Clinical trial NCT03107754
Conditions: Pain
Sponsor: University of Hawaii
Start date: 2017-05-15; Completion date: 2018-10-25
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
For pain relief during a first trimester surgical aspiration, most providers use the paracervical block, either alone or in combination with other pain control techniques. Some providers use buffered lidocaine due to a belief that it decreases pain. Others use plain lidocaine. At our clinics, the standard pain management protocol is using 20 cc of 1% plain lidocaine in a two site injection. Few studies have compared buffered versus unbuffered lidocaine for paracervical blocks during first trimester uterine aspirations. This study seeks to determine if buffered lidocaine decreases injection pain versus plain lidocaine for paracervical blocks.

Detailed description:
Potential participants will be identified at their office visits to the University Women's Health Specialists. If a patient desires uterine aspiration of a first trimester pregnancy or management of a failed pregnancy in the first trimester, they will first receive standard counseling. Only after providing written informed consent for the procedure will the patient's be screened for eligibility for our study. If the patient is eligible, she will be asked by a member of the research team if she is interested in participating. If she is, the study will be explained to her and written consent will be obtained after she is given the opportunity to have all of her questions answered. The patient will then complete a written questionnaire to collect demographic data.

This prospective randomized control trial will consist of two study arms. Participants will be randomly assigned to Arm 1, where a paracervical block will be administered with 20 cc of 1% lidocaine, which is our standard office protocol, or to Arm 2, where a paracervical block will be administered with 20 cc of 1% lidocaine buffered with 8.4% sodium bicarbonate. Prior to the start of the study, study assignments will be generated in a 1:1 ratio.

All patients who consent to the study will receive standard counseling prior to their procedure. The procedure will start with a bimanual exam by the provider. Next, the provider will place a speculum, cleanse the cervix with betadine solution, and place a single-tooth tenaculum on the anterior lip of the cervix. At this point, participants assigned to Arm 1 will receive a paracervical block loaded with 20 cc of 1% lidocaine and injected at 2, 4, 8 and 10 o'clock positions of the cervicovaginal junction. Participants assigned to Arm 2 will receive a paracervical block loaded with 18 cc of 1% lidocaine and 2 cc of 8.4% sodium bicarbonate and inject the block in the same fashion. The research assistant will ask the patient to verbally report their level of pain based on the 100 mm visual analog scale (VAS) at the following points of the procedure:

1. Prior to the start of the procedure (baseline anxiety)
2. After speculum placement
3. After paracervical block
4. After cervical dilation
5. After suction curettage
6. At end of procedure

Arms: arm 1: A paracervical block will be administered with 20 cc of 1% lidocaine, which is our standard office protocol arm 2: A paracervical block will be administered with 20 cc of 1% lidocaine buffered with 8.4% sodium bicarbonate
Interventions: intervention 1: Lidocaine intervention 2: Lidocaine-Sodium Bicarbonate
Intervention descriptions: intervention 1: Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain intervention 2: Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain

Protocol documents:
Prot_SAP_001.pdf: 
Cover Page 
Buffered Lidocaine in Paracervical Blocks 
NCT 03107754 
Most recently updated July 2, 2018 
Approved by University of Hawaii Institutional Review Board August 2, 2018 
 


 
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Personnel Information
1
Subject Checklist
2
Study Location
3
General Checklist
4
Funding
5
Application Type Checklist
5
Expedited Paragraphs
6
Summary, Purpose, Procedures
6
Background and additional procedures
8
Subject Population (a-f)
10
Subject Population (g-j)
11
Recruitment Process, Subject Compensation and Costs
12
Risks
13
Benefits
14
Procedures to Maintain Confidentiality
15
Consent Information
16
Assent Background
17
HIPAA
17
Drugs and Devices
19
Potential Conflict of Interest
19


 
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Attachments
20
Obligations
21
Event History
22


Page 1 of 22
 
1
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
* * * Personnel Information * * *
 Starred items indicate required fields whenever that section is completed.
Is this a student led research?*
N
Principal Investigator
UH defines "Investigator" as an individual who conducts a research study. If the study is conducted by a team of
individuals, the Investigator is the responsible leader of the team. Students, fellows and residents may not act as
a Principal Investigator.
Name of Principal Investigator*
Degree (MD/PhD/BSN/etc.)
Title
Soon, Reni
MD, MPH
Asst Prof
Email*
Phone
Fax
rsoon@hawaii.edu
808-203-6548
808-697-3626
Research Department
UH Status Check ALL that apply*
Mailing Address
University of Hawaii at Manoa,
Obstetrics, Gynecology and
Women's Health
X
Faculty
Staff
Other
1319 Punahou Street Suite 824
Honolulu, HI 96826
ALL research personnel are required to complete Human Subject Research training.
Which human subjects research training was completed for this protocol?*
CITI
See memo regarding appropriate human subjects training.
The Research Compliance Office will verify the last date of completion below.
Attach file of NIH training certificate in Attachments Section.
NIH Completion Date
Training Details
No training data is available.
Other Investigator(s)


Page 2 of 22
 
2
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
Name of Other
Investigator
Degree
(MD/PhD/BSN/etc.)
Title
Research
Department
Type of Investigator
Chin, Jennifer
MD
Ob/Gyn Resident
University of Hawaii
at Manoa,
Obstetrics,
Gynecology and
Women's Health
Co-Investigator
Kaneshiro, Bliss
MD, MPH
Assoc Prof, Fam
Plan Fellowship
Prog Dir
University of Hawaii
at Manoa,
Obstetrics,
Gynecology and
Women's Health
Co-Investigator
Salcedo, Jennifer
MD, MPH, MPP
Asst Prof
University of Hawaii
at Manoa,
Obstetrics,
Gynecology and
Women's Health
Co-Investigator
Raidoo, Shandhini
MD
Family planning
fellow
University of Hawaii
at Manoa,
Obstetrics,
Gynecology and
Women's Health
Co-Investigator
Moayedi, Ghazaleh
DO
Family planning
fellow
University of Hawaii
at Manoa,
Obstetrics,
Gynecology and
Women's Health
Co-Investigator
Administrative Contact
Name of Administrative Contact,
Project Director, or Lab Coordinator
Degree (MD/PhD/BSN/etc.)
Title
Email*
Phone
Fax
Research Department
Mailing Address
---------------------------------------------------------------------------------------------
* * * Subject Checklist * * *


