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Human Subjects Staff Retreat


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									Human Subjects Forms &
  Procedures Update

         AAHRPP Accreditation Overview

 The Association for the Accreditation of Human
  Research Protection Programs (AAHRPP) offers
  accreditation to research organizations that provide
  comprehensive protections to research participants.
 Process
    Voluntary, Peer-driven, and educational
    Renews every three years
    Application process to address AAHRPP requirements
    Site-visit
       Changes to Forms and Procedures

 Why are changes being made?
   Comply with AAHRPP accreditation standards and requests

   Consolidation of the Indianapolis and Bloomington Human
    Subjects Office
   To un-complicate forms

   Revisions/updates haven’t been done since May 2009
                         Major Changes

 Merger of the HRPP
    IUPUI and IUB merged
    IUPUI/Clarian changed to IU on forms
    PI’s can use any IRB, no longer campus specific
 New office name: IU Human Subjects Office
    Research Compliance Administration changed to Human Subjects
    IU Human Subjects Office – Biomedical (Indy)
    IU Human Subjects Office – Behavioral (IUB)
 All forms and SOPs updated
    See Summary of Changes for abbreviated list on HSO website:
           New Human Subjects Website

 Vision
    Single HRPP website
 Updates
    Instruction Packet no longer exists
    See website pages and guidance documents for information
 Timeline
    “Live” on January 15th with new forms and new SOPs
 New Links
    Human Subjects Home:
    Human Subjects Forms: /hs_forms.html
                      Dates to Know

 January 15th
   New forms are available for use on the Human Subjects
 March 15th
   New forms are required for applicable submissions
     New Studies
     Continuing Reviews – Open to Enrollment
     Amendments, as applicable
             Summary Safeguard Statement

 Important changes:
    Section I –
        Clarified instruction on the form; reminder: lay language
    Section II – HIPAA
      Covered Entity Checklist is not automatically required
      Refer to HIPAA form
    Section III – Performance Site
      Reworked to include IUB, IUPUI, etc.
      Read the section for familiarity with changes
    Section IV – Subject Population
      Subjects Outside of US - Transnational Research – will be prompted
       to complete separate request form
         New SOP coming soon
      Clarified Number of Subjects to be involved in the research
             Summary Safeguard Statement

 Important changes continued:
   Section V – Recruitment
        If subject to HIPAA, go straight to the HIPAA & Recruitment Checklist
        Clarified what competing studies means and how to handle
           More guidance coming from Executive Committee
    Section VI – Study Procedures
        Describe frequency and duration
        Attach ancillary materials
    Section VII - Risk and Benefit sections now combined to Risk/Benefit
     Ratio Section
    Section VIII – Protection Procedures
        Is PI lead on Multi-Center Clinical Trial
           Doesn’t mean conducting at multiple locations locally
    Section IX – Data Safety Monitoring Plan
        No Changes
    Section X – Payment
        No Changes
              Summary Safeguard Statement

 Important changes continued:
   Confidentiality and Safeguards section (was Section X prior)
    has been removed from all forms
         Misleading, caused confusion and inconsistency; raised potential
          for noncompliance
     Section XI – Informed Consent Process
         Minor Updates – review form
     Section XVI and XVII – Additional Reviews
         Revised – review form
     Section XVIII – Federal Funding
       Condensed
       Ensure copies of proposal and sample consent are sent with
             Summary Safeguard Statement

 Important changes continued:
   Section XIV – Investigational Test Articles
       Added - If you think the device/drug does not require an
        IDE/IND, fill out the checklist to confirm, or submit the FDA
        confirmation of status
       Question whether IU-affiliated investigator holds the IND/IDE
       Complete risk assessment for NSR devices
       NSR devices are still investigational

     Section XV – Co-investigator section and COI section are
         Separate form now
                        Investigator List

 New form, required for ALL submissions
    Regardless of level of review (exempt, expedited, full Board)
    Not required for non-human subjects research or student projects
 This information removed from SSS
    SSS won’t be connected to co-investigator list or updates
 Includes COI section
    Additional question added to form (discussed during COI section)
 When submitting Co-investigator updates, include:
    Co-investigator update form
    Investigator list (updated with track changes)
            HIPAA & Recruitment Checklist

