Effect of Location of Tetanic Stimuli on Photopethysmogram During General Anesthesia
Phase: NA
Conditions: Stress Reaction
Sponsor: University of California, San Francisco

  Cover page 
 
NCT03648853 
 
Effect of Location of Tetanic Stimuli on Photopethysmogram During General 
Anesthesia  
 
April 18, 2020 

 
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Study Application (Version 1.0)
1.0
General Information
*Enter the full title of your study:
Effect of Location of Tetanic Stimuli on Photopethysmogram During General Anesthesia
 
 
*Enter the study number or study alias
PT1801
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this 
study.
 
 
2.0
Add Department(s)
2.1 List departments and/or research programs associated with this study:
Primary 
Dept?
Department Name
UCSF - 
 - M_Anesthesia
127037
 
3.0
Assign key study personnel(KSP) access to the study
3.1 *Please add a Principal Investigator for the study:
 
Talke, Pekka, MD
Select if applicable
Department Chair
Resident
Fellow
If the Principal Investigator is a Fellow, the name of the Faculty Advisor must be supplied below.
 
3.2 If applicable, please select the Research Staff personnel:
 
A) Additional Investigators
B) Research Support Staff
3.3 *Please add a Study Contact:
 
Talke, Pekka, MD 
The Study Contact(s) will receive all important system notifications along with the Principal 
Investigator. (e.g. The project contact(s) are typically either the Study Coordinator or the Principal 
Investigator themselves).

3.4 If applicable, please add a Faculty Advisor/Mentor:
 
3.5 If applicable, please select the Designated Department Approval(s):
 
Add the name of the individual authorized to approve and sign off on this protocol from your 
Department (e.g. the Department Chair or Dean).
4.0
 Qualifications of Key Study Personnel
4.1  November, 2015 - NEW Definition of Key Study Personnel and CITI Training 
Requirements:
  
include the Principal Investigator, other investigators and research 
UCSF Key Study Personnel 
personnel who are directly involved in conducting research with study participants or who are 
directly involved in using study participants’ identifiable private information during the course of the 
research. Key Personnel also include faculty mentors/advisors who provide direct oversight to 
Postdoctoral Fellows, Residents and Clinical Fellows serving as PI on the IRB application.
 
The IRB requires that all Key Study Personnel complete Human Subjects 
Protection Training through CITI prior to approval of a new study, or a 
modification in which KSP are being added. More information on the CITI 
training requirement can be found on our website.
   
List the study responsibilities and qualifications of any individuals who qualify as Key Study 
 (KSP) at UCSF and affiliated sites ONLY by clicking the "Add a new row" button. 
Personnel
This 
information is required and your application will be considered incomplete without it.
KSP Name
Description of Study 
Responsibilities
Qualifications
Talke, Pekka, MD
Design, administration, data 
collection, data analysis, 
consenting
Dr Talke has conducted 
clinical studies involving 
patients and volunteers at 
UCSF for over 25 years. He is 
a faculty anesthesiologist at 
UCSF. Dr Talke has conducted 
studies using 
photoplethysmography at 
UCSF for over 15 years.
5.0
 Initial Screening Questions - Updated 9/13
(Note: You must answer every question on this page to proceed).
If you are converting to the new form, check questions 5.4, 5.6, 5.7, 5.8 and 
5.10 before saving and continuing to the next section.
5.1  
 Application type:
*
Full Committee 
Expedited 
Exempt 
5.2  
 Risk level 
:
*
(Help Text updated 9/13)

Minimal risk 
Greater than minimal risk 
5.3  
 Subject contact:
*
Yes (including phone, email or web contact) 
No (limited to medical records review, biological specimen analysis, and/or data analysis) 
5.4  
 Funding (past or present):
*
Funded or will be funded (external sponsor, gift, program or specific internal or departmental funds) 
Unfunded (no specific funds earmarked for this project) 
Unfunded student project 
5.5  
The Principal Investigator and/or one or more of the key study personnel has 
 
