ETHICAL ISSUES IN BIOMEDICAL RESEARCH

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Human biomedical research (HBR)

Human biomedical research (HBR) refers to any research on human subjects that involves: a. intervention on, interaction with, or observation of, humans; b. use or manipulation of any human biological derivative (e.g. human cells, tissues and body fluids), including those which were previously acquired and stored; c. review, analysis and publication of previously compiled identifiable data; for the purpose of studying, diagnosing, treating and/or preventing, any ailment, injury or adverse condition of the human mind or body.

Basic ethical principles

All HBR must be conducted in accordance with these three (3) fundamental ethical principles: a. Respect for persons b. Beneficence

c. Justice

Respect for persons

Respect for persons, which incorporates at least two (2) basic ethical considerations: i. 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 selfdetermination; ii. Protection of persons with impaired or diminished autonomy (such as children or the mentally disabled), which requires that those who are dependent or vulnerable be afforded additional security against harm or abuse.

Beneficence
Beneficence, which refers to the ethical obligation to maximize benefits and to minimize harm. In the research context, it is unlikely that direct benefit will accrue (to arise or spring as a growth or result) to research subjects. Consequently, harm and discomfort to subjects must be minimised and the risks of research must be reasonable and justified in the light of the expected benefits. This entails a sound research design, and investigators competent both to conduct the research and to safeguard the welfare of the research subjects.

Justice
Justice, which refers to the ethical obligation to treat each person in accordance with what is morally right and proper, and to give to each person what is due to him/her. For HBR, the investigator must ensure that potential benefits and risks are reasonably balanced and risks are minimized. Justice also requires that research be responsive to the health conditions or needs of vulnerable subjects. Accordingly, a researcher should: i. avoid imposing on any particular group of individuals who are likely to be subjects of over-researching and unfair participation in research; ii. ensure that the selection and recruitment of research subjects are fair; and iii. be non-discriminatory, and not use race, age, gender, disability or religious beliefs for the selection and recruitment of actual or future participants, except where such exclusion or inclusion of particular groups is essential to the objective of the research.

Other important ethical principles

Other important ethical principles include the respect for free and informed consent, and protection of privacy and confidentiality. A special attention must also be given to vulnerable persons, i.e. those with higher susceptibility to harms and/or with reduced ability to protect their rights and welfare, such as pregnant women, minors, prisoners and the mentally incapacitated.

STATEMENT OF GENERAL PRINCIPLES

Any research using the human beings as participants shall follow the principles given below 1. Principles of essentiality 2. Principles of voluntariness, informed consent and community agreement 3. Principles of non-exploitation 4. Principles of privacy and confidentiality 5. Principles of precaution and risk minimisation 6. Principles of professional competence 7. Principles of accountability and transparency 8. Principles of the maximisation of the public interest and of distributive justice 9. Principles of institutional arrangements 10. Principles of public domain 11. Principles of public domain 12. Principles of compliance

Arigato

Abhari ahi

Danyawadh Shukran