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Application for Community Medical Centers Institutional Review Board
Expedited Review
For instructions, study forms and templates, please refer to:
http://forum.cmcinet.org/departments/Compass/irb/IRB%20FORMS/Forms/AllItems.aspx
or
http://www.fresno.ucsf.edu/gro/irb_info.htm
Expedited Reviews: Minimal risk studies which qualify for expedited review are reviewed
weekly by the qualified Board reviewers. Note, only the reviewer may determine whether
studies qualify for expedited review, or are exempt. Investigators are not to make this
determination.
Study title:
Principal Investigator:
Study sponsor:
A. DETERMINING REVIEW CATEGORY
IMPORTANT: “Yes” answers to all items below are required to qualify for expedited review. If you did
not answer “Yes” to all of the questions, please submit your study application using the Full Board Review
Application.
1. It is clear that the nature of the proposed research fits one or more of
YES
NO
the expedited categories listed below.
2. No implications for criminal or civil liability, employability, or damage to
YES
NO
subjects’ financial standing or reputation would exist if data were known
outside of the study.
3. The research does not employ a protected group as subjects (e.g.,
YES
NO
fetuses, pregnant women, prisoners or cognitively disabled persons).
4. The study does not present more than a MINIMAL RISK to subjects.
YES
NO
* Minimal Risk means that the probability and magnitude of harm or
discomfort anticipated in the research are not greater in and of themselves
from those ordinarily encountered in daily life or during the performance
of routine physical or psychological examination or tests. 45CFR46.102(i)
5. Appropriate informed consent procedures will be followed unless
YES
NO
submitting a REQUEST FOR IRB WAIVER OF PATIENT AUTHORIZATION.
B. EXPEDITED REVIEW CATEGORIES
Please indicate which of the following categories are applicable to your research.
Category 1
Clinical studies of drugs and medical devices only when condition (a) or (b) is met:
a. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not
required.
b. Research on medical devices for which (i) an investigational device exemption application (21
CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing
and the medical device is being used in accordance with its cleared/approved labeling.
Category 2
Collection of blood samples by finger stick, heel stick, ear stick or venipuncture as follows:
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a. from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the
amounts drawn may not exceed 550 ml in an 8-week period and collection may not occur
more frequently than 2 times per week; or
b. from other adults and children, considering the age, weight, and health of the subjects, the
collection procedure, the amount of blood to be collected, and the frequency with which it
will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml
or 3 ml per kg in an 8-week period and collection may not occur more frequently than 2
times per week.
Category 3
Prospective collection of biological specimens for research purposes by non-invasive means.
EXAMPLES: (a) hair and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of
exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine
patient care indicates a need for extraction; (d) excreta and external secretions (including
sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by
chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta
removal at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane before or
during labor; (h) supragingival and subgingival dental plaque and calculus, provided the
collection procedure is not more invasive than routine prophylactic scaling of the teeth and the
process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and
skin cells collected by buccal scraping or swab, skin swab, or mouth washings; and (j) sputum
collected after saline mist nebulization.
Category 4
Collection of data through noninvasive procedures (not involving general anesthesia or sedation)
routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
Where medical devices are employed, they must be cleared/approved for marketing. EXAMPLES:
(a) physical sensors that are applied either to the surface of the body or at a distance and do not
involve input of significant amounts of energy into the subject or an invasion of the subject’s
privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d)
electrocardiography, electroencephalography, thermography, detection of naturally occurring
radioactivity, electroretinoraphy, ultrasound, diagnostic infrared imaging, Doppler blood flow, and
echocardiography; (e) moderate exercise, muscular strength testing, body composition
assessment, and flexibility testing where appropriate given the age, weight, and health of the
individual.
Category 5
Research involving materials (data, documents, records, or specimens) that have been collected
or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
Category 6
Collection of data from voice, video, digital, or image recordings made for research purposes.
Category 7
Research on group characteristics or behavior (including, but not limited to, research on
perception, cognition, motivation, identity, language, communication, cultural beliefs or practices,
and social behavior) or research employing survey, interview, oral history, focus group, program
evaluation, human factors evaluation, or quality assurance methodologies.
