[PAGE 1]
Projoct ULTRA, BubproJect 135

Dato Initiated, 15 8optember 1961

Date Expireat 1 October 1962

Punds-current year1 \$24,870.00

Purposet To provide for inveatigaticns involving clinical testing of volunteors in prograas of TaD intereat. Toe project will provide a facility and a teaa of medical-supervisors as well as a large stable reservoir of volunteera.

Statuer Project 1a approved but has not been activated.Activatico, vill be attempted by 1 Saptember 1961.

135-1

[PAGE 2]
Cost Account3125. 1390 -3902

Object Class

135-2.

[PAGE 3]
MEMORANDUM FOR: COMPTROLLER

ATTENTION : —\_ Finance Division

: SUBJECT MKULTRA, Subproject 135

Underfhe authorlty graated in the meinorandum dated 16 June

1961 from the DCI to the DD/A, and the extensioa of this authority In

subsequent memoranda, Subproject 135 has been approved and \$25, 868.00

of the over-all MKULTRA\_project fuads has been obllgated to cover the

subproject expenses. This obligation of funds should be charged to

Allotment 2125-1390-3902.

APPROVED FOR

OBLIGATION OE FUNDS:

TSD/Research Branch

Research Dtrector

CERDFY THAT FUNDS ARE AYAILASLE
QPUGATON RERIC No2
A101251903902 AUDKORZING OFFICER

12

Date:\_

Distributfoa: Orig 4 3 - Addresse e 1-TSD/OC TSD/FASS 2-TSD/RB

135-3

16 June 1961

[PAGE 4]
12 Juy 1961

KHORANLUH PORI CHIEF, PINANCE DIVISION

1 TsD/Bulzet Officer

1MULTaA. Subprojoct 135, InToice f1 A110tment 2125-1390-3902.

1. Iavoice No. 1 covering the sbove subproject is attached. Payoent should be mads as follovsi

2.=Ploase forvard tha chacke to Chief, TSo/Resesrch Branch, throuh Top/oudcot officer, no later than 24 July 196l.

3. Tbis ie a final icvolce. However, since it is apticipated that sdditicoal furdls vill bo oblleated for thia projeet, Whe files ahould not be cloeod.

TSD/Aosearch Brecčh

135-4

[PAGE 5]
CERTIFICATIONS

(1) It ie hereby certified that this is Invoice l  applyuag to sub-project No. 135, of KULTRA, that performance is satisfactory, that services are being eccomplished in accordance with mutual agreemente, that a detailed agenda or the payrenta and receipts is on file in TSD/RB, that this bill is just and correct and that payment thereof has not yet been cade.

Chief, TSD/Research Branch

Date:

(2) It 1s hereby certified that this invoice applies to SubProject 135 of MULTFA waich vas duly approved, and-that the project is being carrled out in accordance vith the memorandua-of 13 April 1953 froa-the DCI to the DD/A, and the extension or this authority in subsequent cecoranda.

\$25,868.00

Date:

135-5

INVOICE

For Services

Reacorch Director

[PAGE 7]
P pPY)

[PAGE 8]
11 June 1964

WMORANN FOR 1THE RECORD

L Sbojt 70, 91,  135

Since the coplesion or tho auiit or Project HuLtt for the period
1 Aucuat loo throih 31 Jemary 1963, acocuatines heve boon roceived
frop ta the enount of 93.677.50.Thia a pmsn grantoea at tho ood of tho auiit porlód.

Subprojoot 70 1ncurrod direct coote of 2,518.34 and \$27,872.16 treosferred froa Dubyrojoct 9h, for a totel of \$30,390.50. Subproject 94 incurred exonsea of \$71,324.87, but trenaferrod h,165.71 to Subpro Joct 91 and \$27,872.16 to Subpraject 70, leaving a nat cost of \$39,207.00. It ws deoidod to divert tho funds for Subprojeot 135 to Gubproject 91, therefore Shoee costa vero inoluded in tho sccowntins froa Saibproject 9l.

Inaasuch as: 1) all four of the subprojeote bad ths sare basto rosearch gcal in aind, 2) the grout length or tise thet bas elapsod aince the grants wore mde, end 3) tho dirficulty in gettins accountings of aayccat fros the grentee, it is rexeronied that ve facilitate this wattor to accouting foe tho balances eo ahown in the Conftdoutial Puods Divieion 760 ecsount for those arojt

Tho above has baon concurred in 6 Staff.

