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STVHCS Research and Development

STVHCS Research and Development. Kimberly Summers, PharmD Assistant Chief for Clinical Research South Texas Veterans Health Care System Research & Development Service. What is Considered VA Research?. Definition of VA Research. Research sponsored by the VA

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STVHCS Research and Development

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  1. STVHCS Research and Development Kimberly Summers, PharmD Assistant Chief for Clinical Research South Texas Veterans Health Care System Research & Development Service

  2. What is Considered VA Research?

  3. 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

  4. 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

  5. What Does It Mean To Have Research Privileges at the STVHCS?

  6. 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

  7. 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

  8. 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        

  9. 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

  10. The R&D Submission Process

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

  12. R&D Submission Date • The first Monday of each month • New Requirement • One of the followingmust 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

  13. 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.

  14. 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

  15. R&D Submission Forms

  16. Electronic form available on Research website Items 1-7. All fields are required. Information entered on page 1 will be auto filled on pages 2 through 6. Item 8. Complete the applicable table for each VA Service that will be utilized as part of your project.

  17. 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

  18. Routing Statement of Clinical Impact Forms • Submit completed forms via email to stxresearch@va.gov • If you have any questions completing the form • Contact Angela Casas in the Research office at VA ext 15523 • The Research office will forward completed forms to the appropriate VA Services for signatures • An electronic signed copy will be provided for your records • If project requirements change for any VA Service, a revised form must be submitted to the Research office

  19. 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

  20. 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

  21. VA-Sensitive Research Data Individually-identifiable research data collected on a veteran subject through a STVHCS approved protocol Individually-identifiable research data collected on a veteran or non-veteran within the STVHCS Individually-identifiable research data collected as part of a VA-funded study

  22. Individually-identifiable - Data HIPAA Identifiers 1. Names 2. ALL geographic subdivisions smaller than the state 3. All elements of dates smaller than a year and all ages over 89 4. Phone numbers 5. Fax numbers 6. E-mail addresses 7. Social Security numbers (SSN) 8. Medical record number 9. Health plan beneficiary numbers 10. Any other account numbers 11. Certificate/license numbers 12. Vehicle identifiers and license plate numbers 13. Device identifiers and serial numbers 14. WEB URL's 15. Internet IP address numbers 16. Biometric identifiers (fingerprint, voice prints, retina scan, etc) 17. Full face photographs or comparable images 18. Any other unique number, characteristic or code

  23. HIPAA Identifiers Continued Any other unique number, characteristic or code Scrambled SSN Initials Last four digits of SSN Employee numbers Etc. HIPPA also states that the entity does not have actual knowledge that the remaining information could be used alone or in combination with other information to identify an individual who is the subject of the information

  24. HIPAA and The Common Rule • Two different regulations • VA requires de-identification by both • Common Rule states the identity of the subject can not be readily ascertained by information remaining after removal of all 18 HIPAA identifiers • After stripping all 18 identifiers the remaining information may still be identifiable (e.g. through statistical analysis)

  25. Not VA-Sensitive Data Non-identifiable data Data collected on non-veterans outside of the VA on a non-VA funded project

  26. Keys To Coding Systems • If non-identifiable information is linked to identifiable information with the use of log (e.g. coding system) • Logs are identifiable and VA-sensitive research data • Applies to both data and specimen logs

  27. 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

  28. 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.

  29. Storage of VA-Sensitive Paper Research Data • Lower risk of loss or compromise • Physical security controls • Within the VA system • Locked room, locked cabinet • Access limited to research staff • At the UTHSCSA • Physical security arrangements must be inspected and approved by ACOS/Research and ISO

  30. Storage of VA-Sensitive Electronic Research Data Risk of loss or compromise is high Must be stored within the VA system (e.g. behind the VA firewall) VA research server recommended Accessed directly through the VA network from a VA computer or Through VPN from a non-VA computer Encrypted VA computer in VA office Rare instances Explain requirement for storage outside the server

  31. R&D Continuing Review Process

  32. 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

  33. 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

  34. Documentation in the Medical Record

  35. Research Record Must Contain • Copy of the signed and dated consent and initial enrollment progress note • Scanning of VA Form 10-1086 (Informed Consent Document) • Information on possible drug interactions and adverse effects of investigational drugs being administered • Scanning of VA Form 10-9012 (Investigational Drug Information Record) • Any research information which has the potential to impact medical care • Research progress notes • Disenrollment or termination from a study

  36. Enrollment Consent Template: Research Consent / Enrollment Note • Must be entered into the subject’s health record (CPRS) after IC has been obtained • Template in CPRS flags patients Medical Record in postings • Template contains all the required information for documentation of consent process • Template must be used in order to scan IC document • Note must indicate if the study involves the use of investigational medications

  37. Investigational Drug Information Record (VA Form 10-9012) • Required for • Investigational drug for which an IND has been filed • Approved drug being studied for unapproved use in a controlled, randomized, or blinded clinical trial • Approved drug being studied for approved use in a controlled, randomized, or blinded clinical trial • PI must ensure a completed and signed copy is submitted to MR for scanning • Pharmacy will not dispense any study medication for a research subject until 10-9012 forms have been scanned

  38. 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

  39. Updated Consent Template: Research Consent / Update Note • Any changes to the IC resulting in an addendum or updated IC document • Must be entered into the subject’s health record (CPRS) after IC has been obtained • Template in CPRS flags patients Medical Record in postings • All IC addendums and updated IC documents must be scanned in CPRS

  40. Research Disenrollment Termination Note • Must be entered into the subject’s health record (CPRS) • Template in CPRS flags patients Medical Record in postings • Required information in template • Title of Study • Date of disenrollment or termination • Contact name and number

  41. External Monitoring Visits

  42. At The Time Of The Monitoring Visit • Study monitor must sign in at the Research Office and receive a visitor badge • Check-in at Room Q202.1 or on BRU • A Research Monitor Log will be maintained by the Research Office • Study monitor will be provided • External Monitor Agreement Form • Must be reviewed and signed at the time of check in • STVHCS Report of Clinical Research Monitoring Visit • Must be returned to the Research office

  43. Completion is required independent of the findings associated with the visit

  44. Findings That Require an Exit Interview • Suspicions or concerns that serious non-compliance may exist • All findings of serious non-compliance with study protocol, IRB requirements or applicable regulations and policies • Monitoring visits conducted by regulatory agencies (FDA, OHRP)

  45. Research Referrals and Recruitment

  46. 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

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