Office of Research Integrity and Compliance Institutional Review Board Basics

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Office of Research Integrity and Compliance
Institutional Review Board Basics

• August 24, 2009

Annie Muñana, Director ORIC Ellen Brooks, PhD,
IRB Chair April Baker, IRB Manager Tricia
Hermanek, Research Compliance Coord. Patty
Zavalza, Research Compliance Coord. Andrea Slay,
Sr. Admin. Asst.
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IRB Staff and Vice-Chairs

• IRB Staff Updates
• Patty- All initial submissions (Full Board,
  Expedited Exempt)
• Tricia- All amendment submissions (Full Board
  Expedited)
• Andrea- All continuing review submissions (Full
  Board Expedited)
• Vice Chairs
• Denise Rizzo, PharmD, MBA- Continuing Reviews
• Elizabeth Powell, MD

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Outline

• IRB STATS FY2006-2009 (Full Board Expedited)
• PI and Research Staff Responsibilities
• Types of Submissions -Requirements for each
• Informed Consents and Waivers
• IRB Personnel Form
• Types of Review

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Outline (cont)

• IRB Process -How a submission becomes a study
• Types of Approval for Full Board Studies
• Unanticipated Problems/Adverse Events
• Emergency Use Requests
• IRB Updates Coming Attractions!

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IRB SubmissionsFull Board and Expedited
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IRB Submissions from FY2006-FY2009
FY 2009
FY 2008
FY 2007
FY 2006
Total Submissions 8,851
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Principal Investigator Responsibilities

• Compliance with the following
• CMH IRB Policies and Procedures, which are
  consistent with the Code of Federal Regulations
  (CFR) and Good Clinical Practice Standards
• Obtain IRB Approval and meet CMH IRB requirements
  human subjects education for all key personnel
• Comply with HIPAA Requirements if PHI is accessed
  as part of the research
• Design and Implement Ethical Research Studies

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More Specifically..it means

• Implement Research as Approved and Obtain Prior
  Approval for Modifications
• Obtain Informed Consent/Assent/Authorizations
• Document Informed Consent/Assent/Authorizations
• Track study expirations and submit Continuing
  Review progress reports in a timely manner
• Report Unanticipated Problems
• Retain Records and Document Activities
• Inform IRB if leaving CMH, and make necessary
  changes to active studies (transfer PI,
  inactivate, etc)

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Types of Submissions

• Initial Review New Studies
• Continuing Review
• Amendments - Revisions
• Unanticipated Problems
• Study Inactivation
• Emergency Use Requests

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Submission Reminders

• The deadline is not the due date
• Always start by using our website
• Please submit one hard copy and one electronic
  copy for every submission, except for
  unanticipated problems
• Submit electronic copies to IRB mailbox
  irb_at_childrensmemorial.org
• Subject line and document titles should be
  relevant to the submission
• Please add the IRB, see website
• Education list of certifications provided on our
  website
• Incomplete Submissions will be returned

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Types of Initial Submissions

• Exempt
• Expedited
• Minimal Risk
• Full Committee Review
• Minimal Risk
• Greater than Minimal Risk

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IRB Process
PI/CRA
PI/CRA
PI/CRA Electronic Approvals
Submission Documents Filed
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Exempt Submissions

• Exempt Application - website
• Research Plan must be incorporated in the
  application
• IRB Personnel Form and education requirements
  apply
• OSP form is not required
• IRB Assigned
• Review Process
• Administrative Review by IRB staff
• Chair review
• Exempt determination letter
• Continuing review is not required
• Any changes need to be submitted to the IRB for
  review to ensure compliance of Exempt status

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New Studies Submission ProcessExpedited and Full
Board

• Website for requirements, use the checklists and
  current forms, IRB mailbox instructions, FAQs,
  etc
• IRB Assigned
• Complete submission requirements
• One electronic copy and one hard copy is required
• All submissions must be complete in order for the
  submission to be processed. PI is notified of any
  deficiencies.

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New Studies (cont)

• Administrative Review PI notified of
  deficiencies
• EXPEDITED All submissions must be
  administratively cleared prior to the IRB Chairs
  review
• FULL BOARD If administrative contingencies are
  not resolved prior to the meeting, they will be
  included in the meeting review.
• Chair/Board Review
• EXPEDITED Chair or designee will contact the PI
  with any review issues
• FULL BOARD Meeting reviews are sent to the PI
  within 7 business days
• Upon IRB approval, documents will be generated
  within seven to ten business days

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IRB Education/Personnel Form

• Use the current template website
• Requires the listing of all research personnel
  who have a significant role in the study,
  including those listed on the OSP form
• All listed personnel must be current in human
  subjects education
• Requirement for certification on IRB website
• Names of certified staff are posted on IRB
  website
• Will be required with every new study and
  continuing review submission

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Informed Consent Documents 3 New Templates

• Parent
• Adolescent Assent
• Adult/Individual

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Informed Consent

• Use the templates and guidelines located on the
  IRB website
• Important Reminders
• Follow the flow of the consent and order of
  sections
• Signature section in each form is different
  complete all blanks PI signature has been added
  
