Tetragraph® Monitor: Tolerance of Preoperative Placement
Phase: NA
Conditions: Surgery
Sponsor: Joseph D. Tobias

 
Train-of-four monitoring using the Tetragraph® Neuromuscular 
Transmission Monitor: Tolerance to preoperative electrode 
placement 
 
NCT05964166 
 
May 16, 2023 

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HRP-503 
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PROTOCOL TITLE: 
Train-of-four monitoring using the Tetragraph® Neuromuscular Transmission Monitor: 
Tolerance to preoperative electrode placement 
 
PRINCIPAL INVESTIGATOR: 
Name: Joseph D. Tobias, MD 
Department/Center: Anesthesiology & Pain Medicine 
Telephone Number: 614-722-4200 
Email Address: Joseph.Tobias@nationwidechildrens.org 
 
VERSION NUMBER/DATE: 
Version: 2 
Date: May 16, 2023 
 
 
Revision History 
 
Version Date 
Summary of Changes 
Consent 
Change? 
2 
Changing this to a multi-center study to add OU 
students. 
N 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.0 
 Study Summary 
 
Study Title 
Train-of-four monitoring using the Tetragraph® Neuromuscular 
Transmission Monitor: Tolerance of preoperative electrode 
placement 
Study Design 
Prospective, non-blinded, single arm study 
Primary Objective 
The primary objective of this study is to evaluate the tolerance to 
preoperative placement of the adhesive sensor for the Tetragraph® 
Neuromuscular Transmission Monitor in pediatric-sized patients ≤ 
12 years of age 
Secondary Objective(s) 
N/A 
Research Intervention(s)/ 
Investigational Agent(s) 
Preoperative placement of the sensing electrode of the Tetragraph® 
train-of-four monitor 
IND/IDE # 
N/A 
Study Population 
Patients who are scheduled for elective surgery that requires the 
use of a non-depolarizing neuromuscular blocking agent. 
Sample Size (finite #, no estimates) 
(Other sites + Local = TOTAL) 
100 
Study End Date 
12/31/2024 
Study Specific Abbreviations/ 
Definitions  
TOF = train-of-four 
NMBA = neuromuscular blocking agent 
MAP = muscle action potential 
EMG = electromyograpy 
 
2.0 
Objectives  
• 
Describe the purpose, specific aims, or objectives.  
• 
State the hypotheses to be tested. 
 
The primary objective of this study is to evaluate whether the sensing electrode for the novel 
Tetragraph® Neuromuscular Transmission Monitor (TOF monitor) can be placed in the preoperative 
holding area prior to surgery in pediatric-aged patients.   
 
We have evaluated and used the Tetragraph® in a previous IRB approved trial (IRB ID: 
STUDY00001075).  The outcome of that study has been published (Owusu‑Bediako K, Munch R, 
Mathias J, Tobias JD. Feasibility of intraoperative quantitative neuromuscular blockade monitoring in 
children using electromyography. Saudi J Anaesth 2022;16;412-418). 
 
3.0 
Background  
• 
Describe the relevant prior experience and gaps in current knowledge. 
• 
Describe any relevant preliminary data. 
• 
Provide the scientific or scholarly background for, rationale for, and significance of the research based on the 
existing literature and how will it add to existing knowledge. 
 
The neuromuscular junction consists of the nerve terminal, the postsynaptic muscle end plate 
(sarcolemma), and the intervening gap. An action potential reaching the end of the neuron triggers the 
release of acetylcholine from synaptic vesicles. Acetylcholine then diffuses across the gap to the 
postsynaptic end plate, where nicotinic acetylcholine receptors are clustered. These receptors convert 
the chemical signal into an electrical impulse, causing depolarization in the postsynaptic membrane, 
release of calcium from the sarcoplasmic reticulum, and muscle contraction. The action of 

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acetylcholine is terminated by its passive dissociation from receptors, diffusion away from the end 
plate, and enzymatic degradation by acetylcholinesterase.  
 
Neuromuscular blocking agents are commonly used during anesthetic care to facilitate endotracheal 
intubation or provide muscle relaxation during surgical procedures. These agents (non-depolarizing 
NMBAs) competitively inhibit the binding of acetylcholine to the sarcolemma thereby inhibiting 
skeletal muscle function. During clinical care, when neuromuscular blockade is no longer required, 
these agents are reversed, most commonly with a medication known as sugammadex which 
encapsulates the NMBA, resulting in cessation of its pharmacological effects. 
 
The dosing of these medications is guided by assessing neuromuscular transmission subjectively by 
using a peripheral nerve stimulator (PNS).  This PNS stimulates the nerve (two impulses per second 
for two seconds) generating what is known as a TOF response. This PNS is routinely used during 
anesthetic care when NMBAs are in use. The electrodes are placed over a peripheral nerve and the 
number of twitches in the distal innervated muscle groups (hand) are noted when the device is 
activated. The number of twitches (0-4) is based on the receptor occupancy ratio of the NMBA. The 
response (number of twitches of the TOF) is used to judge the need for redosing of NMBAs as well as 
efficacy of reversal at the completion of the surgical procedure.  
 
The TetraGraph® TOF provides an electrical stimulation of the peripheral nerve in the same way as a 
standard PNS, but instead of relying on visual observation of the twitch response, it directly measures 
the amplitude of the evoked response of the muscles (Muscle Action Potential or MAP), thereby 
providing a quantitative and automatic measurement of muscle response to a stimulus using 
electromyography (EMG).  This avoids the visual observation of the twitch response and its potential 
inaccuracy. The device also allows a more sensitive measure of the EMG thereby providing 
information with less receptor occupancy than is needed to result in changes in the standard TOF. The 
device has been tested, validated, and approved (FDA cleared) for use in adults. As noted above, we 
have completed a preliminary trial with this monitor which has been published.  
 
