Download SHORT FORM RESEARCH APPLICATION

RESEARCH APPLICATION FORM TO USE
UNSEALED RADIOACTIVE MATERIALS IN HUMAN SUBJECTS
This form may be used only for non therapeutic use of unsealed radioactive materials in human subjects. Submit the completed form,
with any supportive documents, to the Institutional Review Board. A copy must be sent to the Health Physics Services (HPS). For
more information, or if you need assistance in completing the form, kindly contact HPS at ext. 2360/3
1. APPLICANT INFORMATION
Principal Investigator:
Department/Division:
Phone/Pager:
URSC Licensed Radiation User:
Co-investigator/s:
Project Title:
Expected Start Date:
Faculty Position:
e-mail:
Expected Project Duration:
2. DOSE RECEIVED & BRIEF DESCRIPTION OF RADIATION USE
Describe each type of radiopharmaceutical and the number of each type of procedure that the human subject(s) will undergo. If various
subject groups receive different exposures, provide detailed information for each group. For each procedure, provide the Whole Body
dose and list the target organ and its corresponding dose. Use additional sheets as needed.
Radioisotope &
Chemical Form
Route of Administration
Activity per
Administration
(mCi)
Number of
Administrations
Per Subject
Dose Per Administration
(mrad)
Whole Body
Target Organ
3. LOCATION(S) WHERE RADIOACTIVE MATERIAL WILL BE STORED, ADMINISTERED, AND BY WHOM
_______________________________________________________________________________________________
4. TYPE OF RADIOPHARMACEUTICAL TO BE USED IN THIS STUDY (Check One)
[ ] FDA approved
[ ] FDA approved Investigational New Drug, IND number: __________________________________
[ ] Drug without New Drug Application (NDA) filed with or IND issued by FDA
[ ] Other (Specify): _______________
5. ARE LACTATING WOMEN OR OF CHILD-BEARING POTENTIAL INCLUDED?
[ ] Yes
[ ] No
If no, explain how non-pregnancy is assured and the Consent Form must contain the following statement: “You may not participate in
this study if you are pregnant. If you are capable of becoming pregnant, a pregnancy test will be performed before you are exposed to
any radiation. You must tell us if you may have become pregnant within the previous 14 days because the pregnancy test is unreliable
during that time.” If yes, please justify.
______________________________________________________________________________________________
6. ARE HUMAN SUBJECTS BELOW THE AGE OF 18 INCLUDED?
[ ] Yes
[ ] No
If yes, explain the need to include subjects below the age of 18.
______________________________________________________________________________________________
7. RADIATION RISK STATEMENT
A radiation risk statement must be included in the Consent Form. The statement should correlate the total radiation received by the
subject to the average annual dose that a person receives annually due to environmental radiation (~ 300 mrem) and it must contain the
following statement; “Although there are no proven harmful effects from the radiation levels that you will be exposed to during this
research, long term effects on your health cannot be ruled out with certainty.”
I, the Principal Investigator, understand that I am responsible for this project and I agree to abide by the University Radiation
Safety Regulations as stipulated by the Radiation Protection Handbook.
Signature of Principal Investigator: ______________________________
Date: _________________
I, the Department Chair, have reviewed the feasibility and scientific merit of this proposal.
Signature of Department Chair: ________________________ _______ ___
August 2003
Date: _________________