Document text
Machine-read from the scan, so expect some errors. Lines that couldn’t be read are left out.
Page 1
Lawrrnso Brrlmlry Llborrtg Statement of Policy of the Berkeley Lawrence XLL - ation Laboratory CONMITTEE FOR SAFEGUARDS I N RESEARCH I N HI-~TL'.:J SULYLCTS Berkeley Lawrence Radiation Laboratory, February i967 Purpose of Committee The Committee functions in an advisory capac icy tc the c,---;-. isnot c:iarged with sur veil ance or admin is t ratio c of researc?. Apprc-:a1 of a protocol by the Committee satisfies on;y i3erkelz2 Lawreace Radiation Laboratory rules concerning research proce8uzi, a sc. rate approval for the investigation must be obta : .td fr on Berk L2y Campus Advisory Committee on Safeguards in Sz search in exper3er.r: from the extra mural institution should be obtain ea. The col from the appropriate institutions is the functio.: of the resp cns i ble investigator.National Institutes of i~.. ich supported t c Loth the Berkeley LRL Committee and tothe Berkeiey Campus P.2visory Zommittee on Safeguards and Research on H can Subjects. Stat cie nt of Present Policies fic nan s,a protocol describing in detail the purpose, methods and hazards attendant to the experiment should be submitted and approvsd 5ythe above Committee. When such protocols involve experiments; k>e of radio nuclides in humans they should contain a detailed s.;:,r.ary of available information relative to the distribution ai-.. me:a:olic fate of the given radio isotopic aly labeled mace rial ir. the human body, together with 'estimates of initial radiation dos, rate and total radiation dose delivered to the whole koCy and eac'.? critical body organ. In judging acceptable doses,the committee Prior to initiation of any investigation involving the use cf 1 0 8 9 1 3 O HUMAN SUBJECTS 1 BEST COPY AVAILABLE
Page 2
will b c guided by such matters as age and se?: of the su:r,ject, ?.is life expectancy, expectancy o f producing off sg ring, pro2ability of therapeutic or diagnostic value of the procedure Ir. a preser.: illness,establishing controls or normal values for a ? art icu li ; procedure, and the overall balance of risk against scie:.:ific merit of the proposal.If the procedure involves single aC?.;:-..:- t ration of radio nuclides not greater than the maximum permiss-: - 2 value as stated by the United States National Committee on SLL - L - i ly expect Committee approval for use in all mice d number cf z c : - & ; adult human volunteers,as well as for patients. than r he occupational MPBB of a radio nuclide w l th Tafe i '...;.u's css in small nui i ers of normal adults judged unlikely to tear children in the future,or for patients of limited life expec:ar.cj. a single procedure or participate in multiple p roze dure s the :E _ L I a os e received in the procedure as well as the ca xi la ; lve ?re.:,:-, razia tion dose delivered to critical tissues should astir sz t - and such estimates submitted for review bythe Commi-ctee. 2 . The Committee intends to review potentially hazard cus p>.::s;z;1 procedures,specific to the protocol imposed on the hx an s:t;e:t (other than those related to venepuncture for blood samp1ir.q 37.2 b ~ d ye xc ren ent collection).Sterility and lack of pyrogenic,:;, 05 are expected to design their experimental protocols sax2fro - 2::' potentially hazardous mechanical procedures. iste red to a human subject in any experimental protocol a st eir. : acceptably safe when the material is either a nzrmal zody c0r.s:;- tuent which has no known toxicity when administer etin the dose
Page 3
and by the route proposed in the experimental ~rc,.oco;, oradr ; ~ t ration for clinical use when administered in thc dosc and b:. :1-.~ route proposed in the given experimental protocol. When the chemical nature of the material to be used i n any given experi-enz does not correspond t o either of the two above mentioned cates or - e s and represents an experimental drug which has not yet received sanction for clinical use by the United States Food and Drug >.dminis t ration then all restrictions to the use of this drug impose2 by the 'Jnited States Food and Drug Administration are incorporated inthe requirements for the proposed experimental protocol. tion of radio nuclides should be over 21 years of age and when possible should be males. Normal female sub:si-ts may be studies when after history and physical examination ths physii,an i s reasonably certain that they are not pregnant at the tc,eof I;.-.= study. Under circumstances when the individual investigator fea;s it necessary to administer radiation or radio nuclides to normal volunteer subjects under the age of 21 or to study a normal subject dur;ng pregnancy, then each case must be firsr : individually received 5. Written informed consent must be obtained fro:;. each human subj ect as required by the Directors of the laboratory. 6. Adequate written records must be kept including informed consent, when applicable, and the nature and quantity of radio nuclides 01 other experimental materials administered to a given subject. 3.e investigator is obligated to promptly inform the Director of the lak oratory of any difficulties adversely affecting the patient. 7. Confidential ty of information obtained from the subject must 8. All procedures in which radioisotopes are administered t o humans are considered appropriate for review bythe Committee. 9. when the Committee deems a given protocol to be appropriate for routine clinical use it will be SO designated.
Page 4
author as an indication of approval by the Comrr,ircre. ir.e i .,Lati gator is obligated to adhere to the approved protocol. James Born, LL.B., M.D., Assistant Director, Donner Lak orator.. Hardin B. Zones, Ph.D., Professor of Physiology and Medical ?n;~s,cs, Lawrence Radiation Laboratory, Berkeley, Cali for ni a. ii ena to logi st, Lawrence Radiation Laboratory, Berkeie.7, California