Va hrpp accreditation
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VA HRPP Accreditation. October 18, 2011 Accreditation Conference Call PRIDE/Soundia Duche, MA, MS. Conference Call Agenda. Introduction & Call Agenda Accreditation Update Director’s Topic: Accreditation Pending Frequently Cited Elements (FCEs) Local Site Spotlight Future Topics.

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VA HRPP Accreditation

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Va hrpp accreditation

VA HRPP Accreditation

October 18, 2011

Accreditation Conference Call

PRIDE/Soundia Duche, MA, MS


Conference call agenda

Conference Call Agenda

  • Introduction & Call Agenda

  • Accreditation Update

  • Director’s Topic: Accreditation Pending

  • Frequently Cited Elements (FCEs)

  • Local Site Spotlight

  • Future Topics


Question alerts

Question Alerts

Submit anytime

Input


Va hrpp accreditation

Accreditation Update


Accreditation update year to date figures

Accreditation Update: Year-to-Date Figures

  • 94 VA sites currently have Full Accreditation

  • 9 VA sites currently in Accreditation Pending*

  • 3 VA sites are in initial Accreditation process

  • 2 VA sites will submit initial application in 2012

  • 29 Step 1 AAHRPP applications submitted

* One site awaiting reaccreditation of affiliate


Accreditation update year to date figures1

Accreditation Update: Year-to-Date Figures

  • 32 accreditation site visits conducted

  • 21 sites received Full Accreditation/Reaccreditation on initial Council review

    • 5 of which had no observations/comments that warranted a response post-site visit

  • 7 sites required submission of an improvement plan

  • 14 sites lost Full Accreditation during the year


Va hrpp accreditation

Accreditation

Pending


Accreditation pending

Accreditation Pending

  • Nine sites currently in reaccreditation pending*

  • VHA Handbook 1200.05 requires that sites maintain Full Accreditation

  • Change in accreditation status is a reportable event to ORO Central Office within 5 working days

    (VHA Handbooks 1200.05 Section 64d. and 1058.01 Section 7k.)

* One site awaiting affiliate reaccreditation


Accreditation pending common reasons

Accreditation Pending: Common Reasons

  • Failure to include plans for monitoring the effect of proposed changes to policies and procedures when submitting response to the draft site visit report

  • Failure to completely address issues/tasks and provide evidence of completion to AAHRPP when submitting response to the draft site visit report

  • Failure to submit status report by deadline


Va hrpp accreditation

Questions

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Va hrpp accreditation

Frequently Cited Elements


Frequently cited element i 5 b

Frequently Cited Element: I.5.B

The organization conducts audits or surveys or uses other methods to assess the quality, efficiency and effectiveness of the Human Research Protection Program (HRPP). The organization identifies strengths and weaknesses of the HRPP and makes improvements, when necessary, to increase the quality, efficiency, and effectiveness of the program.


Element i 5 b expectations

Element I.5.B: Expectations

  • Existence of a quality improvement plan

  • At least one objective and at least one measure is defined

  • Frequency and responsible party for assessment specified

  • Results used to implement improvements to the HRPP


Element i 5 b common materials that may be used to meet the element

Element I.5.B: Common materials that may be used to meet the element

Review of metrics such as:

  • Turnaround time for expedited and convened IRB review

  • # of lapsed projects

  • # of resolved complaints from investigators/participants

  • # of reportable events to ORO/external agencies

  • # of deviations; SAEs; unanticipated problems involving risks to others

  • # of correct category determinations for exempt/expedited reviews

    Audits; surveys; or other data collection tools

  • Periodic audit of minutes; protocols files; RCO audits

  • Budgetary/resource review

  • Customer satisfaction surveys

    Evaluation reports

  • IRB member and Chair evaluation reports


Element i 5 b frequently cited issues

Element I.5.B: Frequently Cited Issues*

  • RCO annual audits of informed consent form and triennial regulatory audits of research projects are not sufficient to successfully meet the requirements of this element

  • No systematic/formal process to periodically measure quality, efficiency, and effectiveness of the HRPP

  • Plan does not include at least one goal and at least one measure of quality, efficiency, and effectiveness

* Derived from “Areas of Concern” cited in 2011 VA Draft Site Visit Reports


Element i 5 b frequently cited issues cont

Element I.5.B: Frequently Cited Issues (cont…)*

  • No process described to make improvements when necessary

  • Audit findings not evaluated by the HRPP and not used to make improvements when necessary

  • Quality improvement plan still in draft form/not yet implemented

* Derived from “Areas of Concern” cited in 2011 VA Draft Site Visit Reports


Va hrpp accreditation

Questions???

