MONTANA STATE UNIVERSITY
Institutional Review Board Application for Review
(revised 1/01/08)
(to download this form, click on file, save as, change file type
to Plain Text [*.txt], rename your file, and you will be able to pull that file
into MS Word, Word Perfect, or another word processing program -- OR --
click here for a link to MS Word doc)
[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 that from
the National Cancer Institute: http:/Cancer.gov
- Human Participant Protections Education for Research Teams/cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp
Beginning January 1, 2006, University policy requires that all protocols submitted from individuals NOT employeed by Montana State University be charged a $500 review fee per application. Renewals for those proposals will be at no charge.
THIS AREA IS FOR INSTITUTIONAL REVIEW BOARD USE ONLY. DO NOT WRITE
IN THIS AREA.
Approval Date:
Application Number:
SUBMIT 14 COPIES OF THIS APPLICATION (INCLUDING THE
SIGNATURE COPY), ALONG WITH 14 COPIES OF THE SUBJECT CONSENT FORM AND 14
COPIES OF ALL OTHER RELEVANT MATERIALS, TO INSTITUTIONAL REVIEW BOARD, 960 TECHNOLOGY BLVD., ROOM 127, MONTANA STATE
UNIVERSITY, BOZEMAN, MT 59717-3610. (PLEASE STAPLE, BIND
OR
CLIP TOGETHER THE APPLICATION FORM, SURVEYS, ETC. AS 14 INDIVIDUAL PACKETS; ONE
COMPLETE PACKET FOR EACH BOARD MEMBER.) SUBMIT ONE COPY OF GRANT CONTRACT
PROPOSAL FOR THE OFFICE FILE. FOR INFORMATION AND ASSISTANCE, CALL 994-6783 OR CONTACT THE
INSTITUTIONAL REVIEW BOARD CHAIR, MARK QUINN, 994-5721 or CHERYL JOHNSON, ADMINISTRATOR,
994-4706.
PLEASE TYPE YOUR RESPONSES IN BOLD
Date:
I. Investigators and Associates (list all investigators involved; application will be filed under name of first
person listed)
| |
NAME: |
TITLE: |
|
| |
DEPT: |
PHONE: |
|
| |
ADDRESS: |
|
|
| |
E-MAIL ADDRESS: |
|
|
| |
DATE TRAINING COMPLETED: |
|
|
| |
NAME: |
TITLE: |
|
| |
DEPT: |
PHONE: |
|
| |
ADDRESS: |
|
|
| |
E-MAIL ADDRESS: |
|
|
| |
DATE TRAINING COMPLETED: |
|
|
| |
NAME: |
TITLE: |
|
| |
DEPT: |
PHONE: |
|
| |
ADDRESS: |
|
|
| |
E-MAIL ADDRESS: |
|
|
| |
DATE TRAINING COMPLETED: |
|
|
(repeat if needed)
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 the Director of the Technology Transfer Office, Dr. Rebecca Mahurin at 406-994-7868.
II. Title of Proposal:
III. Beginning Date for Use of Human Subjects:
IV. Type of Grant and/or Project (if applicable)
Research Grant:
Contract:
Training Grant:
Classroom Experiments/Projects:
Thesis Project:
Other (Specify):
V. Name of Funding Agency to which Proposal is Being Submitted (if applicable):
VI. Signatures
Submitted by Investigator
Typed Name:
Signature:
Date:
Faculty sponsor (for student)
Typed Name:
Signature:
Date:
THIS AREA IS FOR INSTITUTIONAL REVIEW BOARD USE ONLY. DO NOT WRITE IN
THIS AREA.
Approved:
Disapproved:
HSC Chairman's Signature and Date:
Subject to the following conditions:
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?
By investigator(s):
Referred by investigator(s) to appropriate care:
Other (explain):
- 2. Are facilities/equipment adequate to handle possible adverse effects? (Yes or No. If
no, explain.)
- 3. Describe arrangements for financial responsibility for any possible adverse effects.
MSU compensation (explain):
Sponsoring agency insurance:
Subject is responsible:
Other (explain):
- 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?
Locked file:
Computer with restricted password:
Other (explain):
VIII. Checklist to be Completed by Investigator(s)
- A. Will any group, agency, or organization be involved? (Yes or No. If yes, please confirm
that appropriate permissions have been obtained.)
- 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.)
Name:
Dose:
Source:
How Administered:
Side effects:
- 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.)
Name:
Dose:
Source:
How Administered:
IND Number:
Phase of Testing:
- 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
relevant material.)
- 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
complete the
HIPAA worksheet.
- I. Will audio-visual or tape recordings or photographs be made? (Yes or No.)
- J. Will written consent form(s) be used? (Yes or No. If no, explain.)