Clinical trial NCT03176693
Conditions: Pheochromocytoma Paraganglioma
Sponsor: University of California, Los Angeles
Start date: 2017-05-05; Completion date: 2021-10-10
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pheochromocytoma is a rare, catecholamine (ex. adrenaline) secreting tumor that requires preoperative alpha blockade to minimize intraoperative hemodynamic instability, thereby reducing intra- and postoperative morbidity and mortality. Phenoxybenzamine is a non-selective alpha blocker that is significantly more expensive and is associated with increased adverse effects in comparison with selective alpha blockers such as doxazosin. Retrospective studies show minimal differences in hemodynamic instability and no differences in postoperative morbidity and mortality between selective vs. non-selective alpha blockers. This study is a randomized controlled trial that will compare hemodynamic instability, morbidity, mortality, cost, and quality of life between patients blocked with phenoxybenzamine vs. doxazosin.

Detailed description:
Pheochromocytoma is a catecholamine (ex. adrenaline) secreting tumor for which the primary treatment is surgical resection. Due to the hormones secreted by the tumor, alpha receptors on peripheral blood vessels are activated, causing constriction of these blood vessels and dangerously high blood pressure. During resection of the tumor, the source of excess hormone secretion is abruptly removed, which can lead to life-threatening blood pressure fluctuations during surgery.

Alpha blockers are a class of medication that blocks the alpha receptor on blood vessels. Given preoperatively over a few weeks, these medications negate the effects of the excess hormones secreted by the pheochromocytoma, reducing the frequency and severity of dangerous blood pressure fluctuations intraoperatively and postoperatively. Preoperative alpha blockade is therefore critical to safely perform surgery to resect pheochromocytoma.

Phenoxybenzamine, a non-selective alpha blocker, is the most common medication used to alpha block patients prior to pheochromocytoma resection. However, due to increasing drug costs and increased side effects in comparison with selective alpha blockers, there is a renewed interest in studying alternatives to phenoxybenzamine.

Selective alpha blockers such as doxazosin are also commonly used to alpha block patients prior to pheochromocytoma resection. Selective alpha blockers are significantly less expensive and are associated with fewer side effects than phenoxybenzamine. Most retrospective studies comparing phenoxybenzamine with selective alpha blockers show no difference in intraoperative blood pressure fluctuations, morbidity, or mortality in pheochromocytoma resection. However, no prospective, randomized controlled trials comparing phenoxybenzamine to selective alpha blockers have been performed.

The purpose of our study is to analyze preoperative, intraoperative, and postoperative outcomes in patients randomized to receive phenoxybenzamine (non-selective) or doxazosin (selective) for alpha blockade prior to pheochromocytoma resection. Outcomes will include postoperative morbidity and mortality, intraoperative hemodynamic instability, quality of life, and cost.

Arms: arm 1: 3-4 weeks prior to date of surgery, patient will start phenoxybenzamine 10mg PO twice daily. Phenoxybenzamine will then be titrated to a blood pressure \<120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing). arm 2: 3-4 weeks prior to date of surgery, patient will start doxazosin 1 mg PO daily. Phenoxybenzamine will then be titrated to a blood pressure \<120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing).
Interventions: intervention 1: Phenoxybenzamine intervention 2: Doxazosin
Intervention descriptions: intervention 1: Non-selective alpha blocker intervention 2: Selective alpha blocker

Protocol documents:
Prot_SAP_000.pdf: 
Date: Wednesday, December 15, 2021 8:24:08 AM
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Preoperative Alpha Blockade for 
Pheochromocytoma
NCT03176693
Document Date: June 15, 2021


Study Title and Key Personnel
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to this study.
1.0
*Full Title of the Submission: 
Randomized Controlled Trial of Preoperative Alpha Blockade for Pheochromocytoma
Protocol Version Date and/or Number: 
v1
2.0
*Working or Lay Title: 
Randomized Controlled Trial of Preoperative Alpha Blockade for Pheochromocytoma
3.0
Principal Investigator:
*Name: MICHAEL YEH
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accountability?
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personally
identifiable
info?
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to
code
key?
YASMINE
SURGERY GENERAL
N t A
li
bl
Y
Y
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Other Personnel
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Principal Investigator
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Lay Summary and Keywords
Please provide the following information about your study.
1.0
*Provide a brief lay summary describing this study.  (limit 500 words).
Pheochromocytoma is a catecholamine (ex. adrenaline) secreting tumor for which the primary treatment is surgical resection. Due to the hormones
secreted by the tumor, alpha receptors on peripheral blood vessels are activated, causing constriction of these blood vessels and dangerously high
blood pressure. During resection of the tumor, the source of excess hormone secretion is abruptly removed, which can lead to life-threatening
blood pressure fluctuations during surgery.
Alpha blockers are a class of medication that blocks the alpha receptor on blood vessels. Given preoperatively over a few weeks, these
medications negate the effects of the excess hormones secreted by the pheochromocytoma, reducing the frequency and severity of dangerous
blood pressure fluctuations intraoperatively and postoperatively. Preoperative alpha blockade is therefore critical to safely perform surgery to resect
pheochromocytoma.
Phenoxybenzamine, a non-selective alpha blocker, is the most common medication used to alpha block patients prior to pheochromocytoma
resection. However, due to increasing drug costs and increased side effects in comparison with selective alpha blockers, there is a renewed
interest in studying alternatives to phenoxybenzamine.
Selective alpha blockers such as doxazosin are also commonly used to alpha block patients prior to pheochromocytoma resection. Selective alpha
blockers are significantly less expensive and are associated with fewer side effects than phenoxybenzamine. Most retrospective studies comparing
phenoxybenzamine with selective alpha blockers show no difference in intraoperative blood pressure fluctuations, morbidity, or mortality in
pheochromocytoma resection.
The purpose of our study is to analyze preoperative, intraoperative, and postoperative outcomes in patients undergoing pheochromocytoma
resection. We will compare a prospective group of patients who receive doxazosin (selective) for alpha blockade prior to surgery to a retrospective
group of patients who received phenoxybenzamine (non-selective). Outcomes will include postoperative morbidity and mortality, intraoperative
hemodynamic instability, quality of life, and cost.
2.0
*List three to five keywords describing this study (separate the words with commas).  The keywords may be used for identifying certain
types of studies.
pheochromocytoma, alpha blocker, randomized controlled trial
3.0
* Is this study conducted or supported by HHS (e.g., the National Institutes of Health, Centers for Control and Prevention, etc.)?
Yes
No
4.0
* Is this study regulated by the Food and Drug Administration (FDA)?
Yes
No
If yes, check all that apply:
Human Drugs
Medical Devices
Biological Products
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Food Additives
Color Additives
Other
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trigger additional questions related to the research or are needed for the review process
1.0
*Indicate all that apply to this study. 
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Clinical Trial of a Drug, Biologic, Device or a Behavioral Intervention
Community Based Research
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Human Embryonic Stem Cells and/or Induced Pluripotent Stem Cells
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Infectious Agents
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Radiation (Standard of Care or Investigational Use of radioactive materials, radiation producing machines or ionizing radiation)
Substance Abuse Research (with Medication)
Treatment in an Emergency Setting (with request to waive consent)
None of the above
2.0
*Will the study require services or resources owned/rented/operated or provided by the UCLA Health System (e.g.
clinic and/or hospital visit(s), CTRC, professional medical services, clinical treatment, diagnostics, labs, medical
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Please direct any questions about this to The Financial Coverage & Activation Team at
coverageanalysis@mednet.ucla.edu.
Yes
No
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Funding and Other Study Characteristics
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Application for funding is pending
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2.0
*Check all that apply:
The research will be conducted through the UCLA Clinical and Translational Research Center (CTRC)
The study will be supported by or conducted in collaboration with the U.S. Department of Defense (DOD)
The study will be supported by or conducted in collaboration with the U.S. Department of Energy (DOE)
The study will be supported by or conducted in collaboration with the U.S. Department of Justice (DOJ)
The study will be supported by or conducted in collaboration with the U.S. Department of Education (ED)
The study will be supported by or conducted in collaboration with the U.S. Department of Protection Agency (EPA)
None of the above
If you selected DOD, DOE, DOJ, ED, and/or EPA
support/collaboration, please provide your assurances that
you will review the additional requirements for research
supported by the relevant federal agency.
Agree
Note: Please refer to the Federally-Supported Research section
of the OHRPP guidance document: Funding Considerations for
Federally-Funded and Industry-Sponsored Human Research.
ID: IRB#17-000048
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Study Design
1.0
*Check all that apply to the study design.
Direct subject contact ONLY – The research activities involve direct contact with study participants (e.g., collection of data or specimens in
person or via internet, phone, mail, etc.)
No direct subject contact – None of the research activities involve direct contact with study participants and include only analyses of data,
records and/or human biological specimens (e.g., medical record or other record review, study of specimens left over from clinical
procedures).
BOTH Direct subject contact AND No direct subject contact – Some of the research activities involve direct contact with study
participants and some of the research activities involve analyses of data, records and/or human specimens obtained without
contact with participants.
ID: IRB#17-000048
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Drugs/Biologics/Dietary Supplements
You indicated that this study includes drugs/biologics/dietary supplements (section 2.3/item 1.0). Please provide the following information.
1.0
Approved Drugs or Biologics:  List any drugs or biologics that will be used in this study in accordance with their approved labeling.
