STVHCS STVHCS Research and DevelopmentResearch and Development

Kimberly Summers, PharmDKimberly Summers, PharmDAssistant Chief for Clinical ResearchAssistant Chief for Clinical Research

South Texas Veterans Health Care SystemSouth Texas Veterans Health Care SystemResearch & Development ServiceResearch & Development Service

What is Considered VA Research?

Definition of VA Research

• Research sponsored by the VA• Research conducted using any property or facility of

STVHCS• Research conducted by or under the direction of any

salaried or without compensation (WOC) employee of the STVHCS during and in connection with her/his STVHCS responsibilities

• Funds for the research activities are managed by the STVHCS or Biomedical Research Foundation of South Texas

• Research which recruits subjects at the STVHCS or uses the STVHCS's nonpublic information to identify or contact human research subjects for research purposes

R&D Approval

– Must have R&D approval letter prior to any of the following being conducted at the VA

• Recruitment • Obtaining informed consent

– Having an IRB approved VA consent form does NOT constitute R&D approval

• Enrollment• Providing patient follow up• Accessing CPRS for research purposes

– An IRB approval letter does NOT constitute R&D approval

What Does It Mean To Have Research Privileges at the

STVHCS?

Research Privileges

• Research credentialing and privileges are required prior to work on any VA protocol

• Requirements are different for the following groups– VA Employees

• Investigators and study personnel

– Fellows, Residents, and Students– Non-VA investigators or study personnel– Exempt study staff

VA Research Privileges• VA Appointment

– VA employee or WOC status with research privileges or Trainee– All mandatory training courses– Signed Intellectual Property Agreement (IPA)- WOCs, Trainees, Contract

credentialed providers– Signed Written Release of Information- WOCs only– Copy of Appointment Memo- Trainees– Medical Staff Member Appointment Request signed by appropriate Service

Chief- Contract credentialed providers

• Documentation of Human Subjects Training• Conflict of Interest Form

– Required for all investigators and study personnel

• Scope of practice– Required for all investigators and study personnel EXCEPT credentialed

medical staff providers– Signed by principal investigator(s) and/or supervising physician

Exempt Personnel

• Study personnel who are not physically conducting research on VA property, only have access to de-identified data and/or not directly working with research subjects – Examples: lab personnel, data or administrative

personnel• Requirements

– Information Security 201 for Research and Development Personnel

• LMS account created– Memorandum from PI denoting what their role in the

study will be  – Conflict of Interest Form        

Conflict of Interest Form

• No longer protocol specific• Required for all investigators and collaborators

– Collaborators = all research personnel• New form will be collected as part of

– New personnel application– New protocol submission if old version of form is on

file• Must be verified as accurate or updated annually

– Verified by the PI at continuing review– New protocol submission if investigator or personnel

have not been engaged in research for greater than one year

The R&D Submission Process

http://www.south-texas.med.va.gov/research

R&D Submission Date

• The first Monday of each month

• New Requirement – One of the following must have occurred prior

to application submission to the R&D office• IRB final resubmission for full IRB Board 1

or IRB 3 research protocols• IRB administrative review for IRB expedited

or exempt research • Final IRB approval

R&D Administrative Review Appointments

• New Requirement – An appointment with the investigator and/or study

coordinator is required to address any administrative stipulations

– The intent of the meeting is to address, correct, and finalize any administrative stipulations in real time to shorten the overall approval time

– This appointment may be made at the time of application submission or may be scheduled by calling the R&D office at VA ext 16335.

R&D Administrative Stipulations and Final Approval

• New Requirement – All administrative stipulations must be

addressed at least one week prior to the R&D Committee Meeting for the protocol to be placed on the agenda

– IRB approval may still be pending at the time of resubmission

• Final R&D approval can be granted when– IRB approval is in place– All R&D Committee stipulations have been

addressed

R&D Submission Forms

• Electronic form Electronic form available on available on Research websiteResearch website

• Items 1-7Items 1-7. All . All fields are required. fields are required. Information Information entered on page 1 entered on page 1 will be auto filled will be auto filled on pages 2 through on pages 2 through 6. 6.