Page 3 of 22
 
3
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
Subject Checklist
Select All That Apply :
Children and/or students under 18 years of age (including neonates)
X
Pregnant women/ fetuses
Prisoners
Military personnel
Adult Volunteers
Economically/educationally disadvantaged
Mentally Ill
University students
University employees
Illiterate
Homeless
Public officials/candidates for public office
Institutionalized patients/residents
Persons incompetent to give consent (e.g., dementia, comatose, have legal guardians)
Healthy Individuals
Other (please specify):
---------------------------------------------------------------------------------------------
* * * Study Location * * *
Study Location
Select All That Apply - NOTE: Check "Other" and input text: 1.) If your study location is not listed, or 2.) If
you would like to list details of your already-checked location (e.g., specific school within a school district)
University of Hawaii, Manoa
University of Hawaii, Hilo
University of Hawaii, West Oahu
University of Hawaii Community Colleges
School/School District
 
Hawaii Public School
 
Hawaii Charter School
 
Private school
Medical Health Care Facility
 
Queens Medical Center (QMC)
 
Hawaii Pacific Health (HPH)
 
Castle Medical Center


Page 4 of 22
 
4
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
 
Shriners Hospitals for Children - Honolulu
X
Other (please specify)
Womenʻs Options Center - faculty practice sites
Has this protocol or proposal been or will it be submitted to any Institutional Review Board(s) or ethics review committees other
than the UH IRB?
N
Is this a multi-site project? (A multi-site study is one where different PIs at different institutions are conducting the same study or
aspects of the same study.)
N
If this study also involves site(s) outside UH, will UH function as the
coordinating center or lead institution?(Check N/A for studies done
solely at UH.)
Yes
No
X
N/A
Please attach any and all non-UH IRB approval correspondence or letters of permission / support from external study sites, if
applicable, in the Attachment section.
---------------------------------------------------------------------------------------------
* * * General Checklist * * *
General Checklist
Select All That Apply, unless otherwise indicated :
Section 1: If you are requesting that UH cede IRB authority to another IRB, stop here, do not
use this application. Instead, submit the following materials to the Human Studies Program
Office at uhirb@hawaii.edu.
Request to have UH IRB be the Relying IRB:In addition to completing the application, please also include in the Attachment section the
following required materials:(1)  Memorandum requesting to designate UH IRB as the relying IRB with justification(2) IRB Authorization
Agreement signed by the other institution's Institutional Official (template can be found by clicking the HELP button In the top right corner
of this page).
Section 2: Biomedical Research
Industry-Sponsored Clinical Trial
Human blood, cells, tissues, or body fluids (Institutional BioSafety)
Tissues to be stored for future research projects
Tissues to be sent out of this institution as part of a research agreement (Material TransferAgreement (MTA))
Human Embryos
Human Embryonic Cells? Provide NIH Code Number(s) or state that no federal funding will be
used to support this research.
Use of Patient related equipment? If Yes, specify what equipment is being used.
Radioisotopes/radiation-producing machines, even if standard of care (Radiation Safety)
Investigational Device
This study involves drugs or devices regulated by FDA
Cancer Subjects (e.g., clinical trials, behavior/prevention) or Cancer Tissues (e.g., blood, cells, body fluids).
Investigational drugs, reagents, or chemicals
Commercially available drugs, reagents, or other chemicals administered to subjects (even if they are not being studied)
Section 3: Methodologies
X
Interview


Page 5 of 22
 
5
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
Questionnaire/Survey
Blood Draw
Section 4: For Student-led research
Thesis or Dissertation Project (Please upload proposal and dissertation/thesis committee approval (if available) in Attachments section.)
Class Project
Section 5: Other
X
This study is or will be posted on ClinicalTrials.gov
If checked, specify the number in the field to the right:
TBD
Protocol involves studying potentially addicting drugs.
X
Protected Health Information (PHI) will be viewed, created, accessed, used, or disclosed.
 
X
HIPAA Authorization
 
Waiver or Alteration of Authorization
 
Activities Preparatory to Research
 
Limited Data Set and Data Use Agreement
 
Use and Disclosure of Decedents PHI without Authorization
Specify any other (use the text box to the right)
---------------------------------------------------------------------------------------------
* * * Funding * * *
X
NONE--This project does not have any funding. If you want to add Funding for the study, please uncheck
"NONE."
Funding
Add external and internal grant funding source(s) below: Federal Government, Other Gov. (i.e., State, local),
Foundation  or Other. Select "None" above if there is no external funding for the study.
Funding for this study has been secured by the UH Office of Research Services (ORS)
---------------------------------------------------------------------------------------------
* * * Application Type Checklist * * *
Application type checklist
Not Human Subjects Research/Undefined Research/Training or Infrastructure Grant
Exempt
X
Expedited/Full Board


Page 6 of 22
 
6
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------
* * * Expedited Paragraphs * * *
PLEASE READ: For Expedited Review, all aspects of the research must include activities that (1) present no more than minimal risk to
human subjects, and (2) involve one or more of the specific categories listed below.
Select the following applicable categories to determine if your research project qualifies under Expedited Review. If none of the categories are
applicable to your research project, a Full Committee Review will be required. For Expedited or Full Review, proceed to complete the
following application.If none of the expedited criteria are appropriate for your project, please move to the next screen WITHOUT checking any
of these criteria; your protocol will be reviewed by the full IRB. Note: The IRB will make the final determination if your protocol is eligible for
expedited review.
Select one or more of the following paragraph(s):
Check
all that
apply
Categ
ory
Description
1.
Clinical studies of drugs and medical devices when an IND or IDE application is not required by
the FDA.
2a.
Collection of blood samples by finger stick, heel stick, ear stick or venipuncture from healthy,
non-pregnant adults who weigh at least 110 pounds.
2b.
Collection of blood samples by finger stick, heel stick, ear stick or venipuncture from other
adults and children, considering the age, weight and health of the participants, the collection
procedure, the amount of blood to be collected, and the frequency with which it will be collected.
3.
Prospective collection of biological specimens for research purposes by non-invasive means.
4.
Collection of data through non-invasive procedures, not involving general anesthesia or
sedation, routinely employed in clinical practice, excluding procedures involving x-rays or
microwaves.
5.
Research involving materials, such as data, documents, records, or specimens, that have been
collected or will be collected solely for non-research purposes, such as medical treatment or
diagnosis.
6.
Collection of data from voice, video, digital, or image recordings made for research purposes.
7a.
Research on individual or group characteristics or behavior, including but not limited to research
on perception, cognition, motivation, identity, language, communication, cultural beliefs or
practices, and social behavior.
7b.
Research employing survey, interview, oral history, focus group, program evaluation, human
factors evaluation, or quality assurance.
---------------------------------------------------------------------------------------------
* * * Summary, Purpose, Procedures * * *
Title (Please indicate if the protocol title is different from the proposal title)
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain During First Trimester Surgical Abortions
Proposed Start Date:
02/01/2017
Proposed End Date:
06/30/2019


