A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients
Phase: PHASE2
Conditions: Adenoid Hypertrophy
Sponsor: Arlyne Thung

 
 
A non-opioid technique for post-operative pain relief after 
adenoidectomy  
 
 
 
NCT03714919  
 
 
 
April 8, 2019 
 

PROTOCOL TITLE: A non-opioid technique for post-op pain relief after adenoidectomy 
 
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PROTOCOL TITLE: 
A non-opioid technique for post-operative pain relief after adenoidectomy. 
PRINCIPAL INVESTIGATOR: 
Name: Arlyne Thung, MD 
Department/Center: Anesthesiology & Pain Medicine 
Telephone Number: 614-722-4200 
Email Address: Arlyne.Thung@nationwidechildrens.org 
VERSION NUMBER/DATE: 
Version 2 / April 8, 2019 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
2 
4/8/2019 
Changing recruitment procedures 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: A non-opioid technique for post-op pain relief after adenoidectomy 
 
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1.0 
Study Summary 
 
Study Title 
A non-opioid technique for post-operative pain relief after 
adenoidectomy 
Study Design 
Prospective, open-label 
Primary Objective 
To assess analgesic efficacy of a multi-modal, non-opioid 
analgesic regimen for providing surgical analgesia in 
pediatric patients undergoing adenoidectomy. 
Secondary 
Objective(s) 
To assess recovery characteristics in the PACU and at home 
following surgery. 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Dextromethorphan, Acetaminophen, Dexmedetomidine, 
Ketamine 
IND/IDE #  
138411 
Study Population 
Children aged 4-8 years undergoing adenoidectomy 
Sample Size 
10 
Study Duration for 
individual 
participants 
Day of surgery up to 72 hours post-op 
Study Specific 
Abbreviations/ 
Definitions  
PACU - post anesthesia care unit 
FLACC - Faces, Legs, Activity, Cry, Consolability Scale 
PAED - Pediatric Agitation and Emergence Delirium Scale 
 
2.0 
Objectives 
2.1 
To assess analgesic efficacy of a multi-modal, non-opioid 
analgesic regimen for providing surgical analgesia in pediatric patients 
undergoing adenoidectomy  
2.2 
To assess recovery characteristics in the PACU and at home 
following surgery 
2.3 
We hypothesize in this pilot study that a multimodal analgesic 
technique consisting of oral dextromethorphan, oral acetaminophen, 
dexmedetomidine and ketamine is an effective analgesic regimen 
pediatric patients undergoing adenoidectomy. 
3.0 
Background 
3.1 
Pediatric patients undergoing adenoidectomy experience post-
operative pain that requires pharmacological therapy in which opioid 
medications are the mainstay of treatment. However opioids have 
potential undesirable side effects that may include itchiness, nausea, 
respiratory depression.  In this surgical patient population, where 
symptoms of sleep disordered breathing and nasal obstruction may often 
times be present, side effects such as these are particularly undesirable 
and may lead to lengthened recovery or even hospital admission.  Single 

