Research Involving Human Subjects

1
Research Involving Human Subjects

• Tracy L. Dietz, Ph.D.
• Chair, UCF IRB

2
When is IRB Approval Required?

• According to the OHRP
• If the activity
• Involves any element that is research
• Includes humans subjects
• identifiable data about humans,
• identifiable cell lines,
• data from humans
• According to UCF Policy
• Only the IRB can determine if study is exempt
• Investigators or others may not make this
  determination

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What is Research?

• 45 CFR 46.112 defines research as
• a systematic investigation, including research
  development, testing and evaluation, designed to
  develop or contribute to generalizable knowledge.
  Activities which meet this definition constitute
  research for purposes of this policy, whether or
  not they are conducted or supported under a
  program which is considered research for other
  purposes.

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What is a Human Subject?

• 45 CFR 46.112 defines a human subject as
• a living individual about whom an investigator
  (whether professional or student) conducting
  research obtains
• Data through intervention or interaction with the
  individual, or
• Identifiable private information
• Thus, this includes actually interacting or
  intervening to obtain data but it also means
  identifiable cell lines and identifiable data
  taken from records (which are not public records)

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What is Identifiable?

• Names
• Social Security Numbers
• Addresses
• Also, if the information that is obtained is
  specific enough with the different variables to
  allow someone to determine identity, then it is
  identifiable (such as in a very small population
  size).

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What is a Public Record?

• Public records are those data sources that are
  available to anyone from a public source (such as
  on the internet, from associations, from
  licensing agencies, etc).
• What is not a public record?
• Items that are part of a sealed report or record
• Student records
• Employee records
• Medical records
• Counseling records
• MANY, MANY others. Just because they are
  existing does not mean they are public

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What About Institutional Level Data?

• Studies involving aggregate level data do not
  require IRB approval.
• Examples include
• Numbers of people treated in any given month
• Doctor to patient ratio
• Policies that govern decisions at the clinic, etc.

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How are studies classified

• Full Board greater than minimal risk or needing
  group decision as to risk, ethics, or other
  problem areas.
• Expedited according to specific federal
  regulation list and minimal risk only. See list.
• Exempt according to specific federal regulation
  list and minimal risk only usually this is
  research involving databases, secondary data use,
  or existing (already collected and/or stored)
  data, documents, records, pathological specimens
  or diagnostic specimens. See list.

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Federally designated vulnerable populations

• For more information http//www.hhs.gov/ohrp/irb/i
  rb_chapter6ii.htm
• Fetuses and Human in vitro fertilization
• Pregnant women
• Children
• The Cognitively impaired
• Prisoners
• Traumatized and comatose patients
• Terminally ill patients
• Elderly/aged ONLY when there is cognitive
  impairment or institutionalization
• Socially and economically disadvantaged
• Students, employees, and normal volunteers WHEN
  there are procedures that may create feelings of
  coercion, etc.
• International research

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International Research

• Several regulatory standards provide foundation
  and ethical codes. Much of it
  medically-focused.
• The International Compilation of Human Subject
  Research Protections lists laws, regulations, and
  guidelines governing human subjects research
  world-wide http//www.hhs.gov/ohrp/international/H
  SPCompilation.pdf

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Strategies for Protecting Human Subjects in
Global Project

• See summary report http//www.rti.org/pubs/protect
  ing_research_subjects.pdf
• Informed Consent
• Local language
• Adequate explanation
• Consent from gatekeepers or community leaders
• Avoid undue inducement and avoid social harm (or
  perception of it)
• Consider solicitation of community input
• Signed consent not mandatory (consider literacy)

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Strategies for Protecting Human Subjects in
Global Project (cont)

• Communities can be unaware of their rights
• Communities can be distrustful of researchers
• Issues of concern
• Confidentiality and privacy protection
• Intellectual property
• Access to medicines and vaccines
• Involvement of children in clinical research
• Use of stem cells
• Research with biological weapons
• Appropriate compensation

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Things to consider in International Research

• Risks of Research can be different in an
  international setting
• What is considered private may be different
• Age of majority may be different
• May be gender differences
• Cultural expectations about what is appropriate
  to do/ask

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HIPAA

• The Health Insurance Portability and
  Accountability Act of 1996, also known as the
  Privacy Rule
• Established a set of national standards for the
  protection of certain health information.
• Requires that an IRB or a Privacy Office review
  research involving identifiable health
  information.
• Protected Health Information (PHI) What it is.
  What it isnt.
• UCF HIPAA components
• Communication Sciences Disorders and Health
  Services

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What are the PHI identifiers?

