ActionstoReduceAdministrativeBurden
Doesyourinstitutionplan
toimplementthisaction?
IfNot,WhyNot?
Doesyourinstitution
alreadyhavethisin
place?
AdministrativeSupport
Allowlimitedadditionalopportunitiesfordirectcharging
administrativesalariesifitmeetstherequirementsof2CFR
200(reachingpre‐establishedinstitutionalminimums,suchas
10‐20%FTE).
Provideadministrativeassistancetofacultytotheexent
possible.
AnimalResearch/IACUC
Eliminateannualprotocolrenewalsfornon‐USDAspeciesand
non‐DODprotocols.
DiscontinuetheUSDApainanddistressclassificationsfornon‐
AnimalWelfareActregulatedspecies.
Asthedefault,implementDesignatedMemberReviewrather
thanFullCommitteeReview.
ReduceIACUCrequirementsforexperimentaldetailsthatare
unrelatedtothehealthandsafetyofanimals.
AdoptNIHOLAW'sallowancefor"expediting"protocol
amendmentsviaanewVeterinaryVerificationand
Consultation(VVC)process,therebyreducing/eliminatingfull
IACUCinvolvement.
Expandthescopeofadministrativeapprovalauthorityby
allowingsmallchangestoprotocolstobehandled
administratively(byIACUCstafforviaVeterinaryConsultation
andVerificationprocess).
SimplifytheIACUCprotocolformwithstandardizedlanguage
andcontentrequirementsandprovidetemplatelanguagefor
importingintoprotocols.Allowfor"procedurelibraries"tobe
selectedforprotocols.Enhancementstotheformcouldinclude
thefollowing:
·Astandardrodent,pre‐approved,pre‐operative
preparationplanandpost‐operativerecoveryplantemplate.
·Abuilt‐incommonlyuseddrugformularythatwill
providethepre‐approveddosage,routeandfrequencyof
administration.
·Convertformattedtextboxestosimpledropdownlists
forfastdataselection/entryandenhancedreporting
capabilities.
·Dropdownlistofeuthanasiamethods/dosagesthatare
pre‐approvedforagivenspecies
COGR Action List
1
ActionstoReduceAdministrativeBurden
Doesyourinstitutionplan
toimplementthisaction?
IfNot,WhyNot?
Doesyourinstitution
alreadyhavethisin
place?
Replacerequireddocumentationonhowaproposedprotocol
wasnotunnecessarilyduplicativewithasimpleattestation.
Standardizeveterinaryreviewproceduresand
communicationstoinvestigators.
ReviewSOPsonalessfrequentbasis(e.g.,everytwotothree
years)basedonpotentialrisk(e.g.,skillofinvestigativeteam,
outcomesofPAMreporting).
Allowinvestigatorstoprovideanapproximatenumberor
rangeofanimalsneededoverthecourseofaresearchproject
ratherthananexactnumber.
Allowinvestigatorstoprovidearangeoftimeforpost‐op
observationratherthananexacttime(e.g.,4‐6hoursinsteadof
every4hours)toallowflexibilityandavoidfindingson
deviationsfromthelangaugewhereactionswereappropriate.
Replacemandatorytriennialregulatoryrefresherseminarwith
anarrayofinstructionalsessionstostreamlineprotocol
writingandreview.Solicitfeedbackonhowtheinstitutioncan
assistinvestigators.
Adoptstandardizedmodelsfortraininganddocumentation.
COI
Useatieredreviewprocess–administrativereview;expedited
review;andfullcommitteereview.
Includeacheckboxonaroutingformtoindicatewhetheror
notatransactionwilltriggeranexistingornewsignificant
financialinterest(SFI).
Contract‐relatedrequirements
Developanin‐housecontractnegotiationmanualsothestaff
negotiatingcontractshaveguidelinesonwhattheinstitution
willacceptandwhatmayrequireadditional
approval/discussion.