135-8

[PAGE 9]
Grants Pebruary 1, 1961 to January 31, 1962 \$48,000.00 Less, previously reported 40,000.00 \$8,000.00

February 1, 1962 to July 31, 1962

Total

24,000.00-135 TACCTG \$32,000.00(N S08 91) 2

[PAGE 10]
At Date of Origioal Period-Tiee EstecdedAllotzent fxcunt of Authorization Covered To Mabex Ozllgation

INVOXOS CHEOK LTST

[PAGE 11]
MULA Suoprojeot

At Date of OriginalPeriodTire Extocded Allotreat fncunt of Authorisation Covered To Heober Ogligation

Additional. PeriodTica Extandel—Alictsent ésount of Authorisetions CoveredTo Muaaber Obligation

135-10

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Gentlemen:

Wo axe pleased to be able to transmit to you the following funds!

wt 1, 1961, drawn for \$998.00.

These funde represant a contribution for the vae of your directors in carrying out the very worthwhile rosearch goale of your obligatlone,

Yours truly,

16 August 1961

Attachmente (2)

[PAGE 13]
:Prsiect MKULTRA, Subproject:No.135, Change of Facilityin which Work is Performed

1. The original purpose of this subproject was to evaluate a number of candidate chemical agents in facilities and under the direction of individuals who, it later developed, beczme unavailable for this purpose due to unforeseen circumstances.

2. In the meantime, the funds for this subproject were transferred to the cutout in anticipation of the commencement of the work.

3. In view of the security difficulties involved in the actual return of funds from the cutout and also since another subproject (#91) was being served by the same cutout, and furthermore, since subproject #91 was capable of providing its services on these chemical agents of intereat and during the same fiscal year, it has been decided to'divert the work intended for subproject #135 to the facilities of subproject #91. No significant change in funáing or variation in fiscal year is concerned in this matter.

135-12

D R A F T 31 May\_1962

MEMORANDUM FOR:THE RECORD

SUBJECT

[PAGE 14]
MEMORAMLUR PORICHTK, PINANCE DIVISICH

VIA

1 TSO/Budgot Officer

1MOULTAA, Subproject 135, Invoice\_f1 Al10tment2125-1390-302.

1. Invoice Ho. l eovering the above subproject ie éttachod. Payoant rhould be pade as follovet

n the aount of t23.670.00 d Rayable t B

tho coount of too8.0 d Spayable to B

2. Please forvard the chocke to Chiof, TSD/Research Branch, through TSD/Budget Orricer, no later than 2h July 1961.

3. Shis is a final invoice. Howevor, since it is anticipated that asditiocal Cunde vill de obligated for tbis projeet, the files abould not be closod.

Attachynentet Invoice & Certifications

Orig A 2 - Addreesce

1- TSD/FASS

12 - TSD/RB

A

135-13

12 y 1961

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CERTIFICATIONS

(1) It is hereby certiried that this 1s Invoice l applyung to sub-project No. 13s or MULTRA, that performance 1a satisfactory, that services are being accomplished in accordance vith mutual agreccents, that a\_detailed agenda of the taynenta and receipts is on file in TSD/RB, that:thie bill is Just and correct end that payment thereof has not yet been made.

Chief, TSD/Rescarch Branch

Date:

(2) It is hereby certified that this invoice applies to SubProject 135 of MuLIRA vhich vas duly approved, and that the project ia being carried out in accordance with the meaorandua of 13 April 1953 froa the.DCI to the DD/A, end tho extension orthis euthority in subsequent memoranda.

INVOICZ

135-14

For Services

25,068.00

[PAGE 16]
MEMORANDUM FORECOMPTROLLER

ATTENTION :-Flnaace Division

SUBJECT ;MKULTRA, Subproject 135

Under the authority granted la the memorandum dated 16  une

1961 from the DCI to the DD/à, and the extenaloa of thls authority In

subsequent memoranda, Subproject 135 has been approved and \$25, 868.60

of the over-all MKULTRA project tuads has been obligated to cover the

suboroject expeases. Thls obllgatlon of tunds should be charged to

Allotment 2125=1390-3907.

APPROVED FOR OBLIGATION OF FUNDS:

Resesrcd Director

pate:.

Distrlbutloa:

Ortg à 2 +-Addrosse e

1·TSD/OC

1-TSD/FASS

2TSD/RB

135-15

16 June 1961

[PAGE 17]
MEMORANDUM FOR:THE RECORD

SUBJECT :MKULTRA, Subproject 135

1. The purpose\_of this subproject is to provide fugds to carry out a research program involving utilization of humnan volunteer subjects.

2. This program is designed to exploit clinical and laboratory facilities and professional knowledge in providing answers to specific questions of direct interest to the Agency. The nature of the investigations to be carried out encompasses pharmacological and clinical testing in human volunteers of chemicals, biochemicals, and biologically active materials under controlled conditions. For example, human patch testing or human\_ blood group determinations will be mounted upon setting up a suitably designed experiment.

3. The investigations will be carried out under the general supervision of This individual will serve as project leader and coordinate all phases of the research program, select and provide clinicians to conduct the experiments, assist in planning the experimental design and protocol, and supervise the preparation of data and reports. The\_attached proposal indicates the nature-and-extent of some of the investigations that will be carried out.

