Institutional Biosafety Committee
Administered by the Office of Research Integrity and Outreach
7 Chamberlain Ave.
Portland, ME 04101
Phone (207) 228-8279 Fax (207) 228-8405
 IBC Annual Continuing Review (for Active Projects)
 IBC Revision/Amendment to Protocol
 IBC Study Completion Notification
Check All
That Apply:
Study Completion Notification
Request for IBC Annual Continuing Review (for Active Projects)
Request for IBC Revision/Amendment
Handw ritten Submissions are Not Accepted
MANDATORY SECTION
1.
Study Title:
2.
IBC #:
3.
Principal Investigator (PI) Information
Email address:
In what capacity are you
submitting: (Check One)
Faculty
Staff
Undergraduate
Graduate
Postdoctoral
Other:
Campus Phone:
Fax:
Name of PI:
Campus Mailing
Address:
Department:
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Section I: Status Of Your IBC Protocol
1.
This study is:
Active
Completed or Discontinued
2. Brief summary of work done, findings obtained, adverse safety events (if any), and any other information pertinent to the IBC:
Are you making any changes to your original submission?
YES
NO
If “YES”, please complete Section II: Request for IBC Revision/Amendment.
If “NO”, hand write your initials in the box below and go to Section III: Signatures.
If your study is Completed or Discontinued, please go to Section III and complete the Signatures section.
Section II: Request for IBC Revision/Amendment
1.
Are you changing, adding, and/or deleting any of the following from your study?
If “YES” check
all that apply:
YES*
NO
Transgenic animals
Controlled Substances/Other Drugs
Radioactive Materials
Hazardous Materials/Chemicals
Biological Agents (Use of Risk Group 2, 3, or 4 agents)
Change requiring occupational health review/assessment
CHEMICALS & OTHER MATERIALS – if applicable:
Use of agents requires approval of a separate review committee(s) or department listed below. Attach documentation of approval for
the use of recombinant DNA or potential human pathogens.
Please fill in table below, if applicable:
Check
Category of
All That
Name of Material
Material
Apply
*Risk Group Category
Approving
Committee
Radioactive
Materials
///////////////////////////////
RSC
Recombinant
DNA
////////////////////////////////
IBC
Hazardous
Materials/
Chemicals
/////////////////////////////////
CES&H
Biological Agents
1
2
3
4
Date of
Approval
Committee
Tracking #
IBC
**DEA Schedule #
Drugs
1
2
3
4
5
IACUC
2
To view the CDC *Risk Group Classifications or **DEA Schedule, press Ctrl and click on the link below.
*Risk Group Classifications
**DEA Schedule
Describe the practices and procedures required for the safe handling and disposal of contaminated material associated with this study
in the space below.
(Cell will expand)
Description:
SOP #:
SOP Title:
Additional safety considerations:
(Cell will expand)
REVISION/AMENDMENT:
2. Briefly describe, and explain the reason for the revision/amendment. Include a copy of the affected study pages, with specific
changes highlighted, including any changes in the use of controlled substances, transgenic animals, and biohazards. (If any new
substances (previously noted) have been added to your study, you must request IBC approval prior to making any changes.)
(cell will expand)
Section III: SIGNATURES
Original or Electronic signatures are required. The application will not be processed until all signatures are
obtained.
SIGNATURE OF PRINCIPAL INVESTIGATOR(S):
The undersigned accept(s) responsibility for the study, including adherence to any federal or state regulation; IBC policies and
procedures; requirements of the granting agency (if applicable); and all USM policies regarding research conduct, safety and security.
In the case of student studies, the faculty supervisor and the student share responsibility for adherence to policies.
Print Name:
Signature:
Date:
Print Name:
Signature:
Date:
Print Name:
Signature:
Date:
Return Signed form via USPS or intercampus mail AND an electronic copy via email to:
Office of Research Integrity and Outreach
7 Chamberlain Ave.
Portland, ME 04101
Email: ibc@usm.maine.edu
For questions call: (207) 228-8279.
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