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therapy with a non-opioid analgesic may not provide sufficient post-
operative analgesia, however, using various agents with different 
mechanisms of action allows additive and synergistic effects.  We 
therefore developed a non-opioid analgesic protocol that include 
medications which have been previously utilized for pain management in 
pediatric patient undergoing otolaryngology procedures consisting of pre-
operative dextromethorphan and acetaminophen and intraoperative 
dexmedetomidine, and ketamine. 
3.2 
Dextromethorphan is a readily available over the counter 
medication used most commonly for its antitussive effect in pediatric 
patients with an analgesic mechanism exerted through NMDA 
antagonism. Preoperative use of dextromethorphan has been shown by 
some authors to reduce postoperative opioid requirements with Dawson 
et al1 showing reduced morphine consumption in pediatric adeno-
tonsillectomy patients.  
3.3 
Acetaminophen (paracetamol) is a first-line antipyretic and 
analgesic for mild and moderate pain and is a mainstay treatment in 
pediatric patient undergoing ENT procedures due to its easy accessibility 
and wide use particularly in oral form. Its anti-nociceptive mechanism 
involves central inhibition of the cyclo-oxygenase (COX) enzyme leading 
to decreased production of prostaglandins, which in turn diminishes the 
release of excitatory transmitters involved in nociceptive transmission2,3.   
3.4 
Dexmedetomidine is an α2-adrenergic receptor agonist with 
anxiolytic, nociceptive and sedative properties with minimal respiratory 
depressive properties. It is commonly used for sedation in the intensive 
care unit as well as procedural sedation and has shown to be effective in 
pediatric patients undergoing ENT procedures due to its desirable effect 
of providing effective analgesia and reducing emergence agitation and 
postoperative opioid requirements4-6.  
3.5 
Ketamine is a phencyclidine derivative with well-known sedative 
and analgesic properties modulated through NMDA antagonism. Several 
studies have reported Ketamine’s role as an effective analgesic adjuvant 
in pediatric patients undergoing tonsillectomy when combined with 
opioids, paracetamol and dexmedetomidine in low doses7-9 resulting in 
lower postoperative pain scores and opioid consumption. In a meta-
analysis looking at the efficacy of Ketamine in improving pain after 
pediatric tonsillectomy, Cho et al concluded that pre-emptive 
administration of ketamine was associated with decreased surgical pain 
and analgesic consumption with a low incidence of adverse effects such 
as nausea/vomiting, sedation or hallucinations10. 
3.6 
Adenoidectomy is one of the most common surgeries performed in 
the pediatric population in the United States.  The most frequent 
indications for surgery are airway obstruction leading to obstructive 
breathing and obstructive sleep apnea, and chronic or recurrent infection 

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of the sinuses, ear canal or pharynx.  Adenoidectomy is often performed 
in conjunction with tonsillectomy, however is also frequently performed 
alone.  Whilst adenoidectomy is frequently performed in the ambulatory 
setting, comorbid medical conditions, and risk of post-operative 
respiratory depression may be among reasons for elective hospital 
admission. 
3.7 
The authors hope that this pilot study will illustrate the efficacy 
and viability of a multimodal, completely non-opioid analgesic technique 
for operative pain management after adenoidectomy in the pediatric 
population. Such a technique could be useful not only in pediatric patient 
populations including those at risk of postoperative respiratory 
compromise in whom the use of opioids analgesics for perioperative pain 
managements is a concern but could meaningfully contribute to 
understanding of pediatric pain management in a geographical area where 
the opioid crisis has reached critical proportions. Study results will be 
presented at national meetings and submitted for journal publication. In 
addition, the current study will lay the groundwork for future studies 
which would investigate this non-opioid analgesic technique for use in 
tonsillectomy surgery. 
4.0 
Study Endpoints 
4.1 
The primary outcome will be need for rescue opioid analgesia in 
the PACU. Other variables such as time to extubation in the PACU, time 
to first analgesic delivery, pain scores, number and total dose of opioids 
given, presence of sedation, nausea/vomiting, hallucinations, duration of 
oxygen requirement in PACU, and total PACU time will be recorded 
during the duration of the patient's PACU stay. 
5.0 
Study Intervention/Investigational Agent 
5.1 
Description: Preoperative oral dextromethorphan 1mg/kg, 
preoperative oral acetaminophen 15mg/kg, intraoperative intravenous 
dexmedetomidine 0.5 mcg/kg, intraoperative intravenous ketamine 
0.5mg/kg. 
5.2 
Drug/Device Handling: All study medications will be controlled by 
Investigational Drug Services following the Research Pharmacy SOP for 
the Control of Investigational Drugs.   
5.3 
Dr. Arlyne Thung is the holder of the IND.  All drugs will be 
administered one time in doses that have been previously reported to be 
in recommended dosing range. In reporting adverse events we will follow 
the final regulations issued by the Food and Drug  addressing the safety 
reporting requirements for investigational new drug applications (INDs) 
found in 21 CFR part 312 and for bioavailability and bioequivalence 
studies found in 21 CFR part 320. “Safety Reporting Requirements for 
INDs and BA/BE Studies”. 
5.4 
The classification for adverse events to be used is the following: 