Considercentralizingnon‐federalcontractdevelopment,
reviewandnegotiationtooneorafewindividualsinthe
centralgrantsofficeforconsistencyandfocusedexpertise.
ElectronicSystems/Forms
COGR Action List
2
ActionstoReduceAdministrativeBurden
Doesyourinstitutionplan
toimplementthisaction?
IfNot,WhyNot?
Doesyourinstitution
alreadyhavethisin
place?
Developonlinesystemstoreduceoreliminatetheamountof
requestsforactiontransactionsbeingrequiredandsubmitted
viaemail,hardcopyorotherlaborintensivemethods.
Developdatasystemstoidentifyallapprovalsneededfora
studybeforestart‐up
ProvideclearguidanceonITsecurityfordata,bio‐specimens,
etc.
Integratesystemswhereverpossible.
Createautomateddatainterchanges/interfacesbetweencore
universitysystems(e.g.,grantsandIRB,IACUC,IBC,Payroll)to
expediteproposalpreparationandawardoversighttasks.
Createadashboardthatwilldisplayandlinktoeach
transaction/responsibilitythatrequiresaction.
ExportControl
Usinganelectronicroutingsystemforsponsoredproposals,
routeproposalsfornationalsecurity‐relatedsponsorstothe
ExportControlsOfficer,i.e.DOD,DHS,NASAetc.
Provideadecisiontreetodeterminewhetherexport
regulationsandexportlicenserequirementsareapplicableto
specificprojects.
ProvideatoolforRestrictedPartyScreening.
FinancialManagement
Usethesamebudgetcategoriesininstitutionalreportsas
fundingagencies.
Provide“realtime”financialreports.
Simplifydocumentationforexpensejustifications.
Allowperdiemreimbursementfortravel.
Providebudgetcalculatorsforcreatingbudgets.
Developstandardizedtoolsforreconcilingawardsfor
reporting,invoicingandcloseoutstoensurethateveryoneis
usingthesametoolwithcorrectdata.
Developmilestonestructureinyoursystemtotrack
reconciliations,invoicing,reporting,etc.
Developadditionalexceptionreportsformonitoring.
UtilizeTermsandConditionsfunctionalityinfinancialsystems
toassistwithflaggingawardsforcomplianceterms.
COGR Action List
3
ActionstoReduceAdministrativeBurden
Doesyourinstitutionplan
toimplementthisaction?
IfNot,WhyNot?
Doesyourinstitution
alreadyhavethisin
place?
Alterfinancialsystemstoallowlocaladministratorstoenter
budgetsdirectly.
Movealleffortreportingtosemi‐annual.
Considerpayrollcertificationandothermeasuresasan
alternativetoeffortreporting.
Usemasteragreementsand/orAcceleratedClinicalTrial
Agreement(ACTA)ClinicalTrialContracttemplatesfor
industry‐fundedagreements.
Keepamasterdatabaseofsponsors/programswithlowerF&A
ratesyouarepreparedtoaccept(e.g.,foundations)
General
Considerlimiteduseofmetricstounderstandrealistic
turnaroundsandtodeterminebestuseofinstitutional
resourcestostreamlinehigh‐impactactivities.
Lookforopportunitiesandstrategizetoaddressburdens
acrosscategories(withinthisdocument).
Don'twritetherulesfortheexception.
HumanSubjectsResearch
Onlyproposeconsentchangesthataretiedtoregulationor
subject'scomprehensionorsafetyandprovidearationale.
Focusallreviewstosubjectrightsandwelfare.
Identifymechanismsforreducingturnaroundtimes.
Tierreviewtoriskandfocusonhigherrisk.
AppointstafftoserveasvotingmembersoftheIRBandallow
themtoconductexpeditedreview,asappropriate.
