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Understanding Our HRPP and Your Role in the Accreditation Process

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... faxes, e-mails, Subject diaries, Informed consent forms, ... A subject is lost to follow-up. A subject is dropped from the study. Managing Approved Studies: ... – PowerPoint PPT presentation

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Title: Understanding Our HRPP and Your Role in the Accreditation Process


1
Understanding Our HRPP and Your Role in the
Accreditation Process
2
Introduction
  • Eugene Oddone, MD, Vice Dean for Research

3
What is AAHRPP?
  • Association for the Accreditation of Human
    Research Protection Programs
  • Gold standard for Human Research Protections
    programs is participation in a voluntary
    accreditation process.
  • Independent, non-profit accrediting body that
    incorporates a voluntary, peer-driven,
    educational model to ensure that Dukes Human
    Research Protection Program (HRPP) meets rigorous
    standards for quality and protection

4
Why is Duke Seeking Accreditation?
  • The accreditation process allows us to take a
    comprehensive look at our HRPP in order to
    identify and address any weaknesses and build
    upon our strengths.
  • It helps to ensure
  • The highest possible standards protections
  • An assurance of quality
  • Improved efficiency effectiveness
  • A competitive edge
  • Government recognition
  • Public trust confidence

5
What is My Role in the Process?
  • Investigators and their study teams are an
    important component of an HRPP
  • Prepare for the site visit
  • Familiarize yourself with Dukes HRPP
  • Review Dukes policies
  • Know what resources are available to assist you
  • If identified as a contact on the consent form,
    you may be called to determine if you are
    prepared to answer questions if you respond in
    a reasonable amount of time.

6
Overview of AAHRPP Accreditation
  • Wesley Byerly, PharmD, Associate Dean,
  • Research Support Services

7
Your Clinical Research Environment
Good Clinical Practice Regulations, Guidance,
Policies SOPs
Human Research Protection Programs (HRPP)
Duke HRPP
Institutional (Duke) Policy
  • AAHRPP
  • Research Administration
  • Offices

Site Based Research
Your Human Subjects
8
Good Clinical Practice (GCP)
  • Good Clinical Practice (GCP) is an international
    ethical and scientific quality standard for
    designing, conducting, recording and reporting
    trials that involve the participation of human
    subjects. Compliance with this standard provides
    public assurance that the rights, safety and
    well-being of trial subjects are protected,
    consistent with the principles that have their
    origin in the Declaration of Helsinki, and that
    the clinical trial data are credible
  • ICH HARMONISED
    TRIPARTITE GUIDELINE , GUIDELINE
    FOR GOOD CLINICAL PRACTICE , E6
  • (http//www.ich.org/LOB/media/MEDIA482.pdf)

9
Good Clinical Practice
Goal
Protect Subjects
Laws
Prescribes obligations
Regulations
Mandatory requirements
Guidances
Suggested ways to comply
Standard Operating Procedures

Detailed directions
Standards of Care
Professional Expectations of Practice
10
Which Regulationsdo you Follow?
11
Human Research Protections Program (HRPP)
  • An integrated process where all the various
    components of an organization involved in the
    conduct of human research work together to
    protect the rights and welfare of participants

The HRPP is not an office. The HRPP is the
collective effort of all who participate in the
Conduct, Review, Approval and Facilitation of
Clinical Research at Duke.
12
Goals of an HRPP
  • Improve the systems that protect the rights and
    welfare of individuals who participate in
    research
  • Communicate to the public the strength of an
    organization's commitment to the protection of
    human research participants
  • Improve the overall quality of research by
    consistently applying high standards and
    practices, raising the global benchmark for human
    research protection

13
Duke Medicine Human Research Protection Program
  • Conduct
  • Where?
  • Duke University Hospital
  • Durham Regional Hospital
  • Duke Raleigh Hospital
  • By Whom?
  • Investigators and Study Teams
  • Review and Oversight
  • Site-Based Research Units (SBRs)
  • Institutional Review Board (IRB) and
    Subcommittees
  • Clinical Research Support Office (CRSO)
  • Clinical Trials Quality Assurance (CTQA)
  • Privacy Office
  • Research Integrity Office
  • Information Security Office
  • Sponsorship and Finance
  • Office of Research Administration (ORA)
  • Office of Corporate Research and Collaboration
    (OCRC)
  • Office of Sponsored Programs (OSP)
  • PRMO Clinical Trials Billing Office
  • Research Costing Compliance (RCC)