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Mild adverse event; did not require treatment 
Moderate adverse event; resolved with treatment 
Severe adverse event; inability to carry on normal activities; required 
professional medical attention 
Life-threatening or permanently disabling adverse event 
Fatal adverse event 
In this grading system, severity is not equivalent to seriousness. The 
definitions to be employed will follow the final regulations issued by the 
FDA in September 2010 “Safety Reporting Requirements for INDs and 
BA/BE Studies”, and described in section 7.0 of this protocol. 
5.5 
Dose limiting toxicity (DLT) is defined as any adverse event that is 
possibly, probably, or definitely related to the study agent. This would 
include any grade 3 according to the classification given above. Study 
enrollment will be halted by the investigators when any subject 
experiences a Grade 3, or higher adverse event toxicity that is possibly, 
probably, or definitely related to the study drug. The event will then be 
reviewed by the physician responsible for review and evaluation of 
information relevant to the safety of the drug. 
The PI will fulfill the reporting responsibilities under 21 CFR 312.32(c), 
to notify the FDA in an IND safety report of potentially serious risks, as 
soon as possible, but no later than 15 calendar days after the investigator 
receives the safety information and determines that the information 
qualifies for reporting. The investigator will confer with the, IRB and 
FDA before  enrollment. 
5.6 
The Principal Investigator (PI) will monitor safety data on a 
continual basis throughout the trial. The PI can recommend early 
termination of the trial for reasons of safety. Study enrollment will be 
halted by the investigators when any subject experiences a Grade 3, or 
higher adverse event toxicity that is possibly, probably, or definitely 
related to the study drug. This will include any patient death, important 
clinical laboratory finding, or any severe local complication related to the 
study agent. If after review by the IRB and FDA, the decision is made to 
continue, the study will proceed. 
5.7 
Definition of an Adverse Event 
As stated above this protocol will follow the final regulations issued by 
the Food and Drug Administration addressing the safety reporting 
requirements for investigational new drug applications (INDs) found in 
21 CFR part 312.  
Adverse Event (AE): Adverse event means any untoward medical 
occurrence associated with the use of a drug in humans, whether or not 
considered drug related. 

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Adverse events will be graded by the investigator accordingly: 1 = mild, 
2 = moderate, 3 = severe,   4 = life threatening or debilitating, and 5 = 
fatal. 
Association or relatedness to the study agent, study procedures and the 
subject's preexisting disease will be graded as follows: 5 = unrelated, 4 = 
unlikely, 3 = possibly, 2 = probably, and 1 = definitely related. 
Adverse reaction: An adverse reaction means any adverse event caused 
by a drug. Adverse reactions are a subset of all suspected adverse 
reactions for which there is reason to conclude that the drug caused the 
event. 
Suspected adverse reaction (21 CFR 312.32(a)) Suspected adverse 
reaction means any adverse event for which there is a reasonable 
possibility that the drug caused the adverse event. For the purposes of 
IND safety reporting, ‘reasonable possibility’ means there is evidence to 
suggest a causal relationship between the drug and the adverse event. A 
suspected adverse reaction implies a lesser degree of certainty about 
causality than adverse reaction, which means any adverse event caused 
by a drug. 
5.8 
Serious adverse event (SAE) 
An adverse event or suspected adverse reaction is considered “serious” if, 
in the view of either the investigator or sponsor, it results in any of the 
following outcomes: Death, a life-threatening adverse event, inpatient 
hospitalization or prolongation of existing hospitalization, a persistent or 
significant incapacity or substantial disruption of the ability to conduct 
normal life functions, or a congenital anomaly/birth defect. Important 
medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate 
medical judgment, they may jeopardize the patient or subject and may 
require medical or surgical intervention to prevent one of the outcomes 
listed in this definition. Examples of such medical events include allergic 
bronchospasm requiring intensive treatment in an emergency room or at 
home, blood dyscrasias or convulsions that do not result in inpatient 
hospitalization, or the development of drug dependency or drug abuse. 
To reiterate, an SAE is an event in categories 3, 4, and 5. Category 3 
Severe adverse event; inability to carry on normal activities; required 
professional medical attention Category 4 Life-threatening or 
permanently disabling adverse event Category 5 Fatal adverse event. 
5.9 
Life-threatening (21 CFR 312.32(a)) 
An adverse event or suspected adverse reaction is considered “life-
threatening” if, in the view of either the investigator or sponsor, its 
occurrence places the patient or subject at immediate risk of death. It 
does not include an adverse event or suspected adverse reaction that, had 
it occurred in a more severe form, might have caused death. The PI will 

