Transcript The Institutional Review Board (IRB) at UK MARGARET MCGLADREY, MA RESEARCH ADMINISTRATIVE COORDINATOR 111 WASHINGTON AVE SUITE 104E LEXINGTON, KY 40536 859.218.2023 [email protected].

The Institutional Review Board
(IRB) at UK
MARGARET MCGLADREY, MA
RESEARCH ADMINISTRATIVE COORDINATOR
111 WASHINGTON AVE SUITE 104E
LEXINGTON, KY 40536
859.218.2023
[email protected]
What is the IRB and
Why Do I Need to Know About it?
 Board responsible for monitoring protection of
human subjects in research
 Managed by the Office of Research Integrity:
http://www.research.uky.edu/ori/
 Oversees all activities defined as involving “research”
and “human subjects”
 Ensures UK’s compliance with federal human
subjects protection laws and regulations
“Research” and “Human Subjects”
 Research: “A systematic investigation designed to
develop or contribute to generalizable knowledge.”
[45 CFR 46.102(d)]
 Human Subject: “A living individual about whom an
investigator conducting research obtains:
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Data through intervention or interaction with the individual,
or
Identifiable private information”
Human Subjects Protection Training
 Required of anyone involved with data collection or
analysis of research with human subjects
 Easiest way to meet training requirements is to do
the Collaborative IRB Training Initiative (CITI) webbased training
 http://www.research.uky.edu/ori/human/Human_
Research_Mandatory_Education.htm
 See handout for instructions on CITI
What Needs IRB Review?
 Almost all research with which you will be involved!
 Masters thesis or doctoral dissertations
 Pilot studies
 Clinical trials
 Behavioral and social science research
 Epidemiological research
 Human genetic research
 Retrospective chart reviews
 http://www.research.uky.edu/ori/human/WhatNee
dsIRBReview.htm
Which IRB and Who to Contact?

All College of Public Health protocols are reviewed by the Medical IRB
Exempt research contact at ORI:
Joe Brown, [email protected], 859-257-9084
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Expedited medical research contact at ORI:
Joanne Hines, [email protected], 859-257-9118
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Full medical research contacts at ORI:
IRB #1
Amy Kolasa, [email protected], 859-257-9425
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IRB #2
Jessica Roe, [email protected], 859-257-9118
IRB #3
Beverly Raisor, [email protected], 859-257-9819
IRB #6:
Suzanne Arnold, [email protected], 859-257-0582
What Type of Review? EXEMPT
 Studies eligible for exemption certificate:
1.
2.
Research conducted in established or commonly accepted
educational settings, involving normal educational practices, such as
(i) research on regular or special educational instructional strategies,
or (ii) research on the effectiveness of or the comparison among
instructional techniques, curricula, or classroom management
methods.
Research involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures or
observation of public behavior, unless: (i) information obtained is
recorded in such a manner that human subjects can be identified,
directly or through identifiers linked to the subjects; and (ii) any
disclosure of the human subjects responses outside the research
could reasonably place the subjects at risk of criminal or civil liability
or be damaging to the subjects financial standing, employability, or
reputation.
What Type of Review? EXEMPT
 Studies eligible for exemption certificate:
3.
4.
Research involving the use of education tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures, or
observation of public behavior that is not exempt under category (b)
of this section, if: (i) the human subjects are elected or appointed
public officials or candidates for public office; or (ii) federal
statute(s) require(s) without exception that the confidentiality of the
personally identifiable information will be maintained throughout
the research and thereafter.
Research involving the collection or study of existing data,
documents, records, pathological specimens, or diagnostic
specimens, if these sources are publicly available or if the
information is recorded by the investigator in such a manner that
subjects cannot be identified, directly or through identifiers linked to
the subjects. Must describe data collection procedures.
What Type of Review? EXEMPT
 Studies eligible for exemption certificate:
5.
6.
Research and demonstration projects which are conducted by or
subject to the approval of department or agency heads, and which are
designed to study, evaluate, or otherwise examine: (i) public benefit
or service programs; (ii) procedures for obtaining benefits or services
under those programs; (iii) possible changes in or alternatives to
those programs or procedures; or (iv) possible changes in methods or
levels of payments for benefits or services under those programs.