13
14
Association for the Accreditation of Human
Research Protection Programs (AAHRPP)
Step 1 Institution prepares and submits
application with detailed policies, procedures,
tools

Step 2 A team of experts reviews the materials
and sends report of changes to be made by
institution to meet accreditation standards
Step 3 (Currently at this step) Institution makes
changes, AAHRPP schedules Site Visit to look at
institution's HRPP performance with respect to
accreditation standards
  • Step 4
  • Site Visit occurs A report is received in 30
    days and there is a response period

Step 5 AAHRPPs Council on Accreditation reviews
the application, Site Visit Report and
institutions response and determines sites
accreditation status
15
AAHRPP Accreditation Domains(What will be
reviewed)
  • Organization The entity that assumes
    responsibility for the Human Research Protection
    Program and applies for accreditation
  • Research Review Unit Refers to the arrangements
    that the Organization has made for an independent
    review of ethical and scientific aspects of each
    research protocol involving human participants
  • Investigator Includes the various arrangements
    that the Organization has made for assuring that
    individuals who plan to conduct research
    whether as a principal investigator, co-
    investigator, or other member of a research team
    understand and fulfill their responsibilities
  • Sponsored Research Includes the Organizations
    arrangements for structuring its relationships
    with those who fund or initiate research external
    to the Organization, such as federal agencies,
    foundations, individual donors, and corporations
  • Participant Outreach Refers to the arrangements
    the Organization has made for understanding the
    social, psychological, and physical needs and
    concerns of research participants and their
    communities

16
What Happens During the Site Visit?
  • Twelve study team groups will be interviewed as
    representatives of our research community
  • The interviews will last 45 minutes
  • Groups will be either PI groups or coordinator
    groups
  • Investigators will meet separately with the site
    visitors from the coordinators
  • The CRSO will meet with these representatives of
    our study teams to assist them in preparing for
    the visit
  • Site visitors will ask questions regarding our
    training resources, practices, procedures and
    processes
  • For more information on the site visit, go to the
    CRSOs webpage on AAHRPP
  • http//crso.som.duke.edu/modules/crso_home/index.p
    hp?id6

17
Dukes HRPP
  • Jennifer Holcomb, Director of Operations, CRSO

18
Research Administration Offices
  • CRSO Clinical Research Support Office
  • IRB Institutional Review Board
  • RIO Research Integrity Office
  • OCRC Office of Corporate Research Collaboration
  • ORA Office of Research Administration
  • OSP Office of Sponsored Programs
  • PRMO Patient Revenue Management Organization
  • CTBO Clinical Trials Billing Office
  • IDS Investigational Drug Service
  • CTQA Clinical Trials Quality Assurance
  • DUHS Compliance Duke University Health System
    Compliance

19


Site-Based Research Units (SBRs)
20
What Role do SBRs and Study Teams Play in our
HRPP?
  • Policies, practices and procedures at the
    institutional (Duke), Site-Based Research Unit
    (SBR) and Study Team levels respectively, must be
    followed and reviewed, evaluated and revised
    regularly
  • Communication between the Study Team and Research
    Administration is essential to Compliance with
    Regulations and Institutional Policies

21
SBR Functions
  • Responsible for the integrity, financial
    accountability, regulatory compliance, quality,
    and academic productivity of the projects
    conducted in their groups
  • Provide day-to-day management of site-based
    research activities including
  • Feasibility assessment of potential studies
  • Study selection decisions
  • Personnel management (hiring/supervision) of
    non-faculty research staff
  • Protocol-specific training and study execution
  • Financial management

22
Site Based ResearchInvestigator Responsibilities
  • In addition to regulatory and DUHS requirements,
    Investigators are responsible for
  • Identifying and proposing studies
  • Participating in the development of the Schedule
    of Events, budget, and billing grid
  • Participating in negotiation with sponsors
  • Following SBR Standard Operation Procedures
    (SOPs)
  • The academic productivity of research
  • Compliance with Duke HRPP training requirements -
    new on-line training modules taking effect Jan.
    1, 2009