Category 8
Continuing review of research previously approved by a convened IRB as follows: (a) where (i)
the research is permanently closed to the enrollment of new subjects; (ii) all subjects have
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completed all research-related interventions; and (iii) the research remains active only for the
long-term follow-up of subjects; or (b) where no subjects have been enrolled and no additional
risks have been identified; or (c) where the remaining research activities are limited to data
analysis.
Category 9
Continuing review of research not conducted under an investigational new drug application or
investigational drug exemption where categories two (2) through eight (8) do not apply but the
IRB has determined and documented at a convened meeting that the research involves no
greater than minimal risk and no additional risks have been identified.
C. TYPE OF FUNDING:
Pharmaceutical Co.
State or Federal Government
Private
Internal Department Funding
Foundation
Not Funded
CCFMG
Other
Entity through funds will be administered:
Are sufficient resources in place to conduct
the study?
Yes
No
D. TYPE OF STUDY (please check all that apply):
FDA Approved Drug(s)
Medical Records Review
Retrospective
Prospective
FDA Approved Device
Questionnaire
Biological Sample(s)
Survey
DNA
Blood
Other-Describe:
Tissue
Computerized Database Review
Please describe computer system(s) to be used to obtain data:
Please state who will provide data to Investigators:
If data will be requested from the Health Information Management Dept, please submit an Area
Director Agreement form signed by the director. (Appendix C)
E. SUBJECTS/RECORDS
Indicate whether the project will involve either subjects, or review of medical information from:
Subjects Under the Age of 18
Yes
No
Pregnant Women
Yes
No
Minority Subjects
Yes
No
Non-English Speaking Subjects
Yes
No
If yes, state approximate percentage of
potential research subjects who would be
Non-English speakers & list languages
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If requesting inclusion of non-English speakers in the study, describe the plan to provide information to
the subjects in a language understandable to them:
Advertising for Subject Recruitment
How/where will advertisements be
posted?
Yes
No
If applicable,
expected number of CMC patients:
F. Facility(ies) where study will be conducted:
Community Regional Medical Center
Community Living Center – Fresno
Clovis Community Medical Center
Community Subacute & Transitional Care Center
Fresno Heart & Surgical Hospital
California Cancer Center
Community Behavioral Health Center
University Surgical Associates
7415 N. Cedar Ave., Suite 102
University Cardiology Associates
2210 E. Illinois St., Suite 508
University Central Medical Specialty Center
2828 Fresno St., Suite 203
University Oncology Associates
2335 E. Kashian Lane, Suite 301
University Neurosurgery Associates
2335 E. Kashian Lane, Suite 301
Fresno Plastic Surgery
1855 E. Alluvial Ave., Suite 101
University North Medical Specialty Center
6311 N. Fresno St., Suite 106
Valley Vascular Surgery Associates
1247 E. Alluvial Ave., Suite 101
University Orthopedics Associates
2210 E. Illinois Ave., Suite 401
University Dermatology Associates
2335 E. Kashian Lane, Suite 410
University Gastroenterology & Hepatology
Associates
7015 N. Chestnut Ave., Suite 101
University Neurology Associates
2335 E. Kashian Lane, Suite 301
University Women’s Specialty Center
2210 E. Illinois Ave., Suite 301
University Psychiatry Associates
2027 Divisadero St.
University Rheumatology Associates
2335 E. Kashian Lane, Suite 301
G. CONSENT
Are you requesting a waiver of consent?
Yes
Criteria
Does the research involve minimal risk to the
subjects?
Will the waiver or alteration adversely affect the
rights and welfare of the subjects?
Can the research be practicably be carried out
without the waiver or alteration?
Whenever appropriate, will the subjects be provided
with additional pertinent information after
participation?
Updated 05/30/2013
No
Yes
No
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Will an adequate plan be presented to the IRB to
protect personal health information (PHI) identifiers
for improper use and disclosure?
Are you requesting a waiver of documentation of consent?
If yes, please submit a study information sheet, if applicable.
If you would like to request a template, please contact the IRB Office.