Page 7 of 22
 
7
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
1.
Summary
a)
Provide a brief summary of the scope of work of this project, using non-technical terms that would be understood by a non-scientific
reader. This summary should be no more than 200 words.
First trimester surgical abortions are one of the most common outpatient procedures worldwide. Approximately 42 million are
performed annually. Many different techniques have been used for pain control during this procedure. Some providers use conscious
sedation, general anesthesia, or listening to music. Most providers use the paracervical block, a numbing injection into the cervix,
either alone or in combination with other pain control techniques. The paracervical block has been shown to decrease pain during the
procedure especially at earlier gestations. Some studies have shown a decrease in pain with four site injection paracervical blocks
rather than the conventional two site injection. Some providers believe that a waiting period after the paracervical injection decreases
pain. Some providers use buffered lidocaine due to a belief that it decreases pain. Others use plain lidocaine. At our clinics, the
standard pain management protocol is using 20 cc of 1% plain lidocaine in a two site injection. Few studies have compared buffered
versus nonbuffered lidocaine for paracervical blocks during first trimester surgical abortions. This study seeks to determine if buffered
lidocaine decreases injection pain versus plain lidocaine for paracervical blocks.
2.
Purpose
a)
Describe the purpose for the proposed project as well as the hypotheses/research questions to be examined.
The purpose of this study is to see if using buffered lidocaine for the standard paracervical block will decrease the injection pain
normally associated with the plain lidocaine solution we use as our standard protocol. Plain lidocaine is commonly used for
paracervical blocks. However, some studies have suggested that buffered lidocaine may decrease the pain associated with the
injection of the medication, but few studies have looked specifically at using buffered lidocaine for paracervical blocks during first
trimester outpatient surgical abortions. Our hypothesis is that using buffered lidocaine for the paracervical block during first trimester
surgical abortions will decrease injection pain as compared to using plain lidocaine.
b)
What do the investigators hope to learn from this project?
Primary objective: To assess if buffered lidocaine reduces pain from injection more effectively than plain lidocaine for paracervical
blocks during first trimester surgical abortions
Secondary objectives: To evaluate if buffered lidocaine is more effective than plain lidocaine at reducing pain during dilation and
postoperative pain from first trimester surgical abortions
3.
Procedures
a)
Describe in chronological order of event(s) how the activities will be conducted, providing information about all procedures (e.g.
interventions/interactions with subjects, data collection, photographing, audio and video recording), including follow up procedures.
Potential participants will be identified at their office visits to the University Women’s Health Specialists either at Kapi’olani or
Queen’s. If a patient desires surgical termination of a first trimester pregnancy or management of a failed pregnancy in the first
trimester, they will first receive standard counseling and provide informed consent for the procedure. Next, the patient’s eligibility for
our study will be assessed. If the patient is eligible, she will be asked by a member of the research team if she is interested in
participating. If she is, the study will be explained to her and written consent will be obtained after she is given the opportunity to have
all of her questions answered.  The patient will then complete a written questionnaire to collect demographic data.
This prospective randomized control trial will consist of two study arms.  As participants are enrolled they will be randomly assigned to
Arm 1, where a paracervical block will be administered with 20 cc of 1% lidocaine, which is our standard office protocol, or to Arm 2,
where a paracervical block will be administered with 20 cc of 1% lidocaine buffered with 8.4% sodium bicarbonate.Patients will be
randomly assigned to either Arm 1 or Arm 2 of the study. Prior to the start of the study, study assignments will be generated in a 1:1
ratio. A statistician not involved with the conduct of the study will use a computer random number generator to generate random
permuted blocks.  The random permuted blocks will also be randomly varied in sizes of 4, 6, & 8. This statistician will place allocation
assignment cards in sequentially numbered, sealed, opaque envelopes. A different randomization scheme will be used for each
location, one at the Kapi’olani office and one at the Queen’s office.
A clinic staff member not involved with the conduct of the study will be trained specifically in the opening of the allocation envelopes.
The clinic staff member will be trained to pull envelopes individually in a sequentially numbered order.  The staff member will be
trained to open the envelope and remove the study card to read the allocation group: buffered lidocaine or plain lidocaine.  The staff
member will be trained to not tell anyone involved in the study of the allocation assignment.  The clinic staff member will then draw up
the buffered lidocaine or plain lidocaine in an unlabeled syringe, and give it to the procedural physician or surgical assistant for study
administration.


Page 8 of 22
 
8
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
All patients who consent to the study will receive standard counseling prior to their procedure. The procedure will start with a
bimanual exam by the provider. Next, the provider will place a speculum, cleanse the cervix with betadine solution, and place a
single-tooth tenaculum on the anterior lip of the cervix. At this point, participants assigned to Arm 1 will receive a paracervical block
loaded with 20 cc of 1% lidocaine with 10 cc injected at the 4 and 8 o’clock positions of the cervicovaginal junction. Participants
assigned to Arm 2 will receive a paracervical block loaded with 18 cc of 1% lidocaine and 2 cc of 8.4% sodium bicarbonate in the
same fashion. The research assistant will ask the patient to verbally report their level of pain based on the 100 mm visual analog
scale at the following points of the procedure:
1)Prior to the start of the procedure (baseline)
2)After speculum placement
3)After paracervical block
4)After cervical dilation
5)After suction curettage
6)Fifteen minutes postoperatively
i)
Be sure to identify what procedures are experimental and what are standard of care or established practice for the
condition/situation.
Our current standard of care is to use 20 cc of 1% plain lidocaine for the paracerical block. We are experimenting using a
paracervical block loaded with 18 cc of 1% lidocaine and 2 cc of 8.4% sodium bicarbonate to see if this decreases injection
pain.
b)
Explain who will conduct the procedures and where and when they will take place. Indicate the frequency and duration of
visits/sessions as well as the subject's total time commitment for the study. Include how the data will be collected (i.e. in person or
online).
Abortion care providers will perform the dilation and curettage at University Women’s Health Specialists either at the Kapi’olani or
Queen’s location. The research portion will take place on the same day as the dilation and curettage procedure and will add an
additional 20 minutes to the patient's standard office visit. No additional visits are required for this research study. Data will be
collected in person and recorded on paper then transferred to a secure electronic database.
i)
Indicate that the instruments used are in the public domain or provide appropriate documentation of permission to use each
scale.
All instruments used are in the public domain.
c)
For school-based activities where class time is used, describe in detail the activities planned for non-subjects and explain where both
subjects and nonsubjects will be located during the activities.
N/A
d)
State if deception will be used. If so, provide a rationale and describe debriefing procedures. Submit a debriefing script in attachments
section
N/A
e)
Will audio or video taping of individuals occur? Will photographs of individuals be taken? Describe what will become of the
tapes/photographs (e.g., shown at scientific meetings, erased, etc.).
N/A
f)
Will the proposed research involve the use of existing data/specimens? If so, check all that apply:
i.
The research involves data from publicly available sources
ii.
That data will be recorded by the investigator in such a manner that subjects cannot be identified.
iii.
Any link to identifying information has been destroyed
X
iv.
N/A
---------------------------------------------------------------------------------------------


