Modulation of Drug Intake: Evaluation of Opioid and Cannabinoid Interactions on Drug Self-Administration
Phase: PHASE1
Conditions: Marijuana Use, Opioid Use
Sponsor: Shanna Babalonis, PhD

 
Document Coversheet 
 
Study Title: Modulation of Drug Intake: Evaluation of Opioid and Cannabinoid Interactions 
on Drug Self-Administration 
Institution/Site: 
University of Kentucky 
Document (Approval/Update) Date: 
IRB: 3/12/2025 
NCT Number: 
NCT05485012 
IRB Number: 
45017 
Coversheet Created: 
2/5/2026 
 
 

PI CONTACT INFORMATION
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Principal Investigator (PI) role for E-IRB access
The PI is a UK-affiliated individual holding primary responsibility on the research project with the following permissions on the E-IRB
application:
1. Read;
2. write/edit;
3. receive communications; and
4. submit to the IRB (IR, CR, MR, Other Review*).
Non-UK individuals ("external") are not eligible for the role of Principal Investigator and cannot create a new application, nor will they be
listed in the "Change Principal Investigator" search tool.
If research is being submitted to or supported by an extramural funding agency such as NIH, a private foundation or a
pharmaceutical/manufacturing company, the PI listed on the grant application or the drug protocol must be listed as PI here. 
Please fill in any blank fields with the appropriate contact information (gray shaded fields are not editable). Required fields left blank will
be highlighted in pink after you click "Save".
To change home and work addresses, go to myUK and update using the Employee Self Service (ESS) portal. If name has changed,
the individual with the name change will need to submit a 'Name Change Form' to the Human Resources Benefits Office for entering
into SAP. The new name will need to be associated with the individual's Link Blue ID in SAP before the change is reflected in E-IRB.
Contact the HR Benefits Office for additional information.
The Principal Investigator's (PI) contact information is filled in automatically based on who logged in to create the application.
If you are not the Principal Investigator, do NOT add yourself as study personnel.
To change the PI contact information on an application in Researcher edit status:
click "Change Principal Investigator";
search for the PI's name using the search feature;
click "Select" by the name of the Principal Investigator, then "Save Contact Information".
You will automatically be added as study personnel with editing permissions to continue editing the application.
Change Principal Investigator:
First Name: Shanna
Room# &
Bldg: 845 Angliana Avenue
Last Name: Babalonis
Speed
Sort#: 
40508
Middle Name L
Department:
Dept Code: 7H150
PI’s
Employee/Student
ID#:
10001351
Rank: 
Associate Professor
PI's Telephone #: 8592571881
Degree: PhD
PI's e-mail
address: babalonis@uky.edu
PI's FAX
Number:
PI is R.N. 
Yes
No
HSP Trained: Yes
HSP Trained
Date: 6/4/2024
RCR Trained: Yes
Do you, the PI/researcher, have a significant financial interest related to your responsibilities at the University of Kentucky (that
requires disclosure per the UK administrative regulation 7:2)? 
Yes
No
Behavioral Science - 7H150

Section 4 Page 1 of 2

Section 4 Page 2 of 2

RISK LEVEL
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Indicate which of the categories listed below accurately describes this protocol
(Risk Level 1) Not greater than minimal risk
(Risk Level 2) Greater than minimal risk, but presenting the prospect of direct benefit to individual subjects
(Risk Level 3) Greater than minimal risk, no prospect of direct benefit to individual subjects, but likely to yield generalizable
knowledge about the subject's disorder or condition.
(Risk Level 4) Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious
problem affecting the health or welfare of subjects.
*“Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of
themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological
examination or tests.
Refer to UK's guidance document on assessing the research risk for additional information.
Section 5 Page 1 of 1

SUBJECT DEMOGRAPHICS
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Age level of human subjects: (i.e., 6 mths.; 2yrs., etc..) 18 to 50
Study Population:
Describe the characteristics of the subject population, including age range, gender, ethnic background and health status. Identify the criteria for inclusion and
exclusion. 
Provide the following information:
A description of the subject selection criteria and rationale for selection in terms of the scientific objectives and proposed study design;
A compelling rationale for proposed exclusion of any sex/gender or racial/ethnic group;
Justification for the inclusion of vulnerable groups such as children, prisoners, adults with impaired consent capacity, or others who may be vulnerable to
coercion or undue influence.
Please consider this FDA Guidance on Enrollment of Participants from Underrepresented Populations in Clinical Studies 
Participants will be otherwise healthy, non-physically dependent recreational opioid using adults with histories of marijuana use, ages 18-50, with BMI of
approximately less than/equal to 30. We will recruit participants from local flyers posted in public areas (libraries, coffee shops), magazines (free employment
periodicals), internet postings (Craigslist.com, ResearchMatch.com) and radio ads. To determine basic eligibility criteria, callers respond to our advertisements
(or word-of-mouth referrals) and complete a brief (approx. 20-min) telephone interview with qualified staff to determine eligibility for in-person screening. For
each study, we anticipate completing in-person screening appointments with approximately 75 individuals in order to enroll 15 individuals and obtain 12
completers/study. These attrition rates are based on our current studies enrolling similar populations (e.g., 5 screened for every participant enrolled; 20-25%
attrition with enrolled participants).
Inclusion criteria are itemized below. We conduct several screening visits prior to admission in order to fully assess inclusion/exclusion criteria. In order to
confirm that participants are not opioid dependent, we require each participant to provide at least one opioid negative urine sample in the absence of opioid
withdrawal signs/symptoms. To confirm that participants are active users of opioids, we will also require each participant to provide at least one opioid positive
sample. To confirm that participants have a history of marijuana use, at least one urine sample positive for marijuana/THC during screening. Participants must
have a urine sample negative for all drugs (except THC) and a negative breath alcohol test upon admission. 
1) English-speaking and literate male and female subjects, able to understand and sign Informed Consent Document 
2) ages 18 to 50 years old inclusive
3) not seeking treatment for opioid or any other drug use 
4) BMI of greater than/equal to 17 and approximately less than or equal to 30 
5) self-reported opioid use in the past year and past 30 days 
6) self-reported marijuana use of approximately greater than or equal to 3 occasions in the past 3 months
7) providing at least one observed urine sample testing positive for opioids
8) providing at least one observed urine sample testing positive for THC/cannabinoids
9) providing at least one observed urine sample testing negative for opioids in the absence of opioid withdrawal signs/symptoms
10) self-reported history of intranasal opioid use
11) self-reported history of smoked and/or vaporized marijuana use
12) normal nasal exam during screening
13) women of childbearing potential must not be pregnant or breastfeeding at screening and be using an effective form of contraception throughout study
participation
14) otherwise healthy as determined by the investigator based on medical history, physical examination, vital signs, laboratory chemistries (blood chemistry
with liver function tests and hematology, urinalysis and microscopic evaluation, 12-lead electrocardiogram) 
15) willing and able to comply with all testing requirements defined in the protocol
Exclusion criteria include: 
1) physical dependence on alcohol, opioids, benzodiazepines or sedative/hypnotics requiring medical management/detoxification
2) seeking treatment for drug use
3) acute medical problem (e.g., infection) or chronic medical problem requiring daily medication or ongoing medical care (e.g., hypertension, cardiovascular
disease, diabetes, respiratory disorders [e.g., asthma, COPD])
4) participants taking occasional OTC medications for non-clinically significant issues (e.g., mild seasonal allergies) will be asked to abstain from medication
use during enrollment - if participant is unable to abstain from medication, the participant will not qualify; daily oral contraceptive use is permitted
5) clinically significant abnormal ECG (as determined by study physician/cardiologist)
6) clinically significant abnormal laboratory findings (e.g., liver function tests greater than 3x the upper limits of normal range)
7) history of seizures 
8) clinically significant history of head injury
9) current or past history of major psychiatric disorder that would limit ability to participate in the study (e.g., bipolar disorder).
10) abnormal nasal exam that would suggest the condition would interfere/limit nasal drug administration; abnormal nasal condition that could be exacerbated
by drug exposure
11) recent use of CYP2C9 and CYP3A4 inhibitor or inducer
12) self report of past 30-day synthetic cannabinoid use (K2, Spice)
Attachments
Indicate the targeted/planned enrollment of the following members of minority groups and their subpopulations. Possible demographic
sources: Kentucky State Census, Kentucky Race/Ethnic Table, Kentucky Population Data. 
(Please note: The IRB will expect this information to be reported at Continuation Review time for Pre-2019 FDA-regulated
Expedited review and Full review applications):
Participant Demographics
Cisgender Man 
Cisgender Woman 
TGNB/TGE 
Unknown/Not Reported
Section 6 Page 1 of 3

American
Indian/Alaskan
Native:
Asian:
Black/African
American:
Latinx:
Native
Hawaiian/Pacific
Islander:
White:
American
Arab/Middle
Eastern/North
African:
Indigenous
People Around
the World:
More than One
Race:
Unknown or Not
Reported:
 
If unknown, please explain why:
Indicate the categories of subjects and controls to be included in the study. You may be required to complete additional forms depending on
the subject categories which apply to your research. If the study does not involve direct intervention or direct interaction with subjects, (e.g.,
record-review research, outcomes registries), do not check populations which the research does not specifically target. For example: a large
record review of a diverse population may incidentally include a prisoner or an international citizen, but you should not check those categories
if the focus of the study has nothing to do with that status.
Check All That Apply (at least one item must be selected)
Children (individuals under age
18)
Wards of the State (Children)
Emancipated Minors
Students
College of Medicine Students
UK Medical Center Residents or
House Officers
Impaired Consent Capacity
Adults
Pregnant Women/Neonates/Fetal
Material
Prisoners
Non-English Speaking (translated
long or short form)
International Citizens
Normal Volunteers
Military Personnel and/or DoD
Civilian Employees
Patients
Appalachian Population
ADDITIONAL INFORMATION:
Please visit the IRB Survival Handbook for
more information on:
Children/Emancipated Minors
Students as Subjects
Prisoners
Impaired Consent Capacity Adults
Economically or Educationally
Disadvantaged Persons
Other Resources:
UKMC Residents or House Officers
[see requirement of GME]
Non-English Speaking [see also the
E-IRB Research Description section
on this same topic]
International Citizens [DoD SOP may
apply]
Military Personnel and/or DoD Civilian
Employees
1
0
4
0
25
7
2
2
1
0
70
35
2
1
Section 6 Page 2 of 3