The UCLA Pharmacy will not dispense drugs that have been procured from an external pharmacy or compounding pharmacy.  Contact
the UCLA Pharmacy - Investigational Section at (310) 267-8522 if you require a compounded drug for the study.
Phenoxybenzamine, doxazosin
2.0
Enter any drugs/biologics that will be used as part of this study that do not fit in response to item 1.0 above. 
Generic name of the drug/biologic
Investigational Drug/Biologics Information
There are no items to display
3.0
All drugs and biologics for research at UCLA are to be managed through the UCLA Pharmacy.  Provide your
assurance that you have or will submit an Investigational Drug Study application to the Pharmacy.
Agree
ID: IRB#17-000048
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Information about Study Data
This information is needed to determine how you will best protect the confidentiality of data.
1.0
*Indicate all that apply to the study data.
Check all that apply:
Obtained from a medical or clinical record
Created or collected as part of health or mental health care
Used to make healthcare or mental healthcare decisions and/or provided to other healthcare professionals
Research data will be entered into the participants' medical or clinical record
None of the above
2.0
*Is it reasonably foreseeable that the study will collect information that State or Federal law requires to be reported to other officials (e.g.,
child or elder abuse), ethically requires action (e.g., suicidal ideation), or is a reportable disease?
Yes
No
If yes, explain below and include a discussion of the
reporting requirements in the consent document:
3.0
*Indicate if any of the following are being obtained and used without any direct contact with study participants.
Records (Not medical)
Human biological specimens
None of the Above
4.0
*Indicate all identifiers that may be accessed or included in the research records for the study:
Names
Dates
Age (if over 89 years)
Postal Address
Phone Numbers
Fax Numbers
E-Mail Address
Social Security Number
Medical Record Number
Health Plan Numbers
Account Numbers
License/Certificate Numbers
Vehicle ID Numbers
Device Identifiers/Serial Numbers
Web URLS
IP Address Numbers
Biometric Identifiers (including finger and voice prints)
Facial Photos/Images
Any Other Unique Identifier (this does not include the code assigned by the investigator to identify the data)
None of the above
If social security numbers will be collected explain why they
are necessary, how they will be used, how they will be
protected and how long they will be retained.
5.0
*Select all that apply:
The data and/or specimens will be directly labeled with personal identifying information when acquired by the investigator for this
research
The data and/or specimens will be labeled with a code that the research team can link to personal identifying information when acquired by
the investigator for this research
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the investigator for this research
The data and/or specimens will not be labeled with any personal identifying information, nor with a code that the research team can link to
personal identifying information when acquired by the investigator for this research
The data are restricted use data (A term used in Social-Behavioral research. See guidance on the right.)
Indicate how the data will be used when this study
is completed.
Check all that apply:
Use for this study
Use for possible future research
Use to create a bank or repository at UCLA
Add to existing repository
Other
If Other, specify:
ID: IRB#17-000048
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Privacy and Confidentiality
Important Notes:
·
Privacy is about people. Privacy refers to a person's wish to control the access of others to themselves. 
·
Confidentiality is about data. Confidentiality refers to the researcher's plan to handle, manage, and disseminate the
participant's identifiable private information.
See OHRPP Quick Guide: Protecting Privacy and Maintaining Confidentiality
1.0
*Privacy: How will the investigator maintain privacy in the research setting(s)?
(e.g., interviewing participant in a room or area where conversations cannot be overheard by others, or conducting medical procedures in
an examination room, or behind a curtain in an emergency room).
All activities which include direct patient contact with be conducted as part of our usual standard of practice. The study will be discussed with
potential participants in a private room or area where conversations cannot be overheard by others.
2.0
*Confidentiality:  If the protocol will collect and maintain identifiable data, explain how the planned safeguards to maintain confidentiality
of identifiable data and data security are appropriate to the degree of risk from disclosure.
Note: Other sections of the application (e.g., Sections 9.3, 9.3a, 9.4, 9.5, and 15.3) will request specifications such
as identification of persons who will have access to code keys or measures to comply with HIPAA requirements.
The data will be encrypted and stored in REDCap. Access to the REDCap database will be restricted to study investigators.
ID: IRB#17-000048
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Data Security
You indicated that the study team will have access to personally identifiable or coded information (Section 9.2/item 5).  Please complete the following items.
1.0
*Do you agree to follow the OHRPP Data Security in Research guidance and procedures?
Yes
I have an alternate equally effective plan (Note: The plan must be attached to item #2.1)
2.0
*Do you have a data security plan for this study? (Note: a plan is not required for all studies; it may be recommended in some instance).
Yes
No
If yes, attach it here:
Document Name
Document Version #
Redcap
0.01
3.0
*Indicate all that apply to personally identifiable information or codes during conduct of the study:
The data and/or specimens will be coded
The personal identifying information will be removed and destroyed
Personally identifying information will be maintained with the data and/or specimens
If you indicated that the personal identifying information will
be removed or destroyed or that the data/specimens will be
coded, provide the following information:
◦ The process for removing and destroying the personal
identifying information or for coding the information, and
◦ Indicate who will perform the task
Data will be stored on RedCap utilizing a non-identifying record
ID. Associated personal identifying information including Name,
MRN, and date of birth, etc. will be destroyed at the end of the
study by study personnel.
4.0
*Will coded or personally identifiable data be collected, transmitted or stored via the internet?
Yes
No
If yes, indicate all that apply:
A mechanism such as Survey Monkey, Zoomerang, or an
e-mail anonymizing service will be used to strip off the IP
addresses for data submitted via e-mail.
The data will be encrypted.
A firewall will be used to protect the research computer from
unauthorized access.
Controlled access privileges will be used on the hardware
storing the data.
Other.
If you indicated "Other", describe:
5.0
*Provide your assurances that if there is a data security breach for this study, the PI will notify the IRB and your department's IT
Compliance Coordinator.
Agree
ID: IRB#17-000048
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Data Security Plan - During the Study
You indicated that data and/or specimens for this study will be coded (Section 9.3/item 3).  Please complete the following information.
1.0
During the study indicate how data will be stored and secured including paper records, electronic files, audio/video tapes, specimens.  Specify
how the code key will be securely maintained, as applicable.
Check all that apply:
*Electronic Data
Encryption or password protection software will be
used
Secure network server will be used to store data
Stand alone desktop computer will be used to store data
(not connected to server/internet)
A contracted outside vendor will store the code key. The
vendor will have a business associate agreement with
UCLA.
Other
Not Applicable
*Hardcopy Data, Recordings and Specimens
Locked file cabinet or locked room with limited access
by authorized personnel
Locked lab/refrigerator/freezer with limited access by
authorized personnel
The code key will be kept in a locked file in a locked room
The coded data and/or specimens will be maintained in a
different room
Other
Not Applicable
If you indicated "Other" in item 1.1 or 1.2 above, describe
here.
2.0
*By checking this box, I provide my assurance that all the person(s) who will have access to the code key have been identified in section
1.1 or section 1.1a.
Agree
ID: IRB#17-000048
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Data Security Plan
You indicated that the study will have access to personally identifiable or coded information (Section 9.2/item 5).  Please complete the following items:
1.0
*After the study is completed, indicate how the data codes and/or personal identifying information will be handled. 
Check all that apply:
All data files will be stripped of personal identifiers and/or the key to the code destroyed.
All specimens will be stripped of personal identifiers and/or the key to the code destroyed.
Personal identifiers and/or codes linking the data and/or specimens to personal identifiers will be maintained for future research.
Audio or Video recordings will be transcribed and then destroyed or modified to eliminate the possibility that study participants could be
identified.
Photos or Images will be modified to eliminate the possibility that study participants could be identified.
Restricted use data will be destroyed or returned to the source.
If you indicated that personal identifiers will be maintained
for future research, provide the following information:
  a) How the information will be securely handled and stored
  b) assure confidentiality, and
  c) who will have access to the identifiers and/or codes.
Once the research described in this study is completed, we will
destroy the key linking patient names and identifiers to the data
used for analysis. The de-identified data or spreadsheet used for
analyses will be retained for 1-2 years after the study results are
published.
2.0
Describe any additional steps, if any, to be taken to assure that the subjects' identities and any personal identifying information are kept
confidential.
ID: IRB#17-000048
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Use of Data and/or Specimens without Direct Contact
You indicated that some or all of the research activities do not involve direct contact with study participants (Section 8.1/item 1.0).  Please provide the
following information.
1.0
If all of your research activities are without direct contact with study participants, provide the following information:
Indicate the purpose of the research, specifying the
problems and/or hypotheses to be addressed:
The purpose of our study is to analyze preoperative,
intraoperative, and postoperative outcomes in patients treated
with selective (doxazosin) or non-selective (phenoxybenzamine)
alpha blockade prior to pheochromocytoma resection. Outcomes
will include postoperative morbidity and mortality, intraoperative
hemodynamic instability, quality of life, and cost.
We hypothesize that doxazosin is not inferior compared to
phenoxybenzamine in terms of postoperative morbidity and
mortality, intraoperative hemodynamic instability, quality of life,
and cost.
Describe the study design and proposed data analyses:
Given the difficulty in randomizing patients (high cost of
phenoxybenzamine has caused a large portion of patients
crossing over to the doxazosin arm, resulting in unbalance
between the number of patients in each arm), patients who have
been pre-treated with doxazosin before pheochromocytoma
resection prospectively followed during the course of this study
will be compared to a retrospective group of patients who were
pre-treated with phenoxybenzamine.