• Item 8Item 8. Complete . Complete the applicable table the applicable table for each VA for each VA Service that will be Service that will be utilized as part of utilized as part of your project.your project.

Statement of Clinical Impact Form

• Procedures must be consistent with protocol• List ALL procedures beyond routine clinical

care – Additional, altered process or increased frequency– Procedures should be specific

• Collaborating service will not sign off on statement of clinical impact if information provided is incomplete

Routing Statement of Clinical Routing Statement of Clinical Impact FormsImpact Forms

  • Submit completed forms via email to Submit completed forms via email to

stxresearch@va.gov• If you have any questions completing the formIf you have any questions completing the form

– Contact Angela Casas in the Research office at VA ext 15523Contact Angela Casas in the Research office at VA ext 15523

• The Research office will forward completed forms to The Research office will forward completed forms to the appropriate VA Services for signatures the appropriate VA Services for signatures

• An electronic signed copy will be provided for your An electronic signed copy will be provided for your recordsrecords

• If project requirements change for any VA Service, a If project requirements change for any VA Service, a revised form must be submitted to the Research office revised form must be submitted to the Research office

VA Research Data Security Checklist

• Required for ALL submissions

• If the research does NOT involve human subjects OR their identifiable information– Only PI signature on

front page is required for completion

Data Security Checklist

• Documentation for – Types of information collected– Disclosures to third parties– Location of storage– Length of retention

• Should be consistent in the – Protocol– Data security checklist – Informed consent document

• All sections should state the same information

VA-Sensitive Research DataVA-Sensitive Research Data

• Individually-identifiable research data Individually-identifiable research data collected on a veteran subject through a collected on a veteran subject through a STVHCS approved protocolSTVHCS approved protocol

• Individually-identifiable research data Individually-identifiable research data collected on a veteran or non-veteran collected on a veteran or non-veteran within the STVHCSwithin the STVHCS

• Individually-identifiable research data Individually-identifiable research data collected as part of a VA-funded studycollected as part of a VA-funded study

Individually-identifiable - Data HIPAA IdentifiersIndividually-identifiable - Data HIPAA Identifiers1. Names1. Names

22. ALL. ALL geographic subdivisions geographic subdivisions smaller than the statesmaller than the state

3. All elements of dates 3. All elements of dates smaller than a year smaller than a year and all ages over 89 and all ages over 89

4. Phone numbers4. Phone numbers

5. Fax numbers 5. Fax numbers

6. E-mail addresses6. E-mail addresses

7. Social Security numbers (SSN)7. Social Security numbers (SSN)

8. Medical record number8. Medical record number

9. Health plan beneficiary numbers9. Health plan beneficiary numbers

10. Any other account numbers 10. Any other account numbers

11. Certificate/license numbers11. Certificate/license numbers

12. Vehicle identifiers and license plate numbers12. Vehicle identifiers and license plate numbers

13. Device identifiers and serial numbers13. Device identifiers and serial numbers

14. WEB URL's14. WEB URL's

15. Internet IP address numbers15. Internet IP address numbers

16. Biometric identifiers (fingerprint, voice prints, retina scan, etc)16. Biometric identifiers (fingerprint, voice prints, retina scan, etc)

17. Full face photographs or comparable images17. Full face photographs or comparable images

18. Any other unique number, characteristic or code18. Any other unique number, characteristic or code

HIPAA Identifiers ContinuedHIPAA Identifiers Continued

• Any other unique number, characteristic or codeAny other unique number, characteristic or code– Scrambled SSNScrambled SSN– InitialsInitials– Last four digits of SSNLast four digits of SSN– Employee numbersEmployee numbers– Etc.Etc.

