AAHRPP Accreditation by x4XnSBe0


									AAHRPP Accreditation

  Karen L. Smarr, PhD
  Human Research Compliance Officer
  Truman VA Hospital, Columbia, MO
                                Cincinnati, OH
                               March 19, 2007
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
Why accreditation???
• 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
What’s so different about AAHRPP?
•   NCQA                            •   AAHRPP
       Quantitative model                 Qualitative model
       Focused on policies and            Focuses on policies and
        procedures, and                     procedures, and
        documentation                       PRACTICES
       Involved primarily the             Involves entire Human
        research office, IRB, and           Research Protection
        research pharmacy                   Program (HRPP) –
                                            institutional officials,
                                            research office, IRB,
                                            investigators, sponsored
                                            programs, and subjects
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 (P&P) and
•   Anticipate delays and modification of P&P, and
    creation of new P&P
•   Focus on Final AAHRPP Accreditation
How to Understand What AAHRPP

• Organization            Human
• Research Review Unit    Research
• Investigator            Program

    A shared responsibility
AAHRPP Accreditation Standards

• Organization
• Research Review Unit   Obligations of
• Investigator

• Sponsored Research
                         Obligations to
• Participant Outreach
How does accreditation work?

 Application     Self Evaluation

 Site Visit      Expert site visitors
                 Tailored to setting

 Council on      Determines
 Accreditation   Accreditation category
•   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
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
Categories of Accreditation
•   Full AAHRPP accreditation
•   Qualified AAHRPP accreditation
•   Accreditation-pending
•   Accreditation withheld
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
Sample Interview Questions
General Tips

• Be honest

• If you don’t know something, say who you
  would go to for the answer

• This is not the place to pick or air battles
Investigator Oversight

• Roles and communication with co- or sub-

• Staff qualifications

• Delegation of authority

• Daily management
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
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
• Availability of medical or psychological
  resources that participants may require
Study Personnel Training

• Facility training requirements

• Training records

• Where do you go for information
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?
Study Design
• Sound study design
   Answers the research question
   Adequately powered
   Control groups

• Monitoring the rights and welfare of
   Safety checks (lab, xray, physical exam, etc.)
   Reporting mechanisms
   Data Safety and Monitoring Board (DSMB)
Conflict of Interest
• Articulate what is a conflict of interest
    Any interest of the investigator that competes with
     the investigator’s obligation to protect the rights
     and welfare of research participants

• Disclosure statements

• Evaluation by your institution
Risk Evaluation

• Risks of medical treatment vs. risks of

• How do you minimize risks?
    Avoiding unnecessary procedures
    Using procedures already being performed for
     diagnostic or treatment purposes
    Safety monitoring
Subject Recruitment
• Recruitment (privacy concerns)
• Enrollment (coercion and undue influence
• Inclusion/exclusion criteria determination
• Vulnerable subjects, e.g. prisoners
• Acceptable advertisements and incentives
Informed Consent
• Process vs. paper
   Persons providing consent
   Any waiting period
   Steps to ensure sufficient opportunity to consider
   Minimize possibility of coercion or undue influence
   Language used and understood
   Assessment of decision-making capacity and
    communication with a legally-authorized
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
Subject Questions and Complaints
• What is a complaint?
• Who else should you tell?
• Contact numbers for subjects:
     Research staff
     If research staff can’t be reached, call…
     Someone other than research staff
     Where to voice concerns/complaints
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
       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
Difference between AEs and
Unanticipated Problems
•   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 investigator’s 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.
•   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.
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
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
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
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
Communication Key

• Institutional Official Regarding Response and
• Distribute Policies and Procedures to PI’s and
  research team
• Discuss with IRB Institution’s Response,
  Implications, and Timeline

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