Your Roadmap to IRB Approval
Roadmap to IRB Approval Applications Top 11 Tips for 2011
20112011IRB 101 – HUMAN
SUBJECTS RESEARCH
Boyd Herndon, JD, CIP
Director of Research Compliance
February 26, 2014
UNT Office of Research & Economic Development
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1. Verify Your Project is “Research” with “Human
Subjects” BEFORE You Start a UNT IRB Application
♦
RESEARCH: a systematic investigation, including research
development, testing and evaluation, designed to develop
or contribute to generalizable knowledge
♦
HUMAN SUBJECT: a living individual about whom an
investigator (whether professional or student) conducting
research obtains: (a) data through intervention or
interaction with the individual; or (b) identifiable private
information
» Intervention: physical procedures or manipulations of the
subject or the subject’s environment
» Interaction: communication or interpersonal contact between
investigator and subject
» Private information must be individually identifiable (i.e., the
identity of the subject is known or may readily be
ascertained) in order for obtaining private information to
constitute human subjects research
UNT Office of Research & Economic Development
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What is “Generalizable Knowledge”?
 YES: journal article, book chapter, academic
conference presentation or poster, thesis,
dissertation
 NO: classroom assignment, internal program
evaluation, UNT institutional research (note:
with no external publication of results for each
of these categories)
 If questions, call IRB staff for assistance
UNT Office of Research & Economic Development
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Columbia Food Complaint Study - 2001
 Columbia professor of Organizational Behavior
sent letters to 240 New York City restaurants
complaining about food poisoning for journal
article regarding how restaurants respond to
such complaints
Chez Josephine, 42nd St.
UNT Office of Research & Economic Development
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Texas Department of Public Safety Criminal
Convictions Database
 STATE OF TEXAS VS. DARLIE ROUTIER
CRIMINAL DISTRICT COURT #3 OF DALLAS CO COURT OFFENSE
09990015 (CAPITAL MURDER MULTIPLE) COURT OFFENSE
LITERAL F9639972R CITATION 19.03(A)(7) LEVEL AND DEGREE
OFFENSE FX (FELONY - CAPITAL FELONY) COURT DISPOSITION
310 (CONVICTED) COURT DISPOSITION DATE
02/04/1997 DATE OF SENTENCE/STATUS 02/04/1997 CAUSE
NUMBER F9639973MJ FINAL PLEADING N (NOT
GUILTY) COURT CONFINEMENT DEATH AGENCY RECEIVING
CUSTODY TDCJ COURT PROVISION LITERAL DEATH
SENTENCE COURT PROVISION 335 (DEATH SENTENCE)
UNT Office of Research & Economic Development
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2. If Study Requires Full Board Review (Less Than 5%
Do), Plan Ahead for Monthly Meeting Schedule
UNT INSTITUTIONAL REVIEW BOARD
Patricia Kaminski, Ph.D., IRB Chair, Psychology
Amyn Amlani, Ph.D., Speech and Hearing Sciences
Kathleen Duffy, Community Member
Rebecca Glover, Ph.D., Educational Psychology
Lisa Henry, Ph.D., Anthropology
Debbie Rohwer, Ph.D., Music Education
Richard Smith, Ph.D., Behavior Analysis
Chad Trulson, Ph.D., Criminal Justice
Mark Vosvick, Ph.D., Psychology
UNT Office of Research & Economic Development
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3. Determine Which IRB Application to Complete
 There are 2 IRB applications: a Minimal Review Application
and an Expedited or Full Board Review Application
♦
Both applications are available on the IRB’s main page at:
http://research.unt.edu/faculty-resources/research-integrity-andcompliance/use-of-humans-in-research\
 Answering 6 questions will determine which application you
should fill out based on the risks presented by your study:
♦
♦
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Will your research study involve any vulnerable populations such as
children, prisoners, pregnant women or mentally disabled persons?
Could public disclosure of any identifiable data you collect place the
participants at risk of criminal or civil liability or be damaging to the
participants’ financial standing, employability or reputation?
Will your study involve data collection procedures other than surveys,
educational tests, interviews, or observation of public behavior?
UNT Office of Research & Economic Development
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Which IRB Application? (continued)
♦
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Will your study involve any sensitive topics such as:
• Abortion
• Criminal History
• Sexual Activity
• Sexually Transmitted Diseases
• Prior Mental Health Diagnosis
• Victims of Violence
Will your study involve audio-recording or video-recording the participants?
Will your study involve obtaining or using individually identifiable information
from health care plans, health care clearinghouses, or health care providers?
If the answer to all of these questions is “no,” the Minimal Review Application
should be submitted to untirb@unt.edu
If the answer to any of these questions is “yes,” the Expedited/Full Board
Application should be submitted to untirb@unt.edu
UNT Office of Research & Economic Development
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4. Who is the “Investigator”?