In clinical use, the self-adhesive sensor (see figure below to the left showing the self-adhesive sensor 
attached to a patient) is applied to the patient’s hand then after the induction of anesthesia, but prior to 
the administration of a NMBA, the TOF is evaluated.  In our previous studies, we placed the sensor on 
the patient and attached it to the monitor after the induction of anesthesia. As placement of the sensor 
make take 2-5 minutes, this may disrupt the workflow in the operating room slowing the time to 
administration of the NMBA.  In adult practice, the sensor may be placed in the preoperative holding 
area prior to the induction of anesthesia so that it can be immediately attached to the monitoring 
device (see below right figure) when the patient enters the operating room. 
 
• 
Murphy GS. Neuromuscular monitoring in the perioperative period. Anesth Analg. 2018;126:464-468. 
• 
Naguib M, Brull SJ, Johnson KB. Conceptual and technical insights into the basis of neuromuscular 
monitoring. Anaesthesia. 2017;72(Suppl. 1):16-37. 
• 
Brull SJ, Eriksson L. The French Guidelines on muscle relaxants and reversal in anaesthesia: The chain 
is finally broken and the soul is freed. Anaesth Crit Care Pain Med. 2020;39:31-33. 
• 
Biro P, Paul G, Dahan A, Brull SJ. Proposal for a revised classification of the depth of neuromuscular 
block and suggestions for further development in neuromuscular monitoring. Anesth Analg. 
2019;128:1361-1363 

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4.0 
Study Endpoints  
• 
Describe the primary and secondary study endpoints. 
• 
Describe any primary or secondary safety endpoints. 
 
The primary endpoint of this study is an assessment of the tolerability and feasibility of placing the 
pediatric, self-adhesive sensor on patients in the preoperative holding area prior to entering the 
operating room. 
 
 
5.0 
Study Interventions/ Investigational Agent  
• 
Describe the study intervention and/or investigational agent (e.g., drug, device) that is being evaluated. 
 
The novel intervention for this study is placement of the sensor for the Tetragraph® device in awake 
pediatric patients in the surgical unit prior to transport to the operating room.  The sensor will be placed 
approximately 1 hour prior to transport to the operating room.  When NMBAs are administered, 
standard practice includes the use of a peripheral nerve stimulator (PNS) and visual assessment of TOF 
responses. The study will include only patients scheduled for a surgical procedure that requires uses of 
a NMBA.  
 
 
 
• 
Drug Device Handling: If the research involves drugs or device, describe your plans to store, handle, and 
administer those drugs or devices so that they will be used only on subjects and be used only by authorized 
investigators. 
• If the control of the drugs or devices used in this protocol will be accomplished by following an 
established, approved organizational SOP (e.g., Research Pharmacy SOP for the Control of 
Investigational Drugs, etc.), please reference that SOP in this section. 
 
The monitors and sensors are kept in a locked cabinet in the Anesthesia Research office. 
 
 
 

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• 
If the drug is investigational (has an IND) or the device has an IDE or a claim of abbreviated IDE (non-
significant risk device), include the following information: 
• 
Identify the holder of the IND/IDE/Abbreviated IDE. 
• 
Explain procedures followed to comply with sponsor requirements for FDA regulated research for 
the following: 
 
Applicable to: 
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated IDE 
studies 
21 CFR 11 
X 
X 
 
21 CFR 54 
X 
X 
 
21 CFR 210 
X 
 
 
21 CFR 211 
X 
 
 
21 CFR 312 
X 
 
 
21 CFR 812 
 
X 
X 
21 CFR 820 
 
X 
 
 
The FDA has given 510(k) approval for both the device and the pediatric sensors. 
 
 
6.0 
Procedures Involved  
• 
Describe and explain the study design. 
 
This is a prospective study that will evaluate the feasibility of placing the adhesive sensor for the 
Tetragraph® monitor while in pediatric patients ≤ 12 years of age while they are awake in the 
preoperative holding area.  
 
• 
Provide a description of all research procedures being performed and when they are performed, including 
procedures being performed to monitor subjects for safety or minimize risks. 
 
In order to stimulate the muscle and sense the EMG, the device uses a self-adhesive sensor that 
attaches to the free-standing monitor.  For our first study, we applied the sensor and attached it to the 
monitor in the operating room.  In common clinical practice, placement of the sensor requires 2-5 
minutes which may disrupt the normal flow of an efficient operating room. We therefore want to 
evaluate whether it is feasible to place the self-adhesive sensor (see figure below) while the patient is 
awake in the preoperative holding area. We will only place the sensor, no stimulation of the muscle or 
recording of the EMG will occur. Therefore, there is no discomfort associated with sensor placement. 
The application of the EMG sensor is similar to the application of ECG skin sensors. 
 
