Protection of Clinical Trial Subjects
Subject Protection in Clinical Trials

The application of GCP requirements, including human subject protection (HSP), is widely accepted as one of the primary conditions for conducting research involving humans in an ethically correct manner.  

1) The Directive shall be applied without prejudice to the national provisions concerning the protection of clinical trial subjects, if these provisions are more extensive than those contained in this Directive and conform to the procedures and time-limits set out herein. 

 The foreseeable risks

2) A clinical trial may be undertaken only if, in particular: 

  1. The predicted risks and drawbacks have been balanced with the expected advantages for a particular trial subject and other patients. The clinical investigation can begin only if the Ethics Committee and/or the relevant authority is confident that the anticipated therapeutic and public health benefits outweigh the risks and the project can continue as long as compliance with the requirement is permanently controlled; 
  1. Before the study, the participant or their representative had a chance during a prior discussion with the researcher or a member of the research team to find out what the aims and possible dangers of the study are, what problems might occur during the study, and that they have the right to withdraw their consent at any stage. 
  1. The rights of the subject to physical and psychological integrity, privacy, and protection of data relating to him in accordance with Directive 95/46/EC are respected;  
  1. The trial subject, or, if the subject is not capable of giving informed consent, his or her legally authorized representative has given his or her written consent after receiving adequate information regarding the characteristics, meaning, consequences, and risks of the trial; if the subject is unable to sign the document, in exceptional circumstances oral consent in front of at least one witness can be given according to national laws.  

1 There is no provision for the continuation of participation by the subject in the clinical trial if he wishes to withdraw at any time. 

2 The investigator and sponsor shall be indemnified or insured against any liabilities arising out of their involvement in the trial. 

3 All medical treatment and clinical decision-making regarding subjects in the trial is the responsibility of a qualified medical doctor, or in certain cases, a qualified dentist. 

4) The subject shall be given a contact point from which to obtain more information.