Letter to H M Agnew from C O Mccorkle, Subject: Research Involving Human Subjects and Attachments

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circulata on your campusas the tlnloeroity'm policy without it8 W e have been told that copies of the DHEU docmwnta u e

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Office Of the President 1. The rer pon sibi li tyr or compllrnce with regulations concem5ag exprrl#atation with hmu? subjects s h a l l rest vith the Churccllorrr, the Vice President--Agricultural Sciences, and the Vice President-- Public Service Progrrmrr m d University Dean of Univetrity Extension. 2. The policy o r t b t Department of Health, Educ8tion, and Welfue, 18 cont da cd in the rttachad coyy o f Grants Adainirtration Manu81 Chap ter 1-40 (April 15, 1971). sh8U be applicable t o all activities involving hrrmurn 8ubjectr (as defined in that Cb8pttt) for which the Uniweralty i r rerponriblc, not just those f'unded by the m,except ?Or thore rupported by other grnting 8gancicr vhich have t h e i r QM Sunding agency m d DHEW, the more rer tr ict iv c regulation8 shall prevail. In the cue of conflict betveen regul8tions of the 3. fa or d tr to provide mutimum protection trcm legal ll k bil it y to the retv ort tr ched at and ud form6 titled "Consent t o Act aa Subject for caner except thore where the Connnittae h u determined that Conrent I&'I. .implicit In voluntary participation In an rdequately advertised 7-8 of the attached copy of e Institutional Guide t o DHEtJ Policy on Protection of Human BubJect I n keeping ulth the opinion or the Oanerrl Couasel, In thore cues In vhich the b ufc element8 of infomed consent are t o bt prerented orally t o the rubJect, i.e., caaem for vhich the Short Palp ieto be wtd, the caplrte rtatement of what i r to be raid to the rubl)ect is t o be 8pproVSd by the Cdt tee, not just 4. In no cane shall the securing of required consent be delayed until after the fact follwlng debriefing, u i r permitted by implication on pwt 8 of the ff In rti tut ional Guide." General Cmnsel that such 8 procedure vould not be legally acceptable. It l r the opinion of the protrided to protect an aXper$mtntal rubject against evea ranote posribllitlrs of inJurJr, disability, or death. -Tit urd hospita2itation vhich may be required during or u a result

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6. The crmpwcr shall mubnit t o the Office of the General Counsel the policiem and procedurer required t o be forwrlated rad rubmltted to DggW to 8Srure that lege2 requirements a r e met, prior to p r d - y t i o a or rubqiarion of the CIIP~US' general amsurance to DREW. ?urtherporu, in the event that, in cenacctioa vith a mpeclilc rmeuch proporal, the invertigator o r the cu~ppsrcviw committee Identifies a rigpiticult 1eg.l insue, rpproval of that proposal rbnll be sought from the General Counsel. In der to rsrist the rerearchers a~ well as the campus reviev camritteer in their effort t o identify t h e coamon types of legal issuer vhich right be premented mad t o develop criteria for their rerolutioa, the hncrrl oO\msel h u offered t o review, at leu t for mom in it id period of time, a11 re rev ch proposals involving experimentation with this offer t o have all ruch proposalr reviewed, the General Counsel hrs provided the follovfng list of criteria wbich may be uued i n dctennining vhether to8Ub8dta particular much project for legal For thore who do not v i r h to avail themselven of a. The Involvement of minors. b. The iavolvemeat of adults vhore competence t o give an infomed consent nay, i n the opinlorr of t h e principal lnrest i gator,or the committee, be rubject t o question. Doubt in the mindm of the principal invertigatorr o r m a - bet. of the cdt tee as t o vhether the explanation set forth on the consent fom i t sufficient fully to inform tbt mubject of the research i n regard t o the prpceduren t o be prrfoxmtd mdthe rirkr attendmt thereto. Tbc necersity for the principal investigator or those working under his direction t o perfom mctr requiring llcenaure under the provirious of l w relating t o the e. Questbas coaccning interpretation of DHPX policy. u rubdectr, the Student Her l th Service Director of the cuapur rcrponBible for the rerearch t o be conducted, if not already a mmber of t h e review CoPlDittee, rhall be consulted i n the rerim of that particular invert i gat ion.