Page 9 of 22
 
9
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
* * * Background and additional procedures * * *
4.
Background and additional procedures
a.
Relevant Background: Discuss the present knowledge, appropriate literature and rationale for conducting the research. Include the
rationale for the selected subject population.
A small number of studies have addressed this research question with conflicting results.
A multiphase study was published in 1995 using various techniques of the paracervical block for surgical abortions. Using a 10 cm
visual analog scale (VAS), the study found a statistically significant decrease in injection pain when using buffered lidocaine as
compared to plain lidocaine and bupivacaine. However, the pain immediately after the injection decreased from 3 cm to 2 cm on the
10 cm VAS, which may not be a clinically relevant difference. Several pain studies have found that a 30% or 13-20mm difference on a
100mm VAS is clinically meaningful for patients.
Another study compared buffered lidocaine versus plain lidocaine for paracervical blocks for surgical abortions. Using an 11 point
scale, the investigators found an 8% decrease in pain from injection when using buffered lidocaine versus plain lidocaine.  Although
this difference was statistically significant, the author concluded that this was most likely not clinically significant and thus not worth
the extra cost of preparing the buffered solution.
Buffered lidocaine versus plain has been looked at in non-gynecological procedures as well. One randomized controlled study
compared buffered lidocaine versus plain lidocaine for patients undergoing bilateral periocular surgery. Investigators found a 51%
decrease in injection pain when using buffered lidocaine versus plain lidocaine, which was both statistically and clinically significant.
Another study compared 1% lidocaine with epinephrine versus 1% lidocaine buffered with 8.4% sodium bicarbonate for patients
undergoing loop electrosurgical excision procedure (LEEP) procedure. Using a 100 mm Likert scale, the study found an eight-point
decrease in procedural pain when using buffered lidocaine; however, this was not statistically significant.
Loma Linda University conducted a study comparing pain using 1% lidocaine with epinephrine versus 1% lidocaine with epinephrine
buffered with 8.4% sodium bicarbonate for patients undergoing eyelid surgery. Using a 10 cm visual analog scale, investigators found
a trend toward decreased pain from injection when using buffered lidocaine; however, this was not statistically significant.
Two studies found no difference when using buffered lidocaine versus plain lidocaine. A dental study comparing buffered lidocaine
versus plain lidocaine for maxillary injections found no difference in pain with 5% buffered, 10% buffered, and nonbuffered lidocaine.
Another study compared buffered versus plain lidocaine for patients undergoing incision and drainage for pulpal necrosis. No
significant difference in pain was found.
Thus, very few studies have specifically looked at buffered lidocaine versus plain lidocaine for paracervical blocks during first
trimester surgical abortions. The studies that have been conducted have conflicting results. Some have found benefit by reducing
pain from injection or procedural pain. Other studies have found no difference in pain.
It is important to determine the ideal anesthesia for first trimester surgical abortions since it is one of the most common outpatient
procedures worldwide. Buffered lidocaine for paracervical injections may have benefit for patients. However, it is more expensive to
prepare and requires more planning due to a shorter shelf life. Thus, buffered lidocaine should only be used if there is a definite
benefit. It is therefore important to determine if buffered lidocaine decreases injection pain during paracervical blocks for first trimester
surgical abortions.
We have decided to select our study population from patients at University Women’s Health Specialists offices due to the high volume
of patients seeking surgical terminations of pregnancy or surgical management of miscarriages. We believe our selected patient
population will reflect the diversity of Hawai'i.
b.
Describe the statistical methods of the research and plans for analysis of the data (i.e. planned statistics, justification of sample size,
etc.).
Based on previous research showing that a clinically relevant decrease in pain on a 100 mm VAS is at least 15 mm, we need to enroll
88 patients (44 in each group) to show this difference with 80% power and alpha of 0.05. Inflating this number by 10% to account for
potential dropout (which is unlikely due to the lack of longitudinal follow-up), we obtain a total sample size of 98 patients (49 in each
group).
Based on the typical volume of patients seen in our office practice, we anticipate that enrollment will take approximately 6-8 months.
We will assess the primary objective by comparing the mean pain score after paracervical block from participants receiving buffered


Page 10 of 22
 
10
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
We will assess the primary objective by comparing the mean pain score after paracervical block from participants receiving buffered
lidocaine versus the mean pain score after paracervical block from participants receiving plain lidocaine. To assess our secondary
objectives, we will compare the mean pain score after cervical dilation between participants assigned to Arm 1 and Arm 2 as well as
compare postoperative pain between the two arms. All analyses will assume a statistical significance level of 0.05. In addition, we will
monitor the extra costs of preparing buffered lidocaine solutions and how the preparation of buffered lidocaine impacts clinic flow and
staffing.
c.
Alternative Procedures. Describe any alternatives to participating in the research. (e.g., standard of care treatment, etc.). Any standard
treatment that is being withheld must be disclosed. This information must be included in the consent form.
If a participant decides to withdraw from the study, she will receive our standard of care which is to administer a paracervical block
using 20 cc of 1% plain lidocaine prior to the procedure.
d.
Will subjects be followed after their active participation is complete?
N
If yes, explain why and describe how:
e.
Will subjects have access to the study treatment/procedure after completing the study?
N
If yes, explain why and describe how:
f.
Do any of the following apply.
i.
Will subjects be audio recorded?
N
ii.
Will subjects be videotaped?
N
iii.
Will subjects be photographed?
N
If yes to i, ii or iii, explain the collection process and use in the context of this research of such media
(Explicit consent must be obtained for use of these methods for Expedited and Full Board studies.)
---------------------------------------------------------------------------------------------
* * * Subject Population (a-f) * * *
5.
Subject Population
a)
How many subjects do you intend to enroll and/or how many subject records do you intend to access?
i.
At this site
# of subjects
98
# of records
N/A
ii.
At all sites
X
N/A
# of subjects
# of records
b)
Inclusion and Exclusion Criteria (e.g., Participants must have 20/20 vision, Participants must be 30-45 years of age, etc.)
i.
Identify inclusion criteria.


