Policy and Procedure of the University of California Berkeley Campus, Governing the Protection of Human Subjects

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Lawrmso Borkoly Laboratory POLICY AND PROCEDURE OF THE UNIVERSITY OF CALIFORNIA, BERKELEY CAWPUS, GOVERNING THE PROTECTION OF HUflAN SUBJECTS This document establ lshes the pol fcies and procedures f o r the protection o f human subjects under projects sponsored through the Berkeley Campus o f the University of California. ments of the U. 5 . Department of Health, Educatton and Welfare (USDHEW) asr set forth In the USDHEW Grants Admlnlstratfon Nanual, Chapter 1-40. It also serves to Implernent the specific requfreThe poll cie s and procedures set forth hereln apply to all act iv it les, lrrespective o f fund source, whlch Involve human subfects f o r whlch the Berkeley The National Advisory Health Council, after a study o f the Issues pertalnlng to cl in l cal research and investigatlon lnvolvlng human beings, recormended t o the Surgeon General o f the Public Health Service (PHS) I n December 1965 that PHS adopt a policy statement pertaining t o the protectlon o f human subjects under PHS supported projects. The present DHEW policy, published In Apr ll 1971 as Chapter 1-40 t o the DHEW Grants Administration Hanual, i s an outgrouth o f the basic princlples and premises of prior U. S. Public Health Servlce poli cles issued l n 1966 and 1969. On June 2 5 , 1970, the Office o f the Univarslty Presldent extended the USPHS policies to all act lv it las of the University involvfng human subjects regardless o f the funding source supporting such act lv it les. On March 29, 1972, the 1971 DHEW regulatlons were also made applicable to a l l University sponsored activities. quence of pat tlc lp ation as a subject i n research, development, demonstration, or other act i vlt res. gans, tissues, and services; Informants; and n o m 1 volunteers, Including students who are placed at risk durlng training In medical, psychological, sociologlcal, educational, and other types of act tv lt fes. Of part l cula r concern are those subjects I n groups with Ilm it ed civil freedom. These lncluda prlsoners, resfdents or cl lent s of ln st ltu t lons for the mentally 111 and mentally retarded, and persons subject tom fl lt ary dlsThe unborn and the dead should be consfdared subjects t o the extent that This term describes any indlvldual who may be a trl sk as a conseThls may Include patlents; outpatfents; donors o f or-

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&or legally authorized representatives. top ossi b lli ty of any hrm-phyrIcal, psychological, sociological, or other-as a consequence of any activity which goes beyond the applicatlon of those established and accepted methods necessary t o meet h i s needs. ...Phvsical risks - Unusual physical activity required of a subject, o r the imposition of strong aversive stimulation, o r engaging him l n a social s ltu atl on that could involve violence, might endanger his physical wellcal danger and bring them t o the attention of the Committee. (Cont'd.) they have rights which can be exercised by their next 2. An individual Is considered t o be )'at r i s k " If he may be exposed It Is important that an investigator foresee p ossi bl ll ties of physi- ...Psychological rlsks are far mora pervasive among behavioral science researchers. The rl gh t to privacy i s considered relatively inalienable, and hence Invasion of a subject's privacy is, i so facto, held t o be a "risk". Caralessness about the maintenance of h lalit y of protocols could increase the risk. Any procedure that may conceivably produce humili ation, embarrassment, loss of solf-esteem, feelings of failure or frust ration, feelings of anger toward the experimenter o r others, o r even acute boredom can be considered undesirable outcomes of the research experlance; hence, such procedures must be considered as placing the subject a trl sk. Any personality change, or change i n the subject's feelings o r motlvatlon that extend beyond a debriefing period, must also be considered undeslrsonal stimulus value t o h i s fellows, such as would be represented by the term "his reputatlon", i s something of value t o him, and the possibility of Its being damaged constltutes arisk also. ...Social risks are related i n the main t o procedures that may place the reputation or status of a social group or an institution in jeopardy. Procedures designed t o measure the characteristics of easily defined subgroups of a culture may entail risk if the qualities measured are ones which have positive or negative value I n the eyes of the group. when research does not impinge directly on it, a group may be derogated orits reputation injured. Likewise, an in st ltu tl on, such as a church, a university, o r a prison, must be guarded against derogation, for many people may be affiliated with,or employed by, the institution, and POJ or rti ve Information about It would injure their reputations and self - esteem. I n evaluating social risk, an investigator shouid ask himself how the findings ulll appear t o persons belonging t o any i dant if labia group -- or affiliated with an institution -- studled and reported upon. Thase cautions are as equally warranted i n the case of anthropological field research i n distant cultures as i n studies performed i n domestic 3 . informed consent: This Is an appropriate agreement obtained from a

