Conditions: Inguinal Hernia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 100
Healthy volunteers: no

Brief summary:
The aim of this double-blind clinical trial is to examine outcomes and pain control after surgery in patients who underwent laparoscopic inguinal hernia repair (IHR) with the use of perioperative transabdominal plane (TAP) block.

Research Question: Does transabdominal plane block improve pain when undergoing inguinal hernia repair? The endpoints include whether preoperative TAP blocks improve pain score (primary end point) and decrease opioid use (secondary endpoint) after an inguinal hernia repair. Other end points- complications after surgery.

Detailed description:
Protocol:

After receiving approval for the study, the researchers will conduct a prospective single institution randomized clinical trial assessing if using a TAP block perioperatively can reduce pain scores after surgery. Other endpoints include whether there are differences in pain medication usage and complications.

Patients will be screened by research team members and attending surgeons. If the patient is interested, the researchers will consent the participants for the study after understanding the study details, procedures, and expectations. The researchers will then consent using IRB approved study consent forms and procedures. Patients will undergo a laparoscopic inguinal hernia repair according to standard procedures. The study will assess if a TAP block impacts pain scores. Patients will be randomized to receive the intervention or placebo. Sequentially numbered sealed opaque envelopes with group allocation inside will alert the anesthesiologist \& surgeon to order Tap block composed of 0.25% bupivacaine or placebo (normal saline).

Inguinal hernia repair will be performed in standard fashion that each individual surgeon is familiar with. No additional tests or blood work outside the standard of care for IHR will be performed for research purposes. In addition, some patients will be given TAP blocks before surgery to help in pain management. Patients will be discharged with a worksheet on which the participants are to record analgesic use and pain scores on postoperative days one, two, three and four. The participants are expected to bring the completed log to their two-week follow up visit with their surgeon. Patients may also expect to receive a phone call from a member of the surgical team to remind them to record these metrics.

The TAP block is done pre-procedure using 0.25% bupivacaine. If patients weigh\<100 kg, the patients will receive a total of 50 ml (25 ml on each side of the abdominal wall). If patients weigh\>100 kg, the patients will receive a total of 60 ml (30ml on each side of the abdominal wall). The TAP plane is identified using ultrasound. All anesthesiologists (not surgeons) working with the attendings involved in this study have been trained in this technique; it is a routine part of their practice. It is anesthesiologists who will be performing the block.

Patients will be discharged with a worksheet /survey on which the patients are to record analgesic use and pain scores on postoperative days one, two, three and four. The patients are expected to bring the completed log to their two-week follow up visit.

Arms:
arm 1: Normal Saline:

For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. arm 2: 0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received.

Interventions: intervention 1: 0.25% Bupivacaine intervention 2: Placebo intervention 3: TAP block
Intervention descriptions: intervention 1: received during TAP block intervention 2: placebo equivalent intervention 3: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).

Protocol document:
Prot_SAP_000.pdf: 
Transabdominal Plane (TAP) Blocks for Inguinal Hernia Repairs
PI: Dr. Celia M. Divino
NCT05672680
Document Date: 8-10-2022


Transabdominal plane (TAP) blocks for Laparoscopic Inguinal Hernia Repairs
Protocol Number: STUDY-19-0067
National Clinical Trial (NCT) Identified Number: 
Principal Investigator: Celia Divino, MD
Sponsor: Internal (MSSM)
Funded by: Icahn School of Medicine at Mount Sinai
Version Number:  v.1
July 6th 2021
Effective Date: 8/10/2022
End Date:7/25/2023


NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans
CONFIDENTIALITY STATEMENT
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigator or other participating study leadership and as consistent with the 
NIH terms of award. 
Effective Date: 8/10/2022
End Date:7/25/2023


