Ana G. Méndez University System
Vice Presidency for Planning and Academic Affairs
Associate Vice Presidency for Sponsored Programs and Compliance
Office of Regulatory Compliance
Institutional Biosafety Committee (IBC)
PROTOCOL/RESEARCH SUBMISSION FORM
New registration
I.
Resubmitted registration
IBC Number:
Principal Investigator Basic Information
1. Complete Name:
2. E-mail:
3. Phone/ Fax:
4. Department/School:
5. AGMUS Institution:
6. Category:
II.
Additional Information
Regular Faculty
Visiting Faculty
Graduate Student
Other:
Mentor
Co-Investigator
1. Complete Name:
2. E-mail:
3. Phone/ Fax:
4. Department/School:
5. Institution:
6. Category:
Regular Faculty
Visiting Faculty
Graduate Student
Other:
III. Additional Personnel
Identify the personnel involved in the project (including students, technicians, temporary help,
etc.) and their respective responsibilities. Provide a copy of their curriculum vitae indicating
their level of training and experience in working with biological agents.
P.O. Box 21345 San Juan, PR 00928-1345
Phone: 787-751-0178 ext. 7195, 7197 FAX: 787-759-6411
compliance.suagm.edu
AGMUS-IBC01
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Name:
E-mail:
Phone/ Fax:
Department/School:
AGMUS Institution:
Project Responsibility:
Name:
E-mail:
Phone/ Fax:
Department/School:
AGMUS Institution:
Project Responsibility:
*If more space is needed please attach the additional personnel to this form, using the
format provided above.
IV. Basic Protocol/ Research Information
1. Project Title:
2. Estimated Project duration:
3. Type of funding: Funding
Agency (if applicable):
Institutional
Non-funded
External, Specify:
V. Laboratory Basic Information
1. Registered Laboratory
Yes
No*
*If No, IBC_05 form must be completed and submitted
2. Laboratory Location
(Institution, campus, building,
room, etc.)
3. Identify Risk Group of the
biological agent/ material or
rDNA/ rRNA
4. Identify the Laboratory
Biosafety Level
a. Involving Plants (Appendix
P of NIH Guidelines)
IBC_01-Submission Form
Revised (4/2012)
RG1
RG2
RG3
BSL-1
BSL-2
N/A*
N/A
*Research or academic laboratories where no biological
agents or rDNA/rRNA are currently stored or used.
BSL1-P
BSL2-P
N/A
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b. Involving Animals
(Appendix Q of NIH
Guidelines)
5. Identify the existence of a
Biological Safety Cabinet in
the laboratory (if applicable):
BSL1-N
BSL2-N
N/A
Yes
No
N/A
a. Biological Safety Cabinet
(BSC) Type
Class I
Class II-A
Class II- B1
Class II-B2
Class II-B3
Class III
b. Is it certified?
Yes
No
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
6. Identify the availability of a
fume hood in the laboratory
(if applicable):
a. Is it certified?
b. Are there available storage
cabinets (if applicable)?
a. The storage cabinet is
recommended for:
Flammable
Corrosive
N/A
Other, specify:
VI. Project/ Protocol/ Grant Information
Include a copy of the Project/ Protocol/ Grant proposal with this registration as an
attachment. Include all necessary documents and registrations required by IBC prior to
initiation of the project. Biological agents, rDNA/ rRNA and hazardous chemicals to be used
shall be registered with the IBC.
Be sure to include the following points in your research protocol:
Research Study Proposal
 Study rationale or description
 Specific aims
Detailed Experiment Description (The IBC will evaluate the risks of biological agents and
chemical substances to be used)
 Experimental design
Potential biohazards, precautions to be taken and waste management (biological and
chemical)- IBC Form 9, Risk Assessment Form
VII. Biological Agents Registration
Yes
No
N/A
Complete this part if you intend to use and/or store infectious biological agents that presents a
risk or potential risk to the health of humans and/or animals.
Refer to the IBC Policy and Procedures in order to make a risk assessment of the biohazardous
IBC_01-Submission Form
Revised (4/2012)
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materials based on the Risk Group (RG) of the agent (RG-1, RG-3). The Biosafety in Microbiological and
Biomedical Laboratories (BMBL), which is published by the U.S. Department of Health and Human
Services’ Centers for Disease Control and Prevention and the National Institutes of Health, provides
recommended biosafety standards for specific organisms.
1. Proposed Research
a. Provide a summary of your planned use for the biological agent (s), including significant
risk, if any. Note: you must attach (include) a copy of your protocol.
b. Provide a written emergency plan for handling accidental spills and personnel exposure (if
applicable).
c. Will ionizing radiation be used with this
agent?
Yes
No
d. Will live animals be infected with this agent?
*If, yes, you must obtain prior approval
from the Animal Care and Use Committee.
*Yes
No
Remember to include all biological agents in the IBC Form 9- Risk Assessment.
VIII. Recombinant DNA/RNA Registration
Yes
No
N/A
All activity involving the use and/or storage of rDNA/rRNA must be registered with and
approved by the IBC. The NIH Guidelines for Research Involving Recombinant DNA can be
found at: http://oba.od.nih.gov/rdna/nih_guidelines_oba.html.
Biosafety Assessment
RG1
RG2
RG3
a. Identify Risk Group of the rDNA/ rRNA
RG-1 – Agents that are not associated with disease in healthy adult humans.
