Ethics of Research: Introduction

Ethics is a general term for what is often described as the "science of morality"

Ethics of research was not given much thought prior to the Nazi Era. This Era showed how cruel humans treated each other under the guise of research.

Ethics committees formed after World War II ethical codes were written.

---

Before the Nazis

Albert Neisser tested a vaccine against syphilis and proceeded to infect prostitutes with the disease. This was considered a criminal act and led to the introduction on the first laws regarding informed consent.

---

The Doctors' Trial

---

The Nuremberg Code

1. Informed consent. Voluntary consent of the human subject is absolutely essential

2. Good for society, necessary, not random. Experiment should be done with the intent that results are good for the society, cannot be achieved by any other means of study, and not random and unnecessary in nature.

3. Based on prior study or animal experimentation. Experiment should be designed on the basis of animal testing and knowledge of natural history of the disease, thus anticipating the results of the experiment.

4. Avoid suffering. The experiment should avoid all unnecessary physical and mental suffering and injury.

5. NO a priori death or disabling injury. No experiment should be conducted where there is an a priori reason to believe death or disabling injury will occur.

6. Degree of risk should not outweigh the benefit. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

7. Adequate facilities with proper preparation = prevent injury, disability, or death. Yeah, I don't think further explanation is required.

8. Conducted by experts. The highest degree of skill and care should be required through all stages of the experiment.

9. Subject autonomy to end the experiment. Human subjects should be at liberty to end the experiment when he has reached physical or mental state where continuation is impossible.

10. Judgement to end experiment IF experiment is likely to result in injury, disability, or death. End the experiment if it is dangerous

---

The Tuskegee Syphilis Study

• The presentation is broken. But this shows an experiment aimed at finding a cure for syphilis, which was a major concern as treatment was only successful in 30% of the cases. The experiments were done among black people and researchers continued the experiment knowing the dangers brought towards the subjects.

Beecher's conclusion

The ethical approach to experimentation has several components; two are more important than the others:

1. Informed consent

2. Intelligent, informed, conscientious, compassionate, and responsible investigator

---

The Belmont Report

Aim: Identify the basic ethical principle that should underlie human research.

Consideration:

• Boundaries between biomedical and behavioural research and the accepted routine practice of medicine

• The. role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects

• Appropriate guidelines for the selection of human subjects for participation

• The nature and definition of informed consent in various research settings.

In conclusion, there should be boundaries between research and practice. The basic ethical principles are respect (autonomy), beneficence, and justice. This should be applied when seeking for informed consent, assessment of risk and benefits, and selection of subjects.

---