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be #elected by him to pufonn the following proccdurcb) 8n&/or fair ulplanation of t h e procedure(8) to be followed, including an ident if ication o f those which arc exparimental . I has (have) been explained to me by

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4. I uabrstand that (Name of poraon(t) who w i l l perfoxan procodurc(s) 5. I unborsturd thatI may tumin8te my participation in the mtudy 8t any the, and that, owing tothe scientific nature of the study, the Invertig8tor aay in his absolute dimmetion td nate my participation a t ury -e. 3n the event that I am being compensated for my partkipation

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I and my puticipatian ABt8dnat.d by me or by the investigator I md.tm+.nd fhat r rill be rn titled to pwnt of a rum based upon the Schntiffc value to the study of t h e information obtained frW my pmrdcipadonr providedr howeverr that i n no event shall I receive less than .pu cent of the agreed compensation ifI continue t o participate beyond the (Describe the applicrble time period) of the study. (If subject is 1 minor, or otherwire unable to oign, complete t h e following) : )lother Other person and relationship

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RESEARCR AND INVESTIGATIONS 1 hereby consent to be a participant i n the project named above. A n ucplumtion of t h e procedure (I) and/or investigation ( 6 ) to be followed, including an id cnt if imt ion of those which are uperimental, was provided to me by dareription of the attendant discomforts and riaks to be expected. ime stip ation(6) would be uuwered. I was ah0 asmured and I Understand +hat I un free to wi+h&aw my consent a d to biscontinue participation i n the project or activity atmy time. (To oral presantrtion and signature) (If Bu bj OCt ira minor or otherwise unable to aign, Wp let e the following): subject i s 8 minor (age 1 , or Is -le to B i 9 n becauae hthu Othu person and relationship

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PROTECTION OF HUMAN SUBJECTS To provide for the protection of human rubjects involved in activities supported by DHEW grants or contracts, procedures are prescribed for the initial review and approval of proposals for such support and for the continuing review of all supported T h i s tern describes any individual who.may be at risk 8s a consequence of participation a8 8 subject in'rcsearch, development, demonstration, or other activities supported by DHEW funds. An individual is considered to be .at r i s k " if he m y be exposed to the possibility of harm-physical, sequence of any activity which goes beyond the application of those established and accepted methods necessary to meet his needs. nation o f when an individual i o 8t rimk is a matter of the applScation of common sense and sound professional judgment to the circumstances of the activity in question. Responribility f o r this determination resides at a11 levels of institutional and Departmental review. Definitive determination will be made by the operating agency.

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Info mod oonrent is the a gro ment ' obtained from a subject, or from his authorized te pro rent at ive,to the subject ' s participation in an activity. The basic elements of informed consent are: 1. A fair explanation of the proc edu tor.to be followed, including an identification of those which are experimental ; A description of the attendant discomforts and A description of the benefits to be expected; A disclosure of appropriate alternative procedures that would be advantageous for t h e A n offer t o answer any inquiries concerning withdraw his consent 8nd to dir continue particip ation in the project or activity at any time. 6 . An instruction that the subject is free t o In addition,the agreement, written or oral, entered into by the subject, should include no exculpatory language through which the subject is made t o waive, or to appear to waive, any of his log alright s, or to release the institution or it a ago nts from liability for negligence. Informed consent must be documented. or other legally accountable person, other than an

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k TEC TION OF HUMAN SUBJECT involved i n activftier 8uppOrt.d by grants o r contracts - from the Department of Hmalth, Education, and Welfare is the responsibility of the institution which receives or is accountable to the DHEW for the funds awarded for the Bupport of the 8ctivity. In order to provide for the adequate discharge of t h i s institutional responsibility, it io the policy of the Department that no grant or contract for an activity involving human aubjocts shall be made unless the application for much support has been reviewed and 8pprovtd by am appropriate institutional committee. This review ehall determine that the rights and welfare of the subjects involved are adequately protected, that the risks to an individual are outweighed by the potential benefits to him or by the importance of the knowledge to be gained, and that informed consent is to be obtained by methods that are adequate and In addition the committee must establish a basis for continuing review of the activity in keeping with The institution must submit to the DHEW, for its review, approval, and official acceptance, an assurance of its compliance with this policy. provide with each proposal involving human subjects a certification that it has been or will be reviewed i n accordance with the institution's assurance. The institution must also No grant or contract involving human subjects at r i s k will be made to an individual unless he is affiliated with or rponsored by an institution which can and does assume responsibility for the protection of the -1/ In the United Statos, adherence to the regulations of the Food and Drug Administration (21 CFR 130.371 governing consent in projects involving investigative new drugs (IND) is required by law.

