Navigating the IRB Process Nancy A. Olson Executive Director Institutional Review Board

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Navigating the IRB ProcessNancy A.
OlsonExecutive DirectorInstitutional Review
Board
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Navigating the IRB Process?
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What is an IRB? The Institutional Review Board
(IRB) is a federally mandated committee charged
with overseeing all research projects involving
human participants. The IRB fulfills this
charge by reviewing all proposed research
involving human participants, to protect the
rights and welfare of research participants, and
ensure compliance with Federal, State, and
University requirements.
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Why What How

• Why is IRB review needed?
• What needs IRB review?
• How do you get IRB review?

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Why is IRB review needed?

• No one can be objective about their own work
• People underestimate the risks involved in things
  familiar to them
• People overestimate the benefit of things that
  are important to them

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What needs IRB review?

• All research involving human participants
• Research
• Human participants

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• Is it research?
• Research is a systematic investigation designed
  to develop or contribute to generalizable
  knowledge.
• Is it research that involves human participants?
• Yes and Yes IRB review

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How do you get IRB review?

• What type of IRB review do you need?
• Three levels of review
• Exempt
• Expedited
• Convened

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• Categories of research exempt from further IRB
  review
• Research conducted in established or commonly
  accepted educational settings, involving normal
  educational practices. This category may include
  children.
• Research involving the use of educational tests
  (cognitive, diagnostic, aptitude, achievement),
  survey procedures, interview procedures, or
  observation of public behavior in which
  participants cannot be identified directly or
  through coded identifiers, or, if they can be
  identified, release of the information would not
  be harmful1 to the participant.
• A) Research involving the use of educational
  tests (cognitive, diagnostic, aptitude,
  achievement) in which participants cannot be
  identified, or release of the information would
  not be harmful to the participant. This category
  may include children.
• B) Research involving the use of survey
  procedures, interview procedures, or observation
  of public behavior in which participants cannot
  be identified, or release of the information
  would not be harmful to the participant. This
  category may not include children.
• 3. Survey, interview, or testing of public
  officials, elected or appointed, or candidates
  for public office.
• 4. Research involving the collection or study of
  existing data2, documents, records,
  pathological specimens, or diagnostic specimens,
  if these sources are publicly available or if the
  information is recorded by the investigator in
  such a manner that participants cannot be
  identified, directly or through identifiers
  linked to participants. This category may include
  children.
• 5. Research and demonstration projects that are
  conducted by or subject to the approval of
  Federal Department or Agency heads, and which are
  designed to study or evaluate public benefits or
  services. (e.g. evaluation of public benefits
  programs such as Medicare, Public Assistance).
  This category may include children.
• Taste and food quality evaluation and consumer
  acceptance studies. This category may include
  children.
• If your research involves only the procedures
  listed in one or more of the categories, it may
  be reviewed as exempt.

1 Harm to participants means that any
disclosure of the participants responses outside
the research could reasonably place the
participant at risk of criminal or civil
liability or could be damaging to the
participants financial standing, employability,
or reputation. 2 Existing data means that the
data, documents, records, or specimens are in
existence prior to IRB review. Specimens
obtained prospectively from future discarded
clinical samples do not qualify for exemption.
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Exempt Research

• Claim of Exemption form
• HIPAA Disclosure form
• Research protocol
• All questionnaires, survey instruments, interview
  questions, discussion guides and/or data
  collection instruments

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• CATEGORIES OF RESEARCH THAT MAY BE REVIEWED BY
  EXPEDITED PROCEDURES
• If your research meets the definition of minimal
  risk1 and involves only procedures listed in
  one or more of the categories below it may be
  reviewed by expedited review.
• Clinical studies of drugs and medical devices
  that do not require investigational new drug or
  I investigational exemption
  application.
• Collection of blood samples by finger stick,
  heel stick, or venipuncture.
• Prospective collection of biological specimens
  for research purposes by noninvasive means (e.g.,
  hair and nail clippings, sputum specimen
  collected after saline mist nebulization, to name
  a few).
• Collection of data through noninvasive
  procedures (not involving general anesthesia or
  sedation) routinely employed in clinical
  practice, excluding procedures involving X-rays
  or microwaves (e.g., body weight,
  electrocardiograph, ultrasound, moderate exercise
  when appropriate).
• Research involving materials (data, documents,
  records, or specimens) that have been collected
  or will be collected solely for non-research
  purposes (such as for medical treatment or
  diagnosis). Note some research in this
  category may be exempt from HHS regulations for
  the protection of human research participants
  45CFR 46.101 (b) (4). This listing refers only to
  research that is not exempt.
• Collection of data from voice, video, digital,
  or image recordings made for research.
• Research on individual or group characteristics
  or behavior (including, but not limited to,
  research on perception, cognition, motivation,
  identity, language, communication, cultural
  beliefs or practices, and social behavior),
  research employing survey, interview, oral
  history, focus group, program evaluation, human
  factors evaluation, or quality assurance
  methodologies. Note some research in this
  category may be exempt from the HHS regulations
  for the protection of human research participants
  45CFR 46.101 (b) (4). This listing refers only
  to research that is not exempt.

1 MINIMAL RISK means that the probability and
magnitude of harm or discomfort anticipated in
the research are not greater than those
ordinarily encountered in daily life or during
the performance of routine physical or
psychological examinations or tests.
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Expedited Review

• IRB Initial Application, including appendices,
  questionnaires, interview guides, recruitment
  letters and advertisements
• HIPAA Disclosure form
• Consent document(s)
• Complete research proposal/protocol.

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Convened Review

• 15 collated packages containing
• IRB Initial Application, including appendices,
  questionnaires, interview guides, recruitment
  letters and advertisements
• HIPAA Disclosure form
• Consent documents(s)
• Complete research proposal/protocol and
• 1 copy of the Investigators Brochure, if
  applicable.

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The IRB review process

• Submission logged into database and assigned IRB
  file number
• If qualifies for exemption or expedited review,
  reviewed by IRB Chairman, or designee
• May request additional information or revisions
• May approve or disapprove

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The IRB review process

• Submission logged into database and assigned IRB
  file number
• If requires convened board review, study added to
  meeting agenda, materials sent to board members 2
  weeks before each meeting
• May approve, disapprove, or request additional
  information and/or revisions

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Investigators, IRBs the Review Process

• The research protocol and/application forms
  should provide the information the IRB needs to
  make decisions.
• The IRB must be
• thorough and inquisitive
• sometimes even overly inquisitive.

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Investigators, IRBs the Review Process

• Investigators have the burden of proof when
  submitting research for IRB review.
• IRBs have the burden of making decisions based
  on the evidence (research protocol and
  supporting documents).
• When investigators do not provide, or IRBs do not
  require, sufficient information, the IRBs
  decision-making ability may be delayed.

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Contact Information

• IRB office 601 984-2815
• Facsimile 601 984-2961
• Location U-020
• Lower level Learning Resources building
• http//research.umc.edu/irb.html