 

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Once the sensor is attached by a member of the research team, that member will use a 0-10 Likert scale 
to assess both the ease of placement in the preoperative area and how well the patient tolerates 
placement until arrival in the operating room. The Likert scale will also be used by a parent or guardian 
to assess both of these features including ease of placement and how well it is tolerated until the patient 
is transported to the operating room. As the administration of standard preoperative sedative 
medications (oral midazolam) may impact the outcomes of the study, we will note which medications 
are administered preoperatively.  Once in the operating room, the sensor will be attached to the monitor 
via a standard cable. After the induction of anesthesia, the monitor will be started to record the TOF 
prior to the administration of the NMBA. Function of the monitor and ability to generate a TOF/EMG 
will then be graded in the operating room using the 0-10 Likert scale. 
 
 
• 
Describe:  
• 
Procedures performed to lessen the probability or magnitude of risks. 
• 
All drugs and devices used in the research and the purpose of their use, and their regulatory 
approval status. 
• 
The source records that will be used to collect data about subjects. (Attach all surveys, scripts, and 
data collection forms.) 
 
TetraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring 
of neuromuscular function. It is a precise and easy to use tool for monitoring depth of 
block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce 
the incidence of residual block.  It has received 510K approval for use in both adults and children. 
 
 
• 
What data will be collected during the study and how that data will be obtained. 
 
o Patient demographics - MRN, date of birth, date of surgery, sex at birth, race, ethnicity, ASA, 
height, weight 
o Time of sensor placement 
o Ease of placement and tolerance to pre-op placement using a 0-10 Likert scale will be assessed 
by both a member of the research team and a parent/guardian 
o Function of the monitor and ability to generate a TOF/EMG will be graded in the operating 
room using the 0-10 Likert scale 
o Preoperative and intraoperative medications administered 
o The EMG readings from the TetraGraph will be uploaded to TetraConnect, a secure server 
 
 
• 
If there are plans for long-term follow-up (once all research related procedures are complete), what data will 
be collected during this period. 
 
No plans for long-term follow-up. 
 
 
• 
For Humanitarian Use Device (HUD) uses provide a description of the device, a summary of how you 
propose to use the device, including a description of any screening procedures, the HUD procedure, and any 
patient follow-up visits, tests or procedures. 
 
N/A 
 
 
7.0 
Study Timelines 
• Describe: 

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• The duration of an individual subject’s participation in the study. 
• The duration anticipated to enroll all study subjects. 
• The date for the investigators to complete this study (complete primary analyses, study closure in 
eIRB2). 
 
An individual study subject’s participation in the study should last 1-8 hours depending on the duration 
of the surgical procedure. 
 
All study subjects should be enrolled within 24 months of the start of the study.   
 
The study data will be analyzed, a manuscript written, and the study completed within 30 months of the 
start of the study. 
 
 
8.0 
Inclusion and Exclusion Criteria  
• 
Describe how individuals will be screened for eligibility. 
• 
Describe the criteria that define who will be included or excluded in your final study sample. 
• Please include the age range that will be used (“birth to adult” or specify age range (e.g. 2 years old to 10 years old) 
 
 
Potential subjects will be identified by reviewing the surgery schedule in Epic and will be recruited 
from the pre-operative area the day of their surgery. 
 
Inclusion criteria: ASA 1-4 patients ≤ 12 years of age undergoing a surgical procedure with general 
anesthesia and requiring the administration of an NMBA. 
 
Exclusion criteria: 
o Patients undergoing a surgical procedure in which neuromuscular blockade is not 
required 
o Edematous patients 
o Patients with significant behavioral or neurocognitive issues which affect behavior and 
impact the ability to place the sensor 
 
 
• 
Indicate specifically whether you will include or exclude each of the following special populations: (You 
may not include members of the above populations as subjects in your research unless you indicate this in 
your inclusion criteria.) 
• Adults unable to consent 
• Individuals who are not yet adults (infants, children, teenagers) 
• Pregnant women 
• Prisoners  
 
We will be including children but will be excluding all others as they are not part of our target 
population for this study. 
 
 
9.0 
Vulnerable Populations 
If the research involves individuals who are vulnerable to coercion or undue influence: 
• Check the box for the vulnerable population(s) involved. 
• Review the appropriate checklist (do not include in submission). 
• Describe additional safeguards included to protect their rights and welfare.  
 

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☐ Research involving pregnant women, reference “CHECKLIST: Pregnant Women (HRP-412)” 
 
N/A 
 
 
☐ The research involves neonates of uncertain viability or non-viable neonates, review “CHECKLIST: 
Neonates (HRP-413)” or “HRP-414 – CHECKLIST: Neonates of Uncertain Viability (HRP-414)” 
to ensure that you have provided sufficient information. 
 
N/A 
 
 
☐ The research involves prisoners, review “CHECKLIST: Prisoners (HRP-415)” to ensure that you 
have provided sufficient information. 
 
N/A 
 
 
☒ The research involves persons who have not attained the legal age for consent to treatments or 
procedures involved in the research (“children”), review the “CHECKLIST: Children (HRP-416)” 
to ensure that you have provided sufficient information. 
 
The research involves no greater than minimal risk to children. Permission will be obtained from one 
parent/guardian after thorough explanation of the study.  Assent will be obtained from children aged 9 
years and older who have the capacity to understand the study.  Wards of the state or county will not be 
included in the research study. 
 
 
☐ The research involves cognitively impaired adults, review “CHECKLIST: Cognitively Impaired 
Adults (HRP-417)” to ensure that you have provided sufficient information. 
 
N/A 
 
 
10.0 
Local Number of Subjects   
• 
Indicate the total number of subjects to be accrued locally. 
• 
If applicable, distinguish between the number of subjects who are expected to be enrolled and screened, and 
the number of subjects needed to complete the research procedures (i.e., numbers of subjects excluding 
screen failures.) 
 