• HIPPA also states that the entity does not have HIPPA also states that the entity does not have actual knowledge that the remaining information actual knowledge that the remaining information could be used alone or in combination with other could be used alone or in combination with other information to identify an individual who is the information to identify an individual who is the subject of the informationsubject of the information

HIPAA and The Common RuleHIPAA and The Common Rule

• Two different regulationsTwo different regulations• VA requires de-identification by bothVA requires de-identification by both• Common Rule states the identity of the Common Rule states the identity of the

subject can not be readily ascertained by subject can not be readily ascertained by information remaining after removal of all information remaining after removal of all 18 HIPAA identifiers18 HIPAA identifiers– After stripping all 18 identifiers the remaining After stripping all 18 identifiers the remaining

information may still be identifiable (e.g. information may still be identifiable (e.g. through statistical analysis)through statistical analysis)

Not VA-Sensitive DataNot VA-Sensitive Data

• Non-identifiable dataNon-identifiable data

• Data collected on non-veterans Data collected on non-veterans outside of the VA on a non-VA outside of the VA on a non-VA funded projectfunded project

Keys To Coding SystemsKeys To Coding Systems

• If non-identifiable information is linked If non-identifiable information is linked to identifiable information with the use to identifiable information with the use of log (e.g. coding system)of log (e.g. coding system)– Logs are identifiable and VA-sensitive Logs are identifiable and VA-sensitive

research dataresearch data

– Applies to both data and specimen logsApplies to both data and specimen logs

Disclosures to Non-STVHCS Entities

• Temporary access to research subject information, without removal of any data from the facility– Examples: external study monitors, auditors, collaborators, etc

• Access to research subject information because the data will leave the STVHCS facility– For identifiable information disclosed outside the STVHCS, you

must state how the data will be securely transported– Transfer or transmission other than to the sponsor or its

designated contract monitor or data center, requires prior written approval by the ACOS/Research, STVHCS Privacy Officer and Information Security Officer

• The Data Security Checklist, HIPPA authorization, and protocol should all be consistent

Accounting of Disclosures

• An accounting of disclosures must be kept for all VA sensitive information transferred or transmitted outside the STVHCS– Excluding non-identifiable data and limited data sets– Limited data sets exclude certain direct identifiers but

may contain some identifiable information • Examples: city, state, zip code, scrambled SSN, or initials

– The web-based accounting for Disclosure of VA-sensitive Research Information can be found on the Research and Development Service Webpage: http://www.southtexas.va.gov/research.

Storage of VA-Sensitive Paper Storage of VA-Sensitive Paper Research DataResearch Data

• Lower risk of loss or compromiseLower risk of loss or compromise• Physical security controlsPhysical security controls

– Within the VA systemWithin the VA system• Locked room, locked cabinet Locked room, locked cabinet • Access limited to research staffAccess limited to research staff

– At the UTHSCSAAt the UTHSCSA• Physical security arrangements must be inspected Physical security arrangements must be inspected

and approved by ACOS/Research and ISOand approved by ACOS/Research and ISO

Storage of VA-Sensitive Electronic Storage of VA-Sensitive Electronic Research DataResearch Data

• Risk of loss or compromise is highRisk of loss or compromise is high• Must be stored within the VA system (e.g. Must be stored within the VA system (e.g.

behind the VA firewall)behind the VA firewall)– VA research server recommendedVA research server recommended

• Accessed directly through the VA network from a Accessed directly through the VA network from a VA computer orVA computer or

• Through VPN from a non-VA computerThrough VPN from a non-VA computer– Encrypted VA computer in VA officeEncrypted VA computer in VA office

• Rare instancesRare instances• Explain requirement for storage outside the serverExplain requirement for storage outside the server

R&D Continuing Review Process

Continuing Review Process

• New form• VA specific information in addition to IRB

continuing review form– Submission of the IRB continuing review form and/or

approval letter to the R&D office is NOT required

• Exempt research– VA continuing review form required at least annually– Updated protocol abstract required anually