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Table of Contents
STATEMENT OF COMPLIANCE.......................................................................................................................................1
INVESTIGATOR’S SIGNATURE ........................................................................................................................................2
1
PROTOCOL SUMMARY......................................................................................................................................3
1.1
Synopsis..................................................................................................................................................3
1.2
Schema...................................................................................................................................................3
1.3
Schedule of Activities .............................................................................................................................6
2
INTRODUCTION.................................................................................................................................................7
2.1
Study Rationale ......................................................................................................................................7
2.2
Background ............................................................................................................................................7
2.3
Risk/Benefit Assessment........................................................................................................................7
2.3.1
Known Potential Risks ........................................................................................................7
2.3.2
Known Potential Benefits ...................................................................................................8
2.3.3
Assessment of Potential Risks and Benefits .......................................................................8
3
OBJECTIVES AND ENDPOINTS ...........................................................................................................................9
4
STUDY DESIGN ................................................................................................................................................12
4.1
Overall Design ......................................................................................................................................12
4.2
Scientific Rationale for Study Design....................................................................................................13
4.3
Justification for Intervention................................................................................................................13
4.4
End-of-Study Definition........................................................................................................................13
5
STUDY POPULATION .......................................................................................................................................13
5.1
Inclusion Criteria ..................................................................................................................................14
5.2
Exclusion Criteria..................................................................................................................................15
5.3
Lifestyle Considerations .......................................................................................................................16
5.4
Screen Failures .....................................................................................................................................16
5.5
Strategies for Recruitment and Retention ...........................................................................................17
6
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S)..................................................................18
6.1
Study Intervention(s) or Experimental Manipulation(s) Administration..............................................19
6.1.1
Study Intervention or Experimental Manipulation Description .......................................19
6.1.2
Administration and/or Dosing ..........................................................................................19
6.2
Fidelity..................................................................................................................................................19
6.2.1
Interventionist Training and Tracking...............................................................................19
6.3
Measures to Minimize Bias: Randomization and Blinding ...................................................................20
6.4
Study Intervention/Experimental Manipulation Adherence................................................................21
6.5
Concomitant Therapy...........................................................................................................................21
6.5.1
Rescue Therapy ................................................................................................................22
7
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL.............................................................................................................................22
7.1
Discontinuation of Study Intervention/Experimental Manipulation....................................................23
7.2
Participant Discontinuation/Withdrawal from the Study ....................................................................23
7.3
Lost to Follow-Up .................................................................................................................................24
8
STUDY ASSESSMENTS AND PROCEDURES.......................................................................................................25
8.1
Endpoint and Other Non-Safety Assessments .....................................................................................25
8.2
Safety Assessments..............................................................................................................................27
8.3
Adverse Events and Serious Adverse Events........................................................................................28
8.3.1
Definition of Adverse Events ............................................................................................28
8.3.2
Definition of Serious Adverse Events................................................................................29
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8.3.3
Classification of an Adverse Event....................................................................................29
8.3.4
Time Period and Frequency for Event Assessment and Follow-Up..................................31
8.3.5
Adverse Event Reporting ..................................................................................................33
8.3.6
Serious Adverse Event Reporting .....................................................................................33
8.3.7
Reporting Events to Participants ......................................................................................34
8.3.8
Events of Special Interest .................................................................................................34
8.3.9
Reporting of Pregnancy ....................................................................................................34
8.4
Unanticipated Problems.......................................................................................................................35
8.4.1
Definition of Unanticipated Problems..............................................................................35
8.4.2
Unanticipated Problems Reporting ..................................................................................36
8.4.3
Reporting Unanticipated Problems to Participants..........................................................37
9
STATISTICAL CONSIDERATIONS.......................................................................................................................37
9.1
Statistical Hypotheses ..........................................................................................................................37
9.2
Sample Size Determination..................................................................................................................38
9.3
Populations for Analyses......................................................................................................................39
9.4
Statistical Analyses...............................................................................................................................39
9.4.1
General Approach.............................................................................................................40
9.4.2
Analysis of the Primary Endpoint(s)..................................................................................40
9.4.3
Analysis of the Secondary Endpoint(s) .............................................................................41
9.4.4
Safety Analyses.................................................................................................................42
9.4.5
Baseline Descriptive Statistics ..........................................................................................42
9.4.6
Planned Interim Analyses .................................................................................................42
9.4.7
Sub-Group Analyses..........................................................................................................43
9.4.8
Tabulation of Individual Participant Data.........................................................................43
9.4.9
Exploratory Analyses ........................................................................................................44
10
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ......................................................44
10.1
Regulatory, Ethical, and Study Oversight Considerations ....................................................................44
10.1.1
Informed Consent Process................................................................................................44
10.1.2
Study Discontinuation and Closure...................................................................................45
10.1.3
Confidentiality and Privacy...............................................................................................46
10.1.4
Future Use of Stored Specimens and Data.......................................................................48
10.1.5
Key Roles and Study Governance .....................................................................................49
10.1.6
Safety Oversight................................................................................................................50
10.1.7
