Cutting Through the Red Tape:

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Cutting Through the Red Tape
A Beginners Guide to Navigating the IRB Deborah
Fox, Louis Stokes CVAMC IRB AdministratorIsabel
Sánchez, Case IRB Director
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Objectives

• Provide practical and technical assistance for
  navigating the IRB process.
• Provide an explanation as to the regulatory
  requirements necessary for IRB approval.

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Objectives

• Provide an overview of the informed consent
  process.
• Provide useful tips for writing an informed
  consent document.

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Human Subjects Research
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Human Subject Research
Governed by ethical principles of the Belmont
Report and the requirements of the Department of
Health and Human Services (DHHS) and the Food and
Drug Administration (FDA) regulations regardless
of support.
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Definition of Research

• A systematic investigation, including research
  development, testing and evaluation, designed to
  develop or contribute to generalizable knowledge.
  
• 45 CFR 46.202

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Definition Human Subject

• A living individual about whom an investigator
  conducting research obtains
• data through intervention or interaction with the
  individual, -or-
• identifiable private information.
• 45 CFR 46.202

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IRB Purpose

• The IRB is an administrative body established to
  protect the rights and welfare of human research
  subjects recruited to participate in research
  activities conducted under the auspices of the
  institution with which it is affiliated.
• IRB Guidebook OHRP Department of Health
  Human Services

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Getting Started

• Complete required research education know the
  status of your CREC account
• Determine which IRB or IRBs need to review your
  study
• Contact the IRB for guidance
• Inquire about additional requirements (e.g.,
  employment status or faculty status)

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Getting Started

• Review the IRB forms
• Determine whether other committee approvals are
  required for study approval
• Allow yourself enough time to complete the
  required paperwork, obtain the necessary
  signatures, and obtain the required committee
  approvals
• Once approved, keep track of all expiration dates

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IRB Review Process

• Human Subjects Research
• Exempt Research
• Expedited Review
• Full Board Review

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• Is it human subjects research?

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Exempt Research

• Research that is exempt
• Research in established or commonly accepted
  educational settings, involving normal
  educational practices
• Educational tests, surveys, interviews, or
  observation of public behavior unless identified
  and sensitive
• Research using existing data, documents, records,
  pathological specimens, or diagnostic specimens,
  if publicly available or unidentifiable
• 45 CFR 46.110(b)

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Exempt Research

• Exemptions must be verified by a trained and
  qualified institutional official
• Exemptions may not be determined by the
  investigator

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Expedited Review

• Eligible research includes minimal risk and
• Research involving materials (data, documents,
  records, or specimens) that have been collected,
  or will be collected solely for nonresearch
  purposes
• Collection of data from voice, video, digital, or
  image recordings made for research purposes
• Research on individual or group characteristics
  or behavior or research employing survey,
  interview, oral history, etc. methodologies
• 63 FR 60364 - 60367

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Expedited Review

• Expedited review is not a quick review.
• Review is the same as that performed by the
  convened Board only the number of reviewers is
  different.

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Full Board Review

• Requires full committee to meet in person and
  review the study
• Quorum must be present
• Non-Scientist must be present

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IRB Review Criteria

• Risks to subjects are minimized and reasonable in
  relation to anticipated benefits
• Risks to subjects are clearly and accurately
  identified and considered
• Risks to others (relatives, friends, etc.) are
  accurately identified and considered
• Risks are minimized through sound research design

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IRB Review Criteria

• Risks to subjects are minimized and reasonable in
  relation to anticipated benefits
• Research personnel are qualified
• Anticipated benefits to subject and importance of
  knowledge to be gained are clearly and accurately
  identified

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IRB Review Criteria

• Selection of subjects is equitable
• Minority/ethnic representation is appropriate
• Gender representation is appropriate
• Recruitment methods and advertising materials are
  non-coercive and appropriate
• Additional protections for children, pregnant
  women, fetuses, neonates, and prisoners

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IRB Review Criteria

• Informed consent will be sought from each
  prospective subject or their legally authorized
  representative.

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IRB Review Criteria

• Adequate provisions for monitoring the data
  collected to ensure subject safety
• Greater than minimal risk studies
• Internal and/or external data safety monitoring
• Data Safety Monitoring Board or Data Monitoring
  Committee

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IRB Review Criteria

• Adequate provisions to protect the privacy of
  subjects and to maintain the confidentiality of
  data
• Methods for obtaining, recording, and coding of
  data and/or samples are described and
  satisfactory
• Storage of data and/or samples is described and
  satisfactory

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IRB Review Criteria

• Adequate provisions to protect the privacy of
  subjects and to maintain the confidentiality of
  data
• Procedures for sharing of data and/or samples are
  described and satisfactory

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IRB Review Criteria

• Additional safeguards included to protect the
  rights and welfare of vulnerable subjects
• Children
• Adults with impaired capacity for decision-making
• Pregnant women and fetuses
• Neonates
• Prisoners
• Other

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IRB Review Decisions

• Approved
• Modifications Required
• Tabled/Deferred (Full Review Only)
• Disapproved (Full Review Only)

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Informed ConsentWhat is it?