Traumatic brain injury or acquired brain
injury
Severe depressive disorders or Bipolar
disorders
Schizophrenia or other mental disorders
that
involve serious cognitive disturbances
Stroke
Developmental disabilities
Degenerative dementias
CNS cancers and other cancers with
possible CNS involvement
Late stage Parkinson’s Disease
Late stage persistent substance
dependence
Ischemic heart disease
HIV/AIDS
COPD
Renal insufficiency
Diabetes
Autoimmune or inflammatory disorders
Chronic non-malignant pain disorders
Drug effects
Other acute medical crises
Assessment of the potential recruitment of subjects with impaired consent capacity (or likelihood):
Check this box if your study does NOT involve direct intervention or direct interaction with subjects (e.g., record-review research, secondary
data analysis). If there is no direct intervention/interaction you will not need to answer the impaired consent capacity questions.
Does this study focus on adult subjects with any conditions that present a high likelihood of impaired consent capacity or fluctuations in
consent capacity? (see examples below)
Yes
No
If Yes and you are not filing for exemption certification, go to "Form T", complete the form, and attach it using the button below.
Examples of such conditions include:
Attachments
Section 6 Page 3 of 3

INFORMED CONSENT/ASSENT PROCESS/WAIVER
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For creating your informed consent attachment(s), please download the most up-to-date version listed in "All Templates" under the
APPLICATION LINKS menu on the left, and edit to match your research project.
Additional Resources:
Informed Consent/Assent Website
Waiver of Consent vs. Waiver of Signatures
Sample Repository/Registry/Bank Consent Template
Artificial Intelligence/Machine Learning in Human Research
Consent/Assent Tips:
If you have multiple consent documents, be sure to upload each individually (not all in a combined file).
If another site is serving as the IRB for the project, attach the form as a “Reliance Consent Form” so the document will not receive
a UK IRB approval stamp; the reviewing IRB will need to stamp the consent forms.
Changes to consent documents (e.g., informed consent form, assent form, cover letter, etc...) should be reflected in a 'tracked
changes' version and uploaded separately with the Document Type "Highlighted Changes".
It is very important that only the documents you wish to have approved by the IRB are attached; DELETE OUTDATED FILES --
previously approved versions will still be available in Protocol History.
Attachments that are assigned a Document Type to which an IRB approval stamp applies will be considered the version(s) to be
used for enrolling subjects once IRB approval has been issued. 
Document Types that do NOT get an IRB approval stamp are:
"Highlighted Changes",
"Phone Script", and
"Reliance Consent Form",
"Sponsor's Sample Consent Form".
How to Get the Section Check Mark
1. You must:
a) provide a response in the text box below describing how investigators will obtain consent/assent, and 
b) check the box for at least one of the consent items and/or check mark one of the waivers
2. If applicable attach each corresponding document(s) as a read-only PDF.
3. If you no longer need a consent document approved (e.g., closed to enrollment), or, the consent document submitted does not
need a stamp for enrolling subjects (e.g., umbrella study, or sub-study), only select "Stamped Consent Doc(s) Not Needed".
4. After making your selection(s) be sure to scroll to the bottom of this section and SAVE your work!
Check All That Apply
Informed Consent Form (and/or Parental Permission Form and/or translated short form)
Assent Form
Cover Letter (for survey/questionnaire research)
Phone Script
Informed Consent/HIPAA Combined Form
Debriefing and/or Permission to Use Data Form
Reliance Consent Form
Sponsor's sample consent form for Dept. of Health and Human Services (DHHS)-approved protocol
Stamped Consent Doc(s) Not Needed
Attachments
Attach Type
File Name
Informed Consent/HIPAA Combined Form 45017 M&O Study 1 Screening Consent - v10.0 - Feb 12 2025 (f).pdf
Informed Consent/HIPAA Combined Form 45017 M&O Study 1 Main Study Consent - v13.0 - Feb 12 2025 (f).pdf
Informed Consent/HIPAA Combined Form 45017 M&O Study 2 Screening Consent - v3.0 - Feb 12 2025 (f).pdf
Informed Consent/HIPAA Combined Form 45017 M&O Study 2 Main Study Consent - v13.0 - Feb 12 2025 (f).pdf
Section 7 Page 1 of 4

Informed Consent Process:
Using active voice, in the text box below, describe how investigators will obtain consent/assent. Include:
the circumstances under which consent will be sought and obtained
the timing of the consent process (including any waiting period between providing information and obtaining consent)
who will seek consent
how you will minimize the possibility of coercion or undue influence
the method used for documenting consent
if applicable, who is authorized to provide permission or consent on behalf of the subject
if applicable, specific instruments or techniques to assess and confirm potential subjects’ understanding of the information
Will electronic consent form/process be utilized on-site or remotely for this study?
Yes
No
If yes, in addition to addressing the above bullet points, describe the e-consent method and platform, including any hyperlinks, videos,
or enhancements used to convey information, if applicable. Attach a representation of the e-consent with signature fields. For
guidance, see the ORI E-Consent web page.
Note: all individuals authorized to obtain informed consent should be designated as such in the E-IRB "Study Personnel" section of
this application.
Special considerations may include:
Obtaining consent/assent for special populations such as children, prisoners, or people with impaired decisional capacity
Research Involving Emancipated Individuals 
If you plan to enroll some or all prospective subjects as emancipated, consult with UK legal counsel prior to submitting this
application to the IRB. Include research legal counsel’s recommendations in the "Additional Information" section as a separate
document.
Research Involving Non-English Speaking Subjects 
For information on inclusion of non-English speaking subjects, or subjects from a foreign culture, see IRB Application Instructions
for Recruiting Non-English Speaking Participants or Participants from a Foreign Culture.
Research Repositories 
If the purpose of this submission is to establish a research repository describe the informed consent process. For guidance
regarding consent issues, process approaches, and sample language see the Sample Repository/Registry/Bank Consent
Template.
Trained research staff will obtain sober, written informed consent prior to participation in the screening process (using the Screening
Consent form). An investigator or study coordinator will obtain sober, written study consent prior to research participation (with the
Main Study Consent form). Participants will be required to have a negative alcohol breathalyzer test prior to signing consent and not
be stumbling, nodding or appearing intoxicated. Volunteers who have a positive breathalyzer test or appear intoxicated will be asked
to return at a later time when they are sober. Volunteers must be fluent in English and are required to take a literacy test to determine
reading level. Volunteers will meet with the investigator, physician or the study coordinator on an outpatient basis prior to admission in
order to review all experimental procedures and allow the volunteer to ask any questions regarding the protocol prior to signing the
study Informed Consent form. There is no time limit on this process. The investigator will also inform the volunteer that this is not a
treatment program and that signing the consent form does not obligate them to participate. Each volunteer will receive a copy of the
signed consent forms.
Participants may also be consented via Zoom. All consenting procedures will be identical to an in-person consent, except the PI will
be present via Zoom (instead of the same room). The participant will be screened by in-person research staff (e.g., participants
provided photo ID, negative breathalyzer samples and protocol-appropriate urine samples; staff confirmed participants were not
intoxicated). Research staff will provide a copy of the hardcopy (paper) consent form to the participant, which will be verified on
camera by the PI. This process allows for a thorough discussion and exchange of information with the participant, a method to ensure
the participant’s identity, and documentation of the consent itself.
Subjects may ask study personnel questions about the study or make complaints at any time. All staff will be aware to contact Drs.
Babalonis or Lofwall about any subject concern or complaint as it arises. Phone numbers for the study PI, as well as the Office of
Research Integrity are included in the consent form. It is expected that providing a phone number and contact information for the PI
may offer a safe, confidential and reliable channel for participants to express problems, concerns or questions and obtain study
information.
Request for Waiver of Informed Consent Process
If you are requesting IRB approval to waive the requirement for the informed consent process, or to alter some or all of the
elements of informed consent, complete, Section 1 and Section 2 below.
Note: The IRB does not approve waiver or alteration of the consent process for greater than minimal risk research, except
for planned emergency/acute care research as provided under FDA regulations. Contact ORI for regulations that apply to
single emergency use waiver or acute care research waiver (859-257-9428).
Section 7 Page 2 of 4

SECTION 1.
Check the appropriate item:
I am requesting a waiver of the requirement for the informed consent process.
I am requesting an alteration of the informed consent process.
If you checked the box for this item, describe which elements of consent will be altered and/or omitted, and justify the
alteration.
SECTION 2.
Explain how each condition applies to your research.
a) The research involves no more than minimal risk to the subject.
b) The rights and welfare of subjects will not be adversely affected.
c) The research could not practicably be carried out without the requested waiver or alteration.
d) Whenever possible, the subjects or legally authorized representatives will be provided with additional pertinent information
after they have participated in the study.
Section 7 Page 3 of 4

Request for Waiver of Signatures
If you are requesting IRB approval to waive the requirement for signatures on informed consent forms, your research
activities must fit into one of three regulatory options:
1. The only record linking the participant and the research would be the consent document, and the principal risk would be
potential harm resulting from a breach of confidentiality (e.g., a study that involves participants who use illegal drugs).
2. The research presents no more than minimal risk to the participant and involves no procedures for which written consent
is normally required outside of the research context (e.g., a cover letter on a survey, or a phone script).
3. The participant (or legally authorized representative) is a member of a distinct cultural group or community in which
signing forms is not the norm, the research presents no more than minimal risk to the subject, and there is an appropriate
alternative mechanism for documenting that informed consent was obtained.
Select the option below that best fits your study. 
If the IRB approves a waiver of signatures, participants must still be provided oral or written information about the study.
To ensure you include required elements in your consent document, use the Cover Letter Template as a guide. There is
an English and a Spanish version.
 
