Company: GIFLF
Filing Date: 2025-02-26
Form Type: 6-K
Source: 0001104659-25-017501
Chunk: 55

Company: Grifols SA
Filing Date: 2025-02-26
Form: 6-K
Chunk 55
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 clinical trials, including those with ethical ramifications.    
 The company adheres to three fundamental and universal principles that             
 guide the ethical considerations of its clinical trials, as outlined in its Human  
 Rights Policy.                                                                     
 We subscribe to three fundamental and universal principles:                        
 Clinical trials                                                                    
 Clinical trials are essential for advancing medical knowledge and providing        
 innovative medications to individuals with specific diseases or conditions.        
 Grifols is committed to protecting the rights, safety and well-being of            
 patients who participate in the clinical trials it leads or sponsors. All clinical 
 research led by Grifols or on its behalf adheres to the standards defined in       
 the International Conference on Harmonization of Technical Requirements            
 for Pharmaceutical Products for Human Use regarding Good Clinical                  
 Practice (ICH GCP); the protection of human beings under the Declaration           
 of Helsinki (1964); and applicable local laws and regulations.                     
 Clinical trials are described in a detailed protocol, which is submitted to        
 regulatory authorities and external ethics committees for their evaluation.        
 They only begin once a favorable decision has been handed down.                    
 RESPECT FOR PEOPLE: Respect for an individual’s ability to make                    
 decisions freely and independently, and protection of vulnerable                   
 groups of people who participate as research subjects. This principle              
 is expressed through informed consent forms.                                       
 WELFARE: Guarantee the health of people who participate in clinical                
 trials. Risks must be minimized and benefits maximized for all                     
 participants. For Grifols, protecting people’s health takes precedence             
 over professional and personal interests, research advances and the                
 search for knowledge.                                                              
 JUSTICE: Research must strike a balance between benefits and                       
 risks. All subjects must be treated with equal consideration, with                 
 no discrimination in the selection of subjects. Under this principle,              
 participants are never exposed to unsafe situations to benefit another             
 person. There is an obligation to safeguard the rights of vulnerable               
 groups.                                                                            
 Participants submit a written, signed and dated informed consent form. The         
 lead researcher (or assigned healthcare professional) provides appropriate         
 information, resolves any doubts and gives potential clinical-trial subjects       
 sufficient time to make an informed decision on their participation.               
 In order to maintain quality control, Grifols has standard operating               
 procedures that guarantee that the clinical trial and its related trial data       
 are documented and communicated data according to protocol, ICH GCP                
 principles and applicable regulatory requirements. In addition, Grifols has        
 detection procedures in place that allow clinical professionals to detect and      
 document possible fraud or misconduct in clinical trials.