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?

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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:
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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?
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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
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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
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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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