Policy on Protection of Human Subjects

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The removol o f hunon blood somples involves a voiiety ofprocedures and equipment. A l l of t'liese procedures ore well stonhrdiz-3 and their applicotion in compitsnt hords involves negligible- inherent risk. A s a result, most institutional commitiees concerned with the review of research proposyls involving humon subjects ore ucd ers to ih bly inclin?d to give .scant aticntion to projects util;zin; Lloods. Perhcps, that i s why taking blood has resulted in on inordino!e number o f problems to institutions, considering th? low but rcol The need to pro vidi coctrcls i n researchoften results in an investigator osking for samples lorger than the routirie 10 ml.A drsire to firmly ei:ablish the validity o f o method led to one proposcl to 60 from 10 m l . to 1030 ml.inQ grou? o f seriously malnourished patients. The desire to io113w the time courss OF are pone con led :a such frequent v ~ mpl in a that a patient i s A more ssricus obc;* i s uti!izo:io:i of tt,e szmple for pur por x w!:ich the svbjact cou!d not recsono5ly hove anticipoted o t the time he 33ve explicit or impliclt consent rJ the re:r.waI of the blood. Example: include the pre ser x of i:lejcl drugs. 111 bath instcnzes the the :nv=:ripbr open ta lescl action. To usc the , c i t consent hgshcen ruled to be o viclotion o f his righis\under the Fif!!] Amendment. obta;n informofion that ccn be s xi oll y donogin9 to the subject. V4h;le h t l ! of the exomp!es given shore this pToSlen, a cleorer in:t.nce i s provided by the recen: expr ien ce sf a medical center engo3ed in cidence cmong in-notes c f correctionol institutions, oi?d among n cortrol populotion ottenjing a community hec:!rl; sr vic a o?eratai by the medical center, led to u l : irw : tly p-iitbiiled t k projec; r 3 procq;ci, but oniv prison syrtenrthrough the lote 1960's focusdottzntian o n the potential abuses o f this procedure. Epi&,;icj of viral hepotitis in the prism; were reloted to equipmcnt design ond procedures thot lent thernielv, as to a high level o f contominotion o f technicions' hmds, work surfaces, ond equipment. A committee convened by the Division of Medical Sciences, Notional Acodomy o f Sciences-No:ionol Research Council, issued o rsport in lot e19i0, on "hfeguords for Plomo Donors i n Plounopheresi: PI:- Informed consent in plosmopheresis requires thr attending physici-n to provide o reosonsble ond i n - OR usu ~ l l yminor in the other instances cited. A of substantial hylp in developing rezscnoble cnd i n - telligent explont:ions of rijks. ineffective in relieving the physician of Iiahi ' ity isr foiling to rxercise reamn,ible core i n trectin; t.ie pctient. More o er, the ccurt concluded the c gre mk nt containing such a clause wos rvi ls n ce tznding to Show that the physicion was nzgIir,ent inp ~ o cee di : qwith , Finally, i! skould be noted that i n the use of+xcv:pztory clouses the cosxtr H :!i construe such ogreernenti o l l y refuse to permit tile C~CIUII to exclude suc!i Ii&:!- tioning negligencc does not :over "active" ne j lise v ? The use o f such longusso in con cnt forms undot'Jtobviourly do nct regard this as on cscusc for if-.VIE Ly institutions which provide a pubiic wrvice. This vi9.i

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Lawronco Berkaly Clboratoq subcontractors prior to the award o f subcontracts exceeding $10 ,Oo ~ .oo which are ii' ' ,axempt from the provisions of the Equal Opportunity clause; that he will forward the following notice t o such proposed subcontractors (except where proposed subcontractors have submitted identical c e r t i fications for specific time periods). NOTICE TO PROSPECTIVE SUBCONTRACTORS OF REQUIRE'IENT FOR CERTIFICATION A certification of Nonsegregated Facilities, as required by the May 9. 1967, order (32 F.R. 7439, Hay 19, 1967) on Elimination of Segregated Facilities, by the Secretary of Labor must be submitted prior t o the award ofa subcontract exceeding $10,00O,OD which isnot exempt from the provisions of the Equal Opportunity clause. The certification may be submitted either for each subcontract or for all subcontracts during a period (i,e., quarterly, semiannually, or annually). NOTE: The penalty for making false statements i n offers i s prescrlbed DUPLICATION OF COST The Contractor represents and certifies that any charges contemlated and tncluded i n his estimate of cost for perfonance a r e not duplicatlvc o f any charges against any other Government contract, subcontract, o r other Government source. INYESTIGATIONS INVOLVING HUMAH SUBJECTS Concern over the rights and welfare o f the human being as a subject of research has led to the ilepartment of Health, Education, and Welfare p o l - icy t o help assure his protection. search must provide for the individual's safety, health, and welfare. His rights, including his rights of privacy, must not be infringe?. participation must be voluntary. research must outweigh the inherent risks to the individual. applies to a1 1 research activities supported through grants, awards, tr contracts by the Department o f Health, Education, and Welfare. Any activity which includes sucn r e - The direct or potential benef1:s of :"e The bidder must provide written assurance t o the Department of Health, Education, and Welfare that it will abide by this policy for all research involving human subjects supported by the Department o f Health, Eh cation, and Welfare. This assurance shall consist of a written statement of c m - pliance with the requirements regarding initial and continuing review o f research involving human subjects and a description o f the bidder's review comnittee structure,its review procedures, and the faci 11 ties and personnel available to protect the health and safety of human SubJeCZS. In addition t o providing the assurance, the bidder must also certify t o the Department of Health, Education, and Welfare far each pro?osal f n - vol ving human subjects that its comnittee has reviewed and approved the proposed research before an award may be made.