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Frequently cited element ii 1 b

Frequently Cited Element: II.1.B

II.1.B – The IRB or EC has qualified leadership (e.g., chair and vice chair) and qualified members and staff. Membership and composition of the IRB or EC are periodically reviewed and adjusted as appropriate.


Element ii 1 b expectations

Element II.1.B: Expectations

Policies and procedures include the following:

  • Requirements to be an IRB Chair; Member; Staff; and Alternate Member

  • Who is responsible for appointing Chair and members

  • Appointment tenure for Chair and members

  • Function of alternates should be specified

  • Function of any non-voting members assigned to the IRB should be specified


Element ii 1 b expectations continued

Element II.1.B: Expectations (continued…)

Policies and procedures include the following:

  • Training requirements

  • How each member is periodically evaluated;

  • Who is responsible for suspending/terminating IRB membership


Element ii 1 b common materials that may be used to meet the element

Element II.1.B: Common materials that may be used to meet the element

  • SOPs

  • Appointment Letters

  • Training Records

  • IRB Member, Chair, and Staff Evaluation Instrument

    • See AAHRPP Tip Sheet 7 for examples of content for evaluation of each category of individual (http://www.aahrpp.org/Documents/D000264.PDF)


Element ii 1 b frequently cited issues

Element II.1.B: Frequently Cited Issues*

  • Evaluation of IRB Chair and members did not occur

  • Evaluation of IRB Chair and members occurred, however no individual feedback provided

  • IRB members not aware that they had been evaluated

  • IRB members not knowledgeable of some of the regulatory approval criteria

  • No one evaluated the membership and composition of the IRB to ensure that it continues to meet regulatory and organizational requirements

* Derived from “Areas of Concern” cited in 2011 VA Draft Site Visit Reports


Va hrpp accreditation

Questions???

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Va hrpp accreditation

Local Site Spotlight:

Informed Consent Education

Overton Brooks VAMC

Shreveport, LA


Target audience

Target Audience

  • Investigator initiated studies

  • Studies without monitors

  • Studies with known compliance issues

    WHY???

    Because lack of knowledge & inexperience can lead to Non-Compliance


Educational process

Educational Process

  • R&D Committee & IRB approvals received

  • Meeting scheduled with PI & Staff

  • Pre-Study Monitoring Questionnaire reviews:

    • Protocol knowledge & recruitment process

    • Inclusion/exclusion criteria

    • Definitions & processes for modifications, SAEs/Unanticipated Problems

    • CPRS assistance provided for flagging, etc.


Observation of informed consent process

Observation of Informed Consent Process

  • After education PI notifies RCO when first subject to be consented

  • RCO observes the consent process

  • RCO provides suggestions on how to improve process

  • Assistance provided in completing CPRS template


Common rco observations

Common RCO Observations

  • Ensure all aspects of the consent were covered

  • Information presented in a manner to ensure subject’s understanding

  • Questions were asked to ensure subject’s understanding

  • No undue influence used


Questions

Questions??

Contacts:

Lyndie Carter, RN, RCO

[email protected]

Dorothy Jarzabek, AO/Research

[email protected]


Va hrpp accreditation

Remaining Questions???

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Va hrpp accreditation

Future Topics


Future topics

Future Topics

  • Next call will be in December 2011

  • Focus area: Community outreach activities

  • E-mail [email protected] with suggestions for:

    • Future conference call topics

    • Exceptional forms/tools used at your site for the elements discussed today

    • Innovative practices used at your site that are related to community outreach activities


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