving human beings contribute significantly to the improvement of human health.
c) Research has brought a better quality of life and increased welfare.
d) We owe our present standard of living to the huge amount of research that has made it possible e) Huge numbers of lives have been saved.
f) Advances in our basic understanding of nutrition, sanitation and the environment have had a profound impact on life expectancy and the quality of life.
g) Knowledge may be good for its own sake.
The Necessity for Research involving human beings
i. Monitoring and evaluating treatment’s effectiveness
ii. Development of new treatments –drugs/devices/etc
iii. Answering the unanswered questions in physiological sciences, Pathology, Health management
iv Investigation of other factors in human health.
1.2.5. Rights of Human Research Participants
(i) The respect for their autonomy
(ii) Being informed on issues relating to their health and other matters.
(iii) Being protected against injuries, harm, abuse or exploitation etc.
(iv) Being compensated for costs,injuries, or harm
(v) Having all their issues handled confidentially and respecting their privacy
(vi) Being given a good standard of health care.
(vii) The right to report any abuse of any of their rights or welfare to relevant authorities
What is research ethics
Research ethics is the application of moral rules and professional codes of conduct to the collection, analysis, reporting and publication of information about research participants, in particular active acceptance of participants’ rights to privacy, confidentiality, and informed consent.
What is research ethics
Research ethics is the application of moral rules and professional codes of conduct to the collection, analysis, reporting and publication of information about research participants, in particular active acceptance of participants’ rights to privacy, confidentiality, and informed consent.
The objectives in research ethics
i To protect the rights and welfare of participants and minimise the risk of physical and mental discomfort, harm and/or danger from research procedures
ii. To ensure that research is conducted in a way that serves interests of individuals, groups, and/or society as a whole.
iii. To examine specific research activities and projects for their ethical soundness, looking at issues such as the management of risk, protection of confidentiality and the process of informed consent.
The objectives in research ethics
i To protect the rights and welfare of participants and minimise the risk of physical and mental discomfort, harm and/or danger from research procedures
ii. To ensure that research is conducted in a way that serves interests of individuals, groups, and/or society as a whole.
iii. To examine specific research activities and projects for their ethical soundness, looking at issues such as the management of risk, protection of confidentiality and the process of informed consent.
Principles of Research Ethics
- Respect for Persons
Respect for persons incorporates at least two fundamental ethical considerations, namely:
a) Respect for autonomy, which requires that those who are capable of deliberation about their personal choices should be treated with respect for their capacity for self-determination; and
b) Protection of persons with impaired or diminished autonomy, which requires that those who are dependent or vulnerable be afforded security against harm or abuse. - Beneficence
Beneficence refers to the ethical obligation to maximize benefits. - Non-maleficence.
Non-maleficence requires one to do no harm and to protect others from harm. - Distributive Justice.
requires the equitable distribution of both the burdens and the benefits of participation in research.
1.4. Conflict of role/interest
The medical practitioner’s role in doctor-patient relationship is different from the researcher’s role in the researcher-HRP relationship. And yet the doctor and researcher are the same person and patient and HRP may also be the same person. Thus, there is a potential conflict between these roles.
When this conflict occurs, the doctor –patient relationship must take precedence over the researcher –HRP relationship.
This means that the doctor must be prepared to withdraw the patient from participation in the research.
Principles of Research Ethics
- Respect for Persons
Respect for persons incorporates at least two fundamental ethical considerations, namely:
a) Respect for autonomy, which requires that those who are capable of deliberation about their personal choices should be treated with respect for their capacity for self-determination; and
b) Protection of persons with impaired or diminished autonomy, which requires that those who are dependent or vulnerable be afforded security against harm or abuse. - Beneficence
Beneficence refers to the ethical obligation to maximize benefits. - Non-maleficence.
Non-maleficence requires one to do no harm and to protect others from harm. - Distributive Justice.
requires the equitable distribution of both the burdens and the benefits of participation in research.
1.4. Conflict of role/interest
When medical practitioners are accountable to the patient and also to a third party e.g. government or employer etc. and if the accountabilities are not compatible, the physician shall owe his/her patients complete loyalty.
However, it is generally accepted that; in exceptional situations, physicians may have to place the interest of others above those of the patient.
1.5. Dual loyalty
When medical practitioners are accountable to the patient and also to a third party e.g. government/employer/insurer/military or police or prison official/family member(s) etc., and if the accountabilities are not compatible, the physician shall owe his/her patients complete loyalty.
However, it is generally accepted that; in exceptional situations, physicians may have to place the interest of others above those of the patient.
