Research Ethics

Question 1

Outline the Nuremberg code

Answer 1

1. Required is the voluntary, well-informed, understanding consent of the human subject in a full legal capacity.
2. The experiment should aim at positive results for society that cannot be procured in some other way.
3. It should be based on previous knowledge (e.g., an expectation derived from animal experiments) that justifies the experiment.
4. The experiment should be set up in a way that avoids unnecessary physical and mental suffering and injuries.
5. It should not be conducted when there is any reason to believe that it implies a risk of death or disabling injury.
6. The risks of the experiment should be in proportion to (that is, not exceed) the expected humanitarian benefits.
7. Preparations and facilities must be provided that adequately protect the subjects against the experiment’s risks.
8. The staff who conduct or take part in the experiment must be fully trained and scientifically qualified.
9. The human subjects must be free to immediately quit the experiment at any point when they feel physically or mentally unable to go on.
10. Likewise, the medical staff must stop the experiment at any point when they observe that continuation would be dangerous.

Question 2

Outline the Declaration of Helsinki

Answer 2

1. Biomedical research involving human subjects must conform to generally accepted scientific principles, and be based on adequate laboratory and animal experimentation.
2. Design and performance of exp. procedure involving human subjects should be formulated in a protocol transmitted for consideration, comment and guidance to a specially appointed independent committee which is in conformity with local laws.
3. Experiment involving human subjects should be conducted by scientifically qualified persons, under the supervision of a clinically competent medical person. Responsibility for the human subject must always rest with a medically qualified person and never on the subjects, even though they have given consent.
4. The importance of the research objective must be in proportion to the inherent risk to the subject.
5. Research must be preceded by assessment of potential risks and benefits to subject and others.
Concern for the interests of the subject must always prevail over the interests of science and society
6. Respect the subject’s autonomy and privacy. Minimise harm.
7. Doctors should abstain from engaging in research unless satisfied that hazards involved are believed to be predictable. Doctors should cease investigation if hazards are found to outweigh potential benefits.
8. In publication of the results the physician is obliged to preserve accuracy. Reports not in accordance with the principles laid down in the Declaration should not be accepted for publication.
9. The potential subject must be adequately informed of aims, methods, potential benefits and hazards, discomfort, liberty to abstain from participation, freedom to withdraw at any time. Consent must be obtained preferably in writing.
10. Consent must be free from coercion or duress. In case of dependent relationship consent must be obtained by an independent physician.
11. In case of legal incompetence (inc. minors, psychiatric patients, mentally incap.) informed consent must be obtained from legal guardian, in accordance with national law.

Question 3

How does the requirement for consent differ between the Declaration of Helsinki and the Nuremberg code?

Answer 3

HD authorises consent from guardians/relatives of incompetents according to national legislation and permits the physician to omit informed consent under special circumstances