Brown University
Renewal of Biological Research Authorization
Please contact with any
questions and return
original form to:
IBC # __________ Date ____________
Biological Safety Officer
Office of Environmental Health & Safety
Box 1914
401-863-3087
Action __________________________
▲For EH&S Use Only ▲
Principal Investigator (Last Name, First Name)
Campus Box #:
Academic Title:
Email address:
Department:
Lab Location Building/Room: (list all Rooms):
Office Location:
Shared Labs and Procedural Spaces (list all shared spaces and responsible person for each):
Office Phone #:
Lab Phone #:
Laboratory Supervisor (if not PI) Printed Name and Approval Signature:
Faculty Mentor/Experienced Collaborator (if applicable):
Project Title:
Project Start Date:
Project Duration:
Name and Source of Biological Material:
Repository:
Strain, Genotype, Catalog or CAS # (If you think you may use several cell lines/biological agents, please list all)
Type(s):
Location:
______________
□ Toxin □ Pathogen □ Human Material □ Oncogenic □ Plant □N/A
Does the research involve the use of recombinant DNA (rDNA)?
□ Yes □ No
□ Yes
□ No
If yes, complete and return rDNA addendum.
If none of the above, contact the BSO for further guidance on authorization.
1. Is the material generally regarded as a potential human, animal, or plant pathogen or toxin?
□ Yes □ No
If yes, which?
□ Human
□ Animal
□ Plant
If a toxin, please list the total aggregate amount on hand at any time _______________
Is a vaccine, therapeutic treatment or post-exposure prophylaxis (PEP) available?
□ Yes (explain or attach PEP/treatment protocol)_____________________________________
□ No
2. Are you working with quantities greater than 1 liter? □ Yes, largest volume __________ □ No
3. Are you inactivating the agent/material prior to other laboratory manipulations? □ Yes
□ No
Inactivation method(s) used:
□ Heat □ Chemical___________ □ Radiation
□ Other ____________
4.Are you concentrating the agent/material? □ Yes □ No
Method(s):
□ Centrifuge
□ Filtration
□ Precipitation
□ Other _____________
5. Are you inserting this agent into intact animals?
□ No
□ Yes, species ______________________
IACUC Approval number ________________
Is this a zoonotic agent? □ Yes □ No
6. Does this project at any time involve shipping infectious materials over public thoroughfares?
□ Yes □No
If yes, please explain__________________________________________________________________________________
7. Does the research involve human subjects or human products?
□Yes
□ No
IRB Approval?
□ Yes, number ________________ □ No
□ Pending
8. Biological containment level required:
□ BSL-1
□ BSL-2
□ BSL-3
9. Do you request medical monitoring, baseline serology or vaccinations? □ Yes (explain)_____________________ □ No
10. Are you using a BioSafety Cabinet (BSC)?or other enclosure? □ No □ Yes
If yes, type _________
certification date ____________
BSO-7
2/10/2016
Brown University
Renewal of Biological Research Authorization
If no, will there be alternate special ventilation?
□ Yes, specify ________________ □ No
11. Please list all faculty, employees, and students involved in the project who will come in contact with these materials:
Name and Title
Relevant Experience
Department
Telephone
12. Has there been any change in the scope of your research (e.g., new biological agents, different manipulations or research procedures,
new protocols, new specialized equipment, etc.) since your original authorization or last renewal?
□ No
□ Yes (If yes, please attach a brief overview of the new scope of research containing sufficient information to ensure
adequate review of the protocol to determine compliance with the Brown University Biosafety Program, local, state,
and federal regulations)
13. If answering “yes” to the previous question there should be changes made to the Exposure Control Plan (ECP) thus requiring submission
of an updated ECP using the template found at the following URL: http://www.brown.edu/Administration/EHS/biological/
*However, ALL Biological Research Authorization Renewals submitted after 12/1/2011 must be submitted with an updated Exposure Control
Plan using the template found at the following URL: http://www.brown.edu/Administration/EHS/biological/
As Principal Investigator, I accept responsibility for the safe conduct of work with this material. I will ensure that all personnel
receive training in regard to proper safety practices and protective equipment needed for this work.
Signature (Principal Investigator) __________________________________________________
Date: _______________________
Biosafety Officer Approval ________________________________________________________
Date: _______________________
BSO-7
2/10/2016
Brown University
Renewal of Biological Research Authorization
Recombinant DNA Research Addendum
Principal Investigator
Project Title:
Campus Box #:
Office Phone:
1. Is the recombinant DNA exempt per NIH guidelines (http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html)?
□ Yes, guidelines reference ___________________
□No
2. Is this project part of a course or teaching lab?
□ Yes, course # _______________
□ No
3. Specify gene sequence to be inserted into the recombinant. __________________________________________
4. Do any sequences code for toxins?
□ Yes, LD50__________________
□ No
5. Identify vector(s), specific phage, plasmid, or virus and source* _________________________________________________
(*Attach vector map, do not attach gene sequence.)
6. Host or Environment: _____________________________________________________________(see #18 below)
7. Will VSV-G be used for pseudotyping and are you aware that this can increase the risk of exposure through absorption and inhalation along
with injection and ingestion?
