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									STVHCS Human Research
   Protection Program

        Kimberly Summers, PharmD
   Assistant Chief for Clinical Research
 South Texas Veterans Health Care System
     Research & Development Service
  Human Research Protection
      Program (HRPP)
• The systematic and comprehensive
  approach by an organization to ensure
  human subject protection in all research

• STVHCS HRPP is a focus on
  responsibility and compassion, not only
  compliance
 What are the ethical principles
   that govern the HRPP?
• Beneficence
  – Benefits outweigh risks
• Autonomy
  – Informed consent must be obtained
• Justice
  – Recruitment is fair and equitable
  – Study population represents the group that
    will benefit from the research
Who is the Institutional Official for
the STVHCS Research Program?
STVHCS Research Program
   Institutional Official
             • RICHARD J. BALTZ
               Center Director
               STVHCS
             • Responsible for oversight
               of all VA investigators
               and IRB activities as they
               related to VA research
             • Must ensure VA IRB
               members and PIs are
               knowledgeable to
               conduct research in
               accordance with ethical
               standards and all
               applicable regulations
  When is research human subject
             research?
• Is the project designed to produce generalizable
  knowledge?
• Is the research systematic?
• Is the information about a living individual?
• Is the information about the participants
  gathered through any direct or indirect
  interaction with those participants?
• Is there any intervention via physical procedures
  or manipulation of a subjects environment?
• Is any private information obtained or used in
  the research individually identifiable?
   Which of the following are defined by
   the VA as human subjects research?

• A systematic investigation designed to develop or
  contribute to generalizable knowledge
   – DHHS definition
• Experiment that involves a test article and one or
  more human subjects
   – FDA definition
• Research involving human biological specimens
   – Considered research by VA
     Which of the following are
     considered VA research?
• Research sponsored by the VA
• Research conducted by or under the direction of
  a VA employee
  – Salaried or WOC
  – During official tour of duty or in connection with
    STVHCS responsibilities
• Research conducted using any property or
  facility of VA
  – Includes use of CPRS for recruitment or obtaining
    PHI
  Which of the following is an FDA
        regulated activity?
• Involves the use of an approved or
  unapproved drug
• Testing the efficacy or safety of a medical
  device
• Use of an approved drug in the practice of
  medicine
• Generating data to be presented to the
  FDA
What distinguishes QI activities
       from research?
• Designed solely for internal program
  evaluation purposes
• No external application or generalization
• NOTE:
  – If the intent of the activity changes after it is
    initiated and a desire to generalize and
    disseminate the results develops
  – IRB approval is required
     UPIRSO
   Unanticipated Problem
Involving Risk to Subjects or
           Others
What are the three elements which
       define an UPIRSO?
• Unanticipated
   – Not consistent with either the described risks in the research
     documents or not expected as part of natural progression of
     subjects underlying condition
   – Increases in frequency or severity are considered to be
     unanticipated
• At Least Possibly Related
   – More likely than not that the event is at least partially related to
     the study intervention or interaction
• Greater Risk of Harm
   – Places subjects or others at greater risk of harm than was
     previously known or recognized
   – Includes physical, psychological, economic, or social harm
What are the reporting requirements for study-
 related, non-serious adverse events (AEs)?

• No reporting requirements
   – Wrong answer
• Summary is provided to IRB as part of the progress report
   – OK answer
• As part of the DSMP adverse events are monitored
  regularly for trends and changes, when incidence or
  severity changes as a result of the cumulative events the
  IRB is notified (UPIRSO) and the protocol and or informed
  consent is modified as needed. A summary of cumulative
  events is also provided to the IRB as part of the progress
  report.
   – More complete answer
    What are the reporting requirements if
    an non-serious adverse event occurs
       that is not related to the study?
•   No reporting requirements
   – Must be at least possibly related to study participation
   – Wrong answer
• No reporting requirements
   – Must be serious
   – Wrong answer
• Summary is provided to IRB as part of the progress
  report
   – Correct answer
What are the reporting requirements for
 deaths that may be related to study
            participation?
• Report to IRB as an UPIRSO
  – Must be reported by investigator within 48
    hours (consider all UPIRSO criteria in order)
• IRB reports UPIRSO to Office of Human
  Research Protection (OHRP)
• IRB reports UPIRSO to VA R&D office
  – VA R&D office reports UPIRSO to Office of
    Research Oversight (ORO)
What are the reporting requirements for
 deaths that are not related to study
            participation?
• No reporting requirements
   – Must be at least possibly related to study participation
   – Wrong answer


• All deaths are summarized and provided to IRB as part
  of the progress report
   – Correct answer
     Who makes the determination
    whether research is exempt from
         federal regulations?