Continuing Review Process

• Protocol approval at the STVHCS will expire if– Continuing review is not completed

• Must be approved by IRB AND R&D Committee prior to the expiration date

– Training requirements for the PI are not up-to-date at the time of continuing review

• Co-investigators and other study personnel will be removed from active protocols if training requirements are not up-to-date

• Expiration of approval will be corrected upon receipt and satisfactory review and approval of the required documentation

Documentation in the Medical Record

Research Record Must Contain• Copy of the signed and dated consent and initial enrollment Copy of the signed and dated consent and initial enrollment

progress noteprogress note– Scanning of VA Form 10-1086 (Informed Consent Scanning of VA Form 10-1086 (Informed Consent

Document)Document)• Information on possible drug interactions and adverse effects Information on possible drug interactions and adverse effects

of investigational drugs being administeredof investigational drugs being administered– Scanning of VA Form 10-9012 (Investigational Drug Scanning of VA Form 10-9012 (Investigational Drug

Information Record)Information Record)• Any research information which has the potential to impact Any research information which has the potential to impact

medical caremedical care– Research progress notesResearch progress notes

• Disenrollment or termination from a studyDisenrollment or termination from a study

Enrollment Consent Template: Enrollment Consent Template: Research Consent / Enrollment NoteResearch Consent / Enrollment Note

• Must be entered into the subject’s health record Must be entered into the subject’s health record (CPRS) after IC has been obtained(CPRS) after IC has been obtained

• Template in CPRS flags patients Medical Record Template in CPRS flags patients Medical Record in postingsin postings

• Template contains all the required information for Template contains all the required information for documentation of consent processdocumentation of consent process

• Template must be used in order to scan IC Template must be used in order to scan IC documentdocument

• Note must indicate if the study involves the use of Note must indicate if the study involves the use of investigational medicationsinvestigational medications

Investigational Drug Information Record Investigational Drug Information Record (VA Form 10-9012)(VA Form 10-9012)

• Required forRequired for– Investigational drug for which an IND has been filedInvestigational drug for which an IND has been filed– Approved drug being studied for unapproved use in a Approved drug being studied for unapproved use in a

controlled, randomized, or blinded clinical trialcontrolled, randomized, or blinded clinical trial– Approved drug being studied for approved use in a Approved drug being studied for approved use in a

controlled, randomized, or blinded clinical trialcontrolled, randomized, or blinded clinical trial

• PI must ensure a completed and signed copy is PI must ensure a completed and signed copy is submitted to MR for scanningsubmitted to MR for scanning

• Pharmacy will not dispense any study Pharmacy will not dispense any study medication for a research subject until 10-9012 medication for a research subject until 10-9012 forms have been scanned forms have been scanned

Authorized Prescribers for Investigational Medications

• All prescribers for investigational medications must be listed on VA form 10-9012– Should be consistent with FDA 1572

• Prescribers must be credentialed at the VA to write medication orders– Should be consistent with Scope of Practice if

applicable• VA form 10-9012 must be amended if

– Prescribing investigators are added to a protocol– Principal investigator changes

• Research Pharmacist verifies orders are received by an investigator listed on the 10-9012

Updated Consent Template: Updated Consent Template: Research Consent / Update NoteResearch Consent / Update Note

• Any changes to the IC resulting in an Any changes to the IC resulting in an addendum or updated IC document addendum or updated IC document – Must be entered into the subject’s health Must be entered into the subject’s health

record (CPRS) after IC has been obtainedrecord (CPRS) after IC has been obtained– Template in CPRS flags patients Medical Template in CPRS flags patients Medical

Record in postingsRecord in postings

• All IC addendums and updated IC All IC addendums and updated IC documents must be scanned in CPRSdocuments must be scanned in CPRS