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fulfill the reporting responsibilities to FDA on behalf of Nationwide 
Children’s Hospital, by completing a Form FDA 3500 either online, by 
fax (1-800-FDA-0178) or calling the FDA at 1-800-FDA-1088.   
5.10 Obligations of the Investigator 
The Principal Investigator will submit a voluntary Form FDA 3500 by 
one of the methods mentioned above for any serious adverse event that is 
both unexpected and associated with the use of the study drug(s). 
The Principal Investigator will adhere to any other serious adverse event 
reporting requirements in accordance with federal regulations, state laws, 
and the local institutional policies and procedures, as applicable. 
The Principal Investigator will be responsible for ensuring that the 
reporting requirements are fulfilled and will be held accountable for any 
reporting lapses. 
6.0 
Procedures Involved* 
6.1 
The anesthesia research staff will review the upcoming surgery 
schedules for eligible subjects.  They will then mail the family the study 
information sheet and a copy of the consent form. On the day of surgery a 
member of the investigative team will approach eligible families to: 
answer any questions regarding the study, discuss the study in further 
detail, and obtain consent from parents/guardians who agree to enroll 
their child in the study. 
6.2 
On the day of surgery, if the parent(s)/legal guardian(s) state they 
are not interested in enrolling their child, they will be thanked for their 
time and no further study discussion will occur.  At any time and for any 
reason, parent/guardians who have initially enrolled their child in the 
study, may have their child withdrawn from the study if the 
parents/guardians are uncomfortable with their child’s participation. All 
efforts will be made to recruit patients from the ENT specialists who are 
listed as co-investigators, however the investigative team would like to 
recruit patients from all ENT specialists who meet eligibility criteria and 
who have received the information sheet and consent prior to the day of 
surgery. 
6.3 
Once enrolled, subjects will be administered a standardized 
anesthetic and pain regimen which will consist of: Anesthetic regimen: 
a.   Pre-medication with oral midazolam (0.3 mg/kg to maximum 
dose of 20 mg) given 15-20 minutes before induction  
 
b.   Inhalation induction with sevoflurane and a mixture of N20/02  
c.   Propofol 1-1.5 mg/kg to facilitate endotracheal intubation 
d.   Maintenance anesthesia with isoflurane with a mixture of air 
and oxygen, titrated to a BIS of < 60  

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e.   Ondansetron (0.15 mg/kg, maximum dose of 4 mg) and 
dexamethasone (0.25 mg/kg, maximum dose of 20 mg) for 
postoperative nausea prophylaxis. 
f.   Intravenous fluids (Lactated Ringers or Normal Saline) 20-40 
mL/kg 
6.4 
Pain regimen: 
Preoperative oral dextromethorphan 1 mg/kg  
Preoperative oral acetaminophen 15 mg/kg 
Intraoperative intravenous dexmedetomidine 0.5 μg/kg  
Intraoperative intravenous ketamine 0.5mg/kg  
6.5 
Following surgery and tracheal extubation, baseline vitals will be 
obtained and pain scores will be assessed in the post anesthesia care unit 
(PACU) via FLACC (Faces, Legs, Activity, Cry, Consolability 
Scale).The presence of emergence delirium will be assessed via PAED 
(Pediatric Agitation and Emergence Delirium Scale).  Those subjects 
whose pain score is assessed at < 5 will receive standard postoperative 
care and no analgesics.  Patients with an assessed pain score > 4 will 
receive 0.5 μg/kg fentanyl every 10 minutes as needed. The primary 
outcome will be need for rescue opioid analgesia in the PACU. Other 
variables such as time to extubation in the PACU, time to first analgesic 
delivery, pain scores, number and total dose of opioids given, presence of 
sedation, nausea/vomiting, hallucinations, duration of oxygen 
requirement in PACU, and total PACU time will be recorded during the 
duration of the patient's PACU stay. Subjects will be discharged home 
from the PACU once standard discharge criteria have been met. 
6.6 
Patients will be discharged from the hospital with standard 
instructions to use appropriate weight based doses of oral acetaminophen 
q6hrs for pain and ibuprofen for breakthrough pain.  They will be given a 
pain diary to record pain scores and analgesic use from hospital discharge 
to 72 post-operative hours. A member of the investigative team will 
contact the patients’ guardian by telephone to obtain this information as 
well as answer any questions regarding post-anesthetic recovery.  
7.0 
Data and Specimen Banking* 
7.1 No data or specimens will be banked for future use. 
8.0 
Sharing of Results with Subjects* 
8.1 Study results will not be shared with subjects or others. 
9.0 
Study Timelines* 
9.1 
An individual study subject’s participation in the study should last 
approximately 48 hours total.  

