Vice Presidency for Planning and Academic Affairs

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

IBC New registration Resubmitted registration Number:______

I. Principal Investigator Basic Information Provide a copy of the curriculum vitae indicating their level of training and experience in working with biological agents.

1. Complete Name: 2. E-mail: 3. Phone/ Fax: 4. Department/School: 5. AGMUS Institution: Faculty 6. Category: Other:

II. Additional Personnel Identify the personnel involved in the project (including other faculties, students, technicians, temporary help, visiting personnel, etc.) and their respective responsibilities. Provide a copy of their curriculum vitae indicating their level of training and experience in working with biological agents.

Complete Name: E-mail: Phone/ Fax: Department/School:

AGMUS Institution:

Project Responsibility: Faculty Undergraduate Student Category: Staff Graduate Student Other:

P.O. Box 21345 San Juan, PR 00928-1345 AGMUS-IBC01 Phone: 787-751-0178 ext. 7195, 7197 FAX: 787-759-6411 July-2015 compliance.suagm.edu 1 Name: E-mail: Phone/ Fax: Department/School: AGMUS Institution: Project Responsibility: Faculty Undergraduate Student Category: Staff Graduate Student Other: Name: E-mail:

Phone/ Fax: Department/School: AGMUS Institution: Project Responsibility: Faculty Undergraduate Student Category: Staff Graduate Student Other: *If more space is needed please attach the additional personnel to this form, using the format provided above.

III. Basic Protocol/ Research Information

1. Project Title: 2. Estimated Project duration: Institutional Non-funded External funds: If Yes, complete 3. Type of funding: Funding Grant # Agency (if applicable): Agency: Grant Title:

IV. Laboratory Basic Information

internal location 1. Laboratory Location external* location (Institution, campus, building, room, etc.) * If external, IBC_05 form is not required.

Yes No* 2. Registered Laboratory *If No, IBC_05 form must be completed and submitted.

IBC_01-Submission Form AGMUS Revised (6/ 2016) Eng_Ver_04 2 3. Identify Risk Group of the biological agent/ material or RG1 RG2 RG3 N/A rDNA/ rRNA BSL-1 BSL-2 N/A* 4. Identify the Laboratory Biosafety Level *Research or academic laboratories where no biological agents or rDNA/rRNA are currently stored or used. a. Involving Plants (Appendix BSL1-P BSL2-P N/A P of NIH Guidelines) b. Involving Animals (Appendix Q of NIH BSL1-N BSL2-N N/A Guidelines) 5. Identify the existence of a Biological Safety Cabinet in Yes No N/A the laboratory (if applicable):

a. Biological Safety Cabinet Class I Class II-A Class II- B1 (BSC) Type Class II-B2 Class II-B3 Class III

b. Is it certified? Yes No 6. Identify the availability of a fume hood in the laboratory Yes No N/A (if applicable): a. Is it certified? Yes No N/A

7. Are there available storage Yes No N/A cabinets (if applicable)?

a. The storage cabinet is Flammable Corrosive N/A recommended for: Other, specify: 8. Does your institution have a Yes explain: centralized chemical storage area? No N/A

V. 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 regis tered with the IBC.

Be sure to include the following points in your research protocol:

Research Study Proposal  Study rationale or description  Specific aims

Detailed Protocol Description (The IBC will evaluate the risks of biological agents and chemical substances to be used)  Potential biohazards, precautions to be taken and waste management (biological

IBC_01-Submission Form AGMUS Revised (6/ 2016) Eng_Ver_04 3 and chemical- IBC Form 9, Risk Assessment Form)  Emergency plan for accidents, spills or unanticipated events

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 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 Yes No agent? d. Will live animals be infected with this agent? *If, yes, you must obtain prior approval *Yes No from the Animal Care and Use Committee.

Remember to include all biological agents in the IBC Form 9- Risk Assessment.

IBC_01-Submission Form AGMUS Revised (6/ 2016) Eng_Ver_04 4 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 Section III-B (require Section III-C (require IBC and NIH director approval before NIH/OSP and IBC approval and IRB approval before initiation) before initiation) initiation)

Section III-E (require IBC Section III-D (require only Section III-F notice simultaneously with IBC approval before initiation) initiation) (exempt experiments)

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/OSP.

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 Yes No recombinant? IBC_01-Submission Form AGMUS Revised (6/ 2016) Eng_Ver_04 5 iv. What is the host recipient(s)/ vector(s)/ specific phage or plasmid? v. Is a helper virus to be used? *If *Yes No yes, what is the helper virus

vi. Are plants or animals to be Yes No exposed to the rDNA/rRNA?

*Yes No vii. Will an attempt be made to obtain expression of a foreign gene? *If yes, what protein(s) will be produced? viii. Is this a clinical protocol (Human *Yes No gene transfer protocol)? *If yes, please read applicant’s agreement. c. Describe the containment conditions to be implemented

VI. Hazardous Chemicals Report

All chemicals or mixture of elements and/or compounds which represent a physical or health h azard 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, expl osive, oxidizing, pyrophoric, reactive, organic peroxide or compressed gas. Note that chemicals are not subject to registration, but they do have to be reported to th e 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.

IBC_01-Submission Form AGMUS Revised (6/ 2016) Eng_Ver_04 6 VII. 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 ap propriate.

 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.

 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.  I understand that if my protocol is a clinical protocol (human gene transfer protocol), the IBC may not approve the protocol until the Recombinant DNA Advisory Committee (RAC) has completed its review. The IBC may proceed with the approval process upon receipt of a letter form the NIH. The NIH will send notification to the Principal Investigator within 10 working days after the completion of the RAC meeting at which the protocol was reviewed. http://osp.od.nih.gov/sites/default/files/NIH_Guidelines.html

The information provided herein is accurate to the best of my knowledge.

IBC_01-Submission Form AGMUS Revised (6/ 2016) Eng_Ver_04 7 / / / Signature of Principal Investigator (mm/dd/yy)

/ / / Signature of Mentor (mm/dd/yy)

/ / / Signature of Dean (mm/dd/yy)

Submit this completed form to the AGMUS Office of Regulatory Compliance. IBC Use Only Exempt Non-Exempt Approved Disapproved Identify Biosafety level approved: BSL-1 BSL-2 N/A Laboratory inspection required prior to initiation of use? 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 AGMUS Revised (6/ 2016) Eng_Ver_04 8