Descriptive statistics including mean, median, standard
difference, and frequencies will be calculated for each of the
variables measured.
Differences in hemodynamic instability as indexed by specific vital
sign parameters, ICU length of stay, inpatient length of stay,
morbidity, mortality, cost, and quality of life will be analyzed with t
tests or non-parametric tests as appropriate.
*If you will conduct genetic analysis with specimens, provide
your assurance that the results will not be disclosed to
subjects or used for clinical care.
Agree
Not Applicable
2.0
*Describe specimens and/or data that will be acquired without direct contact with study participants.  Complete this item for each type
used in the study:
Source
Data and/or Specimens Information
View UCLA
medical
records
Data and/or Specimens? Indicate all that
apply:
Data 
Indicate whether the data and/or
specimens are pre-existing, at the time of
this study, and/or if collection will be
prospective:
Pre-existing 
Describe the data and/or specimens and
indicate the original collection dates:
Electronic medical records from patients undergoing adrenalectomy for
pheochromocytoma or paraganglioma from January 1, 2015 to present. Please
see item 4.0 for further details on data to be collected from the EMR. 
Indicate the approximate number of data
records and/or specimens to be collected:
50 
Will the specimens be used with animals?
No 
If yes, indicate the IACUC Number:
No Value Entered
3.0
*If any sources of data and/or specimens are not at UCLA, provide your agreement that the appropriate
institutional approvals for release will be obtained (e.g., IRB approval).
Agree
1.1
1.2
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Not Applicable
If you plan to send UCLA Health data to third parties, please contact the CTSI for directions about additional requirements.
https://www.ctsi.ucla.edu/researcher-resources/pages/third_party
4.0
Attach any data abstraction tools or lists with the data elements to be collected.
Document Name
Document Version #
Study variables
0.01
If you will access information from UCLA Health records, attach a copy of your completed UCLA EHR Data Abstraction template for
research. For more information see: https://ctsi.ucla.edu/researcher-resources/pages/datarequests
ID: IRB#17-000048
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Data and/or Specimens for Possible Future Use
You indicated that prospectively collected data and/or specimens would be stored for future use (Section 9.2/item 5.1). Please provide the following
information.
1.0
*Specify what information directly or indirectly linked to the subject will be provided with data and/or specimens
to other investigators. 
Check all that apply:
No subject identifiers (The data/specimens are anonymous; no one including the investigator could identify the person from whom the
materials were gathered.)
The data will be coded (A code links the data/specimens to the study participants. A key to the code exists.)
Personal Identifying Information
Not applicable, the data will not be shared outside the study team.
2.0
Distribution Rules:  Describe the criteria used to determine the adequacy of requests to obtain data and/or specimens (e.g., the type of
researchers that will be eligible to receive data):
ID: IRB#17-000048
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Study Summary - Research Study
1.0
Study Materials:  As applicable to this study, attach the following:
• Protocol, Dissertation Proposal or Study Plan
• Preliminary Data 
• Surveys, Questionnaires or other instruments to be used with study participants
• References
Document Name
Document Version #
Alpha blockade in pheochromocytoma RCT survey draft.pdf
0.01
Kiernan-2014-Predictors of hemodynamic instabi.pdf
0.01
Medication and Blood Pressure Log v2.docx
0.01
Protocol for Preoperative Alpha Blockade Titration V2.docx no comments.docx
0.02
Prys-Roberts-2002-Efficacy and safety of doxaz.pdf
0.01
Randle-2016-Selective Versus Non-selective alp.pdf
0.01
Study variables
0.01
Timeline.docx
0.01
Weingarten-2010-Comparison of two preoperative.pdf
0.01
2.0
*Specific Aims: Indicate the purpose of the research, specifying the problems and/or hypotheses to be addressed.
The purpose of our study is to analyze preoperative, intraoperative, and postoperative outcomes in patients treated with selective (doxazosin) or
non-selective (phenoxybenzamine) alpha blockade prior to pheochromocytoma resection. Outcomes will include postoperative morbidity and
mortality, intraoperative hemodynamic instability, quality of life, and cost.
3.0
*Background and Significance: Provide a summary of the background for this study and explain how it will
contribute to existing knowledge. 
For greater than minimal risk biomedical studies, include preliminary data.  If necessary, attach in Item 1.0 graphs
or tables used to convey information.  If there no preliminary data are available, briefly indicate why this proposed
study is a reasonable starting point.
Pheochromocytoma is a catecholamine (ex. adrenaline) secreting tumor for which the primary treatment is surgical resection. Due to the hormones
secreted by the tumor, alpha receptors on peripheral blood vessels are activated, causing constriction of these blood vessels and dangerously high
blood pressure. During resection of the tumor, the source of excess hormone secretion is abruptly removed, which can lead to life-threatening low
blood pressure in the absence of preoperative alpha blockade.
Alpha blockers are a class of drug that blocks the alpha receptor on blood vessels. Given preoperatively over a few weeks, these drugs negate the
effects of the excess hormones secreted by the pheochromocytoma, reducing the frequency and severity of dangerous blood pressure fluctuations
intraoperatively and postoperatively. Preoperative alpha blockade is therefore critical to safely perform surgery to resect pheochromocytoma.
Phenoxybenzamine, a non-selective alpha blocker, is the most commonly used drug used to alpha block patients prior to pheochromocytoma
resection. However, due to increasing drug costs and increased side effects in comparison with selective alpha blockers, there is a renewed
interest in studying alternatives to phenoxybenzamine.
Selective alpha blockers such as doxazosin are also commonly used to alpha block patients prior to pheochromocytoma resection. Retrospective
studies comparing phenoxybenzamine with selective alpha blockers suggest that the use of selective alpha blockers does not lead to additional
morbidity or mortality in pheochromocytoma resection. However, no prospective, randomized controlled trials comparing phenoxybenzamine to
selective alpha blockers have been performed.
Our study to our knowledge will represent the first prospective, randomized controlled trial comparing selective and non-selective alpha blockade in
resection of pheochromocytoma.
4.0
*Research Design and Methods: Describe in detail the design and methodology of the study.
PATIENT ACQUISITION. All patients referred to the UCLA Department of Surgery requiring surgical resection of pheochromocytoma or
paraganglioma will be counseled about surgery and the necessity for preoperative alpha blockade. The benefits and risks of the study will
discussed, and the patient will be given the opportunity to enroll. Upon obtaining informed consent regarding enrollment in the study, the patient will
be randomized to either receive preoperative blockade with either phenoxybenzamine or doxazosin.
PREOPERATIVE PREPARATION. The patient will then be referred to the UCLA Preoperative Evaluation and Planning Center (PEPC) for
preoperative planning and optimization by an attending anesthesiologist. Additional testing such as echocardiography or stress testing will be
pursed in accordance with preoperative risk-stratification in the standard fashion. A few weeks prior to surgery, the patient will initiate preoperative
alpha blockade with the drug as determined by randomization. The drug will be titrated to a blood pressure of 120-130/80-85 in the standard
fashion. Adjunctive beta blockers or calcium channel blockers may be initiated at the discretion of the physician.
Titration will be performed utilized the attached log ("Medication and Blood Pressure Log"), which will be emailed to the patient and will be returned
by the patient by email every 2 days. The patients sitting and standing blood pressure will be used to titrate their alpha blocker dosage to pre-
specified targets as noted in the original IRB proposal. Heart rate will be logged to determine whether the patient requires adjunctive
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specified targets as noted in the original IRB proposal. Heart rate will be logged to determine whether the patient requires adjunctive
antihypertensive medications such as beta blockers or calcium channel blockers. This titration will take place over a period of 2-3 weeks. Once the
patient's alpha blockade titration is complete, the log will be saved in a secure, encrypted server and will be linked with the patients record using
non-identifying record ID.
INTRAOPERATIVE PROTOCOL. Intraoperative hemodynamic monitoring will be conducted in the standard fashion, and a phenylephrine dose
response curve will be generated by titration with phenylephrine to estimate the ED30 and therefore the effectiveness of the blockade. Surgery will
proceed in the standard fashion. Times of induction, tumor manipulation, and adrenal vein ligation will be recorded. Vasopressors will be used at
the discretion of the anesthesiologist.
POSTOPERATIVE PROTOCOL. Patients will be taken to the PACU for routine postoperative care. Admission to the surgical ICU will be performed
at the discretion of the attending anesthesiologist and surgeon.
QUALITY OF LIFE / DRUG ADVERSE EFFECTS. Data regarding patient health related quality of life and drug adverse effects will be collected at
five time points pre-blockade, post-blockade, and postoperatively at 3 months, 6 months, and 1 year. Health related quality of life data will be
assessed utilizing the Short Form-36. Patients will be queried to specific adverse effects such as nasal congestion, headaches, palpitation, as well
as their frequency and level of distress caused. Surveys will be complete in person during routine encounters or over the phone.
COST. Preoperative drug costs will be determined using the average wholesale price per unit multiplied by the number of units taken by the
patient. Enrollment of the patient in Medicare and Medicare part D will be noted. Data regarding out of pocket drug costs will be collected. Inpatient
costs will be calculated utilizing patient charges and the application of a charge to cost ratio.
* Will you be providing results of any experimental tests that
are performed for the study?