• Name
• Geographic subdivisions
• Phone numbers
• Fax numbers
• E-mail address
• Social Security number
• Medical record number
• Health plan beneficiary number
• Account numbers
• URLS

• Certificate/license numbers
• VIN, serial number, license plate number
• Device identifiers and serial numbers
• IP address
• Biometric identifiers
• Full face/comparable images
• Any other unique code

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HIPAA Authorization Waiver of Authorization

• HIPAA Authorization
• Waiver of HIPAA Authorization (example
  retroactive chart review for data collection)
• To qualify for a Waiver of Authorization
• Research use of PHI does not represent more than
  a minimal risk to privacy
• Research could not be done without the requested
  PHI
• It would not be practical to obtain signed
  authorizations from research subjects (if you are
  talking to them, it is practical)
• Specific elements of PHI are not more than the
  minimum necessary to accomplish study goals.

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Biosafety Committee Review

• Research involving hazards require biosafety
  and/or radiation committee approval.
• Microbiological/viral agents, pathogens, toxins
  and other selected agents
• Human cell or tissue samples
• Recombinant DNA
• Chemicals
• Controlled substances
• Ionizing Radiation
• Physical agents such as ultraviolet light, lasers
  (class 3b
• or 4)

18
FDA

• FDA regulation occurs with all medical devices
  http//www.fda.gov/oc/ohrt/irbs/irbreview.pdf
• What is a medical device?
• IRB is to make determination of significant
  versus non-significant risk
• How are medical devices classified by FDA?
• Class 1
• Examples elastic bandages, exam gloves)
• Class 2
• Examples powered wheelchairs, surgical drapes,
  infusion pumps
• Class 3
• Examples replacement heart valves, implanted
  cerebellar stimulants

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Other information on FDA

• Premarket notification 510(k)
• Premarket approval PMA http//www.fda.gov/cdrh/
  devadvice/
• Humanitarian use device -- HUD
• Humanitarian device exemption -- HDE
• Medical device clinical investigation IDE
• Request for pre-IDE conference or classification
  513(g)
• Small Manufacturers Division 1-800-638-2041

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IDE Investigational Device Exemption

• Significant Risk Device
• Intended as implant and presents potential for
  serious risk
• For use in supporting or sustaining life and
  presents serious risk
• Substantial importance in diagnosing, curing,
  mitigating, treating disease and presents serious
  risk
• Otherwise presents serious risk
• Regulations for IRB review, marketing, labeling,
  etc. apply as per 21 CFR 812

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Non-significant Risk

• Non-significant risk device
• An NSR device is an investigational device that
  does not meet the definition of a significant
  risk device
• IRB determination that a device is
  non-significant risk relies upon
• Sponsors description of why it is not SR
• Whether proposed NSR research meets the
  definition of significant risk
• Use of device protocol related procedures/tests
  (not just device alone)
• Additional information from sponsor
• PIs are responsible for abbreviated
  requirements at 21 CFR 812
• Exempt Studies
• Subject to informed consent
• Off-label USE of legally marketed device does not
  require IRB approval as in the normal practice of
  medicine, but research to make claims or change
  the label does require IRB review and approval

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Collaboration

• Collaborators from other institutions engaged in
  the research must be identified as well as their
  roles, such as
• Administer research interviews, questionnaires,
  etc.
• Perform invasive or non-invasive procedures or
  experiments
• Manipulate a subjects environment
• Receive or access identifiable private
  information
• Obtain informed consent
• The collaborating institution must have a
  Federalwide Assurance if it receives federal
  research funding
• Collaborators must complete CITI training

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Institutions Not Engaged

• Release individually identifiable information or
  specimens to another institution
• Permit investigators from another institution to
  use their facilities, students, employees, etc.
  for research
• Provide information about research to prospective
  subjects
• Perform commercial or non-collaborative service

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IRB Contact Information

• Barbara Ward, CIMIRB CoordinatorPhone
  407-882-2276 Joanne Muratori, CIM IRB
  Coordinator Phone [phone]
• Janice Turchin, CIP
• IRB Assistant
• Phone [phone]