Question

Ramasakhi Devi from India is 55 years old and had a cancerous tumour removed from her cheek. Then, she was informed that in order to receive necessary follow-up chemotherapy and radiation treatment, she would need to sign up for a clinical trial. Although the consent forms were in English and Hindi, Devi was illiterate. Her son tried to help but even he misunderstood the forms, and told his mother there was only one available treatment option in the trial instead of three. Moreover, Devi never understood that she could drop out and thought she had to finish the treatment regimen to be fully cured.

Question: Is it ethical to conduct experiments on human in this situation? Explain with reference to the Nuremberg code.

Answer 1

Ans: No, it is not ethical to conduct experiments in this situation.

According to Nuremberg code-

1. Voluntary consent is mandatory and here, Ramasakhi Devi didn't understand the possible repercussions of the treatment and so, didn't give her consent also as she is illiterate.

2. The results of an experiment must be for the greater good of society and here if the treatment fails, it won't really make a difference to the society.

3. Human experiments should be based on previous animal experimentation

4. Experiments should be conducted by avoiding physical/mental suffering and injury but the treatment can cause additional injury

5. No experiments should be conducted if it is believed to cause death/disability but here, death can be the possible repercussions of the treatment and so, it is unethical

6. The risks should never exceed the benefits and here, the chances are equal

7. Adequate facilities should be used to protect subjects but still, after complete precautions subject harm can occur