Yes - Complete Items 4.1.1 and 4.1.2
No
Not Applicable
You indicated in Item 4.1 that the research involves
experimental tests.  Please describe the tests, provide a
rationale for providing participants with the experimental test
results and explain what, how and by whom participants and
their health care provider will be told about the meaning,
reliability, and applicability of the test results for health care
decisions.
Will tests be performed by a Clinical Laboratory
Improvement Amendments (CLIA) approved lab?
Yes
No
5.0
*Indicate how much time will be required of the subjects, per visit or contact, and in total for the study. 
The time required of study subjects will includes time that will be standard for the care of the patient and unrelated to participation of the study. This
involves preoperative evaluation by a surgeon (30 minutes) and anesthesiologist (30 minutes), inpatient surgery and routine inpatient postoperative
care (average length of inpatient stay 2-3 days), and postoperative follow up (30 minutes).
Additional time required of the study subjects as related to the study would involve 5 questionnaires administered in person or by phone at the time
points outlined above, with each administration of the survey taking approximately 5 minutes.
6.0
*Statistics and Data Analysis: Describe the proposed statistical procedures or descriptive analyses for the study. 
If applicable, indicate how the sample size was determined.
Descriptive statistics including mean, median, standard difference, and frequencies will be calculated for each of the variables measured.
Differences in hemodynamic instability as indexed by specific vital sign parameters, ICU length of stay, inpatient length of stay, morbidity, mortality,
cost, and quality of life will be analyzed with t tests or non-parametric tests as appropriate.
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Characteristics of the Study Population
1.0
*Is this an observational or ethnographic study for which the number of participants observed or interviewed cannot be determined in
advance.
Yes
No
2.0
If you answered "no" to item 1.0, indicate the maximum number of study participants you hope to enroll: 
62
3.0
How many participants do you expect you will need to recruit, consent and/or screen to meet the target number above?
73
4.0
*Indicate the specific inclusion criteria for enrollment of each of the groups of research participants in this study. 
If there are any inclusion criteria based on gender, pregnancy/childbearing potential, race, ethnicity or language spoken, explain the
nature of and scientific rationale for the inclusions.
Inclusion criteria include:
(1) Diagnosis of pheochromocytoma or paraganglioma as evidenced by appropriate biochemical evaluation and imaging.
(2) Surgical resection recommended.
(3) Patients aged 12 and older.
5.0
*Indicate the specific exclusion criteria for each of the groups of research participants in this study.
If there are any exclusion criteria based on gender, pregnancy/childbearing potential, race, ethnicity or language
spoken, explain the nature of and scientific rationale for the exclusions.
None.
6.0
*How (chart review, additional tests/exams for study purposes, etc.), when and by whom will eligibility be determined?
Eligibility for the study will be evaluated during the time of surgical consultation by review of prior medical records including biochemical tests and
imaging by the attending surgeon.
We expect 100% of patients evaluated for pheochromocytoma resection will be eligible for the study.
Assuming an enrollment rate of 85%, 73 patients will have to be screened to meet our target sample size of 62 patients.
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Characteristics of Study Population
1.0
*Indicate the age range of the study participants.
Check all that apply:
0 to 6 years
7 to 11 years
12 to 17 years
17 or younger in California who can consent for themselves - see note below
17 or younger outside California who can consent for themselves - see note below
18 years or older
NOTE:
• For additional information on minors in California who are permitted to consent for themselves please refer to the section "Legal
Exceptions Permitting Certain Minors to Consent" in the OHRPP Guidance document, Child Assent and Permission by Parents or
Guardians
• For additional information on minors outside of California who are permitted to consent for themselves please refer to the section
"Exceptions Outside of California" in the OHRPP Guidance document, Child Assent and Permission by Parents or Guardians
2.0
*Indicate if any of the following populations/specimens will be specifically recruited/obtained for the study.
Adults who are competent to give informed consent
Adults unable to give informed consent
Adults with diminished capacity to consent
Fetal Tissue
Neonates
Participants Unable to Read, Speak, or understand English
Pregnant Women/Fetuses
Prisoners
UCLA Faculty/Staff
UCLA Students
Wards
Unknown/Not Applicable
3.0
* Is it possible that there may be non-English speakers enrolled in this study or children whose parents are non-English speaking?
Yes
No
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Children (Minors)
You indicated that children will participate in the study (Section 11.2/item 1.0). Please provide the following information.
1.0
*Choose the description that is applicable to this study: 
The research does not involve greater than minimal risk (45 CFR 46.404/21 CFR 50.51)
The research involves greater than minimal risk, but presents the prospect of direct benefit to individuals (45 CFR 46.405/21 CFR
50.52)
The research involves greater than minimal risk and no prospect of direct benefit to individual subjects, but it likely to yield generalizable
knowledge about the subject's disorder or condition (45 CFR 46.406/21 CFR 50.53)
The research does not fall under any of the above categories, but presents an opportunity to understand, prevent, or alleviate a serious
problem affecting the health or welfare of children. (note: after IRB review, studies in this category must be sent to the Secretary, HHS for a
determination)(45 CFR 46.407/21 CFR 50.54)
2.0
If you selected more than one description, indicate the groups of children involved in the study and the category for each group. 
3.0
*Provide justification for involving Minors in this research (check all that apply).
The primary focus of the study is children and/or adolescents
This is a study about a disease or condition that specifically affects children
Other
If you checked "other," describe.
This is a study about a disease or condition that affects both
adults and children.
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Risks & Benefits
Benefits
1.0
*Are there any potential direct benefits (physical, psychological, social or other) to study participants? 
Yes
No
If yes, describe.
2.0
*Describe the potential benefits to society including the importance of the knowledge to be gained.
Currently, the evidence regarding selective vs. non-selective alpha blockade prior to pheochromocytoma resection is based retrospective data. No
prospective, randomized controlled trials have been performed. The potential benefits to society of a prospective, randomized controlled trial of
selective vs. non-selective alpha blockade prior to pheochromocytoma resection include those related to patient cost and quality of life.
(1) Cost. The cost of prescription drugs in the United States is increasing, with the cost of some drugs increasing by over 1000% in the last
decade.[1] Currently, the maximum listed wholesale price per unit of phenoxybenzamine is $197.79 in contrast to $1.42 for doxazosin[2]. In our
anecdotal experience, an increasing number of patients are unable to afford phenoxybenzamine for preoperative alpha blockade prior to
pheochromocytoma resection. As current studies show no differences in morbidity and mortality between selective and non-selective alpha
blockade prior to pheochromocytoma resection, doxazosin is likely to represent a clinically equivalent option associated with significant cost
savings.
(2) Quality of life. Phenoxybenzamine is a long-acting, non-competitive, non-selective alpha blocker that crosses the blood brain barrier, causing
centrally mediated side effects including headaches and sedation that limit the medication's tolerability. Patients who receive doxazosin in
comparison to phenoxybenzamine prior to pheochromocytoma resection less frequently experience postural hypotension, nasal stuffiness, and
headache.[3] In addition to being cost effective, doxazosin may also be associated with increased health related quality of life while receiving alpha
blockade.
Overall, current retrospective data suggest that selective alpha blockade is as effective as non-selective blockade in addition to being less costly
and associated with less frequent adverse effects. A randomized controlled trial demonstrating this will result in societal cost savings and increased
health related quality of life in patients undergoing pheochromocytoma resection.
[1] Kesselheim AS, Avorn J, Sarpatwari A. The High Cost of Prescription Drugs in the United StatesOrigins and Prospects for Reform. JAMA.
2016;316(8):858-871. doi:10.1001/jama.2016.11237
[2] http://micromedex.com/Portals/1/Assets/AWP%20Policy_Oct%202014.pdf
[3] Prys-Roberts C, Farndon JR. Efficacy and safety of doxazosin for perioperative management of patients with pheochromocytoma. World J Surg.
2002;26(8):1037-1042.
Risks
3.0
*Indicate the potential risks/discomforts, if any, associated with each intervention or research procedure.
Additionally discuss any measures that will be taken to minimize risks.  If data are available, estimate (a) the
probability that a given harm may occur, (b) its severity, and (c) its potential reversibility.  The information
provided should be reflected in risks section of the informed consent documents.
If this is an exempt study and there are no risks, indicate N/A.  Otherwise, please see the help text.  
The potential risks of the study include the following:
LOSS OF CONFIDENTIALITY: Although patient identifiers and data will be stored on a secure server with limited access, basic contact information
such as the patient's name, address, and telephone number may be at risk if the server is compromised.
STANDARD OF CARE DRUG RISKS: Since both drugs are standardly used to prepare patients for pheochromocytoma surgery, participating in
this research study will not expose patients to additional risks beyond what is considered standard of care. Studies comparing phenoxybenazime
and doxazosin have mostly shown no difference in blood pressure fluctuations during surgery.
Risk/Benefit Analysis
4.0
*RISKS/BENEFIT ANALYSIS: Indicate how the risks to the participants are reasonable in relation to anticipated benefits, if any, to
participants and the importance of the knowledge that may reasonably be expected to result from the study:
Current retrospective data suggest that selective alpha blockade is as effective as non-selective blockade in addition to being less costly and
associated with less frequent adverse effects. A randomized controlled trial demonstrating this will result in societal cost savings and increased
health related quality of life in patients undergoing pheochromocytoma resection.
Alternatives
5.0
*Indicate the alternatives to participating in this study. 
Check all that apply.
