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Institutional Review Board

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Submission Checklist(download)


Viterbo University Institutional Review Board  ●  900 Viterbo Dr ●  La Crosse, WI  54601 ●  608-796-3097

Please use this checklist to ensure that your protocol meets IRB requirements.

                  NAME _____________________________________________________________

                  ADDRESS  _________________________________________________________

                  TELEPHONE _______________________________________________________

                  ADVISOR __________________________________________________________

 

_____        Submit application no later than two weeks before the date of the IRB meeting on which the review is to occur.

 

                  COVERSHEET

_____        Completed

_____        Typed

_____        Signed (investigators, department IRB designate, and if appropriate, faculty advisor)

 

_____        ABSTRACT

_____        NIH Training Certificate  http://phrp.nihtraining.com/users/login.php                                      This is required for both the researcher and the research mentor.

 

                  PROTOCOL (5 pages maximum)

_____        Pages numbered

_____        Introduction and brief background

_____        Specific aims

_____        Materials and methods

                  a.   project description, including testing, instrumentation, interventions, etc.

_____        b.   how subjects are chosen

_____        c.   why specific subject population chosen

_____        d.   source of subjects

_____        e.   method of obtaining informed consent

_____        f.    costs and payments

_____        g.   flow chart (if applicable)

_____        h.  significance of the research

 

                  PROTECTION OF HUMAN SUBJECTS:  (Risk/Benefit Ratio)

_____        Procedure used to protect confidentiality

_____        Manner of recording information

_____        Use of audio and visual tapes and their disposition

_____        How long identifying information will be kept

_____        Deception or assent (if applicable)     

 

                  QUALIFICATIONS OF INVESTIGATOR(S)

_____        Faculty:        Short biographical sketch

_____        Student:      Short biographical sketch and letter from faculty advisor supporting the project.

 

                  CONSENT FORMS

                  Procedural Details:

_____        a.   Page 1 is on appropriate institution letterhead with 1” or greater margin at top

_____        b.   Title (consent form title and project title are the same)

_____        c.   Pages numbered (protocol and consent form numbered separately).

_____        d.   list all investigators, addresses, and business telephone numbers

_____        e.   Blank for subjects’ initials in lower right corner of each page of consent form.

_____        f.    Signature line for subject, witness, parent, corroborator.

 

                  Separate Consent Forms for:

_____        a.   adults in treatment group

_____        b.   control group

_____        c.   children

_____        d.   parent or guardian

_____        e.   other

 

                  CONTENT

_____        Description of study written in non-technical language

_____        Risks/benefits

_____        Alternative treatments, if applicable

_____        Costs and payments, if applicable

_____        Confidentiality and use of protected health information

_____        Dean's phone number

_____        Right to refuse or end participation

_____        No compensation for injury, if applicable

_____        Voluntary consent

_____        Acknowledgment of parent, if applicable

_____        Investigator's certification

 

                  ADVISOR'S STATEMENT (if applicable):

I , ______________________________________, am the Advisor

for ______________________________________.  My signature below indicates that I have read the enclosed protocol and have checked the contents with the IRB Guidelines.  Below (or on separate page) I have indicated this student's qualifications to perform this research.

 

Qualifications:

   

_____________________________________________

Advisor's signature