MONTANA STATE UNIVERSITY
Institutional Review Board Application for Review
(click here for a link to MS Word doc)
Have you read the instructions? If not, return to the homepage and follow the link to the instructions and adhere to them. (Please use the MS Word doc form. If you use this form, delete the instructions prior to printing and submission.)
Beginning January 1, 2006, University policy requires that all protocols submitted from individuals NOT employeed by or students of Montana State University be charged a $500 review fee per application. Renewals for those proposals will be at no charge. Applications from private entities (i.e. projects not administered by MSU's Office of Sponsored Programs) will be charged the $500 fee per application. Renewals for those proposals will also be at no charge.
All investigators must complete the online training in the use of human subjects. Most investigators will need to choose the Behavioral Sciences Module. Use this link: Collaborative Institutional Training Initiative (CITI)
Please type your responses in bold. Do not use all capital letters.
THIS AREA IS FOR INSTITUTIONAL REVIEW BOARD USE ONLY. DO NOT WRITE
IN THIS AREA.
||IRB Chair's Signature:
I. Investigators and Associates (list all investigators involved; application will be filed under name of first
|| DATE TRAINING COMPLETED:
|Required training: CITI training (see IRB website for link)|
|| DATE TRAINING COMPLETED:
|Required training: CITI training (see IRB website for link)
(repeat for additional investigators if needed; or delete extra if not necessary)
Do you as PI, any family member or any of the involved researchers or their family members have consulting agreements, management responsibilities or substantial equity (greater than $10,000 in value or greater than 5% total equity) in the sponsor, subcontractor or in the technology, or serve on the Board of the Sponsor? _____ YES _____ NO. If you answered Yes, you will need to contact Pamela Merrell, Assistant Legal Counsel-JD at 406-994-3480.
II. Title of Proposal (please be sure this appears on the first page):
III. Beginning Date for Use of Human Subjects:
IV. Type of Grant and/or Project (if applicable)
V. Name of Funding Agency to which Proposal is Being Submitted (if applicable):
Submitted by Investigator
Faculty sponsor (for student)
VII. Summary of Activity. Provide answers to each section and add space as needed. Do not
refer to an accompanying grant or contract proposal.
- A. RATIONALE AND PURPOSE OF RESEARCH (What question is being asked?)
- B. RESEARCH PROCEDURES INVOLVED. Provide a short description of sequence and
methods of procedures that will be performed with human subjects. Include details of painful
or uncomfortable procedures, frequency of procedures, time involved, names of psychological
tests, questionnaires, restrictions on usual life patterns, and follow up procedures.
- C. DECEPTION - If any deception (withholding of complete information) is required for the
validity of this activity, explain why this is necessary and attach debriefing statement.
- D. SUBJECTS
- 1. Approximate number and ages
How Many Subjects:
Age Range of Subjects:
How Many Normal/Control:
Age Range of Normal/Control:
- 2. Criteria for selection:
- 3. Criteria for exclusion:
- 4. Source of Subjects (including patients):
- 5. Who will approach subjects and how? Explain steps taken to avoid coercion.
- 6. Will subjects receive payments, service without charge, or extra course credit? (Yes
or No. If yes, what amount and how? Are there other ways to receive similar benefits?)
- 7. Location(s) where procedures will be carried out.
- E. RISKS AND BENEFITS (ADVERSE EFFECTS)
- 1. Describe nature and amount of risk and/or adverse effects (including side effects),
substantial stress, discomfort, or invasion of privacy involved.
- 2. Will this study preclude standard procedures (e.g., medical or psychological care,
school attendance, etc.)? If yes, explain.
- 3. Describe the expected benefits for individual subjects and/or society.
- F. ADVERSE EFFECTS
- 1. How will possible adverse effects be handled?
Referred by investigator(s) to appropriate care:
- 2. Are facilities/equipment adequate to handle possible adverse effects? (Yes or No. If
- 3. Describe arrangements for financial responsibility for any possible adverse effects.
MSU compensation (explain):
Sponsoring agency insurance:
Subject is responsible:
- G. CONFIDENTIALITY OF RESEARCH DATA
- 1. Will data be coded? (Yes or No)
- 2. Will master code be kept separate from data? (Yes or No)
- 3. Will any other agency have access to identifiable data? (Yes or No. If yes, explain.)
- 4. How will documents, data be stored and protected?
Computer with restricted password:
VIII. Checklist to be Completed by Investigator(s)
- A. Will any group, agency, or organization be involved? (Yes or No. If yes, please confirm
- B. Will materials with potential radiation risk be used (e.g. x-rays, radioisotopes)? (Yes or No)
- 1. Status of annual review by MSU Radiation Sources Committee (RSC). (Pending or Approved. If approved, attach one copy of approval notice.)
- 2. Title of application submitted to MSU RSC (if different).
- C. Will human blood be utilized in your proposal? (Yes or No. If yes, please answer the following:)
- 1. Will blood be drawn? (Yes or No. If yes, who will draw the blood and how is the individual qualified to draw blood? What procedure will be utilized?)
- 2. Will the blood be tested for HIV? (Yes or No)
- 3. What disposition will be made of unused blood?
- 4. Has the MSU Occupational Health Officer been contacted? (Yes or No)
- D. Will non-investigational drugs or other substances be used for purposes of the research?
(Yes or No.)
- E. Will any investigational new drug or other investigational substance be used? (Yes or No.
If yes, provide information requested below and one copy of: 1) available toxicity data; 2)
reports of animal studies; 3) description of studies done in humans; 4) concise review of the
literature prepared by the investigator(s); and 5) the drug protocol.)
F. Will an investigational device be used? (Yes or No. If yes, provide name, source
description of purpose, how used, and status with the U.S. Food and Drug Administration
FDA). Include a statement as to whether or not device poses a significant risk. Attach any
G. Will academic records be used? (Yes or No.)
H. Will 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 under "H.", you must
HIPAA worksheet .
I. Will audio-visual or tape recordings or photographs be made? (Yes or No)
J. Will written consent form(s) be used? (Please use accepted format from our website. Be sure to indicate that participation is voluntary. Provide a stand-alone copy; do not include the form here.) (Yes or No. If no, explain.)