MONTANA STATE UNIVERSITY
Request for Designation of Research as Exempt from the
Requirement of Institutional Review Board Review
(updated 3/22/05)

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[Include copies of PI's and Co-PI's "Completion Certificate(s)" as proof that all have received the education and instructions for researchers using human subjects.  The preferred instruction and education is: Protecting Human Research Participants (http://phrp.nihtraining.com)

THIS AREA IS FOR INSTITUTIONAL REVIEW BOARD USE ONLY. DO NOT WRITE IN THIS AREA.

Confirmation Date:

Application Number:

PLEASE TYPE.  SUBMIT ONE (1) COPY OF THIS APPLICATION , ALONG WITH ONE (1) COPY OF THE SUBJECT CONSENT FORM AND ALL OTHER RELEVANT MATERIALS, TO INSTITUTIONAL REVIEW BOARD CHAIR, MARK QUINN, 960 TECHNOLOGY BLVD., ROOM 127, MONTANA STATE UNIVERSITY, BOZEMAN, MT 59717-3610.  SUBMIT ONE COPY OF GRANT CONTRACT PROPOSAL.  FOR INFORMATION AND ASSISTANCE, CALL 994-6783.
Date:

I. INVESTIGATOR:

Name:
Department/Address:
Telephone:
E-Mail Address:
  DATE TRAINING COMPLETED:
Name of Faculty Sponsor:
         (if above is a student)
Signature: ________________________________________________


II. TITLE OF RESEARCH PROJECT:




III. BRIEF DESCRIPTION OF RESEARCH METHODS (also see section VII):




IV. RISKS AND INCONVENIENCES TO SUBJECTS (also see section VII):




V. SUBJECT:

A. Expected numbers of subjects: __________
B. Will research involve minors (age <18 years)?     Yes     No
      (If 'Yes', please specify and justify.)
C. Will research involve prisoners?    Yes    No
D. Will research involve any specific ethnic, racial, religious, etc. groups of people?   Yes    No
      (If 'Yes', please specify and justify.)
               
E. Will a consent form be used? (Please provide a copy.)  

VI. FOR RESEARCH INVOLVING SURVEYS OR QUESTIONNAIRES:

A. Is information being collected about:

     Sexual behavior?                             Yes      No

     Criminal behavior?                           Yes      No

     Alcohol or substance abuse?            Yes      No

     Matters affecting employment?         Yes      No

     Matters relating to civil litigation?      Yes      No
 
B.  Will the information obtained be completely anonymous, with no identifying information linked to the responding subjects?      Yes      No
 
C.  If identifying information will be linked to the responding subjects, how will the subjects be identified?

      By name                                                   Yes    No

      By code                                                    Yes    No

      By other identifying information                  Yes    No
 
D.  Does this survey utilize a standardized and/or validated survey tool/questionnaire?      Yes    No
 

VII. FOR RESEARCH BEING CONDUCTED IN A CLASSROOM SETTING:
  A. Will research involve blood draws? Yes    No
  If Yes, please follow protocol listed in the: "Guidelines for Describing Risks: blood, etc.", section I-VI.)

VIII.
 FOR RESEARCH INVOLVING PATIENT INFORMATION, MATERIALS, BLOOD OR TISSUE SPECIMENS RECEIVED FROM OTHER INSTITUTIONS: 
  
  A. Are these materials linked in any way to the patient (code, identifier, or other link to patient identity)?      Yes    No
 
B. Are you involved in the design of the study for which the materials are being collected?   Yes     No
  
C. Will your name appear on publications resulting from this research?    Yes    No
  
D. Where are the subjects from whom this material is being collected? 
 
  E. Has an IRB at the institution releasing this material reviewed the proposed project?    Yes    No
(If 'Yes", please provide documentation.)
  
F.


 Regarding the above materials or data, will you be:

     Collecting them     Yes     No
     Receiving them      Yes     No
     Sending them         Yes    No
  
G. Do the materials already exist?     Yes     No
  
H. Are the materials being collected for the purpose of this study?     Yes     No
  
  I. Do the materials come from subjects who are: 
     Minors                   Yes     No
     Prisoners                Yes     No
     Pregnant women     Yes     No
 
J.


 Does this material originate from a patient population that, for religious or other reasons, would prohibit its use in biomedical research?    Yes     No      Unknown source 
 


IX.

 FOR RESEARCH INVOLVING MEDICAL AND/OR INSURANCE RECORDS
 
A.


 Does this research involve the use of:
        Medical, psychiatric and/or psychological records   (Yes  or  No)
        Health insurance records   (Yes  or  No)
        Any other records containing information regarding personal health and illness    (Yes  or  No)
 
    If you answered "Yes" to any of the items in this section, you must complete the HIPAA Worksheet.