Research and Development
StandardOperating
Procedurefor
RESEARCH PROGRAM CLOSURE AND / OR LABORATORY DECOMMISSIONING
VALongBeachHealthcareSystem
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STANDARD OPERATING PROCEDURE FORRESEARCH PROGRAM CLOSURE AND /OR LABORATORY DECOMMISSIONING
Purpose:WhenaPrincipal Investigator has voluntarily decided toendtheirresearchcareer,movetoanotherinstitution,orhasbeen debarred fromperforming researchatVALBonapermanent basis for significant or repeatviolations in human,animal, or laboratory research,researchfacilities including laboratory and/or office space within the purview of the ResearchService must be decommissioned.Decommissioningofthelaboratory and/or officespacewillallowfortheorderlyand timely removal, redistribution,and/ordisposalof chemicals andotherreagents, biological hazards, radioisotopes (seeDecommissioningProcedure for Laboratoriesusing Radioisotopes), other supplies, equipment, andresearchrecords from the previouslyoccupied research laboratory and/or office.
Responsibilities:
Principal Investigator (PI):ThePrincipalInvestigatoris responsible fornotifyingtheAssociateChiefof Staff, R & D when a decision is made toleavethe institution tomovetoanotherinstitute,toretire,ortocloseanongoingresearch program. Notification is given in writingidentifyingthespecificBuildingandroomnumbers tobe vacated bythePIandtheanticipateddate of ending laboratory and or research officeuse activities. The PI will then actively workwith the below-named individuals and committees toensureanorderlyand completedecommissioning ofthelaboratory and/or research office space, as well as closing outactivestudies.
Associate Chief of Staff, R&D: The ACOS, R&D, upon receipt ofnotification fromthe PI that alaboratory and/or research officearea is to be vacated, will notify the Subcommittee for ResearchSpace,the Subcommittee for Research Safety (SRS), the Administrative Officer (AO), HumanResearch Protection ProgramOfficer (HRPPO),the VMU Supervisor, the Radiation SafetyOfficer (RSO), the Subcommittee for AnimalStudies (SAS),andIRBifappropriate,andtheResearch Development Committee.
Administrative Officer (AO): The AO will meet with the PI to ensure that a plan forexcessingand/or discarding laboratory chemicals,reagents, and biological specimens isputin place.
Additionally, the AO will assist thePI in closing outthe PI’s Equipment Inventory List (EIL)byeithertransferringthe equipment to a general Research Service EIL or having the equipmentdiscardedifnotuseableor repairable. TheAOwill assist thePI in distributing excess suppliesharboredinthelaboratorytoother active laboratories inneedofsuch supplies, or discardingunneededand unclaimed supplies,orrelegate useablebut unclaimed suppliestoageneralResearch Service storage area.
Radiation Safety Officer:TheRSOordesigneefromthe Radiation Safety Office willdecommission the laboratory according to protocols approved by the Radiation SafetyCommittee if radioisotopes or other radiation producingequipment were used in thespace.
VMU Supervisor: The VMUSupervisorwill assist thePIandinterface with the VeterinaryMedicalOfficer(VMO)ordesigneeandVeterinary Medical Unit(VMU)andbein
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communicationwiththeSAS regarding disposition of any and all animals that may be left in thePI’s approved protocols.
Subcommittee for Research Space:The Subcommittee will beresponsible for assessing theusabilityofvacatedspace, making recommendations to the ACOS, R&D regardingthe need forrenovations to laboratory space to make the space functional,informing the Subcommittee onResearchSafetyandtheR&D Committee ofthestatusofallassigned and unassigned space, andassigning space to Investigators. Assignedbutunder-utilized spacewill beassessed by theSubcommittee anddecisionsasto re-assigning this space will be made. Upon closeout of thelaboratory (including “dry” laboratoryspace),theSubcommittee will inspectthe spaceto assessthe suitability for new occupants, andwill workwith ResearchAdministration to update theRDIS, part 1 space database for ePROMISE.
Research and Development Committee:TheCommitteehasfinal oversight of both assigned andunassigned space forthepurposeofevaluationof Research Service program needs with regardsto overall space usage and need and the overall safety of laboratory spaces, both occupied andunoccupied.The Committee also has general oversight that all Principal Investigators withanassigned Equipment Inventory Listing havecompletedtheannual equipment inventoryassessment asrequiredbyAcquisitionMaterialManagement. The will also receive and reviewplans developed betweenthe PrincipalInvestigator andrelevant oversight committees (e.g.IRB,SAS,etc)regardingthe closeout or reassignment of active studies.
