Microsoft Word - IBCRegistrationDocument.doc

FORM CMP-

RESEARCH COMPLIANCE

DIVISION OF RESEARCH

State University of New York at Binghamton

INSTITUTIONAL BIOSAFETY COMMITTEE

REGISTRATION DOCUMENT

RESEARCH INVOLVING RECOMBINANT DNA

Attachment A

IBC # ______

Investigator:

Sponsor of Research:

Campus Address:

Campus Telephone #:

Title:

This document is:

a. New Research Grant:

b. Continuation of Grant: RF#

c. Pre/Post Doctoral Fellowship:

d. New Document for Grant in Progress: RF#

e. Instructional

Project:

f. Other

1. Nature of DNA to be cloned and species of origin:

2. Host-Vector(s) system(s) to be used:

3. The project will be prepared in the following Building(s) and Room(s):

4. Proposed Physical Containment Level (Include citation of relevant sections of NIH Guidelines, May 1986):

5. Proposed Biological Containment Level (Include citation of relevant sections of NIH Guidelines, May 1986):

6. The proposed experiments are covered in the following class(es) according to NIH nomenclature:

Class III-A ______ Class III-B ______ Class III-C _____ Class III-D _____

7. The experiment is Exempt according to current NIH Guidelines: Yes _____ No _____

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4 Revised 6/07/04

8. The experiment needs prior approval from the funding Agency: Yes _____ No _____

9. Project Personnel: List name, degrees, relevant training and/or experience:

10. For research at the BL3 and/or BL4 levels, I do ______, do not _______ recommend that a Health surveillance

program be carried out for the project.

11. I have consulted the Acting Biosafety Office

r regarding my laboratory and I believe that my facilities are in

compliance with the current NIH Guidelines for the proposed physical and biological containment levels described above.

____________ (check)

12. I have been informed of the IBC's emergency plan covering accidental spills and personnel contamination.

____________ (check)

The information that I have supplied on this Registration Document is complete and true to the best of my knowledge.

Signature of Principal Investigator

Date

PO Box 6000, Binghamton, NY, 13902-6000. Ph: 607-777- 4905

FORM CMP-

4 Revised 6/07/04

MEMORANDUM OF UNDERSTANDING AND AGREEMENT

Attachment B

IBC # _______

Investigator:

Sponsor of research:

Campus Address:

Campus Telephone:

Project Title:

Please attach Registration Document and Project Description, including an assessment of the levels of

Physical and Biological Containment. (NOTE: If this is the Principal Investigator's first Application, it is

mandatory that he/she consults with the Biosafety Officer).

1) I agree to accept responsibility for the training of all laboratory personnel involved in the project.

2) I agree to comply with the National Institutes of Health (NIH) requirements pertaining to the shipment

and transfer of recombinant DNA materials. I am familiar with and agree to abide by the provisions of

the current NIH Guidelines and other specific NIH instructions pertaining to the proposed project. The

information submitted with this application is accurate and complete.

________________________________ _______________

Signature of Principal Investigator Date

1) I certify that the Institutional Biosafety Committee (IBC) has reviewed the proposed project involving

recombinant DNA experiments on ____________, and has found it to be in compliance with the NIH

Guidelines and other specific NIH instructions pertaining to the proposed project.

AND/OR

I assure that the IBC has reviewed the proposed project and the plans for the proposed facilities

which are under construction or renovation on __________. Recombinant DNA experiments will not

occur until the completed facilities have been reviewed by the IBC and a certified MUA has been

submitted to NIH.

2) I certify that the IBC will monitor throughout the duration of the project the facilities, procedures, and

the training and expertise of the personnel involved in the recombinant DNA activity.

3) The Institution does _________, does not ________ recommend a health surveillance program for

his project.

__________________________________ _____________________

IBC Chairperson Date

__________________________________ _____________________

Applicable Institutional Official Date

PO Box 6000, Binghamton, NY, 13902-6000. Ph: 607-777- 4905

FORM CMP-

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PROJECT DESCRIPTION

Attachment C

IBC # _______

Investigator:

Project Title:

Please provide a description of the proposed project. The description must include information

on (i) the original organism(s) used as sources(s) of DNA, (ii) the nature of inserted DNA

sequences, and (iii) the host(s) and vector(s) to be used for biological containment. Please

provide an initial assessment of the physical and biological containment levels with citation of

relevant sections of the "Guidelines for Research Involving Recombinant DNA Molecules" (May,

1986).