100 subjects will be enrolled at NCH. 
 
 
11.0 
Withdraw of Subjects  
• 
Describe anticipated circumstances under which subjects will be withdrawn from the research without their 
consent. 
• 
Describe any procedures for orderly termination. 
• 
Describe procedures that will be followed when subjects withdraw from the research, including partial 
withdrawal from procedures with continued data collection.  
 
There are no anticipated circumstances under which subjects will be withdrawn from the research 
without their consent. 
 

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12.0 
Risks to Subjects 
• 
List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the subjects related the 
subjects’ participation in the research. Include as may be useful for the IRB’s consideration, a description of 
the probability, magnitude, duration, and reversibility of the risks. Consider physical, psychological, social, 
legal, and economic risks. 
 
Although not likely, there may be a potential risk for breach of patient health information. There is no 
study related physical risk to study subjects associated with this study.  
 
 
• 
Describe what actions will be taken to minimize the risks (listed above).  
 
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. Subject PHI will be stored in a locked cabinet, and will be stored and 
maintained in password protected computer files. 
 
 
• 
If applicable, indicate which procedures may have risks to the subjects that are currently unforeseeable. 
(Include what actions will be taken to minimize the risks.)  
 
N/A 
 
 
• 
If applicable, indicate which procedures may have risks to an embryo or fetus should the subject be or 
become pregnant. (Include what actions will be taken to minimize the risks.) 
 
N/A 
 
 
• 
If applicable, describe risks to others who are not subjects. (Include what actions will be taken to minimize 
the risks.) 
 
N/A 
 
 
13.0 
Potential Benefits to Subjects 
• 
Describe the potential benefits that individual subjects may experience from taking part in the research. 
(Consider and include the probability, magnitude, and duration of the potential benefits). 
 
OR  
 
• 
Indicate if there is no direct benefit. Do not include benefits to society or others. 
 
There are no specific benefits to the subjects by participating in this study. 
 
 
14.0 
Data Management and Confidentiality  
• 
Describe the data analysis plan, including any statistical procedures or power analysis. 
 
Statistical analysis and data presentation will be a descriptive analysis of the feasibility of placing the 
sensor in awake patients and using the device in pediatric-aged patients. Feasibility, for the purpose of 

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using this monitor intraoperatively, will defined as the generation of appropriate EMG for monitoring 
in ≥ 75% of the patients.  This will depend on the ability of the device to stimulate a peripheral nerve 
and generate the EMG of the muscle. 
 
• 
Describe the steps that will be taken to secure the data (e.g., training, authorization of access, password 
protection, encryption, physical controls, certificates of confidentiality, and separation of identifiers and data) 
during storage, use, and transmission. 
 
All data collected during this study will be stored in secure password protected computer files and a 
locked cabinet to which only trained members of the research team and collaborators directly involved 
with this research project will have access.  
 
 
• 
Describe any procedures that will be used for quality control of collected data. 
 
Data will be entered into a REDCap database which will be created with built in quality control 
elements. 
 
 
• 
Describe how data or specimens will be handled study-wide: 
• 
What information will be included in that data or associated with the specimens? 
• 
Where and how data or specimens will be stored? 
• 
How long the data or specimens will be stored? (Must be kept for a minimum of 6 years, once deidentified may be 
kept longer if specified)  
• 
Who will have access to the data or specimens? 
• 
Who is responsible for receipt or transmission of the data or specimens? 
• 
How data or specimens will be transported? 
 
All data collected during this study will be stored in a secure password protected computer files and a 
locked cabinet to which only trained members of the research team and collaborators directly involved 
with this research project will have access.  
 
 
15.0 
Provisions to Monitor the Data to Ensure the Safety of Subjects 
**This section is required when research involves more than Minimal Risk to subjects. 
• 
Describe: 
• 
The plan to periodically evaluate the data collected regarding both harms and benefits to determine 
whether subjects remain safe.  The plan might include establishing a data monitoring committee and a 
plan for reporting data monitoring committee findings to the IRB and the sponsor. 
• 
What data are reviewed, including safety data, untoward events, and efficacy data 
• 
How the safety information will be collected (e.g., with case report forms, at study visits, by telephone 
calls with participants). 
• 
The frequency of data collection, including when safety data collection starts. 
• 
Those responsible to review the data. 
• 
The frequency or periodicity of review of cumulative data. 
• 
The statistical tests for analyzing the safety data to determine whether harm is occurring. 
• 
Any conditions that trigger an immediate suspension of the research. 
 
Since this is a minimal risk study, it will only be monitored by the study investigators. 
 
 
16.0 
Provisions to Protect the Privacy Interests of Subjects 

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• 
Describe the steps that will be taken to protect subjects’ privacy interests. “Privacy interest” refers to a 
person’s desire to place limits on whom they interact or whom they provide personal information. 
• 
Describe what steps you will take to make the subjects feel at ease with the research situation in terms of the 
questions being asked and the procedures being performed. “At ease” does not refer to physical discomfort, 
but the sense of intrusiveness a subject might experience in response to questions, examinations, and 
procedures. 
• 
Indicate how the research team is permitted to access any sources of information about the subjects. 
 
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.  
 
 
17.0 
Data and Specimen Banking  
Data and/or Tissue "banking" refers to data and/or tissue that will be stored in large databanks or tissue banks 
for future research. This does not refer to storage of data during a specific ongoing study that is not going to be 
shared with a large data bank. Data for one study is stored by the investigator in a secure manner can be 
described in the Data Management section in the protocol. 
 
