1. Ethical Theories and Principles in Clinical and Research
Aung Myo Tun

2. 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

3. Ethical Theories Utilitarian theory Kantian theory Rights theory
Virtue theory

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

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

7. 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

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

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

11. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

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

21. 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

30. Thank You.