UNIVERSITY OF CALIFORNIA, SAN FRANCISCO Base #

tenn ae

MEMORANDUM OF UNDERSTANDING AND AGREEMENT Supplement #

RECOMBINANT DNA

 

 

he information in this MUA may be madé public upon proper request.

A) DESCRIPTION:

Below is a layman's description of the experiments being conducted which involve
recombinant DNA molecules and the significance of this research. On the right
is an assessment of the physical and biological containment required for the
experiment.

Description:

Recombinant DNA molecules containingy sequences derived from

Containment

P

papovativuses and retroviruses will be introduced into eukaryotic P2/P1

cells by transfection under conditions which do not permit
production of virus.

The papovavirus DNA (simian virus-40 or polyoma virus DNA)
will be obtained either from infected mammalian cells or from
EK host vector systems in which it has been previously cloned.
The DNA will be disabled by the insertion of foreign DNA into
regions of the genome essential for virus replication; in some
cases, a portion of the papova virus genome will alee have been
deleted.

The retrovirus DNA will consist of subgenomic portions cf the
DNA of avian or murine retroviruses which in some cases will be
linked to the eukaryotic cell DNA to which it is joined after
natural infection. The eetrovirus DNA (and any adjacent celluiar
DNA) will have been cloned in EK host vector systems and
characterized by restriction mapping and molecular hybridization.

The recombinants between papovavirus and retrovirus DNA to be
used for transfection may, in seme cases, be cloned in EK host
vector systems and characterized by restriction mapping and
molecular hybridzation prior to administration to eukaryotic

cells.

cases include sequences derived from the EK host vector sy stems
used in the primary cloring of either DNA end/or in the secondary
cloning of virue-ywirus recombinants.

The recombinant DNA's will be used under P2 conditions to
transfect cultured cells which are not permissive for replication
of the involved papovaviruste.g. cells other than murine cells for
recombinants containing polyoma virus DNA, and cells other than
simian cells for recombinants containing SV40 DNA). Successful
transfection will be scored by morphological transformation
of the recipient cells. When transformed recipients have been
characterized with respect to acauired recombinant DNA and shown

The papovavirus-retrovirus recombinant DNA's will in most

to be free of such DNA replicating independently of the host genome,

the cells will be propagated under Pl conditions.

 

SHIPMENT AND TRANSFER:
I agree to comply with the NIH requirements pertaining to shipment and transfer

of

~combinant

NA materials as stated in the December 22, 1978 Federal Register

ano .n supplemental instructions provided the IBC and me.

Daic

eee a eo

 

HV

Not applice
able
yf MUA Base #

4pe 2 eer eens:

Supplement #

CERTIFICATION SECTION;
1) PRINCIPAL INVESTIGATOR:

I have read and become familiar with the NIH revised guidelines regarding
recombinant DNA published in the December 22, 1978 Federal Register and

I agree to abide by their provisions to the best of my ability. I agree

to abide by all subsequent instructions issued by NIH and received hy

me. I agree to inform those working on this project about the availability
of health surveillance and to ensure that they have received training in
good laboratory practices. JI agree to immediately inform the I8C of any
significant research related accidents and illnesses. I agree to submit
this study to institutional review at least annually. I agree to gain
interim approval of modifications to the study, the facilities or the

 

 

 

 

procedures.
Date t- ()- ro Signature (fs Oeertti
Date Signature
Date Signature

 

 

2) BIOSAFETY COMMITTEE:

The Biosafety Committee has reviewed this MUA and has approved it. It
has been found to be in compliance with the NIH guidelines dated December
22, 1978 and with the subsequent instructions which have been received by
the IBC. The date the MUA was approved is .

 

The Principal Investigator is required to comply with the NIH requirements
pertaining to health surveillance as stated in the December 22, 1978
Federal Register. The investigators are required to inform those on

the project that they have the option/requirement of seeking the services
of the Fmployee Health Service.

Date Signature

 

 

Chairman, IBC, UCSF
3) INSTITUTIONAL OFFICIAL:

The University of California, San Francisco retains responsibility for
the procedures to be performed under this MUA. The requirements stated
in the NIH guidelines published in the Federal Register of December 22,
1978 and in subsequent instructions received by this institution will be
transmitted to the IBC.

Date Sipnature

 

 

Shirley S. Chater
Vice Chancellor
Academic Affairs, UCSF
 
   
   
 

Instructions; Submit 13 copies of
Pages 1 and 3 stapled in 13 sets for
distribution. Submit 1 copy of the
Slenatiure nate

eee FLT .

MUA SUPPLEMENT - INTERNAL DOCUMENT

) IDENTIFICATION:

  

 

* . i
Prin Investigator WE Varmus __ SCRMOEEENL Sey eee ere ogersict sopaeromas
Mailing Address HSE 465 Phone x2824 _ Secretary B. cook Phone 42324
Co/other Investigators (optional ) JImM Bishop

 

 

am : SIE a TESS RI OLE Ce ER SR “BETA CEs EILEEN
B) SCIENTIFIC INFORMATION:

 

Host: Variols mammalian tissue culture cells
Vector: Not applicable

Species source of DNA: Various avian and mammalian cells

Purity of DNA: Greater than 99  * ~~ Less than 99% x
If greater than 99% is claimed, provide the basis for the claiin:

In some cases, the DNA to be used will be cloned in EK host vector

systems and characterized by restriction mapping and molecular hybridization

 

 

 

Facilities: Room(s) HSE 457 HSE 469
Classification Pe PY™
mm CEP TE TIE TP RT OY IY LTC E SPST IL OED HL PRS LS Bi GTI EAC ele 2 al Bee en a,

 

 

C) SUBMISSION DATA:

This MUA should be submitted to NIH for approval.
This MUA should be submitted to NIH for registration.
This MUA should be submitted elsewhere. Secbelow.

This MUA is:
x New
Renewal of MUA base #
____ xy )- Modification of MUA base #

 

 

 

 

 

 

 

 

” Other Submitted for transmission to new agency or for new grant.
Other
MESES: SSE SEAL IMATE SNS TEDESE OR ICL, SEIMEI LPN ISLC VRE TES RR LTE mt ~~
D) SUPPORT DATA:
1) PI H.E. Varme Agency NCI Grant # 19287
Grant title: Molecular Biolosy of mouse mammary tumor virus
2) PI Agency Grant #

 

Grant title

 

gears CFSE RTT BD VI POET USPC SEL,

Address to which MUA should be sent by IBC: Date received by IBC __
(1) Carrett Keefer (2) use 465 (3) ORDA
Div. of Cancer Cauee and Date approved

Prevention
NCI