Introduction to INSPIRIntroduction to INSPIR

OCR Seminar SeriesOCR Seminar Series

January 21, 2004January 21, 2004

Mary Banks, RNMary Banks, RN

Administrator, Office of the IRBAdministrator, Office of the IRB

““The Future Is Now”The Future Is Now” Yogi BerraYogi Berra

What is INSPIR ?What is INSPIR ?

IIntegrated ntegrated NNetwork etwork

for for SSubject ubject PProtection rotection IIn n RResearchesearch

INSPIR BackgroundINSPIR Background

• Developed as BRAIN at Baylor Developed as BRAIN at Baylor School of MedicineSchool of Medicine

• Currently used at Baylor and Currently used at Baylor and University of Maryland University of Maryland (BRAAN)(BRAAN)

• Result of IRB Improvement Result of IRB Improvement Grant (NIH)Grant (NIH)

• Customized to fit Boston Customized to fit Boston University requirementsUniversity requirements

• Will be used at BUMC and Will be used at BUMC and Charles River Campus Charles River Campus

• Used by BUMC IRB and IACUCUsed by BUMC IRB and IACUC

System RequirementsSystem Requirements

• January Issue of CR Times (January Issue of CR Times (www.bu.edu/crtimes)-www.bu.edu/crtimes)- link link

• Connecting to INSPIRConnecting to INSPIR• Browser Browser

– Macintosh, Netscape version 7Macintosh, Netscape version 7– Safari for MacSafari for Mac– PC- Internet Explorer 6.0 or higherPC- Internet Explorer 6.0 or higher

• Cookies must be enabledCookies must be enabled• Pop-up Blockers must be disabledPop-up Blockers must be disabled

www.bumc.bu.edu/Departments/PageMain.asp?www.bumc.bu.edu/Departments/PageMain.asp?Page=8725&DepartmentID=368Page=8725&DepartmentID=368

Useful TipUseful Tip

• Attachments (drug Attachments (drug brochures, sponsor’s brochures, sponsor’s protocol, grant applications) protocol, grant applications) will have to be scanned and will have to be scanned and “attached” to the IRB “attached” to the IRB applicationapplication

• Extremely helpful if you Extremely helpful if you have a scanner within the have a scanner within the department to use to scan department to use to scan these documentsthese documents

Access to INSPIRAccess to INSPIR

• Website “Getting Access”Website “Getting Access”

• Presence in BU’s electronic Presence in BU’s electronic directorydirectory

• BU Login Name, BUID BU Login Name, BUID Number, and Kerberos Number, and Kerberos passwordpassword

• If you don’t have a presence If you don’t have a presence in BU’s directory (BMC, VA) in BU’s directory (BMC, VA) instructions availableinstructions available

• Do this now- don’t waitDo this now- don’t waitwww.bumc.bu.edu/Departments/PageMain.asp?www.bumc.bu.edu/Departments/PageMain.asp?Page=8636&DepartmentID=368Page=8636&DepartmentID=368

Difficulties Logging Into Difficulties Logging Into INSPIRINSPIR• Login issues and Login issues and

technical issues will NOT technical issues will NOT be managed by the IRB be managed by the IRB officeoffice

• Contact the Contact the IT INSPIR IT INSPIR TeamTeam at at BRAAN@bu.eduBRAAN@bu.edu

• Helpful advice on Helpful advice on website under “Help!” website under “Help!”

www.bumc.bu.edu/Departments/PageMain.asp?www.bumc.bu.edu/Departments/PageMain.asp?Page=8094&DepartmentID=368Page=8094&DepartmentID=368

What Does INSPIR Do?What Does INSPIR Do?

• Allows for IRB protocols to be created, Allows for IRB protocols to be created, routed, reviewed, signed, and routed, reviewed, signed, and approved within the systemapproved within the system

• Provides for transparent processing- Provides for transparent processing- everyone who has access can see everyone who has access can see where the protocol is at each step in where the protocol is at each step in the processthe process

• Creates IRB meeting agendas and Creates IRB meeting agendas and minutes minutes

• Gives reviewers and investigators Gives reviewers and investigators access to the entire study file access to the entire study file (including previous versions that are (including previous versions that are archived in the system)archived in the system)

• Automatically generates continuing Automatically generates continuing review remindersreview reminders

Why Be INSPIRed?Why Be INSPIRed?

• Electronic submission of Electronic submission of protocolsprotocols– No longer need to submit multiple No longer need to submit multiple

copies to IRBcopies to IRB– Not rely on interdepartmental Not rely on interdepartmental

mailmail– No need to hand deliver No need to hand deliver

documents to the IRB officedocuments to the IRB office– Documents won’t get lostDocuments won’t get lost– Accurate study files- investigator Accurate study files- investigator

files will match IRB filesfiles will match IRB files

Why Be INSPIRed? (cont.)Why Be INSPIRed? (cont.)