Option 1
Describe how your study meets these criteria:
a) The only record linking the participant and the research would be the consent document:
b) The principal risk would be potential harm resulting from a breach of confidentiality (i.e., a study that involves subjects
who use illegal drugs).
Under this option, each participant (or legally authorized representative) must be asked whether (s)he wants to sign a
consent document; if the participant agrees to sign a consent document, only an IRB approved version should be
used.
Option 2
Describe how your study meets these criteria:
a) The research presents no more than minimal risk to the participant:
b) Involves no procedures for which written consent is normally required outside of the research context (i.e. a cover
letter on a survey, or a phone script):
Option 3
Describe how your study meets these criteria:
a) The subject (or legally authorized representative) is a member of a distinct cultural group or community in which
signing forms is not the norm.
b) The research presents no more than minimal risk to the subject.
c) There is an appropriate alternative mechanism for documenting that informed consent was obtained.
Section 7 Page 4 of 4

RESEARCH DESCRIPTION
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comment(s)
You may attach a sponsor’s protocol pages in the “Additional Information” section and refer to them where necessary in
the Research Description. However, each prompt that applies to your study should contain at least a summary paragraph.
Pro Tips:
Save your work often to avoid losing data.
Use one of the attachment buttons in this section or under the Additional Information section to include supplemental
information with your application. During the document upload process, you will be able to provide a brief description
of the attachment.
Background
Include a brief review of existing literature in the area of your research. You should identify gaps in knowledge that should be addressed
and explain how your research will address those gaps or contribute to existing knowledge in this area. For interventional research,
search PubMed and ClinicalTrials.gov for duplicative ongoing and completed trials with same condition and intervention(s).
Opioid misuse in the United States is at epidemic levels – in 2015, 4.1 million individuals 12 years and older reported misuse of
prescription opioids and heroin and 2.6 million Americans met criteria for opioid use disorder. On an average day in the U.S., 3,900
individuals initiate non-medical use of prescription opioids and 580 initiate heroin use. Across the whole of 2014, 2.1 million individuals
initiated non-medical prescription opioid use, second only to marijuana (which had 2.6 million initiates). There were more than 33,000
opioid-related overdose deaths in 2015,29 with an average of 78 individuals dying every day from an opioid-related overdose30 –
these deaths occur in pain patients and illicit drug users and can be either intentional or unintentional. This substantial increase in
opioid abuse is occurring on a background of a changing landscape of marijuana availability, use and misuse. Marijuana use is now at
peak levels in the U.S., with 8.3% of individuals 12 years and older reporting past month marijuana use. Although marijuana and opioids
are misused at high rates (with many more taking these drugs therapeutically), there is little to no data available on their co-use,
specifically in regard to the impact of marijuana use on opioid response and safety. 
A 2014 paper published in JAMA received considerable attention from both the popular press and scientific and medical communities
– it reported on the association between medical marijuana laws (MMLs) and rates of opioid overdose mortality. The authors examined
the opioid-related death rates (confirmed by death certificate reports) in all 50 U.S. states for several years before and after MMLs
were enacted in a time-series analysis. When an age-adjusted model was implemented, states with MMLs had higher rates of opioid
overdose deaths compared to states with no MMLs. However, when the models were further adjusted to capture enacted laws (when
citizens of the state actually had access to marijuana, rather than the year the law was passed), the opposite relationship emerged –
MMLs decreased the rates of opioid overdose deaths by 24.8% annually. However, the exact relationship between these two variables
is unclear, as these observations are all correlational and subject to several confounds. If it is marijuana use itself that provides a
protective effect, there are no data to directly support this – there is no information regarding the rates of marijuana use (e.g., post-
mortem marijuana positive samples) in those who died vs. a comparator group across states. One key factor may be the use of tax
revenue (often 25% and greater) from marijuana sales for drug use treatment and prevention/education programs. An extreme
example is Colorado (where there were $1 billion in medical/recreational marijuana sales in 2016 and $100 million in tax revenue)
which devotes approximately $25 million dollars per year to substance abuse programs (with an additional $11 million for
mental/behavioral health programs, $7.5 million for health care, and $45 million for schools).
Another theory on why MMLs could be protective surrounds drug substitution – that is, replacing opioid use with marijuana use.
Marijuana clearly has a superior safety profile (e.g., little risk of overdose) compared to opioids (e.g., high risk of respiratory
depression/overdose), which would likely make drug substitution a safer choice and potentially reduce death rates. There is some
evidence that substitution occurs in a subset of chronic pain patients. However, there is relatively weak evidence that marijuana is a
substitute in those who have opioid use disorder. Data from controlled human laboratory studies (our laboratory and others) suggest
that pharmaceutical cannabinoids are a weak-to-moderate substitute for opioids during opioid withdrawal. Overall, additional research
needs to be conducted to determine if 1) marijuana use changes the safety profile and physiological effects of opioids across a full
range of doses, 2) marijuana use modulates opioid response on an array of abuse-related measures, 3) marijuana use modulates
opioid intake, 4) opioid use modulates marijuana intake, and 5) there are behavioral/cognitive effects of the two drugs in combination.
Objectives
List your research objectives. Please include a summary of intended research objectives in the box below.
Aim 1: To explore the effects of vaporized doses marijuana over a range of THC concentrations (0, 10 & 30 mg THC) on response to
intranasal oxycodone (0, 15 & 30 mg) using a full battery of pharmacodynamic outcomes, including safety/physiological response and
abuse-related subjective and observer-rated effects. Secondary aims will examine the psychomotor/cognitive effects across the dose
conditions. 
Aim 2: To examine 1) the impact of marijuana use on opioid drug-taking behavior by examining the effects of smoked marijuana pre-
treatment (0, 30 mg THC) on intranasal oxycodone (0, 15 & 45 mg) self-administration, and 2) the impact of opioid use on marijuana
drug-taking behavior by examining intranasal oxycodone pre-treatment (0, 45 mg) on smoked marijuana (0, 10 and 30 mg THC) self-
administration. 
Section 9 Page 1 of 11

Overall, these timely and innovative studies will provide some of the first empirical data on the pharmacodynamic interaction of agents
from the two most commonly misused drug classes, yielding outcomes on the safety, physiological response, abuse liability, and
impact on reinforcing efficacy. These studies may simultaneously inform regulatory considerations related to an emerging public health
question (i.e., is marijuana functionally protective against the deleterious effects of opioid misuse or does it cause further harm to
those who have ongoing opioid misuse problems) and provide new controlled information on potential interactions relevant to clinical
practice, prescribing, and public safety.
Study Design
Describe and explain the study design (e.g., observational, secondary analysis, single/double blind, parallel, crossover, deception, etc.).
Clinical Research: Indicate whether subjects will be randomized and whether subjects will receive any placebo.
Community-Based Participatory Research: If you are conducting community-based participatory research (CBPR), describe
strategies for involvement of community members in the design and implementation of the study, and dissemination of results from
the study.
Qualitative research: Indicate ranges where flexibility is needed, if a fixed interview transcript is not available, describe interview
topics including the most sensitive potential questions.
Research Repositories: If the purpose of this submission is to establish a Research Repository (bank, registry) and the material
you plan to collect is already available from a commercial supplier, clinical lab, or established IRB approved research repository,
provide scientific justification for establishing an additional repository collecting duplicate material. Describe the repository design
and operating procedures. For relevant information to include, see the UK Research Biospecimen Bank Guidance or the UK
Research Registry Guidance.
If the study design includes using or developing Artificial Intelligence (AI), see “AI Protocol Submission Guidance for
Researchers” on the Artificial Intelligence/Machine Learning in Human Research webpage for additional information.
Two studies will be conducted during this 4-5 year project using randomized, within-subject, double-blind, double-dummy, placebo-
controlled designs and enrolling samples of non-physically dependent recreational opioid users with histories of marijuana use as
inpatients.
Attachments
Subject Recruitment Methods & Advertising
Describe how the study team will identify and recruit subjects. Please consider the following items and provide additional information as
needed so that the IRB can follow each step of the recruitment process.
How will the study team identify potential participants?
Who will first contact the potential subjects, and how?
Will you use advertisements? If so, how will you distribute those?
How and where will the research team meet with potential participants?
If applicable, describe proposed outreach programs for recruiting women, minorities, or disparate populations.
How you will minimize undue influence in recruitment?
Attach copies of all recruiting and advertising materials (emails, verbal scripts, flyers, posts, messages, etc.).
For additional information on recruiting and advertising:
IRB Application Instructions - Advertisements
PI Guide to Identification and Recruitment of Human Subjects for Research
Volunteers are recruited primarily through regular newspaper ads, local flyers posted in public areas (e.g., bars, marketplaces), internet
postings (including Craigslist.com; ResearchMatch.com; Facebook; BuildClinical; UK Cannabis Center website; among others), by
geo-fencing techniques (advertising within a defined geographical location), and by word-of-mouth. We will also utilize IRB-approved
radio advertisements for subject recruitment. Flyers and advertisements have our telephone number listed on them, so volunteers
typically make initial contact with us by phone or through Facebook, BuildClinical, UK Cannabis Center website, among others. We will
also access the UK CCTS Participant Self-Referral Database and will contact individuals who have expressed interest in marijuana-
related studies. When calling, a volunteer will speak with one of our trained research staff, all of whom have completed human subjects
protection training (web-based CITI and HIPAA-compliance modules). If a volunteer self-discloses information that makes them
potentially eligible for the study, he/she will be invited to come in for a screening appointment. Screening is completed by one of our
research assistants/research nurses/investigators at the Robert Straus Behavioral Research Facility and/or the UK CCTS. Study
investigators may interact with volunteers in any of these settings and appropriate cautions are in place to ensure privacy during the
intake process. 
We will primarily use ads/flyers to advertise (see attached; approved by UK PR). We are also requesting permission to use Facebook
and BuildClinical (see attached screenshot; approved by UK PR) to communicate with participants and to advertise our study.
Attachments
Attach Type
File Name
Advertising
Update to Recruitment Plan.pdf
Advertising
Facebook page - revised Dec 17 APPROVED.pdf
Advertising
Business Card 1 APPROVED.pdf
Section 9 Page 2 of 11

