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D.LJAiiTiV.ZNT OF MEALTR. EZIJCAT.3N. AND WELF AZ lor group review to protect the right6 aod welfare of the hmzn sub;accs izvolved. The oziginal pollcy invoPqed oilly :ka support 05 rzsearci szL ix s a arch training. !.:.1 .pants and awards of the Pabl2c Zealth Service i n the o qg ort of rLThe app li c stic n of tM3 policy has bsc at ended to w:.:;;: Lac;; qp ii cat ioa. Attached to tk is memorandun isa statement of re- .. :;Lined i n administering this poXcy Lis hi to revision and The Ecjor 2z ocs dmz i revision is one for The YL:blLc HealEI, Saw ice will cont bu e i.ts study of the issues 02 invzstigatoza 02 grantee institutions to assist the Service inthe conduct of F23 I ti-cbt that these revisions, reflective of the advice I have rec ei wd from ZIZA ~ of you, will facilitate your tiischarge of this important obliga-
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811 Public Xealth Service Grants and Awards i:'~,i~,e;-:>stion icv.r.'L~~;:;s huczil beings shall be cxarded grax2e institution wlll provide prior rsvisw 02 the judgment or' the principal ime stig nt or OT 2rogra-m director ky a cammittea.of his institut hz - e l associeces. This review should esxre L'.= independezlc 6eterminet;c::: eethogs used to sew x info;=msd consent, zi=d (3) 05 &e A description of tne committee of the associates who wili ?rovide the review shsll be included i n the app1icc::im." renewal, .,= 3 :ntiz.:;stion reseerch or resezrch
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-.If lcial of :he grantee in st ix tion involved and all Public Health
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ai ,3ii51Lc Eaalth Service policy and Procsdure, invss; ..gation of human subjec2s sene t o 3 s , and have approved, nn Vc skl'l. ziso need attachmaits to this state a eni a description of the iai ?;-otecting the rights and wzifare of tne subjects, oil the appropri.atsness of ti12 mecholis used t o secure the informed consenc of tke subjzccs, and on the risks and poeeFtial A on page 2 and section IV on page 3) changes in investigative prorocol ,which mly affect the subJects, before such changes are made, and emergent problems oI investigation, which may afi ect the subjects,wlrm such c. Conveying the advice of the committee of associates to the I Group review and decision on the adequacy of provisions Bringing t o the a;=cntion of the committee of associates lnves ~ Lgcto rconcerned i J. Assbring tlic institution that the investigator follows the aiv i cz of the committee of associates( please see section 2. The competencies represerited i n the committee of associates (please see section III A on pags 2 and section IV on page 3) * 3. The sources of consultants, i f employed (please see section &. ?Tovi.sion of facilities and professional attention necessary la-: che lwili.; and safety of the subjects (please see section I11
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5 , yne appllcabiiicy of your stbtement, i.e., whether to the inszitution as 6 whole or 5 0 a specified compooenr of the inacitution (piease see section on' page 3) Yous sarly re2ly will help us hasten the review.
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In accordance with the of the Surgeon General of the to clarify and regarding investigations on human ' .. . human subjects, prror review and endorsement b y an independent commi'ttee of peers is required. shall be obtalned from the participating the Unlvcrsity has appointcd a Commlttec Investigations involving human subjects, regardless . Before such projects are undertaken, a written prothe Comit tee on Clinical Investigation; If changes in experimental approach are made in the course of the project, the investigator , with the procedures approved by the Committee on Clinical-lnv-estfgation. Documentation o f the Informed consent will be kept I n accordance. These pol icles are designed to underscore the Institution's attentlon to end scientific excellence. .. Rob Roy Purdy Senior Vice Chancellor Director of Medical A ffe irs,rsa : School of Hcdlclne
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only changes i n procedures involving human subjects. : ' procodures to be carrfed out on that-group (see example attached \. . Below each group of patients or volunteers, indicate the Invest; atlone\.
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, , 0, The consent form which is approved for inclusion in the Medical Records . , ' -tion of the methods to be used in obtaining informed consent must be consent form is not to be used in all of the proposed studies, an ezplana-' E, 1. Radioisotopes will be admlnstered to human volunteers: I .; 2. If "Investigational New brugs" ar.e to be administered to human volunteers, D copy of the appropriate F.D.A. application accompanies this proposal if this has been filed. of the approprlatc F.D.A. a p p l icatlon wlll bo subrnI ttcd to tho Corn{ t t a o ..I( on Clinical lnvcstigation prior to use of such agent. I f investigational drugs not so covcrcd a r o uscd in tho study, a COPY 1 ; ; d 3. Written evidence of informed consent w i l l be obtained in all investige- . ' tions involving human subjects'.