•   Any member of the study team
•   Principal Investigator
•   Sponsor
•   IRB
•   Any of the above
  Who must approve human subject
research before it can be conducted at
               the VA?
•   IRB
•   ACOS for R&D
•   Chief of Staff
•   Director
•   R&D Committee
•   Subcommittee for Research Safety
    The STVHCS R&D Committee
  cannot approve a human subject
 research protocol that has not been
   approved by the UTHSCSA IRB

  The STVHCS R&D Committee can
disapproval a human subject research
protocol that has been approved by the
            UTHSCSA IRB
What types of research have special restrictions
            for conduct at the VA?
 • Research involving children
    –   Waiver from the Chief Research and Development Officer
    –   Must present no greater than minimal risk
    –   Meets all requirements of the DHHS and FDA regulations
    –   VA Medical Center Director must certify that the facility is able to
        respond to pediatric emergencies
 • Pregnant women
    – Adequate provisions to monitor the risks to the participant and the
      fetus
    – Adequate consideration is given to the manner in which prospective
      participants are going to be selected
    – Adequate provision is made to monitor the actual consent process
 • Prisoners
    – Waiver from the Chief Research Development Officer
What research populations and situations
 are NOT conducted at the STVHCS?

• Research in which the subject is a fetus,
  in-utero or ex-utero (including human fetal
  tissue)
• Research related to in vitro fertilization
• Planned emergency research
     When can non-veterans be
      enrolled in a VA study?
• Non-veterans may be entered into VA
  approved research studies only when
  there are insufficient veterans available to
  complete the study and accordance with
  all federal regulations
• All regulations pertaining to veterans as
  research subjects pertain to non-veteran
  subjects enrolled in VA approved research
     Who can serve as the legally authorized
representative if a potential subject is decisionally-
                     impaired?
• Health care agent appointed by the person in a durable power of
  attorney for health care
• Court appointed guardian of the person
• Next of kin in the following order of priority
    – Patient’s spouse
    – An adult child of the patient who has the waiver and consent of all other
      qualified adult children of the patient to act as the sole decision-maker
      or a majority of the patient’s responsibly available adult children
    – Patient’s parents
    – Patient’s adult sibling
    – Patient's grandparent
    – Patient’s adult grandchild
• Since VA and Texas state law differ, follow the more restrictive
  regulation
• Consult with legal counsel in cases of uncertainty
  Who can dispense an investigational
     drug to a research subject?
• Research Pharmacy
   – All investigational medications must be dispensed through the
     VA research pharmacy
• Principal Investigator
   – Only under exceptional situations when a contractual agreement
     is in place with the VA research pharmacy may the PI dispense
     medication directly to a research subject
• Research Coordinator
   – Under no circumstances
   – Study coordinator may receive the dispensed medication from
     the research pharmacists (or PI if agreement is in place) and
     then provide the medication to the research subject
    What are the elements of sound
            study design?
•   Study problem
•   Relevance of the project
•   Literature review
•   Specific study objectives
•   Research methods
•   Selection of subjects and recruitment
•   Data collection
•   Intervention
•   Statistical considerations
Who is ultimately responsible for ensuring
a research protocol has sound design and
       minimizes risks to subjects?

•   IRB
•   R&D Committee
•   Principal Investigator
•   Research Coordinator
•   Hospital Director
 What educational programs and activities
are available to investigators and their study
                    staff?
• On line CITI course in the Protection of Human
  Research Subjects
• Monthly research Training Seminars
• IRB Forums
• UTHSCSA Course in “Conducting Clinical Research”
• STVHCS Investigator Handbook
• Individualized Training

• Which of these educational programs and activities
  are required to conduct research at the VA?
   Monitoring of compliance with human
 subjects research regulations is conducted
          by who at the STVHCS?

• STVHCS Compliance Office
• UTHSCSA Compliance Office
  – At the request of the IRB
• R&D Committee
  – Through the QI/QA subcommittee
• Sponsor of the study
• STVHCS Compliance Executive Board
  – STVHCS Compliance Office reports to this committee
To whom should research non-
   compliance be reported?
• UTHSCSA IRB
• STVHCS R&D Office

• Research non-compliance or alleged
  improprieties may be identified through
  self-reporting by the PI or by other
  members of the study team.
 How should subject complaints be
      handled and reported?
• Gather information related to the complaint
• Evaluate the complaint on a case-by-case basis
  – Make an effort to correct at the administrative level
• Forward complaint to R&D office when
  – Corrective action can not be implemented at the study
    staff / PI level
  – If an ethical conflict exists with review by study staff/
    PI
• If complaint is an alleged impropriety which
  involves potential harm to subjects or others
  – R&D Chairman and IRB Director must be notified
  – Notification may be through the R&D office
 What happens when you fail to submit
the continuing review paperwork for an
  approved protocol by the deadline?
• Research protocol expires
• All research activity must cease
  – Except for those activities required for patient safety
    reasons
  – Exception to continue for safety reasons must be
    approved by the IRB Director and the VA Chief of
    Staff
• Research activities may resume when all
  paperwork for continuing review is received,
  reviewed, and approved
    Who has the authority to suspend
    or terminate a research protocol?

