IRB Manual

 

4.4

 

Signature Statements

  4.4.1

Consent to Research Participation

     

I voluntarily consent to participate in this research study described above.  I may choose not to participate, or to discontinue participation at any time, without any penalty or  loss of benefits to which I am otherwise entitled.


________________________                        
Patient’s Name                                                   
________________________                         __________
Patient’s Signature                                              Date


  4.4.2

Person Obtaining Consent

     

I believe that this consent is freely given, by a subject with sufficient capacity to consent. The subject has been given all of the information deemed necessary by the IRB or requested by the subject.
_____________________________                        
Name of Person Obtaining Consent
_____________________________          ___________
Signature of Person Obtaining Consent          Date

( Note: The purpose of this signature is to confirm that the subject was fully informed, was not coerced, was capable of consenting and consented to participate.)

  4.4.3

Capacity Assessment (should be a separate page from subject signature)

     

When an independent assessment of capacity is conducted:
I have examined              (name of subject)                        on     (date)        
for the purpose of determining whether he/she is capable of understanding the
purpose, nature, risks, benefits and alternatives (including non-participation)
of the research, making a decision about participation, and understanding that
the decision about participation in the research will involve no penalty or loss
of benefits to which the patient is otherwise entitled for Dr. (investigator name)
research project,                    (name of project)                                              .
           
On the basis of this examination, I have arrived at the conclusion that:
             A.  This patient has capacity at this time.
             B.  There is a question about this patient’s capacity at this time.
             C.  This patient clearly lacks this capacity.
Signature                                                          Date                                            

 

  4.4.4 Treatment Team Approval (Signature Form)
     

For all studies that involve more than minimal risk:
Participation in the research project described above will not come into substantial conflict with
                        (name of subject)             's treatment plan and is approved by the treatment team.
                                                                                                                                         
Signature                                                 Date


       
     


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