• Investigators can track the progress Investigators can track the progress of own protocols of own protocols

• Multiple copies of documents Multiple copies of documents (approval letters, consent forms, (approval letters, consent forms, etc.) with version control can be etc.) with version control can be printedprinted

• Applications are automatically Applications are automatically routed for required signaturesrouted for required signatures

• Continuing Review process is much Continuing Review process is much easier because amendments, SAEs, easier because amendments, SAEs, etc. are cumulatively trackedetc. are cumulatively tracked

• Investigators can access INSPIR Investigators can access INSPIR from any internet connected from any internet connected computercomputer

Jan Feb Mar April May

summer

3/8 - 3/15IRB officeCLOSED

2/23 - 3/15Train the Investigators

Mar. 8IRB office

Stops Accepting

Paper

Mar. 15GO LIVE

2004

Important Dates for Important Dates for Investigators and Research Investigators and Research

Staff at BUMCStaff at BUMC• February 23 - March 15February 23 - March 15

Investigator trainingInvestigator training• March 8March 8

IRB Office stops IRB Office stops accepting paper accepting paper

submissionssubmissions• March 8 - 15March 8 - 15

IRB Office closedIRB Office closed• March 15March 15

Go Live DateGo Live Date

Investigator TrainingInvestigator Training

• Feb. 23 - Mar.15Feb. 23 - Mar.15

• Training will includeTraining will include– Online trainingOnline training– Investigator ManualInvestigator Manual– Large group classesLarge group classes– Small group classesSmall group classes

• Schedule of classes will be Schedule of classes will be postedposted

• Practice site will be available Practice site will be available for investigators to usefor investigators to use

IRB Office Stops Accepting IRB Office Stops Accepting PaperPaper

• March 8, 2004March 8, 2004• All paper Progress Reports All paper Progress Reports

must be submitted by this must be submitted by this date date

• Can submit Progress Reports Can submit Progress Reports for for March, April and MayMarch, April and May

• Last date to accept new Last date to accept new Research Applications in paperResearch Applications in paper

• Last date to accept Last date to accept amendments in paperamendments in paper

IRB OFFICE CLOSEDIRB OFFICE CLOSED

• March 8-15March 8-15• No paper or electronic No paper or electronic

submissions accepted submissions accepted during this weekduring this week

• Investigator training will Investigator training will be ongoing during the be ongoing during the weekweek

• IRB office staff will be IRB office staff will be available for training available for training and to answer questionsand to answer questions

GO LIVEGO LIVE

• March 15, 2004March 15, 2004• First day protocols can First day protocols can

be submitted be submitted electronicallyelectronically– New protocolsNew protocols– Progress Reports Progress Reports

(Continuing Reviews)(Continuing Reviews)– AmendmentsAmendments

New IRB ApplicationsNew IRB Applications

• Full Board, Expedited Full Board, Expedited and Exemptand Exempt

• Submit on paper by Submit on paper by March 8March 8 OR OR

• Must hold and submit Must hold and submit on or after on or after March 15March 15 electronicallyelectronically

• Investigators can work Investigators can work on drafts prior to on drafts prior to March 15March 15

Continuing ReviewContinuing Review

• Progress Reports must be Progress Reports must be submitted by submitted by March 8March 8 on paper on paper OROR

• Must be held until Must be held until March 15March 15 for for submission electronicallysubmission electronically

• Investigators may submit on Investigators may submit on paper for paper for March, April, MayMarch, April, May onlyonly

• Studies that expire after Studies that expire after May May 31, 200431, 2004 – Progress Reports – Progress Reports must be submitted electronicallymust be submitted electronically

Continuing ReviewContinuing Review

• After After March 8 March 8 all Progress all Progress Reports (CRs) must be Reports (CRs) must be submitted electronicallysubmitted electronically

• To submit a Progress Report To submit a Progress Report the investigator must first the investigator must first enter the study into the enter the study into the system using a new system using a new applicationapplication

Continuing ReviewContinuing Review

• If PI submits a new protocol If PI submits a new protocol on March 8 on paper - will on March 8 on paper - will have to re-submit the have to re-submit the study electronically at time study electronically at time of next Continuing Reviewof next Continuing Review

• Investigators must ensure Investigators must ensure that studies will not lapsethat studies will not lapse

• Progress Reports must still Progress Reports must still be submitted at least 5 be submitted at least 5 weeks prior to expiration weeks prior to expiration

AmendmentsAmendments

• After After March 8March 8 all all amendments must be amendments must be submitted electronicallysubmitted electronically

• Prior to submitting an Prior to submitting an amendment the amendment the investigator must enter the investigator must enter the protocol into the system protocol into the system (by completing a Research (by completing a Research Application for the study)Application for the study)

Serious Adverse EventsSerious Adverse Events

• March 8March 8 deadline does deadline doesnot not apply to SAEsapply to SAEs

• SAEs may be submitted on SAEs may be submitted on paper until the study is up paper until the study is up for Continuing Review (or for Continuing Review (or an amendment is needed)an amendment is needed)

• More information on SAEs More information on SAEs will be coming - the IRB is will be coming - the IRB is modifying the policy on modifying the policy on submitting SAEs to the IRB submitting SAEs to the IRB

Demonstration of INSPIRDemonstration of INSPIR

• Demonstration site (practice Demonstration site (practice site) will be available soon site) will be available soon for use by investigatorsfor use by investigators

• Final modifications being Final modifications being made to the systemmade to the system

• We will provide investigators We will provide investigators paper copies of screen shots paper copies of screen shots

• We will provide an electronic We will provide an electronic Investigator’s manual Investigator’s manual

Go To DemoGo To Demo