* 
financial interests
related to this study:
  Yes   
  No
If 
, the Conflict of Interest Advisory Committee (COIAC) office may contact you for additional 
Yes
information.
5.6  
This is an investigator-initiated study:
* 
 Yes   
 No
5.7  
This study 
 involves retrospective records review and/or identifiable biospecimen analysis:
* 
ONLY
  Yes   
  No
5.8  
This is a clinical trial:
* 
  Yes   
  No
Clinical Trial Registration
"NCT" number for this trial:
5.9  * This is a multicenter study:
  Yes   
  No
5.10  
This application involves the study of 
 or 
 drugs, devices, biologics or in vitro 
* 
unapproved
approved
diagnostics:
  Yes   
  No
5.11  * This application involves a Humanitarian Use Device:
No 
Yes, and it includes a research component 
Yes, and it involves clinical care ONLY 

5.12  
This study involves human stem cells (including iPS cells and adult stem cells), gametes or 
* 
embryos:
No 
Yes, and requires CHR and GESCR review 
Yes, and requires GESCR review, but NOT CHR review 
5.13  * This is a CIRB study (e.g. the NCI CIRB will be the IRB of record):
  Yes   
  No
5.14  
This application includes a request to rely on another IRB (other than NCI CIRB):
* 
  Yes   
  No
Note: If this request is approved, the CHR will 
 review and approve this study. Another institution 
NOT
will be the IRB of record.
6.0
 Expedited Review Categories
6.1  
If you think this study qualifies for expedited review, select the regulatory category(ies) that the 
* 
research falls under:
Category 1: A very limited number of studies of approved drugs and devices
Category 2: Blood sampling
Category 3: Noninvasive specimen collection (e.g. buccal swabs, urine, hair and nail clippings, etc.)
Category 4: Noninvasive clinical procedures (e.g. physical sensors such as pulse oximeters, MRI, EKG, 
EEG, ultrasound, moderate exercise testing, etc.)
Category 5: Research involving materials (data, documents, records, or specimens) that were 
previously collected for either nonresearch or research purposes
Category 6: Use of recordings (voice, video, digital or image)
Category 7: Low risk behavioral research or research employing survey, interview, oral history, focus 
group, program evaluation, human factors evaluation, or quality assurance methodologies
7.0
 Sites
7.1  Institutions (check all that apply):
UCSF
China Basin
Helen Diller Family Comprehensive Cancer Center
Mission Bay
Mount Zion
San Francisco General Hospital (SFGH)
SF VA Medical Center (SF VAMC)
Blood Centers of the Pacific (BCP)
Blood Systems Research Institute (BSRI)
Fresno (Community Medical Center)
Gallo
Gladstone
Institute on Aging (IOA)
Jewish Home

SF Dept of Public Health (DPH)
7.2  Check all the other types of sites not affiliated with UCSF with which you are cooperating or 
collaborating on this project 
:
(Help Text updated 9/13)
Other UC Campus
Other institution
Other community-based site
Foreign Country
List the foreign country/ies:
7.3  Check any research programs this study is associated with:
Cancer Center
Center for AIDS Prevention Sciences (CAPS)
Global Health Sciences
Immune Tolerance Network (ITN)
Neurosciences Clinical Research Unit (NCRU)
Osher Center
Positive Health Program
8.0
 Study Design
8.1  
Study design 
:
* 
(Help Text updated 9/13)
This is a single center, clinical research study that plans to enroll 20 surgical patients undergoing general 
anesthesia.
8.2  If this is a clinical trial, check the applicable phase(s) 
:
(Help Text updated 9/13)
Phase I
Phase II
Phase III
Phase IV
9.0
 Scientific Considerations
9.1  Hypothesis 
:
(Help Text updated 9/13)
This study has a hypothesis:
 Yes   
 No
If yes, state the hypothesis or hypotheses:
During general anesthesia a tetanic stimulus-induced noxious stimulus will elicit a brief peripheral 
vasoconstrictive response which can be measured as a decrease in the AC component of a 
photoplethysmogram, and an increase in the DC component of the photoplethysmogram. The hypothesis 
of this study is that the location where the tetanic stimulus is applied has no effect on the ripheral 
vasoconstrictive response.