• If data or specimens will be banked for future use (not for use with this study only), describe where the data 
and/or specimens will be stored, how long they will be stored, how the data and/or specimens will be 
accessed, and who will have access to the data and/or specimens. 
• List the data to be stored or associated with each specimen. 
• Describe the procedures to release data or specimens, including: the process to request a release, approvals 
required for release, who can obtain data or specimens, and the data to be provided with specimens. 
 
There will be no data or specimens banked for future use. 
 
 
18.0 
Sharing of Results with Subjects 
• Describe whether results (study results or individual subject results, such as results of investigational 
diagnostic tests, genetic tests, or incidental findings) will be shared with subjects or others (e.g., the subject’s 
primary care physicians) and if so, describe how the results will be shared. 
 
Study results will not be shared with subjects or others.  Results will be uploaded to ClinicalTrials.gov 
at the completion of the study. 
 
 
 
19.0 
Recruitment Methods 
• 
Describe when, where, and how potential subjects will be recruited.  
• 
Describe the source of subjects.  
• 
Describe the study team member’s relationship to the potential participant.  
• 
Describe the methods that will be used to identify potential subjects.  
• 
Describe materials that will be used to recruit subjects. (Attach copies of these documents with the 
application. For advertisements, attach the final copy of printed advertisements. When advertisements are 
taped for broadcast, attach the final audio/video tape. You may submit the wording of the advertisement prior 
to taping to preclude re-taping because of inappropriate wording, provided the IRB reviews the final 
audio/video tape.) 
 

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Potential subjects will be recruited in the surgical preoperative area on the day of surgery.  The 
research team will explain the study to the parents/guardians and obtain written permission.   
 
The patients to be recruited are those who are scheduled for surgery under general anesthesia in the 
NCH operating rooms and will be identified using EPIC. 
 
 
20.0 
Process to Document Consent in Writing  
• 
Describe whether you will be following “SOP: Written Documentation of Consent (HRP-091).” If not, 
describe whether and how consent of the subject will be documented in writing. 
**If your research presents no more than minimal risk of harm to subjects and involves no procedures for which 
written documentation of consent is normally required outside of the research context, the IRB will generally 
waive the requirement to obtain written documentation of consent. 
**If you will document consent in writing, attach a consent document. If you will obtain consent, but not 
document consent in writing, attach a consent script. Review “CHECKLIST: Waiver of Written Documentation of 
Consent (HRP-411)” to ensure that you have provided sufficient information. You may use “TEMPLATE 
CONSENT DOCUMENT (HRP-502)”to create the consent document or script. 
 
We will be following “SOP: Written Documentation of Consent (HRP-091). 
 
 
21.0 
Consent Process  
• 
Indicate whether you will be obtaining consent, and if so describe: 
• 
Where will the consent process take place.  
• 
Any waiting period available between informing the prospective subject and obtaining the consent 
• 
Any process to ensure ongoing consent.  
• 
Whether you will be following “SOP: Informed Consent Process for Research (HRP-090).” If not, 
describe:  
• The role of the individuals listed in the application as being involved in the consent process. 
• The time that will be devoted to the consent discussion. 
• Steps that will be taken to minimize the possibility of coercion or undue influence. 
• Steps that will be taken to ensure the subjects’ understanding. 
 
Consent will take place in the surgery pre-op area on the day of surgery.  We will be following SOP: 
Informed Consent Process for Research (HRP-090). 
 
 
Considerations for Consent Process 
☐   Waiver or Alteration Consent Process (consent will not be obtained, required information will 
not be disclosed, or the research involves deception) 
 
• Provide a justification for the waiver or alteration in the response box below.  
• Review the “CHECKLIST: Waiver or Alteration of Consent Process (HRP-410)” to ensure you have 
provided sufficient information for the IRB to make these determinations. 
• If the research involves a waiver the consent process for planned emergency research, please review 
the “CHECKLIST: Waiver of Consent for Emergency Research (HRP-419)” to ensure you have 
provided sufficient information for the IRB to make these determinations. 
 
There will be no waiver or alteration of the consent process. 

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☐  Waiver of Written Documentation of Consent (verbal, virtual, and/or eConsent without 
signature) 
• Review the “CHECKLIST: Waiver of Written Documentation of Consent (HRP-411)” to ensure you 
have provided sufficient information for the IRB to make these determinations. 
 
 
There will be no waiver of written documentation of consent. 
 
 
Non-English Speaking Subjects- (if not known, 
skip) 
• Indicate what language(s) other than English 
are understood by prospective subjects or 
representatives. 
• If subjects who do not speak English will be 
enrolled, describe the process to ensure that the 
oral and written information provided to those 
subjects will be in that language. Indicate the 
language that will be used by those obtaining 
consent. 
 
It is not known what other languages will be 
understood by prospective subjects. 
Subjects who are not yet adults (infants, 
children, teenagers) 
• Describe the criteria that will be used to 
determine whether a prospective subject has not 
attained the legal age for consent to treatments 
or procedures involved in the research under the 
applicable law of the jurisdiction in which the 
research will be conducted. (E.g., individuals 
under the age of 18 years.) 
o For research, conducted in the state, 
review “SOP: Legally Authorized 
Representatives, Children, and Guardians 
(HRP-013)” to be aware of which individuals 
in the state meet the definition of “children.” 
o For research, conducted outside of the 
state, provide information that describes 
which persons have not attained the legal 
age for consent to treatments or 
procedures involved the research, under 
the applicable law of the jurisdiction in 
which research will be conducted. One 
method of obtaining this information is to 
have a legal counsel or authority review 
your protocol along the definition of 
“children” in “SOP: Legally Authorized 
All of the potential subjects for this study will be 
under the age of legal consent. Parental 
permission will only be obtained from one parent 
and assent will be obtained from children aged 9 
years and older who have the capacity to 
understand the study. 