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All types of studies - Choose not to participate in the study
Clinical/Intervention Studies - Receive standard of care instead of participating in the study
Clinical/Intervention Studies - Medication, device, or other treatment is available off study
Item is Not Applicable (e.g., study of existing data)
Other
If "other" was selected, specify.
If this is a clinical/intervention study:
Describe the standard of care or activities at UCLA (or study
site) that are available to prospective participants who do not
enroll in this study.  If not applicable to your study, state not
applicable (N/A).
ID: IRB#17-000048
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Data & Safety Monitoring Plan
1.0
*Is a Data and Safety Monitoring Plan (DSMP) required by the funding agency or other entity? 
Yes
No
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Data & Safety Monitoring Plan (continued)
Important Note:
All interventional studies involving more than minimal risk must include a Data and Safety Monitoring Plan (DSMP).  A DSMP is a plan established to
assure that each research study has a mechanism for appropriate oversight and monitoring of the conduct of the study to ensure the safety of participants
and the validity and integrity of the data.  The DSMP should indicate specifically whether or not there will be a formal Data Safety Monitoring Board (DSMB)
or Data Monitoring Committee (DMC).
Most, but not all studies (i.e., non-interventional studies) undergoing full board review will require a DSMP.  You will need a DSMP if any of the following
apply:
1.  This is a Phase I, II or III clinical trial 
2.  This is an investigator initiated trial (Section 2.1/item 3.0)
3.  This study involves treatment in an emergency setting (Section 2.3/item 1.0)
4.  A Data/Safety Monitoring Plan is required by the funding agency (Section 15.1/item 1.0)
5.  This study is greater than minimal risk (Section 1.1b/item 1.0)
1.0
*Indicate who will be responsible for overseeing the study safety. Check all that apply.
The Principal Investigator
Designee of the Principal Investigator
The DSMP includes at least one person who is not associated with the study
A formally constituted Data and Safety Monitoring Board (DSMB)
Medical monitor designated by the sponsor
Other
If you indicated that a designee would be responsible for
overseeing the study safety, or that the DSMP would include
at least one person not associated with the study, provide
the name(s) of this individual (s). Also, provide a brief
explanation of why this person(s) would be appropriate in
this role(s).
If you indicated "other," describe or indicate where the
information can be found in the attached protocol.
2.0
*Provide your assurance that information about serious, unanticipated problems related to the study (e.g., adverse events, incidents and
violations) will be reported to the IRB within the time frames specified by the Summary Sheet of Reporting Requirements.
Agree
Provide the following information as appropriate to the study:
3.0
*Are there plans to perform an interim safety analysis? 
Yes
No
If yes, describe or indicate where the information can be
found in the attached protocol.
Interim safety analysis will be performed at the point at which
50% of the targeted cohort has been followed-up for 30 days.
4.0
*Have stopping rules been established for the study?
Yes
No
If yes, describe or indicate where the information can be
found in the attached protocol.
The primary outcomes that will be compared at the interim safety
analysis include postoperative morbidity as manifested by rates of
stroke and myocardial infarction as well as postoperative mortality
within 30 days. Rates of stroke, myocardial infarction, and
mortality will be compared with the chi square test and the study
will be stopped if a significant difference is found with a threshold
of P < 0.05.
5.0
*Are there defined rules for withdrawing participants from study interventions?
Yes
No
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Yes
No
If yes, describe or indicate where the information can be
found in the attached protocol.
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Payment, Costs, and Injury
1.0
*Indicate what the participants will receive for their participation in the study. 
Check all that apply.
No payment will be provided
University check
Course Credit
Cash
Gift Cards/Bruincard Deposit
Non-Monetary Gifts or Services
Other (including vouchers for parking)
If you selected Non-Monetary Gifts or Services or Other,
describe:
If you selected Cash and/or Gift Cards/Bruincard Deposit
please specify the estimated total amount of money you will
require to pay all participants during the length of the entire
study.  This information is required by UCLA Business and
Finance Services (BFS), the office that will provide the
cash/gift cards for payment.
2.0
If study participants will receive financial or other payment for their participation in the study, please
provide the following information:
-
If applicable, the amount each participant will receive and the payment schedule to be followed including
whether partial payment will be provided when the participant does not complete the study.
-
If there are different plans for different populations or sub-studies, specify the groups and describe the plans.
-
If families or children will be involved in the research, clarify how the payments, items or services will be
apportioned.
3.0
*Will subjects incur any financial obligations from participation in the study? 
Yes
No
If yes, describe:
4.0
*Indicate below that you are familiar with UCLA policy related to treatment and compensation for injury and that you will use in the
consent form for this study the appropriate UC required statement describing "Treatment and Compensation for Injury."  Click here to
access the UCLA policy:  Treatment and Compensation for Research Related Injury.
Note: Select Not Applicable if study is minimal risk.
Agree
Not Applicable
ID: IRB#17-000048
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HIPAA Authorization
According to your responses to section 9.2/item 1.0, this study uses protected health information. Please provide the following information.
1.0
*Indicate all that apply to use of or disclosure of PHI in this study: 
All UC participants will sign a UC HIPAA Research Authorization for Release of Personal Health Information for Research.
Another Institutions' Healthcare Authorization for Release of Health Information will be used or a waiver for release of health information
will be granted from another Institution.
A Waiver of HIPAA Research Authorization is requested for screening using UC medical records. I assure that the PHI collected for
this study will not be reused or disclosed, except as indicated in this application.
A Total Waiver of HIPAA Research Authorization is requested for the entire study. I assure that the PHI collected for this study from
UC records will not be reused or disclosed, except as indicated in this application.
Limited Data Set with a Data Use Agreement will be obtained from UC medical records. I assure that I will follow the data security plan
outlined in this application to protect the identifiers from improper use or disclosure.
None of the above. This study will be conducted outside the United States
If you will access information from UCLA Health records, additional permissions are required. These permissions are described at:
https://ctsi.ucla.edu/researcher-resources/pages/datarequests
Please identify the persons who will access UC
Health records:
CTSI Informatics Program Staff (https://ctsi.ucla.edu
/researcher-resources/pages/datarequests)
Key personnel listed in Section 1.1/5.0
2.0
*Indicate to whom or where you will grant access to personal identifying information (including PHI) as part of the study process:
There is no plan to share identifiers outside the study team
The study sponsor; on site only (if there is more than one study sponsor, specify below).
A foreign country or countries
Other
If you checked "other", "a foreign country or countries", or if
"there is more than one sponsor", specify.
3.0
*The investigator's agreement is needed to the following: 
- The protected health information requested is the minimum necessary to meet the research objectives
- The protected health information that is obtained as part of this study will not be used or disclosed to any other person other
than study personnel or to the parties listed in item Section 17.1/item 2, except as required by law.
- Study Sponsors will not be provided with personal identifying information (including PHI) to take from the study site at any
time, including the end of the study.
- Data and specimens shared with outside entities, such as study sponsors, will be coded or de-identified.
Agree
ID: IRB#17-000048
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HIPAA - Waiver of Authorization
According to your responses to Section 17.1/item 1, a waiver of authorization is requested. Please provide the following information.
In addition to the information that will be requested later in this application for a waiver of informed consent, HIPAA requires the following information for a
waiver of authorization:
1.0
*Indicate why the research could not be practicably conducted without access to and use of the protected health information.
Check all that apply.
The PHI is needed to identify potential participants with a specific medical condition
It would not be feasible to individually contact the large numbers of potential subjects in the study
It would not be possible to locate many of the individuals whose records would be used for the study
Many of the individuals, whose records would be used for the study, are now deceased
Other
If you checked "other", specify.
ID: IRB#17-000048
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Identification/Recruitment Methods
1.0
*How will you identify and/or recruit participants for this study.
Check all that apply:
Advertisements/Flyers/Information Sheet/Internet Postings
Direct recruitment of potential study participants (e.g., physicians talking with their own or clinic patients about the study, contact
between the study team and potential subjects in person, on the phone or on the internet, etc.)
Random or Other Probability Sampling
Recruitment Letters/Emails
Referrals (e.g., referrals from non-investigator healthcare providers, snowball sampling, participants referring other participants, etc.)
Review of medical records to identify potential research participants
Review of publicly available records
Review of other records
Participant pool for which potential research participants have given permission for future contact
Potential Study Participants are identified from another IRB approved study or IRB approved screening protocol
Other
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Recruitment Methods
1.0
Please upload copies of your recruitment materials below. This includes advertisements, flyers, internet postings, recruitment scripts
and letters/emails.
Document Name
Document Version #
There are no items to display
Ads/Flyers/Info Sheets/Internet Postings
2.0
If you have indicated that study participants will be recruited with advertisements/flyers (Section 18.1/Item 1.0), please indicate the type of
media that will be used (e.g., newspaper, radio, internet, etc.) and/or where information will be posted or distributed.
Direct Recruitment
3.0
If you have indicated that participants will be recruited through direct contact (Section 18.1/Item 1.0), please provide the following
information: 
-
A description of how, when, and where initial contact would be made (e.g. in a public setting, in a waiting
room, via a phone call, via a letter, via the internet, etc.)
-
If applicable to the study, indicate how the potential research participant’s privacy will be maintained.
-
Who will make the contact (e.g. the investigator, a patient’s physician, etc.)
If a patient meets inclusion criteria for the study, the study will be discussed with the patients at the time of surgical consultation in a private
exam room by the attending surgeon.