Advertising
Non-Dep OPI Ad Blue APPROVED.pdf
Advertising
Non-Dep OPI Ad Plain APPROVED.pdf
Advertising
Non-Dep Vol Ad Blue APPROVED.pdf
Advertising
PR Approved Ads.pdf
Advertising
45017 Ads - July 2019.pdf
Advertising
20185 RADIO DRAFT 02 24 2020 APPROVDED[1].pdf
Advertising
Cannabis Ad (f) PR STAMPED.pdf
Advertising
Cannabis Ad (f).pdf
Advertising
BuildClinical Landing Page - PR stamped.pdf
Advertising
BuildClinical Opioid ads - PR stamped.pdf
Advertising
BuildClinical Secure questionnaire.pdf
Advertising
MJ & Opioid Cards - Final 6.1 - PR APPROVED.pdf
Advertising
MJ & Opioid Cards - Final 6.1 - CLEAN COPY.pdf
Advertising
MJ & Opioid Digital Ads - Final 6.1 - PR APPROVED.pdf
Advertising
MJ & Opioid Digital Ads - Final 6.1 - CLEAN COPY.pdf
Advertising
MJ & Opioid Flyers - Final_6.1 - PR APPROVED.pdf
Advertising
MJ & Opioid Flyers - Final 6.1 - CLEAN COPY.pdf
Section 9 Page 3 of 11

Back to Top
Research Procedures
Describe how the research will be conducted.
What experience will study participants have?
What will study participants be expected to do?
How long will the study last?
Outline the schedule and timing of study procedures.
Provide visit-by-visit listing of all procedures that will take place.
Identify all procedures that will be carried out with each group of participants.
Describe deception and debrief procedures if deception is involved.
Differentiate between procedures that involve standard/routine clinical care and those that will be performed specifically for this
research project. List medications that are explicitly forbidden or permitted during study participation.
Please see the attached document outlining the research procedures.
Attachments
Attach Type
File Name
ResearchProcedures
45017 Research Procedures April 20 2023.pdf
ResearchProcedures
Example Questionnaire Packet.pdf
ResearchProcedures
Screening Packet.pdf
Data Collection & Research Materials
In this section, please provide the following:
Describe all sources or methods for obtaining research materials about or from living individuals (such as specimens, records,
surveys, interviews, participant observation, etc.), and explain why this information is needed to conduct the study.
For each source or method described, please list or attach all data to be collected (such as genetic information, interview scripts,
survey tools, data collection forms for existing data, etc.).
If you will conduct a record or chart review, list the beginning and end dates of the records you will view.
See the general guidelines in the “AI Design Description” under AI Protocol Submission Guidance for Researchers on the Artificial
Intelligence/Machine Learning in Human Research webpage if Artificial Intelligence (AI) is being used to collect and/or analyze
data.
Outcome measures for this study will include physiological measures (such as heart rate, blood pressure, oxygen saturation,
respiratory rate, and body temperature), performance on subject-rated questionnaires (such as visual analog questionnaires, Addiction
Research Center Inventory, street value questionnaire, and Pharmacological Class Questionnaire), observer ratings,
psychomotor/cognitive tasks (such as the Digit Symbol Substitution Task, Trails Making Task), ocular assessments (such as the Flicker
Fusion).
Attachments
Attach Type
File Name
DataCollection
Example Session Packet.pdf
Resources
Describe the availability of the resources and adequacy of the facilities that you will use to perform the research. Such resources may
include:
Staffing and personnel, in terms of availability, number, expertise, and experience;
Computer or other technological resources, mobile or otherwise, required or created during the conduct of the research;
Psychological, social, or medical services, including equipment needed to protect subjects, medical monitoring, ancillary care, or
counseling or social support services that may be required because of research participation;
Resources for communication with subjects, such as language translation/interpretation services.
The proposed studies will be conducted at the Straus Behavioral Science Research Building and at the UK Center for Clinical
Translational Science (CCTS) Inpatient Research Unit at the UK Hospital. The laboratory and CCTS staff have experience working with
and monitoring volunteers with drug abuse histories during participation in clinical pharmacology research protocols. The CCTS is a
12-bed unit and is supervised by nursing staff around the clock. The unit is a secure setting in which it is possible to ensure that
volunteers are abstinent from unauthorized drug use during their participation and provides the intensive monitoring and care
necessary to conduct these studies safely. 
At admission, prior to dosing, every enrolled participant's urine sample will be tested for synthetic cannabinoids (K2, Spice) with
standard immunoassay tests. Participants testing positive will be discharged (as these chemical pose a safety risk for study
participation). Participants testing positive for THC at admission (which may be common, given the time course of the metabolites and
the study population), confirmatory testing (GCMS) will be completed for (approximately) the first three days after admission to make
Section 9 Page 4 of 11

sure that THC metabolite concentrations are indicative of past use and are washing out (e.g., metabolite concentrations decreasing).
During admission, Urine samples will be collected and tested daily (via immunoassay dipstick) to confirm abstinence from illicit drug
use. Participants are maintained on a caffeine-free diet throughout their inpatient stay. Because approximately 90% or more of our
volunteers are smokers, we allow smoking during these inpatient studies in a designated outdoor area under staff supervision, but
smoking is prohibited during all experimental sessions and for a minimum of 30 min prior to each session. Participants will be required
to finish eating approx. 1.5 hr prior to drug administration. Aside from these restrictions, volunteers receive three meals/day and a
variety of snacks, fresh fruit and supplemental food for evening snacks or to substitute for a regular meal. Participants are provided
with recreational activities (reading, movies, video and board games, crafts) for the duration of their stay. Participants are monitored
daily by nursing staff who collect vital signs, weight, and query side effects. Under these conditions, we have been successful in
recruiting and retaining participants in studies lasting up to 6 weeks and longer. 
Participants will be transported under supervision from the CCTS to the Straus Behavioral Science Research Facility, in which the
smoking laboratory is located for each experimental session. The laboratory has on-site medical staff (Dr. Lofwall; a full time ACLS-
trained research nurse) and the offices of the PI, Co-Is, the lab supervisor, and research assistants/nurses. This team has safely and
successfully conducted several human drug studies in this facility and it is fully equipped for the proposed work, including a BLS crash
cart in case of emergency (e.g., naloxone, oxygen, AED), secure Schedule I drug storage facilities, a marijuana smoking laboratory
that is equipped with a state-of-the-art ventilation system (equipped with an OSHA-regulated air exchange system for indoor smoking),
physiological monitoring equipment, experimental test areas, private exam rooms, wet lab for urine testing and accommodations for
observing urine samples. Staff have experience working with and monitoring volunteers receiving opioids and cannabinoids, including
smoked marijuana, and conducting drug interaction and self-administration sessions. The laboratory is designed to accommodate
comfortable sessions, with a spacious dayroom where participants may relax under supervision when not participating in data
collection. After session completion, staff will transport participants back to the CCTS Inpatient Unit (<2 miles away). Participants will
complete ECGs once per week to monitor safety.
Potential Risks & Benefits
Risks
Describe any potential risks – including physical, psychological, social, legal, ability to re-identify subjects, or other risks. Assess
the seriousness and likelihood of each risk.
Which risks may affect a subject’s willingness to participate in the study?
Describe likely adverse effects of drugs, biologics, devices or procedures participants may encounter while in the study.
Qualitative research - describe ethical issues that could arise while conducting research in the field and strategies you may use to
handle those situations.
Describe any steps to mitigate these risks.
Benefits
Describe potential direct benefits to study participants – including diagnostic or therapeutic, physical, psychological or emotional,
learning benefits. This cannot include incentives or payments.
State if there are no direct benefits.
Describe potential benefits to society and/or general knowledge to be gained.
Describe why potential benefits are reasonable in relation to potential risks. If applicable, justify why risks to vulnerable subjects are
reasonable to potential benefits.
During the screening process, it is possible that volunteers may feel uncomfortable answering personal questions about their health,
psychiatric and drug use histories. However, they may stop answering questions at any point (and are informed of this option during the
informed consent process). During the screening, subjects will also have a venipuncture in order to draw blood for testing purposes. It
is possible that this could lead to bruising, infection, or a blood clot, but this risk is minimal and limited by the sterile procedures,
universal precautions and well-trained nursing staff. 
The primary risks to the study participants are related to the ingestion of the study drugs. The proposed drug doses of oxycodone and
marijuana have been safely administered to humans in previous studies. All participants will be current opioid users with experience
using opioids intranasally, have a history of marijuana use and will be familiar with the effects of these drugs. The possible side effects
of these compounds are well known and documented. Although many of the participants will likely have histories of co-abusing
marijuana and opioids, there is little to no data on their interaction effects (which will be assessed in these studies). The administration
of any drug involves some risks simply because individuals differ in their reactions to drugs. Individuals with known allergies or adverse
reactions to the study drugs/substances (e.g., marijuana-induced panic) will be excluded. During the test sessions, the participants are
never left unattended and a trained nurse will monitor safety throughout the session. We will monitor oxygen saturation, blood pressure
and heart rate once per minute during session and respiration rate and expired CO2 at least every 15 min for the first 2 hr after drug
administration and every 30 min thereafter. A registered nurse will monitor these readings throughout each session; after session has
been completed, nurses on the inpatient unit will continue to monitor participant safety. 
Oxycodone produces the typical side effect profile of mu opioid agonists, and these may include nausea, vomiting, headache, dry
mouth, itchiness, drowsiness, sweating, dizziness, stimulation, somnolence, lightheadedness, restlessness, a feeling of well being,
talkativeness, urinary retention and constipation. More serious side effects may include allergic reaction and respiratory depression.
The doses were selected with care to preclude those that produce clinical relevant respiratory depression (Study 1: 15, 30 mg IN;
Study 2: 15, 45 mg IN) and are doses we have administered in prior studies without serious adverse events. Participants will be
required to have previous recreational experience with opioids, which will reduce the likelihood of an allergic reaction. Our laboratory
Section 9 Page 5 of 11