Page 11 of 22
 
11
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
•Pregnant women 14 years and older
•Desiring surgical termination of pregnancy or surgical management of a miscarriage
•Gestational age up to 13 weeks and 6 days to be established by best dating (i.e. LMP or earliest ultrasound)
•Treatment plan involves outpatient surgical termination
•Participant able to provide informed consent in English and willing to participate in the study
ii.
Identify exclusion criteria.
•Unable to read, speak, or understand English
•Unable to provide informed consent
•Currently incarcerated
•Under the age of 14 years
•Contraindications to receiving lidocaine or buffered lidocaine
c)
What is the rationale for studying the requested group(s) of participants?
We believe that our inclusion criteria select for a group of participants that will be able to provide informed consent and reflect a
diverse population of patients requesting dilation and curettage either for termination of a pregnancy or surgical management of a
miscarriage. Thus, we will ensure the safety of our participants as well as collect valuable data from our participants.
d)
If your participants include pregnant women, human fetuses, neonates, children, adults with diminished capacity, and/or prisoners,
describe the protocol-specific safeguards used to protect the rights and welfare of this study population:
This study will recruit two possibly vulnerable populations: pregnant women and minors. This could raise the possibility of additional
risk to the pregnant woman or the fetus due to the pregnancy. However, women coming to either clinic are already choosing to
terminate their pregnancies and thus there are no additional risks to either the women or the fetus due to enrolling in this study. Also,
this study will recruit patients who are below the age of 18. Patients below the age of 18 will require patient assent and parental
consent.
e)
Provide a clear compelling rational for excluding women, minorities, or minors, if they are intentionally excluded from the
research.
X
N/A
f)
State if any of the subjects are students, employees, or laboratory personnel. Please explain how subjects will be
protected from coercion and undue influence
X
N/A
g)
Please describe the expertise you have, or have access to, which prepares you to conduct research in this location and/or with this
subject population, including specific qualifications (e.g., relevant coursework, background, experience, and training). Also, explain
your knowledge of local community attitudes and cultural norms and cultural sensitivities necessary to carry out the research (e.g.,
differences with U.S. culture).
My co-investigators and I have extensive experience and training in providing abortion care. I completed a reproductive health
externship in medical school, attended the Abortion Training Institute, and have completed my family planning rotation in residency.
My co-investigators have completed fellowships in family planning and conducted numerous research projects in family planning,
some specifically related to pain control. Because this research project does not alter the actual procedure being done, local
community attitudes, cultural norms, and cultural sensitivities should not hinder our project. In general, Honolulu is a city that supports
a woman's right to choose; thus, this project should not meet too much resistance.
---------------------------------------------------------------------------------------------
* * * Subject Population (g-j) * * *
5.
Subject Population
g)
Will bilingual or multilingual subjects be recruited?
N


Page 12 of 22
 
12
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
h)
Will non-English speaking subjects be recruited?
N
If yes, state language(s) spoken (other than English):
i)
Will subjects be less than 18 years of age?
Y
Age Ranges:
0-7
8-13
X
14-17
j)
Describe any planned screening procedures. Attach your screening document(s) (e.g., health history questionnaire) in the Attachment
Section (#16).
We plan to collect demographic data including age, race, marital status, highest education level, level of menstrual symptoms,
previous pregnancies and outcomes, medications, pre-existing conditions, and any previous cervical procedures.
---------------------------------------------------------------------------------------------
* * * Recruitment Process, Subject Compensation and Costs * * *
6.
Recruitment Process:
a)
Describe the step-by-step procedures for identifying and recruiting potential research subjects or requesting pre-existing data or
materials.
-    List any specific agencies or institutions that will provide access to prospective subjects.
-    Identify who will contact prospective subjects and how.
Potential participants will be identified at their office visits to the University Women’s Health Specialists either at Kapi’olani or
Queen’s. If a patient desires surgical termination of a first trimester pregnancy or management of a failed pregnancy in the first
trimester, they will first receive standard counseling and provide informed consent for the procedure. Next, the patient’s eligibility for
our study will be assessed. If the patient is eligible, she will be asked by a member of the research team if she is interested in
participating. If she is, the study will be explained to her and written consent will be obtained after she is given the opportunity to
have all of her questions answered.
b)
Planned Subject Identification Methods:
N/A
Direct advertising
Chart/database review
Living conditions (e.g., nursing home residents)
Class participants
X
From PI's own practice/clinic
Organization mailing lists
UH Participant Recruitment Pool(e.g.,SONA)
Circumstance (e.g., homelessness)
If referrals, explain how much they will be compensated for referrals if compensation
is given.
Other (please specify):
c)
Planned Recruitment Materials/Methods:
N/A
Flyers/posters
Phone Scripts
Letters to providers/schools/organizations
Television ads
Newspaper ads


Page 13 of 22
 
13
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
Letters to prospective subjects
Radio ads
Oral Scripts
PowerPoint presentations
Internet ads/postings
Email
X
Face to face interactions
UH Subject Pool
Other (please specify):
(All advertising must be submitted for review in its final printed/recorded form)
Note: Attach copies of ALL recruitment materials in the  Attachment Section
7.
Subject Compensation and Costs:
a)
Will subjects receive compensation for participation?
N
Total amount (in dollars or equivalent)
b)
Form of Compensation:
Cash
Voucher
Check
Course/extra credit
Gift card/certificate
Reimbursement only
Other (please specify):
c)
Describe the remuneration plan (Include when subjects will be paid, whether payment will be prorated and whether a 1099 will be
issued.)
d)
If extra course credit is offered be sure to address the alternative means by which students can accrue extra course credit should they
not wish to participate in the study.
e)
Will subjects or their health care providers be required to pay for any study related procedures or products?
i.
If yes, explain:
f)
Who is responsible for costs incurred due to injury/harm?
---------------------------------------------------------------------------------------------
* * * Risks * * *
8.
Risks
US Department of Health & Human Services (HHS) Regulations define a subject at risk as follows: "...any individual who may be
exposed to the possibility of injury, including physical, psychological, or social injury, as a consequence of participation as a subject in
any research, development, or related activity which departs from the application of those accepted methods necessary to meet his
needs, or which increases the ordinary risks of daily life, including the recognized risks inherent in a chosen occupation or field of
service."


