Informed Consent
                    
                    
                        
                          
                            
                          
                        
                        
                          
                            
                          
                        
                     
                        What does 'informed consent' mean?
                    
                
            	Informed consent provides the individual with the pertinent information regarding the research in which s/he is being asked to participate, and the opportunity to make an informed decision regarding whether or not to participate in the research. The primary purpose of informed consent is to protect the prospective human subject.
                    
                    
                        
                          
                            
                          
                        
                        
                          
                            
                          
                        
                     
                        How do I write an informed consent form?
                    
                
            	The informed consent form documents the information regarding the research that the subject has been given, and his/her agreement to participate in the research. More information:
                    
                    
                        
                          
                            
                          
                        
                        
                          
                            
                          
                        
                     
                        Must I always use an informed consent form?
                    
                
            	No. A waiver of documented informed consent may be granted by the Institutional Review Board in certain circumstances. However, in such cases, the subject must give verbal informed consent and an information sheet similar to the informed consent form is often required.
                    
                    
                        
                          
                            
                          
                        
                        
                          
                            
                          
                        
                     
                        What is the difference between 'consent' and 'assent'?
                    
                
            	Minors (nonemancipated individuals younger than 18) may not give legal informed consent. In research involving minors, informed consent must be obtained from the minor’s parent or guardian. This does not mean that the minor has no say in whether they participate in the research, however. In cases where the minor is able to understand what his/her participation would entail, informed assent must be obtained from the minor.
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Still Have Questions?
- Marissa Hamilton, Associate Director, Human Research Protection Program
- Michelle Rosie, Senior Analyst, Human Research Protection Program
Contact Information
                                                                                                        Human Research Protection Program
                                                                                        
                                                                                                            Bernstein-Marcus 2nd floor, MS 116
                                                                                        
                                                                                                            Brandeis University
                                                                                        
                                                                                                            415 South Street
                                                                                        
                                                                                                            Waltham, MA 02453
                                                                                            
                                                                                                        Phone: 781-736-8133
                                                                                        
                                                                                                            Fax: 781-736-2123
                                                                                        
                                                                                                            hrpp@brandeis.edu