CMTT# _______________
Request for Recombinant DNA Committee (RDC) Review
Affiliate
Rhode Island Hospital
The Miriam Hospital
Women & Infants Hospital
Principal Investigator/Mentor_______________________
Phone/Beeper________ Fax_________ Email ________
Principal Researcher (if different) ____________________
Phone/Beeper_________
Fax________ Email________
Department/Division______________________
interoffice mailing address__________
Department/Division_______________________
interoffice mailing address___________
Project Title___________________________________________________________________________
Short Title (limit 20 characters) _________________________________
Sponsor
Outside funding
Dept. funding RC #____________________
Name of sponsor________________________________________________________________________
If you checked “outside funding” please be aware externally sponsored projects require separate review and approval through the
Sponsored Programs Office prior to initiation of the study. See: http://www.lifespan.org/research/policies/grantfundingprocess.asp
for information regarding this process or contact Sponsored Programs (401) 444-5195.
Committee Considerations (check all that apply)
nucleic acid molecules
Human subjects/tissue
Animal subjects
Recombinant or Synthetic
Conflict of Interest (COI) Statement
The Principal Investigator (PI) must insure that all Investigators disclose any significant financial interest, or
certify that they have no such “significant financial interest”, when the application is submitted to Research
Administration for approval.
Do you, or any research staff listed on the personnel list, have a Conflict of Interest or a “significant financial
interest” as defined in Lifespan Policy in this project, or with this sponsor?
Yes
No, If YES,
Complete a COI registration form for each person with a conflict and contact the Office of Research
Administration at 444-5113.
Principal Investigator/Mentor Signature certifies that the individual accepts responsibility for the scientific
conduct and design of the project, determines that the resources necessary to protect participants are present
before conducting the research study and agrees to provide the required administrative reports if this application
is approved and activated.
Signature: ____________________________________________________________ Date: ____________
Department approval Signature(s) indicates that the individual(s) certifies that the application is true and complete to the best of
their knowledge and the individual(s) below has reviewed the research proposal to ensure its scientific merit and adequacy and that it
meets the standards of the Affiliate and Department. Approval also certifies that the investigator is authorized to use departmental
resources to conduct this research project.
Date
Dept. Chief/Chair
Date
Dept. Administrator (if applicable)
RDC application
1
06/2014
Date of most recent Laboratory Safety Inspection (within the past year) ___________________________________
Date of most recent Recombinant DNA BSL-2 Safety Inspection (within the past year)_______________________.
If you are uncertain of the safety inspection status of your lab, please contact the Safety Office at 4-8064 or 3-5060.
INVESTIGATORS: Please review Sections III A-F of the NIH GUIDELINES FOR RESEARCH
INVOLVING RECOMBINANT OR SYNTHETIC NUCLEIC ACID MOLECULES (NIH GUIDELINES)
before submitting this application
Information to be supplied by investigator:
1. Does this research project utilize recombinant or synthetic nucleic acid methodology (e.g. use of plasmids, viral
vectors or other genetic constructs with foreign DNA, cell lines containing foreign DNA)? Note: Answer yes even if
the materials are obtained commercially or from a collaborator. Yes
if yes, please identify the appropriate section
of the NIH Guidelines your research falls under and complete the remainder of the application form: No
Section III-A- The deliberate transfer of a drug resistance trait to microorganisms that are not known to
acquire the trait naturally and would render that microorganism resistant to the primary drug available to
and/or indicated for certain populations, for example children or pregnant women.
Section III-B- Deliberate formation of recombinant DNA containing genes for the biosynthesis of toxin
molecules lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight
Section III-C – involves experiments involving the deliberate transfer of recombinant or synthetic DNA, or
DNA or RNA derived from recombinant or synthetic DNA, into one or more human research participants that
meet any one of the following criteria:
a. Contain more than 100 nucleotides; or
b. Possess biological properties that enable integration into the genome (e.g., cis elements involved in
integration); or
c. Have the potential to replicate in a cell; or
d. Can be translated or transcribed.
Section III-D-Experiments involving the introduction of recombinant or synthetic DNA (nucleic acid
molecules to include RNA and DNA) into Risk Group 2, 3, or 4 agents or restricted agents as host-vector
systems;
Or, experiments in which DNA from Risk Group 2, 3 or 4 agents is transferred into nonpathogenic
prokaryotes or lower eukaryotes host-vector systems;
Or, experiments involving the use of infectious DNA or RNA viruses or defective DNA or RNA viruses in
the presence of helper virus in tissue culture systems;
Or, experiments involving whole animals; (this includes breeding of transgenic animals)
Or, experiments involving whole plants;
Or, experiments involving more than 10 liters of culture;
Or, experiments involving influenza viruses.