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EXAMPLE OF INFORMATION NEEDED \ N SECTION A 1. ,- Adult Patients with Paroxysmal Nocturnal tiemoqloblnurla. c. Bone marrow cxamlnation. Blood, urine and stool collactlons. 6. Volunteers Pcdlatric Age Group..
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The intra-University transmittal form which accompanies each .... signed by t h e Department Chaiiman: of the individuals and ilic risks and potential medical bc nc fit a ' ,.. have been reviewcd. a . protocol will be undertaken in human subjects without prior approval of the Vanderbilt Committee on Clinical Invectigation e'' ,, .....
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Procedures for the Implementation of Vnndcrbilt ' s Policy on Investigations following the acceptance of this policy by the United State e Public Health: a , involving Human Subjects will be sent.to all faculty mernbers of the School ' * The following are the academic positions of the membere of the Vanderbilt' * * . Associate Tk-ofessor of Mcdicinc and Pharmacology (Clinical Pharmacology) I Associate Professor of Mcdicinc (Staff of t h e Thayer Veterans Adminis*a- ' '- i Associate Professor of Medicine and Radiology Associate Professor of Physiology Professor of Medicine (Staff of Nashville General Hospital) Professor of Philosophy (Research i n Medical Ethics) individ\ialu who can contribute e pcc in l knoctlcdgc regarding tho oc i ent if i c. merit and the rida of propoecd in v co tiga tion a.....
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VANDERB I LT UNI VERS I TY MED I CAL CENTER Consent for Clinical, Research Study TITLE OF PROJECT: t o participate as a volunteer In a program of lnvcstlgatlon under the super- . .,.. vlsion of Or. This Is to certify that 1 hereby agree Tho studlcs havc been deflned and fully explained by Or. and I undcrstand that thc studlas will Involve the fol lowlng spcclol proccdurcs:I I, tho undersigned, have defined and fully explalned the studles Involved t o ' f
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1 1 1 . Relation o f Other Committces to the Committee on Clinical Investlgetion: * . review and approval of all projects in which radioisotopes are used is required, and the administrative mcchanlsm for review of projects b y . the Vanderbil t Comrnittcc on C1 inical lnvcstlgation Automatically brings these investigations before the Radioisotope Committee. the Radioisotope Committee i s also a member of the Committee on Cllnlcal The Radioisotope Committee i s assisted in Its functions Advisory Committee to the Clinical Research Center: A conriderable ' ' . proportion of the clinical research at Vanderbilt University Hospital is provided prior rcvicw of projects carried out on thc Ccntcr, and has con-., sidercd thc scicntific morlts of the projccts and thc risks and rlghts of attending on the Center, he i s an ex-officio member of the Advisory Committee and thereby keeps the cornmi ttce in touch with the day-to-day opthe subjccts involved as integral parts of the process of revicw and multi-categorical centcr thrcc timcs weekly; during the time that he Is the Clinical Research Center Advisory Committee Is also a member of the A n attending physiclan makes rounds on all patients on the -. . eration o f the Genfsr and the conduct sf pro jsc ts thsreon, Qne member of * ..I. and consult with the Committee On Clinical University projects arising outside of the medical school which are primarily . in the areas of psychology, sociology and engineering, a sub-committee composed of two psychologists, one sociologist, one engineer and one philosopher has been appolnted. This group reviews and comments on these projects before they are submitted to the Committee on Clinical investigation for final review; Investigation in the rev1eb.r of Committees in Vanderbilt Affiliated Hospitals: A Committee on Clinical Investigation has been in operation f o r some time at the Veterans Admini-stra- '. . .. human subjects within that hospital. tion Hospital committee is also a member of the Vanderbilt Committee on Clinical lnvcstigation. A similar committee has been established at the Central' State Psychiatric Hospital and one of the members o f this com ltte e i s also a member of the Vanderbilt Committee an Clfnlcal investigation. Theso. lance of projects In .their respective institutions and cooperate with the. ., This committee provides prior review on studies involving One member of the Veterans AdmInlstra- 'Unlverslty Commfttee on Cllnical Investigation In these activities.. Their,