PO Box 6000, Binghamton, NY, 13902-6000. Ph: 607-777- 4905

FORM CMP-

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ANNUAL REVIEW OF PROJECTS INVOLVING RECOMBINANT DNA

MOLECULES

Attachment D

IBC # _______

Investigator:

Department:

Date:

The following project involving the use of recombinant DNA molecules was submitted by you to the

Institutional Biosafety Committee (IBC). Please check whether or not this project is active. Note: Any

proposed changes affecting the physical and/or biological containment level must be submitted to IBC for

review.

IBC #:

Title:

Sponsor:

Laboratory Building and Room #:

Physical Containment Level:

Date Project Approved:

Current Update:

Active: Yes No

I have consulted the Acting Biosafety Office (

Connie Corey, Director, Environmental Health and Safety, ext. 2211)

regarding my laboratory and he has determined that no substantive changes have occurred in the laboratory since the last

approval date. (Check)

___________________________________________

__________

Signature of Principal Investigator Date

Please sign and return by _____________ to:

Sharon A. Sickles

Director of Research Compliance

Office of Research and Sponsored Programs

SUNY-Binghamton, AD 242

Binghamton, New York 13902

Office use:

Copy sent to

Kelley Donoron(BSO) on____________________.

PO Box 6000, Binghamton, NY, 13902-6000. Ph: 607-777- 4905

FORM CMP-

4 Revised 6/07/04

REGISTRATION OF RESEARCH INVOLVING BIOHAZARDOUS

MATERIALS

Attachment E

IBC # _______

OSEH Reg #

Date

Biosafety Level

Action

Principal Investigator:

Academic Title:

2. Department:

3. Addresses: Office:

Lab: _____________

Telephone #

4. Project Title:

5. Name of biological agent or toxin, or description of infectious or oncogenic material, source of human

material:

Specific Strain, Genotype, Catalog Number, or CAS Number:

6. Is agent or material a potential human or animal pathogen or toxin? Yes No

If Yes,

Human Animal

If Yes, and if a toxin, is LD

more than 100 nanograms per kilogram body weight? Yes

7. Do you work with quantities greater than 1 liter?

Yes

If Yes, Largest volume

8. Do you inactivate the agent prior to other laboratory manipulations? Yes No

If Yes, Inactivation Method(s) Used: Heat Chemical

Radiation Other

9. Do you concentrate the agent or material? Yes No

If Yes, Method(s): Centrifuge

Filtration Precipitation Other

10. Do you insert this agent or material into animals?

Yes

If Yes, Species:

If Yes, location of animal housing:

11. Biological containment level required: Biosafety Level #:

12. Do you request biological monitoring, serum samples, or medical surveillance?

Yes No

13. Please list all professional personnel, employees and students involved in the project who will come into contact with

these materials:

Name

Mailing Address

PO Box 6000, Binghamton, NY, 13902-6000. Ph: 607-777- 4905

FORM CMP-

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14. Please attach a brief overview of the proposed research containing sufficient information to ensure adequate

review of the protocol to determine compliance with (i) the State University of New York at Binghamton

Biosafety Program, (ii) local, state and federal regulations. Please include information such as:

a) An abstract of the proposed research written in layman's terms.

b) The purpose of the research;

c) An assessment of risks to personnel working with the agent or material;

d) An outline of the procedure and techniques to be employed;

e) Specifically describe the safe practices (including training program), equipment, and facilities that will

be used to protect personnel from exposure to the agent or material;

f) Specifically describe methods of inactivation or disposal of the agent or contaminated materials.

PO Box 6000, Binghamton, NY, 13902-6000. Ph: 607-777- 4905 FORM CMP-

4 Revised 6/07/04

5. I accept responsibility for the safe conduct of work with this material. I will inform all personnel of the

hazards associated with this work and the level of containment required to perform this research safely.

Principal Investigator

Date

RETURN TO:

Mr. Kelly Donovan

Environmental Health & Safety Office (IN-116)

Binghamton University

P.O. Box 6000

Binghamton, NY 13902

COPY TO:

Karl Wilson

Chair, Institutional Biosafey Committee

Dept. of Biological Sciences (Sci 3, 180)

Binghamton Universit, P.O. Box 6000

Binghamton, NY 13902

-6000

PO Box 6000, Binghamton, NY, 13902-6000. Ph: 607-777- 4905

FORM CMP-

4 Revised 6/07/04