RG-2 – Agents that are associated with human disease which is rarely serious and for which
preventive or therapeutic interventions are often available.
RG-3 – Agents that are associated with serious or lethal human disease for which preventive
or therapeutic interventions may be available (high individual risk but low community
risk).
b. Identify the NIH Guidelines category of rDNA/rRNA research (check all that apply)
Section III-A (require
IBC and NIH director approval
before initiation)
Section III-D (require only
IBC approval before initiation)
IBC_01-Submission Form
Revised (4/2012)
Section III-B (require
NIH/OBA and IBC approval
before initiation)
Section III-E (require IBC
notice simultaneously with
initiation)
Section III-C (require IBC
and IRB approval before
initiation)
Section III-F
(exempt experiments)
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Proposed Research with rDNA/ rRNA
a. Provide a summary of your planned use of rDNA/ rRNA, including significant risk, if
any. If you intend this registration to include multiple constructs, please list them. Note:
you must attach (include) a copy of your protocol.
b. Provide a written emergency plan for handling accidental spills and personnel exposure
to rDNA/rRNA (if applicable).
Additional information
a. Section III-A, III-B and III-C Research Only: Attach a copy of all relevant information
submitted to NIH or NIH/OBA.
b. Section III-D, III-E and/or III-F Research Only: Provide the following information:
i. Sources of rDNA/rRNA
ii. The nature of the inserted DNA
sequences
iii. Do you plan to propagate the
recombinant?
Yes
No
*Yes
No
Yes
No
*Yes
No
iv. What is the host recipient(s)/
vector(s)/ specific phage or
plasmid?
v. Is a helper virus to be used? *If
yes, what is the helper virus
vi. Are plants or animals to be
exposed to the rDNA/rRNA?
vii. Will an attempt be made to obtain
expression of a foreign gene?
*If yes, what protein(s) will be produced?
c. Describe the containment conditions to be implemented
IBC_01-Submission Form
Revised (4/2012)
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IX.
Hazardous Chemicals Report
All chemicals or mixture of elements and/or compounds which represent a physical or health
hazard to humans under the registered investigation must be informed to the IBC. Use this
form to report any chemical which falls within the following categories: flammable, combustible,
explosive, oxidizing, pyrophoric, reactive, organic peroxide or compressed gas.
Note that chemicals are not subject to registration, but they do have to be reported to
the IBC as they may pose a threat to personnel if handled without caution.
Proposed Research
a. Provide a summary of your planned use for the all chemicals or mixture of elements
and/or compounds, including significant risk, if any. Include descriptions of the
procedures, concentration at which it will be used, the frequency of use, etc. Note: you
must attach (include) a copy of your protocol
b. Provide a written emergency plan for handling accidental spills and personnel exposure
(if applicable).
Remember to include all chemicals reactants to be used in the IBC Form 9- Risk
Assessment.
X.
Applicant’s Agreement
The signature certifies that the PI understands and accepts the following obligations in this
study:
 I recognize that as the PI it is my responsibility to ensure that this research will conform with
the IBC approved protocol and the provisions of the NIH Guidelines for Research Involving
Recombinant DNA, the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories
manual, and the Select Agent Rule (http://www.cdc.gov/od/ohs/Irsat/42cfr72.htm) where
appropriate.
 I will oversee the development and implementation of standard operating procedures to
secure the Biological Safety in the laboratory.
 I will inform the IBC of any unanticipated biosafety related problems encountered while
doing the research.
 Any significant proposed changes, including addition of new personnel, will be reported to
and approved by the IBC before the change is implemented or personnel added.
 I will maintain all required laboratory management records on file and I recognize that
representatives of the Office of Regulatory Compliance are authorized to inspect these
records.
 I understand that it is my responsibility to assure that all associated personnel are trained in
the laboratory safety practices required for the work described.
IBC_01-Submission Form
Revised (4/2012)
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 I understand that failure to comply with NIH regulations, IBC requirements/policies, and the
provisions of the protocol as approved by the IBC may result in suspension or termination of
my research project.
 I understand that IBC approval is valid for up to three years, subjected to a yearly
submission of a continuation form (IBC Form 7).
 Any spill of biological agents, chemical hazards or rDNA/rRNA, any equipment or facility
failure (e.g., ventilation failure), and/or any breakdown in procedure that could result in
potential exposure of laboratory personnel and/or the public to infectious material will be
reported to the Office of Regulatory Compliance.
 I understand that if I use the project described above as a basis for a funding proposal
(either intramural or extramural), it is my responsibility to ensure that the description of the
work in it is identical in principle to the one contained in this registration.
 The information provided herein is accurate to the best of my knowledge.
/
/
(mm/dd/yy)
/
Signature of Principal Investigator
/
/
(mm/dd/yy)
/
Signature of Dean
Submit this completed form to the AGMUS Office of Regulatory Compliance.
IBC Use Only
Exempt
Non-Exempt
Approved
Identify Biosafety level approved:
Disapproved
BSL-1
BSL-2
Laboratory inspection required prior to initiation of use?
N/A
Yes*
No
*Use of infectious agents cannot begin until the IBC or its designee has inspected the laboratory
and approved it for BSL-2.
IBC Chair Signature
/
/
(mm/dd/yy)
/
IBC-signed copy returned to Registrant
IBC_01-Submission Form
Revised (4/2012)
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