AAHRPP Accreditation - PowerPoint PPT Presentation

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AAHRPP Accreditation

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Truman VA Hospital, Columbia, MO. Cincinnati, OH. March 19, 2007. AAHRPP Accreditation Process ... 1999 Kiser testimony to Congress ... – PowerPoint PPT presentation

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Title: AAHRPP Accreditation


1
AAHRPP Accreditation
  • Karen L. Smarr, PhD
  • Human Research Compliance Officer
  • Truman VA Hospital, Columbia, MO
  • Cincinnati, OH
  • March 19, 2007

2
AAHRPP Accreditation Process
  • Background (Accreditation and AAHRPP)
  • How to Approach the AAHRPP Application
  • Understanding AAHRPP Accreditation
  • AAHRPP Standards and Domains
  • How to Get AAHRPP Accreditation
  • AAHRPP Site Visit and Reviewer Questions
  • AAHRPP Draft Report and Response

3
Why accreditation??? Why AAHRPP???
VA HRPP
4
Background
  • 1999 Kiser testimony to Congress
  • VA would become the driving force to establish an
    accreditation program
  • 2000 5-year 5.8 million contract to NCQA
  • 72 VA facilities accredited
  • 2005 5-year 4.9 million contract to AAHRPP
  • 3 VA facilities accredited

5
Whats so different about AAHRPP?
  • NCQA
  • Quantitative model
  • Focused on policies and procedures, and
    documentation
  • Involved primarily the research office, IRB, and
    research pharmacy
  • AAHRPP
  • Qualitative model
  • Focuses on policies and procedures, and PRACTICES
  • Involves entire Human Research Protection Program
    (HRPP) institutional officials, research
    office, IRB, investigators, sponsored programs,
    and subjects

6
Approach to AAHRPP Accreditation Application
Process
  • Do Not Underestimate Time Commitment
  • Begin Early- Allow at least 4-6 months
  • Allow Time for Input/Review by Team
  • Organization and Communication Key
  • Request Guidance/Assistance from COACH and AAHRPP
    staff
  • Be Familiar with policies and procedures (PP)
    and practices
  • Anticipate delays and modification of PP, and
    creation of new PP
  • Focus on Final AAHRPP Accreditation

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8
How to Understand What AAHRPP accredits?
  • Organization
  • Research Review Unit
  • Investigator

Human Research Protection Program
A shared responsibility
9
AAHRPP Accreditation Standards Domains
  • Organization
  • Research Review Unit
  • Investigator
  • Sponsored Research
  • Participant Outreach

Obligations of
Obligations to
10
How does accreditation work?
Application
Self Evaluation
Expert site visitors Tailored to setting
Site Visit
Determines Accreditation category
Council on Accreditation
11
Self-evaluation
  • 77 elements
  • Review of all HRPP policies and procedures
  • Overview of HRPP program
  • Range of pages in a completed self-evaluation
    application 350 to 1500

12
Site Visit Process
  • 2 6 site visitors
  • 2 4 days
  • Records review
  • Interviews
  • Front-line
  • Management
  • Senior Management
  • Exit briefing
  • Draft report sent in 30 days

13
Categories of Accreditation
  • Full AAHRPP accreditation
  • Qualified AAHRPP accreditation
  • Accreditation-pending
  • Accreditation withheld

14
Domain III Investigators
  • What is AAHRPP looking for?
  • Competent, informed, conscientious,
    compassionate, and responsible investigators and
    research staff who provide the best protection
    for research participants.

15
Sample Interview Questions
16
General Tips
  • Be honest
  • If you dont know something, say who you would go
    to for the answer
  • This is not the place to pick or air battles

17
Investigator Oversight
  • Roles and communication with co- or
    sub-Investigators
  • Staff qualifications
  • Delegation of authority
  • Daily management

18
Relationship with the IRB
  • This is a general area of just what it is like to
    work with the IRB
  • Communication
  • Work load
  • Review process

19
Study Resources
  • Access to a population that would allow
    recruitment of the required of participants
  • Sufficient time
  • Adequate numbers of qualified staff
  • Adequate facilities
  • A process to ensure legally-effective informed
    consent
  • Availability of medical or psychological
    resources that participants may require

20
Study Personnel Training
  • Facility training requirements
  • Training records
  • Where do you go for information

21
Submitting a Protocol
  • What is human subjects research?
  • When do you need IRB review?
  • When can you start your study?
  • What changes can you make to your protocol
    without IRB review?

