Introduction to Human Subjects Research and the IRB Process

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Introduction to Human Subjects Research and the
IRB Process

• Presented By
• Office of Research Compliance (ORC)
• Ross Hickey, Associate Director and IRB
  Coordinator

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Federal Definition of Research

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

45 CFR 46.102
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Definition of a Human Subject for Purposes of
Research Compliance

• A living individual(s) about whom an
  investigator (whether professional or student)
  conducting research obtains
• (a) data through intervention or interaction with
  the individual, or
• (b) identifiable private information.

45 CFR 46.102
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What is the IRB?

• IRB stands for the Institutional Review Board
• The primary institutional body charged with
  protecting the rights welfare of individuals
  recruited to participate in research

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Why have an ORC or an IRB?

• The help prevent human rights/research atrocities
  and tragedies
• Nazi research during WWII (Nuremburg Trials,
  1946)
• Thalidomide studies (1960s)
• Holmsburg (1974)
• Untreated Syphilis Studies in Negro Males
  (Tuskegee Studies 1930-1970s)
• AIDS Drug Tests on Negro and Latino Infants in
  Foster Care in New York (late 1980s-2000)

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Why have an ORC or an IRB?

• At any given point, there are over 50 statutes,
  rules or regulations in effect, including
• 45 CFR 46 (a.k.a the Common Rule)
• The Health Insurance Portability and
  Accountability Act of 1996 (HIPAA)
• Uniting and Strengthening America by Providing
  Appropriate Tools Required to Intercept and
  Obstruct Terrorism (USA PATRIOT ACT) Act of 2001
• Family Educational Rights and Privacy Act (FERPA,
  20 U.S.C. 1232g 34 CFR Part 99)

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Why have an ORC or an IRB?

• There are a lot of Federal Agencies involved in
  human subjects research oversight, compliance,
  and enforcement, including
• Office of Human Research Protections (OHRP, a
  division of DHHS)
• Centers for Disease Control (CDC)
• Office of Research Integrity (ORI)
• Homeland Security
• Departments of Corrections and Justice
• Etc.

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Why have an ORC or an IRB?

• The ORC is the only institutional body at USM
  legally allowed to determine what is (is not)
  research for purposes of human subjects research
  compliance
• All human subjects research MUST be reviewed and
  approved by the ORC and the IRB before any data
  collection can begin
• The IRB and the ORC are the only legally
  authorized bodies at USM allowed to review and
  approve human subjects research

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Categories of Review/Determinations

• Not Human Subjects Research
• Student Classroom Projects
• Minimal risk study
• The intent of the classroom project is not to
  disseminate knowledge, but to teach research
  methodology or to demonstrate course material and
  concepts.

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Categories of Review/Determinations

• 3. Exempt
• Minimal risk study
• Study falls into a recognized category
• Does not involving sensitive information or
  protected populations
• The typical norm for undergraduate or
  inexperienced student research where data will be
  disseminated outside the classroom
• Review is conducted by the ORC

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Categories of Review/Determinations

• 4. Expedited Review
• Middle level of review (case by case)
• Review is conducted by ORC and 1 IRB member
• Minimal risk study
• Study falls into a recognized category
• May potentially involve a protected population,
  sensitive information or HIPAA
• May not be suitable for inexperienced or
  undergraduate research

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Categories of Review/Determinations

• 5. Full Board Review
• Greater than minimal risk study
• Involves protected populations, sensitive
  information and/or HIPAA
• Review is conducted by an initial IRB Reviewer
  and then by the Full IRB
• USM has determined that Full Board Reviews are
  not appropriate for student protocols

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What are Greater than Minimal Risk Projects?

• Greater than minimal risk projects include
• The use of vulnerable (protected) populations
• Children/Minors (Under the age of 18)
• Prisoners (now includes non-publicly available
  secondary data)
• Pregnant women
• People with diminished capacity to give consent
• Mentally or physically challenged individuals
• Protocols and/or questions that examine or elicit
  sensitive information

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Types of Sensitive Information

• Sexual attitudes, preferences, or practices
• Use of alcohol, drugs, or other addictive
  products
• Information pertaining to illegal conduct
• Information that if released could reasonably
  damage an individuals financial standing,
  employability, or reputation within the community
• Health and medical information contained in a
  medical record or chart or insurance file
• Psychological, psychiatric or mental health
  information about a specific individual
• Genetic information

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Examples of Research Typically Eligible for IRB
Exemption

• In general, anonymous surveys that do not link
  sensitive information to an individual
  participant
• Educational tests and tools that assess teaching
  methods
• Non-interactive behavioral observations
• Interview procedures that do not include
  potentially liable information
• Use of secondary data sets without subject
  identifiers
• Use of publicly available data sets (census
  information, vital statistics, public health
  data, etc.)

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Examples of Research Typically Eligible for IRB
Student Classroom Projects

• Interviewing individuals for a project where the
  results will only be shared with the faculty
  member who is teaching the class or fellow class
  members would also qualify as a Student Classroom
  Project.
• A program evaluation, quality assurance, or needs
  assessment for a third party agency, where the
  collected information will be remain in the
  classroom and would not be disseminated to the
  third party agency, would qualify as a Student
  Classroom Project
• A student presentation to fellow class members
  that shares the results of a survey taken of USM
  students, concerning a non-sensitive topic area.

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IRB Review and Approval Criteria

• Risks to subjects are minimized
• Procedures used are consistent with sound
  research design and do not unnecessarily expose
  subjects to risk
• Risks to subjects are reasonable in relation to
  anticipated benefits
• The subject selection is equitable

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IRB Review and Approval Criteria

• Written Informed Consent is sought from each
  prospective subject or their legal representative
• Informed consent is documented
• There are adequate provisions to protect the
  privacy of subjects and to maintain the
  confidentiality of data
• Additional safeguards are in place for subjects
  that are likely to be vulnerable to coercion or
  undue influence.

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Guidance on Informed Consent

• Written consent is required, unless waiver
  criteria are met (very strict federal
  requirements)
• Passive, blind, general and/or blanket informed
  consent forms are generally not allowable under
  federal law
• Informed Consent form should be crafted to be
  specific to the study
• Readability must be at either
• The 6-8th grade reading level or
• At target audiences reading level (i.e. 4th
  grade for 4th graders)

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Important Notes for Student Researchers

• The ORC is the only institutional body at USM
  legally allowed to determine what is research for
  purposes of human subjects research compliance
• The IRB and the ORC are the only legally
  authorized bodies at USM allowed to review and
  approve human subjects research

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Important Notes for Student Researchers

• All human subjects research MUST be reviewed and
  approved by the ORC and the IRB before any data
  collection can begin
• Any changes to an approved protocol must be
  submitted to the ORC for review and approval
  prior to continue with the research

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Important Note for Student Researchers

• Any adverse event, privacy violation, security
  breech, etc. must be reported to the ORC ASAP

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Questions?