Page 14 of 22
 
14
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
a)
PI's evaluation of the overall level of Risk. (Please check one: minimal or  minimal.)
X
Minimal (everyday living)
 Minimal (greater than everyday living)
b)
Describe all known risks or discomforts associated with study procedures whether physical, psychological or social (e.g., pain, stress,
invasion of privacy, breach of confidentiality) noting probability and magnitude of potential harm.  Specify the risk(s) associated with
each research procedure or test.
This study poses minimal risk to the research participants. Paracervical blocks are commonly performed in gynecological procedures
both in the office and in the operating room and are generally well tolerated. Routine care in our practice is to administer paracervical
blocks with 20 cc of 1% plain lidocaine.  There is no evidence to suggest that adding the buffering agent would present any additional
risks to the patient. Therefore risks of participating in this study are commensurate with the risks associated with having a surgical
abortion. Potential risks associated with enrollment in our study include the potential loss of privacy of medical information. However,
we are taking steps to mitigate these risks as outlined below.
c)
Describe the procedures or safeguards in place to protect against or minimize potential risks (e.g., referral to psychological counseling
resources).
Patient’s medical information will be protected to the best of our ability using password protection and limiting access to investigators
and research staff. In addition, data will be de-identified prior to statistical analysis. If, during the study, new information is available
that would affect the safety of participants, they will be informed and the study will be modified to reflect this information.
d)
How will subjects be assessed for adverse events?
All investigators will protect and monitor the rights, safety, and welfare of all participants. All participants will be informed to report any
adverse events or severe adverse events. Investigators will review these reports and follow all adverse events until they resolve. Any
severe adverse events will be reported to the principal investigator within 24 hours as well as to the IRB and to the FDA if appropriate.
If a participant is withdrawn from the study due to a severe adverse event, the participant will be referred for or provided appropriate
medical follow up.
e)
Is there a plan to monitor study data for subject safety?
Y
If yes, discuss who will monitor the study data and describe the monitoring plan:
Investigators will meet regularly to review study progress, adverse events, severe adverse events, and any necessary changes to
study protocol. If at any point the study is suspected to place participants at unnecessary risk, the study may be unblinded and
terminated.
---------------------------------------------------------------------------------------------
* * * Benefits * * *
9.
Benefits
a)
Discuss any potential benefits that would justify involvement of subjects in this study. Compensation is not considered a benefit.
i.
Direct benefits to subjects (if applicable)
There is a potential medical benefit to participants who receive the buffered lidocaine for their paracervical injection due to a
possible decrease in injection pain.
ii.
Indirect benefits to society
Participants will also benefit from their ability to contribute to the improvement of medical care.
b)
Explain how the potential benefits justify the potential risks involved in participation in this research.
It is important to determine how to decrease pain during one of the most common outpatient procedures worldwide. The potential
risks to the participants are minimal and commensurate with the risks associated with having the planned procedure. Thus the


Page 15 of 22
 
15
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
potential benefits justify the potential risks.
---------------------------------------------------------------------------------------------
* * * Procedures to Maintain Confidentiality * * *
10.
Procedures to Maintain Confidentiality or Anonymity
Will your research involve any of the following types of data listed below?
Y
Which of the following types of data will you work with:
X
IdentifiableInformation is considered to be identifiable when it can be linked to specific individuals by the investigator(s) either directly or
indirectly through coding systems, or when characteristics of the information obtained are such that by their nature a reasonably
knowledgeable person or investigator could ascertain the identities of individuals. Therefore, even though a dataset may have been
stripped of direct identifiers (names, addresses, student ID numbers, etc.), it may still be possible to identify an individual through a
combination of other characteristics (e.g., age, gender, ethnicity, and place of employment).
AnonymousData are anonymous if no one, not even the researcher, can connect the data to the person who provided it--no identifying
information is collected from the individual. Investigators must be aware, however, that even if no direct identifiers (name, address,
student ID, etc.) are collected, identification of a participant may be possible from unique individual characteristics (indirect identifiers).
For example, a participant who is a member of a certain ethnic group or who was studied because of distinctive personal
accomplishments or medical history might be identifiable from even a large data pool.
De-identifiedIf the dataset has been stripped of all identifying information and there is no way that it could be linked back to the subjects
from whom it was originally collected (through a key to a coding system or by any other means). Note: This also applies if the source of
the data is identifiable but the data collected is not.
CodedThis refers to data that have been stripped of all direct subject identifiers, but in this case each record has its own study ID or code,
which is linked to identifiable information such as name or medical record number. The linking file must be separate from the coded data
set. This linking file may be held by someone on the study team (e.g. the PI) or it could be held by someone outside of the study team
(e.g. researcher at another institution). A coded data set may include limited identifiers under HIPAA. Of note, the code itself may not
contain identifiers such as subject initials or medical record number.
a)
If information derived from the study will be provided to the subject's personal physician, a government agency, or any other person or
group (other than the research team), describe to whom the information will be given and the nature of the information, if applicable.
•Government or university staff may have access to patient information for review.
•Providers and other healthcare staff of University of Hawaii may have access for direct patient care.
•Federal, state and local agencies having oversight over this research, such as The Office for Human Research Protections in the
U.S. Department of Health and Human Services, Food and Drug Administration, and the National Institutes of Health may have
access to patient information for research purposes.
b)
Explain how you will protect subjects' privacy. Note: Privacy refers to persons and their interest in controlling the access of others to
themselves. For example, based on their privacy interest's people want to control:
-
The time and place where they give information.
-
The nature of the information they give.
-
The nature of the experiences that are given to them.
-
Who receives and can use the information.
For example, persons might not want to be seen entering a place that might stigmatize them, such as a pregnancy-counseling center
that is clearly identified as such by signs on the front of the building. Please keep this definition in mind as you respond to this item.
Both of our clinic locations share space with other Ob/Gyn practitioners. Thus, patients are not clearly identified as seeking abortion
care when they walk through our doors. Once a patient is seen, she will receive counseling for the procedure and information about
the research project, if she is interested, in a private, confidential setting.


Page 16 of 22
 
16
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
c)
Describe how you will maintain the confidentiality of subjects' information. Note: Confidentiality pertains to the treatment of information
that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others (without
permission) in ways that are inconsistent with the understanding of the original disclosure. Please keep this definition in mind as you
respond to this item.
Data will initially be recorded in a paper chart and then entered into an online database on a password protected computer. Only
study investigators and research staff will be allowed to access data. Data will be de-identified prior to analysis.
d)
Who will have access to study records or specimens? (Please identify specific team members by name.)
All co-investigators will have access to study records, including Drs. Soon, Chin, Kaneshiro, Salcedo, Raidoo, Moayedi, and Mary
Tschann.
e)
If you plan to use existing data, records or specimens, what is the source of the data/records/specimens, and how will you access
them?NOTE: "Existing" means data or specimens collected (i.e., on the shelf) prior to the IRB application submission. It includes data
or specimens collected for research and non-research activities.
N/A
f)
How will subjects be asked to provide their permission for release of identifiable data collected as a part of this proposed research
(e.g., pictures, recordings, responses to research questions), now or in future? Explain and include appropriate statements in consent
materials.
Subjects will sign a written consent form, which will be explained by a member of the research team and all questions answered.
g)
If using existing data/biological specimens, will the researchers have access to a code linking the data to personally identifiable
information?
N/A
h)
If the data is coded, explain where the key to identifiers will be stored, how it will be protected, and who will have access to it.
N/A
i)
Explain why, where, in what format, and for how long data/specimens will be retained.
Data will be kept electronically on a password protected computer for seven years after study completion in order to access
information if needed.
---------------------------------------------------------------------------------------------
* * * Consent Information * * *
11.
Consent Information
11 a & b only apply to exempt applications
a)
How will subjects be informed of procedures, intent of the study, and potential risks to them?
b)
How will subjects be informed they may withdraw at any time without penalty?
Note: Attach, in the Attachments Section, written and/or verbal instructions the subject will receive.
See sample consent forms at  https://manoa.hawaii.edu/researchcompliance/templates