Allowsmallchangestoprotocolstobehandled
administratively,includingadministrativerequeststoadd,
deleteorchangeafundingsource.Consideranadministrative
requestsystemforstudyteamadditionsandremovals(where
notthePI)toavoidtheneedforformalamendments.Provide
interfacetosponsoredprojectssystemstoallowPIstoidentify
sponsoredfundingfromadrop‐downlistofactiveawardsor
recentlysubmittedcompetitiveproposals.
Adoptstandardizationofbestpracticesforinclusioninthe
protocol.
COGR Action List
4
ActionstoReduceAdministrativeBurden
Doesyourinstitutionplan
toimplementthisaction?
IfNot,WhyNot?
Doesyourinstitution
alreadyhavethisin
place?
Reducehumansubjectstrainingrequirementstowhatis
necessaryforsafetyandtailortrainingtotheresearchbeing
conducted.Consideradoptingatrainingdecisiontreethat
rapidlydirectsinvestigatorsandtheirstafftothecorrect
trainingfortheirwork.
Employflexibilitywhereallowedandavoidover‐regulationfor
non‐federallysupportedprotocols.Limitthescopeofthe
FederalWideAssurance(“uncheckthebox”).
Granttwo‐orthree‐yearapprovalperiodsfornon‐federally
supportedandnon‐FDAregulatedstudies.
Useexpeditedreviewforallminimalrisknon‐federally
supportedprojects(categoriesnotlistedaseligiblefor
expeditedreview).
Utilizewaiversoralterationofinformedconsentandwaivers
ofdocumentationofinformedconsentwhereappropriate.
Onlyregulateresearchthatmeetsthedefinitionofhuman
research.Considerusingthe2008guidancefromOHRPonthe
engagementofinstitutionsinhumansubjectsresearchto
determinecaseswhenyourinstitutionisnotengagedandno
reviewisrequired.
IfaClinicalandTranslationalScientAward(CTSA)institution,
haveumbrellareliancearrangementswiththeother
institutionsinyourCTSA{forexamplessee:
https://catalyst.harvard.edu/programs/regulatory/reliance.ht
ml}
Proactivelyoffertoenterintosingle‐studyrelianceagreements
inordertoavoidduplicationofreviewwherethiswould
reduceadministrativeburdenandcost.
Offerawebtooloutsideyournormalsubmissionsystemfor
determiningifsomethingrequiresIRBreviewatall,alongwith
guidanceaboutthedifferencebetween“research”asdefined
by45CFR46andqualityimprovement,publichealthpractice,
andothernon‐researchactivity.
Createchecklist‐styleformstocapturetherequiredandbest‐
practicefindingsatyourIRBmeetings,whicharepartiallypre‐
filledpriortothemeetingbytheIRBanalystwhoscreenedthe
study.
InternationalResearch
COGR Action List
5
ActionstoReduceAdministrativeBurden
Doesyourinstitutionplan
toimplementthisaction?
IfNot,WhyNot?
Doesyourinstitution
alreadyhavethisin
place?
Developandmaintainaglobalresearchoperationssupport
groupofkeyleadersinvariouscentraladminofficestodevelop
standardprocessesandtroubleshootissues.
ConsiderpartneringwithotherIHEstoprovideacentral
informationrepositoryonbestpracticesandguidelinesfor
internationalresearchactivities.
LaboratorySafety/Radiation/Biosafety
Consolidatelaboratoryinspectionsforvariousdisciplines.
CoordinatedatabetweenHealthandSafety,IACUC,and
IBCactivitiestoeliminateduplicativerequests,policies,
orprocedures.
ImplementtheAPLU‐AAUrecommendationsoncultureof
safety.
Developrisk‐basedpoliciesandproceduresfor
laboratoryspecifichazards.
Implementfunction/role‐basedtrainingrequirements
(e.g.,investigatorspecific,wastedisposalperson,etc.).
Providealldidactictrainingonlineandfocusonhands‐on
trainingforin‐personsessions.