9.2  
List the specific aims:
* 
To evaluate the effect of a noxious stimulus (tetanus) on the AC and DC components of a 
photoplethysmogram immediately before and after a tetanic stimulus applied to three different sites 
(ulnar nerve, thorax at mid axillary line, and over tibia).
 
9.3  Statistical analysis: 
Maximum changes in the AC and DC components of the photoplethysmogram will be determined during a 
60 second period after a tetanic stimulus.  Maximum changes in the AC and DC components will be 
compared to their respective baseline values using paired students t-test. p<0.05 will signify statistical 
significance. The maximum changes in the AC and DC components between the three different sites will 
be compared using ANOVA.
9.4  If this study has undergone scientific or scholarly review, please indicate which entity performed the 
review:
Cancer Center Protocol Review Committee (PRC) (Full approval is required prior to final CHR approval 
for cancer-related protocols.)
CTSI Clinical Research Center (CRC) advisory committee
Departmental scientific review
Other:
Specify 
:
Other
10.0
 Background
10.1  Background:
Noxious stimuli will induce a stress response in humans that activates the autonomic nervous 
system.  This response can be observed in various ways such as peripheral vasoconstriction, increase in 
circulating catecholamine levels, increase in heart rate and blood pressure, etc. Numerous previous 
studies have used photoplethysmography (measures change in volume) to record these responses. 
Photoplethysmography is part of a commonly used noninvasive clinical monitoring system called pulse 
oximetry.
 
Heat, cold, and electrical current have been used as noxious stimuli in awake subjects.  In surgical 
patients, tetanic stimulus has been established as a noninvasive, standardized noxious stimulus, that has 
been compared in intensity to the stimulus of a skin insicion. Tetanic stimuli are routinely used during 
general anesthesia to monitor neuromuscular function.
 
A photoplethysmogram has two components, commonly referred to as AC and DC.  The AC component is 
due to pulsatile changes in tissue volume (mainly arterial pulsation).  The DC component is due to 
transmission of light by nonpulsatile tissues, including venous blood and nonpulsatile portions of arterial 
blood. Noxious stimuli-induced stress responses mediate peripheral vasoconstriction and will decrease the 
AC and increase the DC component of the photoplethysmogram.  It is not known if the location of the 
tetanic stimulus has an effect on this stress response.
 
The aim of this study is to investigate the effect of a known noxious stimulus (tetanic stimulus), applied 
to three different sites, on both the AC and DC components of the photoplethysmogram in order to 
determine which component is best in detecting perioperative stress responses and if the location of the 
stimulus has an effect on the stress response.
10.2  Preliminary studies:
Numerous studies have 1) established the tetanic stimulus as a standardized noxious stimulus during 
general anesthesia, and 2) documented the resulting stress responses using various combinations of 
anesthetics. However, tno data exist on the effect of the location of the tetanic stimulus on the stress 
response.

 
During several of my previous intraoperative studies using photoplethysmography, I have observed both 
the tetanic stimulus and surgical stimulus to have an effect on both the AC and DC components of the 
photoplethysmogram.  Unfortunately, those previous studies were not designed specifically to study and 
record the effect of the location of the tetanic stimulus on the photoplethysmogram.
 
THIS STUDY IS IDENTICAL TO A RECENTLY COMPLETED STUDY (15-17499) WITH THE 
DIFFERENCE THAT TETANIC STIMULUS WILL BE ADMINISTERED TO ADDITIONAL SITES 
(ULNAR NERVE, MID AXILLARY LINE OF THORAX AND OVER TIBIA)
10.3  References:
Hamunen K, Kontinen V, Hakala E, Talke P, Paloheimo M, Kalso E. Effect of pain on autonomic 
 Br J 
nervous system indices derived from photoplethysmography in healthy volunteers.
Anaesth. 2012 May;108(5):838-44.
 