□ Yes
□ No
8. If using adeno or lentivirus, will you be using third or fourth generation systems for safety? □ Yes
□ No
9. If using oncogene inserts, a DNA sequencing library shall be kept. Indicate the location of these records____________________________
10. Is volume Large Scale, i.e., > 10 liters culture?
□ Yes
□ No
11. If virus source, is it more than 2/3 of the viral genome?
□ Yes
□ No
12. Is a helper virus, packaging system, complementary cell used?
□ Yes
□ No
13. Are intact animals exposed to the recombinant?
□ Yes(list all spp.)_____________________________________□ No
14. Are mammalian cells exposed to the recombinant?
□ Yes
□ No
15. Are Human Subjects exposed to the recombinant?
□ Yes
□ No
16. If you answered yes to 14 or 15, indicate the shedding period for the virus/viral vector__________________________________________
17. For lentiviral or retroviral vectors, will you use safety engineered sharps?
□ Yes
□ No
18. Please check the relevant situation(s) that apply to your project. For “Yes”, indicate Biosafety Level.
Host
Biosafety Level
□ Yes
□ Yes
□ Yes
□ Yes
□ Yes
□ Yes
□ Yes
□ No
□ No
□ No
□ No
□ No
□ No
□ No
Tissue Culture Cells
□ Yes
□ No
a. rDNA/ Plasmids
b. Segment of virus
c. Virus vector
d. If virus vector
e. Defective viral vector
f. Replication competent viral vector
□ Yes
□ Yes
□ Yes
□ Adeno
□ Yes
□ Yes
□ No
□ No
□ No
□ Retro(Lenti)
□ No
□ No
Intact Lab Animal Recipient
□ Yes
□ No
a.
b.
c.
d.
e.
f.
g.
E. coli K12
Other bacteria
Non-Pathogen
Pathogen
Toxin gene
Drug Resistance gene
Yeast/ YAC
□ BSL-1
□ BSL-1
□ BSL-1
□ BSL-2
□ BSL-2
□ BSL-2
□ BSL-1
□ BSL-2
□ BSL-2
□ BSL-2
□ BSL-2
□ BSL-2
□ BSL-2
□ Vaccinia
□ Sindbis □ Other _________
a. University Animal Use & Care Committee Protocol Number _____________________ Approval Date: ___________
b. Animal Housing (building and room no.) _____________________________________________________________
c. rDNA/ Plasmid
□ Yes
□ No
□ ABSL-1
□ ABSL-2
d. Transgenic
□ Yes
□ No
□ ABSL-1
□ ABSL-2
e. Virus vector
□ Yes
□ No
□ ABSL-1
□ ABSL-2
f. SCID/ Nude/Immunodeficient strain □ Yes
□ No
□ ABSL-1
□ ABSL-2
Human Subject Recipient
□ Yes
□ No
a. I.R.B. Protocol Number ________________________________________________ Approval Date: ____________
b. rDNA/ Plasmid
□ Yes
□ No
□ BSL-2
BSO-7
2/10/2016
Brown University
Renewal of Biological Research Authorization
□ Yes
□ Yes
c. Pathogen
d. Virus Vector
□ No
□ No
□ BSL-2
□ BSL-2
Recombinant DNA Research Addendum (cont.)
Plants □ Yes □ No
Insects □ Yes □ No
Field Release □ Yes
□ BSL-2-P
□ BSL-3-P
□ No
Reference your experiment from the appropriate section or appendix of the NIH Recombinant DNA
Guidelines _____________________________________________________
(The current guidelines are available at http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html)
The application form (summary and any attachments) must provide sufficient detail for the Biological Safety
Committee to understand and evaluate rDNA components of the project in order to review the application. For
attached published references, please highlight pertinent paragraphs or sentences. Submissions that lack detail
or are illegible will be deferred from action and returned for revision and resubmission. Incomplete applications
will be returned.
Certification and Signature
The information contained in this application is accurate and complete. I am familiar with and agree to abide by
the provisions of the current NIH Guidelines, the NIH Guide for Grants and Contracts, Brown University policies
and procedures, and local, state, and federal regulations.
In addition, I agree to abide by the following requirements:
a. I will initiate no recombinant DNA research subject to the NIH Guidelines until that research has been
reviewed by the Biological Safety Committee.
b. I will follow appropriate biosafety level laboratory techniques in the research.
c. I will comply with all shipping requirements for recombinant DNA materials.
d. I will make available to the laboratory staff copies of the approved protocols that describe the
potential biohazards and the precautions to be taken.
e. I will have a specific protocol in place for post-exposure prophylaxis and/or treatment.
f. I will train the laboratory staff in good microbiological practices and techniques required to ensure
safety for this project, in the procedures for dealing with accidents, and in waste management
procedures, prior to any project work and at least annually thereafter.
g. I will ensure that all laboratory staff are listed with the Office of Environmental Health & Safety.
h. I will submit in writing a request for approval from the Biological Safety Committee for any significant
modifications to the study, facilities, or procedures.
i. I will supervise staff, and correct work errors and conditions that could result in breach of the NIH
Guidelines or Brown University policy.
j. I will submit to the Biosafety Officer, the Biological Safety Committee, and the Office of Recombinant
DNA Activities at NIH (if applicable), reports of any research related accident, exposure incident,
release of rDNA materials to the environment, problems pertaining to the implementation of biological
and physical containment procedures, or violations of the NIH Guidelines
Principal Investigator _______________________________________
Date: _________
Biosafety Officer _________________________________________
Date: _________
BSO-7
2/10/2016
Brown University
Renewal of Biological Research Authorization
BSO-7
2/10/2016