IRB SUBMISSION PROCESS

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IRB SUBMISSION PROCESS

• Pamela Cedeno
• IRB Education Coordinator
• Office of Human Research Participant Protection
• 271-2045
• 11/17/2006

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IRB History

• Nuremberg Trials ? Nuremberg Code in 1945 ?
  Declaration of Helsinki in 1964
• 1966 - NIH required that all NIH-supported
  research be reviewed by a human subjects review
  panel
• 1970s NIH rules revised led to establishment
  of IRBs at 100s of institutions

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IRBs Mission

• Protect the rights, privacy and
• welfare of human research
• participants

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Federal Regulations

• Title 45 Public Welfare
• Part 46 Protection of Human Subjects
• Subpart A Basic HHS Policy for Protection of
  Human Research Subjects
• Subparts B, C D Additional protections for
  vulnerable populations

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Federal Regulations

• Title 21 Food, Drugs and Cosmetics
• Part 50 Protection of Human Subjects
• Part 54 Financial Disclosure by Investigators
• Part 56 Institutional Review Boards

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Meet the crew

• Meg Ribaudo Director
• Donna Hogan Assistant Director  
• June Pearson Business Analyst
• Janice Gales QI Coordinator
• Deidre Williamson Staff Assistant
• Mary Seyfried Staff Assistant

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• Board 1
• Traci Brannon IRB Coordinator
• Board 2
• Denette Roulinson IRB Coordinator
• Tracie Revis IRB Coordinator
• Board 3
• Blair Williams IRB Coordinator
• Treasure Tytenicz IRB Coordinator
• Board 4
• Michelle Morrow IRB Coordinator

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A Sail Around the IRB Website

• http//www.ouhsc.edu/irb/

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IRB Review 3 types

• Full Board
• Expedited
• Exempt

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OUHSCInstitutional Review Boards

• Board 1 - Medical/Behavioral
• First Monday
• Board 2 -Oncology/Medical/Surgical/Radiotherapy
• Second and Fourth Mondays
• Board 3 - Medical/Pediatric
• Third Monday
• Board 4 - Medical/Behavioral/Pediatrics
• Fourth or Last Monday

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Other committee involvement.

• Cancer Center Scientific Review Committee
• VA Research Development Committee
• General Clinical Research Center (GCRC)
• Radiation Safety Committee Review
• Biosafety Committee Review

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Research Determinations

• Research -
• a systematic investigation, including research
  development, testing and evaluation, designed to
  develop or contribute to generalizable knowledge.
  

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Human Research?

• Does the project involve interaction or
  intervention with human participants?
• Does the project involve access to identifiable
  private information?

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Research vs. Non Research

• Were the data/specimens obtained in a systematic
  manner?
• Is the intent of the data/specimen collection for
  the purpose of contributing to generalizable
  knowledge?

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Examples

• Case Studies
• Educational Surveys
• Quality Assurance Projects
• Pilot Testing - Survey

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Expedited Criteria

• Minimal risk to participants
• Identification of participants
• Retrospective or prospective data collection

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Expedited Review Categories

• Clinical studies of drugs and medical devices
  when an IND or IDE is not required
• Collection of blood samples
• Collection of biological specimens by noninvasive
  means
• Collection of data through noninvasive procedures
• Research that involves data, documents, records,
  or specimens collected for medical treatment
• Collection of data from voice, digital or image
  recordings
• Research on group characteristics or behavior

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Exempt Research

• Exempt from CFR Title 45, Part 46
• Exempt from full board review and continuing
  review
• Must submit to the IRB for Chair review and
  determination

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Exempt Criteria

• Minimal to no participant involvement
• Retrospective data collection
• Participants or data not identifiable

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Exempt Criteria

• Normal Educational Practices Settings
• Anonymous Educational Tests, Surveys, Interviews,
  or Observations
• Identifiable Subjects in Special Circumstances
• Collection of Existing Data
• Public Benefit or Service Programs
• Taste Food Evaluations

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• SUBMISSION PROCESS

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New Research Project What do I need to submit?

• IRB Application Form
• Protocol / Description of Study
• Informed Consent Document
• Appropriate HIPAA Form
• Investigational Brochure
• Advertisements / Questionnaires

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New Research Project ApplicationPoints to
Consider.

• PI Registration Sheet
• Who qualifies for PI/Co-PI
• Key Personnel
• Education Status

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Key Personnel

• Individuals who provide study-related services
  or assistance, who have knowledge of the study
  protocol AND
• the identity of study participants or their
  protected health information.

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Education Requirements

• Attendance of the IRB In-House Education Program
• Completion of the CITI web-based Course
• Submission of a signed dated written
  attestation
• Completion of CITI Refresher Course (required
  every two years)

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New Research Project What do I need to submit?

• IRB Application Form
• Protocol / Description of Study
• Informed Consent Form
• Appropriate HIPAA Form
• Investigational Brochure
• Advertisements / Questionnaires

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New Research Project What do I need to submit?

• IRB Application Form
• Protocol / Description of Study
• Informed Consent Form
• HIPAA Privacy Form
• Investigational Brochure
• Advertisements / Questionnaires

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HIPAA Privacy Forms

• HIPAA covers..
• All research activities involving the use of PHI
  that is collected by any employee of a covered
  entity (CE).

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HIPAA Privacy Forms

• 3 Main Categories
• Authorization Forms
• Waiver of Authorization Form
• Verification Forms

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New Research Project What do I need to submit?

• IRB Application Form
• Protocol / Description of Study
• Informed Consent Form
• HIPAA Privacy Form
• Investigational Brochure
• Advertisements / Questionnaires

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Once reviewed..

• Approval
• Contingent Approval
• Deferral
• Disapproval

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Remember, in order to begin

• Final Approval Letter
• Contract Holds

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OTHER SUBMISSIONS

• Continuing Review Application
• Amendments to a currently approved study

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Continuing Review

• Continuing Reviews are conducted at intervals
  appropriate to the degree of risk, but not less
  than once per year
• The frequency will be determined at the time of
  initial approval
• Make note of your approval expiration

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Submission of Amendments

• An amendment includes any proposed change to the
  previously-approved research project
• Protocol
• Informed Consent Form
• Patient Questionnaires
• Investigator Brochures

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Can simply be a change in..

• Number of participants to be enrolled
• Principal Investigator or Sub-Investigators
• Addition of an Advertisement

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An amendment requires that you submit

• Completed Protocol Modification Form
• PMF
• Protocol / Informed Consent with changes
  highlighted
• Other pertinent documents

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Avoid approval delays by

• Applications all investigators and key
  personnel indicated must have completed education
• Consistency between application, protocol
  consent document
• Answer all questions or indicate N/A
• Provide version dates for your protocol
  informed consent document
• Sign date all forms

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Assistance

• Is statistical support available for
• quantitative studies?
• For assistance contact Brianna Bright, M.A.,
• College of Public Health at 271-2342 or at
  brianna-bright_at_ouhsc.edu

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THE END