Subcommittee on Research Safety:The Subcommittee will beresponsible for the formalsemi-annual inspections ofallassigned and unassignedresearchspaceto ensure thatthelaboratorywork environment is safe, that outdated chemicals are properly disposed of, fume hoods andbiological safety cabinets have been inspected onan annual basis and repairs made as needed tokeep such hoods and safety cabinets infunctionalstatus,thatany fire hazards are immediatelycorrected,andallother requirements forpersonal laboratory safety of employees inanindividuallaboratory are up to date. Upon closeout of the laboratory (including “dry” laboratoryspace),theSubcommittee will make an inspection ofthe vacatedspace to ensure that the vacatingPrincipalInvestigatorhas completed thenecessary removal of outdated chemicals, and biohazards and hasidentifiedanddevelopedaplanforthetransferordisposalofall other useable chemicals and/orsupplies.
IRB: For those researchprograms having human subjects, the IRB will be responsible forensuring that the Principal Investigator has finalized all activeprotocols (IRB-7 Form), or hasidentified another acceptable PrincipalInvestigator to which activeprotocolsmay be reassigned,that any patientsthat hadbeen actively enrolledhavebeenreturnedtousualcarewitha primarycare provider, and that all research records are catalogued as to date of future destruction, andboxedappropriatelyandlabeledasto contents and date of destruction.
SAS: For those researchprograms having animal subjects, the SAS will be responsible forensuring that the Principal Investigator has finalized all activeprotocols orhasidentifiedanotheracceptable Principal Investigatortowhichactiveprotocols may be reassigned, thatanacceptableplanforthedispositionofanyanimalsubjectsactively enrolled inastudyhavebeendeveloped
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(e.g. transferred to another investigator, put up for adoption, humanely euthanized, etc), and thatall remaininganimal per diems or other VMU charges have been paid.
Procedures:
1.ThePrincipalInvestigatorinforms the ACOS, R&D by written notification (by memo or e-mail) whenhe/shehasdecidedtoretire,leave VALB, or close or transfer their research programandtheanticipatedlastdayatVALB. Notification shouldbeatleast60daysinadvanceofdeparting VALB or earlier if the final departure date is known.
2.TheACOS,R&DuponreceiptofPrincipalInvestigatornotificationoftheclosure/transferof theresearch program, willinformtheR&D Committee atitsnext meeting, and immediatelyinformthe Chairs of the Subcommittee on Research Safety and the Subcommittee for ResearchSpace, and the Administrative Officer. The Radiation SafetyOfficer(or designee) (if necessary),theVMU Supervisor (if necessary), andthe Human Research ProtectionsProgramOfficer(ifnecessary) will also be informed bythe ACOS, R&D of impendingresearchprogram closure.
3.The Point of Contact between ResearchService andthe Principal Investigator for “wet”laboratory decommissioning processwillbetheAO.The AO will meet with the PI to ensurethat a plan for accessingand discarding laboratory chemicals, reagents, and biological specimensis put in place.Additionally, the AO will assist the PI in closing out the PI’s EquipmentInventory List (EIL)byeither transferring the equipment toageneral Research Service EIL orhavingthe equipment discardedifnot useable orrepairable.TheAOwill assist thePIindistributingexcesssuppliesharboredinthelaboratoryto otheractivelaboratoriesinneedofsuch supplies,ordiscardingunneededand unclaimedsupplies, or relegate useable but unclaimedsuppliestoageneral Research Service storage area. However,inall cases, itisthe ultimateresponsibility of the PI to have the equipment, supplies,biological specimens, etc. distributed ordisposed.Ifthe PI has notprocessedthe closure ofthespacewithin thetime specified, theResearchOfficewill have itdone and thePIwillbe assessed achargeof$100/hourpayabletothe SouthernCalifornia Institute for Researchand Education (SCIRE), the NPC for VALB.
4.Subsequent to disposal, turn-in, redistributionof equipment,supplies, biological specimens,etc, theSubcommittee for ResearchSafetywillmake a formalinspectionofthe laboratoryfacility to besure thatallchemicals on the Chemical Inventoryhavebeenappropriatelydiscarded or redistributed, all gas tanks, and liquid nitrogen containers have been shut down,transferred,orotherwisereturnedtovendors,andanyother items ontheLaboratoryDecommissioning Checklist (Attachment A) have been completed.The Subcommittee onResearch Safety will alsocoordinate with the Radiation Safety Officer tobesure that anyradioactive areasinthe laboratory, any equipment and/or hoods used for radioisotopeexperimentation have been decommissionedaccording to Radiation Safety protocol. Oncecompleted, theResearch Safety Subcommittee will report to the R&D Committee that alllaboratorysafetyissueshavebeen completedand the laboratory can be released for re-occupancy.
5.For research programs having enrolled human subjectsor human specimen use,theHRPPOfficer will assist thePIin identifying all active human subjects projects andtofinalizethem
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using IRB 7 form. All items on the Human Subjects Program Closeout Checklist (Attachment
B) will be completed bythe PI with the assistance ofthe HRPP Officer and/or the RCO.Theseitems include, 1) returning remaining enrolled patients to routineclinicalcare with aprimarycare provider if one is available;2)completingthedis-enrollment note in CPRS for each activehuman subject(workingdirectlywith the RCO); 3) gatheringandboxingallresearchrecords(consent forms, clinicalresearchcharts/records,etc.)anddenotingonthebox,thePIname,VAStudy Number, Sponsor,anddatethattherecordscanbedestroyed;4)inconcertwiththeSubcommittee on Research Safety, destroying ortransferringresponsibility of specimens toanotherPrincipalInvestigator,or banking human biological specimens. TheHRPPOfficerwillthen assist thePIin finding suitablestorageforthe records on site orarranging foroff-sitestorageof the records.