Huiku M, Uutela K, van Gils M, Korhonen I, Kymäläinen M, Meriläinen P, Paloheimo M, Rantanen M, Takala 
P, Viertiö-Oja H, Yli-Hankala A. 
 Br J 
Assessment of surgical stress during general anaesthesia.
Anaesth. 2007 Apr;98(4):447-55.
 
Mustola S1, 
, 
, 
, 
, 
. Performance of Surgical 
Parkkari T Uutela K Huiku M Kymäläinen M Toivonen J
Stress Index during Sevoflurane-Fentanyl and Isoflurane-Fentanyl Anesthesia. Anesthesiol Res Pract. 
2010;2010.
 
Wennervirta J, Hynynen M, Koivusalo AM, Uutela K, Huiku M, Vakkuri A. Surgical stress index as a 
 Acta Anaesthesiol 
measure of nociception/antinociception balance during general anesthesia.
Scand. 2008 Sep;52(8):1038-45.
 
Ahonen J, Jokela R, Uutela K, Huiku M. Surgical stress index reflects surgical stress in 
 Br J Anaesth. 2007 Apr;98(4):456-61.
gynaecological laparoscopic day-case surgery.
 
Struys MM, Vanpeteghem C, Huiku M, Uutela K, Blyaert NB, Mortier EP. Changes in a surgical stress 
 Br J 
index in response to standardized pain stimuli during propofol-remifentanil infusion.
Anaesth. 2007 Sep;99(3):359-67.
 
Rantanen M, Yli-Hankala A, van Gils M, Yppärilä-Wolters H, Takala P, Huiku M, Kymäläinen M, Seitsonen 
E, Korhonen I. Novel multiparameter approach for measurement of nociception at skin incision 
 Br J Anaesth. 2006 Mar;96(3):367-76.
during general anaesthesia.
 
Rantanen M, Yppärilä-Wolters H, van Gils M, Yli-Hankala A, Huiku M, Kymäläinen M, Korhonen I. Tetanic 
stimulus of ulnar nerve as a predictor of heart rate response to skin incision in propofol 
 Br J Anaesth. 2007 Oct;99(4):509-13.
remifentanil anaesthesia.
If you have a separate bibliography, attach it to the submission with your other study documents. 
11.0
 Sample Size and Eligibility
11.1  Number of subjects that will be enrolled at UCSF and affiliated institutions:
20
11.2  Total number of subjects that will be enrolled at all sites 
:
(Help Text updated 9/13)
20
11.3  Estimated number of people that you will need to consent and screen here (but not necessarily 
enroll) to get the needed subjects:
30

11.4  Explain how and why the number of subjects was chosen 
:
(Help Text updated 9/13)
Based on the previously completed trial, 12 subjects will be needed. I'm requesting to study up to 20 
patients in case there will be patients with poor technical data quality.
11.5  * Eligible age range(s):
0-6 years
7-12 years
13-17 years
18+ years
11.6  Inclusion criteria:
1) 18 years old or older
2) Willing to participate (signed informed consent)
3) English speaking (for consent reasons)
4) Surgery under general anesthesia
 
11.7  Exclusion criteria:
1) Unable to consent
2) Non english speaking
4) Under 18 years old
11.8  There are inclusion or exclusion criteria based on gender, race or ethnicity:
  Yes   
  No
If
, please explain the nature and rationale for the restrictions:
 yes
12.0
 Other Approvals and Registrations
12.1  
Do any study activities take place on patient care units:
* 
  Yes   
  No
If 
, attach a letter of support for the study from the involved patient care manager(s).
Yes
12.2  
Does your protocol involve any radiation exposure to patients/subjects? The UCSF Radiation 
* 
 