If a patient has been already evaluated for surgery but has not yet received surgery and the study has not been introduced, a phone call
will be made to the patient to discuss the study over the phone.
If you will be directly recruiting potential participants who are
your patients, students, laboratory workers or any others
with whom you have a relationship of authority or unequal
power, describe what measures you will put in place to avoid
those approached from feeling pressured or unduly
influenced to participate in the study.
We will let the patients know that their participation is voluntary
and will not affect our clinical relationship or their treatment
options.
Recruitment Letters/Emails
4.0
If you have indicated that recruitment letters will be distributed to participants (Section 18.1/item 1.0), please indicate who will send out
the recruitment letter (i.e. will it be the investigator or other persons who have authorized access to the information), how inquiries will be
handled, and if there will be follow-up contacts.
Referrals
5.0
If you have indicated that study participants will be identified from referrals (Section 18.1/item 1.0), please indicate the source of the
referral (e.g., friends, other participants, healthcare providers) and how the referral will be elicited.
Research Participant Pools/Recruitment Databases
6.0
If you have indicated that subjects will be identified and recruited from a subject pool(s) or recruitment database, (Section 18.1/item 1.0),
please indicate the name of the Pool or Recruitment Database and UCLA Department. If the Pool or Recruitment Database is not at UCLA,
identify the location.
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Review of Medical Records
1.0
*You have indicated that potential research participants will be identified from medical records (Section 18.1/item
1). Indicate the specific records to be reviewed and the information that will be obtained to identify potential
participants for this study.
Potential research participants will be identified at the time of their surgery consultation.
The records to be reviewed to identify potential participants for this study include those that would be reviewed in the standard surgical consultation
in patients undergoing evaluation for pheochromocytoma resection including laboratory tests and imaging.
No review of medical records beyond what is required for a standard surgical consultation will be required.
If you have a data sheet summarizing the information that
will be obtained from the records, you can upload it here
instead of listing the information above.
Document Name
Document Version #
There are no items to display
Federal and State Regulations require that the IRB review the information below to determine if a waiver of consent and authorization is
appropriate for use of medical record information for recruitment purposes.
2.0
*Do you assure the following?
-
The information that will be reviewed is the minimal necessary to identify potential research participants for
this research.
-
The information that will be obtained for identification of participants will not be reused or disclosed outside
the research team, except as required by law.
-
All study personnel will comply with HIPAA regulations.
-
Review of the medical records will not result in greater than minimal risk by taking appropriate precautions to
protect the confidentiality of the information.
Agree
3.0
*Indicate why the potential study participants’ rights and welfare would not be adversely affected by waiving consent to review their
medical records.
Check all that apply.
Precautions will be taken to protect the confidentiality of the research participants
The information from the medical records will not be used in any way other than to identify potential research participants
Other
If other, describe
4.0
*Indicate why the research could not practicably be carried out without a waiver of consent.
Check all that apply.
The identities of the potential study participants who would meet the criteria for this study would not be known without access to
their medical records
Other
If other, specify
5.0
NON-UC INSTUTITION(S) / AGENCY(IES) HIPAA POLICIES AND PROCEDURES
If your research will involve access, use, or disclosure of PHI held by a non-UC institution/agency, please provide your assurances that you will
comply with that (those) instutition(s)/agency(ies)' HIPAA policies and procedures.
Agree
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Eligibility Screening
1.0
*Will you be conducting a preliminary assessment with potential research participants to determine study eligibility during the
recruitment process? 
Yes
No
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Informed Consent Process
You indicated that adults (and/or minors who are permitted to consent for themselves) are participating in the study (Section 11.2/item 1.0 or Section
12.2/item 1.0).
For additional information on minors who are permitted to consent for themselves please refer to the section "Legal Exceptions
Permitting Certain Minors to Consent" in the OHRPP Guidance document, Child Assent and Permission by Parents or Guardians. 
1.0
*Indicate your plans for obtaining informed consent for this study. 
Check all that apply:
Signed consent will be obtained from the research participant or Legally Authorized Representative.
• Signed consent means research participants will be asked to sign and date a written consent form.
A waiver of signed consent is requested for the entire study. One of the following procedures will be conducted:
• A written information sheet will be used. Signed consent will not be obtained from research participants.
• Oral consent will be obtained from the research participant or Legally Authorized Representative (LAR)
• This option should be selected if the study involves consenting participants via the internet.
A waiver of consent is being requested.
• Research participants will not be asked to sign a consent form or give oral consent
Consent will be obtained by a collaborating institution.
-  If you checked more than one plan above, list the study
groups and the plan that you will use for each.
-  If you checked "Consent will be obtained by a
collaborating institution", explain the consent process and
upload a copy of the most recent approved consent
document in item 1.2.
Signed consent obtained from patients who were randomized to
phenoxybenzamine or doxazosin.
Requesting a waiver of consent for the retrospective cohort of
patients who were pre-treated with phenoxybenzamine.
If applicable, attach the consent document(s) from
collaborating institution(s).
Document Name
Document Version #
There are no items to display
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Description of the Consent Process
1.0
*Indicate the type of setting(s) in which the consent process will be conducted.
Check all that apply.
In a private home
In a private room
In a waiting room
In a public setting
In a group setting
On the internet
Over the telephone
Other
If you checked more than one response, or indicated other,
describe.
If a patient meets inclusion criteria for the study, the study will be
discussed with the patients at the time of surgical consultation in
a private exam room by the attending surgeon and informed
consent obtained at that time.
If a patient has been already evaluated for surgery but has not yet
received surgery and the study has not been introduced, a phone
call will be made to the patient by an MD to discuss the study
over the phone. The patient will be mailed a consent form to
either return by mail or in person at their next visit.
All patients enrolled in the study will have had an in person
encounter with an attending surgeon prior to obtaining consent.
If the setting is not private, describe the measures to protect
confidentiality or indicate "not applicable."
2.0
*Indicate the measures that will be taken to provide prospective research participants with sufficient opportunity to consider whether or
not to participate in the study.
Check all that apply.
Member(s) of the study staff will meet with the prospective participants/families to review the consent document(s) and/or provide
an oral explanation of the study. Individuals will be given a chance to ask questions before making a considered decision about
whether or not to participate in the study.
Prospective participants/families will have the opportunity to take the consent form(s) home and may discuss the documents with
others prior to deciding whether or not to participate in the study.
Prospective participants will self-administer the consent and send it back if they decide to participate in the study.
Other
If you indicated other, describe.
3.0
*Indicate the length of time subjects are given to decide whether they wish to participate in the study.
Patients will have approximately 1-2 weeks from the time of their initial surgical consultation to decide whether they wish to participate in the study.
4.0
*How will you assess whether subjects understand the information conveyed during the consent process?
Check all that apply.
Use the Subject Comprehension Tool form for research
Investigator or study team member will evaluate during the consent process
Other
Not Applicable
If you indicated other, describe.
5 0
*Attach copies of the informed consent documents information sheets consent scripts as applicable to this study Include copies of
1.1
1.2
2.1
4.1
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5.0
*Attach copies of the informed consent documents, information sheets, consent scripts as applicable to this study.  Include copies of
translated forms, if applicable.
Document Name
Document Version #
Alpha blockade in pheochromocytoma RCT consent form v4.doc
0.02
Blood pressure log
0.01
ID: IRB#17-000048
View: NEW 20.4 - Request to Waive Informed Consent for the Study
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Request to Waive Informed Consent for the Study
You indicated that you are requesting a waiver of consent (Section 20.1/item 1). The following information is needed.
1.0
*Does this study pose more than minimal risk?
Yes
No
2.0
*Would the participants' rights and welfare be adversely affected by waiving consent?
Yes
No
3.0
*Explain why the research could not practicably be carried out without the waiver of consent.
Check all that apply.
It would not be possible to contact all of the participants associated with the data or specimens to obtain consent
The design of the study does not allow the possibility of obtaining consent
The size of the potential study population is so large that it would not be feasible to obtain consent
Requiring informed consent may introduce systematic bias into the data
The risk of contacting the participants is greater than the risk of the study procedures
Other
If you indicated that the study design does not allow the
possibility of obtaining consent, or that requiring consent
may introduce systematic bias or checked “other”, provide
any information that may assist the IRB to understand why
obtaining consent would not be feasible.
4.0
*Would it be appropriate to provide participants with information about the study after their participation?
Check all that apply.
No, the data will not be stored with identifiers with which to contact the participants
No, the information that is found will have no impact on treatment or care
No, there is not a feasible mechanism by which to notify participants/respondents
No, other
Yes
Not Applicable - analysis of secondary data
If you checked "no other," specify.
If you indicated "yes," indicate the information that would be
provided and the mechanism.
ID: IRB#17-000048
View: NEW 21.1 - Permission/Assent Process - Minors
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Permission/Assent Process - Minors
You indicated that minors are participating in the study (Section 11.2/Item 1.0 or Section 11.2/Item 2.0). Please provide the following information.
1.0
*Indicate your plans for obtaining assent and parental permission for this study. 
Check all that apply.
Signed assent will be obtained from all minors
Signed assent will be obtained for some minors
Minors will receive an oral explanation of the study, a written information sheet, or both and will not be asked to sign an assent form.
Signed permission will be obtained from the parent or guardian
Request to waive assent for this study; parental permission will be obtained.
Parents will receive an oral explanation of the study, written information sheet or both and will not be asked to sign a permission form.