6.For researchprograms having animal subjectsor specimens, theVMUSupervisorwill assistthePIinidentifyingallactiveprojectsinvolving animals andtofinalize or transfertheproject.All items on the Animal Subjects ProgramCloseout Checklist (Attachment C)willbe completedby the PI with the assistance of the VMU Supervisor. These items include, 1) disposition bytransfertothecareoftheVMU,anotherPI,oreuthanasia of any livinganimalsremaining in anactive protocol or not part of aprotocolbutinthePI’sresearch program; 2)returningclinicalrecords of animal care and use to the VMU/VMOwhen animals havebeenkeptinapprovednon-VMUlaboratoryspacefor animals; 3)in concert with the Subcommittee on Research Safety,disposing ofor transferring biological specimens derived fromanimalexperimentation toanotherPrincipalInvestigator;4)returning all unused/outdated controlledsubstancesandrelatedrecords usedin animal researchtothe Pharmacy; 5) removing the laboratory fromthe list ofcurrently approved non-VMU animal care and use laboratories.
7.The SubcommitteeforResearchSpace will formallyinspect the laboratory oncelaboratory closeout has been completed bythe Subcommittee on Research Safety.Theitems on the SubcommitteeforSpaceChecklist(Attachment D) will 1) identifyfeaturesthatneedtoberepairedorpotentiallyrenovatedfornew occupancy; 2)listthetypeoflaboratory and any useful features (e.g. available biological safetycabinets for cellculture, chemicalfume hood for volatile chemical or radioisotope procedures; gas, water,vacuumconnectivity, if“dry”labarea, whether usefulforofficeareaonly,storage,orpotentialclinicalresearcharea,etc).The Subcommittee will make recommendationsrelativetowhetherthe space canbe offered toPrincipal Investigators incurrentlylessdesirable space, orto new Principal Investigators as the needarises.The Subcommitteewill alsomakerecommendations on whether thelaboratoryspace can be leased orrentedto outside VA entities ifneeds for VA Investigators have beenmet. The Subcommittee atits regularmeetings willassignand re-assignspace as neededbut will informResearchAdministration of all space, both occupied andvacant,sothattheRDIS,Part1reportforePROMISE can be updated by Research Administration. The Subcommittee will informthe R&D Committee of all space recommendations.
8.If the PI does not complete the process for the closureofthespacewithinninety(90)days ofthe PI’s initialnotificationor thirty(30)daysofbeingnotifiedofachangeintheallocation ofspace by the Research Space Subcommittee, whichever is earlier, the spacewill be decommissioned for himat a chargeof $100 /hourtobepaidwithfunds
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VALBHS Decommissioning SOPVersion 11-07-2013
Replaces 11-04-2010
depositedwithSCIREorapersonalcheckmadepayabletoSCIRE. IfthePI'sspaceisbeingdecommissioned duetodeathordisabilityandthePIhasnofundsavailablethroughSCIRE,thenallfeeswillbewaived.
ApprovedbyR&DCommittee: 11/7/2013Nextreviewrequired: 11/2016
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AttachmentA
GENERALLABORATORY COMPONENTS DECOMMISSIONING CHECKLIST
CHEMICAL INVENTORIES / Yes / No / NotesChemical Inventory Verified
Prohibited/Restricted HazardousChemicalsIdentified
Disposal Requested
Excess Chemicals Identified
Disposal Requested
Expired Chemicals Identified
Disposal Requested
ChemicalsTransferred
BIOLOGICALSPECIMENS/REAGENTS
Biological Specimens Identified
Non Expired Specimens Transferred
Expired Specimens Disposed
BiologicalReagents Identified
NonExpiredReagentsTransferred
Expired Reagents Disposed
GASES / LIQUID N2
Research gas tanks returned or transferred
Liquid Nitrogen tanks returned or transferred
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ATTACHMENT B
HUMANSUBJECTSPROGRAMCLOSEOUT
ItemDateCompleted
1)IRB Close or Transfer of study documentationcompleted.
2)All subjects dis-enrolled fromstudy:
a.Patientreturnedtostandardofcarewith primary provider
b.Research Termination Notes completed in CPR
c.Research Flag (if required byIRBduringstudy) removed.
3)All files for storage labeled with
a.PI Name,
b.VA Study Number,
c.To Be Destroyed by Date.
4)LocationofStorage Identified:Bldgand Room:
5)If study is ongoing but PI is leaving facility:
a.Identification of Successor PI:
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