23

Study Conduct and Management
24
Managing Approved StudiesDocumentation What
Why
  • Source Data (Documentation) All information in
    original records and certified copies of original
    records (ICH GCP 1.51)
  • Includes
  • Clinical findings
  • Observations
  • Other study activities
  • Necessary for
  • The reconstruction and evaluation of the study
  • Confirmation of subject existence and
    observations
  • Substantiation of study data integrity
  • Source Document A record which contains ORIGINAL
    source data (e.g. Medical records, Lab reports,
    X-rays, ECGs, Intake/ Screening forms, Telephone
    contact records, faxes, e-mails, Subject diaries,
    Informed consent forms, CRFS)

25
Managing Approved StudiesDocumentation What
Why
  • Note/Memo to File
  • Used to clarify missing or inaccurate data or
    procedures.
  • Store memo in the appropriate regulatory binder
    and with the source documentation.
  • Not a panacea for all things that have gone
    wrong.
  • Document problem Not enough.
  • Document problem -gt document corrective action
    identified for preventing recurrence -gt
    institute corrective action
  • Examples
  • An assessment is missed or completed out of
    sequence
  • Are unable to obtain a blood sample at a visit
  • A subject failed to initial one page of a consent
    document
  • If an original document is destroyed and only a
    copy remains
  • A subject is lost to follow-up
  • A subject is dropped from the study

26
Managing Approved StudiesRecord Retention
Quick Takes
  • Drugs/Biologics 2 years following the date of
    market application approval, market application
    non-approval or discontinuation of the
    investigation (21 CFR 312.62c)
  • Devices For a period of 2 years after the latter
    of the following investigation termination/complet
    ion date , or date that records no longer
    required to support premarket approval
    application (21 CFR 812.140d)
  • FYI - ICH Guidelines 2 years after the last
    approval of a marketing application in an ICH
    region and until there are no pending or
    contemplated marketing applications in an ICH
    region or at least 2 years have elapsed since the
    formal discontinuation of clinical development of
    the investigational product. (ICH GCP (E6), 4.9.5)

27
Study Conduct Subject Protection
  • How do Privacy and Confidentiality Differ?
  • Privacy is about protecting the person
  • Confidentiality is about protecting the private
    information (DATA) you
  • have access to

28
Study Conduct Subject ProtectionHow do I
Maintain the Privacy of my Subjects?
  • Do not cold contact subjects
  • When designing the recruitment process, remember
    that the study must be introduced by healthcare
    personnel known to the potential subject. If the
    subject indicates interest in the study, then
    research personnel may approach the subject to
    discuss the study further.
  • Ensure interviews are convened in a private
    setting
  • If others are present, ensure that their presence
    is appropriate
  • Consider how the subject might like to be treated
    given their age, ethnicity, or gender

29
Study Conduct Subject ProtectionProtecting
Confidentiality
  • Refers to the protections that you provide for
    private information
  • Expectation that data will not be divulged except
    in ways previously agreed upon
  • It's about DATA
  • verbal
  • written
  • electronic

30
Study Conduct Subject ProtectionProtecting
Confidentiality
  • Does your subject have an expectation that
    information provided will be kept confidential?
  • How do you identify potential subjects?
  • What data are you collecting?
  • Is the information you are recording of a
    personal nature?
  • Are you recording information about a third
    party?
  • How are the data going to be stored?
  • Who is going to have access to the data?

31
Study Conduct Subject ProtectionProtecting
Confidentiality
  • There are tools to protect it both inside and
    outside of Duke
  • HIPAA Set of tools (and rules) for maintaining
    confidentiality now and after disclosure
    (commonly referred to as the Privacy Rule)
  • Certificate of Confidentiality Allows you
    to keep the data away from outsiders even from a
    court order (Applies to any research, not just
    NIH funded)

32
Study Conduct Subject ProtectionRecruitment
The Foundation ofInformed Consent
  • How is equitable selection operationalized?
  • Who has first contact with prospective
    participants?
  • When is it appropriate to approach a family
    member or friend first?
  • Is it acceptable to leave a consent with the
    medical provider to pass on?
  • How is first contact made?

33
Study Conduct Subject Protection Do You Have
Informed Consent?
  • When does Informed consent beginend?
  • What do you assess to determine the individual's
    capability to provide legally effective informed
    consent?
  • What criteria should be in place to ensure you
    have informed consent?