 New form
    Moved from SSS to new form
    Formerly the Recruitment Checklist and supplemented with other
     HIPAA information and considerations
    Intended to reduce redundancy: all HIPAA/recruitment information
     located on one form
        Section I – Recruitment Section
          Competing Studies section
           • More guidance coming from Executive Committee
      Section II – Same
      Section III – Authorization section
        Previously in SSS
        Waivers of authorization:
           • Recruitment vs. Participation
     HIPAA & Recruitment Checklist

 Template language for VA Waivers for Recruitment and Informed
  Consent available from VA R&D office
 When you will receive a signed Checklist back from HSO office:
   At initial review: if a waiver of authorization is approved by the
   With amendments: if ANY changes are made to the HIPAA &
    Recruitment Checklist
   With CR: no.

 Authorizations for recruitment:
   Only one authorization form is necessary

   Subject should sign prior to recruitment

   Additional signature at time of consent not necessary
                  Child Request Form

 New process for requesting waivers of assent
   Based on capability

   Waivers not required for children incapable of assent

   Also see SOP on Vulnerable Populations
Waiver of Assent for Children

              Informed Consent Statement

 New Informed Consent template includes new stamp
    Will start to see new stamp on word version of forms
 New IU IRB Guidance on Informed Consent Statement
    Templates are now embedded in the guidance form
    Found on HSO website: /hs_forms.html
    Template includes required language and optional sections as
    SOP separates what is required on consent and what is not
        Example: Compensation for Injury section
    Study number included on consent is helpful for reviewers
                Authorization Form(s)

 Healthy Subjects
   Use when medical charts will not be accessed; will only be
    collecting research data directly from subject

 Non-Healthy Subjects
   Use when collecting information from some or all of subject’s
    health records
 VA
   Specific VA Template
           Transnational Research Form

 For use when enrolling subjects outside of the US.
 Requires information on
   Local IRB review where the research will be conducted

   Local context (social, economic, political, etc.) that may impact
   Communication between PI and local investigators,
    community leaders, etc.
                       Other Updates

 Exempt Studies
   Documentation of Review and Approval now required with
 Amendment form
   Now required for exempt, expedited, and full Board
 Noncompliance, Prompt Reporting, and Misc.
  General Information form
     Signed upon approval of the item
 Continuing Review form
   Category 9
                    Minutes Template

 New format for IRB Board minutes
 Updated to reflect new assent process
 Minimal risk vs. greater than minimal risk
    For ALL full Board new studies
    For all full Board CRs
                      SOP Updates

 Overarching changes
   Added SOP Intro

   Added new sections to each SOP
     VA
     FDA
     HIPAA
     And other including DOD, DOJ and DOE, BOP
                SOPs with Minor Changes

 Introduction to SOPs
   New Section: Mission Statement, Charter, Scope

 IRB Operations
     Continuing Review expiration date
       The study expires at 11:59pm on the IRB approved expiration date
       EXAMPLE: If the study was approved on July 20, 2010, the
        investigator can conduct study activities through 11:59pm on July
        19, 2011
       Approval stamp: continuing review date is now expiration date

 Confidentiality and Privacy
     HIPAA is reorganized to be independent section
              SOPs with Minor Changes

 Definitions
   Changes and Additions made, review for updates.
 Exempt and Expedited New Study Process
   Added IRB staff can grant exemptions
   Amendment form is required for all exempt changes now
 Investigator Responsibilities – New SOP
   Combined PI, Research Personnel, Investigator Qualifications SOPs
   NOW Applies to all investigators (Co and Principle)
   Updates: CITI, DOD, DOJ
 Planned Emergency Research
   Separated from Research with Investigational Test Articles SOP
   No changes to communicate
 Emergency Use of Investigational Test Articles
   VA – can’t do emergency research at the VA, can receive the
    intervention as a patient but not as a research subject
 Auditing SOP updated to more accurately reflect the
 current process
    Now includes language regarding more than one auditor
    Updated to IU language from IUPUI/Clarian and other new SOP
     format changes
 SOP Covers Three Major Areas Regarding Auditing
    How PIs/studies are chosen for audit
        Directed and Scheduled
          Changed to require approval from Shelley for Scheduled Audit List
           instead of the Executive Committee
    Describes the general audit process from notification, to site visit, to
     audit report, response to findings, and then IRB Review
        Changed the requirement that noncompliance noted during an audit
         must be reported by the PI
    Responsibilities related to external audits
    Genetic Information Nondiscrimination Act