Clinical Monitoring ...........................................................................................................50
10.1.8
Quality Assurance and Quality Control.............................................................................52
10.1.9
Data Handling and Record Keeping ..................................................................................53
10.1.10
Protocol Deviations ..........................................................................................................56
10.1.11
Publication and Data Sharing Policy .................................................................................57
10.1.12
Conflict of Interest Policy..................................................................................................57
10.2
Additional Considerations....................................................................................................................58
10.3
Abbreviations and Special Terms .........................................................................................................58
10.4
Protocol Amendment History ..............................................................................................................60
11
REFERENCES....................................................................................................................................................61
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STATEMENT OF COMPLIANCE
The trial will be conducted in accordance with International Council on Harmonisation Good 
Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR). The 
Principal Investigator will assure that no deviation from, or changes to the protocol will take place 
without prior agreement and documented approval from the Institutional Review Board (IRB), 
and the Investigational New Drug (IND) or Investigational Device Exemption (IDE) sponsor, if 
applicable, except where necessary to eliminate an immediate hazard(s) to the trial participants. 
All personnel involved in the conduct of this study have completed Human Subjects Protection 
and ICH GCP Training.
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval. Approval of both the protocol and the consent 
form(s) must be obtained before any participant is consented. Any amendment to the protocol 
will require review and approval by the IRB before the changes are implemented to the study. All 
changes to the consent form(s) will be IRB approved; a determination will be made regarding 
whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form.
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1
PROTOCOL SUMMARY
1.1
SYNOPSIS 
Title:
Transabdominal plane (TAP) Blocks for Laparoscopic Inguinal Hernia 
Repair
Grant Number:
Study Description:
Inguinal hernias are bulges in the groin region that arise from 
weaknesses in the abdominal wall. Often, due to discomfort, pain or 
cosmetic dissatisfaction, these hernias must be surgically repaired. The 
use of a transabdominal plane (TAP) block—a local injection given in 
the abdomen to block pain receptors on nerves—during surgery can 
presumably decrease postoperative pain. The aim of our study is to 
investigate whether the use of a TAP block can decrease the use of 
opioids and pain scores after surgery.
Objectives*:
The aim of our study is to examine outcomes and pain control after 
surgery in patients who underwent laparoscopic inguinal hernia repair 
(IHR) with the use of perioperative transabdominal plane (TAP) block. 
Research Question: Does transabdominal plane block improve pain 
when undergoing inguinal hernia repair?
Endpoints*:
To evaluate whether preoperative TAP blocks improve pain score 
(primary end point) and decrease opioid use (secondary endpoint) after 
an inguinal hernia repair. Other end points- complications after surgery.
Study Population:
We will be enrolling 100 patients from Mount Sinai Hospital 
undergoing laparoscopic inguinal hernia repair.
Phase* or Stage:
Description of 
Sites/Facilities Enrolling 
Participants:
All enrollment will occur at one site (Mount Sinai Hospital) at Faculty 
Practice Associates and Emergency Department.
Description of Study 
Intervention/Experimental 
Manipulation:
The study intervention is the administration of a TAP Block (0.25% 
bupivacaine or placebo (Saline). For patients weighing <100 kg, they 
will receive a total of 50 mL ((25 mL on each side of the abdominal 
wall). If patients weigh>100 kg, they will receive a total of 60 mL
 (30mL on each side of the abdominal wall). The TAP plane is identified 
using ultrasound. All anesthesiologists working with the surgical 
attendings involved in this study have been trained in this technique; it 
is a routine part of their practice. Anesthesiologists will be performing 
the block.
Study Duration*:
2 Years
Participant Duration:
2 Weeks
1.2
SCHEMA 
1.3
SCHEDULE OF ACTIVITIES 
2
INTRODUCTION
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2.1
STUDY RATIONALE 
Pain after surgery is common among patients. This pain may contribute to using of opioids and other 
medications to control discomfort and pain. Other clinical trial studies for hernias have shown potential 
benefit of a perioperative block on pain post-surgery. This investigation of using the TAP block peri-
operatively will provide important information on pain control for the laparoscopic inguinal hernia repair. 
2.2
BACKGROUND 
Inguinal hernias are bulges in the groin region that arise from weaknesses in the abdominal wall. Often, 
due to discomfort, pain or cosmetic dissatisfaction, these hernias must be surgically repaired. The use of 
a transabdominal plane (TAP) block—a local injection of bupivacaine given in the abdomen to block pain 
receptors on nerves—during surgery can presumably decrease postoperative pain. Currently, TAP blocks 
are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on 
every case, others variably, etc.). The aim of our study is to investigate whether the use of a TAP block can 
decrease the use of opioids and pain scores after surgery. 
Papers - PMID: 27555193, 29605459, 25558340, 23060979 - have analyzed their data using chi-square 
test/ Fisher exact test and Student t-test/Wilcoxon Signed rank test. This method of analysis does not take 
into account longitudinal nature of the data. We will take into account the fact that same patient is being 
examined throughout the study at different time points. In addition to the above mentioned statistical 
procedures we will examine the trajectory between the TAP group vs. placebo group over time using 
mixed effects models (will also take into account correlation structure between different time points) for 
the outcome of opiate consumption and pain scores.
2.3
RISK/BENEFIT ASSESSMENT 
2.3.1
KNOWN POTENTIAL RISKS 
There always exists the potential for loss of private information. There is also always the risk that the TAP 
block may not provide adequate analgesia.
There is also a risk of bowel perforation during TAP injection. However, this risk is minimal given that the 
bowel is well visualized with ultrasound guidance and thus avoided at all costs.
All injections of anesthetic carry a <1% risk of local anesthetic systemic toxicity (LAST) which can cause 
seizures or even cardiac arrest. 
As all risks for harm are those included as part of standard treatments, there are no provisions for harm 
or injury. Any follow-up tests, treatments, or procedures will performed at cost to the participant.
2.3.2
KNOWN POTENTIAL BENEFITS 
It is possible that the patient may receive no benefit from this study. However, benefits may include 
improved postoperative pain management, decreased opioid use and quicker return to normal function 
and daily activities. 
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The larger population will benefit from the increased knowledge of TAP use for hernia repair, allowing 
future patients with inguinal hernia to be more knowledgeable about the benefits and risks of this option.
2.3.3
ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
All physical risks for harm are those included as part of standard treatments, there are no added provisions 
for harm or injury due to the study. All information will be stored securely and in accordance with IRB 
policies and expectations. This treatment could prove beneficial to the patient and the larger public in 
terms of pain control and reducing opioid use.
3
OBJECTIVES AND ENDPOINTS   
OBJECTIVES
ENDPOINTS
JUSTIFICATION FOR 
ENDPOINTS
PUTATIVE 
MECHANISMS OF 
ACTION
Primary
Do TAP blocks improve pain 
score?
Change in pain 
score for the 
intervention 
versus placebo 
groups.
Assessing causal effect of TAP 
block on pain levels through 
the RCT design is the gold 
standard approach. 
Secondary
Do TAP blocks decrease 
opioid and other pain 
medication use after 
surgery?
Assessing 
number/volume of 
pain medication. 
TAP blocks should directly 
impact pain medications 
usage.
Tertiary/Exploratory 
Does TAP block usage affect 
complications after surgery?
Assessing 
complication rate 
differences 
between the 
intervention and 
placebo groups 
with regards to 
complications.
Complications can differ 
based on treatment. We want 
to assess if complications 
rates differ between the two 
groups.
4
STUDY DESIGN
4.1
OVERALL DESIGN
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After receiving approval for the study, we will conduct a prospective single institution 
randomized clinical trial assessing if using a TAP block perioperatively can reduce pain scores 
after surgery. Other endpoints include whether there are differences in pain medication usage 
and complications. 
Patients will be screened by research team members and attending surgeons. If the patient is 
interested, we will consent them for the study after they understand the study details, 
procedures, and expectations. We will then consent using IRB approved study consent forms 
and procedures. Patients will undergo a laparoscopic inguinal hernia repair according to 
standard procedures. Our study will assess if a TAP block impacts pain scores. Patients will be 
randomized to receive the intervention or placebo. Sequentially numbered sealed opaque 
envelopes with group allocation inside will alert the anesthesiologist/ surgeon
 to order Tap block composed of 0.25% bupivacaine or placebo (normal saline).
Inguinal hernia repair will be performed in standard fashion that each individual surgeon is 
familiar with. No additional tests or blood work outside the standard of care for IHR will be 
performed for research purposes. In addition, some patients will be given TAP blocks before 
surgery to help in pain management. In addition, patients will be discharged with a worksheet 
on which they are to record analgesic use and pain scores on postoperative days one, two, 
three and four. They are expected to bring the completed log to their two-week follow up visit 
with their surgeon. Patients may also expect to receive a phone call from a member of the 
