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Berkeley City College has no IRB policy!

But -here is the UC Berkeley IRB policy:

P&P:RR 402 

Version No:1.3 Effective Date: 6/1/2013




PoliciesandProcedures 9/1/2007


1.     POLICY 


An expedited reviewprocedureconsists ofareviewof research involvinghuman subjects by theIRBChair, orbyoneormore experienced reviewers designated thebytheChairperson from amongthemembers ofthe committees.


In orderto beeligibleforexpedited review, all aspects oftheresearch mustinclude activities that (1)present no morethan minimal risk to human subjects, and (2)involveonlyprocedures included in oneormoreofthespecificcategorieslisted in the regulations at Federal Register Volume63, No 216.




1.1Important Definitions


1.1.1  Minimal risk is defined by45 CFR 46.102 as theprobabilityand magnitudeof harm ordiscomfort anticipated in the research arenot greaterinand ofthemselves than thoseordinarilyencountered in dailylifeorduringtheperformanceofroutine physical orpsychologicalexaminations ortests.


1.1.2  Children aredefined by45 CFR 46.402 as persons who havenotyet attained the legal age for consent to treatment orprocedures involved in the research, underthe applicablelawofjurisdiction in which the research is conducted (beit local, national, foreign ordomestic).


1.2  Applicability 


1.2.1    The activities listed in the regulations atFederalRegisterVolume63, No216 should not bedeemed tobeofminimal risk simplybecausetheyareincluded on the list.Inclusion on this listmeans onlythat theactivityis eligibleforreviewthrough the expedited reviewprocedurewhen thespecificcircumstances oftheproposed research involveno morethan minimal risk to human subjects.


1.2.2    The categories in this listapplyregardless oftheageofsubjects, except asnoted.


1.2.3    Unless reasonable andappropriateprotections will beimplemented so that risks related to invasion ofprivacyand breach of confidentialityarenogreaterthan minimal, the expedited reviewproceduremaynotbeused whereidentification of theparticipants and/ortheir responseswould reasonablyplacethemat risk of criminal or civil liabilityorbedamagingto their financial standing, employability, insurability, reputation, orbestigmatizing.


1.2.4    The expedited reviewproceduremaynot beusedfor classifiedresearch involving human subjects. Furthermore, UC Berkeleypolicyprohibits investigatorsfrom conducting research involvinghuman subjects that is considered classified bythe US government.


1.2.5    The expedited proceduremaynot beused forresearch involvingprisoners,unless theprisonerrepresentativeoftheIRBis oneofthedesignated reviewers.

1.2.6    Thestandardrequirements forinformed consent (orits waiver, alteration,or exception) applyregardless of whethertheresearch is reviewed bytheconvened IRB(thefull committee)orbyexpedited procedures.


1.3    Expedited ReviewCategories (this informationis quoted directly from the regulations at FederalRegisterVolume63, No216.) 


(1)  Clinical studies ofdrugs and medical devicesonlywhencondition (a)or (b)is met.


(a)  Research on drugs forwhich an investigationalnewdrugapplication (21 CFR Part

312)is not required. (Note: Research on marketeddrugs that significantlyincreases the risks ordecreases theacceptabilityoftherisks associated with theuseofthe product is not eligible forexpedited review.)


(b)  Research on medicaldevices forwhich (i)an investigational device exemption application (21 CFR Part812)is not required; or(ii)themedical deviceis cleared/approved formarketingand themedical deviceis beingused in accordance with its cleared/approvedlabeling.


(2)  Collection ofblood samples byfingerstick, heel stick, earstick, orvenipuncture as follows:


(a)  from healthy, nonpregnantadults who weigh at least 110 pounds. Forthese subjects, the amounts drawn maynotexceed 550ml in an 8 week periodand collection maynot occurmore frequentlythan 2 times per week; or


(b)  from otheradults andchildren, consideringtheage, weight, and healthofthe subjects, the collection procedure, the amount ofblood to be collected, andthe frequencywith which itwill be collected.Forthesesubjects, the amount drawn may not exceed thelesserof50 ml or3 ml perkgin an8 week period and collection may not occurmorefrequentlythan 2 times per week.


