ND Department of Human Services
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Transcript ND Department of Human Services
Approval of Human Subjects
Research: Who needs it
and why?
Dr. Paula Garcia McAllister, IRB Director
Northern Arizona University
[email protected]
928-523-4236
Web: research.nau.edu/compliance/irb
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What is the IRB?
The Institutional Review Board is a panel of
researchers, non-researchers, and community
members concerned with protecting the rights
of individuals participating in research in terms
of:
Risk of physical, mental, emotional or financial
harm
Full disclosure of research procedures and
outcomes
Confidentiality of personal information, views
and opinions
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Does my project need to be
reviewed by the IRB?
Does it involve human subjects?
Will you be obtaining personal identifiable
information?
Does it involve a systematic investigation
in which you interact with people?
Will it be published, presented, or
disseminated beyond the classroom
environment?
Is it a thesis or dissertation?
3
What is human subjects research?
Research
is “a systematic investigation that is
designed to develop or contribute to
generalizable knowledge.”
Human
subject means “a living individual about
whom an investigator conducting research
obtains:
data through intervention or interaction with the
individual, or
identifiable private information.”
Source: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
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Past events shaped today’s
regulations:
Nazi Human Experimentation, search
Steven Spielberg Video Archive of
Nuremberg Trials
Monster Study, 1939, settled in 2007
Tuskegee Syphilis Study, 1932-1972
Guatemalan STD Study, 1946-1948
Stanford Prison Experiment, 1971
ASU – Havasupai Tribe settlement of
$700,000 plus scholarships and facilities
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What do I need to do as a
researcher?
Have a research plan that warrants the
use of human participants
Be knowledgeable about the federal
guidelines for human subjects research
(CITI tutorial)
Provide the IRB with a fully-detailed plan
for complying with the guidelines
Carry out your plan in good faith
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What are the responsibilities of the
faculty sponsor?
To guide the student researcher through
the research design process
To take the CITI tutorial
To review the student researcher’s IRB
application and provide feedback
To accept the student’s online IRB
application and respond to the conflict of
interest question
To make sure students file continuations
and amendments
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What will the IRB ask for?
1. Participants
How many?
Different groups
Age range
Social or occupational situations
Special categories:
◦ children, pregnant women and their fetuses, and prisoners are
considered vulnerable,
◦ economically or educationally disadvantaged persons, and
cognitively impaired persons may also require additional
safeguards
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2. Recruitment
What is your plan for recruiting
participants?
Include all flyers, email messages, memos,
etc. that will be used
Should include topic, what is expected
from participants, time/place, benefits and
risks, compensation, contact info
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3. Informed Consent
PLAN for disseminating informed consent
info to participants
How will it be delivered? (in person, email,
telephone)
Must include specific elements
Templates available on website
Signature can be waived in rare
circumstances
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4. Methodology and Data Collection
What instruments will be used: surveys,
focus groups, observations, etc.
Special requirements for photographs,
audio and video recordings
Off-campus sites, collaborators, partners,
etc.
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5. Confidentiality
Will identifiers be revealed?
How will confidentiality be maintained?
Data must be kept secure for 3 years
after completion of study
Photos and audio/video recordings
require a disposition plan and checkbox
on informed consent form
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6. Benefits
What are the potential benefits to the
participants?
What are the benefits to society or the
field?
There may not be any direct benefits to
individuals
Compensation is described separately and
should not be coercive, should be a small
token of thanks that is culturally
appropriate
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7. Risks
What are all the possible risks
participants may face, including
psychological, social, or physical
If minimal, say ‘no more than the risk
encountered in everyday life’
What will you do to minimize risks? (e.g.,
provide contact information for
counseling service)
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8. Attachments
Instruments: surveys, interview questions,
observation checklists, tests, etc.
Informed consent, parental consent, and
child assent documents
Letters of support/permission to collect
data
Recruitment flyers, emails, scripts
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What else will the IRB ask for?
Descriptions of the research free of jargon,
acronyms, and overly technical language
Support documents from collaborating
partners, target agencies, or off-campus
locales
Designation of other researchers involved
All instruments (surveys, questionnaires,
checklists, assessments, etc) even if in draft
form
Informed consent documents
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Types of Review
Full Board: greater than minimal risk,
vulnerable populations
Expedited: low risk, recordings, focus
groups, non-invasive procedures
Exempt: minimal risk, surveys, records
review, de-identified data
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Other Functions
Continuing review: extend IRB approval
beyond the usual 12 month period
Amendments: report changes in
instruments, participants, sample,
additional partners, sites, or researchers
Adverse events: unforeseen complications,
problems, or other research-related
negative consequences should be
reported to the IRB as soon as possible
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Consequences of NonCompliance
All researchers are required to follow the
guidelines in 45 CFR 46
Anybody can report non-compliance
Disciplinary actions can include
suspension or termination of research,
seizure of all data, prevention of
publication or presentation, written
reprimand, and sanction from conducting
future research
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Other Local IRBs
Flagstaff Medical Center: [email protected],
Director, Pediatrics/Perinatal Services & Evidence-Based
Practice OR [email protected]
Evidence-Based Practice Project Manager/Coordinator,
928-773-2346
Navajo Nation Human Research Review Board meets the
3rd Tuesday of each month at 9 AM in Window Rock, AZ,
open to the public: http://www.nnhrrb.navajo.org/
Hopi Cultural Preservation Office:
http://www.nau.edu/~hcpo-p/
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Resources
Federal Government: http://www.hhs.gov/ohrp/
IRB Profession: http://www.irbforum.org/,
http://www.primr.org/
Educational Research Ethics (AERA):
http://www.aera.net/AboutAERA/Default.aspx?
menu_id=90&id=717
Psychological Research Ethics (APA):
http://www.apa.org/ethics/
Political Science Research Ethics (APSA):
http://www.apsanet.org/content_9350.cfm?navI
D=12
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