Ethical Theories and Principles in Clinical and Research Aung Myo Tun

Moral Status Human properties Sentience Cognitive properties Moral agency Relationship Reference: Tom L. Beachamp and James F. Childress, 2013, Principles of Biomedical Ethics, Seventh Edition, Oxford University Press

Ethical Theories Utilitarian theory Kantian theory Rights theory Virtue theory

Ethical Principles Respect for Autonomy Nonmaleficence (Do no harm) Beneficence Justice

Biomedical Ethics Vs Research Ethics Respect for autonomy of person / patient / participant Beneficence Do no harm Justice Informed consent Benefit and risk Participants selection

Respect for autonomy of person Doctor - patient relationship informer, facilitator, co- ordinator, co-operator make clinical decision together Researcher - participant relationship abuse of doctor-patient relationship diminished autonomy special population voluntary participation

Beneficence Decide by doctor and patient Do no harm for terminally ill patients by Academic Board of University / Principal investigator done in healthy person

Justice Fairness Equity Distributive justice Equipoise Use of placebo Randomization Blind trial early termination of and withdrawal from clinical trials

Conditions for ethically justified research a goal of valuable knowledge a reasonable prospect that the research will generate the knowledge that is sought the necessity of using human subjects a favorable balance of potential benefits over risks to the subjects fair selection of subjects measures to protect privacy and confidentiality informed consent

1. Collaborative Partnership Clinical research is meant to serve a social goal to enhance the health and health care of people. Clinical research is not meant to be done to people but done with people. Autonomy, Beneficence, Justice

Autonomy, Beneficence, Justice 2. Social Value Not an end in itself has instrumental value because it generates knowledge that leads to improvement in health and health care. Without social value, research exposes participants to risks for no good reason and wastes resources. Autonomy, Beneficence, Justice

Autonomy, Beneficence, Justice 3. Scientific Validity Science and ethics do not conflict. Valid science is a fundamental ethical requirement. Research must be designed in a way that provides valid and reliable data. Scientific Design Autonomy, Beneficence, Justice

4. Fair Participant Selection Historically, population that were poor, uneducated, or powerless to defend their own interests were targeted for high-risk research. Requires that the research objectives be the primary basis for determining eligibility. Autonomy, Beneficence, Justice

5. Favorable Risk-Benefit Ratio The uncertainty is greater in early phase research. In case in which potential risks outweigh benefits to individual participants, the social value of the study must be sufficient to justify these net risks. Autonomy, Beneficence, Justice

Autonomy, Beneficence, Justice 6. Independent Review IRB, ERC, REC To minimize concerns regarding researchers’ conflict of interest and To ensure public accountability Autonomy, Beneficence, Justice

Autonomy, Beneficence, Justice 7. Informed Consent To show respect for the autonomy of individuals. Autonomy, Beneficence, Justice

8. Respect for Participant The ethical conduct of research does not end when informed consent is obtained. Researchers have ongoing obligations to treat individuals with respect from the time they are approached — even if they refuse enrollment — throughout their participation and even after their participation ends. Autonomy, Beneficence, Justice

Thank You.