Safety Committee requires review of your protocol if it includes administration of radiation as part 
of standard of care 
 research exposures:
OR
  Yes   
  No
12.3  
This study may generate genetic data that may be broadly shared (e.g. submitted to NIH for 
* 
 in 
, 
, etc):
Genome-Wide Association Studies (GWAS)
dbGaP TCGA
  Yes   
  No

12.4  
This study involves administration of vaccines produced using recombinant DNA technologies to 
* 
human subjects:
  Yes   
  No
12.5  
This study involves human gene transfer (NOTE: Requires NIH Recombinant DNA Advisory 
* 
Committee (RAC) review prior to CHR approval):
  Yes   
  No
12.6  This study involves other regulated materials and requires approval and/or authorization from the 
following regulatory committees:
Institutional Biological Safety Committee (IBC)
Specify BUA #:
Institutional Animal Care and Use Committee (IACUC)
Specify IACUC #:
Radiation Safety Committee
Specify RUA #:
Radioactive Drug Research Committee (RDRC)
Specify RDRC #:
Controlled Substances
13.0
 Procedures
13.1  
Procedures/Methods 
* 
(Help Text updated 9/13)
 
For clinical research list all study procedures, test and treatments required for this study, including 
when and how often they will be performed. If there are no clinical procedures, describe the 
Methods:
In addition to the clinically used pulse oximeter probe, two additional, noninvasive pulse oximeter probes 
(Masimo, Irvine CA, identical to the one used clinically) will be applied to both index fingers after 
induction of anesthesia. The probes are noninvasive and pose no known additional risk.  Data from these 
probes will be collected using a laptop computer and ADC software, which is designed to collect 
photoplethysmography data from Masimo pulse oximeters.  Data will be collected while patients are 
anesthetized.  Data will be analyzed offline.
 
In addition to the pulse oximeter data, other available hemodynamic data will be collected electronically 
from GE hemodynamic monitors using another laptop computer and S/5 Collect software, which is 
commercially available for this purpose.
 
Tetanic stimulus: The study will use the same neuromuscular function monitor as is used clinically. 
Tetanic stimuli will be applied to the ulnar nerve, thorax at mid axillary line and over tibia.  A 5 second, 
100 Hz, 60 mA, stimulus will be used (similar to the one used clinically). Tetanus will be applied twice at 
each location (random order, minimum of 2 minuted apart.
 
Other than electronic data collection and addition of the two noninvasive pulse oximeter probes and 
periodic tetanic stimuli, this study will have no influence on surgery, anesthesia, or hemodynamic 

1.  
2.  
3.  
4.  
5.  
monitoring, all of which are left to the discretion of the surgeon and anesthesiologist in charge of the 
patient.
 
In summary, the following data will be recorded:
Demographic data from APEX
Pulse oximeter data will be collected electronically using a laptop computer
Anesthetic agents will be recorded from APEX
Timing and location of the tetanic stimuli  will be marked on the laptop computer.
All available electronic monitoring data (blood pressure, heart rate etc.) will be recorded 
electronically from the operating room hemodynamic monitors using a laptop computer.
If you have a procedure table, attach it to the submission with your other study documents.
13.2  Interviews, questionnaires, and/or surveys will be administered or focus groups will be conducted:
  Yes   
  No
List any standard instruments used for this study:  
Attach any non-standard instruments at the end of the application.
13.3  Conduct of study procedures or tests off-site by non-UCSF personnel:
  Yes   
  No
If yes, explain:
13.4  Sharing of experimental research test results with subjects or their care providers:
  Yes   
  No
If yes, explain:
13.5  * Specimen collection for future research and/or specimen repository/bank administration:
  Yes   
  No
13.6  Time commitment (per visit and in total):
Study will be conducted intraoperatively, and will not increase surgical or anesthesia time. Time 
commitment is limited to the consent process.
13.7  Locations:
Moffatt Long operating rooms
13.8  Describe the resources in place to conduct this study in a way that assures protection of the rights 
and welfare of participants:

