Institutional Review Board

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Institutional Review Board

• Nuts and Bolts of
• CGU IRB Procedures
• Hours 830AM-500PM
• Phone [phone]
• Email irb_at_cgu.edu
• Website http//www.cgu.edu/pages/1075.asp
• Location 135 E. 12th St. (next to Writing
  Center)Mail Address Office of Research and
  Sponsored Programs
• 150 E. 10th St., Claremont, CA 91711

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What is the IRB?

• IRB Institutional Review Board
• Tasked with assuring the policies of OHRP, DHHS,
  and the FDA
• According to the Office of Human Research
  Protection
• The purpose of IRB review is to assure, both in
  advance and by periodic review, that appropriate
  steps are taken to protect the rights and welfare
  of humans participating as subjects in the
  research. To accomplish this purpose, IRBs use a
  group process to review research protocols and
  related materials (e.g., informed consent
  documents and investigator brochures) to ensure
  protection of the rights and welfare of human
  subjects of research.

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The Purpose of IRB Review

• Assure compliance with federal regulations and
  university policies
• The IRB did not author those policies but is
  responsible to implement them
• Charged to assure that faculty and students meet
  specific ethical standards in all research that
  involves human participants
• All such research must conform to the Belmont
  Principles for protection of human participants

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IRB Process in a Nutshell

• Accepts written applications to review specific
  study designs (protocols) from CGU, HMC and KGI
  faculty or from students with faculty endorsement
  
• One or more IRB staff AND one or more IRB members
  reads each entire application package
• Research is designated by the risk level into
  exempt, expedited, or full board review

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IRB Process, continued

• Usually the IRB seeks written clarification or
  revision of one or more elements of the
  application
• After one or more written exchanges with the
  applicant, the IRB almost always approves the
  protocol
• The IRB reviews and approves around 200 new
  applications per year
• This does not include amendments and renewals

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Why do we need an IRB?

• Human subjects research was unregulated until the
  mid-20th century, triggered by highly troubling
  medical studies, including
• Medical experiments in Nazi prison camps
• Tuskegee syphilis experiment
• Human radiation exposure experiment
• Willowbrook hepatitis study
• Recognition of ethical issues led to push for
  acceptance of Nuremberg Code, Belmont Principles,
  and finally the Common Rule

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IRB DNA The Belmont Principles

• Beneficence
• Do no harm
• Maximize benefits minimize harm
• Justice
• Equitable distribution of burden and benefits
• Respect for persons
• Individual autonomy is respected
• Persons with diminished autonomy need extra
  protection (special populations)

• http//ohsr.od.nih.gov/guidelines/index.html

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Do You Need IRB Review?Determining the
Applicability of 45 CFR Part 46

• Consider the following questions
• Does the activity involve Research?
• Does the activity involve Human Participants?
• Is the activity eligible for Exemption?
• Human Subject Regulations Decision Charts
• http//www.hhs.gov/ohrp/policy/checklists/decision
  charts.htmlc2

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IRB Classifications

• Exempt. Studies to improve or evaluate standard
  practices in educational institutions fully
  anonymous non-sensitive surveys analysis of
  pre-existing anonymous data other specific
  exemptions
• Expedited. No more than minimal risk, no special
  populations such as pregnant women, prisoners,
  minors, mentally disabled
• Standard (Full Board Review). Higher than minimal
  risks or studies of special populations

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Writing the Application (1)

• The current IRB application forms (Regular,
  MTurk)
• http//www.cgu.edu/pages/1837.asp

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Writing the Application (2)

• Checklist for Initial Review
• IRB protocol completely filled out (MTurk or
  Regular?!)
• Signature of PI, Faculty Advisor, and Co-PI (if
  applicable)
• Two (2) copies of IRB application, unstapled
• Informed Consent form / Assent form (minors)
• Recruitment scripts, email, or flyers
• Copies of all Questionnaires or other Research
  Materials (if applicable)
• Protecting Human Subjects training certificate
• http//phrp.nihtraining.com/users/login.php
• Timeline
• Minimum 2-3 wks (Exempt Expedited)--seasonally
  longer
• Full Board Review may require additional time
  note the IRB calendar deadline for assuring
  review by the next monthly full board meeting

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Informed Consent

• Consent form vs. Assent form
• Consent subjects over 18 years of age
• Assent minors (under 18 years of age)
• Waiver of Signed Consent
• (1) When the only record linking the subject and
  the research would be the consent document and
  the principal risk would be potential harm
  resulting from a breach of confidentiality.
• (2) When the research presents no more than
  minimal risk of harm to subjects and involves no
  procedures for which written consent is normally
  required outside of the research context.

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Consent Components

• Study leadership (who is the PI? Who is the
  faculty advisor?)
• Sponsorship (if applicable)
• Purpose of the study
• Eligibility (inclusion and exclusion criteria)
• Participation (what will participants be asked to
  do, for how long?)
• Risks of participation
• Benefits of participation (remember helping you
  out with a study is NOT a benefit to
  participants)
• Compensation
• Voluntary participation
• Confidentiality
• Further information
• Consent statement (either signed or click-box)
• See Informed Consent Form with Embedded
  Instructions for in-depth instructions

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Pay Attention to.

• Consent Vs. Assent (samples on website)
• Deception (Temporary only!  Is it really
  necessary? Causes extra scrutiny)
• Confidentiality (keeping it secret) Vs. Anonymity
  (no names are taken or learned)
• Special populations
• Clarity and Organization
• Grammar and Spelling

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How to Respond to IRB Questions and Comments

• IRB Responses are sent via email to the PI and
  Faculty Advisor--responses can be sent via email
  to irb_at_cgu.edu or drop off hard copy
• Respond directly to each IRB point using
  different font, italics, or bold text to
  highlight your response
• Submit revised materials two ways with bold or
  other markers to show changes, and in a final
  (clean) version

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Aftermath Amendment Vs. Renewal Vs. Addendum

• When to use the Amendment form?
• For any changes to approved protocols, use the
  amendment form at http//www.cgu.edu/pages/1837.a
  sp
• When to use the Renewal and Closure form?
• To request continuation of approved research or
  if the Research has been completed, to close out
  the IRB process, use the form at
  http//www.cgu.edu/pages/1837.asp
• When to submit an Addendum?
• For unsolicited changes to a protocol that has
  not yet been approved, send a cover letter
  indicating what changes are proposed and include
  all documents that are being modified, with
  changes clearly marked

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Most Common Mistakes

• Using the wrong form
• Missing signatures
• Missing documents/materials
• On response, submitting entire IRB application
  instead of revisions only
• Not marking changes clearly
• Expecting a different, quicker review process for
  exempt protocols
• Need only CGU IRB approval for multiple
  institutions study
• Got IRB approval dont need permission letter
• IF YOU DID NOT GET IRB APPROVAL FOR A STUDY YOU
  ALREADY FINISHED, YOU MUST STILL SEEK RETROACTIVE
  APPROVAL PRIOR TO PUBLISHING OR PRESENTING AT
  ACADEMIC CONFERENCE!

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More Information

• Frequently Asked Questions
• http//www.cgu.edu/pages/1792.aspWhat_Is_Research
  
• http//www.hhs.gov/ohrp/policy/faq/index.html
• Contact the IRB for clarifications
• Email irb_at_cgu.edu Phone [phone]