Institutional Biosafety Committee Research
Protocol Submission Form
For studies utilizing Recombinant DNA, Pathogens, Toxins and /
or Human Sera / Tissue
Instructions:
1. Please complete all the sections in this form, (handwritten forms will not be accepted)
2. Submit both hard and soft copy :
i. This Form – “Research Protocol Submission Form”
ii. A completed protocol and consent form (Keeping a copy for your records).
iii. Lay Summary – 250 word maximum
1. Objectives and rationale
2. Description of the biohazardous agent
3. Experimental design synopsis
4. Medical relevance
5. Expected outcome
iv. Include a resume of all study team members listed on section 5.
v. Section 8 federal stipulations
3. Obtain all required signatures, on section 10
1. Submission Date (mm/dd/yyyy):
/
/
2. Duration of Study
Anticipated Start Date (mm/dd/yyyy):
Anticipated End Date (mm/dd/yyyy) :
3.
/
/
/
/
This Study Involves (Choose one) ,
Funding Agency or Source of Funds:
New Study Protocol Title:
Locations.
Please list all relevant locations where the research will be conducted. If you have additional locations, place them
on section 6
Purpose
Institutional name /
Department
Address
Contact Person
Primary Site
Treatment/Experiment
Secondary Site
(if applicable)
Treatment/Experiment
Preparation of Agent
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*Disposal
**Transportation of
agent / subject
Storage of agent
(Add others as needed)
*Describe method of biohazard disposal:
** From:
to:
reason :
4. Investigator(s) Contact Information:
Name and Title:
Institution:
Department:
Mailing Address:
Phone number:
Fax number:
E-mail address:
Sub-Investigator (if applicable):
Name and Title:
Institution:
Department:
Mailing Address:
Phone number:
Fax number:
E-mail address:
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5. Authorized Personnel:
List all research study team members who will be involved in this project and include a curriculum vitae/resume. If
there is a major change in the personnel involved in the protocol, this list should be updated immediately. If no
personnel changes occur, the list should be updated annually during periodic review. If you have additional personnel,
please add them on section 10
Name &
Department
Role in the Study
Specific Experience with Materials in
this Study*
Contact information
Phone /Pager/E-mail:
PI
Sub-PI
Coordinator
* if a study team member has no experience in this type of study, describe the training plan:
6. Please use this space for additional locations (section 3) or authorized personnel (section 5).
7. Does this project involve recombinant DNA? (Chose one) Nature of strain :
a.
b.
c.
d.
If yes please indicate the source (Choose one) If Virus type (Choose one)
Sequence Length
bp
Promoter / Enhancer (Choose one)
Biosafety Level……………………………………………………………………………....
(Choose one)
e. Will attempts be made to express the Gene………………………………………………….
(Choose one)
f. Will genetically modified organisms be deliberately released into the environment……......
(Choose one)
g. Do the DNA clones contain genes for biosynthesis of molecules that are toxic for vertebrates...
(Choose one)
h. Will more than 10 liters of culture be grown at any one time………………………………..
(Choose one)
i. If yes to question 8, do you have a BSO assigned on section 5 …………... (Choose one)
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8.





Please include the following documents
For Human studies
For animal studies
Response to NIH Guidelines Appendix M Animal protocol and IACUC approval
II-A and B
letter
Clinical Trial Registry
Investigators / Drug Brochure
Consent from the IRB approval letter
NIH recombinant DNA advisory committee
(RAC) approval
1. Estimated number of subjects to take part in this study at your site
2. Sample collection (Choose one) If yes, indicate type : (Choose one)
9.
1.
2.
3.
Public Health consideration (Appendix M-II-B-4)
Significant possibility that the DNA could have horizontal transition ….(Choose one)
Significant possibility that the DNA could have vertical transition….….(Choose one)
Significant possibility that the DNA could spread to the environment….(Choose one)
If you have answered yes to any of the above questions please explain what precautions will be taken against such
spread.
What measures will be undertaken to mitigate the risk, if any, to public health.
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10. Investigators Assurance:
I certify that the information provided in this application is complete and accurate. As Principal Investigator, I have
ultimate responsibility for the conduct of this study, the ethical performance of the project, the Biosafety controls and
strict adherence to any stipulations designated by the IBC. I agree to comply with all MRI policies and procedures, as
well as with all applicable Federal state and local laws regarding recombinant DNA, pathogens and human sera/tissue
research including but not limited to the following:
 Performing the project by qualified personnel according to the approved protocol.
 Obtaining adequate training in the safe handling of recombinant DNA, pathogens and human sera/tissue.
 Promptly reporting adverse events under the policies and procedures of the Office of Research Integrity.
Principal Investigator’s Name
Principal Investigator’s Signature
Date
Sub - Investigator’s Name
Sub - Investigator’s Signature
Date
Department Chairman Name
Department Chairman Signature
Date
(use this space as needed to add other Sub-Investigators)
11.
Hard Copy Submission:
MedStar Research Institute
ORI – Institutional Biosafety Committee
6525 Belcrest Road. Suite 700
Hyattsville, MD 20782
IBC Received Date Stamp
ORI use only
IBC Protocol Number
ORI only
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