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Representatives, Children, and Guardians 
(HRP-013).” 
• Describe whether parental permission will be 
obtained from: 
o Both parents unless one parent is 
deceased, unknown, incompetent, or not 
reasonably available, or when only one 
parent has legal responsibility for the care 
and custody of the child. 
o One parent even if the other parent is 
alive, known, competent, reasonably 
available, and shares legal responsibility 
for the care and custody of the child. 
• Describe whether permission will be obtained 
from individuals other than parents, and if so, 
who will be allowed to provide permission. 
Describe the process used to determine these 
individuals’ authority to consent to each child’s 
general medical care. 
• Indicate whether assent will be obtained from 
all, some, or none of the children. If assent will 
be obtained from some children, indicate which 
children will be required to assent. 
• When assent of children is obtained describe 
whether and how it will be documented. 
 
Cognitively Impaired Adults   
• Describe the process to determine whether an 
individual is capable of consent. The IRB allows 
the person obtaining assent to document assent 
on the consent document and does not routinely 
require assent documents and does not routinely 
require cognitively impaired adults to sign 
assent documents. 
 
Cognitively impaired adults will not be enrolled. 
Adults Unable to Consent  
• List the individuals from whom permission will 
be obtained in order of priority. (E.g., durable 
power of attorney for health care, court 
appointed guardian for health care decisions, 
spouse, and adult child.). 
o For research conducted in the state, 
review “SOP: Legally Authorized 
Representatives, Children, and Guardians 
(HRP-013)” to be aware of which 
individuals in the state meet the definition 
of “legally authorized representative.” 
o For research conducted outside of the 
state, provide information that describes 
Adults unable to consent will not be enrolled. 

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which individuals are authorized under 
applicable law to consent on behalf of a 
prospective subject to their participation 
in the procedure(s) involved in this 
research. One method of obtaining this 
information is to have a legal counsel or 
authority review your protocol along the 
definition of “legally authorized 
representative” in “SOP: Legally 
Authorized Representatives, Children, and 
Guardians (HRP-013).” 
• Describe the process for assent of the subjects. 
Indicate whether: 
o Assent will be required of all, some, or 
none of the subjects. If some, indicate 
which subjects will be required to assent 
and which will not. 
o If assent will not be obtained from some 
or all subjects, an explanation of why not. 
o Describe whether assent of the subjects 
will be documented and the process to 
document assent. The IRB allows the 
person obtaining assent to document 
assent on the consent document and does 
not routinely require assent documents 
and does not routinely require subjects to 
sign assent documents. 
 
Consent for HUD  
• For HUD uses provide a description of how the 
patient will be informed of the potential risks 
and benefits of the HUD and any procedures 
associated with its use. 
HUD will not be used in this study. 
 
22.0 
Compensation for Research-Related Injury 
• 
If the research involves more than Minimal Risk to subjects, describe the available compensation in the event 
of research related injury. 
• 
Provide a copy of contract language, if any, relevant to compensation for research-related injury. 
 
This is a minimal risk study. 
 
 
23.0 
Compensation to Subjects 
• 
Describe the amount and timing of any payments to subjects. 
 
Subjects will not be paid for participation in this study. 
 
 

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24.0 
Economic Burden to Subjects 
• 
Describe any costs that subjects may be responsible for because of participation in the research, e.g., fuel, 
parking, childcare. 
 
There will be no costs to participants in this study.   
 
 
25.0 
Setting  
• 
Describe the local sites or locations where your research team will conduct the research. 
• 
Identify where your research team will identify and recruit potential subjects. 
• 
Identify where research procedures will be performed.  
• 
Describe the composition and involvement of any community advisory board. 
• 
For research conducted outside of the organization and its affiliates describe: 
• 
Site- specific regulations or customs affecting the research for research outside the organization. 
• 
Local scientific and ethical review structure outside the organization. 
 
Potential subjects will be identified from the OR schedule in EPIC and recruited from the Surgery Unit 
on the day of surgery.  All research procedures will be performed in the pre-op area and the OR. 
 
 
26.0 
Resources Available  
• 
Describe the resources available to conduct the research. For example, as appropriate: 
• 
Justify the feasibility of recruiting the required number of suitable subjects within the agreed 
recruitment period. For example, how many potential subjects do you have access to? What 
percentage of those potential subjects do you need to recruit? 
• 
Describe the time that you will devote to conducting and completing the research. 
• 
Describe your facilities. 
• 
Describe the availability of medical or psychological resources that subjects might need as a result of 
an anticipated consequences of the human research. 
• 
Describe your process to ensure that all persons assisting with the research are adequately informed 
about the protocol, the research procedures, and their duties and functions. 
 
We will need approximately 20 minutes per patient to explain the research protocol, obtain consent, 
and enroll patients. The Department of Anesthesiology & Pain Medicine has 2 research coordinators 
and 4 research associates who will be enrolling subjects for this study.  All study staff will be trained 
regarding the study procedures. Before the study starts, the involved personnel will be informed by e-
mail and during a pre-study meeting about the study protocol, the research procedures, research 
member’s duties, and functions. 
 