Study will be conducted in the operating room with an anesthesiologist present.  Study data collecting 
and consenting will be done by the principal investigator who is a faculty anesthesiologist. Data will be 
coded and stored in the principal investigators locked office to protect privacy.
14.0
 Risks and Benefits
14.1  
Risks and discomforts:
* 
Risks: Pulse oximeter probes ate noninvasive and have no known associated risks. Electronic data 
collection has no known associated risks.  Tetanic stimulus has no known associated risks, and will not 
cause discomfort as the study will be done during general anesthesia.
Benefits: None
14.2  Steps taken to minimize risks to subjects:
No known risks.
14.3  Benefits to subjects:
 
  Yes   
  No
If yes, describe:
14.4  Benefits to society:
Better understanding of the effect on perioperative noxious stimuli on plethysmogram may improve 
anesthetic management in the future.
14.5  Explain why the risks to subjects are reasonable: 
No known risks.
15.0
 Confidentiality and Privacy
15.1  Plans for maintaining privacy in the research setting:
Study will be conducted in the operating room during surgery. Access to operating rooms is limited to 
health care providers.
 
15.2  Possible consequences to subjects resulting from a loss of privacy:
None known.
15.3  Study data are:
Derived from the Integrated Data Repository (IDR) or The Health Record Data Service (THREDS) at 
SFGH
Derived from a medical record (e.g. APeX, OnCore, etc. Identify source below)
Added to the hospital or clinical medical record
Created or collected as part of health care
Used to make health care decisions
Obtained from the subject, including interviews, questionnaires
Obtained from a foreign country or countries only

Obtained from records open to the public
Obtained from existing research records
None of the above
If 
, identify source:
derived from a medical record
Demographics and anesthesia drug data from APEX
15.4  Identifiers may be included in research records:
 Yes   
 No
If 
, check all the identifiers that may be included:
yes
Names
Dates
Postal addresses
Phone numbers
Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers
Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers
Biometric identifiers
Facial photos or other identifiable images
Any other unique identifier
* Required for studies conducted at the VAMC
15.5  Identifiable information might be disclosed as part of study activities:
  Yes   
  No
If 
, indicate to whom identifiable information may be disclosed:
yes
The subject's medical record
The study sponsor
Collaborators
The US Food & Drug Administration (FDA)
Others (specify below)
A Foreign Country or Countries (specify below)
If 
, specify:
Others
No research related information will be placed on patient's medical record
15.6  Indicate how data are kept secure and protected from improper use and disclosure (check all that 
apply):
 
NOTE: Whenever possible, do not store subject identifiers on laptops, PDAs, or other portable 
devices. If you collect subject identifiers on portable devices, you MUST encrypt the devices.

Data are stored securely in My Research
Data are coded; data key is destroyed at end of study
Data are coded; data key is kept separately and securely
Data are kept in a locked file cabinet
Data are kept in a locked office or suite
Electronic data are protected with a password
Data are stored on a secure network
Data are collected/stored using REDCap or REDCap Survey
Data are securely stored in OnCore
15.7  Additional measures to assure confidentiality and protect identifiers from improper use and 
disclosure, if any:
Patient names are associated only with consent forms. Unique study numbers will be used to collect and 
analyze data.  These study numbers are not related to patient identifyers.
This study is unique in a sense that the PI can identify the patients using the date and time of the study 
which can be correlated with the operating room schedule.  No MR number and unique study number 
links will be used. Non UCSF employers do not have acces to this information.  To assure confidentiality, 
in addition, the case report forms that contain the date and time of the study will be kept at the 
investigators office in a locked cabinet.
 