Research Disenrollment Research Disenrollment Termination NoteTermination Note

• Must be entered into the subject’s health Must be entered into the subject’s health record (CPRS) record (CPRS)

• Template in CPRS flags patients Medical Template in CPRS flags patients Medical Record in postingsRecord in postings

• Required information in templateRequired information in template– Title of StudyTitle of Study– Date of disenrollment or terminationDate of disenrollment or termination– Contact name and number Contact name and number

External Monitoring Visits

At The Time Of The Monitoring VisitAt The Time Of The Monitoring Visit

• Study monitor must sign in at the Research Study monitor must sign in at the Research Office and receive a visitor badgeOffice and receive a visitor badge– Check-in at Room Q202.1 or on BRUCheck-in at Room Q202.1 or on BRU– A Research Monitor Log will be maintained by the A Research Monitor Log will be maintained by the

Research OfficeResearch Office

• Study monitor will be provided Study monitor will be provided – External Monitor Agreement FormExternal Monitor Agreement Form

• Must be reviewed and signed at the time of check inMust be reviewed and signed at the time of check in

– STVHCS Report of Clinical Research Monitoring VisitSTVHCS Report of Clinical Research Monitoring Visit• Must be returned to the Research officeMust be returned to the Research office

• Completion Completion is required is required independent independent of the of the findings findings associated associated with the visitwith the visit

Findings That Require an Exit InterviewFindings That Require an Exit Interview

• Suspicions or concerns that serious non-Suspicions or concerns that serious non-compliance may existcompliance may exist

• All findings of serious non-compliance with All findings of serious non-compliance with study protocol, IRB requirements or study protocol, IRB requirements or applicable regulations and policiesapplicable regulations and policies

• Monitoring visits conducted by regulatory Monitoring visits conducted by regulatory agencies (FDA, OHRP)agencies (FDA, OHRP)

Research Referrals and Recruitment

Physician Referral

• Veteran patients may be formally referred from VA staff for a VA-approved research protocol

• Veteran patients may NOT be formally referred from VA staff to off-site locations for non-VA approved research protocols– Veteran patients have a right to seek care from and

enroll in research studies outside the VA– Informing veteran patients of the availability of an

outside research study is not considered a referral, if the referring physician will not have ongoing participation in the care of the patient

Informing Veterans About Off-site Non-VA Research Studies

• Veterans must be informed that VA will not be responsible for any costs related to their care as part of the off-site research

• Enrollment should occur through the veterans’ own initiative in contacting the study personnel at the off-site institution

• Provision of information to a veteran regarding off-site research and their associated responsibility for cost should be documented by the VA physician in a progress note in CPRS

• VA records may not be accessed to obtain information for research purposes of a non-VA off-site study

CPRS can be accessed for information on any Veteran enrolled in a research

protocol?

• YES– For VA approved research – Following signed informed consent by the veteran– As per approved research protocol

• NO– For Veterans enrolled in non-VA approved research

• Must obtain a signed release of information from the subject and receive copies thru Medical Records

Recruitment Advertisements Recruitment Advertisements Posted at the STVHCSPosted at the STVHCS

• Steps requiredSteps required

– Approved and stamped by UTHSCSA IRBApproved and stamped by UTHSCSA IRB

– Verification of active protocol and stamped by VA Verification of active protocol and stamped by VA

Research Office Research Office

– Posting approval by VA Public Affairs OfficePosting approval by VA Public Affairs Office

• Recruitment of VA patients into non-VA studies Recruitment of VA patients into non-VA studies through posted advertisements in NOT allowedthrough posted advertisements in NOT allowed

http://www.south-texas.med.va.gov/research

Questions?Questions?

Kimberly Summers, PharmDKimberly Summers, PharmD

Office: (210) 617-5300 ext 15969Office: (210) 617-5300 ext 15969

Email: kimberlyk.Summers@va.govEmail: kimberlyk.Summers@va.gov