VERY RARELY USED
Taste and food quality evaluation and consumer studies, (i) if
wholesome food without additives are consumed or (ii) if a food is
consumed that contains a food ingredient at or below the level and
for a use found to be safe, or agricultural chemical or environmental
contaminant at or below the level found to be safe
How to Apply for Exemption Certificate
http://www.research.uky.edu/ori/ExemptionCertification
Application.htm
Contact: Joe Brown
 Core Application Form (download at URL above)
 Informed consent/assent process forms
 HIPAA forms if applicable. Studies are regulated by the
UK HIPAA Privacy Rule if the investigator obtains
protected health information from a UK covered entity
department. See
http://www.research.uky.edu/ori/HIPAA/main%20page
.htm
 Additional study materials and disclosures of financial
interests as applicable.
What Type of Review? EXPEDITED
 1) Clinical studies of particular types of drugs and
medical devices
 2) Collection of blood samples by finger stick, heel
stick, ear stick, or venipuncture from particular types
of individuals
 3) Prospective collection of biological specimens for
research purposes by noninvasive means. (Nail
clippings or hair)
 4) Collection of data through noninvasive procedures
(not involving general anesthesia or sedation)
routinely employed in clinical practice, excluding
procedures involving x-rays or microwaves.
What Type of Review? EXPEDITED
 5) Research involving materials (data, documents,
records, or specimens) that have been collected or will be
collected solely for nonresearch purposes (such as
medical treatment or diagnosis).
 6) Collection of data from voice, video, digital, or image
recordings made for research purposes.
 7) Research on individual or group characteristics or
behavior (including, but not limited to, research on
perception, cognition, motivation, identity, language,
communication, cultural beliefs or practices, and social
behavior) or research employing survey, interview, oral
history, focus group, program evaluation, human factors
evaluation, or quality assurance methodologies
How to Apply for Expedited Review
http://www.research.uky.edu/ori/MedicalExpedRevie
wApplication.htm
 Core Application forms
 Informed Consent/Assent process forms
 HIPAA forms if applicable (see Exempt review slide)
 Additional study materials
 Vulnerable Population forms
 Disclosure forms, if applicable.
 See checklist handout
What Type of Review? FULL
 Research involving greater than minimal risk to
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participants
Clinical intervention research
Research involving invasive procedures
Surveys or qualitative data collection on sensitive
topics or risky behaviors
Most studies involving vulnerable populations:
children, prisoners, pregnant women, and those with
impaired capacity to consent
Unlike other types of review, investigator must
attend this IRB meeting
Completing the Forms
 Give yourself at least one week, assuming that you
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have a detailed and thorough study protocol
Ask advisors and colleagues for examples of their
research descriptions (Form B) and consent/assent
forms as guidance
Use templates for informed consent/assent
documents
Set up an appointment with the appropriate ORI
staffer (Joe Brown, Joanne Hines) to review your
complete packet before submission of forms to ORI
Follow instructions re: # of copies required
Timelines for Review: EXEMPT
 One IRB member reviews materials
 Receive revisions or approval within 2-3 weeks of
submission to ORI
 If revisions are required, another 2-3 weeks for
approval notification.
 If IRB determines the study does not meet exempt
criteria, then resubmission as an expedited or full
review study is recommended by IRB
Timelines for Review: EXPEDITED
 Reviewed by one IRB member
 Receive revisions or approval within 2-3 weeks of
submission to ORI
 If revisions are required, another 2-3 weeks for
approval notification.
 If IRB determines the study does not meet exempt
criteria, then resubmission as an expedited or full
review study is recommended by IRB
Timelines for Review: FULL
 All Full Review protocols are placed on an IRB agenda
and reviewed by the Full Committee at a convened
meeting. Medical Full Reviews are assigned to meeting
dates on a first-come first-served basis.
 Investigators should receive requested revisions
(sometimes approval) within 1 week after the IRB
meeting.
 If the study requires minor revisions, the investigator can
expect to wait another week after submitting the IRB's
requested revisions to determine the status of their
study. If the study requires major revisions, the
investigator’s response will be scheduled for review at the
next available convened meeting (up to four weeks).
 Investigators should receive the IRB’s determination
within 1 week after the IRB meeting.
Modifications and Continuations
 If you need to modify your study protocol or change
study personnel, you must request a modification
prior to implementation. See instructions here:
http://www.research.uky.edu/ori/human/IRBRevie
wTypes.htm#Modification
 If your study continues beyond one year in duration,
you must have your protocol re-reviewed. See
instructions here:
http://www.research.uky.edu/ori/human/IRBRevie
wTypes.htm#CR
ORI Contact Information
 Office of Research Integrity
315 Kinkead Hall
University of Kentucky
Lexington, KY 40506-0057
Ph: (859) 257-9428
FAX: (859) 257-8995
Hours of Operation: 8am-12pm; 1pm-5pm
 Staff directory:
http://www.research.uky.edu/ori/staff.htm