• A process/statement that the study involves
  research, an explanation of the purposes of the
  research and the expected duration of the
  subject's participation, a description of the
  procedures to be followed, and identification of
  any procedures which are experimental.

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Informed ConsentForms vs. the Process

• Informed consent is a process.
• Written informed consent is a requirement unless
  waived by an IRB.
• Meeting this requirement does NOT relieve
  researchers of their ethical duty to obtain
  meaningful consent, if written consent alone is
  not effective.

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Informed ConsentWhy is it so Important?

• Informed consent is giving people the opportunity
  to decide what will and will not happen to them.
• Subjects need to know what they are getting
  themselves into.

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Informed ConsentWhy is it so Important?

• Effective informed consent means the researcher
  understands their audience/target population.
• Non-English speaking? Blind? Upset?

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Steps in the Informed Consent Process

• Recruitment
• When and where does it happen?
• Who is the first to approach or interact with the
  prospective subject?

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Steps in the Informed Consent Process

• Disclosure
• What is your consenting format? e.g. read to them
• Note The person who best understands the
  consent document may not always be the
  responsible investigator. Are other staff
  members involved? How have they been trained?

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Steps in the Informed Consent Process

• Discussion
• Allow enough time for questions.
• Take subjects concerns seriously.

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Steps in the Informed Consent Process

• Assessment of Understanding
• Ask if the subject understands what they are
  expected to do and how often.
• Asking questions of participants vs. asking if
  they have questions.

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Steps in the Informed Consent Process

• Post-enrollment Feedback
• The RI, CI, staff, and subjects must report all
  changes, adverse events and/or problems.
• Post-enrollment Disclosure
• Investigators have a moral responsibility to
  disclose new information that could affect
  subjects.
• Remind them they have the right to withdraw.

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Steps in the Informed Consent Process

• Post-enrollment Dissemination
• Do subjects want a copy of your final report?
• Did they have that option at the very beginning?
• Report in a manner that protects subject
  identity/privacy.

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Privacy Confidentiality

• Privacy - having control over the extent, timing,
  and circumstances of sharing oneself (physically,
  behaviorally, or intellectually) with others.
• Confidentiality - methods used to ensure that
  information obtained by researchers about their
  subjects is not improperly divulged.

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Informed Consent Process

• RESEARCHERS MUST
• Provide subjects with sufficient opportunity to
  consider whether or not to participate.
• Eliminate coercion or undue influence.
• Use language that is understandable to the
  subject.
• Not include exculpatory language through which
  the subject is made to waive, or appear to waive,
  any legal rights.
• Not include language which releases, the
  investigator, the sponsor, the institution, or
  its agents from liability for negligence.

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In summary, IRBs review

• Study Design
• Recruitment
• Subject Population
• Informed consent document and process
• Risk/Benefit Ratio
  
• Privacy Confidentiality
• Data Storage/Protection
• Protections for Vulnerable Subjects

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Helpful Hints

• Know your research and methodology
• Know the potential ethical issues associated with
  your research
• Use the correct and current version of the IRB
  forms
• Be consistent throughout the application
• Answer all questions in the application fully and
  completely

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Helpful Hints

• Write to your audience
• In general, write consent form at the 6th to 8th
  grade reading level however, consider your
  subject population
• Make clear in the application who will be
  obtaining informed consent, and how

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Helpful Hints

• Proof read all documents before final submission
  to the IRB
• Contact the IRB if you have any questions
• Be prepared to receive feedback from the IRB
• Plan ahead
• Know the committee deadlines

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Contact Information

• Case Institutional Review Board
• Isabel Sánchez, IRB Director
• 10900 Euclid AvenueSears Library 657 Location
  Code 7230
• Cleveland, Ohio 44106-7230(216) 368-6993
• ias5_at_cwru.edu

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Contact Information

• Case Cancer
• Institutional Review Board
• Mariesa Malinowski, Administrative Director
• School of MedicineHarland Goff Wood Building
  Location Code 7230
• Cleveland, Ohio 44106
• [phone]
• Mariesa.malinowski_at_case.edu

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Contact Information

• Cleveland Clinic IRB
• Deborah McCleave, IRB Manager
• 9500 Euclid Avenue Wb-2
• Cleveland, Ohio 44195
• [phone]
• irb_at_ccf.org

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Contact Information

• Louis Stokes Cleveland VA
• Medical Center IRB
• Deborah Fox, IRB Administrator
• 10701 East Blvd. 151W
• Cleveland, Ohio 44106
• [phone] ext. 4624
• deborah.fox2_at_va.gov
• http//www.cleveland.med.va.gov/research/irb.htm

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Contact Information

• MetroHealth System IRB
• Kathy Lawry, IRB Manager
• 2500 MetroHealth Drive
• Rammelkamp 103
• Cleveland, Ohio 44109-1998
• [phone]
• klawry_at_metrohealth.org
• http//mhirb.metrohealth.org/IRB

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Contact Information

• University Hospitals of Cleveland Institutional
  Review Board
• 11100 Euclid Avenue
• Cleveland, OH 44106
• [phone]
• clinicalresearch_at_uhhs.com
• http//www.uhhs.com/DisplayContent.aspx?pageID339
  MID3

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Questions?