 For those UNT theses or dissertations which
require IRB review, the graduate student is the
“Student Investigator” and the faculty
member is the “Supervising Investigator”
♦
♦
♦
IRB application is transmitted to untirb@unt.edu from the
faculty member’s email account
IRB Chair and IRB staff communicate with both regarding
approval questions
Office for Human Research Protections (OHRP) & UNT IRB
may audit study records for up to 3 years following end of
research; informed consent forms and copies of summary
study records must be retained at UNT
UNT Office of Research & Economic Development
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5. Submit IRB Training Certificates for All
Investigators & Key Personnel
 Submit a completion certificate for either the NIH or
CITI IRB training course for the Student Investigator,
the Supervising Investigator and all “key personnel”
responsible for the design, conduct, and reporting of
the study
 NIH IRB Training Course: “Protecting Human
Research Participants”
http://phrp.nihtraining.com/users/login.php OR
 CITI IRB Training Course: “Social & Behavioral
Human Subjects Research”
https://www.citiprogram.org/default.asp?language
=english (CITI= Collaborative Institutional Training Initiative, University of Miami)
UNT Office of Research & Economic Development
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6. Draft Informed Consent Forms That Clearly
Describe Study Activities and Potential Risks
 Informed consent is a process that seeks to assure that
research subjects voluntarily agree to participating in the
study after receiving required disclosures
 Obtain and document informed consent (from subject or from
parent or guardian if subject is under 18) and assent (from
subjects 7-17) in accordance with federal regulations and as
approved by the IRB; use templates for adult or minor
subjects on UNT IRB website (see templates on IRB main page at
http://research.unt.edu/faculty-resources/research-integrity-and-compliance/use-ofhumans-in-research
 Use lay language (with a goal of 8th grade reading level for
general population studies); clearly explain what participants
will be asked to do and what risks (if any) are involved in
those activities
UNT Office of Research & Economic Development
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Scope of Informed Consent
 Havasupai Tribe vs. Arizona State University
♦
♦
$700,000 settlement to tribe members in 2010
Blood samples/DNA obtained for diabetes study
also used to study mental illness & geographic
origin of tribe (in conflict with Havasupai legends)
UNT Office of Research & Economic Development
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7. Do International Requirements Apply?
 Office for Human Research Protections (OHRP)
maintains compilation of international
research requirements
♦See
OHRP website for country chart at:
http://www.hhs.gov/ohrp/international/intlcompi
lation/intlcompilation.html
♦Give special attention to local customs in drafting
written informed consent documents or proposing
alternative consent formats
UNT Office of Research & Economic Development
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8. Does Your Study Involve HIPAA?
 DHHS regulations to implement HIPAA (the Health Insurance
Portability & Accountability Act) restrict a researcher’s access
to and use of PROTECTED HEALTH INFORMATION (PHI)
 Will the proposed research involve:
♦any information that relates to the provision of health care to an
individual; the past, present, or future physical or mental health or
condition of an individual; or the past, present, or future payment for
the provision of health care to an individual;
♦that will be obtained from a health care plan, a health care
clearinghouse, or a health care provider that transmits any health care
information in electronic form in connection with a health care
transaction; and
♦such information identifies the individual or could reasonably be used
to identify the individual?
 If yes, researcher must comply with the HIPAA Privacy Rule
UNT Office of Research & Economic Development
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Methods for Research with PHI
 Obtain signed authorization from subjects
 Use de-identified PHI (all 18 identifiers removed)
 Access “Limited Data Set” pursuant to Data Use
Agreement
 Obtain waiver of authorization from IRB or Privacy
Board
 Review PHI that is necessary to prepare a protocol
(no data removal)
 Limit study to PHI of deceased individuals
For details, see NIH’s “Protecting Personal Information in
Research: Understanding the HIPAA Privacy Rule
http://privacyruleandresearch.nih.gov/pr_02.asp
UNT Office of Research & Economic Development
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9. Attach All of These Items When Your
Application is Submitted to untirb@unt.edu
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Copies of all NIH or CITI IRB training completion certificates
not previously submitted to the IRB Office
A copy of all recruitment materials (flyers, emails,
advertisements, script of classroom announcements)
A copy of approval letters from each data collection site
(other than UNT); example: school district approval
A copy of all informed consent forms/notices you plan to
use (unsigned; no contact with subjects before IRB approval)
A copy of all data collection instruments, intervention
protocols, and interview scripts
UNT Office of Research & Economic Development
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10. Contact the IRB Staff for Help
 The IRB GuideIines at
http://research.unt.edu/faculty-resources/research-integrityand-compliance/use-of-humans-in-research contain the
answers to the most commonly asked questions about the IRB
approval process
 For assistance beyond the IRB Guidelines, please contact the
IRB staff at untirb@unt.edu or call Jordan Harmon, Research
Compliance Analyst for Minimal Review studies, at 940-5654258, or Shelia Bourns, Research Compliance Analyst for
Expedited or Full Board Review studies, at 940-565-2018
 To request presentations about the IRB: Boyd Herndon,
Director of Research Compliance, Boyd.Herndon@unt.edu or
940-565-3941
UNT Office of Research & Economic Development
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