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Transcript
TEXAS SOUTHERN UNIVERSITY
3100 CLEBURNE AVENUE • HOUSTON, TEXAS 77004 • 713-313-1044
Recombinant DNA Safety Committee (RDSC)
RECOMBINANT DNA REGISTRATION FORM
Document Certification (internal use only)
rDNA Approval (by rDNA Chairperson) ____________________________ Date _______________________
Project Registration No.: ____________________________________
Electronic version on file?
INSTRUCTIONS: All sections must be completed; Use additional pages as necessary. Upon completion, please print a copy,
then sign and date the signature page. Return a signed paper copy of the entire form to TSU Science Center room #403. If
there is any question regarding this form, please contact Dr. Clement (ext. 1044 or email: [email protected]).
PART 1 - GENERAL INFORMATION
BIOSAFETY LEVEL (indicate all that apply)
EXEMPT
BL1
BL2
BL3
BL4
TITLE OF PROJECT
PRINCIPAL INVESTIGATOR INFORMATION
FIRST NAME
MIDDLE INITIAL
CAMPUS ADDRESS
LAST NAME
BUILDING/ OFFICE #
WORK POSITION OR TITLE
OFFICE PHONE
CERTIFIED LABORATORY
LABORATORY SAFETY REPRESENTATIVE NAME
CITY
STATE
DEPARTMENT
LAB PHONE
BIOSAFETY LEVEL
DATE
E-MAIL ADDRESS
FAX NUMBER
DATE
PHONE
BY
EMAIL
ZIP CODE
PART 2 - PROJECT INFORMATION
List all Laboratories/Facilities where research is to be conducted and the corresponding biosafety level includes cold/warm rooms, tissue culture rooms
and animal housing if appropriate. Please indicate room(s) where biosafety cabinets (BSC) are located:
Laboratory Room No.:
Biosafety Level:
Is this project part of a course or teaching lab?
Yes
No
PART 3 PROJECT DESCRIPTION
Outline the overall goal(s) and specific objectives of the project. Provide sufficient information that the techniques used and purpose of the experiments
are clear:
SOURCE of GENE, INSERT or CLONE (Answer the following questions as appropriate) :
Specify DNA/RNA source (or probe), nature of insert, is a protein expressed, and percent of any viral genome in construct:
Do any sequences code for toxins? If so, what LD50?
Is the DNA source from a USDA-regulated plant or animal?
Yes
If the regulated organism is grown or stored at TSU, please include a
copy of the USDA permit:
No
Identify cloning/expression/transfection vectors used, recipient bacterial strains, and recipient host cell lines (human, mouse, plant, etc.). Provide a
restriction map of vector. Describe the location and type of promoters and other control sequences and percent of any viral genome in construct:
Vectors and Host Cells - If using viral vectors, indicate packaging cell lines and assay system used to measure helper virus titre or titre of replication
competent virus (background) generated. Include host range of packaged viral vector.
Use of Recombinant DNA in Animals - Will transgenic or “knockout” animals be generated or used in the project? If so, indicate injected gene and
vector as well as the recipient animal/mouse strain.
What is the expected phenotype of the animal, (e.g., immunodeficient, early disease onset/ resistance, etc.)?
Large-Scale Research - Do experiments involve growth of more than 10 liters of culture at a time? If YES, identify culture room and type of equipment
used for culture growth and handling
Does the project involve human subjects or
clinical samples? If yes, please specify:
Yes
No Specify:
Does the project involve animals?
Yes
No
If you answered yes to any of these questions please
submit your Committee for the Protection of Human
Subjects or Animal Care and Use approval letter.
Are pre-project serum samples, immunization or medical monitoring or surveillance advisable? Is an FDA approved vaccine available if individuals
working with micro-organisms involved in this research project want it?
2
PART 4. CERTIFICATION AND SIGNATURES
This is to acknowledge that 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, and other
specific NIH instructions pertaining to the proposed project even though my current grant application is not for an NIH
grant.
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
and approved/registers with the Committee on Recombinant DNA.
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 train staff in good microbiological practices and techniques required for this project to ensure safety.
f.
I will ensure that all laboratory workers are registered with the Committee.
g. I will supervise staff, and correct work errors and conditions that could result in breeches of the NIH Guidelines.
_
_
_
Principal Investigator
_
Date
_
Recombinant DNA Committee Chair
_
Date
3