Page 17 of 22
 
17
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
c)
Click Add to answer consent process questions and provide the consent forms.
Informed Consent
Title
Consent Type
Attached Date
Consent
Consent
02/28/2017
Parental Consent
Consent
02/28/2017
---------------------------------------------------------------------------------------------
* * * Assent Background * * *
12.
Assent Background
(Complete if applicable)
Assent Document: A form or script of the information that will be conveyed to the child about the study. In general, researcher must obtain the
affirmative agreement of children ages seven years and older for their participation. Assent forms should be written at a level understandable
to the child. If the study includes a broad age range of  hildren, more than one assent form may be needed (i.e., an assent from suitable for a
17 year old is not usually suitable for a 7 year old child).
Assent Waiver: No child assent will be sought at all. This means that the IRB is asked to waive the requirement for child assent. Among other
circumstances, this option is appropriate when the capability of the child to understand the research is too limited or when the research holds
out a prospect of direct benefits that is important to the health or well-being of the child.
All minors must provide an affirmative consent to participate by signing a simplified assent form, unless the Investigator(s) provides evidence
to the IRB that the minor subjects are not capable of assenting because of age, maturity, psychological state, or other factors.
See sample consent/assent forms at  https://manoa.hawaii.edu/researchcompliance/templates/
Click Add to attach the Assent forms and provide assent process background information for each Assent Form, Alteration Form and Waiver.
Assent Background
Title
Assent Information Type
Attached Date
Assent Form
Assent Form
01/29/2017
---------------------------------------------------------------------------------------------


Page 18 of 22
 
18
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
* * * HIPAA * * *
13.
Health Insurance Portability and Accountability Act (HIPAA)
If you are using PHI and this page is not active you must return to the General Checklist and
check the box regarding the use of PHI in this research.
The HIPAA Privacy Rule establishes the right of an individual to authorize a covered entity, such as health plan, health care clearinghouse or
health care provider, to use and disclose his/her Protected Health Information (PHI) for research purposes.
The Privacy Rule defines the elements of individual information that comprise PHI and establishes the conditions under which PHI may be
used or disclosed by covered entities for research purposes. It also includes provisions to allow an individual's PHI to be disclosed or used in
research without the person's authorization (i.e., IRB Waiver of HIPAA Requirement Authorization).
Is Your Research Covered by HIPAA's Privacy Rule? - Decision Tree
HIPAA /Privacy Rule Authorization Template
Protected Health Information (PHI) is health information with one or more of the following identifiers. For more information see:
https://www.hawaii.edu/researchcompliance/human-studies or consult HIPAA Privacy Rule for Research
Research which involves the use of de-identified data is exempt from HIPAA requirements. In order to be de-identified data. NONE of the
subject identifiers listed below can be collected, used, reviewed, recoded, accessed or disclosed.
Please review the following list and indicate if any of the information will be collected from any medical records for the purpose of this
research project.
1.
X
Names
2.
X
Social Security Numbers
3.
X
Telephone Numbers
4.
X
All geographic subdivisions smaller than a state, including street address, city, county, precinct, zip code, and their equivalent
geocodes, except for the initial three digits of a zip code, if according to the current publicly available data from the Bureau of the
Census;
i.
The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people;
and
ii.
The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000.
5.
X
All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date,
date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and
elements may be aggregated into a single category of age 90 or older.
6.
Fax Numbers
7.
Electronic Mail Addresses
8.
Medical Record Numbers
-
You must attach a data collection sheet identifying the data points being collected from the MRN
9.
X
Health Plan Beneficiary Numbers
10.
X
Account Numbers
11.
Certificate/License Numbers
12.
Vehicle Identifiers and Serial Numbers, including License Plate Numbers
13.
Device Identifiers and Serial Numbers
14.
Web Universal Resource Locations (URLs)
15.
Internet Protocol (IP) Address Numbers
16.
Biometric Identifiers, including Finger and Voice Prints
17.
Full Face Photographic Images and any Comparable Images
18.
Any other unique identifying number, character, or code (note this does not mean the unique code assigned by the Investigator(s)
to code the research data)


Page 19 of 22
 
19
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
to code the research data)
---------------------------------------------------------------------------------------------
* * * Drugs and Devices * * *
14.
Drugs and Devices
Drugs
Name
IND Number (if applicable)
Type of Research
lidocaine
Therapeutic
---------------------------------------------------------------------------------------------
* * * Potential Conflict of Interest * * *
15.
Potential Conflict of Interestrr
Conflict of Interest and the definitions related to the Conflict of Interest Policy and the following questions, please refer to the Help Screen.
Conflict of Interest: Please check Yes or No for each item below.
a)
N
Does the research involve a drug, device, or biological invented by you, an immediate family member or other Research
Personnel?
b)
N
Is the research sponsored by an entity with which you, an immediate family member, or other Research Personnel have a paid
consulting or advising relationship?
c)
N
Will you, members of your immediate family, or other Research Personnel receive special compensation or increased
compensation if the research generates a favorable outcome?
d)
N
Will you, members of your immediate family, or other Research Personnel receive any money, gift or anything of monetary value
above and beyond the actual costs of enrollment, conduct of the research, and reporting on the results, including, but not limited
to, finders fees, referral fees, recruitment bonuses, and an enrollment bonus for reaching an accrual goal or similar types of
payments?
e)
N
Do you, members of your immediate family or other Research Personnel have any other interests or relationships (including
volunteer services) that might constitute a conflict of interest or an appearance of conflict of interest in connection with the
research project?
f)
N
Will the payment you receive for services provided during the conduct of the research (e.g., investigator and Research Personnel
time and tests) be inconsistent with fair market value for those services?
Significant Financial Interest: Please check Yes or No for each item below.
g)
N
Will you, your immediate family members or other Research Personnel receive salaries, royalties and/or other payments for
services (e.g., consulting fees, honoraria, research design, management position, independent contractor, service on advisory or
review committees, board membership seminars, lectures or teaching engagements when totaled together exceeded $5,000
during the previous 12 months or are expected to exceed $5,000 over the next 12 months)? This excludes reasonable costs of
conducting the research, as specified in the research agreement.
h)
N
Do you, your immediate family members, or other Research Personnel hold any ownership interests including stocks, bonds, or
stock options that exceed $5,000 and/or that constitute more than a five percent (5%) ownership interest in the sponsoring
organization? This does not include any interests held solely by reason of investment in a business by a mutual, pension or other
institutional investment fund over which the investigator and/or his or her immediate family do not exercise day-to-day control of
investment decisions.