•   STVHCS Director
•   R&D Committee
•   IRB
•   ACOS for Research
What are the requirements for financial
disclosure before or during the conduct
    of human research proposals?
• COI form must be completed for each study
  personnel
• COI form must be updated at the time of any
  change
• As part of the continuing review process, each
  PI must verify for ALL collaborators (all study
  personnel approved for a protocol)
  – Either no COI changes have occurred
  – All changes have been provided to the R&D office
  What is the importance of disclosing
   financial conflicts of interest in the
      conduct of human research?


• Preserves the public trust in the integrity
  and quality of research carried out by the
  investigators at the STVHCS
 What is the difference between
  privacy and confidentiality?
• Privacy
   – Control over the extent, timing and circumstances of
     sharing oneself (physically, behaviorally, or
     intellectually) with others
• Confidentiality
   – Pertains to the treatment of information that an
     individual has disclosed in a relationship of trust and
     with the exception that it will not be divulged to others
     in ways that are inconsistent with the understanding
     of the original disclosure without permission
When can you implement a change
 in your study without having IRB
             approval?

• To eliminate an immediate hazard for
  enrolled subjects
  – This includes calling subjects to let them know
    about a new risk to determine if they want to
    continue, halt or not start enrollment until new
    consent form is approved
How are other providers within the STVHCS
 notified regarding study related enrollment
      and events for a veteran subject ?
• Informed consent and enrollment are documented in CPRS
  through a “Research Consent/Enrollment Note”
• Informed consent updates and addendums are documented
  in CPRS through a “Research Consent/Update Note”
• Research procedures, treatments, or interventions that may
  impact a patient’s clinical care are documented in CPRS
  through a “Research Progress Note”
• All informed consents and drug information records are
  scanned into CPRS
• Disenrollment or termination is documented in CPRS through
  a “Research Disenrollment/ Termination Note”
• Use of the note templates ensures CPRS is flagged to
  indicate when the participant is either enrolled or disenrolled
  in a research study
What approaches for subject recruitment
      may be utilized at the VA?
• IRB-approved mechanisms
   – Physician referral

   – Posting of IRB-approved advertisements

• “Preparatory to Research” by HIPAA Privacy Rule
   – VA guidelines are more restrictive

   – In the VA, using individually-identifiable information to contact
     potential research subjects as part of recruitment into a research
     protocol is NOT considered “preparatory to research” and requires
     IRB and R&D approval
     What are the requirements for
recruitment ads for research protocols?
Advertisements should include:                Advertisements should not include:
                                              •   Claims that the test article is safe or
•   The name and address of                       effective for the purpose of the
    investigator and/or research facility         investigation
•   The condition under study and/or          •   Claims that the test article is known
                                                  to be equivalent or superior to any
    purpose of the study                          other drug
•   A summary of the criteria used to         •   Terms which imply the receipt of
                                                  newly improved products of proven
    determine eligibility                         worth such as “new treatment”, “new
•   A brief list of participation benefits,       medication”, or “new drug”. The
                                                  advertisement must explain that the
    if any                                        drug or device is investigational.
•   The amount of time or other               •   Promises of free medical treatment
    commitment required of subjects               when intent is only to state that
                                                  subjects will not be charged for
•   The location of the research                  taking part in the investigation
•   A person or office to contact for         •   Emphasis of payment for
                                                  participation
    further information
What incentives are allowed that assist
 in recruiting patients into studies?

• Sponsor provided bonuses for subject
  recruitment
  – Prohibited by UTHSCSA and STVHCS


• Finder’s fees
  – Prohibited UTHSCSA and STVHCS
What is the difference between a data
safety and monitoring plan and a data
       safety monitoring board?


     Local PI Responsibilities
          Local PI Responsibility
• DSMB                          • DSMP
   – Limited to collecting         – Capturing and
     information and                 collecting data
     forwarding to DSMB for        – Monitoring collected
     analysis                        data
   – Implementing local            – Interpretation and
     actions based on DSMB           analysis of collected
     analysis if needed              data
   – Studies which include         – Reporting results of
     an established DSMB by          analysis
     an external entity still      – Implementing actions
     require a local DSMP            based on analysis if
                                     needed
Studies Which Require a DSMP
• All studies considered to be more than
  minimal risk
  – Involve high risk populations and/or high
    risk therapies
• Multi-site research where UTHSCSA is
  the coordinating site
• Studies where there is an NIH or FDA
  requirement for a plan
• Studies when requested by the IRB
   Questions?
   Kimberly Summers, PharmD
 Office: (210) 617-5300 ext 15969
Email: kimberlyk.Summers@va.gov

								
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