34
Study Conduct Subject ProtectionDiminished
Capacity/Cognitive Impairment
  • Indications of potentially diminished capacity
    are
  • A diagnosis of dementia or cognitive impairment
  • Presenting for an evaluation of dementia
  • A report, in medical records or from a family
    member or person well acquainted with the
    subject, that the subject has symptoms of
    cognitive impairment or dementia
  • An abnormal degree of confusion, forgetfulness,
    or difficulties in communication that is observed
    in the course of interacting with the subject
  • Psychotic symptoms, bizarre or abnormal behavior
    exhibited by the subject
  • For research that may involve subjects with
    diminished capacity to make an informed decision,
    you need to inform the IRB of
  • What special protections will you ensure are in
    place?
  • Who will assess for decisional capacity?
  • When will this occur?
  • Under what circumstances will reassessment occur?
  • What provisions will be made to obtain the
    consent of the research subject if the period of
    diminished capacity is temporary?
  • UC Davis Alzheimer's Disease Center

35
Study Conduct Subject ProtectionDiminished
Capacity/Cognitive Impairment
  • Considerations for the Informed Consent Process
  • Determining extent of cognitive impairment
  • Will the individual have enough information to
    make an informed decision?
  • Will the individual be able to make a decision?
  • Will the individual understand the consequences
    of the decision?
  • Will the individual be able to communicate the
    decision?
  • Will the subject need a legally authorized
    representative to act on behalf of the subject?
  • Will assent be sought?
  • Circumstances under which the subjects failure
    to assent can be overridden by the subjects
    legally authorized representative
  • Periodic reassessment of the subjects cognition
    will it be necessary? If yes, when it will
    occur, and by whom?
  • Will the subject will be asked to consent for
    continued study participation if the subjects
    decisional capacity improves, and if not, why
    not?

36
Study Conduct Subject ProtectionN.C. Order
of Authority for Serving as a Legally Authorized
Representative (LAR)
  • Court-approved guardian
  • Health care agent
  • Spouse
  • Adult son and/or daughter
  • Parent
  • Adult brother and/or sister
  • Uncle and/or aunt
  • Other adult kin

37
Study Conduct Subject ProtectionAssent
Diminished Capacity Children
  • Subjects with Diminished Capacity/Cognitive
    Impairment IRB does not have specific policies
    regarding assent for this population
  • Children
  • In NC residents under 18 years of age are
    considered minors in unless they are
    "emancipated" by court order
  • In determining whether children are capable of
    assenting, the IRB will take into account the
    ages, maturity, and psychological state of the
    children involved. This judgment may be made for
    all children to be involved in research under a
    particular protocol, or for each child, as the
    IRB deems appropriate
  • Age related IRB consent requirements
  • gt 6 years of age should be involved in the
    decision to participate in a research project
  • 12 years of age must sign assent after the
    parent or legal guardian has given consent (for
    exceptions consult IRB manual)

38
Study Conduct Subject ProtectionDocumenting
Informed Consent
  • Document that the Subject was given a (signed)
    copy of the ICF in the case history
  • If subject is a patient, DUHS requires a copy of
    the consent form in the subjects DUHS medical
    record (JCAHO requirement)
  • Best Practice
  • Document the consent process in the case history
    the medical record
  • Include
  • IRB approval obtained prior to subject consenting
  • How subject was informed (read consent,
    discussion, QA, video)
  • Who participated in the consent process and how
    (investigator, study coordinator, legal
    authorized representative, family, etc.)
  • How subjects understanding of the information
    was assessed
  • Disposition of the signed consent form (original
    and copies)
  • Special or unusual circumstances (e.g. Illiterate
    subject how did you ensure the subject was
    informed and that your process met regulatory
    requirements?)

39
Study Conduct Subject Protection Unanticipated
Problems vs. Adverse Events
  • Most adverse events are not unanticipated
    problems
  • Unanticipated problems include other incidents,
    experiences, and outcomes not considered adverse
    events


40
Study Conduct Subject Protection Medical
Devices, Adverse Events and Effects
Investigator Reporting Requirements
(Sponsor Obligation)
41
Managing Approved Studies Protocol Departures,
a.k.a. Noncompliance
  • Types of Departures
  • Deviation Unintentional
  • Violation Intentional
  • Departures must be reported when the following
    are impacted
  • Rights, welfare or safety of subject
  • Integrity of the research data
  • Subjects willingness to continue study
  • Forms to use
  • Notification of Protocol Deviation/Violation
  • If departure is both unanticipated and meets
    above criteria, the Notification of a Problem
    or Event requiring Prompt reporting to the IRB as
    a New or Increased Risk must also be submitted
    to IRB
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