has a long history of safely administering opioids through various routes (IV, IN and oral) on both an inpatient and outpatient basis and
the procedures and doses in this study were selected with care to minimize risk. 
Marijuana is a partial CB1/CB2 agonist that has a high therapeutic index and low risk of acute toxicity. Marijuana with high levels of THC
(up to 23%, with doses of 29.3, 49.1 and 69.4 mg THC administered) has been safely administered to a similar population in several
research studies without complication. High potency strains (with up to 30%+ THC) and cannabinoid concentrates (with up to 89-90%
THC) are legally available in U.S. dispensaries and in several international countries (e.g., Netherlands). Similar strains are also being
used for medicinal purposes (and medicinal strains are being diverted for recreational use). Participants reporting adverse events from
previous marijuana use (e.g., anxiety, panic) or a history of a condition that would increase the likelihood of an adverse event (e.g.,
bipolar disorder, asthma) will not be enrolled. Marijuana produces an array of side effects that are typical of CB1/CB2 agonists,
including feeling high/intoxicated, euphoria, increased hunger and thirst, perceptual changes, anxiousness, lightheadedness/ dizziness,
performance impairment, drowsiness, orthostatic hypotension, resting increases or decreases in blood pressure, increased heart rate,
red/bloodshot eyes, dry mouth, sleepiness, concentration difficulties, faintness, restlessness, confusion, loss of coordination,
shakiness, stomach upset, headache, paleness, flushing, sweating, slurred speech, fatigue. All of the participants will have a history of
recreational marijuana use and will be familiar with its effects, decreasing the risk of unanticipated reactions. We have selected
inclusion criteria similar to previous well-controlled marijuana studies (conducted by NIDA, our research group, and others) and studies
that have specifically examined high potency marijuana strains. Our laboratory has experience administering smoked and oral
pharmaceutical cannabinoids on both an inpatient and outpatient basis and the procedures and doses in this study were selected with
care to minimize risk. We will also administer the dose combinations in ascending order (lower dose combinations prior to highest
combination) for the first three participants. Safety data will be submitted to the IRB and with the IRB's approval, we will then initiate
fully randomized dosing (see attached Research Description for further details). 
The cold water task produces some painful sensations. However, the participant has full control over their exposure and can remove
their arm from the cold water at any point during the trial. The safety cut-of of 5 minutes of immersion was selected to avoid the risk of
tissue damage. We have successfully and safely used this model in several other studies without any safety concerns.
The degree of risk to which individual study volunteers are exposed as a consequence of their research participation is low. In
contrast, the potential and probable benefits to be derived by society and to public health and safety appear to be considerable. The
major benefits of this study are scientific and clinical ones related to the knowledge gained regarding concurrent marijuana/opioid use
and how marijuana may affect the decision to take opioids. Individual volunteers are expected to benefit personally from the medical
and psychiatric evaluations, referrals for medical and psychiatric treatment that are provided whenever appropriate, and the financial
payments, which are provided for their research participation. Overall, the risk/benefit ratio appears favorable and the conduct of this
research seems well justified.
Available Alternative Opportunities/Treatments
Describe alternative treatments or opportunities that might be available to those who choose not to participate in the study, and which
offer the subject equal or greater advantages. If applicable, this should include a discussion of the current standard of care treatment(s).
This is not a treatment study - there are no available alternative treatments.
Back to Top
Records, Privacy, and Confidentiality
Specify where the data and/or specimens will be stored and how the researcher will ensure the privacy and confidentiality of both.
Specify who will have access to the data/specimens and why they need access.
Describe how data will be managed after the study is complete:
If data/specimens will be maintained, specify whether identifiers will be removed from the maintained information/material.
If identifiers will not be removed, provide justification for retaining them and describe how you will protect confidentiality.
If the data/specimens will be destroyed, verify that this will not violate retention policies and will adhere to applicable facility
requirements.
If this study will use de-identified data from another source, describe what measures will be taken to ensure that subject identifiers are
not given to the investigator. If applicable, describe procedures for sharing data/specimens with collaborators not affiliated with UK.
If the study will use Artificial Intelligence (AI) to collect and/or analyze data, see the “Data Security” section under AI Protocol
Submission Guidance for Researchers on the Artificial Intelligence/Machine Learning in Human Research webpage.
For additional considerations: 
Return of Research Results or Incidental Research Findings 
HIPAA policies 
FERPA policies 
Procedures for Transfer agreements 
Information regarding multi-site studies 
NIH Genomic Data Sharing (GDS) Policy 
Digital Data
Section 9 Page 6 of 11

The new data security compliance requirements under 28 CFR Part 202 are in effect as of 10/6/25. For any questions please contact
Sara Poll, UK’s Research Security Administrator, researchsecurity@uky.edu
Sources of research material obtained from our volunteers during screening and study participation include: blood and urine
specimens, expired breath samples for alcohol, electrocardiogram, self-reported information gathered from the volunteer about their
and their families psychiatry and medical history, demographic information, volunteer self-report and study staff observation of drug
effects, vital signs (oxygen saturation, temperature, blood pressure, pulse), and other physiologic indices (e.g., pupil diameter). All
sources of research material will be obtained in a HIPAA compliant manner and are collected specifically for the proposed study by
trained study staff. The principal investigator and medical team will have access to private health information about volunteers so that
determination of study eligibility can be determined. All data with personal health information is kept in a locked file cabinet separate
from other volunteer data without identifiable private health information. Prior medical records may be obtained with volunteer consent
if there is any question about the volunteers’ health history. Each participant will sign a form that details the HIPAA-compliant manner in
which research material is collected.
All sources of research material will be obtained in a HIPAA compliant manner and are collected specifically for the proposed study by
trained study staff. Identifying information will be stored in a separate locked area from all other data and codes that could link the two.
Incidental materials containing subject identifiers will be shredded or incinerated. Identification and access of identifying
data/specimens will be available only to study investigators when it is detrimental to subject safety or the conduct of the research
protocol. For example, if a subject has an adverse event we will want to obtain a quantitative drug screen to identify whether there may
have been illicit drug use while in the study versus a true adverse even related to the study procedures. In addition, a Certificate of
Confidentiality will be obtained.
All participants are carefully screened (history and physical exam with physician, routine labs such as CBC, urinalysis, ECG and
psychiatric assessment) to exclude those with potential increased risk of adverse effects. Those at increased risk include a history of
heart disease, history of seizure or head injury associated with more than a brief loss of consciousness, hypertension, psychosis, and
history of adverse reactions to the study drugs. During sessions participants remain under careful observation and are monitored
continuously by on-site research staff. Vital signs, including ongoing monitoring of blood pressure and heart rate, will be collected at
regular intervals throughout the dosing period. Clinical staff (e.g., M.D. or R.N.) will be available for management of medical issues.
Trained personnel draw blood according to routine hospital procedures under sterile conditions that should significantly reduce the risk
of any adverse effects from blood draws. In addition, we have substantial experience testing cannabinoids and alcohol in human
subjects under a variety of dosing conditions. Female participants will be given pregnancy tests prior to each experimental session to
ensure that we do not administer drugs to a pregnant woman. To protect confidentiality, all research subjects are identified by a subject
identification code (Subject ID) consisting of their initials and sequentially assigned subject numbers on all forms and data files, and
not by their names. Actual subject names and corresponding subject IDs are kept in a locked master file separate from the actual data
collected during the study. All personal and experimental information is kept locked and is accessible only to key personnel involved in
the research. All volunteer information and data are confidential and never released to anyone outside of the project purview without
the volunteer’s written authorization. The identity of participants is never revealed in research reports. All intake documentation that
contains PHI is handled separately from the actual data collected during the study. For instance, written records with PHI will be stored
in a separate, locked area from all other de-identified data and codes linking the two will be kept under lock and key. Electronic data
with PHI (e.g., blood and urine test results) are stored in the University of Kentucky’s medical database that has limited medical
personnel access, is password protected, and monitored for abnormal activity. Incidental materials containing subject identifiers will be
shredded or incinerated.
Participants choosing to leave the study early will be advised to complete a vitals check before leaving the research facility (Inpatient
Unit, Straus Building). However, we are not permitted to retain participants against their will, so they may choose to leave AMA before a
vitals check or before research staff are able to notify to the investigator/physician.
UK IRB policies state that IRB-related research records must be retained for a minimum of 6 years after study closure.
Check this item to confirm that you will retain all IRB-related records for a minimum of 6 years after study closure.
Payment
Describe the incentives (monetary or other) being offered to subjects for their participation. If monetary compensation is offered,
indicate the amount and describe the terms and schedule of payment. Please review this guidance for more information on payments to
subjects, including restrictions and expectations.
Participants will be paid for each screening visit at the rate of $50 per visit. If only a urinalysis or ECG or vital signs are needed
subjects will be paid $15. Volunteers will earn $25 for their 2- to 4-week follow-up appointment after study discharge. Volunteers will
earn $80 base pay for each session in which they participate. While enrolled as inpatients, participants will be paid $60 per night. They
will earn a completion bonus of $60/night if they complete the full study. If the volunteer chooses to leave before completing the study,
they will not receive the completion bonus. However, if the participant is discharged early due to unrelated medical issues or
investigator decision related to safety (e.g., an adverse reaction to the study drug), they will be paid the completion bonus for the
duration of their participation.
Costs to Subjects
Include a list of services and/or tests that will not be paid for by the sponsor and/or the study (e.g., MRI, HIV). Keep in mind that a
subject will not know what is “standard” – and thus not covered by the sponsor/study – unless you tell them.
Section 9 Page 7 of 11