Request to waive parental permission for this study; assent will be obtained
Request to waive both Parental Permission and Assent
Consent will be obtained by a collaborating institution.
-  If you will use different plans for obtaining assent and/or
permission with different groups of participants, list the
groups and plans here.
-  If you checked "Consent will be obtained by a
collaborating institution", explain the consent process and
upload a copy of the most recent approved consent
document in Item 1.2.
12 year old subjects will sign the child assent form and 13-17
years old subjects will sign the youth assent form.
Document Name
Document Version #
There are no items to display
Note: If there is more than one group of minors participating in the study with varying degrees of risk, you may be presented with more than one
screen requesting information on plans to obtain parental permission.
ID: IRB#17-000048 View: NEW 21.8 - Parental Permission (Research Greater than Minimal Risk with Prospect of Direct Benefit - 45 CFR 46.405/21 CFR 50.52)
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Parental Permission (Research Greater than Minimal Risk with Prospect of Direct Benefit - 45 CFR 46.405/21 CFR 50.52)
You indicated that you will be obtaining parental permission for this study (Section 21.1/item 1.0) and that the study meets criteria greater than minimal risk
with the prospect of direct benefit – 45 CFR 46.405/21 CFR 50.52 (Section 12.1/item 1). Please provide the following information.
1.0
*Choose one of the following.
Permission from one parent is sufficient. Given the nature of the study, it is not likely to provoke disagreement between the parents
about their child's participation
Permission from both parents will be obtained if both are reasonably available.
2.0
*Indicate how parental permission and assent will be obtained taking into account the age of the child, risk of the study and if steps will
be taken to assure that the child will be given an independent opportunity to consider study participation.
Check all that apply.
The study will be discussed with the child and parent together before conducting the permission and assent processes
Parental permission will be obtained before the child is approached for assent
Assent will be obtained before the parents are approached for permission
Only parental permission will be obtained
If you checked more than one choice above explain why. (For
example, the decision of how to handle the assent and
permission process may depend on an assessment of the
family dynamics or the ages of the children involved in the
study).
ID: IRB#17-000048
View: NEW 21.11 - Description of the Permission/Assent Process
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Description of the Permission/Assent Process
1.0
*Indicate the type of setting(s) in which the assent/permission process will be conducted.
Check all that apply.
In a private home
In a private room
In a waiting room
In a public setting
In a group setting
On the internet
Over the telephone
Other
If you indicated more than one response or other, describe.
If the setting is not private, describe the measures to protect
confidentiality or indicate “not applicable.”
2.0
*Indicate the measures that will be taken to provide prospective research participants with sufficient opportunity to consider whether or
not to participate in the study.
Check all that apply.
Member(s) of the study staff will meet with the prospective participants/families to review the assent/permission document(s)
and/or provide an oral explanation of the study. Individuals will be given a chance to ask questions before making a considered
decision about whether or not to participate in the study.
Prospective participants/families will have the opportunity to take the assent/permission form(s) home and may discuss the documents with
others prior to deciding whether or not to participate in the study.
Prospective participants will self administer the assent/permission and study measures (e.g., assent/permission forms and surveys that are
sent through the mail or internet).
Other
If you indicated other or checked more than one response,
describe.
3.0
*Indicate the timing of the assent/permission process with respect to initiation of the study procedures.
Check all that apply.
Procedures will commence after the assent/permission form(s) are signed or oral permission/assent is provided.
Participants/families will be allowed a period of time to consider participation in the study.
*Indicate the amount of time between the assent/permission
process and initiation of the study procedures (e.g., 4 hours,
overnight, etc.)
Time between assent/permission process and initiation of study
procedures will be the time between the clinic visit and the time
the patient starts the preoperative blockade medication. Typically
1 or 2 days.
4.0
*How will you assess whether subjects understand the information conveyed during the assent/permission process? 
Check all that apply.
Use the Subject Comprehension Tool form for research
Investigator or study team member will evaluate during the consent process
Other
Not Applicable
If you indicated other, describe.
1.1
1.2
2.1
3.1
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5.0
Attach copies of the parental permission forms, assents forms, information sheets, screening or scripts as applicable to this study. 
Include copies of translated forms, if applicable.
Document Name
Document Version #
Child_Assent_v1.doc
0.02
Parent_Perm_v1.doc
0.03
Teen_Assent_v1.doc
0.02
ID: IRB#17-000048
View: NEW 22.1 - Cultural Considerations
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Cultural Considerations
The following items are designed to acquaint the IRB with cultural features of the population that you are studying that may require procedures to ensure
truly informed consent.
1.0
*Check all that apply to the population(s) with which this study will be conducted.
Participants may be illiterate or insufficiently literate to be able to comprehend a conventional written informed consent form.
The participants may be reluctant or unwilling to sign a written informed consent form.
The husbands make decisions for their wives.
Elders make decisions for younger adult family members.
Elders make decisions for their community.
It is considered impolite to refuse a request.
People are fearful of refusing requests that they regard as coming from authorities.
None of the above are applicable to this study.
If any of the above items are applicable to this study, indicate
the steps that you will take to ensure voluntary participation
after providing the study information, and if applicable, any
planned involvement with the community regarding the
consent process.
ID: IRB#17-000048
View: NEW 22.2 - Non-English Speaking Study Participants
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Non-English Speaking Study Participants
You indicated that you would involve non-English speaking participants in the study (Section 11.2/Item 2.0) and/or that there is a possibility that non-English
speaking participants may be enrolled in the study (Section 11.2/Item 3.0). Please provide the following information.
1.0
*Indicate the method that you use to conduct the consent process1 with participants who do not speak English.
Check all that apply.
The consent form and other study documents will be available in the participants' primary language. Study personnel (or qualified
translators) able to discuss the participation in the patients' language will be present for the consent process.
Study staff or qualified translators will discuss the study in the participants' language.
An oral consent process will be used. Study personnel (or qualified translators) able to discuss the participation in the participants' language
will be present for the consent process.
The short form or another method will be used to conduct the consent process.
Important Note: The short form may be used in very limited circumstances. For additional information please refer to the " 'Short Form'
Method" section of the OHRPP guidance document, Research Involving Non-English Speaking Research Participants.
If you checked "short form or another method", provide
additional details.
2.0
*How will you maintain the ability to communicate with non-English speakers throughout their participation in the study?
Indicate "N/A" if not applicable to your study.
Qualified translators will be used to communicate with participants in accordance with UCLA standards.
3.0
*If you are conducting research for which there is a real or foreseeable risk of biomedical harm in the state of California, indicate your
agreement that you will provide the participants who do not read, speak, or understand English a copy of the Research Participants Bill
of Rights in a language in which they are fluent.  Translations into the most common languages in the greater Los Angeles area are
available for download on the OHRPP website.
Agree
Not Applicable
1 If minors are involved in the study, this would also include the processes of obtaining parental permission and assent, as applicable.
ID: IRB#17-000048
View: NEW 24.0 - Additional Information and/or Attachments
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Additional Information and/or Attachments 
1.0
Attach any other documents that have not been specifically requested in previous items, but are needed for IRB Review.
Document Name
Document Version #
JustinLee_CITItraining.pdf
0.02
JustinLee_UCLA HIPAA.pdf
0.01
2.0
If there is any additional information that you want to communicate about this study, include it in the area provided.  Note: this section
should not be used instead of the standard application items.
ID: IRB#17-000048
View: NEW 100.0 - Instructions for Study Submission
1.1
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Instructions for Study Submission
You have completed your application, but it has not yet been submitted.
FOLLOW THESE STEPS TO SUBMIT THE APPLICATION TO THE IRB FOR REVIEW:
1. Click the Finish button to return to exit the SmartForm and return to the study workspace.
2. Use the View SmartForm Progress function to make sure that the application is complete.
3. If you are the PI or PI Proxy, click Submit Study under My Activities. If you are a member of the study team,
you can let the PI know that the study is ready to submit by clicking Send Ready Notification.
4. Once the study is submitted, the state indicator at the top of the page will no longer display Pre-Submission.
5. After submission of the study, the PI Assurances activity will immediately become available under My Activities.
The PI should provide his/her assurances at that time. If the PI is not available, the study can be submitted by a PI
Proxy and the assurances provided at a later time. The study will be reviewed by the IRB while the PI
Assurances are pending; however, it will not be approved until the PI assurances are completed.
6. If there is a Faculty Sponsor for the study: The study can not be submitted to the IRB until the Faculty
Sponsor provides his/her assurances through FS Assurances activity.
ID: IRB#17-000048
View: Display - Method Description
Audio, Visual or Digital Recordings
Click "OK" below to return to the SmartForm page where you can select the appropriate response.
ID: IRB#17-000048
View: Display - Method Description
Certificate of Confidentiality for research not supported by NIH
The Certificate of Confidentiality button in this section is only if your study is NOT supported or conducted by NIH but you will obtain a
Certificate of Confidentiality (for example, for studies collecting information about illegal drug use).
If you previously checked this box for an NIH-supported study before the policy change, you do not need to change your
response here.
Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect the privacy of research subjects by protecting
investigators and institutions from being compelled to release information that could be used to identify subjects with a research project.
Certificates of Confidentiality are issued to institutions or universities where the research is conducted. They allow the investigator and
others who have access to research records to refuse to disclose identifying information in any civil, criminal, administrative, legislative, or
other proceeding, whether at the federal, state, or local level.
