The Declaration of Helsinki and ethics

Question 1

what are the 10 parts of the Nuremberg code

Answer 1

1. The voluntary consent of the human subject is absolutely essential.
2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
5. No experiment should be conducted where there is an a prior reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
6. 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. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Question 2

when was the declaration of Helsinki made

Answer 2

1964 - reached an agreement, has been amended 10 times so far - last version in 2013

Question 3

name 5 of the key principles of the declaration of Helsinki

Answer 3

• requirement of consent
• The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions
• While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.
• In medical practice and in medical research, most interventions involve risks and burdens. = Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.
• Medical research should be conducted in a manner that minimises possible harm to the environment.
• Research involving humans must conform to generally accepted scientific principles

Question 4

what does a research ethics committee do

Answer 4

The main responsibility of a research ethics committee is to protect potential participants in the research, but it must also take into account potential risks and benefits for the community in which the research will be carried out
- they are independent of the research

Question 5

Who can make consent for you

Answer 5

• power of attorney
• proxy
• professional legal representative - usually a nurse and acts in the assumption that the patient would have given their consent if they could have