University of Pennsylvania  Institutional Review Board
Biomedical Sciences Application for Review of Human Research
Responsible
Org:
Section I
IND
Sponsor:
IDE
Sponsor:
(or 510K
Sponsor)
Grant #:
IND
Number:
IDE
Number:
(or 510K
number)
Project Title:
Short Title:
BILLING
INFORMATION
(for industry
sponsored
clinical
research)
Business
Administrator
(Grant Title if different from Project Title)
The IRB charges fees to cover the costs associated with the review of industry sponsored investigational
drug and device studies. Fees do not influence the decision of the board and the same fee is charged
regardless of the decision. Fees are charged for initial review and annually for continuing review.
Bill fees directly to:
CRO
Drug or Device Sponsor
Sponsor name:
Name of sponsor’s representative:
Address:
Phone:
FAX:
E-mail:
Name of Reponsible Penn Business Administrator:
Phone:
E-Mail:
Clinical
Company Name:
Research
Address:
Organization
Phone:
managing
FAX:
conduct of
E-mail:
study?
Principal Investigator
Name:
Job Title:
Address:
Zip+4:
Study Contact (complete if primary contact is different
from PI)
Name:
Job Title:
Address:
Zip+4:
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Ed.D.
Pharm.D.
J.D.
R.N.
Phone:
M.D.
Ph.D.
Other (specify):
D.M.D.
V.M.D.
D.M.D.
V.M.D.
Fax:
Cell
Pager:
phone:
PennCard
Email:
ID:
Human Research Training Completed?
Yes
No Expiration Date:
Ed.D.
Pharm.D.
Phone:
J.D.
R.N.
M.D.
Ph.D.
Other (specify):
Fax:
Cell
Pager:
phone:
PennCard
Email:
ID:
Human Research Training Completed?
Yes
No Expiration Date:
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University of Pennsylvania  Institutional Review Board
Co-Investigator
Student
Fellow
Resident
Ed.D.
Pharm.D.
Name:
Job Title:
J.D.
R.N.
M.D.
Ph.D.
Other (specify):
Phone:
D.M.D.
V.M.D.
Fax:
Cell
Pager:
phone:
Address:
PennCard
Email:
ID:
Human Research Training Completed?
Zip+4:
Yes
No Expiration Date:
Key Study Personnel
Key study personnel include all individuals responsible for the design or conduct of the study.
If more than 6, attach a separate sheet. Do not list personnel already listed above.
Note: All personnel (faculty, research fellows, students, and staff) engaging in human research must have documented,
discipline-appropriate training in human research protections. Certification is required every 3 years. Information on training
requirements is available at the IRB website.
Department,
Name & Degree
Division or
Role in
Affiliation
Project
Human Subjects Training Completed?
/
Yes
No Expiration Date:
/
Yes
No Expiration Date:
/
Yes
No Expiration Date:
/
Yes
No Expiration Date:
/
Yes
No Expiration Date:
Please answer ALL of the following questions. Does this protocol contain or involve:
1. For research involving drugs or devices, will the study be conducted under an IND (Investigational
New Drug Application) or an IDE (Investigational Device Exemption) or 510K Application?

IF YES, submit documentation of the IND/IDE number and ensure the IND/IDE Sponsor and
IND/IDE number(s) are properly recorded at the top of page 1 of this form.

IF YES, attach the appropriate number of copies of the Drug or Device Brochure, or an FDA
approved labeling (these items will not be returned to you) as indicated in Section III of this
IRB application (full-board vs. expedited review).