 
27.0 
Confidentiality of Data Collection  
• How long will identifying information on each participant be maintained? (Study data and identifiers 
must be stored for at least six years after study closure; a longer period may be used. A specific date 
or number of years must be listed.)   
 
Following completion of study, research records will be stored for a period of 6 years and then will be 
destroyed by placing in a secure shredding bin and deleted from REDCap. 
 
 
• Describe any plans to code identifiable information collected about each participant. 
 

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There are no plans to code identifiable information collected about each participant. 
 
 
• 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. 
 
• Describe the provisions included in the protocol to protect the privacy interests of subjects, where 
"privacy interests" refer to the interest of 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.  
 
 
• Will it be necessary to record information of a sensitive nature? 
“Sensitive information includes but is not limited to ‘information relating to sexual attitudes, 
preferences, or practices; information relating to the use of alcohol, drugs, or other addictive 
products; information pertaining to illegal conduct; information that, if released, might be damaging 
to an individual's financial standing, employability, or reputation within the community or might lead 
to social stigmatization or discrimination; information pertaining to an individual's psychological 
well-being or mental health; and genetic information or tissue samples.’” 
 
 
☐ Yes    ☒ No 
 
• Do you plan to obtain a federally-issued Certificate of Confidentiality as a means of protecting the 
confidentiality of the information collected? (If the study is NIH funded, Certificate of 
Confidentiality will be issued; please mark “Yes”).  
“Certificate of Confidentiality (Certificate) protects the privacy of research participants enrolled 
in biomedical, behavioral, clinical, or other types of health-related research that collect or use 
identifiable, sensitive information. With limited exceptions, researchers may not disclose names 
or any information, documents or biospecimens containing identifiable, sensitive information. 
The Certificate prohibits disclosure in response to legal demands, such as a subpoena.” 
 
☐ Yes   ☒ No 
28.0 
Protected Health Information (PHI) Recording  
 
PHI: individually identifiable health information transmitted or maintained in any form (electronic 
means, on paper, or through oral communication) that relates to the past, present or future physical 
or mental health or conditions of an individual plus any of the following 18 identifiers. 
Are you accessing or recording information related to the provision of healthcare or payment for 
healthcare services (medical records, lab test results, diagnoses, etc.)?  
Consider sources such as the medical record, clinic schedules, billing statements, etc. This includes 
screening for potential subjects for recruitment purposes. 
 

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☒        If yes, complete section 28.0. 
☐        If no, skip section 28.0. 
 
 
Indicate which subject identifiers will be ACCESSED for this research.  
☒ Name 
☐ Address (including street, city, state, zip code 
and county) 
☒ Dates (treatment dates, birth date, date of 
death) 
☐ Telephone  
☐ Fax Number 
☐ Email address,  
☐ Social Security Number (do not check if only 
used for ClinCard)  
☒ Medical Record Number or other account 
number (specify below) 
☐ Health Plan Beneficiary Identification 
Number 
 
 
☐ Account Numbers 
☐ Certificate/License Numbers 
☐ Vehicle Identifiers and Serial Numbers  
☐ Device Identifiers and Serial Numbers 
☐ URL 
☐ IP address   
☐ Biometric identifiers, including finger and voice 
prints 
☐ Full face photographic images and/or any 
comparable images 
☐ Other number, characteristic or code that could be 
used to identify an individual (specify below) 
☐ None (Complete De-identification Certification 
Form) 
 
 
 
If the “Medical Record Number or other account number) and/or “Other number, characteristic or code 
that could be used to identify an individual” please respond below.  
The Medical Record Number is required to locate the potential subject’s health records to assess 
for inclusion/exclusion criteria. 
 
 
Indicate which subject identifiers will be RECORDED for this research. 
☒ Name 
☐ Address (including street, city, state, zip code 
and county) 
☒ Dates (treatment dates, birth date, date of 
death) 
☐ Telephone  
☐ Fax Number 
☐ Email address,  
☐ Social Security Number (do not check if only 
used for ClinCard)  
☒ Medical Record Number or other account 
number (specify below) 
☐ Health Plan Beneficiary Identification 
Number 
 
 
☐ Account Numbers 
☐ Certificate/License Numbers 
☐ Vehicle Identifiers and Serial Numbers  
☐ Device Identifiers and Serial Numbers 
☐ URL 
☐ IP address   
☐ Biometric identifiers, including finger and voice 
prints 
☐ Full face photographic images and/or any 
comparable images 
☐ Other number, characteristic or code that could be 
used to identify an individual (specify below) 
☐ None (Complete De-identification Certification 
Form) 
 
 
 

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If the “Medical Record Number or other account number) and/or “Other number, characteristic or code 
that could be used to identify an individual” please respond below. 
The Medical Record Number will need to be recorded so that study data can be collected from the 
medical record following enrollment.  
 
 
 
29.0 
Confidential Health Information Recording  
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 
☐  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 
  
If the information you are collecting does not match any of the options listed above, please list what 
information you will be gathering. 
N/A 
 
 
 
 
 
 
30.0 
Waiver or Alteration of HIPAA Research Authorization 
• Check the appropriate category and attach the required form on the Local Site 
Documents, #3. Other Documents, page of the application.  (Mark all that apply.) 
 
☒  Protocol meets the criteria for waiver of authorization. (Continue filling out section 30.) 
☒  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 is using de-identified information. (Attach the HRP-902, DE-IDENTIFICATION 
CERTIFICATION form.) 
☐  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.) 

