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Overview of Accreditation Changes

Overview of Accreditation Changes. Sara Brand Associate Director Research Compliance Administration. Objectives. Communicate recent changes in policies and procedures from recent AAHRPP re-accreditation Detailed Self-Assessment Accreditation Site Visit in December 2007

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Overview of Accreditation Changes

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  1. Overview of Accreditation Changes Sara Brand Associate Director Research Compliance Administration

  2. Objectives • Communicate recent changes in policies and procedures from recent AAHRPP re-accreditation • Detailed Self-Assessment • Accreditation Site Visit in December 2007 • Report from Self-Assessment and Site Visit Necessitated Changes • Accreditation Council meets in March 2008 to decide outcome NOTE: This is not a detailed explanation of how the changes will be implemented New policies and procedures and forms posted on website March 2008

  3. Overall Changes • Standard Operating Procedures • Meeting Deadlines • Fridays @ 5:00pm • New Forms • Request Forms for Vulnerable Populations • Continuing Review Forms • Noncompliance Reporting Form • IND/IDE Checklists • Human Subjects Research Engagement • Examples and Requirements

  4. Summary Safeguard Statement • Section III: Performance Sites • III.B – List other facilities where research-related procedures will be performed (pharmacy, nursing, pathology, etc.) and ensure these entities are adequately informed • Section IV: Subject Population • Questions specific to each subject population removed and included on new request forms • “Reasonable expectation of enrollment” • Section VIII: Protection Procedures • Clarification re: information the IRB wants to see if IUPUI is the lead site of a multi-site study • Section IX: Data Safety Monitoring Plan • Checkbox for repository/database protocols

  5. Summary Safeguard Statement cont'd • Section X: Confidentiality & Safeguards • Study Manager (data recording/collection method and measure for safeguarding information) • Section XIV: Informed Consent Process • Questions added re: who and how informed consent will be obtained (training, consent interview and consent document language) • Checkboxes for describing steps to minimize possible coercion or undue influence • Clarification re: waivers of informed consent and modifications to consent document • Financial Conflict of Interest section removed • Section XX: Investigational Drugs/Devices • Clarification re: when IND or IDE is required

  6. Vulnerable Populations

  7. Vulnerable Populations • New Request Forms • Prisoners, Children, Pregnant Women, Cognitively Impaired • VA Requirements • No research involving prisoners, pregnant women, or children unless waiver granted by the Chief R&D Officer • Additional questions/requirements re: surrogate consent for incompetent individuals and individuals with impaired decision-making capacity • Research Involving Children • Assent/Waiver of Assent: some, all, or no children • Parental Permission/Waiver of Parental Permission • Policy when a child reaches the legal age of consent

  8. IND/IDE Guidance • Guidance re: when IND or IDE is required • IND and IDE Checklists • Guidance when investigator is the holder of the IND or IDE (i.e. sponsor) • Formal face-to-face presentation • Eventual on-line presentation • Validation of IND or IDE Number • Sponsor protocol; or • Communication from FDA

  9. Unanticipated Problems • Regulations • Unanticipated Problems (45 CFR 46.103(b)(5) & 21 CFR 56.106(b)) • Adverse Events (21 CFR 312.32 & 21 CFR 812.3) • Guidance • OHRP (Jan 15 2007) • FDA (Apr 2007) – Draft For more info… OHRP Guidance: http://www.hhs.gov/ohrp/policy/AdvEvntGuid.pdf FDA Guidance: http://www.fda.gov/cber/gdlns/advreport.pdf

  10. Unanticipated Problems (UP) cont'd • IUPUI/Clarian Policy for Prompt Reporting of UPs • Adverse Events: Unexpected, related, greater risk of harm, revision to protocol/IC • Other UPs: Major Protocol Deviations, Suspensions or Holds • Report on Prompt Reporting Form • Report within (5) business days (both internal and external) • If IRB determines internal event represents UP, report to federal agencies (OHRP, FDA) and other entities, as applicable

  11. Noncompliance • IUPUI/Clarian Policy on Prompt Reporting of Noncompliance • Report all noncompliance • Report on Noncompliance Reporting Form • Report with (5) business days • If IRB determines noncompliance to be serious or continuing, report to federal agencies (OHRP, FDA) and other entities, as applicable

  12. VA-Specific Requirements • Continuing Review • Study not reviewed by expiration date….automatically suspended • List of subjects given to IRB and COS at VA to determine if research can continue on current subjects • Determine Level of Risk • Based on level of risk, IRB determines when patient medical records should be flagged re: participation in research • Minutes will reflect this decision • Enrollment of Non-Veterans • Justification • Regulations pertaining to veterans in research also pertain to non-veterans enrolled in VA research

  13. VA-Specific Requirements cont'd • Waiver of Consent for Planned Emergency Research is prohibited at the VA • Waiver of Authorization/Informed Consent for Recruitment • Office of Research Oversight (ORO) Guidance (10/09/2007) • Accessing patient records for recruitment into research requires the IRB to approve waivers of authorization and informed consent for recruitment (even when accessing own patients’ records

  14. Questions?

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