There are no costs to volunteers who participate in this study.
Data and Safety Monitoring
The IRB requires review and approval of data and safety monitoring plans for greater than minimal risk research or NIH-funded/FDA-
regulated clinical investigations.
If you are conducting greater than minimal risk research, or your clinical investigation is NIH-funded, describe your Data and Safety
Monitoring Plan (DSMP). Click here for additional guidance on developing a Data and Safety Monitoring Plan.
If this is a non-sponsored investigator-initiated protocol considered greater than minimal risk research, and if you are planning on
using a Data and Safety Monitoring Board (DSMB) as part of your DSMP, click here for additional guidance for information to
include with your IRB application.
Please see attached DSMP. (within grant application)
Back to Top
Future Use and Sharing of Material (e.g., Data/Specimens/Information)
If the material collected for this study will be used by members of the research team or shared with other researchers for future studies,
please address the following:
list the biological specimens and/or information that will be kept
briefly describe the types, categories and/or purposes of the future research
describe any risks of the additional use
describe privacy/confidentiality protections that will be put into place
describe the period of time specimens/information may be used
describe procedures for sharing specimens/information with secondary researchers
describe the process for, and limitations to, withdrawal of specimens/data
There is a possibility that data/tissue/specimens/blood collected may be shared with other investigators in the future. If that is the case,
the data/tissue/specimen/blood will not contain identifying information unless the individual provides consent/authorization or an
Institutional Review Board (IRB) approves the research. Language to this effect is included in IRB-approved Marijuana & Opioid
Screening, Study 1 & Study 2 consent forms. 
See Confidentiality section of Research Description for additional information about confidentiality/privacy protections.
Are you recruiting or expect to enroll Non-English Speaking Subjects or Subjects from a Foreign Culture? (does not include short
form use for incidentally encountered non-English subjects)
Yes
No
Non-English Speaking Subjects or Subjects from a Foreign Culture
Recruitment and Consent:
Describe how information about the study will be communicated to potential subjects appropriate for their culture, and if necessary,
how new information about the research may be relayed to subjects during the study. 
When recruiting Non-English-speaking subjects, provide a consent document in the subject’s primary language. After saving this
section, attach both the English and translated consent documents in the “Informed Consent" section. 
Cultural and Language Consultants:
The PI is required to identify someone who is willing to serve as the cultural consultant to the IRB.
This person should be familiar with the culture of the subject population and/or be able to verify that translated documents are
the equivalent of the English version of documents submitted.
The consultant should not be involved with the study or have any interest in its IRB approval.
Please include the name, address, telephone number, and email of the person who agrees to be the cultural consultant for
your study.
ORI staff will facilitate the review process with your consultant. Please do not ask them to review your protocol separately.
For more details, see the IRB Application Instructions on Research Involving Non-English Speaking Subjects or Subjects from a
Foreign Culture. 
Local Requirements:
If you will conduct research at an international location, identify and describe:
Section 9 Page 8 of 11

relevant local regulations
data privacy regulations
applicable laws
ethics review requirements for human subject protection
Please provide links or sources where possible. If the project has been or will be reviewed by a local ethics review board, attach a
copy in the “Additional Information/Materials” section. You may also consult the current edition of the International Compilation of
Human Research Standards
Section 9 Page 9 of 11

Does your study involve HIV/AIDS research and/or screening for other reportable diseases (e.g., Hepatitis C, etc…)?
Yes
No
HIV/AIDS Research
If you have questions about what constitutes a reportable disease and/or condition in the state of Kentucky, see ORI’s summary
sheet: “Reporting Requirements for Diseases and Conditions in Kentucky" [PDF].
HIV/AIDS Research: There are additional IRB requirements for designing and implementing the research and for obtaining
informed consent. Describe additional safeguards to minimize risk to subjects in the space provided below.
For additional information, visit the online IRB Survival Handbook to download a copy of the "Medical IRB's requirements for
Protection of Human Subjects in Research Involving HIV Testing" [D65.0000] [PDF], and visit the Office for Human Research
Protections web site for statements on AIDS research, or contact the Office of Research Integrity at 859-257-9428.
PI-Initiated FDA-Regulated Research
Is this an investigator-initiated study that:
1) involves testing a Nonsignificant Risk (NSR) Device, or
2) is being conducted under an investigator-held Investigational New Drug (IND) or Investigational Device Exemption (IDE)?
Yes
No
PI-Sponsored FDA-Regulated Research
If the answer above is yes, then the investigator assumes the regulatory responsibilities of both the investigator and sponsor. The
Office of Research Integrity provides a summary list of sponsor IND regulatory requirements for drug trials [PDF], IDE regulatory
requirements for SR device trials [PDF], and abbreviated regulatory requirements for NSR device trials [PDF]. For detailed
descriptions see FDA Responsibilities for Device Study Sponsors or FDA Responsibilities for IND Drug Study Sponsor-
Investigators.
Describe the experience/knowledge/training (if any) of the investigator serving as a sponsor (e.g., previously held an
IND/IDE); and
Indicate if any sponsor obligations have been transferred to a commercial sponsor, contract research organization (CRO),
contract monitor, or other entity (provide details or attach FDA 1571).
This study is covered by IN 141,123 - see attached confirmation. Through her work with Dr. Walsh, Dr. Babalonis has gained
extensive experience submitting INDs, amendments, is familiar with reporting requirements for adverse events, annual progress
reporting requirements and record keeping requirements. She is also familiar with Good Clinical Practice guidelines and has
participated in numerous related trainings over the years. She has assisted with training and managing a multi-disciplinary staff on
regulatory affairs, confidentiality issues, reporting requirements, data management, data quality assurance, data storage, and
human subjects’ protections. Dr. Babalonis has completed the FDA investigational drug sponsorinvestigator training available
through the ORI.
IRB policy requires mandatory training for investigators who are also FDA-regulated sponsors (see Sponsor-Investigator FAQs).
A sponsor-investigator must complete the applicable Office of Research Integrity web based training, (drug or device) before final
IRB approval is granted.
Has the sponsor-investigator completed the mandatory PI-sponsor training prior to this submission?
Yes
No
If the sponsor-investigator has completed equivalent sponsor-investigator training, submit documentation of the content for the
IRB’s consideration. 
Attachments
Attach Type
File Name
SponsorInvTraining
SBabalonis Certificate.pdf
SponsorInvTraining
IND 141123.pdf
Section 9 Page 10 of 11

Section 9 Page 11 of 11

HIPAA
0 unresolved
comment(s)
Is HIPAA applicable?
Yes
No
(Visit ORI's Health Insurance Portability and Accountability Act (HIPAA) web page to determine if your research falls under the HIPAA
Privacy Regulation.)
I have attached a HIPAA Waiver of Authorization.
Yes
No
Attachments
Section 10 Page 1 of 1

STUDY DRUG INFORMATION
0 unresolved
comment(s)
Drugs are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and articles (other than food)
intended to affect the structure or any function of the body of man or other animals.
The term drug may include:
FDA approved drugs,
unapproved use of approved drugs,
investigational drugs or biologics,
other compounds or products intended to affect structure or function of the body, and/or
complementary and alternative medicine products such as dietary supplements, substances generally recognized as safe (GRAS)
when used to diagnose, cure mitigate, treat or prevent disease, or clinical studies of e-cigarettes examining a potential therapeutic
purpose.
Does this protocol involve a drug including an FDA approved drug; unapproved use of an FDA approved drug; and/or an
investigational drug?
Yes
No
If yes, complete the questions below. Additional study drug guidance.
LIST EACH DRUG INVOLVED IN STUDY IN THE SPACE BELOW
Drug Name:
Study 1: 
Oxycodone (0, 15, 30 mg), intranasal 
Marijuana (0, 10, 30 mg THC), vaporized
Study 2: 
Oxycodone (0, 15, 45 mg), intranasal 
Marijuana (0, 10, 30 mg THC), vaporized 
Study 2 Qualification sessions:
Oxycodone (0, 30 mg), intranasal 
Marijuana (0, 20 mg THC), vaporized
Note: Inpatient studies are required by Hospital Policy to utilize Investigational Drug Service (IDS) pharmacies (Oncology or
Non-Oncology). Use of IDS is highly recommended, but optional for outpatient studies. Outpatient studies not using IDS
services are subject to periodic inspection by the IDS for compliance with drug accountability good clinical practices. 
Indicate where study drug(s) will be housed and managed:
Investigational Drug Service (IDS) UK Hospital
Other Location:
Oxycodone and matched placebo will be stored and managed at the IDS. Marijuana will be stored at the Robert Straus
Research Facility in our secure Schedule I drug storage area.
Is the study being conducted under a valid Investigational New Drug (IND) application?
Yes
No
If Yes, list IND #(s) and complete the following:
IND 141,123
IND Submitted/Held by:
Sponsor:
Held By:
Investigator:
Held By: Shanna Babalonis,
Ph.D.
Other:
Held By:
Section 11 Page 1 of 2

Checkmark if the study is being conducted under FDA’s Expanded Access Program (e.g., Treatment IND)
or if this is an Individual Patient Expanded Access IND (FDA Form 3926).
See FDA's Expanded Access Program Information for Individual Patient Expanded Access INDs, and attach
the following:
FDA Form 3926;
FDA expanded access approval or correspondence;
Confirmation of agreement from manufacturer or entity authorized to provide access to the product.
For guidance and reporting requirements at the conclusion of treatment see the Expanded Access SOP.
Complete and attach the required Study Drug Form picking "Study Drug Form" for the document type. Any
applicable drug documentation (e.g., Investigator Brochure; approved labeling; publication; FDA correspondence,
etc.) should be attached using "Other Drug Documentation" for the document type.
Attachments
Attach Type
File Name
Study Drug Form
SBabalonis - DEA license.pdf
Study Drug Form
Study Drug Marijuana-Oxycodone.pdf
Section 11 Page 2 of 2

STUDY DEVICE INFORMATION
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Medical devices are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention
of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals.
A DEVICE may be a:
component, part, accessory;
assay, reagent, or in-vitro diagnostic device;
software, digital health, or mobile medical app;
other instrument if intended to affect the structure or function of the body, diagnose, cure, mitigate, treat or prevent disease; or
a homemade device developed by an investigator or other non-commercial entity and not approved for marketing by FDA.
For additional information, helpful resources, and definitions, see ORI's Use of Any Device Being Tested in Research web page.
Does this protocol involve testing (collecting safety or efficacy data) of a medical device including an FDA approved device,
unapproved use of an approved device, humanitarian use device, and/or an investigational device?
Yes
No
[Note: If a marketed device(s) is only being used to elicit or measure a physiologic response or clinical outcome, AND, NO data will
be collected on or about the device itself, you may answer “no” above, save and exit this section, (Examples: a chemo drug study
uses an MRI to measure tumor growth but does NOT assess how effective the MRI is at making the measurement; an exercise study
uses a heart monitor to measure athletic performance but no safety or efficacy information will be collected about the device itself, nor
will the data collected be used for comparative purposes against any other similar device).]
If you answered yes above, please complete the following questions.
LIST EACH DEVICE BEING TESTED IN STUDY IN THE SPACE BELOW
Device Name:
Is the study being conducted under a valid Investigational Device Exemption (IDE),
Humanitarian Device Exemption (HDE) or Compassionate Use?
Yes
No
If Yes, complete the following: 
IDE or HDE #(s)
IDE/HDE Submitted/Held by:
Sponsor:
Held By:
Investigator:
Held By:
Other:
Held By:
 Check if this is a Treatment IDE or Compassionate Use under the Food and Drug Administration (FDA)
Expanded Access program.
For Individual or Small Group Expanded Access, see FDA's Early Expanded Access Program Information,
and attach the following:
FDA expanded access approval or sponsor’s authorization;
An independent assessment from an uninvolved physician, if available;
Confirmation of agreement from manufacturer or entity authorized to provide access to the product.
For guidance and reporting requirements at the conclusion of treatment see the Medical Device SOP.
Section 12 Page 1 of 2