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t o the subject's participation in a project or activity. ments o f informed consent are: subject, o r from his authorized representative, afair explanation of the procedures t o be followed, including an ident l fl crt ion of those which are experimental; a description o f the attendant discomforts and risks; a description of the benefits t o be expected; a disclosure of appropriate alternative procedures that would be advantageous f o r the subject; an offer to answer any inquiries concarning the procedure; and an instruction that the subject Is free to withdraw his consent and t o discontinue participation in the project or activity at any time. I n addition, the agreement, written or oral. entered into by the subject, may not Include any exculpatory language through which the subject i s made t o waive, orto appear t o waive, any ofhis legal rights or to release the inst it uti on or its agents from liability for negligence. STATEHENT OF ETHICAL PRINCIPLES The University of California at Berkeley, accepts as baslc principles that: (a) no human being Isto be exposed t o unreasonablr rf sk to health o r well being, (b) the rights and welfare ofall subjects involved f n research, training, demonstration, development and other activities who are subject to risk shall be adequately protected, (c) that the risks to an individual nust be outweighed by tha potential benefit t o him o r by the importance of the knowledge t o be gained, and (d) that adequate and appropriate informed consent Isto be obtained without duress o r deception I n those cases where human beings will be o r are likely to be "at risk". All persons involved ln Initiating, approvlng, conductlng, o r supervising activities involving human subjects must be aware of their joint responsibi lit y for the welfare o f the indlviduats who serve as subjects. i t shall be the resp on si bill ty of the Individual investigator t o declde when he does not have adequate knowledge o f the possible consequences ofhis research orof research done under his direction. When he isin doubt, he must obtain tho advice of others who do have the requisite o r Any possible hazard t o health resulting from procedures utilizing human subjects must be f i r s t investigated through animal research, whenever such be possible and relevant. Whenever medications, operattve procedures, o r exposures t o hazardous

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STATEMENT OF ETHICAL PRINCIPLES (CONT'D.) enviromtental conditions are usod (or occur), the activity must be porformod undor medical protectton and supervision. The naturo of tho activity, tho prosodures t o bo followod, and tho possible risks involved must bo carefully and fully explained t o the subjoct, parent, o r guardian, as appropriate. have been f u l l y understood and informed consent obtained as approprlate. received from him must bo protected. Any subject may request termination of his participation In an experiment a t any time, and this request will bo honored promptly and without Remuneration may bo offered toa subject as recompense for his time providod that such remuneration I s not so large as to constitute an Improper Tho oxplanation must 7. Tho subject's personal privacy and the confidentiality of Information IO. if participation as a subject is part of the academic work ofa student, i t must not be a coercive requirmmnt and, as appropriate, informed consent must be obtained. 11. The University will provldo, a t no cost t o the subject, adequate medical treatment for hospital lz ation as required during o r as a direct result o f an experiment. Such individual care shall be provided without the necessity for establlshing legal liability on the part o f the University. The subject's right to compensation for damages must, however, be established on the basis o f legal liability, e.g., nen en ce or wrongdoing, on the part o f the University. COMMITTEE FOR PROTECTION OF HUMAN SUBJECTS (a Subconunittee o f the Graduate Council) Gra uate Division, t o review research proposals contemplating use o f human subjects, as required by USPHS regulations then in effect and as later revised i n 1969. With the extension o f the USPHS requirements toail University act iv i - ties.as requlred by the 1970 and 1972 University directives. the status o f the advisory corn it tea was reconstituted as an administrative subcommittee of the Organization o f the Comnltteo: ofat least fivo membors, one o f whom isto be the Director o f the Student Health experience which will assure complete and adequate revlew o f projects and acti - vi ties commonly admlnistered o r sponsored by the campus: No lass than two members of the Cormnittee shall bo licensed t o practice the healing arts, and a t least one member shall not be so licensed but shall be competent i n other releI n 1966, an advisory comaittee was appointed by the Dean o f the The Comaittee, inits present form, must consist Other members must possess varying qualifications, backgrounds, and Appointment of tho chairman and members o f the Comnittee shall be made by the Graduate Council and the term o f service shall be a t the pleasure o f the Graduate