Section III E- Experiments not included in Sections III-A, III-B, III-C, III-D, or III-F.
2. If you know that this research is EXEMPT from review according to the NIH Guidelines for Research Involving
Recombinant DNA Research (refer to Section III-F and Appendix C) indicate the reason(s) why below. No further
information is required, however you must sign item 12. If you are uncertain, you must complete the entire
application.
Common reasons why research project is exempt from review:
recombinant or synthetic DNA molecules utilized are not in organisms or virus (ex: PCR products or probe,
siRNA)
recombinant or synthetic DNA experiments which utilize E.coli K-12 host-vector systems, provided the E.coli
host contains no conjugation proficient plasmids or generalized transducing phage (ex: common plasmid such as
Bluescript propagated in commercial E.coli lab strain)
synthetic nucleic acid segments not expressed in vivo as a biologically active polynucleotide or polypeptide
product
RDC application
2
6/2014
other, please explain
________________________________________________________________________________
For non-exempt projects or projects in which status is unknown, complete all questions below:
3. Identify all abbreviations used in this application
Abbreviation
Definition/Description
4. Please provide a complete inventory of ALL Biosafety Level 2 (BL2) agents currently located in the
laboratory, or to be constructed in the proposed project.
4a. BL2 reagents that will be used for this project: List all BL2 reagents currently on hand or to be
constructed for use on this project. BL2 agents include viral vectors of any type, plasmids containing whole
viral genomes, plasmids containing viral genes to be used for packaging, plasmids containing transforming
genes (such as SV40 large T antigen), or stable cell lines containing any of these constructs. This is not intended
to be a complete list: for additional information on BL2 agents please consult Appendix B-2 of the NIH
Guidelines for Research Involving Recombinant or synthetic Nucleic Acid Molecules.
(http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html) Research involving Class III and IV agents is not allowed at
any Lifespan facility.
Vector
(name/type)
Supplier
(name)
Expressed
gene
Gene
source
Promoter/
Enhancer
Packaging Storage
line
Area
Currently Plan to
*NIH
on hand construct Guidelines
ex. PLZRNL J. Jones, PhD LacZ, neo
retroviral
UCSD
E. coli
hCMV
PA317






-80 Freezer
NAB 201
Key: Include Vector name and type. If the source of the vector is a colleague from another institution, provide
colleague’s name and institution. Describe the nature of inserted sequences (e.g. structural gene, oncogene, etc.). Indicate
the storage area and bldg. where the reagents will be stored (e.g. liquid nitrogen tank, Rm 311, SWP).
*Insert relevant section of the NIH Guidelines (e.g. III-A, III-B, III-C, etc)
b. All Other BL2 reagents: List all BL2 reagents currently on hand that will not be used for this project.
Please refer to question 4a for a definition of BL-2 agents.
Vector
(name/type)
Supplier
(name)
Expressed
gene
Gene
source
Promoter/
Enhancer
Packaging
line
Storage
Area
Currently *NIH
on hand
Guidelines
ex. PLZRNL J. Jones, PhD LacZ, neo
retroviral
UCSD
E. coli
hCMV
PA317
-80 Freezer
NAB 201



*Insert relevant section of the NIH Guidelines (e.g. III-A, III-B, III-C, etc)
c.
Please describe the constructs that you plan to create for this project.
RDC application
3
6/2014
5. Personnel
a. List of personnel who will be working with the reagents:
Specify previous relevant recombinant DNA training and experience of investigators. List years and type of training
or experience.
Names of
personnel
involved
Tel. #
e.g. B. Smith
4444444
Role in
Project
Relevant recombinant or synthetic nucleic acid
Experience/Training
# of
Years
Cell culture, molecular cloning, retroviral
constructs
2
Date when
on-line
training
was
completed*
*Please refer to the RDC website for additional information and instructions
http://www.lifespan.org/research/administration/recombinant-dna-research.html
6. Cell Culture Experiments: List primary culture or cell line to be infected. Include species and tissue of origin, name of
cell line, and recombinant or synthetic nucleic acid source (from above) to be utilized. Indicate source of cells (e.g.
commercial source, distribution from another researcher). If the source of the vector is a colleague from another
institution, provide colleague’s name and institution.
Cells to be used
(primary culture or cell
line)
Cell Type
recombinant or synthetic DNA
vector and expressed gene
Supplier
Will any recombinant or synthetic nucleic acid materials be used in large cell culture experiments of 10 liters or more?