surgical team to remind them to record these metrics.
The TAP block is done pre-procedure using 0.25% bupivacaine. If patients weigh<100 kg, they 
will receive a total of 50 mL (25 mL on each side of the abdominal wall). If patients weigh>100 
kg, they will receive a total of 60 mL (30mL on each side of the abdominal wall). The TAP plane 
is identified using ultrasound. All anesthesiologists (not surgeons) working with the attendings 
involved in this study have been trained in this technique; it is a routine part of their practice. It 
is anesthesiologists who will be performing the block.
Patients will be discharged with a worksheet /survey on which they are to record analgesic use 
and pain scores on postoperative days one, two, three and four. They are expected to bring the 
completed log to their two-week follow up visit.
4.2
SCIENTIFIC RATIONALE FOR STUDY DESIGN
The double blinded randomized clinical trial is the gold standard design with causal implications of the 
intervention.
4.3
JUSTIFICATION FOR INTERVENTION
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The one time perioperative mode of delivery for the intervention is best design and appropriate. Post-
surgery patients will complete a worksheet for pain scores and pain medication. Study procedures will 
remain same for all patients.
4.4
END-OF-STUDY DEFINITION
End-of-study is defined as completing the intervention and any portion of worksheet. Study times are 
expected to take place during a 2 week time period.
5
STUDY POPULATION 
5.1
INCLUSION CRITERIA
Patients undergoing laparoscopic inguinal hernia repair at the Mount Sinai Hospital
5.2
EXCLUSION CRITERIA
Patients who are younger than 18 years old, have a history of chronic opiate usage, liver or kidney disease, 
pain syndromes, allergy to bupivacaine, are pregnant or are unable to independently give consent will be 
excluded from the study preoperatively. 
Pregnant patients will be excluded due to safety of surgery and anesthetics in pregnant patients
5.3
LIFESTYLE CONSIDERATIONS
N/A
5.4
SCREEN FAILURES
Patients who do not receive the intervention or placebo.
5.5
STRATEGIES FOR RECRUITMENT AND RETENTION
100 patients will be recruited at Mount Sinai Hospital who are scheduled to receive a laparoscopic inguinal 
hernia repair. Patients will be screened by research team members and attending physicians. Recruitment 
will occur if a patient is interested in the study and they meet the inclusion criteria and do not meet 
exclusion criteria. Potential patients will receive an explanation of study procedures and expectations. If 
they would like to participate, they will be consented according to standard procedures. Patients will be 
discharged with a worksheet that asks for pain levels and pain medication usage after their operation. 
They will be expected to bring the completed sheet during their post-operation follow up visit. There will 
be no incentives for participation in the study. 
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Given that patients will be enrolled in the clinic and the emergency department after presenting with a 
disease, they may be overwhelmed and may have limited time to process the risks and benefits of 
enrolling in this trial. To address the increased vulnerability as described above, we will train all persons 
involved in the consent process in best practices for consenting a patient. Ultimately, the physician will 
make the decision for enrollment.
6
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S)
6.1
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION
6.1.1
STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION
The study intervention is 0.25% bupivacaine. This neural block will be administered at the transabdominal 
plane. Other clinical trials have shown benefit of a neural block for hernia repairs on pain scores. We 
believe this intervention will work according to similar mechanism.
6.1.2
ADMINISTRATION AND/OR DOSING
Patients are randomized to receive one time administration of either 0.25% bupivacaine or normal saline. 
The TAP block is done pre-procedure using 0.25% bupivacaine. If patients weigh<100 kg, they will receive 
a total of 50 mL (25 mL on each side of the abdominal wall). If patients weigh>100 kg, they will receive a 
total of 60 mL (30mL on each side of the abdominal wall). The TAP plane is identified using ultrasound. All 
anesthesiologists (not surgeons) working with the attendings involved in this study have been trained in 
this technique; it is a routine part of their practice. It is anesthesiologists who will be performing the block.
6.2
FIDELITY
6.2.1
INTERVENTIONIST TRAINING AND TRACKING
The intervention will be administered at one time point by an anesthesiologist who is trained to administer 
the medication.
6.3
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING
This is a double blinded study. Assignment of the intervention is made prior to the study beginning in pre-
numbered envelopes at a 1:1 ratio to optimize power. The data analyst will not be aware of a treatment 
for any specific patient. Due to the same quantity of the placebo and intervention drug, the treatment 
should remain indistinguishable with regards to blinding.
6.4
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE
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The intervention is completed during the surgery thus no adherence to intervention is required of the 
patient. The patient will complete a form describing pain score post-surgery and pain medications which 
will be tracked at the post-operation visit. 
6.5
CONCOMITANT THERAPY
For this protocol, participants are not restricted to the pain medication they use. Rather, they are to record 
opioid based and over the counter medication used for pain control.
6.5.1
RESCUE THERAPY
There will no rescue therapy for this intervention.
7
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL
7.1
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION
The intervention will occur at one time point during surgery. There will be no discontinuation after therapy 
administration.
7.2
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY
Patients may stop participating in the study at any time without penalty. This will not affect their ability 
to receive medical care at Mount Sinai or to receive any benefits to which they are otherwise entitled.
Patients may withdraw permission for the use and disclosure of any protected information for research, 
but they must do so in writing to the Principal Investigator.
Name: Celia Divino, MD
Physical Address: The Mount Sinai Hospital Division of General Surgery, 5 East 98th Street, 14th Floor
Mailing Address: 5 East 98th Street, 15th Floor, Box 1259
Academic Office Phone: 212-241-5499
Clinic Phone: 212-241-3348
Even if they withdraw permission, the Principal Investigator for the research study may still use the 
information that was collected if that information is necessary to complete the study. Patients' health 
information may still be used or shared after they withdraw authorization if they should have an adverse 
event from participating in the study.
The study doctor, the sponsor or the institution may terminate patients' involvement in this study at any 
time without the patient's consent. This may be because the study itself has stopped, the instructions of 
the study team have not been followed, the investigator believes it is in patients' best interest to be 
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withdrawn, or for any other appropriate reason. If specimens or data have been stored as part of the 
study, they too can be destroyed without patient consent.
7.3
LOST TO FOLLOW-UP
Before being considered lost to follow up, every attempt will be made by the investigator and/or the 
research team to contact the participant.
8
STUDY ASSESSMENTS AND PROCEDURES.
8.1
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS
Study recruitment will include patients who are schedule for a laparoscopic inguinal hernia repair and 
meet the inclusion criteria but not the exclusion criteria. The screening will be completed by the research 
team and/or physician. If a patient is interested, they will be approached to consent for the study. If they 
are still interested and understand the study and its expectations, they will consent using standard 
consenting procedures. The intervention will be given perioperatively and the procedure will continue 
according to standard procedures. No deviation from standard care will be made for the inguinal hernia 
repair. The patient will be discharged with worksheet asking for pain scores and pain medication usage. 
8.2
SAFETY ASSESSMENTS
As all procedures are according to standard of care, all parts of care will be administered and any 
complications and events will be tracked.
8.3
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS. 
8.3.1
DEFINITION OF ADVERSE EVENTS
Any adverse event as a result of the study intervention. As the intervention in study is a standard of care 
drug for pain, we do not expect adverse events.
8.3.2
DEFINITION OF SERIOUS ADVERSE EVENTS
Serious adverse events as a result of the study intervention will be classified by the attendings. As the 
intervention in study is a standard of care drug for pain, we do not expect adverse events.
8.3.3
CLASSIFICATION OF AN ADVERSE EVENT
8.3.3.1
SEVERITY OF EVENT
Severity will be graded by the PI and attendings, if required.
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8.3.3.2
RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION
Adverse events related of the study intervention will be classified as related or not related by the PI and 
other attendings.
8.3.3.3
EXPECTEDNESS 
A clinician with appropriate expertise in anesthesiology/surgery will be responsible for determining 
whether an adverse event (AE) is expected or unexpected. An AE will be considered unexpected if the 
nature, severity, or frequency of the event is not consistent with the risk information previously described 
for the study procedures.
8.3.4
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP
After notification of an event, the PI will be alerted regarding the event to classify as related or 
unrelated to the intervention.
8.3.5
ADVERSE EVENT REPORTING 
Adverse events due to study intervention will be reported to IRB.
8.3.6
SERIOUS ADVERSE EVENT REPORTING 
Serious adverse events due to study intervention will be reported to IRB.
8.3.7
REPORTING EVENTS TO PARTICIPANTS 
N/A
8.3.8
EVENTS OF SPECIAL INTEREST 
N/A
8.3.9
REPORTING OF PREGNANCY 
Pregnant women will be excluded from the study.
8.4
UNANTICIPATED PROBLEMS
8.4.1
DEFINITION OF UNANTICIPATED PROBLEMS
N/A
8.4.2
 UNANTICIPATED PROBLEMS REPORTING 
N/A
8.4.3
REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS 
N/A
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9
STATISTICAL CONSIDERATIONS 
9.1
STATISTICAL HYPOTHESES