 
 
15.8  This study may collect information that State or Federal law requires to be reported to other 
officials or ethically requires action:
  Yes   
  No
Explain:
15.9  This study will be issued a Certificate of Confidentiality:
  Yes   
  No
16.0
 Subjects
16.1  Check all types of subjects that may be enrolled:
Inpatients
Outpatients
Healthy volunteers
Staff of UCSF or affiliated institutions
16.2  Additional vulnerable populations:
Children
Subjects unable to consent for themselves
Subjects unable to consent for themselves (emergency setting)
Subjects with diminished capacity to consent
Subjects unable to read, speak or understand English
Pregnant women

Fetuses
Neonates
Prisoners
Economically or educationally disadvantaged persons
Investigators’ staff
Students
Explain why it is appropriate to include the types of subjects checked above in this particular study:
Describe the additional safeguards that have been included in the study to protect the rights and welfare 
of these subjects and minimize coercion or undue influence:
17.0
 Recruitment
17.1  * Methods (check all that apply):
Study investigators (and/or affiliated nurses or staff) recruit their own patients directly in person or 
by phone.
Study investigators recruit their own patients by letter. Attach the letter for review.
Study investigators send a “Dear Doctor” letter to colleagues asking for referrals of eligible patients. If 
interested, the patient will contact the PI or the PI may directly recruit the patients (with documented 
permission from the patient). Investigators may give the referring physicians a study information 
sheet for the patients.
Study investigators provide their colleagues with a “Dear Patient” letter describing the study. This 
letter can be signed by the treating physicians and would inform the patients how to contact the 
study investigators. The study investigators may not have access to patient names and addresses for 
mailing
Advertisements, notices, and/or media used to recruit subjects. Interested subjects initiate contact 
with study investigators. Attach ads, notices, or media text for review. In section below, please 
explain where ads will be posted.
Study investigators identify prospective subjects through chart review. (Study investigators request a 
Waiver of Authorization for recruitment purposes.)
Large-scale epidemiological studies and/or population-based studies: Prospective subjects are 
identified through a registry or medical records and contacted by someone other than their personal 
physician. (Study investigators request a Waiver of Authorization for recruitment purposes.)
Direct contact of potential subjects who have previously given consent to be contacted for 
participation in research. Clinic or program develops a CHR-approved recruitment protocol that asks 
patients if they agree to be contacted for research (a recruitment database) or consent for future 
contact was documented using the consent form for another CHR-approved study.
Study investigators list the study on the School of Medicine list of UCSF Clinical Trials website or a 
similarly managed site. Interested subjects initiate contact with investigators.
Study investigators recruit potential subjects who are unknown to them through methods such as 
snowball sampling, direct approach, use of social networks, and random digit dialing.
Other
If 
, explain:
Other
 
17.2  
How, when, and by whom eligibility will be determined:
* 
Principal Investigator (Pekka Talke MD) will review upcoming operating room schedules in advance, and 
will identify patients who are likely to be suitable for the study.
17.3  
How, when, where and by whom potential subjects will be approached:
* 

Principal Investigator (Pekka Talke MD) will approach potential subjects when the patients arrive to the 
ML preoperative area.
17.4  * Protected health information (PHI) will be accessed prior to obtaining consent:
 Yes   
 No
18.0
 Waiver of Consent/Authorization for Recruitment Purposes
This section is required when study investigators (and/or affiliated nurses 
or staff) recruit their own patients directly.
18.1  
Study personnel need to access protected health information (PHI) during the recruitment 
* 
process and it is not practicable to obtain informed consent until potential subjects have been 
identified:
Yes 
If 
, a waiver of consent/authorization is NOT needed.
no
18.2  
 A waiver for screening of health records to identify potential subjects poses no more than 
* 
minimal risk to privacy for participants:
Yes 
If 
, a waiver of authorization can NOT be granted.
no
18.3  
Screening health records prior to obtaining consent will not adversely affect subjects' rights and 
* 
welfare:
Yes 
If 
, a waiver of authorization can NOT be granted.
no
18.4  
Check all the identifiers that will be collected prior to obtaining informed consent:
* 
Names
Dates
Postal addresses
Phone numbers
Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers
Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers
Biometric identifiers
Facial photos or other identifiable images
Any other unique identifier