Are you requesting a waiver of patient authorization for use and disclosure
of protected health information?
If yes, see Appendix A
Note: if the recruitment plan includes a retrospective review of a database
to search for prospective subjects, then a waiver of patient authorization
preparatory to research must be requested.
H. Reimbursement
Will the investigator, sub-investigators, study staff or institution be
financially reimbursed for subjects enrolled or data submission?
If yes, please submit a Research Financial Disclosure form for all
investigators and study staff. (Appendix B)
If yes, state the amount of reimbursement per subject:
To whom will the reimbursement be paid?
Will subjects be paid?
If yes, state the amount:
Yes
Yes
No
No
Yes
No
Yes
No
Please describe method by which
subjects will be paid and at what
intervals (e.g. cash, gift card, check
will be paid after each study visit, at
completion of study, etc.):
Please describe methods by which
subjects will be recruited, and
whether any study advertisements
are planned.
I. INVOLVEMENT OF CMC/CCFMG EMPLOYEES/STAFF
Will the study require assistance/participation by CMC or CCFMG employees/staff?
Yes
No
Examples include: Requests for data from Health Information Management, Non-Standard of Care
blood draws by hospital Laboratory staff, Imaging studies required as part of the research,
Preparation/Dispensing of drugs/medications by Pharmacy, Involvement of Nursing staff, Pulmonary
function testing by Respiratory Care, etc.
IMPORTANT: If yes, a copy of the Area Director Agreement to Participate in Research (Appendix C)
must be completed by the administrative Director of each hospital area which will be required for the
conduct of the study.
Area Director Agreement Form(s) attached?
Yes
Not Applicable
J. RESEARCH-REQUIRED PROCEDURES
Will the study include any research-required procedures which are not
part of the usual care?
IMPORTANT:
Updated 05/30/2013
Yes
No
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



If yes, these procedures may not be charged to the research subject, or their
insurance payor.
Investigators must contact the Finance Office 459-1742 to negotiate
reimbursement to CMC for all new non-standard of care research- required
procedures.
These procedures must be clearly outlined in the informed consent document along
with a statement that such procedures will not be charged to the subject or their
insurance payor.
Investigators must complete the Registration Mnemonic Request Form (see IRB
website: http://www.fresno.ucsf.edu/gro/irb_info.htm
Research-required procedures/tests, etc. which will be performed by
INVESTIGATORS/ STUDY STAFF:
Research-required procedures/tests, etc. which will be performed by CMC or CCFMG
Staff:
Procedure Name
Charge Code (Required)
In addition, investigators must complete the Research Mnemonic Request Form
http://www.fresno.ucsf.edu/gro/irb_info.htm and follow the instructions for submission.
Research Mnemonic Request Form attached? Yes
Not Applicable
K. REVIEW BY NON-LOCAL IRB
Has this study been reviewed by another IRB and been disapproved?
If yes, a copy of the written statement from the previous IRB should be
included with this study documentation.
Yes
No
L. INVESTIGATORS/STUDY STAFF
Principal Investigator (PI)
Note: For studies conducted by UCSF faculty, students, and staff, the Principal Investigator must
be a UCSF faculty member who meets the eligibility requirements for PI status on grant
applications. Postdoctoral fellows may serve as PI in limited circumstances.
PI name
PI email address
Sub-Investigator(s)

IMPORTANT:
All investigators outside the CMC and UCSF Fresno institutions must have a CMC
physician or staff member listed as a co-investigator
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Please list all staff
(e.g., data
managers, study
coordinators,
volunteers) who
will be assisting
with the study and
state their role(s)
in the study.
Study Staff Member
Role of Study Staff
Member
Applicable training in
the protection of
human subjects
completed?
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
NOTE: All persons listed above must complete mandatory training in the protection of
human subjects in research.
Non-UCSF physicians, investigators, research staff:
http://phrp.nihtraining.com/users/login.php or http://ethics.jaeb.org
UCSF physicians & research staff: www.citiprogram.org
Note: The Basic/Refresher Human Subjects course is REQUIRED.