Yes  No 
** Greater than 10 liters requires special approval from the RDC.
7. Animal Experiments NOTE: If Yes, to 7a or 7b, IACUC approval is also required
a. Will any recombinant or synthetic nucleic acid materials, including cell lines which contain recombinant or
synthetic nucleic acid, be utilized in animal experiments at Lifespan facilities, including animal facilities?
Yes
If yes, please complete below:
No
Species of animal
Recombinant or synthetic
nucleic acid
Vector and expressed gene
amount and titer
Cell Line
b. Do you have any plans to breed transgenic animals?
Yes
No
If Yes, list the transgenic animals to be bred and attach the Breeding Appendix from your IACUC Animal Care
and Use Protocol form (ACUP).
RDC application
4
6/2014
male parent strain, transgene, and
vector system
female parent strain, transgene
and vector system
Offspring
c. Please describe the route of recombinant or synthetic nucleic acid administration.
8. Will any recombinant or synthetic nucleic acid materials be administered to human subjects at Lifespan facilities?
Yes if yes, please complete below:
No
NOTE: if yes, IRB approval is also required for this activity
Proposed # of
subjects
a.
9.
Recombinant or synthetic DNA
Vector and expressed gene
amount and titer
Please describe the route of recombinant or synthetic nucleic acid administration.
a. Will this project use viral vectors Yes
If yes, please complete item c below No
b. Will this project use constructs which include whole viral genomes?
Yes
If yes, please complete item c below No
c. Are the vectors/constructs replication competent? Yes
If yes, what is the known host range of the virus?
No
If no, what specific method will be used to determine non-replication of viruses (refer to the RDC Manual
for acceptable methods)?
10. Containment and safety precautions to be utilized in the proposed work. Note where work will be conducted (bench
top, Biological Safety Cabinet, other facilities), how material will be disposed of and what precautions will be taken
by those handling materials. List specific type of biological safety cabinets used if relevant.
Building and Room:
Work sites in the laboratory:
Disposal of material:
Precautions by personnel
handling materials:
RDC application
5
6/2014
Training Plan Statement:
I agree to comply with and accept responsibility for the following:
1. Specific formal (documented) staff training for all biosafety level II agents to be utilized within the laboratory,
including but not limited to personal protective equipment (PPE), spill/release controls and procedures to be use within
the laboratory. All affected support staff must also be notified and formally (documented) trained concerning any
biosafety level II agent, and protective procedures to be utilized.
Please be advised: On-line training in general Recombinant DNA technology is required in addition to department
specific training in the particular BL2 agents that will be used for this project.
2. All staff have been formally (documented) trained, initially upon employment and annually thereafter, concerning
Hospital-wide and Departmental safety policies, procedures, and protocols.
3. Documentation of all formal training will be maintained within the laboratory.
Emergency plan statement: I agree to comply with the emergency procedures for cleaning spills involving recombinant
and/or synthetic DNA within the laboratory as described in the NIH Laboratory Safety Monograph.
(http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html) A spill kit for the implementation of the emergency plan
will be accessible within the laboratory. I accept responsibility for ensuring that all personnel working with recombinant
and/or synthetic DNA will be familiar with the plan.
Investigator’s Certification of Compliance: I agree to comply with NIH requirements pertaining to shipment, use and
transfer of recombinant and/or synthetic DNA materials. I am familiar with and agree to abide by the provisions of the
current NIH Guidelines and other specific NIH and Lifespan RDC instructions pertaining to this project. The information
above is accurate and complete.
Principal Investigator (signature, per not acceptable)
Date
Have you attached the necessary forms for a complete submission? Please check the RDC
check list before submitting your new application.
Recombinant DNA Committee (RDC) New Application Checklist
Review Sections III A-E of the NIH GUIDELINES FOR RESEARCH
INVOLVING RECOMBINANT or synthetic nucleic acid MOLECULES (NIH
GUIDELINES) before submitting this application
RDC Application form – must be signed by the PI and Dept. Chief/Chair
Scientific Abstract- from your grant or research plan
Safety Information Sheet (viral and/or non-viral as applicable)
Biohazard Level 2 Training Document- documentation of training is required for all
listed personnel, training must be specific to the agents that will be used on this project
RDC application
6
6/2014
Have all listed personnel completed RDC on-line training module?
Research plan or protocol or Specific Aims from grant application
Informed Consent form (clinical trials only)
Investigator Brochure -3 copies (for clinical trials only)
Please contact the RDC coordinator, Kate Brilliant at 444-2093 if you require assistance with this application form.
RDC application
7
6/2014