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9.2 
All study subjects should be enrolled within 2 years of study start. 
9.3 
The study should be completed within 3 years of study start.  
10.0 Inclusion and Exclusion Criteria* 
10.1 Inclusion: 
Male or female patients aged 3-8 years undergoing adenoidectomy 
+/- bilateral myringotomy tube placement 
Subjects who have a parent/guardian who are compliant with routine 
medical care, capable of subjective evaluation and able to read, 
understand and sign the informed consent in accordance with HIC 
regulations. 
10.2 Exclusion: 
An American Society of Anesthesiologists Physical Status ≥ 4 
(severe disease that is life threatening); 
A known hypersensitivity or allergy to any of the study medications; 
A history of chronic opioid use prior to surgery;   
Coexisting renal or hepatic disease; 
Morbid obesity (BMI% ≥ 99). 
10.3 We are including children, and will not include: 
• 
Adults unable to consent 
• 
Pregnant women 
• 
Prisoners 
11.0 Vulnerable Populations* 
11.1 The research involves greater than Minimal Risk to subjects, but 
presents the prospect of direct benefit to the individual subjects.  Subjects 
have the potential benefit of needing less opioid pain medication 
following surgery.  The relation of the anticipated benefit to the risk is at 
least as favorable to the subjects as that presented by available alternative 
approaches, which include opioids administered post-operatively. 
11.2 Because of the prospect of direct benefit, permission of one parent 
is sufficient even if the other parent is alive, known, competent, 
reasonably available, and shares legal responsibility for the care and 
custody of the child.  . 
12.0 Local Number of Subjects 
12.1 We plan to enroll 10 study subjects. 
13.0 Recruitment Methods 
13.1 The anesthesia research staff will review the upcoming surgery 
schedules for eligible subjects.  They will then mail the family  the study 

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information sheet and a copy of the consent form. On the day of surgery a 
member of the investigative team will approach eligible families to: 
answer any questions regarding the study, discuss the study in further 
detail, and obtain consent from parents/guardians who agree to enroll 
their child in the study. 
13.2 Subjects will not be paid. 
14.0 Withdrawal of Subjects* 
N/A 
15.0 Risks to Subjects* 
15.1 The common side effects associated with acetaminophen are 
nausea, vomiting, constipation, itching, agitation, and difficulty breathing 
which may occur in approximately 5% of patients. 
Occasional or rare side effects are low blood count; fast heartbeat; 
abdominal pain; diarrhea; pain, swelling, abnormal lab values; muscle 
spasm; headache; difficulty sleeping; frequent peeing; high or low blood 
pressure.  This may occur in approximately 1% of patients.   
15.2 The common side effects associated with dextromethorphan are 
dizziness, drowsiness, restlessness, nausea, vomiting and stomach pain. 
Occasional or rare side effects are difficulty breathing, fast heartbeat or 
hallucinating (seeing things or hearing voices that do not exist). 
15.3 The common side effects associated with ketamine are fast 
heartbeat, high blood pressure, confusion and hallucinations. 
Occasional or rare side effects are vomiting, abnormal heart rhythm, 
difficulty breathing, double vision and increased muscle tone.  
15.4 Common side effects of dexmedetomidine are low or high blood 
pressure, nausea, slow heart rate, dry mouth and prolonged sleepiness or 
sedation. 
16.0 Potential Benefits to Subjects* 
16.1 Subjects have the potential benefit of needing less opioid pain 
medication following surgery.  
17.0 Data Management* and Confidentiality 
17.1 All data and observations will be documented by source 
documentation. The PI will be responsible for reviewing and evaluation 
of information relevant to the safety of the drug. 
17.2 This is a pilot study examining the feasibility of a non-opioid 
technique for pediatric patients undergoing adenoidectomy. 10 volunteer 
patients were the agreed upon number between the Departments of 
Anesthesiology and Otolaryngology.  

