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Guidelines for the Preparation of Informed Consent Forms

Vulnerable Research Populations

  1. Minors: When minors are used as research subjects, written informed consent must be obtained from the parent or legal guardian. Modify the informed consent form by substituting "my child" for "I". Also, Item 14 should be modified as follows: 

        I, the parent/legal guardian of the minor named below, acknowledge that the investigator has explained to me the need for this research, identified the risks involved and offered to answer any questions I may have about the nature of my child's participation. I freely and voluntarily consent to my child's participation in this study. I understand all information gathered during the interview will be completely confidential (or anonymous). I also understand that I may keep a copy of this consent form for my own information. 


    __________________________________
    Name of Minor Participant
     


    __________________________________
    Signature of Parent/Legal Guardian


    __________________
    Date


    __________________________________
    Witness (Signature)
     

    In addition, minors 12 years of age or older must be given the opportunity to refuse to participate. The assent of children 12 years of age or older should be documented as follows:

    Child's Assent:
           I understand why this research is being done. I understand how it may help me or other children and any discomforts it may cause me. I have been told that I don't have to give an answer if I do not want to and that I can stop the interview at any time for any reason. All the questions I had about this study have been answered. I would like to take part in this study. 


    __________________________________
    Name of Minor Participant


    __________________
    Date


    __________________________________
    Witness (Signature)
     
      
  2. Mentally Disabled Subjects: When subjects are not mentally capable of providing informed consent, Statement 14 should read: 

        I, the legal guardian of the research participant named below who is not currently able to give proper informed consent, acknowledge that the investigator has explained to me the need for this research, identified the risks involved and offered to answer any questions I may have about the nature of my ward's participation. I freely and voluntarily consent to my ward's participation in this study. I understand all information gathered during the interview will be completely confidential (or anonymous). I also understand that I may keep a copy of this consent form for my own information. 


    __________________________________
    Name of Participant
     


    __________________________________
    Signature of Legal Guardian


    __________________
    Date


    __________________________________
    Witness (Signature)
     
      
  3. Saint Xavier University Students: When Saint Xavier University Students are recruited for participation in a study, the following statement should be included in the informed consent form:

        I understand that my participation in this investigation may be discontinued at any time at my discretion or at the discretion of the investigators and will not influence my academic evaluation or grades at Saint Xavier University.
          
  4. Saint Xavier University Employees: When Saint Xavier University employees are used as research volunteers, Statement 14 of the informed consent form should be modified as follows: 

        I acknowledge that the investigator has explained to me the need for this research, identified the risks involved and offered to answer any questions I may have about the nature of my participation. As an employee of Saint Xavier University, I have been informed that participation in this study is not part of my University duties and that my participation or refusal to participate will not affect my employment with the University, or the benefits, privileges or opportunities associated with University employment. Furthermore, I affirm that:

        1. I have not been directed to participate in this study by my supervisors or by anyone else;
        2. I have not been threatened with loss of benefits, privileges or opportunities associated with University employment if I choose to participate; and
        3. I have not been offered any special consideration associated with University employment as a result of my participation. 
        I freely and voluntarily agree to participate in this study. I understand all information gathered during the interview will be completely confidential (or anonymous). I also understand that I may keep a copy of this consent form for my own information.


    __________________________________
    Signature of Voluntary Participant


    __________________
    Date


    __________________________________
    Witness (Signature)
     
      
  5. Prisoners: When prisoners are used as research volunteers, Statement 14 should read:

        I acknowledge that the investigator has explained to me the need for this research, identified the risks involved and offered to answer any questions I may have about the nature of my participation. As an inmate of a correctional facility, I have been informed that participation in this study is in no way a requirement of my incarceration and that my participation or refusal to participate will not in any way affect any benefits or privileges otherwise available to me. Furthermore, I affirm that: 

        1. I have not been directed to participate in this study by prison/jail officials or by anyone else;
        2. I have not been threatened with loss of benefits or privileges otherwise available to me if I choose to participate, and
        3. I have not been offered any special consideration related to my sentence as a result of my participation.
        I freely and voluntarily agree to participate in this study. I understand all information gathered during the interview will be completely confidential (or anonymous). I also understand that I may keep a copy of this consent form for my own information.


    __________________________________
    Signature of Voluntary Participant


    __________________
    Date


    __________________________________
    Witness (Signature)