Primary Endpoint(s): 
We hypothesize that patients randomized to the intervention will be have lower pain scores as compared 
to the placebo arm.

Secondary Endpoint(s):
We hypothesize that patients randomized to the intervention will have lower intake of opioid and as 
compared to the placebo arm.
9.2
SAMPLE SIZE DETERMINATION
Based on previous clinical trials using a pain medication intervention prior to surgery, our sample of 100 
will be enough to detect a difference, should one exist. Moreover, the intervention and placebo will be 
administered randomly with an overall ratio of 1:1 to maximize power for analysis.
9.3
POPULATIONS FOR ANALYSES
Intention to treat analysis will be used for the study. Other sensitivity analyses will include analyses for 
treatment as administered.
9.4
STATISTICAL ANALYSES
9.4.1
GENERAL APPROACH
For descriptive analyses categorical variables will be described using the frequency and proportions. 
Continuous variables will be described using median and the interquartile range (Q1, Q3). All p-values of 
statistical tests will be two-tailed with a p<0.05 considered statistically significant. 
9.4.2
ANALYSIS OF THE PRIMARY ENDPOINT(S)
The primary endpoint of differences on pain score will be analyzed using the Wilcoxon rank sum test or 
Mann-Whitney U test. 
9.4.3
ANALYSIS OF THE SECONDARY ENDPOINT(S)
The secondary endpoint will be assessed using either Chi-square, Fisher’s exact, Mann Whitney U or the 
best test for the data. 
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9.4.4
SAFETY ANALYSES
N/A
9.4.5
BASELINE DESCRIPTIVE STATISTICS
Demographic and pre-intervention variables will be described as following:
Categorical variables will be described using the frequency and proportions. Continuous variables will be 
described using median and the interquartile range (Q1, Q3). Chi-square or Fisher’s test and Student’s t-
test or Mann-Whitney U test will be used depending on type of data.
9.4.6
PLANNED INTERIM ANALYSES 
N/A
9.4.7
SUB-GROUP ANALYSES
N/A
9.4.8
TABULATION OF INDIVIDUAL PARTICIPANT DATA
No individual data will be presented.
9.4.9
EXPLORATORY ANALYSES
Other analyses that will occur will be compare types of complications and their rates between the 
intervention and placebo groups.
10
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS
10.1.1 INFORMED CONSENT PROCESS
10.1.1.1 CONSENT/ASSENT 
AND 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
PARTICIPANTS
Consent forms describing in detail the study intervention, study procedures, and risks will be given to the 
participant and written documentation of informed consent will be completed prior to starting the study 
intervention.
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION
Adults will be consented after they receive information regarding the study and express interest. All 
procedures will be conducted according to institutional regulations. 
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10.1.2 STUDY DISCONTINUATION AND CLOSURE
Study discontinuation may be as a result of PI choice and or as a result of the oversight committee of the 
IRB.
10.1.3 CONFIDENTIALITY AND PRIVACY 
Data will be obtained using a patient medical record number and saved on a database to be analyzed at a 
later time. The research data will be stored under a random research code that will be linked to a subject's 
medical record number. It will be separate from the data collection sheet, which uses identifiable data. 
To reiterate: patient names and MRNs will not be used on this separate sheet. Each patient must be linked 
to their information to ensure the data is accurate and corresponds to the appropriate patient. In addition, 
information must be stored with identifiers in the event that an additional parameter of import is found 
at a later time and must be retrospectively obtained. Data will be stored on a computerized database with 
a unique code number not related to any subject identifiers. The link between the code and the data itself 
will be stored in separate locations. The code sheet will be kept on a separate password protected hard 
drive (another computer) that only listed investigators will have access to. Data files that are not stored 
on a server maintained by Mount Sinai's IT department will be encrypted. All files containing identifiers 
that are stored on a computer connected and managed by the Mount Sinai server will be password 
protected and restricted to the research team.
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA 
There is no future use or storage of data after completion of the study.
10.1.5 KEY ROLES AND STUDY GOVERNANCE
Principal Investigator
Celia Divino, MD
Icahn School of Medicine at 
Mount Sinai 
5 East 98th St, 15th Fl, New 
York, NY
212 241 6509 
Celia.divino@mountsinai.org
Dr. Divino is the principal investigator and will be overlook all parts of recruitment, study procedures, and 
study execution. She has ample experience running multiple clinical trials.
10.1.6 SAFETY OVERSIGHT
The research team, the PI and other investigators will be responsible for oversight.
10.1.7 CLINICAL MONITORING
Clinical site monitoring will be conducted to ensure that the rights and well-being of trial participants 
are protected, that the reported trial data are accurate, complete, and verifiable, and that the conduct 
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of the trial is in compliance with the currently approved protocol/amendment(s), with International 
Council on Harmonisation Good Clinical Practice (ICH GCP), and with applicable regulatory 
requirement(s).
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL
Quality management will occur with oversight of the PI and other investigators. The research team with 
regular meetings will discuss and keep appropriate quality for the study.
10.1.9 DATA HANDLING AND RECORD KEEPING 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
Data collection will be the responsibility of the research members. The investigator will be responsible for 
ensuring the accuracy, completeness, legibility, and timeliness of the data reported.
All source documents will be completed in a neat, legible manner to ensure accurate interpretation of 
data. Hard copies of the study visit worksheets will be provided for use as source document worksheets 
for recording data for each participant consented/enrolled in the study.
10.1.9.2 STUDY RECORDS RETENTION 
Study records will be kept for no longer than 6 years after the study.
10.1.10
PROTOCOL DEVIATIONS  
All protocol deviations will be recorded and reported to IRB.
10.1.11
PUBLICATION AND DATA SHARING POLICY 
Data will not be shared with any other institutions or sites. All policies as required by the IRB.
10.1.12
CONFLICT OF INTEREST POLICY
All conflicts of interest will be reported to the IRB and FCOI committee.
10.2 ADDITIONAL CONSIDERATIONS
N/A
10.3 ABBREVIATIONS AND SPECIAL TERMS
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The list below includes abbreviations utilized in this template. However, this list should be customized for 
each protocol (i.e., abbreviations not used should be removed and new abbreviations used should be added 
to this list). Special terms are those terms used in a specific way in the protocol. For instance, if the protocol 
has therapist-participants and patient-participants, those terms could be included here for purposes of 
consistency and specificity. 
AE
Adverse Event
ANCOVA
Analysis of Covariance
CFR
Code of Federal Regulations
CLIA
Clinical Laboratory Improvement Amendments
CMP
Clinical Monitoring Plan
COC
Certificate of Confidentiality
CONSORT
Consolidated Standards of Reporting Trials
CRF
Case Report Form
DCC
Data Coordinating Center
DHHS
Department of Health and Human Services
DSMB
Data Safety Monitoring Board
DRE
Disease-Related Event
EC
Ethics Committee
eCRF
Electronic Case Report Forms
FDA
Food and Drug Administration
FDAAA
Food and Drug Administration Amendments Act of 2007
FFR
Federal Financial Report
GCP
Good Clinical Practice
GLP
Good Laboratory Practices
GMP
Good Manufacturing Practices
GWAS
Genome-Wide Association Studies
HIPAA
Health Insurance Portability and Accountability Act 
IB
Investigator’s Brochure
ICH
International Council on Harmonisation 
ICMJE
International Committee of Medical Journal Editors
IDE
Investigational Device Exemption
IND
Investigational New Drug Application
IRB
Institutional Review Board
ISM
Independent Safety Monitor
ITT
Intention-To-Treat
LSMEANS
Least-squares Means
MedDRA
Medical Dictionary for Regulatory Activities
MOP
Manual of Procedures
NCT
National Clinical Trial
NIH 
National Institutes of Health
NIH IC
NIH Institute or Center
OHRP
Office for Human Research Protections
PI
Principal Investigator
QA
Quality Assurance
QC
Quality Control
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SMC
Safety Monitoring Committee
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SOA
Schedule of Activities
SOC
System Organ Class
SOP
Standard Operating Procedure
UP
Unanticipated Problem
US
United States
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10.4 PROTOCOL AMENDMENT HISTORY
The table below is intended to capture changes of IRB-approved versions of the protocol, including a 
description of the change and rationale. A Summary of Changes table for the current amendment is 
located in the Protocol Title Page. 
Version
Date
Description of Change 
Brief Rationale
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11
REFERENCES 
Effective Date: 8/10/2022
End Date:7/25/2023