• Version date in footer do not use auto-date
• Use simplified language especially in the assent
• Include the location of where the research takes
  place

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Informed Consent (cont)

• Only use IRB-stamped consents when consenting
• Review IRB policy regarding translated consents
  for non-English speaking families
• Proxy consent
• Wards of the state
• HIPAA language is now dependent on type of study
  and has been removed from the assent
• Current consents must be updated at the time of
  continuing review or at the time of an amendment

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HHS Requirements for Waiving Informed Consent

• IRB must approve and document findings
• When Permitted
• Research is no more than minimal risk
• The rights and welfare of subject are not
  adversely affected
• Research could not be practicably conducted
  without the waiver
• Subjects provided with pertinent information
  after participation

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HIPAA Waiver

• Preparatory research (screening of patients, not
  requiring a consent form)
• Submit an Excel datasheet containing a list of
  patients studied and what information was
  accessed to the Medical Records Department
  (Information Management)
• Retrospective chart reviews - include the dates
  of the charts you will be reviewing
• Use HIPAA Waiver form - website
• Plan for protecting any identifiers from improper
  use and disclosure, and for destroying
  identifiers at earliest opportunity (unless
  retention is required by law and/or IRB)
• Describe what protected health information is
  needed and why it is needed

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Types of IRB Approvals

• Expedited Review
• Approved without contingencies
• Approved with minor directed contingencies
• Full Board Review
• Approved without contingencies
• Approved with contingencies
• Minor or Major
• Tabled Disapproved/Rejected

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Approved with Minor Directed Contingencies

• Requires clarification/revision of an aspect of
  the study or revision to one or several documents
• Example of minor directed editorial changes,
  directed consent form changes
• Usually reviewed by Chair (expedited)
• Response to contingency deadline is 4 months,
  otherwise full resubmission is required.

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Approved with Major Contingencies (FB)

• Example of a major contingency clarify,
  justify subjective, non-directed
  contingencies
• The IRB will make the determination whether or
  not the Major Contingency review can be eligible
  for the conference call.
• PI has the option to submit response for major
  contingency conference call
• Response must be complete and submitted by the
  deadline Chair and staff determine if response
  is eligible for call
• Conference calls occur outside of regular
  meetings
• Response to contingency deadline is 4 months,
  otherwise full resubmission is required.

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Tabled Disapproved/Rejected (FB)

• Usually major issues with the protocol design,
  ethics, and/or consent documents
• Requires resubmission of the entire proposal with
  a point by point response to each question
• No resubmission deadline follow meeting
  deadline schedule
• Disapproved/Rejected may be appealed

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Amendments and Revisions

• Approval before implementation (unless to
  eliminate immediate safety issue)
• Evaluate impact of change risk/benefit assessment
• Personnel changes (add or delete)require an
  amendment
• IRB Process
• Submit with a cover letter summarizing the
  changes and tracked and clean versions of revised
  documents
• One electronic copy and one hard copy
• Minor expedited Major full board
• NEW!! Amendment submission form

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Continuing Reviews

• All ongoing studies (Exp. and FB) must undergo
  continuing review no less than once a year
• PI responsible for monitoring the approval
  periods and timely submission
• As a courtesy, IRB sends out progress report
  notices approx. 2-3 months prior to the studies
  expiration date
• Use the CR form on the website
• FDA if PI holds the IND/IDE, submit required
  information including IND , date of issuance and
  a copy of the most recent annual report to FDA
• NOTE Do not submit amendments as part of the
  continuing review submission.

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Protocol Inactivations

• Studies may only be closed once all research
  activities have been completed including data
  analysis
• If the study is part of a large multi-center
  trial, the study may be inactivated at our site
  once all enrolled subjects have completed the
  study and data is no longer being submitted to
  the sponsor
• Inactivation submissions should be timely, do not
  wait for CR
• Final report is required
• See FAQs
• NEW!!! Inactivation Submission Form

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Unanticipated Problems/Adverse Events

• Policy, forms and flow sheets on the website
• Reporting Forms
• Use the correct form internal, external, etc.
• Answer all questions as required instructions
  and definitions are included on the form
• If not reportable do not report!! Only events
  that meet the definitions should be reported to
  the IRB. All other types of events are to be
  maintained in the PIs research files.
• Unanticipated Problems/Violations Researcher
  must provide interpretation of events and
  description of precautions taken to prevent
  reoccurrence

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Emergency Use Requests

• Patient requires emergent treatment with an
  unapproved drug or device in the event of life
  threatening situation
• No approved standard therapy exists
• No approved IRB Protocol
• No time for IRB review
• HHS Regulations do not prevent MD from
  administering treatment in an emergent situation
  Do not consider it prospective research
• FDA Has procedures report to FDA and IRB within
  5 days, allows informed consent waiver
• www.fda.gov/oc/ohrt/irbs/drugsbiologics.htmlemerg
  ency
• Intended to be used only once

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IRB Coming Attractions

• IRB Application Form - Debut
• Pilot testing
• Amendment Form
• Termination Form

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Questions and Answers