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Find the HIPAA forms in the eIRB2 Website Library, Templates. 
 
 
• Please indicate the type of waiver or alteration needed for this study.   
Note: If the research involves more than one type of waiver, check the appropriate box. 
☒  A. Partial Waiver (to access PHI for recruitment purposes only) 
☐  B. Full Waiver (entire research study) 
☐  C. Alteration (waiver of written documentation of authorization; obtaining verbal authorization 
to use PHI) 
 
 
• Please discuss why it is necessary to access and review the health information noted in your 
response above. 
 
A partial waiver is required so that we can screen for inclusion/exclusion criteria prior to 
recruitment. 
 
 
• Is the health information to be accessed and reviewed the minimal necessary to achieve the 
goals of this research? Please provide an explanation, as well.  
 
☒ Yes    ☐ No 
We will only be looking at information related to the inclusion/exclusion criteria. 
 
 
• Explain how the access, use, or disclosure of PHI presents no more than a minimal risk to 
the privacy of the individual. 
Only certified research personnel will be given access to identifiable subject information. 
 
 
• Describe your plan to protect the identifiers (or links to identifiable data) associated with the PHI 
from improper use and disclosure, including where PHI will be stored, what security measures will 
be applied, and who will have access to the information. Describe the safeguards for electronic 
and/or hard copy records. 
All PHI will be stored in a locked cabinet, and a password protected computer file in the Dept. 
of Anesthesiology and only the department investigators and study coordinators will have 
access to the cabinets and computer system.  The PHI may also be accessed by the IRB or the 
Research Compliance Office (RCO) upon request and both the entities are NCH trusted bodies 
governing research investigations. 
 
 
• Will identifiers (or links to identifiable data) be destroyed? Provide a justification for your 
answer.  
☒  Yes – Describe the plan to destroy the identifiers at the earliest opportunity consistent with 
the conduct of the research.  Include when (consistent with section 27) and how 
identifiers will be destroyed. 
 
☐  No – Provide the legal, health, or research justification for retaining the identifiers.  Legal 
justification should include a brief description/citation of the legal requirement. 
 

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☐  N/A – Will not record identifiers or create links or codes to connect the data. 
 
Following completion of study, research records will be stored for a period of 6 years and then 
will be destroyed by placing in a secure shredding bin and deleted from REDCap. 
 
 
• Explain why a waiver/alteration (instead of written authorization) is needed to conduct the 
research.  
We require the partial waiver to be able to review the surgery schedule for potential subjects. 
 
 
NOTE:  Only those personnel listed on the IRB-approved application may access PHI and medical 
information. 
 
Reminder: Protected Health Information obtained as part of this research will not be reused or disclosed to any 
other person or entity other than those listed (except as required by law for authorized oversight of the research 
project) without additional approval.   IRB/Privacy Board approval must be obtained for other research 
involving the use or disclosure of this PHI. 
 
 
 

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31.0 
Multi-Site Research  
**This section is required when research will be conducted at multiple sites. Check the 
appropriate box. 
 
☒ NCH IS participating in multi-site research.  
☐ NCH IS NOT participating in multi-site research. No further information is needed in this 
section.  
 
• 
TOTAL Number of Subjects to be Enrolled Study-Wide 
• 
List the locations of the additional sites. Please indicate which sites are International.  
 
OU will be a relying site solely for the purpose of adding their medical students as study staff for the 
summer. No subjects will be enrolled at OU. 
 
• 
Study-Wide Recruitment Methods  
** If this is a multicenter study and subjects will be recruited by methods not under the control of the 
local site (e.g., call centers, national advertisements) describe those methods here.  Local 
recruitment methods are described earlier in the protocol (Section 19.0). 
• 
Describe when, where, and how potential subjects will be recruited.  
• 
Describe the methods that will be used to identify potential subjects. 
• 
Describe the materials that will be used to recruit subjects. (Attach copies of these documents with 
the application. For advertisements, attach the final copy of printed advertisements. When 
advertisements are taped for broadcast, attach the final audio/video tape. You may submit the 
wording of the advertisement prior to taping to preclude re-taping because of inappropriate 
wording, provided the IRB reviews the final audio/video tape.) 
 
Subjects will only be recruited and enrolled at NCH. 
 
• 
Multi-Site Data Management  
• 
Check all applicable boxes below.  
☐  NCH will SEND data to other sites 
☐  NCH will RECEIVE data from other sites 
 
• 
Describe the procedures for maintenance or confidentiality of data at non-NCH sites.  
• 
Where and how data or specimens will be stored? 
• 
How long the data or specimens will be stored?  
• 
Who will have access to the data or specimens?  
• 
Who is responsible for receipt or transmission of the data of specimens? 
• 
How data specimens will be transported?  
 
No data will be exchanged with OU.  All data will be maintained at NCH. 
 
☒  NCH investigator IS the LEAD investigator in the study.  
☐  NCH IS NOT the LEAD investigator in the study. No further information needed in this section.  
 
• 
Review “WORKSHEET: Communication and Responsibilities (HRP-830)” 
• 
Describe the processes for communication among sites to conduct the study in accordance with applicable 
federal regulations and local laws.  
• 
Describe the method for reporting the following: 
• 
Problems (inclusive of reportable events) 
• 
Non-compliance with the study protocol of applicable requirements 

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• 
Interim results 
• 
The closure of the study  
• 
 
OU will be notified in writing when study closes.