 New SOP
 Guidance for studies involving testing or tracking of a
  particular disease or disorder in an individual’s family
       Includes what needs to be on consent document and
        considerations to be made by Board for approval (what protections
        need to be in place when using genetic information)
   Consent language (applies to VA as well):
        This research follows the Genetic Information Nondiscrimination
        Act (GINA), a federal law which generally makes it illegal for
        health insurance companies, group health plans, and most
        employers to request the genetic information we get from this
        research and discriminate against you based on your genetic
Genome-Wide Association Study (GWAS)

 New SOP
 Provides guidance on studies that intend to identify
  common genetic factors that influence health and disease
 New form
       What it is, when to use it, when to submit
         These studies will be identified as GWAS studies – our office
          fills in before issuing approval
         Prospective asking to submit to GWAS or Retrospective we’ve
          already collected and now we want to submit to study
          • Specific determinations the IRB must make associated with this now
          • On form – text boxes: IRB Certification and Institutional
          • Say appropriate use and explicit use of specimens
        Humanitarian Use Devices (HUD )

 New, separate SSS for HDE (HDE SSS)
 FDA guidance included
 Need to include product information and FDA letter of
  approval with submission
 Two directions
     Clinical purposes only
       Submit HUD Application
       Clinical Consent only (no separate research consent)
       Can go Expedited on continuing review, but not initial review
     Clinical + investigation
       If data is to be collected, study needs “regular” IRB documents
         (SSS, research consent, etc.)
                      Informed Consent

   SOP Reorganized
   Additional VA guidance (not new, additions have been
     Guidance on when you can access student records; IRB review is only
      concerned when using student records for research
     If researcher has legitimate access to student records, consent not
        Academic researchers do have legitimate access
        If intent is for IU purposes to improve, report, etc. it is consistent
         with FERPA
        School official definition
     IRB can make determination regarding whether the researcher has
      legitimate access
            Informed Consent – Short Form

 Document that provides basic elements of informed
  consent: non study-specific information, includes info
  that is relevant to all research
     Languages available at IU : English, Arabic, Chinese, French,
      Russian, Spanish, Vietnamese
 When they can be used:
   Study participant or LAR does not speak English
   Speak only a language not anticipated for study population
   Appropriate consent form in their language has not been
    approved by the IRB
   There is not enough time or demand for IRB to approve a
    consent in their language
         Informed Consent – Short Form

 How they are used
   Short Form consent document should be translated in a
    language understandable and given to subject with study
    summary document (e.g. English consent document)
   Signatures
     Has to be a witness
     Subject signs the short form
     Witness signs short form and copy of study summary English version
      (e.g. English consent)
     Study team member signs English version

 IRB Approval Requirements
     Report use of short form at time of continuing review
     Board will determine trends and whether a translated consent form is
             Transnational Research

 New SOP
 Provides procedures on conducting research outside
  of the US and enrolling populations outside of the
 Guidance document and Transnational Research
  form are also available
                 Vulnerable Populations

   If study population includes a vulnerable population, but
    members of the vulnerable population cannot be explicitly
    identified, then the Request form does not need to be
   Research with Children (review)
     Request for waiver of assent is not necessary if the population of
      children is not capable of assent
     PI provides justification as to why requested population of children
      are not capable of assent
     Any questions, please contact our office.
   Research with Prisoners
     When using prisoners as a study population, the research has to meet
      one of the four categories of prisoner research
     Expedited review of research involving prisoners is allowed
Conflict of Interest and IRB:
 Principles and Processes

                 Table of Contents

 Individual Conflict of Interest
   Principles/Mission

   Process: Flow Chart

 Institutional Conflict of Interest
                   Principles /Mission

 CoI: Objectivity in Research
    PHS: CFR 42 Part 50 Subpart F. Responsibility of Applicants
     for Promoting Objectivity in Research for which PHS Funding
     is sought.