PersonnelManagement
Develop/requireatrainingprogramforalladministratorsto
ensureunderstandingandconsistent/appropriatehandlingof
tasksandreductionoferrors.
Createtemplatesforcommoncommunications.
Proposalorreportpreparation
Considermakingproposalreviewprocessesmorerisk‐based
orconditional,addingparallelratherthansequential
workflows,andchangingsomeapprovalstoinformational
copies.
Implementonlineproposaldevelopment/routingtool.
Expandlimitedsignatureauthoritytoexperiencedstaffinnon‐
managementpositions(oncetheyhavedemonstrated
proficiency).
COGR Action List
6
ActionstoReduceAdministrativeBurden
Doesyourinstitutionplan
toimplementthisaction?
IfNot,WhyNot?
Doesyourinstitution
alreadyhavethisin
place?
Developandmaintainproposalreviewguidelinesandcriteria
toensurecentralofficereviewisfocusedonkeyareasandnot
redundant,overzealousornon‐valueadded.
Considergrantinglimitedsignatureauthorityforlow‐risk
activities(i.e.,NCE'sandjust‐in‐timerequests).
Considertheinstitutionalriskofdelegatingsubmissionof
ResearchPerformanceProgressReports(exceptfinal)to
investigators.
Developandenforceinternalproposaldeadlinestoensure
sufficienttimeformeaningfulandvalue‐addedreview.
Purchasing
Provideawebsitethatfacilitatessearchandpurchaseofitems
thathavebeenstrategicallysourced.
Developandprovideansimpleandeffectiveconflictof
interestpolicythataddressesprocurement.
Provideasimpleandeffectivesolesourcejustificationform
andprocess.
Subcontracts
Developasystemfordepartments/researcherstorequest
subcontracts(includesvendorvssubdeterminationandfull
requestdetails).
Havetheofficeofsponsoredprojectssetupsubcontract
purchaseorders.Thisallowsthepurchaseordernumbertobe
availablequicklytoenterintothesubcontract.
Maintainacentraltrackingsystemforsubrecipiententities
informationtominimizeredundantrequestsforinformation
andtimerequiredtoobtaininformation.
UtilizetheFederalDemonstrationPartnership's(FDP)
standardizedsubawardagreementtemplatesandtermsand
conditionsclauselibrarytostreamlineissuance.
Reduceriskassessmentactivitiesoninstitutionsthatare
subjecttoSingleAudit.ForFDPmemberinstitutions,consider
joiningtheFDPExpandedClearinghouse.
Considerissuingunilateralmodificationstoasubsetoflowrisk
subrecipientsand/orforcertainlow‐risktransactions,suchas
anticipatedincrementalfundingorno‐costextensions.
TechnologyTransfer
COGR Action List
7
ActionstoReduceAdministrativeBurden
Doesyourinstitutionplan
toimplementthisaction?
IfNot,WhyNot?
Doesyourinstitution
alreadyhavethisin
place?
Consideradoptingawrittentriageprocessforallnew
inventions.Thistakesmoretimeupfront,butreducesburdens
downtheroadinmanagingalargetechnologyportfolioand
providesfacultywithbetterandmoreconsistentfeedback.
Training
Optimizetrainingtimeandcontent(e.g.,towhatisessentialfor
safetypurposesandtomeetfederal/agencyrequirementsand
tailoredtodisciplineandcareerstage)toappropriately
balanceadministrativeburdenbetweeninvestigatorsand
trainingproviders.
Offershorterrefreshermodules.
Utilizeonlinetrainingmechanismswheneverfeasible.
Considerusingstandardizedmodels(e.g.,CITIwithshort
customizationsforinstitution‐specificguidance)fortraining
anddocumentation.
Providedocumentationoftrainingtoreduceadministrative
burden,inparticularforfacultyandstudentstransferringto
anotherinstitution.
Monitorwebsites,policies,procedures,training,and
communicationstoconfirmconsistencyacrossallformsof
communications.
COGR Action List
8