Page 20 of 22
 
20
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
Minimizing Risks and Disclosure to Subjects
i)
N
Have you disclosed any actual, potential or perceived conflicts of interest in the consent form? Research Personnel are required
to disclose all such conflicts to all research participants in the research consent form.
j)
What steps, if any, have you taken or will you take to manage the conflict of interest and minimize the risks associated with any actual,
potential or perceived conflicts of interest arising out of this research?
If you checked Yes to any statement (a-h, except f) above, please identify the research team member(s) below and provide details
concerning the potential conflict of interest.
By submitting this form, you are attesting that you have read the UH HRPP Policy on Conflict of Interest and agree to abide by its terms. You
will update this disclosure form when new or changes in conflict of interest arise, and that you will comply with any conflict management plan
required by the Institutional Review Board (IRB) to manage, reduce, or eliminate any actual or potential conflict of interest for the duration of
the research.
Link to UH's Conflict of Interest Policy: https://manoa.hawaii.edu/.
---------------------------------------------------------------------------------------------
* * * Attachments * * *
16.
Attachments
Attach relevant documents here. These could include:
-
NIH/ CITI Training Certificate
-
Advertisements
-
Bibliography
-
Conflict of Interest Information
-
Cooperating Institution(s) Approval
-
Data Collection Sheet
-
Explanatory diagram (Sequence of events)
-
Grant proposal
-
Impact Statement
-
Information Sheets/Brochures
-
Investigators Brochure
-
Material Safety and Data Sheet
-
Package Inserts
-
Phone Scripts
-
Program Project Grant/List
-
Questionnaires
-
Recruitment Material (e.g., flyers, e-mail text)
-
Recruitment Statement
-
Protocol
-
Protocol Modification Requests
-
Training Grant/List
-
Other files associated with the protocol (you can upload most standard file formats: xls, pdf, jpg, tif, etc.)


Page 21 of 22
 
21
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
Please be sure to attach all documents associated with your protocol. Failure to attach the files associated with the protocol may result in this
protocol being returned to you for completion prior to being reviewed.
Students: Be sure to attach the Methods section of your thesis or dissertation proposal. If this protocol is associated with a grant proposal,
please remember to attach your grant.
To update or revise any attachments, please delete the existing attachment and upload the revised document to replace it.
Document Type
Attachment Name
Attached Date
Submitted Date
Protocol
Chin_Protocol_Jan29
01/30/2017
01/30/2017
Data Collection Sheet
Chin_Procedure_data_for
m_Jan29
01/30/2017
01/30/2017
Other
Chin_SAE_form_Jan29
01/30/2017
01/30/2017
Other
Chin_AE_form_Jan29
01/30/2017
01/30/2017
Other
Chin_Eligibility_Jan29
01/30/2017
01/30/2017
Other
JS - CITI HSR
01/31/2017
02/01/2017
Other
JS - CITI IPS
01/31/2017
02/01/2017
Other
RS - CITI HSR
01/31/2017
02/01/2017
Other
RS - CITI IPS
01/31/2017
02/01/2017
---------------------------------------------------------------------------------------------
* * * Obligations * * *
Obligations
Obligations of the Principal Investigator include the following:
Provide all subjects a copy of the signed consent form, if applicable.
 Modifications - Changes in any aspect of the study (for example, project design, procedures, consent forms, advertising materials, additional
key personnel or subject population) will be submitted to the IRB for approval before instituting the changes.
 Training - Human subject training certificates, including those for any newly added personnel, will be provided for all key personnel.Training
must be updated every three (3) years.
Final Report - The IRB will be notified when the study is complete.
I certify that I have reviewed this application, including attachments and that all information contained herein is accurate to the best of my
knowledge. I agree to report any substantive changes to the information contained in this application immediately to the UH IRB.
I agree to not enroll any subjects or collect any data intended only for research use prior to issuance of an IRB approval.
I understand that I am fully responsible for the execution and management of this study and that I am responsible for the performance of any
sub-investigators or key personnel including their adherence to all of the applicable policies and regulations.
This study will not begin until the investigator receives written final approval or determination of exemption.
X
The Principal Investigator has read and agrees to abide by the above obligations.
Submit the Continuing Review Form in order to maintain active status of the approved protocol. This form must be submitted to the IRB at
least 30 days (AHSIRB) or 45 days (SSIRB) prior to the date of expiration.


Page 22 of 22
 
22
PROTOCOL
Unified IRB Form
University of Hawai'i
Protocol # 2017-00083
 Date Printed: 02/28/2017
Protocol Title:
Buffered Lidocaine for Paracervical Block to Decrease Injection Pain
During First Trimester Surgical Abortions
Protocol Type:
Unified IRB Form
Date Submitted:
01/30/2017
Approval Period:
Draft
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
-------------------------------------------------------------------------------------
Submit the Protocol Violation Form to report protocol Deviations/Violations or the Event Reporting Form to report Adverse Events (AEs) or
Unanticipated Problems that occur in the course of the protocol.
X
The Principal Investigator has read and agrees to abide by the above obligations.
 "blue"Please click "Check for Completeness" to your left to continue to the next step.  If the protocol is complete and ready for submission,
please click "Submit Form" to your left to submit your protocol for IRB Review.
---------------------------------------------------------------------------------------------
* * * Event History * * *
Event History
Date
Status
View Attachments
Consent Forms
Letters
01/29/2017
NEW FORM CREATED
01/30/2017
NEW FORM SUBMITTED
Y
01/31/2017
NEW FORM RETURNED
02/01/2017
NEW FORM RESUBMITTED
Y
02/01/2017
NEW FORM RETURNED
02/01/2017
NEW FORM RESUBMITTED
Y
02/03/2017
NEW FORM PANEL ASSIGNED
02/06/2017
NEW FORM REVIEWER(S)
ASSIGNED
02/27/2017
NEW FORM CONTINGENT