ICF_001.pdf: 
Transabdominal Plane (TAP) Blocks for Inguinal Hernia Repairs
PI: Dr. Celia M. Divino
NCT05672680
Document Date: 7-29-2023


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 1 of 11
Study ID: STUDY-STUDY-19-00677
Form Version Date: 06.28.2023
----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)
__________________________
STUDY INFORMATION:
Study Title: Transabdominal Plane (TAP) Blocks in Laparoscopic Inguinal Hernia Repair
Study site(s): Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital
Lead Researcher (Principal Investigator): Celia M Divino, MD
Physical Address: 5 E 98th Street, 15th Floor, New York, NY 10029
Mailing Address: One Gustave L Levy Place, Box 1259, New York, NY 10029]
Phone: 212-241-5499
____________________________
SUMMARY OF THIS RESEARCH STUDY:
This document explains a research study you might be interested in joining.  Participation in the study 
is voluntary. You can agree to join or not. Your decision will not limit your ability to receive care at 
Mount Sinai. You should only agree to take part if you understand the study and if all of your 
questions about the research study are answered. If you do join the study, the research team must 
share any new information with you that may change your mind about taking part.
An inguinal hernia is a weakness in the layers of your abdominal wall through which abdominal contents 
may bulge and get stuck. The bulge may be transient, but there is a risk that the abdominal contents 
get stuck. Due to this risk, patients may elect to have the weakness repaired surgically. 
There are multiple methods to help manage pain after surgery. Patients may be given oral or 
intravenous medication for their pain. Another form of pain management that patients can elect to 
have is a local anesthetic block performed in the abdomen called a transabdominal plane (TAP) block.  
This will be done prior to surgery (while you are under general anesthesia) and may help decrease 
pain related to the incisions made during surgery and thus decrease the use of additional pain 
medication after the operation
The purpose of this study is to assess whether TAP blocks reduce opioid requirements and pain scores 
after inguinal hernia repair. In this study, you will be randomly assigned to receive either (1) standard 
local anesthesia at the incision sites + the TAP block or (2) standard local anesthesia at the incision 
sites + a placebo saline injection during your inguinal hernia repair. Two different formulations of local 
anesthetics will be used for the TAP block. This study will be blinded, meaning you will not know if you 
are receiving the TAP block with medication or with saline. Your chances of receiving the TAP block 
are 50% (like the flip of a coin). Both group one and two are currently standard of care; in other words, 
regardless of which group you are randomized to, you will not be undergoing any novel procedures or 
receiving new medications that are not currently used in standard practice. Additionally, the duration of 
the operation will be equivalent for both groups. 
Effective Date: 7/29/2023
End Date:7/24/2024


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 2 of 11
Study ID: STUDY-STUDY-19-00677
Form Version Date: 06.28.2023
----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)
If you choose to take part, you will be asked to sign the research consent form. In addition, after the 
hernia repair surgery you will be discharged from the hospital with a worksheet on which you are to 
record your analgesic (pain relieving) use and pain scores (called “metrics”) on postoperative days one, 
two, three and four. You are asked to bring the completed log to your two-week follow up visit with your 
surgeon. You will also receive a phone call from a member of the surgical team on postoperative day 
two or three (approximately 5 minutes in duration) to remind you to record these metrics.
If you choose to take part, the main risks to you are The main risks to you if you choose to participate 
include postoperative sensation of pain and discomfort, prolonged stay in the hospital, side effects from 
anesthetic medications, and discomfort from injection site of TAP block. There is also the risk of local 
anesthetic systemic toxicity (LAST), which occurs when the anesthetic agent is injected into a systemic 
blood vessel
 
You may benefit from taking part in this research. Some potential benefits may include decreased pain 
after surgery, a shorter hospital stay and a quicker return to normal function.
If you are interested in learning more about this study, please continue to read below.
____________________________
STUDY PARTICIPATION: 
You may qualify to take part in this research study because you are undergoing laparoscopic (surgery 
done using a camera placed through a small incision cut) inguinal hernia repair.
Your participation in this research study is expected to last the duration of your hospital stay and to 
the first follow-up outpatient appointment.
There are 100 people expected to take part in this research study Mount Sinai Hospital.
Funds for conducting this research study are provided by Mount Sinai.
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This website will not include information that can identify you. At most, the website will include a 
summary of the results. You can search this website at any time.
__________________________
DESCRIPTION OF WHAT IS INVOLVED:
If you agree to take part in this research study, here is what may be involved:
In this study, you will be randomly assigned to receive either (1) the TAP block or (2) a placebo saline 
injection during your inguinal hernia repair. Two different formulations of local anesthetics will be used 
Effective Date: 7/29/2023
End Date:7/24/2024


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CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 3 of 11
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----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)
for the TAP block. This study will be blinded, meaning you will not know if you are receiving the TAP 
block with medication or with saline. Your chances of receiving the TAP block are 50%. Both group 
one and two are currently standard of care; in other words, regardless of which group you are 
randomized to, you will not be undergoing any novel procedures or receiving new medications that 
are not currently used in standard practice. Additionally, the duration of the operation will be 
equivalent for both groups.
If you choose to participate, you will be asked to sign the research consent form. In addition, after the 
hernia repair surgery you will be discharged from the hospital with a worksheet on which you are to 
record your analgesic use and pain scores (called “metrics”) on postoperative days one, two, three 
and four. You are asked to bring the completed log to your two-week follow up visit with your surgeon. 
This visit is standard and will be conducted in the same manner as it would be if you were not enrolled 
in the study. The only difference is that you will return your worksheet. You will also be asked to 
answer questions regarding the severity of your pain on that day, again which is standard of practice 
(“What is your current pain level, on a scale from 1-10, at rest today?” and “What is your current pain 
level, on a scale from 1-10, when you cough or move?” and “What are you taking to control your pain, 
and how much are you taking?”). You will receive a phone call from a member of the surgical team 
(approximately 5 minutes in duration) on postoperative day two or three to remind you to record these 
metrics.
Because this research study involves the use of a TAP block, a note must be included in your 
electronic medical record that you are taking part in the research. This way, anyone involved in your 
medical care will know that you are a study participant, and they can work to avoid any problems or 
negative outcomes that could arise if they do not know.
Randomization
No one, not you, or anyone from your medical team or from the research team will be able to choose 
what group you are assigned to or what study drug you get. It will be by chance, like flipping a coin. 
You will have an equal chance of being given a TAP block or placebo. Neither you nor the Lead 
Researcher or your own doctor will know which study drug you are getting. If there is an emergency, 
they can get this information.
____________________________
USE OF YOUR DATA AND/OR SAMPLES:
The researchers would like your permission to keep your personal information (such as, name, 
address, date of birth) or study data to use or share in future studies. Before anything is shared, all of 
your identifying personal information will be removed and it will be replaced with a code. Researchers 
are not planning on giving you the details of any of this future research nor the results. That means 
that a research project might be done that you would not consent to if provided with the details of that 
research project. You can still be part of the study if you do not allow us to use or share them. Please 
Effective Date: 7/29/2023
End Date:7/24/2024


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AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
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Study ID: STUDY-STUDY-19-00677
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----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)
select Yes or No to each of the questions below. To decline all future uses/sharing please select ‘No’ 
each time.
(1) Will you allow the researchers to store your data and/or samples to use in future research studies?
Please initial your choice: Yes________ No_________ 
If you select No, please stop here and move to the next section, 'Your Responsibilities If You Take 
Part in This Research' section below."
If yes, please continue to the next question and tell us how your personal information, study data 
and/or samples may be used in future research studies. 
(2) Do you give the researchers permission to keep the data and/or samples, so they could use them 
in future studies that are directly related to the purpose of the current study?
Please initial your choice: Yes_________ No _____________________________
____________________________
YOUR RESPONSIBILITIES IF YOU TAKE PART IN THIS RESEARCH:
If you decide to take part in this research study, you will be responsible for the following things:
Signing of the research consent form. In addition, you will be discharged with a worksheet on which 
you are to record your analgesic use and pain scores on postoperative days one, two, three and four. 
You are expected to bring the completed log to your two-week follow up visit with your surgeon. You 
will receive a phone call from a member of the surgical team between three and four days after you 
have been discharged from the hospital to remind you to record these metrics.
____________________________
COSTS OR PAYMENTS THAT MAY RESULT FROM PARTICIPATION:
You will not be paid for taking part in this study. Being in this study will not cost you anything extra.
____________________________
POSSIBLE BENEFITS:
There is a chance this study may benefit you, but this is not guaranteed. Others may benefit from 
what researchers learn from the study. Possible benefits to you include:
It is important to know that you may not benefit from taking part in this research and it is possible that 
others may not benefit either. However, possible benefits may include decreased pain after surgery, a 
shorter hospital stay and a quicker return to normal function.
Effective Date: 7/29/2023
End Date:7/24/2024