The Good Clinical Practice (GCP) and Responsible Conduct in Research (RCR) courses are optional for
most people.
THE IRB IS UNABLE TO GRANT APPROVAL UNTIL ALL KEY PERSONNEL HAVE COMPLETED
THE REQUIRED TRAINING.
For questions, please refer to UCSF’s website at:
http://www.research.ucsf.edu/chr/Train/CITI_FAQ.asp
P.I. Status Form
NOTE: UCSF Fresno investigators who are not paid more than 50% by UCSF must complete a P.I.
Status Form per UCSF requirements. The form is found at:
http://www.research.ucsf.edu/cg/forms/pistatus.doc and should be forwarded to the UCSF Fresno
Dean’s Office. For questions, or assistance with this form, please contact the UCSF Fresno Contracts
and Grants Office at 559-499-6414.
Completed applications should be submitted to:
IRB@communitymedical.org
Office Address:
UCSF Fresno Center for Medical Education and Research
155 N. Fresno St., Suite 290
Fresno, CA 93701
559-499-6651 Office
559-499-6633 FAX
BY SIGNING THIS FORM I AM AGREEING TO ABIDE BY ALL APPLICABLE FEDERAL, STATE
AND LOCAL REGULATIONS, INCLUDING, BUT NOT LIMITED TO, HIPAA, OHRP, FDA, UCSF
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AND CMC REGULATIONS, LAWS, POLICIES, PROCEDURES AND GOOD CLINICAL PRACTICE. I
CERTIFY THAT THERE ARE ADEQUATE RESOURCES IN PLACE TO CONDUCT THE STUDY TO
COMPLETION. IN ADDITION, I ACCEPT RESPONSIBILITY FOR OVERSIGHT OF ALL STUDY
STAFF AND SUB-INVESTIGATORS AND WILL CONDUCT THE STUDY AS OUTLINED IN THE
STUDY PROPOSAL.
Signature of Principal Investigator
Updated 05/30/2013
_____________________________
Date
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Appendix A
REQUEST FOR IRB WAIVER OF PATIENT AUTHORIZATION
Research Project Title:
Principal Investigator:
1. The use or disclosure of Protected Health Information (PHI) involves no more than a
minimal risk to the privacy of individuals. Explain why. Include a detailed list of the
PHI to be collected and a list of the source(s) of the PHI.
2. Describe the plan to protect identifiers and indicate where PHI will be stored and who
will have access (researchers must list all of the entities that might have access to the
study’s PHI such as IRB, CMC representatives, sponsors, FDA, data safety monitoring
boards and any others given authority by law).
3. All identifiers collected during the study will be destroyed at the earliest opportunity
consistent with the conduct of research, which is: (explain below).
4. Please describe the procedure used to destroy all the data collected during the study
(electronically, paper, audio/video, photography, other). OR
5. Alternatively, the identifiers collected during the study will not be destroyed because:
(explain below).
6. Reasons the research could not practicably be conducted without the waiver.
7. The research could not practicably be conducted without access to and use of the
protected health information because (explain below).
* PHI: individually identifiable health information transmitted or maintained in any form (electronic, on paper, or through oral communication)
that relates to the past, present or future physical or mental health or conditions of an individual.
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The HIPAA regulation requires reasonable efforts to limit protected health information to
the minimum necessary to accomplish the intended purpose of the use, disclosure or request.
Please note that researchers are also accountable for any PHI released under a waiver.
Explain why PHI obtained for this study is/are the minimum information needed to meet the
research objectives.
The information listed in the waiver application is accurate and all research staff will comply
with the HIPAA regulations and the waiver criteria. All research staff will complete CMC’s
privacy competency training prior to study initiation.
I assure that the information I, or my study staff, obtain as part of this research (including
protected health information) will not be reused or disclosed to any other person or entity other
than those listed on this form, except as required by law. If at any time I want to reuse this
information for other purposes or disclose the information to other individuals or entity I will
seek approval by the IRB.