Does the intended use of any research device being tested (not clinically observed) in this study meet the regulatory definition
[FDA's PDF] of Significant Risk (SR) device?
Yes. Device(s) being tested in this study presents a potential for serious risk to the health, safety, or welfare of a subject and
(1) is intended as an implant; or (2) is used in supporting or sustaining human life; or (3) is of substantial importance in
diagnosing, curing, mitigating or treating disease, or otherwise prevents impairment of human health; or (4) otherwise presents
a potential for serious risk to the health, safety, or welfare of a subject.
No. All devices being tested in this study do not present a potential for serious risk to the health, safety, or welfare of
subjects/participants.
Complete and attach the required Study Device Form, picking the "Study Device Form" for the document type. Any
applicable device documentation (e.g., Manufacturer information; patient information packet; approved labeling; FDA
correspondence, etc.) should be attached using "Other Device Documentation" for the document type.
Attachments
Section 12 Page 2 of 2

RESEARCH SITES
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To complete this section, ensure the responses are accurate then click "SAVE".
A) Check all the applicable sites listed below at which the research will be conducted. If none apply, you do not need to check any
boxes.
UK Sites
UK Classroom(s)/Lab(s)
UK Clinics in Lexington
UK Clinics outside of Lexington
UK Healthcare Good Samaritan Hospital
UK Hospital
Schools/Education Institutions
Fayette Co. School Systems *
Other State/Regional School Systems
Institutions of Higher Education (other than UK)
*Fayette Co. School systems, as well as other non-UK
sites, have additional requirements that must be
addressed. See ORI's IRB Application Instructions -
Off-site Research web page for details.
Other Medical Facilities
Bluegrass Regional Mental Health Retardation Board
Cardinal Hill Hospital
Eastern State Hospital
Norton Healthcare
Nursing Homes
Shriner’s Children’s Hospital
Veterans Affairs Medical Center
Other Hospitals and Med. Centers
Correctional Facilities
Home Health Agencies
International Sites
Research activities conducted at performance sites that are not owned or operated by the University of Kentucky (UK) or
at sites that do not fall under the UK IRB’s authority, are subject to special procedures for coordination of research
review. Additional information is required (see IRB Application Instructions - Off-Site Research web page), including:
A letter of support and local context is required from non-UK sites. See Letters of Support and Local Context on the
IRB Application Instructions - Off-Site Research web page for more information.
Supportive documentation, including letters of support, can be attached below. When attaching reliance documents,
please ensure that you select the correct ‘Document Type’ from the drop-down menu. See below for the
“Document Types” in bold, followed by examples of reliance documents for each type:
- Individual Investigator Agreement (IIA)
A completed Individual Investigator Agreement
Section 13 Page 1 of 2

- IRB Approval (Non-UK)
A Letter of Approval from a Non-UK IRB
- IRB Authorization Agreement (IAA)
A SMART IRB Agreement
An OHRP Agreement
A DoD Agreement
An IREx Reliance Notification
Any Reliance Agreement
- Letter of Support & Local Context
A Letter of Support from an organization at which some research activities are occurring
Communications Plan
Local Context Form
Please reach out to IRBReliance@uky.edu if you have any questions or concerns.
NOTE: If the non-UK sites or non-UK personnel are engaged in the research, there are additional federal and
university requirements which need to be completed for their participation. For instance, the other site(s) may need
to complete their own IRB review, or a cooperative review arrangement may need to be established with non-UK
sites.
Questions about the participation of non-UK sites/personnel should be discussed with the ORI staff at (859) 257-
9428.
List all other non-UK owned/operated locations where the research will be conducted:
Robert Straus Research Facility
Describe the role of any non-UK site(s) or non-UK personnel who will be participating in your research.
Please describe the plan for the management of reporting unanticipated problems, noncompliance, and submission of
protocol modifications and interim results from the non-UK sites:
Attachments
B) If your research involves collaboration with any sites and/or personnel outside the University of Kentucky, then it is considered
multisite research and IRB reliance issues will need to be addressed. This may include national multi-center trials as well local studies
involving sites/personnel external to UK. If you would like to request that the University of Kentucky IRB (UK IRB) serve as the lead
IRB for your study, or if you would like the UK IRB to defer review to another IRB, please contact the IRBReliance@uky.edu.
Section 13 Page 2 of 2

RESEARCH ATTRIBUTES
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Instructions: For various reasons, it is necessary to determine whether your research activities meet the definition of clinical
research and/or a clinical trial. Your responses to the next series of questions will make that determination. For more details on
the definitions, go to ORI’s clinical research vs. clinical trial web page or visit NIH's decision tree for the NIH Clinical Trial
definition. 
Contact the Clinical Research Support Office (CRSO) if your study provides clinical services (e.g., labs, biopsies, tissue
samples, physical exams, PT, counseling) regardless of payer (grant, federal, UK, industry), utilizes UKHC space, or meets the
NIH definition of a clinical trial (thereby requiring registry with CT.gov) as your study will need to be entered in OnCore to ensure
appropriate regulatory tracking and billing. Visit CRSO FAQs for more information; requests for CCTS/CRSO services can be
submitted via their service request form. For other questions, you can contact the CRSO Director, Jessica Heskel.
My research activities include one or more of the following:
Patient-oriented research regarding mechanisms of human disease, therapeutic interventions, clinical studies, or
development of new technologies
Yes
No
Material of human origin (such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague)
directly interacts with human subjects
Yes
No
Epidemiologic or Behavioral Studies
Yes
No
Outcomes Research or Health Services Research
Yes
No
Does your research study involve one or more human subjects prospectively assigned into one or more interventions
(which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or
behavioral outcomes? If yes, your study meets the NIH definition of a clinical trial.
Yes
No
Indicate the items below that apply to your research. Depending on the items applicable to your research, you may be required to
complete additional forms or meet additional requirements. Contact the ORI (859-257-9428) if you have questions about additional
requirements.
Not applicable
Check All That Apply
Academic Degree/Required Research
Alcohol/Drug/Substance Abuse Research
Biological Specimen Bank Creation (for sharing)
Cancer Research
CCTS-Center for Clinical & Translational Science
Certificate of Confidentiality
Collection of Biological Specimens for banking and use
Community-Based Participatory Research
Deception
Educational/Student Records (e.g., GPA, test scores)
Emergency Use (Single Patient)
Gene Transfer
For additional requirements and information:
Cancer Research (MCC PRMC)
Certificate of Confidentiality (look up
"Confidentiality/Privacy...")
CCTS (Center for Clinical and Translational
Science)
Clinical Research (look up "What is the definition
of....)
Clinical Trial
Collection of Biological Specimens for Banking
(look up "Banks, Repositories, Registries...")
Collection of Biological Specimens (look up
"Repositories, Registries, Specimen/Tissue
Banks...")
Community-Based Participatory Research (look
up "Community-Engaged...")
Data & Safety Monitoring Board (DSMB)
*For Medical IRB: Service Request Form for
CCTS DSMB
Data & Safety Monitoring Plan
Deception*
Section 14 Page 1 of 2

Genetic Research
NIH Genomic Data Sharing (GDS) (databases such as GWAS,
dbGaP, GenBank)
Treatment with Human Cells, Tissues, and Cellular and Tissue
Based Products
Individual Expanded Access or Compassionate Use
International Research
Planned Emergency Research Involving Exception from
Informed Consent
Recombinant DNA
Registry or data repository creation
Stem Cell Research
Suicide Ideation or Behavior Research
Survey Research
Transplants
Use, storage and disposal of radioactive material and radiation
producing devices
Vaccine Trials
*For deception research, also go to the E-IRB
Application Informed Consent section,
checkmark and complete "Request for Waiver
of Informed Consent Process"
Emergency Use (Single Patient) [attach
Emergency Use Checklist] (PDF)
Genetic Research (look up "Banks,
Repositories, ...Genetic/Genomic Data Sharing...")
Gene Transfer
*For gene transfer research, also go to the E-
IRB Application Other Review Committees
section, and checkmark Institutional Biosafety
Committee
International Research (look up "International &
Non-English Speaking")
NIH Genomic Data Sharing (GDS) Policy (PDF)
Planned Emergency Research Involving
Exception to Informed Consent*
*For Planned Emergency Research Involving
Waiver of Informed Consent, also go to the E-
IRB Application Informed Consent section,
checkmark and complete "Request for Waiver
of Informed Consent Process"
Use, storage and disposal of radioactive material
and radiation producing devices
Section 14 Page 2 of 2

FUNDING/SUPPORT
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If the research is being submitted to, supported by, or conducted in cooperation with an external or internal agency or funding program, indicate below
all the categories that apply. 
Not applicable
Check All That Apply
Grant application pending
(HHS) Dept. of Health & Human Services
(NIH) National Institutes of Health
(CDC) Centers for Disease Control & Prevention
(HRSA) Health Resources and Services
Administration
(SAMHSA) Substance Abuse and Mental Health
Services Administration
(DoJ) Department of Justice or Bureau of Prisons
(DoE) Department of Energy
(EPA) Environmental Protection Agency
Federal Agencies Other Than Those Listed Here
Industry (Other than Pharmaceutical Companies)
Internal Grant Program w/ proposal
Internal Grant Program w/o proposal
National Science Foundation
Other Institutions of Higher Education
Pharmaceutical Company
Private Foundation/Association
U.S. Department of Education
State
Click applicable listing(s) for additional requirements and information:
(HHS) Dept. of Health & Human Services
(NIH) National Institutes of Health
(CDC) Centers for Disease Control & Prevention
(HRSA) Health Resources & Services Administration
(SAMHSA) Substance Abuse & Mental Health Services Administration
Industry (Other than Pharmaceutical Companies) [IRB Fee Info-look up "Does the
IRB Charge a Fee..."]
National Science Foundation
(DoEd) U.S. Department of Education
(DoJ) Department of Justice or Bureau of Prisons 
(DoE) Department of Energy Summary and Department of Energy Identifiable
Information Compliance Checklist
(EPA) Environmental Protection Agency
Other:
Specify the funding source and/or cooperating organization(s) (e.g., National Cancer Institute, Ford Foundation, Eli Lilly & Company, South
Western Oncology Group, Bureau of Prisons, etc.):
 NIDA grant R01 DA045700-01
Add Related Grants
If applicable, please search for and select the OSPA Account number or Electronic Internal Approval Form (eIAF) # (notif #)
associated with this IRB application using the "Add Related Grants" button. 
If required by your funding agency, upload your grant using the "Grant/Contract Attachments" button.
Add Related Grants
Grant/Contract Attachments
Attach Type
File Name
GrantContract
Grant Application.pdf
The research involves use of Department of Defense (DoD) funding, military personnel, DoD facilities, or other DoD resources. (See DoD SOP
and DoD Summary for details)
Yes
No
Using the “attachments” button (below), attach applicable materials addressing the specific processes described in the DoD SOP.
DOD SOP Attachments
Section 15 Page 1 of 2