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CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 5 of 11
Study ID: STUDY-STUDY-19-00677
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Rev 11.11.2022 (Amendment 1-03.09.2023)
____________________________
POSSIBLE RISKS AND DISCOMFORTS:
Possible risks of study participation include potential risk of bowel injury, postoperative sensation of 
pain and discomfort, prolonged stay in the hospital, side effects from anesthetic medications, and 
discomfort from injection site of TAP block. There is also the risk of local anesthetic systemic toxicity 
(LAST), which occurs when the anesthetic agent is injected into a systemic blood vessel. All injections 
of anesthetic carry a <1% risk of local anesthetic systemic toxicity (LAST) which can cause seizures 
or even cardiac arrest. Common side effects include temporary loss of feeling in the abdominal area, 
decreased muscle strength, dizziness, nausea/vomiting, drowsiness, ringing in ears, tremor, vision 
changes and headache. The risk of psychological harm is minimal or low. (or something to that 
effect). You may feel uncomfortable discussing your medical history with the members of the research 
team.
There always exists the potential for loss of private information; however, there are procedures in 
place to minimize this risk.
____________________________
OTHER OPTIONS TO CONSIDER:
You may decide not to take part in this research study. If you decide not to take part, this will not 
affect the clinical care you receive at Mount Sinai. The choice is totally up to you.

Proceeding with the surgery without a TAP block 

Proceeding with the surgery with a TAP block

Proceeding with watchful waiting (to select patients with asymptomatic or mildly symptomatic 
groin hernias)
____________________________
IN CASE OF INJURY DURING THIS RESEARCH STUDY 
If you believe that you have suffered an injury related to this research as a participant in this study, you 
should contact the Principal Investigator.  
If you are injured or made sick from taking part in this research study, you will get medical care. 
Generally, it will be billed to you or your insurance. You will be responsible for all treatment costs not 
covered by your insurance, including deductibles, copayments, and coinsurance. This does not 
prevent you from seeking payment for injury related to malpractice or negligence. You can contact the 
Lead Researcher for more information.
____________________________
ENDING PARTICIPATION IN THE RESEARCH STUDY:
Effective Date: 7/29/2023
End Date:7/24/2024


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
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Study ID: STUDY-STUDY-19-00677
Form Version Date: 06.28.2023
----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)
You may stop taking part in this study at any time.  No matter what you choose, your care and 
benefits through Mount Sinai will not be negatively impacted.
If you decide to stop being in the study, please contact the Lead Researcher or the research staff.
You may also withdraw your permission for the researchers to use and share any of your protected 
information for research, but you must do so in writing to the Lead Researcher at the address on the 
first page. Even if you withdraw your permission, the Lead Researcher may still use the information 
that was already collected if that information is necessary to complete the research study. Your health 
information may still be used or shared after you withdraw your authorization if you have an adverse 
event (a bad effect) from taking part in the research study.
If you stop being in the research study, the research team may not remove information they have 
already placed in the study database, and may continue to use that data as part of this study. The 
research team may ask you whether they can continue to collect information from your medical 
record.
If you decide you don’t want your data to be used for research anymore, you can contact the 
researcher and ask to have your data withdrawn or labeled so that they will not to be used in 
additional projects or shared. If your data have already been shared with researchers, those 
researchers will be asked to stop using them. However, if any data have already been shared without 
your identity or a linking code, it won’t be possible to retrieve them. Data that have already been used 
will not be affected by your decision. If your data have already been deposited in an external 
repository, the study team will request that your data and/or samples be removed.
Withdrawal without your consent: The Lead Researcher, the funder or Mount Sinai may stop your 
involvement in this research study at any time without your consent. This may be because the 
research study is being stopped, the instructions of the research team have not been followed, the 
Lead Researcher believes it is in your best interest, or for any other reason. If data and/or samples 
have been stored as part of the research study, they too can be destroyed without your consent.  
____________________________
CONTACT INFORMATION:
If you have any questions, concerns or complaints at any time about this research, or you think the 
research has harmed you, please contact the office of the research team and/or the Lead Researcher 
at phone number 212-241-5499.
If there is an emergency, please contact your primary care physician or call 911 or go to the 
emergency room. Let the emergency room staff know you are in a research study so they can contact 
the Lead Researcher if needed.
Effective Date: 7/29/2023
End Date:7/24/2024


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 7 of 11
Study ID: STUDY-STUDY-19-00677
Form Version Date: 06.28.2023
----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)
____________________________
DISCLOSURE OF FINANCIAL INTERESTS:
Researchers sometimes get paid for consulting or doing work for companies that produce drugs, 
biologics or medical devices. If you have questions regarding industry relationships, you are 
encouraged to talk to the Lead Researcher or visit our website at http://icahn.mssm.edu/ where Mount 
Sinai publicly discloses the industry relationships of our faculty.   
The principal investigators have no financial interests to disclose.
____________________________
MAINTAINING CONFIDENTIALITY – HIPAA AUTHORIZATION:
As part of this study, some of your private and/or protected health information will be obtained, used, 
and shared with your permission. There is a Federal Health Insurance Portability and Accountability 
Act (HIPAA) that makes sure this is done correctly and safely. 
What is protected health information (PHI)? 
PHI is the combination of two things:
1.
PHI contains information that identifies you. It will be used to contact you and link you to your 
health information, like name, date of birth, medical record number, and address.  
2.
PHI also contains health information, including information about your mental and physical 
health from your visits to doctors or hospitals, or from study visits. 
Every time you visit a hospital or your doctor, PHI is created and recorded in your medical record by 
your healthcare providers. In the same way, the PHI created as part of this study will be linked to who 
you are and your medical information. 
What PHI is collected and used in this research study, and might also be shared with others? 
As part of this study, the research team at the hospital(s) involved in the research will collect your  
address, telephone/fax numbers, dates directly related to the individual (birth, admission, discharge, 
date of death, etc.), e-mail addresses, medical records number.
The researchers will also obtain information from your medical record at the Mount Sinai Hospital or 
from your private doctor.
During the study, the researchers will gather information by: 

Reviewing and/or taking your medical history (includes current and past medications or 
therapies, illnesses, conditions or symptoms, family medical history, allergies, etc.) 

