VA HRPP AccreditationOctober 18, 2011Accreditation Conference Call

PRIDE/Soundia Duche, MA, MS

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Conference Call Agenda1. Introduction & Call Agenda

2. Accreditation Update

3. Director’s Topic: Accreditation Pending

4. Frequently Cited Elements (FCEs)

5. Local Site Spotlight

6. Future Topics

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Question Alerts

Input Submit anytime

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Accreditation Update

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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

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• 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

Accreditation Update: Year-to-Date Figures

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Accreditation Pending

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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

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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

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Questions

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Frequently Cited Elements

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Frequently Cited Element: I.5.BThe 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.

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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

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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

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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

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• 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

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

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

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Questions???

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Frequently Cited Element: II.1.BII.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.

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Element II.1.B: ExpectationsPolicies 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

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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

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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)

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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

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Questions???

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Local Site Spotlight:Informed Consent Education

Overton Brooks VAMCShreveport, LA

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Target Audience• Investigator initiated studies

• Studies without monitors

• Studies with known compliance issues

WHY???Because lack of knowledge & inexperience can lead to

Non-Compliance

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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.

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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

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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

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Questions??Contacts:

Lyndie Carter, RN, RCOLyndie.Carter@va.gov

Dorothy Jarzabek, AO/ResearchDorothy.Jarzabek@va.gov

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Remaining Questions???

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Future Topics

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Future Topics• Next call will be in December 2011

• Focus area: Community outreach activities

• E-mail soundia.duche@va.gov 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