Principal Investigator’s Signature _
Date
_________________
Updated 05/30/2013
_________________________________
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FOR SPONSORED STUDIES:
Appendix B
DISCLOSURE: FINANCIAL INTERESTS AND ARRANGEMENTS OF CLINICAL
INVESTIGATORS
(TO BE COMPLETED BY PRINCIPAL INVESTIGATOR)
Name:
Title:
Dept/Organization:
Study Title:
Study Sponsor(s):
I am participating as:
Principal Investigator in the above named clinical trial.
Indicate by marking Yes or No if any of the financial interests listed below apply to you, your
spouse or dependent children. If yes, please describe the conflict, along with a description of
steps taken to minimize the potential bias of clinical study results by any of the disclosed
arrangements or interests.
Yes
Yes
No
1. Any financial arrangement entered into between the sponsor of the
covered study and the clinical investigator involved in the conduct of the
covered study, whereby the value of the compensation to the clinical investigator
for conducting the study could be influenced by the outcome of the study.
If yes, please describe:
No
2. Any payments made by the sponsor of the covered study, to
investigators, such as funds to conduct the study, grants to fund ongoing
research, compensation in the form of equipment, retainer for ongoing
consultation, or honoraria
If yes, please describe the type of payments, to whom the funds will be paid, and
the amount:
If yes, please attach study budget
Yes
No
3. Any payments made by the sponsor of the covered study, to
departments or institutions, such as funds to conduct the study, grants to fund
ongoing research, compensation in the form of equipment, retainer for ongoing
consultation, or honoraria
If yes, please describe the type of payments, to whom the funds will be paid and
state amount
Updated 05/30/2013
Page 12 of 16
Yes
No
4. Will you, your department or institution accept recruitment bonuses or
incentives for this trial? If yes, please describe:
.
Yes
No
5. Any proprietary interest in the product tested in the covered study held by
the investigator/study staff.
If yes, please describe
Yes
No
6. Any significant equity interest as defined in 21 CFR 54.2(b)*, held by the
investigator/ study staff in the sponsor of the covered study.
If yes, please describe
Yes
Yes
No 7. Any significant equity interest in investigator’s study-related business.
If yes, please describe
No
8. Any non-financial conflict of interest. If yes, please describe:
In accordance with 21 CFR Parts 54.1 to 54.6, I declare that the information provided on this
form is, to the best of my knowledge and belief, true, correct, and complete. Furthermore, if my
financial interests and arrangements, or those of my spouse and dependent children, change from
the information provided above during the course of the study or within one year after the last
patient has completed the study as specified in the protocol, I will notify the Institutional Review
Board promptly.
Signature of Principal Investigator
Updated 05/30/2013
Date
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FOR SPONSORED STUDIES:
DISCLOSURE: FINANCIAL INTERESTS AND ARRANGEMENTS OF CLINICAL
INVESTIGATORS
(To be completed by each Sub-Investigator and Study Staff member)
Name:
Title:
Dept/Organization:
Study Title:
Study Sponsor(s):
I am participating as: sub-investigator
trial.
study staff
in the above named clinical
Indicate by marking Yes or No if any of the financial interests listed below apply to you, your
spouse or dependent children. If yes, please describe the conflict, along with a description of
steps taken to minimize the potential bias of clinical study results by any of the disclosed
arrangements or interests.
Yes
Yes
Yes
No
Any financial arrangement entered into between the sponsor of the
covered study and the clinical investigator involved in the conduct of the
covered study, whereby the value of the compensation to the clinical investigator
for conducting the study could be influenced by the outcome of the study.
If yes, please describe
No
Any significant payments of other sorts made from the sponsor of the
covered study such as a grant to fund ongoing research, compensation in the form
of equipment, retainer for ongoing consultation, or honoraria
If yes, please describe
No
Will you, your department or institution accept recruitment bonuses or
incentives for this trial? If yes, please describe:
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Page 14 of 16
Yes
No
Any proprietary interest in the product tested in the covered study held by
the investigator/study staff.
If yes, please describe
Yes
No Any significant equity interest as defined in 21 CFR 54.2(b), held by the
investigator/ study staff in the sponsor of the covered study.
