Malwina Pabiniak-Bęczkowska

Prawne i etyczne aspekty rezygnacji z uczestnictwa w badaniach klinicznych prowadzonych w Polsce
2015-11-18

Legal and ethical aspects of cancellation of participation in clinical trials carried out in Poland

This work came into existence with the thought about the summary messages about the participation of the participant in the clinical research and his possible resignation from the participation in examining in the reference to in force of regulations and ethical. My reading was a main aim from appropriate with legal documents and principles ethical applying to persons which they are absorbing oneself in one’s traineeship with examinations clinical. In the future career I am planning using the described issue to confirm of it with proper statistical analysis. In the article I concentrated on analysis of regulations mainly acts Pharmaceutical Law, of relevant regulations and legal documents, Code of Ethics of the Doctor. For exploring the issue I used also appropriate literature on the subject in the form of book publications. For years ethical principles were being developed and legal resolving the procedure of the conduct of research and the participation in them of examined persons. Leading the clinical research with the participation of people he is subject to a rigorous regulation legal, and observing appropriate standards he is ensuring the protection of rights and preserving conditions safeties of persons participating in examinations. Provisions of law contain different restrictions, but belongs of them ruthlessly and strictly to follow. International with medical, ethical and scientific standard in planning, running, documenting, of announcing results of the clinical research there are principles of the so-called best practice with the participation of people clinical, in short GCP (good clinical practice). A clinical research of the medical product is experiment medical with using the medical product conducted on people pursuant to a law about the medical professions and of doctor of the dentist. According to of pharmaceutical law clinical research it every examination conducted with the participation of people in order to discover or confirmations clinical, pharmacological, in it of pharmacodynamics effects action one or of many test products healing, in the destination of identifying adverse effects one or of substantial amount examined of medical products or keeping up with absorbing, of distribution, the metabolism and expelling one or of substantial amount of inspected. medical products, the safety having them on the account and the effectivene ss. In the clinical research both volunteers, and patients participate, which must to express to it voluntary conscious agreement. For expressing the informed consent he recognizes oneself expressed in writing, dated and signed declaration of intent about the participation in the examination clinical, folded voluntarily by the gifted person for filing such a statement, and in the case of person incapable of filing such a statement - by her legal guardian. Every clinical research should deliver replies to certain questions. In order to assure safety and the accuracy of the results, the clinical research they are being led according to the specific protocol. Every test phase serves other purposes in the process of drawing the medical product up. In every of three first phases of the clinical research one should inform participants about possible dangers and threats, for risk while examining. The clinical research on people is being commenced only upon completion of proper to screens and preclinical on animals. Signing the informed consent never means, that the decision is irreversible and it isn’t possible oneself from it to cancel. Every participant has the right to withdraw oneself from examining without stating the cause. Participant of clinical research must be conscious of it, his participation in the examination is voluntary can to retreat from it without prejudice to oneself, also has right to the interrogation and getting on not a reply. The patient should advise of doctor about one’s decision, and also to hold the visit test after the stated time, in the purpose of assessing of the state health upon completion of the participation in the examination. Doctor a duty is supposed to continue treating the patient after the resignation from examinations according to adopted principles of physic. Patient he is getting information about the medicine, and after acquainting in detail a conscious decision is being taken about the involvement in the clinical research or from it he is giving up. In the event that during the running of clinical research will appear any event, which could affect the safety of participants in the clinical research, the sponsor or the researcher they are giving from conducting the clinical research according to the protocol in force of the clinical research. If this is the case the sponsor and the researcher adequate means are supposed to apply the obligation in the destination of the safety assurance for participants of clinical research. The resignation of the participant in the clinical research can to be held at every stage examinations and in every for phase, and reasons for the resignation or refusals of the participation in examining healthy volunteers and patients they can be different and closely are tied from individual with phase of the clinical research. Detailed statistical data, being documentation of reasons for the resignation of participants in the clinical research, are largely with reflecting the quality of these examinations. Current legal status being in force in Poland is supporting the safety of participants in the clinical research, when is being followed by all sides involved in the running of these examinations.

Keywords: clinical research, documentation of resignation, legal and ethical regulation of clinical trials

© Farm Pol, 2015, 71(8): 471-476