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8. Since the welfare of subjects is matter of concern to the Depar-nt of Walth, Education, and Welfare 8SWell a8 to the institution, no grant or contract involving human subjects shall be made unless the propoeal for such 8upport h.8 been zoviewsd and 8pp row d by an appropriate prof ers ional coxnittee within the responsible component of the Department. described i n the proposal, will not interfere with or impair the rights .nd welfare of the subjects, nor involve risks that outweigh either potential benefits t o the subjects or the expected value of the knowledge sought, nor deny the rights of the subject t o adequate and appropriate informed consent. The committee may recommend to the operating agency, and the operating agency may require, the imposition o f specific grant or contract terms providing for the protection of human subjects, including zequiremtnts for informed consent. This policy applies to all grants and contracts ' which support activities in which subjects may be atri rk.Since the identification of ouch programs requires the application of round professional judgment, such determination should involve professional staff within the component agencies of The ASSi8tUt Secretary for Administration, the Assistant Secretary for Health and Scientific Administrator of the Soci.1 and - habilitation Service, and the Carnmirrioner of Social Security 8hall report annually tothe Socretary, DHEW, the identity of those progrunr within the irrespective agencies which shall be subject to the provisions of this policy. prepared t o document its purpose and objectives in including or excluding a program from the list. The agency involved should be DHEW staff and consultants serving programs included inthe list shall be rer pon rib le for identifying those specific projects or activities which require 8ppl i cation of the policy. DHEW staff m d conruEtants, however, from identifying individual projects i n excluded programs which, i n their opinion, a180 require the application of this policy. The Division of Research Grants, NIH, PHS, will be responsible for implementation and enforcement of this policy. Nothing ohall prevent

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OF HUNAN SUBJECTS Negotiation of Assurances A n institution applying to the DHEW for a grant or contract involving human subjects must provide written assurance that it will abide by DHEW policy. The assurance shall embody a atatement of compliance with DHEW requirements for initial and continuing committee review of the supported activities; a set of implementing guidelines, including identification of the committee; and a description of its review procedures or, in the case of special assurances concerned with single projects or activities, a report of initial findings and proposed continuing review procedures. Institutions that have not previously filed assurances should requtrt instructions foz the preparation of an assurance from the Division of Research Grants, NIH. Negotiation of assurances is the responsibility of the DRG, NIH. Negotiation will be initiated on receipt of a copy of a grant application, a contract proposal, or other documentation identifying the project and the offeror or sponsoring institution. Assurances will not be accepted from institutions or institutional components which do not have control over the expenditure of DHEW grant or contract funds unless they are an active part of a An assurance w i l l be accepted only after review and approval by the DRG, NIH. ’ cooperative project or activity. Types of Assurance Assurances may be one of two types: A general assurance describes the review and implementation procedures applicable to all DHEW-supported activities within an institution, regardzess of the number, location, or types of i t s components. (See Exhibit X1-40-1.) General assurances will be required from institutions having a significant number of concurrent DHEW projects or activities involving human subjects.

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.A 8peci8l asiurancc will, as a rule, describe tbore review and Laplanentation procedures 8pplicable to a single project or activity. also be approved in moditi.6 forms to meet unusual requirements oither of the operating agency or of the institution receiving a grant or contract, .Special arcurances are not to be 8olfcfted from inrtitutions which have accepted general assurances on file. C. Minimum Requirements for General Assurances 1. Statement of Compliance. A formal ttatement of compliance with DHEW policy must be executed by an appropriate institutional The institution must include as part of its cally provide for: a. The statement of principles that will assist the institution in the dircharge of its rerponsibilitier for protecting the rights and welfare of subjects. This may be an appropriate existing code or declaration or one formulated by the institution itself. It is to be understood that no …