Effective October 1, 2017, NIH has updated its policy for issuing Certificates of Confidentiality for NIH-funded and conducted research. For
information about the policy change or about obtaining Certificates for research supported by other agencies, please see
https://humansubjects.nih.gov/coc/index.
Click "OK" below to return to the SmartForm page where you can select the appropriate response.
ID: IRB#17-000048
View: Display - Method Description
Clinical Trial of a Drug, Biologic, Device or a Behavioral Intervention
A clinical trial is a research study designed to answer specific questions about medical or behavioral treatments. The trial may be
interventional or observational. Interventional studies are those in which the research participants are assigned by the investigator to a
treatment or other intervention, and the outcomes measured. Observational studies are those in which individuals are observed and the
outcomes are measured by the investigators.
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ID: IRB#17-000048
View: Display - Method Description
Community Based Research
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ID: IRB#17-000048
View: Display - Method Description
Controlled Substances (Schedule I or II)
Check here only if you are using a Schedule I or II Controlled substance in this study. Research using Schedule I or Schedule II controlled
Substances must be submitted to the Research Advisory Panel of California for review and approval prior to initiation. Research using
Schedule III, IV, or V Controlled Substances as a study drug do not require review by the Research Advisory Panel. For further information
see: http://ag.ca.gov/research/guide.php o Schedule I Controlled Substances are drugs or substances with a high potential for abuse, that have
no currently accepted medical use in treatment in the United States. Examples of Schedule I Controlled Substances are: heroin, lysergic
acid diethylamide (LSD), methylenedioxy-methamphetamine (MDMA), marijuana, and psilocybin. o Schedule II Controlled Substances are
drugs or substances with a high potential for abuse, that have a currently accepted medical use in treatment in the United States, or a
currently accepted medical use with severe restrictions. Examples of Schedule II Controlled Substances are: fentanyl, methadone,
methylphenidate, morphine, and oxycodone. For further information see: http://www.deadiversion.usdoj.gov/schedules/index.html
Click "OK" below to return to the SmartForm page where you can select the appropriate response.
ID: IRB#17-000048
View: Display - Method Description
Deception or Partial Disclosure
Deception includes withholding information about the real purpose of the study or purposely giving subjects false information about some
aspect of the research to prevent bias. Some professions, such as the American Psychological Association (APA) have ethical codes
regarding the use of deception in research. ( See sections 8.07 and 8.08 at http://www.apa.org/ethics/code/index.aspx#807 ) If deception is
included in the study, you must also apply for approval of a waiver of the informed consent process (Section 20.1) in addition to selecting
the other consent procedures planned for the study (e.g., written or oral consent).
Click "OK" below to return to the SmartForm page where you can select the appropriate response.
ID: IRB#17-000048
View: Display - Method Description
Devices/Diagnostics (Note: Submit all HUDs in BruinIRB)
A medical device is defined, in part, as any health care product that does not achieve its primary intended purposes by chemical action or
by being metabolized. Medical devices include, among other things, surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts,
intraocular lenses, and orthopedic pins. Medical devices also include diagnostic aids such as reagents and test kits for in vitro diagnosis
(IVD) of disease and other medical conditions such as pregnancy. For further information see: http://www.fda.gov/oc/ohrt/irbs/irbreview.pdf
Click "OK" below to return to the SmartForm page where you can select the appropriate response.
ID: IRB#17-000048
View: Display - Method Description
Drugs/Biologics/Dietary Supplements
• Drug: The term "drug" means: articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia
of the United States, or official National Formulary, or any supplement to any of them; and articles intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease in man or other animals; and articles (other than food) intended to affect the
structure or any function of the body of man or other animals.
• Biologics vs. Drugs: Most drugs consist of pure chemical substances and their structures are known. Most biologics, however, are
complex mixtures that are not easily identified or characterized. Biological products differ from conventional drugs in that they tend
to be heat-sensitive and susceptible to microbial contamination. This requires sterile processes to be applied from initial
manufacturing steps. For more information see: http://www.fda.gov/consumer/updates/biologics062608.html#drugs
• Dietary Supplements are products that are intended to supplement the diet and have one of the following ingredients:
 A vitamin
 A mineral
 An herb or other botanical
 An amino acid
 A dietary substance for use by man to supplement the diet by increasing the total daily intake
 A concentrate, metabolite, constituents, or an extract of combinations of these ingredients.
For additional information see: http://www.foodsafety.gov/~dms/supplmnt.html
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Genetic Analyses/Genotyping
Genetic analyses/genotyping include, but are not limited to, studies of inheritable conditions or traits, gene markers or mutations, and
pedigrees.
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ID: IRB#17-000048
View: Display - Method Description
Human Embryonic Stem Cells and/or Induced Pluripotent Stem Cells
Research with human embryonic stem cells (hESC) and related lines requires IRB review under the following conditions: o Clinical research
in which human subjects are given hESCs or related products. o When the UCLA research team will have a research related direct
interaction or intervention with the cell donors, including donation of blastocysts or gametes for the purpose of creating hESCs,. o Cells
provided to the UCLA research team that have identifiers or codes that can be linked back to the donor. Research involving hESC requires
review and approval by the ESCRO Committee. For further information see: http://www.stemcell.ucla.edu/research
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ID: IRB#17-000048
View: Display - Method Description
Human Gene Transfer/ Recombinant DNA
Studies involving gene transfer and/or recombinant DNA require approval of the UCLA Institutional Biosafety Committee (IBC).  Human gene
transfer is an investigational method for correcting defective genes responsible for disease development through one of the following
techniques: o A normal gene may be inserted into a nonspecific location within the genome to replace a nonfunctional gene. o An abnormal
gene could be swapped for a normal gene. o The abnormal gene could be repaired through selective reverse mutation, which returns the
gene to its normal function. o The regulation of a particular gene could be altered. Recombinant DNA molecules, according to the NIH
Guidelines, are defined as either: (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to
DNA molecules that can replicate in a living cell, or (ii) molecules that result from the replication of those described in (i) above.
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ID: IRB#17-000048
View: Display - Method Description
Infectious Agents
Studies involving the use of Risk Group 2 or 3 infectious agents (such as bacteria, fungi, parasites, prions, rickettsia, viruses, etc.) require
approval of the UCLA Institutional Biosafety Committee (IBC).
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ID: IRB#17-000048
View: Display - Method Description
Non-FDA approved medical equipment used with UCLA hospital patients or research participants that operate under the UCLA Hospital License.
Clinical Engineering is responsible for completing incoming inspections on investigational devices that are used to diagnose, treat or monitor
a patient and that are used in the patient care area on site at UCLA, but not in other hospitals such as Cedars Sinai, CHLA, or Drew. If a
device is FDA and/or testing - laboratory approved for the purpose it was designed, then evaluation is not required of the device. If you
have a copy of an inspection report from Clinical Engineering, please attach here. As appropriate, please contact Clinical Engineering at
310-267-9000 to arrange an inspection.
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ID: IRB#17-000048
View: Display - Method Description
Radiation (Standard of Care or Investigational Use of radioactive materials, radiation producing machines or ionizing radiation)
Note: This includes CT-guided biopsy, fluoroscopy use, etc.; MRI is not included. The radiological procedures included in this study must be
described in the SafetyNet system. Please create a new SafetyNet application after submitting this webIRB application to the IRB for review.
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ID: IRB#17-000048
View: Display - Method Description
Substance Abuse Research (with Medication)
Research for the treatment of controlled substance addiction or abuse that uses any drug (scheduled or not) as treatment, requires the
review and approval of the Research Advisory Panel of California prior to initiation. For further information see: For further information see:
http://ag.ca.gov/research/guide.php
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ID: IRB#17-000048
View: Display - Method Description
Treatment in an Emergency Setting (with request to waive consent)
Federal regulations allow certain research activities to be conducted in emergency settings with waiver of informed consent - in the interest
of facilitating potentially life-saving and life-enhancing research with protecting the rights and welfare of participants. For further
information see: o OHRP Guidance: http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc97-01.htm o FDA Guidance: http://www.fda.gov/oc/ohrt
/irbs/except.html
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ID: IRB#17-000048
View: Display - Method Description
None of the above
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ID: IRB#17-000048
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Specimens and/or Data that will be Acquired without direct
contact with study participants
1.1
*Data and/or Specimens?  Indicate all that apply:
Data
Specimens
1.2
*Indicate the source of the data and/or specimens.  If the source is UCLA or a previous study, also indicate the IRB#:
UCLA medical records
1.3
*Indicate whether the data and/or specimens are pre-existing, at the time of this study, and/or if collection will be prospective.  Check all
that apply:
Pre-existing
Prospective
1.4
*Describe the data and/or specimens and indicate the original collection dates.  If collection is in progress,
indicate the planned end date or "continuing." (e.g., academic records for children 6-12 years for the time period between
1995-2005, or tumor samples collected from adults between January 1, 2009 to December 31, 2009).
Electronic medical records from patients undergoing adrenalectomy for pheochromocytoma or paraganglioma from January 1, 2015 to present.
Please see item 4.0 for further details on data to be collected from the EMR.
1.5
*Indicate the approximate number of data records and/or specimens to be collected.
50
1.6
If you indicated that you will be using specimens, provide the following information.
Will the specimens be used with animals?
Yes
No
If yes, indicate the IACUC Number:
1.6.1
1.6.1.1
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