How to Obtain Institutional Review Board IRB Approval

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How to Obtain Institutional Review Board (IRB)
Approval

• Richard Wagner
• Associate Director
• UCSF Human Research Protection Program
• September 3, 2009

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Topics to be covered

• What the IRB is looking for
• Tips for obtaining IRB approval
• Types of review/application required

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UCSF Acronyms of Relevance

• IRB Institutional Review Board (generic)
• CHR Committee on Human Researchthe IRB for
  UCSF, SFGH, VAMC, SFDPH . . .
• HRPP Human Research Protection Program

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Addressing Human Research Protection Issues

• NIH Application
• Essay-like discussion
• CHR Application
• Multiple detailed check boxes and questions
• Embedded guidance
• Application supplements for specific issues
  (Prisoners, surrogate consent, waiver of consent
  for some types of study)

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Determinations the IRB Must Make (1)

• Risks to subjects are minimized
• Procedures are consistent with sound design and
  do not unnecessarily expose subjects to risk
• Study utilizes procedures already performed for
  diagnosis/treatment
• Risks to subjects are reasonable in relation to
  anticipated benefits, if any, and to the
  importance of the knowledge that may reasonably
  be expected to result from the study
• Selection of subjects is equitable
• Inclusion/exclusion criteria are adequate
• Research purpose and setting is appropriate
• Recruitment process is fair

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Determinations the IRB Must Make (2)

• Informed consent will be sought in accordance
  with regulations
• Informed consent will be documented in accordance
  with regulations
• Provisions for monitoring collected data are
  adequate to ensure the safety of subjects
• Provisions to protect privacy of subjects are
  adequate
• Provisions to maintain confidentiality of data
  are adequate
• Vulnerable populations are adequately protected
  by additional safeguards

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Determinations the IRB Must Make (3)

• More complete list of determinations has 74
  items.
• The study cannot be approved unless the CHR
  determines the study meets the above criteria.
• If substantive clarifications or modifications
  are needed before the application can satisfy the
  criteria, the study must be returned to the
  committee for additional review

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Tips for Success 1 Sound Science

• Scientific review or scholarly review, by peers
  or a mentor, should occur before submitting to
  the CHR.

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2 Level of Review/Type of Application

• Level of review and type of application are
  determined by level of risk.
• Full Committee
• more than minimal risk, including social risks
• Expedited
• minimal risk, specific categories
• subject contactyes or no

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Determine the Level of Review (continued)

• Exempt
• Minimal risk, specific categories, usually no
  identifiers recorded
• You must have formal certification of exemption
  from CHR!
• No Human Subjects
• Research does not meet definition of human
  research
• No identifiers seen

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Determining Level of Review Is IRB Approval
Needed?

• See decision tree on CHR website
• http//www.research.ucsf.edu/chr/Guide/HSDecisTree
  .pdf
• In general, for specimens and data if the
  researcher
• does not access identifiers no human subjects
• does not record identifiers may be exempt
• records identifiers expedited review

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3 Current Forms, Supplements and Consent
Templates

• Full Committee Application
• ExpeditedSubject Contact
• ExpeditedNo Subject Contact
• Exempt
• Supplements
• Human Biological Specimen
• Collection and/or Banking
• Human Gene Transfer
• Human Stem Cell
• Investigational Drugs
• Investigational Devices
• Inclusion of Minors
• Inclusion of Prisoners
• Surrogate Consent
• Waiver of Consent
• Biomedical Consent
• Biomedical Cancer Consent
• Social or Behavioral
• Simple Blood Draw

• Download the most current CHR Application Forms
  from the HRPP website.
• Check to see which Application Supplements are
  needed.
• Use and follow the most current consent and
  assent templates.

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4 The Audience

• Not all IRB members are scientists.
• The scientists are your peers, but may not know
  your field.
• Spell out acronyms at first use.
• Write consent form at 8th grade reading level.
• Use lay language in consents forms and study
  summary.

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5 Consistency

• Make sure that
• All sections within the CHR application are
  consistent with each other (i.e., purpose,
  benefits, alternatives)
• All sections within the consent form are
  consistent.
• CHR application matches the group or sponsor
  protocol.
• Protocol and consent form are consistent.
• Use the same name for the subjects groups
  throughout submission.
• Use the same name for the study drugs throughout
  the submission.

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6 Important Explanations

• Explain what happens to subjects in study that is
  different from those who do not participate.
• Distinguish procedures being performed purely for
  research from standard of care.
• Describe procedures in chronological order.
• Describe each study group clearly.
• Describe how risks will be minimized and managed.
• Discuss Data Safety Monitoring Plan, and Data
  Safety Monitoring Board if required.

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7 Recruitment and Consent

• Provide a detailed discussion of the who, what,
  when, where and how of recruitment and consent.
• Submit copies of all recruitment materials and
  consent documents, including scripts and text of
  ads.
• Consider and address special populations
• Children and minors
• Cognitively impaired
• Those who do not read, speak or understand
  English
• Justify any alterations of consent
• Waiver of signed consent
• Waiver of consent

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8 Cover Letter

• Use a cover letter to
• Explain and highlight any difficult or sensitive
  issues.
• Inform the CHR if you have special time
  constraints.

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9 Final Review

• Do one last review before submitting.
• If you are not the PI, make sure the study PI has
  read the application and consent documents before
  he or she signs the application.

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10 Ask Questions Along the Way

• Ask your mentor
• Ask the CHR
• Main Line 476-1814
• Analyst of the Day 476-1814
• http//www.research.ucsf.edu/chr/
• chr_at_ucsf.edu
• Research Online https//www.researchonline.ucsf.e
  du/
• To check status of applications and for online
  training

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Bonus Tip Dont Overload

• Do not group related studies into a complicated
  application.
• Get separate CHR approval for each discrete
  study.
• You may have several CHR approvals for a single
  grant.