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18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
18.1 The study will be monitored in compliance with the relevant parts 
of 21 CFR and according to the ICH GCP Guidelines. The procedures 
outlined in the protocol and case report forms will be carefully reviewed 
by the PI and staff prior to study initiation to ensure appropriate 
interpretation and implementation. No deviations from the protocol shall 
be made except in emergency situations where alternative treatment is 
necessary for the protection, proper care and wellbeing of subjects. 
18.2 All subjects will be clinically monitored as it pertains to routine 
anesthetic care during the surgical procedure. This includes the use of 
standard ASA (American Society of Anesthesiology) monitors which 
measure ventilation (end tidal C02, inspired anesthetic gases), 
oxygenation (pulse oximetry), temperature and circulation (heart rate, 
blood pressure and EKG assessments every 5 minutes). In addition, all 
subjects will have BIS (Bispectral Index) monitoring used to assess the 
depth anesthetic as well as guide titration of anesthetic agents. Following 
completion of their surgical procedure all subjects will be monitored in 
the post anesthesia care unit as per routine in which vitals, pain scores 
and recovery variables (i.e. presence of emergence delirium as assessed 
by the Pediatric Agitation and Emergence Delerium scale, 
nausea/vomiting, hallucinations) will be assessed by the nursing team. 
Duration of PACU time will be recorded once subjects have 
demonstrated discharge criteria. 
18.3 Amendments will be submitted to the Nationwide Children’s 
Hospital IRB for their review and approval prior to implementation. 
When an amendment to a protocol substantially alters the study design or 
increases potential risk to the study subject, the Informed Consent Form 
will be revised and if applicable, subject's consent to continue 
participation will again be obtained. 
19.0 Provisions to Protect the Privacy Interests of Subjects 
19.1 Subject information will not be given to any other investigators. 
Subjects and their information will be closely monitored and guarded 
by study staff; there will be limited access to patients and their 
information by trained study staff; and subject information will only 
be shared and discussed between study staff specific to this study. 
20.0 Compensation for Research-Related Injury 
20.1 None 
21.0 Economic Burden to Subjects 
21.1 None 
22.0 Consent Process 

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22.1 The consent process will begin in the ENT clinic and continue in the 
preoperative surgery unit on the day of surgery, by PI, 
Sub-Investigators, Study Coordinators, and/or trained research staff. 
22.2 The study will be thoroughly explained to the patient and their 
family. There will be ample time allotted for questions and answers. 
An explanation of voluntary participation will take place, and the 
family will be asked if they are interested in participating in the 
study. If the patient and their parent(s), or legal guardian agrees to 
participate they will be asked to sign consent and assent forms. The 
patient will then be enrolled in the study with the understanding that 
they can elect to stop the study and be withdrawn from the study at 
any time.  
23.0 Process to Document Consent in Writing 
23.1 We will be following “SOP: Written Documentation of Consent 
(HRP-091).”  
24.0 Setting 
24.1 Potential subjects will be identified and recruited from the ENT 
clinic.  Research procedures will be performed in the Surgery Unit, 
OR, and PACU. 
25.0 Resources Available 
25.1 The department of Anesthesiology and Pain Medicine has 2 research 
coordinators and 2 research associates that will be enrolling subjects 
for this study.  All study staff will be trained on the study 
procedures. 
26.0 Multi-Site Research* 
N/A 
 
