Ethics in Clinical Pharmacology

- Giovanni Monte, Ph.D.

National Cardiovascular Center Research Institute, Osaka, Japan

Eubios Ethics Institute Newsletter 2 (1992), 59.

Recently I had an interesting dinner with a group of clinical pharmacologists, and we discussed the ethical behaviour of clinical pharmacological investigators and their responsibility. This is a serious matter, since society, politicians, consumer groups and the mass media take an increasingly critical interest in clinical drug research.

Is it possible to do medical research according to ethics and law? Yes, I strongly believe that it is. After starting the discussion we soon realised that clinical pharmacologists do not sufficiently apply the ethical rules. Too often, they do not obey the rules because they need to find money quickly in their department, due to either internal or external pressure. The principal investigator of the project must be a good teacher for the junior investigators. But, very often, the principal investigator of the clinical trials asks some junior investigators to take the responsibility for applying the ethical rules. Also, sometimes, the principal investigator claim that the ethical rules do not allow him/her to pursue the investigation. I believe that it is the responsibility of the clinical pharmacologists to consider the ethical rules.

The pharmacology societies must be advised to report any unethical behaviour either by a single pharmacologist or a team. Guidelines for clinical pharmacologists are available in any local research ethics committee. All members of the committee must have all the information regarding the investigation and the clinical research must have public confidence. However, despite technological advance, ethical rules are not followed. Ethics comprises moral values and the law comprises enforceable rules. The law is used to regulate conflicting interests; and although it is based on ethical principles, it may sometimes conflict with them. Of course, law must be followed by moral justice. I believe that in clinical pharmacology, ethics and law must be strictly followed. Clinical pharmacologists have the privileges of conducting research in human beings, but they should not abuse their power. Law imposes the duty of care for others. The individual has a right of free choice in participating or not in a clinical trial.

At the end of the dinner we concluded that considering the high technological achievement in the last decade and as science has become international, it is necessary that every clinical pharmacologist takes on the full responsibility imposed by the ethical rules; and, we toasted for more ethical clinical pharmacologists in the future.

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