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LV. Procedures f o r Review and Approval of Projects by the Committee: c . .A. All investigations involving human subjects must bc reviewed and approvcd b y thc Conimi ttcc prior to lni tiation. Ptaposals are submitted to thc Sccrctsry, Coinmi ttcc on CI inical Investigation, Office of tlic Dircctor of Medical Affairs. Appllcations must bc favorably recommended by the Committee before submlrsion to g rant i ng agenc ies . i s employed f o r all project proposals to the Committee on Clinical B. Method of Review: The Clinica1,Investigation proposal form which supporting information are reviewed by the members o f the Comnlttee ' . individually prior to the Committee meeting, and considered by the .. .' Committee in session. For all projects whet-e the Committee may recommendat ions regarding improvement 1 n the experimental I reviewed. The,potential of the invcstigatlon to producc medlcal i ! benefits and to advance scientific knowledge are considered, and may be made to the investigator. I In-projects where the risk a n d indications vary considerably tiependof the project i s that the departmental chairmen accept the responsibility f 3 r insuring appropriate independent consultation on the individual patients prior to the investigation. ing upon the condition o f the patient, a condition f o r the approval ' For all projects involving the use of investigational drugs, the proposals to the Food and Brug Administration for investigatlng or sponsoring these agents are rev - hyed. At the end of the Clinical Investigation proposal, the investlgator signs a statement which reiterates h i s compliance with the Univers!ty'S pol icy that " i f changes in the experimental approach are to be made . in thc future, I will seck p r i o r approval of the Committee on Cllnlceli L E T h & k for obtslninq and documcntinq informcd consent: For all projects, the methods for obtaining and documenting informed ,. - consent will be reviewed b y the Committee on Clinical Investigation. , . .which are in accord with the pol icies o f the Unlversfty States Public Health Service will be approved. V. Role of the Department Chairmen in the School of Mediclne in the Implemen- . tation of the Policy. A. The exccutlve faculty o f the Vanderbilt University School of Medicine (whtch includes the Chairmcn of all Departments ln the Medical School).. has unanimously approved the Vandcrbilt policy on investigations Involving human subjects, and affirmed the departmental chairman's responslbility for the lmplementatlon of this pollcy by the members of their ' . *. '
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I I am eaclosing copy of Dr. Dunlzan's letter with attaehents about clinical researoh and investigation involving human subjects. W e will need to get s o m e w together on this bfore the next BioBIedicai Directors? Meeting -- which ie February 13-14, 1967.
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ATOMIC ENERGY COMMISSION Director, Medical Division O a k Ridge Associated Universities Oak Ridge, Tennessee 37831 Following the lead of the Surgeon General in instituting a code of ethics for human experimentation, it seems appropriate that we i n the Atomic Energy Commission assure ourselves that our own house i,rin order. I should, therefore, like to propose that we consider a t our next Program Directors' meeting procedures that each of you are following at your respective institutions and compare them with Public Health Service requirements. Enclosed isa copy of the Surgeon General's statement as well as the check list which Public Health Service staff uses t o evaluate the institution ' s compliance. Uivision of Biology and Medicine As stated above
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UAV IU EDITION Division of Biology and Medicine USSE QF HUMAN VOUNXEEZIS IN BIc%rzEsICAL RESEARCH This is in reference to a proposed memorandum to bring to the attention of the General Manager the contemplnted new AEC biomedical research project involving the uee of human volunteers. convicts, college students, and other individuals, twenty one years of age or older, will be invited tojolunteer, and monetary consideration will be paid for their services. conducted for AM: by the Hanford Occupational Health Foundation. have asked for our views. A6 we understand it, These indiv6ls will ingest or be !Phis program will be From the legal standpoint, there are two areas of potential risk which should be considered in the use of human volunteers in experiments: 1. Risk of adverse effects from the radiation experiments properly carried out; for example, the risk that the intended dosage of 0.1 roentgens might cause some pathological condition in certain 2. Risk of injury from negligent conduct in the course of the experiment; for example, the risk that an experimenter might be negligent in the operation of the radiation source and give dosage of 1.0 rather than 0.1 roentgens causing injury to the volunteer. It is our opinion that each volunteer should sign a1written, witnessed agreement in which he or she states that he or she is in sound mental and physical condition and is participating in the experiment on his or her own volition, that he or she understands that what is being done i s for experimental purposes and not for the treatment or diagnosis of the individual, apd that he or she understands the nature, procedures, and probable effects of the experiment. forth the nature and purpose of the experiment, the procedure to be used (including a description of the individual volunteer's participation or u6e in the experiment), the known possible risks, if any, and the arrangements, if necessary, for possible termination of the experiment or research (e.6. if the volunteer later desires to withdraw from the experiment). It would be advisable if the agreement also negated any inference that the paid voluntcera are employees of the contractor for purposes of the experiment. The agreement should be …
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