None
Note: HIPAA rules require that you collect the minimum necessary.
18.5  
 Describe any health information that will be collected prior to obtaining informed consent:
*
Operating room schedules will be screened for patients that will fit the inclusion criteria.
Note: HIPAA requires that you collect the minimum necessary.
18.6  
Describe your plan to destroy the identifiers at the earliest opportunity consistent with the 
* 
research 
 provide a health or research justification for retaining the identifiers, or indicate and 
or
explain that retention is required by law:
Patient names are associated only with consent forms. Unique study numbers will be used to collect and 
analyze data.  These study numbers are not related to patient identifyers.
This study is unique in a sense that the PI can identify the patients using the date and time of the study 
which can be correlated with the operating room schedule that the PI has access to.  No MR number and 
unique study number links will be used. Non UCSF employers do not have access to this information.  To 
assure confidentiality, in addition, the case report forms that contain the date and time of the study will 
be kept at the investigators office in a locked cabinet.
 
19.0
 Informed Consent
19.1  * Methods (check all that apply):
Signed consent will be obtained from subjects and/or parents (if subjects are minors)
Verbal consent will be obtained from subjects using an information sheet or script
Electronic consent will be obtained from subjects via the web or email
Implied consent will be obtained via mail, the web or email
Signed consent will be obtained from surrogates
Emergency waiver of consent is being requested for subjects unable to provide consent
Informed consent will not be obtained
19.2  
Process for obtaining informed consent:
* 
Principal investigator will approach the patient, and if allowed, will explain the study to the subjects in 
detail. All questions will be answered.
19.3  
How investigators will make sure subjects understand the information provided to them:
* 
Principal investigator will recruit only english speaking patients.  The investigator has conducted several 
similar studies and is experienced in consenting subject, and will not consent subjects who do not clearly 
understand the study procedures.
20.0
 Financial Considerations
20.1  Subjects payment or compensation method (check all that apply):
Payments will be (check all that apply):
Subjects will not be paid
Cash
Check

Debit card
Gift card
Reimbursement for parking and other expenses
Other:
Specify 
:
Other
20.2  Describe the schedule and amounts of payments, including the total subjects can receive for 
completing the study. If deviating from recommendations in Subject Payment Guidelines, include 
specific justification below. 
none
20.3  Costs to Subjects:  Will subjects or their insurance be charged for any study procedures?
  Yes   
  No
If 
 describe those costs below, and compare subjects’ costs to the costs associated with alternative 
yes,
care off-study. Finally, explain why it is appropriate to charge those costs to the subjects.
21.0
 CTSI Screening Questions
21.1  
This study will be carried out at one of the UCSF Clinical Research Services (CRS) centers or will 
* 
utilize CRS services. CRS centers are at the following sites:
SFGH Clinical Research Center
Moffitt Adult Clinical Research Center
Moffitt Hospital Pediatrics & NCRC
Mount Zion Hospital Clinical Research Center
Tenderloin Center
CHORI Children's Hospital Pediatrics & Adult Clinical Research Center
Kaiser Oakland Research Unit
SF VA Medical Center Clinical Research Unit
 
Please note: Effective 3/1/14, the CRS form will no longer be completed and submitted in iRIS. The 
CRS budget request form can be found at: https://accelerate.ucsf.edu/files/crs
/BudgetRequest2015.docx. Follow the instructions on the form to submit.
 
Even if you click 'Yes' to this question, the form will no longer proceed to the Clinical Research 
Services (CRS) Application Form section.
  Yes   
  No
21.2  This project involves community-based research:
  Yes   
  No
21.3  This project involves practice-based research:
  Yes   
  No
22.0
 End of Study Application
22.1  
End of Study Application Form

 
: Click on the section you need to edit in the 
To continue working on the Study Application
left-hand menu. Remember to save through the entire Study Application after making 
changes.
 
: Click Save and Continue. If this is a new 
If you are done working on the Study Application
study, you will automatically enter the Initial Review Submission Packet form, where you 
can attach consent forms or other study documents. Review the Initial Review Submission 
 for a list of required attachments.
Checklist
 
Answer all questions and attach all required documents to speed up your approval.