    FDA: CFR 21 Part 54. Financial Disclosure by Clinical
                  Principles /Mission

 IRB: Protection of Human Research
    PHS: CFR 45 Part 46. Protection of Human Subjects

    FDA: CFR 21 Part 50. Protection of Human Subjects.
Point of Intersection:

 Protecting human
subjects when there
   is a conflict of
                     AAHRPP Standards

 Standard I-6. Organization has and follows written
 policies/procedures to ensure that research is
 conducted so that financial CoIs are identified,
 managed and minimized or eliminated
    I.6.A. … to identify, manage, and minimize or eliminate
     financial CoIs of the Organization that could influence the
     conduct of the research or integrity of HRPP
    I.6.B. … to identify, manage, and minimize or eliminate
     financial CoIs of researchers and research staff that could
     influence the conduct of the research or integrity of HRPP.
        Organization works with IRB
Process: Flow Chart
                   Process: Flow Chart

 Disclosures
   Annual Disclosure

     All faculty and other researchers
     Disclosure   based on IU policy
         Based on PHS/NSF standards
     Updatesas appropriate
     ORA routing sheet ask for disclosure of any potential
       All Key Personnel
       As per specific project
                    Process: Flow Chart

 IRB CoI Disclosure
   All Researchers conducting human subjects research must
    complete IRB protocol with questions regarding CoI.
   Disclosure
     Based on FDA standards
     For all Key Personnel
     Asks for interests related to a specific project
              Process: Flow Chart

 CoI Management
   CoI Committee reviews:
     To determine if financial interest constitutes CoI
       If no, process stops

       If yes, next step

     If management plan is necessary
       If no, process stops

       If yes, management plan developed and shared with IRB
                  Process: Flow Chart

 IRB reviews management plan
   Accepts as sufficient to protect human subjects

   Adds additional restrictions to protect human subjects
               Process: Flow Chart

 Common elements of management plan
   Public disclosure of financial interests

   Monitoring of research by independent reviewers

   Modification of research plan

   Disqualification from participating in all or portion of research

   Severance of relationship that create conflict
     Institutional Conflict of Interest

 Definition: Conflicts of interest based on either the
  financial interests of the institution itself or of its
  officials acting in leadership or supervisory positions,
  are of special concern in the conduct of human
  subjects research (AAMC).
 Specifically relevant to:
    Intellectual Property (IP) and Institutional Investments
    Gifts
    Financial interests of Senior Administrative Officials
     Institutional Conflict of Interest

 Intellectual Property (IP) and Institutional
    All IU IP and investments of IURTC held by and managed by
    IURTC
      Committed in principle and practice to respecting and maintaining
       autonomy of IU’s research integrity and operations, in general,
       and to its human research protection program and processes, in
      Passed resolution committing itself to non-interference with IU’s
       program and processes for protecting human subjects in research.
    Institutional Conflict of Interest

 Major Gifts and investments
   All major gifts to IU and investments of IUF are held by and
    managed by the IUF
   IUF
     Committed in principle and practice to respecting and maintaining
      autonomy of IU’s research integrity and operations, in general,
      and to its human research protection program and processes, in
     Passed resolution committing itself to non-interference with IU’s
      program and processes for protecting human subjects in research.
    Institutional Conflict of Interest

 Financial interests of Senior Administrative Officials
   Such officials must comply with:
      IU Financial Conflict of Interest Policy
     Indiana State Law on Conflict of Interest (35-44-1-3)
         Institutional Conflict of Interest

 Disclosure of I-CoI
   Investigators identify, to the best of their knowledge, if a
    proposed project involves IU IP or IU gifts
   IURTC and IUF provide relevant information as requested by
    IRB and CoI Committee
          Institutional Conflict of Interest

 Review of I-CoI
   IRB staff and IRB evaluate and review institutional significant
    financial interests related to conduct of human subjects
    research as they do individual significant financial interests.
Biomedical Human Subjects Office
    Office of Research Administration
    Indiana University

Behavioral/Social Sciences Human Subjects Office
    Office of Research Administration
    Indiana University

Research Ethics, Education, & Policy Office
    Office of Research Administration
    Indiana University

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