Claremont Graduate University Institutional Review Board

1
Claremont Graduate UniversityInstitutional
Review Board

• Nuts and Bolts of
• CGU IRB Procedures
• Dean R. Gerstein, PhD, Vice Provost for Research
• Krissyvan Khamvongsa, MA, Assistant Director of
  Research
• February 6, 2009

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The Purpose of IRB Review

• The IRBs sole purpose is to assure compliance
  with well-defined federal regulations and
  university policies. The IRB did not author
  those policies but is responsible to implement
  them
• Specifically, the IRB is 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

• The IRB accepts written applications to review
  specific study designs (protocols) from CGU
  faculty or from students with faculty endorsement
  
• The IRB encourages students to ask questions or
  discuss protocol issues with the IRB staff before
  submitting applications
• One or more IRB staff AND one or more IRB members
  reads each entire application package (about ¼
  of the time, the entire Board and staff read the
  applicationthis is Full Board Review)

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IRB Process, continued

• Usually, but not always, 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
  protocolabout 200 per year
• The total elapsed time from receipt of
  application to approval is a median of one month
  
• However, there is wide variation in the time
  frame, mostly depending on how long the applicant
  takes to respond to IRB questions and comments

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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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Determining the Applicability of 45 CFR Part 46

• Consider the following questions
• Does the activity involve Research?
• Research is a systematic investigation designed
  to develop or contribute to generalizable
  knowledge.
• Does the activity involve Human Participants?
• Human participants are living individuals,
  about whom an investigator obtains data through
  intervention or interaction with the individual
  or identifiable private information from some
  other sources.
• Is the activity eligible for Exemption?

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IRB Classifications

• Human Subject Regulations Decision Charts
  http//hhs.gov/ohrp/humansubjects/guidance/decisio
  ncharts.htm
• 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 http//www.hhs.gov/ohrp/humansubjects
  /guidance/45cfr46.htm46.101
• Expedited. No more than minimal risk, no special
  populations such as pregnant women, prisoners,
  minors, mentally disabled
• http//www.hhs.gov/ohrp/humansubjects/guidan
  ce/expedited98.htm
• Standard (Full Board Review). Higher than minimal
  risks or studies of special populations

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Writing the Application (1)

• The IRB encourages students to ask questions or
  discuss protocol issues with the IRB staff before
  submitting applications

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Writing the Application (2)

• Use the current IRB application form
• http//www.cgu.edu/pages/1075.asp
• The application, including the description of the
  research protocol, should be written for an
  audience that includes non-scientists who are not
  impressed by esoteric knowledgeso minimize and
  clearly define all jargon.
• Write clearly and concisely with linear logic,
  include everything the application specifically
  asks for, avoid duplication, and avoid TMI
• How to fill out the IRB applicationDo it right
  the first time and the review process will be
  completed much faster

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Writing the Application (3)

• Checklist for Initial Review
• IRB protocol completely filled out
• Signature of PI, Faculty Advisor, and Co-PI (if
  applicable)
• Two (2) copies of IRB application
• Informed Consent form / Assent form (minors)
• Recruitment scripts, email, or flyers
• Copies of all Questionnaires or other Research
  Materials (if applicable)
• Timeline
• Minimum 2 to 3 weeks (Exempt Expedited)
• 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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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
  or hard copy (new signature pages require 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. Continuing Review 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 Update 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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Informed Consent

• Consent form vs. Assent form
• Consent parents and/or 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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Pay Attention to.

• Consent Vs. Assent
• (samples on website)
• Deception (Is it absolutely necessary?)
• Confidentiality (keeping it secret) Vs. Anonymity
  (no names are taken or learned)
• Special Populations
• Clarity and Organization
• Grammar and Spelling

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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
• Expecting a different, quicker review process for
  exempt protocols
• Failing to contact the IRB for clarifications
• Email irb_at_cgu.edu Phone [phone]
• Location Harper Hall Rm.152
• Hours 830AM- 500PM