Doing a physical examination that generally also includes blood pressure reading, heart rate, 
breathing rate, and temperature.
Why is your PHI being used?
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THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 8 of 11
Study ID: STUDY-STUDY-19-00677
Form Version Date: 06.28.2023
----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)
Researchers need the information that identifies you so they can contact you during the study. They 
need your health information and the results of any tests and procedures being collected as part of 
this study to answer the questions posed in the study. The purpose of the study is discussed earlier in 
this consent form. Before researchers analyze the data, they remove any information that would let 
others know who you are or that you took part in the study. If researchers publish or present study 
results at scientific meetings, lectures, or other events, their presentations would not include any 
information that would let others know who you are, unless you give separate permission to do so.
The Lead Researcher may also use and share the results of these tests and procedures with other 
healthcare providers at Mount Sinai who are involved in your care or treatment. The research team 
and other authorized members of The Mount Sinai Health System (“Mount Sinai”) workforce may use 
and share your information to ensure that the research meets legal, institutional or accreditation 
requirements. For example:

The Mount Sinai Program for the Protection of Human Subjects is responsible for overseeing 
research on human participants and may need to see your information. 

If you receive any payments for taking part in this study, the Mount Sinai Finance Department 
may need your name, address, social security number, payment amount, and related 
information for tax reporting purposes.  

If the research team uncovers abuse, neglect, or reportable diseases, this information may be 
disclosed to appropriate authorities. 
Who, outside Mount Sinai, might receive your PHI?
As part of the study, the Lead Researcher, research team and others in the Mount Sinai workforce 
may disclose your PHI, including the results of the research study tests and procedures, to the 
following people or organizations: (It is possible that there may be changes to the list during this 
research study; you may request an up-to-date list at any time by contacting the Lead Researcher.)
-
The United States Department of Health and Human Services (DHHS) and the Office of 
Human Research Protection (OHRP) (the government organization that is responsible for 
protecting human research participants).
-
The United States Food and Drug Administration.
In all disclosures outside of Mount Sinai, you will not be identified by name, address, telephone 
number, or any other direct personal identifier unless disclosure of the direct identifier is required by 
law. Some records and information disclosed may be identified with a unique code number. The Lead 
Researcher will ensure that the key to the code will be kept in a locked file, or will be securely stored 
electronically. The code will not be used to link the information back to you without your permission, 
unless the law requires it, or rarely if the Institutional Review Board (IRB) allows it after determining 
that there would be minimal risk to your privacy. It is possible that a sponsor or their representatives, a 
data coordinating office, a contract research organization, may come to inspect your records. Even if 
those records are identifiable when inspected, the information leaving the institution will be stripped of 
Effective Date: 7/29/2023
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THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 9 of 11
Study ID: STUDY-STUDY-19-00677
Form Version Date: 06.28.2023
----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)
direct identifiers.  Additionally, when applicable, the monitors, auditors, the IRB, OHRP, as well as the 
Food and Drug Administration (FDA) will be granted direct access to your medical records for 
verification of the research procedures and data. OHRP and FDA are authorized to remove 
information with identifiers if necessary to complete their task. By signing this document you are 
authorizing this access. The results of this research may be published. However, your name and other 
identifying information will be kept confidential.
For how long will Mount Sinai be able to use or disclose your PHI?
Your authorization for use of your PHI for this specific study does not expire.
Will you be able to access your records?
During your participation in this study, you will have access to your medical record and any study 
information that is part of that record. The investigator is not required to release to you research 
information that is not part of your medical record.
Do you need to give the researchers permission to obtain, use or share your PHI?
NO! If you decide not to let the research team obtain, use or share your PHI, you should not sign this 
form, and you will not be allowed to volunteer in the research study. If you do not sign, it will not affect 
your treatment, payment, or enrollment in any health plans or affect your eligibility for benefits.
Can you change your mind?
If you decide to stop being in the study, please contact the Lead Researcher or the research staff.
The research team may ask you whether they can continue to collect information from your medical 
record. You will also have to decide if you wish to limit the continued use of the information collected 
during the study. Under US privacy laws you may also withdraw your permission for the researchers 
to use and share any of your protected information for research, but you must do so in writing to the 
Lead Researcher at the address on the first page. 
Even if you withdraw your permission, the Lead Researcher may still use the information that was 
already collected, but only to complete this research study. Your health information may still be used 
or shared after you withdraw your authorization if you have an adverse event (a bad effect) from 
taking part in the research study.
It is important for you to understand that once information is disclosed to others outside Mount Sinai, 
the information may be re-disclosed and will no longer be covered by the federal privacy protection 
regulations. However, where possible, Mount Sinai has entered into agreements with those who will 
receive your information to continue to protect your confidentiality.
If researchers are reviewing your medical records or asking questions about your medical history or 
conditions, it is possible that they may learn information related to your HIV status. If that is the case, 
Effective Date: 7/29/2023
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THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 10 of 11
Study ID: STUDY-STUDY-19-00677
Form Version Date: 06.28.2023
----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)
the following information concerns you. If researchers are not reviewing your medical records or 
asking questions about your medical history or conditions, then you may ignore the following section.
_________________________________________________________________________________
Notice Concerning HIV-Related Information 
If you are authorizing the release of HIV-related information, you should be aware that the recipient(s) is 
(are) prohibited from re-disclosing any HIV-related information without your authorization unless permitted 
to do so under federal or state law. You also have a right to request a list of people who may receive or 
use your HIV-related information without authorization. If you experience discrimination because of the 
release or disclosure of HIV-related information, you may contact the New York State Division of Human 
Rights at (888) 392-3644 or the New York City Commission on Human Rights at (212) 416-0197. These 
agencies are responsible for protecting your rights.
_____________________________________________________________________________________
____________________________
How the Institutional Review Board (IRB) can help you:
This research has been reviewed and approved by an Institutional Review Board (IRB). You may 
reach a representative of the Mount Sinai Program for Protection of Human Subjects at telephone 
number (212) 824-8200 during regular work hours (Monday-Friday, 9am-5pm, excluding holidays) for 
any of the reasons listed below. This office will direct your call to the right person within the Mount 
Sinai Health System:

Your questions, concerns, or complaints are not being answered by the research team.

You cannot reach the research team.

You are not comfortable talking to the research team.

You have questions about your rights as a research participant.

You want to get information or provide input about this research.
Effective Date: 7/29/2023
End Date:7/24/2024


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 11 of 11
Study ID: STUDY-STUDY-19-00677
Form Version Date: 06.28.2023
----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)
ADULT PARTICIPANT:
Your signature below documents your permission to take part in this research study and to the use 
and disclosure of your protected health information. A signed and dated copy will be given to you.
_________________________
_________________________
__________
__________
Signature of Participant
Printed Name of Participant
Date
Time
[required if used 
for FDA 
documentation 
purposes]
PERSON EXPLAINING STUDY AND OBTAINING CONSENT:
_________________________
_________________________
__________
__________
Signature of Consent Delegate
Printed Name of Consent Delegate
Date
Time
WITNESS SECTION:
When a witness is required to observe the consent process, it should be documented below (for 
example, when participant is illiterate, visually impaired, or this document accompanies a short form 
consent).
My signature below documents that the information in the consent document and any other written 
information was accurately explained to, and apparently understood by, the participant, and that 
consent was freely given by the participant.
_________________________
_________________________
__________
__________
Signature of Witness
Printed Name of Witness
Date
Time
Effective Date: 7/29/2023
End Date:7/24/2024