22
Study Design
  • Sound study design
  • Answers the research question
  • Adequately powered
  • Control groups
  • Monitoring the rights and welfare of participants
  • Safety checks (lab, xray, physical exam, etc.)
  • Reporting mechanisms
  • Data Safety and Monitoring Board (DSMB)

23
Conflict of Interest
  • Articulate what is a conflict of interest
  • Any interest of the investigator that competes
    with the investigators obligation to protect the
    rights and welfare of research participants
  • Disclosure statements
  • Evaluation by your institution

24
Risk Evaluation
  • Risks of medical treatment vs. risks of research
  • How do you minimize risks?
  • Avoiding unnecessary procedures
  • Using procedures already being performed for
    diagnostic or treatment purposes
  • Safety monitoring

25
Subject Recruitment
  • Recruitment (privacy concerns)
  • Enrollment (coercion and undue influence
    concerns)
  • Inclusion/exclusion criteria determination
  • Vulnerable subjects, e.g. prisoners
  • Acceptable advertisements and incentives

26
Informed Consent
  • Process vs. paper
  • Persons providing consent
  • Any waiting period
  • Steps to ensure sufficient opportunity to
    consider participation
  • Minimize possibility of coercion or undue
    influence
  • Language used and understood
  • Assessment of decision-making capacity and
    communication with a legally-authorized
    representative

27
Disclosures in Consent Form
  • Study procedures
  • Risks
  • Circumstances under which participation might be
    terminated
  • Consequences of withdrawal
  • Additional costs
  • Confidentiality of records
  • Liability
  • Conflict of interest

28
Subject Questions and Complaints
  • What is a complaint?
  • Who else should you tell?
  • Contact numbers for subjects
  • Research staff
  • If research staff cant be reached, call
  • Someone other than research staff
  • Where to voice concerns/complaints

29
Unanticipated Problems Involving Risks to
Subjects or Others
  • OHRP considers unanticipated problems, in
    general, to include any incident, experience, or
    outcome that meets all of the following criteria
  • unexpected (in terms of nature, severity, or
    frequency) given the research procedures and the
    subject population being studied
  • related or possibly related to participation in
    the research (in this guidance document, possibly
    related means there is a reasonable possibility
    that the incident, experience, or outcome may
    have been caused by participation in the
    research) and
  • suggests that the research places subjects or
    others at a greater risk of harm (including
    physical, psychological, economic, or social
    harm) than was previously known or recognized.

30
Difference between AEs and Unanticipated Problems
31
Examples
  • An investigator conducting behavioral research
    collects individually identifiable sensitive
    information about illicit drug use and other
    illegal behaviors by surveying college students.
    The data are stored on a laptop computer without
    encryption, and the laptop computer is stolen
    from the investigators car on the way home from
    work.
  • This is an unanticipated problem that must be
    reported because the incident was
  • unexpected (i.e., the investigators did not
    anticipate the theft)
  • related to participation in the research and
  • placed the subjects at a greater risk of
    psychological and social harm from the breach in
    confidentiality of the study data than was
    previously known or recognized.

32
Examples
  • As a result of a processing error by a pharmacy
    technician, a subject enrolled in a multi-center
    clinical trial receives a dose of an experimental
    agent that is 10-times higher than the dose
    dictated by the IRB-approved protocol. While the
    dosing error increased the risk of toxic
    manifestations of the experimental agent, the
    subject experienced no detectable harm or adverse
    effect after an appropriate period of careful
    observation.
  • This constitutes an unanticipated problem for the
    institution where the dosing error occurred that
    must be reported because the incident was
  • unexpected
  • related to participation in the research and
  • placed subject at a greater risk of physical harm
    than was previously known or recognized.

33
Data Safety and Monitoring Plans
  • This is more than adverse event reporting
  • Timing and collection of safety data
  • Monitoring of the safety data
  • Who does the monitoring?
  • Risks include more than physical risks
  • Psychological, social, economic and legal

34
Case History (Research Records)
  • Case report forms
  • Supporting data
  • Medical records
  • Progress notes
  • Signed and dated consent form
  • Documentation that consent was obtained prior to
    subject participation

35
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36
Post AAHRPP Site Visit
  • Take a Break from AAHRPP Activities
  • 30 days Before Draft Report Arrives
  • Review Notes from Site-visit
  • Meet with Team and Discuss strategies
  • Begin Communicating with AAHRPP

37
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38
Receipt of Draft Report
  • Review Carefully Report
  • Compare to Site Visit Notes
  • Compare to Your Draft Response
  • Electronically Communicate with AAHRPP
  • Element number in message line
  • One element per message
  • Include observation from draft report
  • Anticipate Several Communications per Element

39
Communication Key
  • Institutional Official Regarding Response and
    Timeline
  • Distribute Policies and Procedures to PIs and
    research team
  • Discuss with IRB Institutions Response,
    Implications, and Timeline

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