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COMMITTEE FOR PROTECTION OF HUMAN SUBJECTS (CONT'D.) Organization o f the Cornittee (Cont'd.) Council. Comnittee membership as o f June 1 , 1972, is set forth in Appendix A. The Comnittee may establish subcomnittees as deemed necessary by workload o r search units, are normally chaired by a member o f the Comnittee. Ing o f such departmental subcomnittees i s informal and their main roi ois to provide a focus o f expertise within a specific unit for the rendering o f advice and assistance and preliminary review o f the adequacy o f protocols. I.n accordance w i t h DHEU requirements, only the Comnittee or a quorum thereof may finally review a project involving human subjects and Issue a certification that the requirements o f the institution a1 assurance and USDHEU policy have Functions o f the Comnittee: The Comnittee has two responsible functions whlch must be given equal priority : sponsored activities utilizing human subjects conform t o the regulations and policies of the USDHEW and University concerning the safety, welfare, health, rights and privileges of human subjects; and (2) to facilitate,within the 1lm its of applicable regulations, policies and procedures, accomplishment o f project o r program objectives by those whose work involves the use o f human The policies and procedures set forth herein concern mostly the first functlon. The second function, though o f equal importance, i s not easily set forth in formal statements. However, the Cannittee and the campus administration recognize the importance o f the second function and desire, a t all times, t o be o f service t o members o f the campus comnunity and consultation with the Comnittee, o r individual corn it tee members i n project planning 1s strongly rncouraged. The Comnittee i s not an authoritarian 'katchdog", but rather serves t o benefit the University, the scientific comnunity, and the publlc, through the fac ll lta - tion of activities whlch wi11 extend the boundaries o f human knowledge t o the ultimate good o f a11 mankind. Such subcomnittees, constituted within teaching o r re- (I)to determine and certify that all campus PROCEDURES FOR OBTAINING COMMITTEE REVIEW Initial Review: The following procedures are prescribed for the initial review o f proposals and activities to Insure compiianct with University and USDHEU requirements for the protection o f human subjects: 1.0 Projects Supported from Solicited Extramurai Funds: 1.1 The Approval Form for Extramural Support Proposai, accompanying ail applications for funding submitted t o the Campus Research Office for ln st it ut lon al endorsement, shall contain an appropriate entry or entries on the prospective use ofhwn subjects. If human subjects are t o be used, the following procedures must be A protocol, insufficient detail, must be submitted t o the Campus Research Office w i t h the proposal. As a mlnimum, the protocol

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In it lal Rov1.w (Cont'd.) should contain tho following Informrtlon: 1.2.1 A statement of the signiflcanca and bonoflts o f tho proposed projoct or act l vi ty, 1.2.2 A statement whether the project involvos: 1.2.2. Posearch on tho nature and effects of marijuana and 1.2.2~ Invostigatlon o f new drugs. u 1.2.3 A n evaluation o f the need or desirability for the utilization 1.2.4 A statemmt as t o whether any subjects wiII be minors (under ago 18 per California law) o r Universlty o f California students. 1.2.5 Tho preciso way i n which subjects will bo util izod, 1.2.6 An analysis o f the possible physical, psychological, emotional, and socially doleterious effects upon the subjects. 1.2.7 A description o f the means t o be taken t o minimize each such deletorious effect includlng the means by which the subJect's personal privacy is to be protected and confidentiality of Information received maintained. A statement concerning the method t o be employed I n documenting informed consent: 1.2.8. Written consent agrement (regular form) i n format of Appendix 8 (Include completed copy), or 1.2.8b Written consent agreement (short form) with w rl tten script of oral presentation t o be made t o the subjects flust be reviewed by the State Research Advisory …