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STVHCS Human Research Protection Program

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Title: Documentation of Human Subjects Research in the Patient s Health Record Author: Kimberly Summers Last modified by: OIT Created Date: 1/7/2008 5:43:15 PM – PowerPoint PPT presentation

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Title: STVHCS Human Research Protection Program


1
STVHCS Human Research Protection Program
  • Kimberly Summers, PharmD
  • Assistant Chief for Clinical Research
  • South Texas Veterans Health Care System
  • Research Development Service

2
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

3
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

4
Who is the Institutional Official for the STVHCS
Research Program?
5
STVHCS Research Program Institutional Official
  • RICHARD J. BALTZCenter DirectorSTVHCS
  • 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

6
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?

7
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

8
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

9
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

10
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

11
UPIRSO
  • Unanticipated Problem Involving Risk to Subjects
    or Others

12
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

13
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

14
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

15
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 RD office
  • VA RD office reports UPIRSO to Office of
    Research Oversight (ORO)

16
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

17
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

18
Who must approve human subject research before it
can be conducted at the VA?
  • IRB
  • ACOS for RD
  • Chief of Staff
  • Director
  • RD Committee
  • Subcommittee for Research Safety

19
The STVHCS RD Committee cannot approve a human
subject research protocol that has not been
approved by the UTHSCSA IRB
  • The STVHCS RD Committee can disapproval a human
    subject research protocol that has been approved
    by the UTHSCSA IRB

20
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

21
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

22
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

23
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
  • Patients 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 patients responsibly
    available adult children
  • Patients parents
  • Patients adult sibling
  • Patient's grandparent
  • Patients adult grandchild
  • Since VA and Texas state law differ, follow the
    more restrictive regulation
  • Consult with legal counsel in cases of
    uncertainty

24
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

25
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

26
Who is ultimately responsible for ensuring a
research protocol has sound design and minimizes
risks to subjects?
  • IRB
  • RD Committee
  • Principal Investigator
  • Research Coordinator
  • Hospital Director

27
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?

28
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
  • RD Committee
  • Through the QI/QA subcommittee
  • Sponsor of the study
  • STVHCS Compliance Executive Board
  • STVHCS Compliance Office reports to this committee

29
To whom should research non-compliance be
reported?
  • UTHSCSA IRB
  • STVHCS RD Office
  • Research non-compliance or alleged improprieties
    may be identified through self-reporting by the
    PI or by other members of the study team.

30
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 RD 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
  • RD Chairman and IRB Director must be notified
  • Notification may be through the RD office

31
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

32
Who has the authority to suspend or terminate a
research protocol?
  • STVHCS Director
  • RD Committee
  • IRB
  • ACOS for Research

33
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 RD office

34
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

35
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

36
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

37
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 patients 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

38
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 RD approval

39
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

40
What are the requirements for recruitment ads for
research protocols?
  • Advertisements should include
  • The name and address of
  • investigator and/or research facility
  • The condition under study and/or
  • purpose of the study
  • A summary of the criteria used to
  • determine eligibility
  • A brief list of participation benefits,
  • if any
  • The amount of time or other
  • commitment required of subjects
  • The location of the research
  • A person or office to contact for
  • further information
  • Advertisements should not include
  • Claims that the test article is safe or effective
    for the purpose of the investigation
  • Claims that the test article is known to be
    equivalent or superior to any other drug
  • Terms which imply the receipt of newly improved
    products of proven worth such as new treatment,
    new medication, or new drug. The
    advertisement must explain that the drug or
    device is investigational.
  • Promises of free medical treatment when intent is
    only to state that subjects will not be charged
    for taking part in the investigation
  • Emphasis of payment for participation

41
What incentives are allowed that assist in
recruiting patients into studies?
  • Sponsor provided bonuses for subject recruitment
  • Prohibited by UTHSCSA and STVHCS
  • Finders fees
  • Prohibited UTHSCSA and STVHCS

42
What is the difference between a data safety and
monitoring plan and a data safety monitoring
board?
  • Local PI Responsibilities

43
Local PI Responsibility
  • DSMP
  • Capturing and collecting data
  • Monitoring collected data
  • Interpretation and analysis of collected data
  • Reporting results of analysis
  • Implementing actions based on analysis if needed
  • DSMB
  • Limited to collecting information and forwarding
    to DSMB for analysis
  • Implementing local actions based on DSMB analysis
    if needed
  • Studies which include an established DSMB by an
    external entity still require a local DSMP

44
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

45
Questions?
  • Kimberly Summers, PharmD
  • Office (210) 617-5300 ext 15969
  • Email kimberlyk.Summers_at_va.gov
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