Additional Certification: (If your project is federally funded, your funding agency may request an Assurance/ Certification/Declaration of Exemption
form.) Check the following if needed:
Protection of Human Subjects Assurance/Certification/Declaration of Exemption (Formerly Optional Form – 310)
Assurance/Certification Attachments
Section 15 Page 2 of 2

OTHER REVIEW COMMITTEES
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If you check any of the below committees, additional materials may be required with your application submission.
Does your research fall under the purview of any of the other review committees listed below? [If yes, check all that apply and attach
applicable materials using the attachment button at the bottom of your screen.]
Yes
No
Institutional Biosafety Committee
Radiation Safety Committee
Radioactive Drug Research Committee
Markey Cancer Center (MCC) Protocol Review
and Monitoring Committee (PRMC)
Graduate Medical Education Committee (GME)
Office of Medical Education (OME)
Additional Information
Institutional Biosafety Committee (IBC) - Attach required IBC
materials
Radiation Safety Committee (RSC) - For applicability, see
instructions
Radioactive Drug Research Committee (RDRC)
Markey Cancer Center (MCC) Protocol Review and Monitoring
Committee (PRMC)** - Attach MCC PRMC materials, if any, per
instructions.
Office of Medical Education (OME)
Graduate Medical Education Committee (GME)
Attachments 
** If your study involves cancer research, be sure to select "Cancer Research" in the "Research Attributes"
section. ORI will send your research protocol to the Markey Cancer Center (MCC) Protocol Review and Monitoring
Committee (PRMC). The MCC PRMC is responsible for determining whether the study meets the National Cancer Institute
(NCI) definition of a clinical trial and for issuing documentation to you (the investigator) which confirms either that PRMC
approval has been obtained or that PRMC review is not required. Your IRB application will be processed and reviewed
independently from the PRMC review.
Section 16 Page 1 of 1

ADDITIONAL INFORMATION/MATERIALS
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Do you want specific information inserted into your approval letter?
Yes
No
Approval Letter Details:
If you wish to have specific language included in your approval letter (e.g., serial #, internal tracking identifier, etc…), type that
language in the box below exactly as it should appear in the letter. The text you enter will automatically appear at the top of all
approval letters, identical to how you typed it, until you update it. Don't include instructions or questions to ORI staff as those will
appear in your approval letter. If these details need to be changed for any reason, you are responsible for updating the
content of this field.
Additional Materials:
If you have other materials you would like to include for the IRB's consideration, check all that apply and attach the corresponding
documents using the Attachments button below.
Detailed protocol
Dept. of Health & Human Services (DHHS) approved protocol (such as NIH sponsored Cooperative Group Clinical Trial)
Other Documents
Protocol/Other Attachments
NOTE: Instructions for Dept. of Health & Human Services (DHHS)-approved protocol]
If you have password protected documents, that feature should be disabled prior to uploading to ensure access for IRB review.
To view the materials currently attached to your application, click “All Attachments” on the left menu bar.
Section 17 Page 1 of 1

SIGNATURES (ASSURANCES)
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Introduction
All IRB applications require additional assurances by a Department Chairperson or equivalent (DA), and when applicable, a Faculty
Advisor or equivalent (FA). This signifies the acceptance of certain responsibilities and that the science is meritorious and deserving of
conduct in humans. The person assigned as DA should not also be listed in the Study Personnel section, and the individual assigned
as FA should be listed in the Study Personnel section.
For a list of responsibilities reflected by signing the Assurance Statement, refer to "What does the Department Chairperson’s
Assurance Statement on the IRB application mean?"
For a detailed illustration of how to complete this section, please review the short online video tutorial "Signatures
(Assurance) Section - How to Complete." Otherwise, follow the steps below.
Required Signatures:
Individuals chosen as signees may remove the application from their Inbox without signing the Assurance Statement by
clicking "Return to PI" with a comment about why it is being returned (e.g., specific edits are deemed necessary). 
The PI, and personnel chosen as a contact, will receive an email notification that edits are needed, and can find the draft
application in both the "Draft" folder and the "Signatures Status" folder located in the menu in the left margin of the default
Inbox page. The researcher does not have a 'reply' option to the signee's comments and must make the requested edits
directly in the application, or communicate outside the E-IRB system as to why not. Once the response is finalized, the
researcher must re-visit the "Assurances Required" section to click the "Return to Signee" button for their re-
consideration; the signee will receive an email notification at that time. 
Hover your mouse cursor here for additional instructions.
First
Name
Last
Name
Role
Department
Signee
Return
Comment
Date
Signed
 
 
 
Carl
Leukefeld
Department
Authorization
Behavioral
Science
 
05/17/2018
06:37 AM
View/Sign
Shanna
Babalonis
Principal
Investigator
Behavioral
Science
 
05/17/2018
09:14 AM
View/Sign
Department Authorization
 This is to certify that I have reviewed this research protocol and that I attest to the scientific validity and importance of
this study; to the qualifications of the investigator(s) to conduct the project and their time available for the project; that
facilities, equipment, and personnel are adequate to conduct the research; and that continued guidance will be provided
as appropriate. When the principal investigator assumes a sponsor function, the investigator has been notified of the
additional regulatory requirements of the sponsor and by signing the principal investigator Assurance Statement, confirms
he/she can comply with them.
*If the Principal Investigator is also the Chairperson of the department, the Vice Chairperson or equivalent should complete
the "Department Authorization".
**IF APPLICABLE FOR RELIANCE: I attest that the principal investigator has been notified of the regulatory requirements of
both the Reviewing and Relying IRBs, according to the information provided in the E-IRB application. The attached Reliance
Assurance Statement, signed by the principal investigator, confirms that he/she can comply with both sets of IRB
requirements.
Principal Investigator’s Assurance Statement
Section 18 Page 1 of 2

I understand the University of Kentucky's policies concerning research involving human subjects and I agree:
1. To comply with all IRB policies, decisions, conditions, and requirements;
2. To accept responsibility for the scientific and ethical conduct of this research study;
3. To obtain prior approval from the Institutional Review Board before amending or altering the research protocol or
implementing changes in the approved consent/assent form;
4. To report to the IRB in accord with IRB/IBC policy, any adverse event(s) and/or unanticipated problem(s) involving risks to
subjects;
5. To complete, on request by the IRB for Full and Expedited studies, the Continuation/Final Review Forms;
6. To notify the Office of Sponsored Projects Administration (OSPA) and/or the IRB (when applicable) of the development of
any financial interest not already disclosed;
7. Each individual listed as study personnel in this application has received the mandatory human research protections
education (e.g., CITI);
8. Each individual listed as study personnel in this application possesses the necessary experience for conducting research
activities in the role described for this research study.
9. To recognize and accept additional regulatory responsibilities if serving as both a sponsor and investigator for FDA
regulated research.
Furthermore, by checking this box, I also attest that:
I have appropriate facilities and resources for conducting the study;
I am aware of and take full responsibility for the accuracy of all materials submitted to the IRB for review;
If applying for an exemption, I also certify that the only involvement of human subjects in this research study will be in the
categories specified in the Protocol Type: Exemption Categories section.
If applying for an Abbreviated Application (AA) to rely on an external IRB, I understand that certain items above (1, 3, 4, 7-8)
may not apply, or may be altered due to external institutional/IRB policies. I document my agreement with the Principal
Investigator Reliance Assurance Statement by digitally signing this application.
*You will be able to "sign" your assurance after you have sent your application for signatures (use Submission section). Once all
Assurance Statement signatures have been acquired, return to this section to submit your application to ORI. 
Section 18 Page 2 of 2

SUBMISSION INFORMATION
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*** If this Continuation Review entails a change in the scope of your activities to include COVID-19 related research, please
insert “COVID19” at the start of your Project and Short Titles.***
Each Section/Subsection in the menu on the left must have a checkmark beside it (except this Submission section) indicating the
Section/Subsection has been completed. Otherwise your submission for IRB review and approval cannot be sent to the Office of
Research Integrity/IRB.
If applicable, remember to update the Approval Letter Details text box under the Additional Information section.
If your materials require review at a convened IRB meeting which you will be asked to attend, it will be scheduled on the next available
agenda and you will receive a message to notify you of the date.
If you are making a change to an attachment, you need to delete the attachment, upload a highlighted version that contains the changes
(use Document Type of "Highlighted Changes"), and a version that contains the changes without any highlights (use the appropriate
Document Type for the item(s)). Do not delete approved attachments that are still in use.
Principal Investigator’s Assurance Statement
I understand the University of Kentucky’s policies concerning research involving human subjects, and I attest to:
1. Having reviewed all the investigational data from this study, including a compilation of all internal and external unanticipated
problems.
2. Having reviewed, if applicable, information from the sponsor including updated investigator brochures and data and safety
monitoring board reports.
I also attest that I have reviewed pertinent materials concerning the research and concluded either:
A. The human subject risk/benefit relationship is NOT altered, and that it is not necessary to modify the protocol or the informed
consent process,
OR,
B. The human subject risk/benefit relationship has been altered, and have previously submitted or am including with this
continuation review submission, a modification of the research protocol and informed consent process.
By checking this box, I am providing assurances for the applicable items listed above. 
Your protocol has been submitted.
Section 19 Page 1 of 1