Education Research and Social

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Education Research and Social Behavioral
Science IRB
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BACKGROUND

• Nuremberg Code
• Infamous Cases 1950s through 1970s
• 1971 - DHEW Guidelines Pamphlet
• 1979 - Belmont Report
• 1981 - 45 CFR 46

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FWA

• Agreement between UW and DHHS which allows for
  the conduct of HS research
• OHRP/Common Rule
• UW will be guided by the ethical principals of
  the Belmont Report regardless of source of
  funding

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UW IRB WILL REVIEW IF

• Research is sponsored (i.e. funded) by UW
• Conducted by, or under the direction of, any UW
  employee
• Uses UW property or facilities
• Requires non-public UW information to identify or
  contact subject

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DEFINITIONS

• Research 46.102(d)
• A systematic investigation, including research
  development, testing and evaluation, designed to
  develop or contribute to generalizable knowledge
• Human Subject 46.102(f)
• A living individual about whom an investigator
  obtains data through intervention or private
  information

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RISK

• For a study to be considered minimal risk, the
  risks associated with participating in the study
  must be equal to or less than the level of risk a
  participant will encounter in their daily lives
• Acknowledgement of risk is acceptable and
  expected. What the IRB wants to see is the ways
  you will mitigate those risks (for example,
  encrypting data, pseudonyms, etc.)

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STUDENT RESEARCH

• All students conducting human subject research
  must obtain IRB approval
• Senior Thesis
• Hilldale Awards
• Independent Study
• Masters Thesis
• Doctoral Dissertation

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STUDENT RESEARCH

• Class Projects
• May be research if Federal definition is met
• If the results are for course credit/class
  assignment and will not be disseminated beyond
  the University, IRB approval is probably not
  required
• Course assignments that are not research must be
  carried out ethically to protect individuals
  involved

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INFORMED CONSENT

• Informed consent is a process with its basis in
  ethical principals its not just a signature
• Written, signed consent is the default
• Oral Consent
• Literacy concerns
• Cultural Norms
• Protection of Participants
• Waiver of Documentation of Consent
• The only link to participants is the signed
  consent document

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INFORMED CONSENT

• Assent
• Waiver of Consent
• Waiver of Parental Consent
• HIPAA Authorization
• If the researcher works for or is a member of a
  HIPAA protected entity
• PHI is being collected
• Passive consent

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ELEMENTS OF INFORMED CONSENT

• 1) Statement that the study involves research
• Identify it as a UW-Madison research project
• 2) Description of any risks
• Can be emotional
• Risk of a breach of confidentiality
• 3) Description of any benefits to the subject
• There are typically NO direct benefits to
  participating in research
• 4) Disclosure of alternative procedures

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ELEMENTS OF INFORMED CONSENT

• 5) Confidentiality of records
• Use of pseudonyms
• Data encryption
• Password protected laptop
• Use of audio or video recording
• 6) If more than minimal risk steps the research
  will take to mitigate those risks
• 7) Contact information for answers to pertinent
  questions
• 8) Statement that participation is voluntary
• Participants can withdraw at any time, skip any
  questions they do not wish to answer

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ELEMENTS OF INFORMED CONSENT

• Compensation Compensation is NOT a benefit
• Parking pass
• Gift cards
• Drawings, raffles
• Extra credit
• If cash is offered, is the amount coercive?

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Use the IRB Consent Wizard

• The IRB wizard is a tool to help ensure all
  federally required elements of consent are
  included
• https//rcr.gradsch.wisc.edu/cfwizard/start.asp?wi
  sc
• The majority of modifications requested by the
  IRB are due to consent form errors. Use the
  wizard to avoid these errors.

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WAIVERS OF INFORMED CONSENT

• Waiver of documentation of informed consent
• Only document linking subject to research and
  principal risk is breach of confidentiality
• Minimal risk and involves no procedures for which
  written consent is normally required outside of
  research

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WAIVERS OF INFORMED CONSENT

• Waiver of Informed Consent
• Minimal Risk
• No adverse affect to rights welfare of subjects
• Research could not practicably be carried out
  without waiver
• If possible, provide subjects with additional
  information after participation

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EXEMPT RESERACH

• Falls within one of the six categories listed at
  45 CFR 46.101(b)(1-6)
• Minimal Risk
• Is human subject research, but is exempt from
  the regulations
• IRB - not the PI - determines exemption
• Does not require full IRB review

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EXEMPT CATEGORIES

• Conducted in established or commonly accepted
  educational settings, using normal educational
  practices
• Educational tests, survey or interview procedures
  or observation of public behavior unless
  information is identifiable and sensitive

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EXEMPT CATEGORIES

• Educational tests, survey or interview procedures
  or public observation not exempt under the
  previous item if subjects are elected or
  appointed public officials or Federal statutes
  require confidentiality
• Collection or study of existing data or documents
  if they are publicly available or anonymous

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EXPEDITED REVIEW

• Minimal risk
• Falls within one of the categories found at 45
  CFR 46.110
• All the regulations apply (unlike exempt)
• The full IRB does not review the protocol

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CATEGORIES ELIGIBLE FOR EXPEDITED REVIEW

• Research on individual or group characteristics
  or behavior or employing a survey, interview,
  oral history, focus group, program evaluation,
  human factors evaluation, or quality assurance
  methodologies

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CHILDREN AS SUBJECTS

• In most cases, children may participate only if
  the research involves no more than minimal risk
• Consent of parent or guardian
• Assent of the child
• Age appropriate language
• Written assent age 11 and up
• Oral assent age 10 and under

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INTERNATIONAL RESEARCH

• Guidelines for International Research
• Cultural, political or economic conditions that
  would increase risk to participants
• Local IRB or ethics committee
• Local contact for questions
• Consent forms in native language of participants
• Because traveling internationally increases the
  risk of a confidentiality breach, you will need
  to encrypt your data.

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INTERNATIONAL RESEARCH

• Consider the most appropriate method for
  obtaining informed consent
• Take into account the literacy level of
  participants, cultural norms and confidentiality
  concerns.
• All key personnel must complete CITI training,
  even if they are from outside the U.S.
• In many cases it wont be possible to expedite
  international protocols.

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INTERNET RESEARCH

• Surveys administered via the internet
• How sensitive is the data
• Security
• Confidentiality
• Consent Issues
• FaceBook
• Blogs
• Chat rooms
• Expectation of privacy by the subject
• Minors

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COLLABORATION WITH OTHER INSTITUTIONS

• Must be a UW PI
• PIs must be tenure or tenure track faculty
• Must provide evidence of approval from the other
  IRB
• Must obtain approval from a UW IRB
• All key personnel must complete human subject
  training

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OTHER CONSIDERATIONS

• Conflict of Interest
• Status Relationships
• Classroom or clinic environment
• Community-based research
• Issues of engagement of the community partner
• Going into homes?
• Sensitive Population
• Non-English speaking participants