(3)  Prospectivecollection ofbiological specimens for research purposes bynoninvasive means.

Examples: (a)hair and nail clippings in anondisfiguringmanner; (b)deciduous teeth at timeof exfoliation orif routinepatient careindicates aneed for extraction;

(c)permanent teeth if routinepatient careindicatesaneed for extraction; (d)excreta and external secretions (includingsweat); (e)uncannulated saliva collectedeitherin an unstimulated fashion orstimulated bychewing gumbaseor waxorbyapplyinga dilute citricsolution to thetongue; (f)placentaremoved at delivery; (g) amniotic fluid obtained at thetimeof ruptureofthemembranepriorto orduringlabor; (h)supra- and subgingival dental plaque andcalculus, provided the collection procedureis not moreinvasivethan routineprophylacticscalingoftheteeth and theprocess is accomplished in accordance with accepted prophylactictechniques; (i)mucosal and skin cells collected bybuccal scrapingorswab, skin swab, ormouth washings; (j) sputum collected aftersalinemist nebulization.


(4)  Collection ofdatathrough noninvasiveprocedures (not involving general anesthesia orsedation) routinelyemployed in clinical practice, excludingprocedures involving x-rays ormicrowaves. Wheremedical devices areemployed, theymust be cleared/approved formarketing. (Studies intendedto evaluatethesafetyand effectiveness ofthemedical device arenot generallyeligible forexpedited review, includingstudies of cleared medical devices fornewindications.)

Examples: (a)physical sensors that are applied eitherto thesurfaceofthebodyorat a distance and do not involveinput ofsignificant amounts of energyinto thesubject or an invasion ofthesubjects privacy; (b)weighing ortestingsensoryacuity;(c) magnetic resonanceimaging; (d)electrocardiography, electroencephalography, thermography, detectionofnaturallyoccurringradioactivity, electroretinography, ultrasound, diagnosticinfrared imaging, dopplerblood flow, and echocardiography;

(e)moderate exercise, muscularstrength testing,bodycomposition assessment, and flexibilitytestingwhereappropriategiven theage, weight,and health ofthe individual.


(5)  Research involvingmaterials (data, documents,records, orspecimens)that havebeen collected, or will becollected solelyfornonresearch purposes (such as medical treatment ordiagnosis). (NOTE: Some research inthis categorymaybeexempt from the HHS regulations fortheprotection ofhuman subjects. 45 CFR 46.101(b)(4). This listingrefers onlytoresearch that is not exempt.) 


(6)  Collection ofdatafrom voice, video, digital, orimage recordings madefor research purposes.


(7)  Research on individual orgroup characteristics orbehavior (including,but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs orpractices, and social behavior)or researchemployingsurvey, interview, oral history, focus group, program evaluation, human factorsevaluation, or qualityassurancemethodologies. (NOTE: Some research in this categorymaybe exempt from the HHS regulations fortheprotection ofhuman subjects. 45CFR 46.101(b)(2)and (b)(3).This listingrefers onlytoresearch that is not exempt.) 


(8)  Continuingreviewofresearch previouslyapproved bythe convenedIRBas follows:


(a)  where(i)theresearchis permanentlyclosed tothe enrollment ofnewsubjects; (ii) all subjects have completed all research-related interventions; and (iii)theresearch remains activeonlyforlong-term follow-up ofsubjects; or


(b)  whereno subjects havebeenenrolled and noadditional risks havebeen identified; or


(c)  wheretheremainingresearch activities arelimited to data analysis.


(9)  Continuingreviewofresearch, not conducted under an investigational newdrug application orinvestigational deviceexemption wherecategories two (2)through eight (8)do not applybut theIRBhas determinedand documentedat a convened meetingthat theresearchinvolves no greaterthanminimal risk and no additional risks havebeen identified.


