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Ethical Considerations in Human Experimentation

Another topic of my fav reportings

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Carl Arao-arao
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0% found this document useful (0 votes)
75 views2 pages

Ethical Considerations in Human Experimentation

Another topic of my fav reportings

Uploaded by

Carl Arao-arao
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

9.

Moral Issue of Human Experimentation

Aristotle- great Greek philosopher and is one of the great biologists of all time
“VIVISECTION”-latin vivus”living or alive”+sectionis which means cutting
-it is an ancient experimentation performed on living animals which includes man by
means of operations designed to promote some knowledge of physiological and pathological processes.

Nuremberg Code-it is a ten point statement of the principles that should be followed in conducting
human experimentations.

Justifications of Human Experimentation

1. To test of the correctness and effectiveness of medical treatments


2. Animal studies are inadequate because human physiology and psychology are different and
unique
3. Biochemical constitution and metabolism of humans are far different
4. Necessary if we want to develop new drugs, new therapies intended for humans

The basic moral issue is to advance medical knowledge so that the future patients of same case may be
healed; thus experimental patient is being used as a means for the benefit of future patients

*Medical Therapy or Therapeutic Experiment-it is designed and conducted for the benefit of the
experimental subject either to diagnose or to treat an illness. It aims at relieving the suffering of
experimental subject and restoring them to health.

*Medical Research (Non Therapeutic Experiment)-is an experiment designed only to derive knowledge
that can be utilized in the treatment of other persons with similar ailments.

*Informed Consent-it is a basic requirement for a medical research to be morally legitimate. Prospective
experimental subject must be briefed and informed about:
a. the humane purpose
b. the procedure
c. possible inconvenience and pain
d. the risk of the experiment
-the basic point in the informed consent is the recognition of an individual’s
Autonomy(right to self-determination) or the right to make decisions concerning one’s own life.

*Proxy Consent-it is intended for children, mental patients and prisoners; thus consent proxy is being
given by immediate relatives, patients or guardians.

Element of Informed Consent


1. Explanation of the procedures and their purposes; make it clear if it is experimental
2. Underscore the risks and discomforts of the procedure
3. Describe the possible benefits
4. Point out appropriate alternatives that might be helpful to the subject
5. Offer to answer any questions about the procedure
6. Make it clear to the subject that he/she is free to withdraw consent and abandon the research
project.

*Drug Testing-refers to the medical procedure whereby a new drug is tried and experimented to
determine its effectivity, usefulness, and other effects.

Twofold Procedure:
1. Preclinical Testing-done on animals; conducted to determine its therapeutic index(toxic or
nontoxic, effective or ineffective; indication of dosage, effect on body tissues and particular
organs; to check side effects and hazards)
2. Clinical Testing-is conducted with human beings as experimental subjects and carried out in 3
phases
1st phase-to determine whether it produces toxic effects on normal human volunteer
2nd phase-if results of 1st phase are acceptable; drug is administered to a limited number of
people
3rd phase-if it produces desirable results and no side effects based on 2nd phase then it is
administered on a large number of patients.
*Placebos-is a medically harmless ineffective substance (sugar or dummy pill) that is usually used in
testing a new drug when it is given to a control group.
- It avoids possible biases influences or prejudice in drug testing

Test Design in the Use of Placebo

1. Single Blind Test Design-one in which the evaluation of the results of a treatment is kept from
the patients who have received it to prevent any alteration of the results.
2. Double Blind Test Design-investigators and the patients involved are kept ignorant about the
process. Literally kept blind.

Justification of Placebo: Placebos legitimizes deception

Paternalistic-it is carried out for the patient’s own good and for others who are similarly situated.

Utilitarian-knowledge gained from them is socially valuable and beneficial for the needs of society
at large.

Application of Ethical Theories:

Utilitarianism-specifies sacrifices of a few will bring great benefits to the many

Kantian Ethics-informed consent must be obtained for both medical treatment and research to
Support the autonomous principle of Kant
Natural Law Ethics
Principle of Double Effect-if one decides to give his consent; it must be given freely
Principle of Totality-forbids a healthy individual to submit an experiment which
involves possibility of mutilation or death

Ross Ethics-human research must be based on what is right and not on what is useful

Rawl’s Principle of Justice-experiments which are violative of individual liberty are forbidden

Pragmatist-human experimentation that promises to yield great benefits to all human beings
Is acceptable

Common questions

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Human experimentation is justified for advancing medical knowledge to develop new treatments and improve health outcomes for future patients . To ensure moral legitimacy, the Nuremberg Code outlines that informed consent must be obtained, highlighting the procedure's purpose, risks, and benefits, while respecting the subject's autonomy . Ethical theories such as Utilitarianism and Kantian Ethics also emphasize the importance of maximizing benefits and ensuring autonomy through informed consent .

Clinical testing has three phases: the first phase tests toxicity on normal volunteers, raising ethical concerns regarding exposing healthy individuals to risk . The second phase involves administering the drug to a limited patient group, assessing safety and efficacy while ensuring informed consent . The third phase tests on a larger population to confirm effectiveness and monitor adverse reactions, requiring rigorous informed consent and ethical oversight to protect participant welfare .

Placebos serve as controls in clinical trials to determine the actual effectiveness of the experimental drug by eliminating psychological biases or placebo effects that can skew results . Single and double-blind test designs ensure unbiased evaluation by keeping patients and/or investigators unaware of who receives the actual treatment, thereby maintaining objective assessments of the drug's efficacy .

Medical therapy or therapeutic experiments are conducted to benefit the individual subject by diagnosing or treating an illness, aligning with ethical principles of beneficence and patient welfare . Conversely, non-therapeutic experiments aim to derive knowledge for treating others, with challenges in justifying individual risks when the subject does not directly benefit, highlighting ethical tensions in balancing collective knowledge gains against individual rights and safety .

Utilitarianism justifies the use of placebos as they provide valuable knowledge that benefits society by contributing to medical advancements . In contrast, Kantian ethics would challenge the use of placebos without informed consent as it breaches the autonomous principle, undermining respect for participants' rational decision-making and self-determination .

Pragmatist philosophy supports human experimentation if it promises substantial benefits for humanity, focusing on outcomes and practical results rather than ethical absolutes . This results in weighing the potential societal advancements against ethical considerations, such as individual autonomy and consent, suggesting a flexible approach to ethical norms based on outcomes rather than rigid adherence to predetermined rules .

Ross's ethics prioritize doing what is right over what is useful, emphasizing obligations to uphold integrity and moral duties in conducting human research . Rawl’s principle of justice prohibits experiments violating individual liberty, insisting on fairness and equality, leading to research practices that protect subjects' rights and ensure equal treatment under ethical frameworks .

Proxy consent is ethically justified for children, mental patients, and prisoners, who may lack the capacity to provide informed consent on their own. Immediate relatives, guardians, or appointed proxies grant consent on behalf of these individuals, aiming to protect their interests while enabling necessary research. Ethical justification hinges on the belief that proxies act in the best interest of the individual, balancing potential benefits against risks .

The principle of double effect in natural law ethics allows ethically permissible actions that may have harmful side effects if the intention is to achieve good effects . In human experimentation, this principle might justify participation if the subject consents freely, acknowledging the pursuit of a potential good outcome despite possible adverse effects .

Informed consent protects individual autonomy by allowing subjects to make informed decisions about their participation in research, thereby exercising their right to self-determination . Essential elements include explaining procedures and purposes, underscoring risks and discomforts, describing potential benefits, outlining alternatives, offering to answer questions, and ensuring freedom to withdraw without penalty .

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