135-16

DRAFT

16 June 1961

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4. The funds for this project will be transferred using the S a cut-out.

5. The cost of this program for a period of one year beginning l July

1961 will not exceed \$24, 870.00. To this sum must be added \$998, 00 representing a 4% service charge to th B who will act as a cut-out, making the total amount \$25, 868. 00. .Charges should be made against allotment #2125-1390-3902.

6. The will require the principal investigator who administers the grant to submit to them a summary accounting upon an\_annual basis of all monies received from the B Also they will require that any unexpended funds be returned as soon as possible upon the close of the grant year.

7.-The requirement for a six months'informal accounting on the part of the principal investigator is waived. 2.

8. It is not anticipated that any permanent equipment will be required for this program. - x

9. It has been agreed that documentation and accounting for travel expenses which are reimbursable shall conform to accepted practices. 10. It is agreed that technical reports reflecting the progress of the research program will be accepted at mutually accepted intervals.

11 gas signed a memorandum of agreement and holds a TOP SECRET Agency Security Agreement. The project will be unclassified after it reaches the

135-16

B

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APPROVED FOR OBLIGATION OF FUNDS:

Research Director

Attachment: Proposal & Budget

Distribution: Original only

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135-16

PROPOSAL

OBJECTIVE :

To establish a professional organizatton for the primary purpose of servicing and conducting complete clinical evaluations and testings upon demand.

In addition to prescribed activities, to maintain itself on a standby basis and to be able to mount clinical projects on an ad hoc bašis.

PROCEDURE : see attached sample protocol for patch testing.

CLINICAL FACILITIES :

LABORATORY FACILITIES:

[PAGE 21]
BUDGET : ( 12 months period)

no overhead or\_fee

[PAGE 22]
PROTOCOL

OBJECTIVE :

To determine whether an unknown compound, either chemical or biological, is capable of eliciting a reaction when applied topically to the skin, either locally or systemically, or both,

BACKGROUND:

If the skin is able to deal with the irritant compound, the reaction is physiological or normal. However, if the áction of the irritant is excessive, the reaction is pathological or abnormal and irritation results. Irritation is an extreme reaction of tissues tó an insult or injury and is best characterized as incipient inflammation.i The inflammatory process may vary from a barely perceptible hyperemia, to edema formation and vesiculation and finally to a suppurative process.

A primary irritant may be defined as a substance producing an injury on first contact, The resultant injury will depend on the nature of the irritant, concentration of the irritant, and the total elapsed time of exposure, Primary irritation of the skin is usually measured experimentally by the patch test technique on abradedor intact sjin of the experimental animal, for example, rabbits,"guinea pigs or man.

Exposure of man is predicated on small animal studies used to screen all compounds to be tested to obylate exposing man to severely sensitizing substances. Granted, in the case of compounds which may be only mildly sensitizing or in which small animal studies are\_unable to furnish unequlvocal results, man may appear to be the only feasible final test subject.

Animal experimentation data should include acute, subacute and chronic dermal toxicity experimentation that will allow some logical assessment of the local and systemic toxicity of substances\_to be appltéd topically to man in the proper amounts; concentration and frequency of application that may be tolerated,

135-16

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PROCEDURE :

For pilot studies, human testing should employ 20 test subjects per compound tested. Prlor to experimental testing, maximum efforts must be\_made to\_minimize the\_risk of incurring unforseeable sensitivities and untoward responses by establishing a base line profile that will encompass the following :

1. Complete medical histories with emphasis on known sensitivities and drug idiosyncracies.

2, Preliminary physicial examinatlon

3. Hematological evaluation (complete blood count)

4.Urinalysis(microscopic)

5.Radiological screening(chest and long bone)

Acute dermal toxicity. (Single éxposure or primary irritation)

This will utilize the patch test technique on intact skin on a minimum of five subjects per test compound.

Methodology will consist of introducing under a one inch patcg 0.5 ml (liquid) or 0.5 gm (solid or semi-solid) of test sübstance and securing the gátch in place with non-sensitizing adhesive.

After 24 hours, the patch is removed and readings made on the resultant reactions evaluated on the basis of the following scores :

Evaluation of Skin Reactions

1. Erythema and Eschar Formation

No erythema

Very slight erythema (barely perceptible)

Well defined erythema

Moderate to severe erythema !

Severe erythema (beet redness) to

Slight eschar formation (injuries in depth)

Total possible erythema score

2, - Edema Formation

No.edema 0

Very slight edema (barely perceptible) 1

Slight edema (edges of wall well defined, raised)\_2

Moderate edema (raised approx I mm)

Severe edema (raised more than 1 mm and

extending beyond area of exposure)4

Total possible edema score

Readings are again made after 72 hours of exposure. The . i-

final score represents the average of 24-72 hour readings.

135.16