100120L – RESEARCH ETHICS: RESEARCH ON HUMANS

Lecture for 6^th year medical students at KFMC Faculty of Medicine on 20^th January 2010 1-3pm by Professor Omar Hasan Kasule Sr.

1.0 HISTORICAL BACKGROUND

Early humans experimented with several plants and by trial and error found some to be useful as medicines and others to be poisonous. These early experiments were not planned in a systematic way neither were they documented.

Galen founded experimental medicine before 200 CE. Historical experiments were carried out by James Lind In 1747 on scurvy, Dr Edward Jenner in 1798 on small pox, and Goldberger in 1914 on pellagra. Community trials were carried out on vitamin C, the Salk and HBV vaccines, cardiac disease risk factors, and water fluoridation for dental caries. Clinical trials were on streptomycin in TB 1948, aspirin and vitamin C for cancer prevention, alpha-tocopherol and beta-carotene in lung cancer prevention in smokers.

Unethical experiments without informed consent were carried out in the 1940s, 1950s, and 1960s. The Nuremberg code of 1946 laid down rules on voluntary informed consent, unnecessary experiments, animal before human experimentation, physical and mental suffering, scientific qualification of researchers, freedom of subjects to withdraw, and stopping the investigation if patient are in danger.

The Helsinki Declaration of 1964 incorporated the Nurenberg code. Its basic principles were: conformity to generally accepted scientific principles, qualified researchers, risk benefit assessment, research subject welfare, and full disclosure before informed consent.

The Nuremberg and Helsinki codes on experimentation did not stop all unethical research. They were neither laws enforceable by the state nor moral standards enforced by conscience. They are an unsuccessful attempt at bridging the secular divide between morality and public life. New international conventions and national legislation have been used to give legal effect to many ethical guidelines.

2.0 PURPOSES OF THE LAW IN HUMAN EXPERIMENTATION

The permissibility of human research is based on the 5 purposes of the Law: morality, life, progeny, the mind, and wealth. If any of those 5 necessities is at risk permission is given to undertake human experiments that would otherwise be legally prohibited.

Therapeutic research fulfills the purpose of protecting health and life. Infertility research fulfils the purpose of protecting progeny. Psychiatric research fulfills the purpose of protecting the mind. The search for cheaper treatments fulfills the purpose of protecting wealth.

3.0 PRINCIPLES OF THE LAW IN HUMAN EXPERIMENTATION

Research is judged by its underlying and not expressed intentions.

Research is prohibited if there is no evidence to indicate that better treatment is likely to result.

Research is allowed if benefits outweigh the risks or if public interest outweighs individual interest. If the risk is equal to the benefit, prevention of risks from research has priority over pursuit of a benefit of equal worth.

The Law chooses the lesser of the two evils, injury due to disease or risk of experimentation.

The principle of custom is used to define standards of good clinical practice as what the majority of reasonable physicians consider as reasonable.

An existing treatment is continued until there is evidence to the contrary.

A physician can ignore results of a new experiment because of some inclination in his mind.

4.0 INFORMED CONSENT

Informed consent by a legally competent research subject is mandatory. Informed consent does not legalize risky non-therapeutic research with no potential benefit. It is illegal to force participation of the weak (prisoners, children, the ignorant, mentally incapacitated, and the poor) in clinical trials even if they sign informed consent forms.

5.0 OUTSTANDING ETHICO-LEGAL ISSUES

Research on fetal human tissues may encourage abortion.

Cadaver dissection and post mortem examination are permitted under necessity.

Use of human bodies in auto crass experiments violates human dignity.

Genetic experiments may cause diseases hitherto unknown.

The Law allows research on ageing as long as the aim is not prolongation of life or preventing death because those aspects are under divine control.