[Clinical drug research from medical ethics and legal perspectives].
Medical ethics and law in clinical drug research are the two main points that have been discussed in public and medical circles. Conducting drug research on "easily affected and vulnerable groups", such as psychiatric patients, has always been a controversial issue in medicine. How should human subjects be protected, especially psychiatric patients, who are defined as "vulnerable subjects and groups"; what are the ethically and legally justifiable reasons for basing drug research on psychiatric patients; and what can be said about responsibilities in the context of medical ethics and law? Patients who are in the mentioned groups can not be informed clearly about the characteristics of research which they would be involved in. In recent years psychiatric, geriatric, anesthesiology and pediatric patients are defined as "patients who do not have the ability for consent". In this article answers will be given to questions such as why medical ethics is interested in clinical drug research, and what kind of roles should ethics play in drug research. The situation worldwide will be analyzed from a historical approach with regard to laws and regulations concerning drug research. The legal rights of human subjects who have the ability to give informed consent and of those who do not will be discussed and the place of psychiatric patients as human subjects in drug research will be addressed. Some unethical examples and their consequences will be considered and discussed. In this context, a critical evaluation will be made of the situation in Turkey.
Ornek Büken
Nüket
N
Hacettepe U Tip Fak., Deontoloji, Tip Etiği Tarihi AD, Ankara.
Büken
Erhan
E
D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence*; D015507:Drugs, Investigational; D004992:Ethics, Medical; D032984:Ethics, Research; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy*; D011619:Psychotropic Drugs / Q000627:therapeutic use*; D014421:Turkey
D015507:Drugs, Investigational; D011619:Psychotropic Drugs