Transcript (Presentation Title Slide)

Linguistics IRB Seminar
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Sept 13, 2012
Ron Banks- Human Subjects
Coordinator
[email protected]; 244-3939
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OVERVIEW: Human Subjects Protections
at UIUC
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The Belmont Report and regulations
What is human subjects research
Informed consent
Overview of IRB procedures/pathways to approval
Example IRB application topics (Linguistics, SIP)
Research with student participants
UIUC IRB/ application approval criteria
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History leading to IRB
system
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PHS Syphilis Study (Tuskegee)
Willowbrook
Milgram
Beecher article in 1966
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National Research Act
1974
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The National Commission for the
Protection of Human Subjects of
Biomedical and Behavioral Research is
established, and Congress passes the
National Research Act.
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Belmont Report - 1979
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Respect for Persons
Beneficence
Justice
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Federal Regulations
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45 CFR 46 – Common Rule - Regulations for the
Protection of Human Subjects of Biomedical and
Behavioral Research
– Basic regulations established in 1974
– Adopted by 16 federal agencies as the Common
Rule in 1991
– Proposed changes in the regulations being
reviewed
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What is a Human Subject?
A living individual about whom an
investigator obtains data through
intervention or interaction with
the individual
OR
…about whom an investigator
obtains individually identifiable,
private information
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What is Research?
A systematic investigation
designed to lead to generalizable
knowledge
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What this means for UIUC
Researchers…
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All research involving humans, human
tissues or fluids, or records
Funded or not
Regardless of where the research is
conducted
Regardless of level of risk
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What this means for UIUC
Students
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If you are conducting research with
humans including senior theses or
dissertation…
– Complete an IRB application
– Complete the required training
– Get IRB approval before starting!
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Informed Consent
Overview
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Informed consent is an ongoing process rather than
just given/obtained at a moment of time.
no exculpatory language, 8th grade reading level,
correct grammar/typos
Give participants opportunities to ask questions
Ensure participants understand what they have
consented to do
Ensure participants understand that they can
discontinue at any time
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Elements of Informed
Consent
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Purpose
Procedures
Risks and Benefits
Voluntariness
Confidentiality
Contact Information
Signature Statement
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Informed Consent Overview
cont’d
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Signed (written) Informed Consent
Waiver of Informed Consent
Alteration of Informed Consent
Waiver of Documentation
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UIUC IRB Procedure
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Submit an IRB-1 application OR
Application for Exemption along with:
– Consent documents
– Measures
– Recruitment flyers
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Pre-review procedure
Board member review if study is not
exempt
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Pathway to Approval
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Submit application and complete the required training
Respond to IRB Office comments quickly (pre-review from
office staff reviewer)
Review level determination will be made at the IRB Office exempt, expedited, full board
– if exempt approval after pre-review complete
– If not exempt, sent to one board member or full board
Respond to board member modifications letter
Approval is good for three years for exempt, one year for
expedited or full board (sometimes just 6 months)
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Example #1 - Sensory motor representation of
vowel production
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Articulograph study done with native speakers of
Chinese or Chinese second language learners
2 hour session reading words, sentences or telling
a story using pictures or cards or from a computer
screen
only adults
signed consent
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Sensory motor representation of vowel
production - sample IRB issues
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Make sure inclusion/exclusion criteria are comprehensive: no
metal implants/objects such as pacemakers or insulin delivery
systems, no latex allergies, no non-removable metal jewelry,
subjects can’t be pregnant.
Clarifying that recruitment not occurring in classes researchers
are teaching
explaining technical terms in lay language on consent
clarifying confidentiality protections
voice dissemination is obtained via the consent letter
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Example #2-Incipient second language
acquisition in school-age children learning
Spanish
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Early childhood education study – longitudinal study
of young children learning Spanish.
Obtaining speech samples across time
Observations of teacher-student interactions video
recorded.
Peabody Picture Vocabulary Test given at onset
Comprehension task with eye tracking
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Incipient second language acquisition in
school-age children learning Spanish – sample
IRB issues
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Clarify identity key issue
Video for dissemination or just research analysis,
supply appropriate checkbox statements on
parental consent.
Accuracy related to dissemintation of identifiable
images
Use lay language on parental consent for
“examining morphosyntactic and phonological
achievements…”
Only board member concern document support
from school
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Example #3 - Restaurant kitchens as Spanish
speaking communities of practice
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Recording conversation of workers in kitchens in
Mexican restaurants along with follow-up
interviews.
Interest in the way workers use teasing/joking
language
waiver of documentation of consent (oral consent)
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Example #3 - Restaurant kitchens as Spanish
speaking communities of practice
IRB issues
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Consent for audio recording in kitchen, what if some aren’t
interested.
Inclusion requirement of allowing audio recording
how much time between initial consent for kitchen audio
recording and interviews (or is there separate consent?)
specify exactly how the consent process would work
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Students as research participants - general
ethical issues
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Belmont principal of ‘respect for persons’ - students may have
perceptions of coercion
 May feel that if they decline participation it could affect the
instructor’s opinion of them and their grade.
If extra credit alternative ways to earn it equivalent in time effort
If paid/extra credit not so much as to be coercive
Campus policies on research using students as participants:
 recruitment not done in such a way as to be coercive
 Conduct your research in classes for which you have no
grading responsibility to the greatest extent possible
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When instructors are the researchers
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Blind process setup somehow so non-instructors do the
research - set up so instructors who are researchers can’t
know/infer who is participating.
research activity fits with course curricula and data has
dual purpose of course evaluation and research
Don’t’ know who allows their data to be used for research
until after grades have been assigned
If no other possible way then fully inform students in
syllabus and course announcements that research
participation is required - IRB evaluates on a case by
case basis.
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Purpose and Composition
of UIUC IRB
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To facilitate safe and ethical research with human
subjects conducted by UIUC faculty, staff and
students.
Two boards – Social/Behavioral/Educational and
Biomedical
Approximately 15 faculty, community members,
physicians on each board
IRB office - 7 person staff
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Required online training – CITI
Program + UIUC (home grown)
module)
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Belmont Report and CITI Course Introduction
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History and Ethical Principles - SBR
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Defining Research with Human Subjects - SBR
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Assessing Risk in Social Behavioral Sciences - SBR
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Informed Consent - SBR
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Privacy and Confidentiality - SBR
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Seven Criteria for
Approval
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Risks to subjects are minimized.
Risks to subjects are reasonable in
relation to anticipated benefits and the
importance of the knowledge that may
reasonably be expected to result.
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Seven Criteria for Approval
cont’d
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Selection of subjects is equitable.
Informed consent will be sought from
each prospective subject.
Informed consent will be
appropriately documented.
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Seven Criteria for Approval
cont’d
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The research plan makes adequate
provision for monitoring the data
collected.
Adequate provisions to protect the
privacy of subjects and to maintain the
confidentiality of data.
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Assistance Available
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Tip sheets online with examples
Phone: 333-2670
Email: [email protected]
Schedule appointments with IRB staff
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