1.4    Authority oftheIRB Chairand Designee 


TheIRBChairmayexercise all ofthe authoritiesoftheIRB,except that heorshemay not disapprovethe research application. Aresearch application maybedisapproved only afterreviewbytheconvenedIRB. The Designeemayexercise authorityaspermitted and specified bytheChair.

1.5       Notification oftheIRB 


The OPHS staffprovideIRBmemberswith alist of all new applications, continuation applications, and amendments approved under expedited reviewbymonth.Ingeneral, the list is provided to members at thenext convenedmeeting.Ifthelist cannot beprovided bythen, it is provided atthenext possible convened meeting.


1.6    Documentation 


When research is reviewed byexpedited procedures,IRBrecords must include documentation oftheresearch, thepermissiblecategoryorcategories of expedited review that apply(for example,surveyresearch perF(7)), and that the research is minimal risk.


1.7    Additional Items That May be Reviewed by the ChairorIRB Designee 


Minor changes: AnIRB Chair/Designeemayusethe expedited reviewprocedureto reviewminor changes inresearch protocols that werepreviouslyapprovedvia expedited and/or full committee reviewduringtheperiod forwhich approval is authorized. Any protocol revision that presents morethan aminimal risk ofharm to thesubjects must be reviewed bythe full committee at a convened meeting.


2.     SCOPE 


Thesepolicies and procedures applyto all non-exempt human subjects’ research.




OPHS staff areresponsible for facilitatingthereviewof expedited applications and pre- reviewingsubmissions that qualifyfor expedited review, as well as providingalist of protocols reviewed underexpedited procedures to IRBmembersat convened meetings. Staff will consult with theIRB Chair/Designee and/orOPHS Director as necessaryin orderto determineif anapplication maybe reviewed byexpedited procedures.


TheIRBChair/Designeeis responsible forthereview and approval ofall applications eligible for expedited review.


OtherIRBmembers maybe consulted and/orconduct reviewsas needed or requested bythe IRBChairbased on theirspecific expertise. Anadhoc consultant mayalsobe asked to reviewtheresearch, iftheChair/Designee,OPHS Director, oraseniorstaffmember feels that the researchactivities involveissues that necessitatethe additional consultation of someone with relevant expertiseoutsidethe realm oftheIRBmembers.It is important to notethat a consultant does not have authorityto voteortakeaction on aresearch study.




Expedited ReviewofNewStudy, Amendment,and Renewal


Ingeneral, OPHS staffcoordinatethereviewprocess and performapreliminarycheck of applications that appearto qualifyfor expedited review.If additional information or clarification is necessary,the responsiblestaffmemberinitiates correspondenceto the investigator. When theinvestigatorresponds, thestaffmemberverifies that all items have

been addressed and theapplication is complete. The application and response arethen routed to theIRBChair/Designee at which point heorshe will reviewtheresearch.If anyconcerns areidentified, theChair/Designee will return theapplication alongwith his orher comments to thestaffmemberwhocommunicates thesecomments to theinvestigatorin writing.If thereareno concerns, orthe concerns havebeenaddressed, theIRBChair/Designee will approvetheresearch.


Aftertheapplication is approved, all approved informed consent, parent permission, and assent documents (English and foreign language)will bemade availabletotheinvestigator alongwith theprotocol approval letterAnyforeign languagetranslations of approved consent documents must besubmitted, either with initial application materials, as responsive materials to a conditionalapproval bytheIRB, oras an amendmentafterinitial approval of the researchand English consent documents.


Ifthereare anyissues that cannot be resolved oriftheChair/Designeedetermines that the application does not meet the criteria for reviewbyexpedited procedures, the application must go to the full committee (convenedIRB) forreview.TheIRBChair/Designeecannot disapproveastudyviathe expedited reviewprocess.



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Are you required to complete some sort of training?
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