If yes, please describe
Yes
No Any significant equity interest in investigator’s or employer’s business
If yes, please describe
Yes
No Any non-financial conflict of interest
If yes, please describe
In accordance with 21 CFR Parts 54.1 to 54.6, I declare that the information provided on this
form is, to the best of my knowledge and belief, true, correct, and complete. Furthermore, if my
financial interests and arrangements, or those of my spouse and dependent children, change from
the information provided above during the course of the study or within one year after the last
patient has completed the study as specified in the protocol, I will notify the Institutional Review
Board promptly.
Signature of Sub-Investigator/Study Staff member
Date
Signature of Principal Investigator
Date
Updated 05/30/2013
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Appendix C
Area Director Agreement to Participate in Research
Research studies often require the participation of one or more hospital departments or service
areas. In order to ensure that areas have sufficient staff and resources to support research
activities, all investigators will obtain the agreement from each area Director to participate.
A copy of this form must be completed by the Director of each area which will be necessary for
the conduct of the study. Required areas include, but are not limited to Medical Records,
Laboratory, Pharmacy, Radiology, Inpatient/outpatient nursing units, Nutrition Services,
Pathology Registration & Billing services and others.
A copy of the study protocol, along with an explanation of services needed (see below) shall be
submitted to each Director for review, along with specific study requirements for their area.
Directors are requested to complete the review in a timely fashion and return the signed form
to the Investigator/Study Coordinator. The form must then be submitted to the IRB Office as
part of the application. IRB applications will not be considered complete until the signed
form(s) is/are received.
Study Title:
Principal Investigator
Study Coordinator
Contact Information
Hospital/Practice Site/Facility Area(s) Required for Conduct of the Study:
Print Name of Director/Contact Person
Contact Information
Information/services being requested of Director (please be very specific):
I have reviewed the study protocol and study requirements for the participation of
my department in the research study.
I agree to the participation of my staff and department in the research study.
I do not agree to the participation of my staff and department in the research
study.
I have the following concerns regarding the research:
Signature of Director:
Updated 05/30/2013
Date:
Page 16 of 16
PLEASE REVIEW THE INSTRUCTIONS ON WHOM TO SEND THE REQUEST TO
LISTED AT THE BOTTOM OF THIS FORM.
For any questions, please contact the IRB Office at IRB@communitymedical.org
or 559-499-6553
Study Registration Mnemonic Request form
Full name of Research Project:
Mnemonic Requested:
(please choose a mnemonic between 4-8 characters,
beginning with the letter “R” which you would like
to have assigned to your project – Choose
something that will readily identify your study, for
example “RSNAKBTE” for a study which would
involve rattlesnake bites)
Physician overseeing project:
Study Coordinator name(s):
Contact phone # & e-mail for each:
Research-required procedures/CPT codes
which are not to be charged to the patient
or insurer, and which will be performed
by CMC. Please list all specific
procedures, including screening
procedures, using a bulleted format:

Charge Codes for each procedure listed at left:
(i.e. arterial blood gas – 90630906…)
If unsure, please contact your study manager, or
hospital staff contact person

Hospital department(s) involved in study:
(i.e., lab, radiology, pathology, etc.)
Facility(ies) where testing may done:
[ ] CRMC [ ] SIERRA OUTPT. [ ] CLOVIS
[ ] FHSH [ ] OTHER (specify __ )
Please e-mail this request form to CustomerSupport@communitymedical.org
You will be given a HEAT TICKET number. When the study mnemonic is completed,
you will be notified that the HEAT TICKET is completed.
You must cc the following people to your request:
 ISHospitalBillingTeam@communitymedical.org
 Deborah Garcia (DGarcia@communitymedical.org)
 IRB Office (IRB@communitymedical.org)
Please request the mnemonic in advance to allow sufficient time for the Customer Support
analysts to complete the request. IN ORDER TO ENSURE COMPLIANCE WITH
RESEARCH STUDY BILLING, FINAL IRB APPROVAL WILL NOT BE GRANTED
UNTIL THE STUDY MNEMONIC IS ACTIVATED IN THE SYSTEM. To request the
status of a HEAT TICKET, please contact Customer Support at 459-6560.
Updated 05/30/2013