27.0  Protected Health Information Recording 
 
1.0 
Indicate which subject identifiers will be recorded for this research. 
☒  Name 
☒  Complete Address 
☒  Telephone or Fax Number 
☐  Social Security Number (do not check if only used for ClinCard) 
☒  Dates (treatment dates, birth date, date of death) 
☐  Email address , IP address or url 
☒  Medical Record Number or other account number 
☐  Health Plan Beneficiary Identification Number 
☐  Full face photographic images and/or any comparable images (x-rays) 
☐  Account Numbers 
☐  Certificate/License Numbers 

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☐  Vehicle Identifiers and Serial Numbers (e.g. VINs, License Plate Numbers) 
☐  Device Identifiers and Serial Numbers 
☐  Biometric identifiers, including finger and voice prints 
☐  Other number, characteristic or code that could be used to identify an 
individual 
☐  None (Complete De-identification Certification Form) 
 
2.0   
Check the appropriate category and attach the required form* on the Local 
Site Documents, #3. Other Documents, page of the application.  (Choose one.) 
☒  Patient Authorization will be obtained. (Include the appropriate HIPAA 
language (see Section 14 of consent template) in the consent form OR attach 
the HRP-900, HIPAA AUTHORIZATION form.) 
☐  Protocol meets the criteria for waiver of authorization. (Attach the HRP-901, 
WAIVER OF HIPAA AUTHORIZATION REQUEST form.) 
☐  Protocol is using de-identified information. (Attach the HRP-902, DE-
IDENTIFICATION CERTIFICATION form.) (Checked "None" in 1.0 above) 
☐  Protocol involves research on decedents. (Attach the HRP-903, RESEARCH 
ON DECEDENTS REQUEST form.) 
☐  Protocol is using a limited data set and data use agreement. (Contact the 
Office of Technology Commercialization to initiate a Limited Data Use 
Agreement. 
 
*Find the HIPAA forms in the IRB Website Library, Templates. 
 
Attach the appropriate HIPAA form on the “Local Site Documents, #3. 
Other Documents”, page of the application. 
 
3.0    How long will identifying information on each participant be maintained? 
Following publication of study results, research records will be stored for a period 
of 3-5 years and then will be destroyed by placing in a secure shredding bin. 
 
4.0 
Describe any plans to code identifiable information collected about each 
participant. None 
 
5.0 
Check each box that describes steps that will be taken to safeguard the 
confidentiality of information collected for this research: 
☒ Research records will be stored in a locked cabinet in a secure location 
☒ Research records will be stored in a password-protected computer file 
☐ The list linking the assigned code number to the individual subject will be 
maintained separately from the other research data 
☒ Only certified research personnel will be given access to identifiable 
subject information 
 
6.0 
Describe the provisions included in the protocol to protect the privacy 
interests of subjects, where "privacy interests" refer to the interest of 

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individuals in being left alone, limiting access to them, and limiting access to 
their information. (This is not the same provision to maintain the 
confidentiality of data.) 
 
Subject information will not be given to any other investigators. Subjects and 
their information will be closely monitored and guarded by study staff; there will 
be limited access to patients and their information by trained study staff; and 
subject information will only be shared and discussed between study staff specific 
to this study. 
 
Confidential Health Information 
 
1.0 
Please mark all categories that reflect the nature of health information to be 
accessed and used as part of this research. 
 
☒  Demographics (age, gender, educational level) 
☐  Diagnosis 
☐  Laboratory reports 
☐  Radiology reports 
☐  Discharge summaries 
☒  Procedures/Treatments received 
☒  Dates related to course of treatment (admission, surgery, discharge) 
☐  Billing information 
☒  Names of drugs and/or devices used as part of treatment 
☐  Location of treatment 
☐  Name of treatment provider 
☐  Surgical reports 
☒  Other information related to course of treatment 
☐  None 
 
2.0 
Please discuss why it is necessary to access and review the health information 
noted in your response above. 
It is necessary to meet the objectives of the study and to analyze the data. 
 
3.0 
Is the health information to be accessed and reviewed the minimal necessary to 
achieve the goals of this research?  ☒ Yes    ☐ No 
 
4.0 
Will it be necessary to record information of a sensitive nature?  ☐ Yes   ☒ No 
 
5.0 
Do you plan to obtain a federally-issued Certificate of Confidentiality as a means 
of protecting the confidentiality of the information collected?  ☐ Yes   ☒ No