IF NO, and the study involves use of FDA approved drug(s) or device(s) in any manner listed
below, the IRB requires attached documentation of IND exemption from FDA or OHR (Penn
Office of Human Research or the Abraham Cancer Center).
Drugs or products administered to subjects not indicated in the FDA-approved drug labeling.
Drugs administered to subjects in combination with other drugs that is not considered
standard of care.
Drugs, products or devices prepared or used in a manner not in the FDA-approved labeling.
2. For research involving investigational devices, you are required to review the guidance on Medical
Device Accountability: www.med.upenn.edu/pennmanual/docs/DeviceAccountability.pdf
3. Are research subjects receiving any radiation exposure (e.g. X-rays, CT, Fluoroscopy, DEXA,
pQCT, FDG, Tc-99m, etc.) that they would not receive if they were not enrolled in this protocol?
 IF YES, the protocol must be approved by the Radioactive Drug Research Committee. Consult
EHRS website: www.ehrs.upenn.edu/protocols/radiohuman.html for submission requirements.
If you have questions, call 215-898-7187. For Pennsylvania Hospital studies, contact Dr. Len
Shabason: 215-829-3865.
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Yes
No
Not
Applicable
Yes
No
Not
Applicable
Yes
No
Template Version: 2 October 2009
University of Pennsylvania  Institutional Review Board
4. Does this research involve gene transfer (including all vectors) to human subjects?
 IF YES, the protocol must be approved by the Institutional Biosafety Committee. Consult EHRS
website: www.ehrs.upenn.edu/protocols/bio_humans.html for submission requirements.
If you have questions, call 215-898-4453.
Yes
No
5. Does this research include collection or use of human source material (i.e., human blood, blood
products, tissues or body fluids)?
 IF YES, consult the EHRS web site: www.ehrs.upenn.edu/programs/bio/bbpathogens.html
for information on OSHA Blood borne Pathogens requirements (training, vaccination, work
practices and Exposure Control Plan).
If you have questions, call 215-898-4453.
Yes
No
6. Does the research involve Center for Advanced Computed Tomography Imaging Services (CACTIS)
and CT studies that research subjects would not receive if they were not part of this protocol?
 IF YES, consult CACTIS website: www.uphs.upenn.edu/radiology/depa/CACTIS for application
requirements
Yes
No
7. Does the research involve Center for Advanced Magnetic Resonance Imaging and Spectroscopy
(CAMRIS) and MRI studies that research subjects would not receive if they were not part of this
protocol?
 IF YES, consult CAMRIS website: www.mmrrcc.upenn.edu/CAMRIS for application requirements
Yes
No
8. Does the research project involve the use of an investigational agent or device within the Operating
Room?
 IF YES, contact Associate Executive Director, Surgical Services: (215) 662-2089
Yes
No
9. Does the research involve cancer-related clinical trials that are not subjected to outside peer
review?
 IF YES, the protocol must be submitted to the Cancer Center’s Clinical Trials Scientific Review
Committee for scientific review and approval prior to obtaining IRB approval. Consult the
CTSRMC website: www.ctsrmc.org for application requirements
Yes
No
Yes
No
Yes
No
The protocol may require review by the Vice Provost for Research’s Human Research
Advisory Committee. Contact: 215-573-1206.
Will clinical investigational materials involve any in-house manufacturing (including investigational
cellular preparations)? If yes, provide documentation of Good Manufacturing Practices (GMP)
certification of the facility.
If the materials are not manufactured at Penn, what is the source of the Investigational material?
(check all that apply)
10.
Supplied by license holder or funding agency
Purchased
Commercially manufactured for this study
10.a Will the research involve processing (such as over encapsulating, or compounding)?
Yes
No
11. For research involving drugs, herbal products, or other chemical entities administered to human
subjects, has the study received a registration number from the Investigational Drug Service (IDS)
Unit?
 IF YES, Print IDS Registration #:
 Obtain a registration number if the test materials will be processed, distributed, blinded and
accounted for through the Investigational Drug Service (IDS) by calling (215) 349-8817.
Note: The study protocol must describe the storage, handling, administration and test material
accountability tracking that will be maintained in the study.
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Not
Applicable
Template Version: 2 October 2009
University of Pennsylvania  Institutional Review Board
12. Does the research proposal involve the use and disclosure of research subject’s medical information
for research purposes?

Yes
No
Yes
No
IF YES, please check the box next to one of the following that is provided with this submission:
Separate authorization for use and disclosure of identifiable health information.
Modified research informed consent document that incorporates HIPAA requirements.
Request for HIPAA Waiver of Authorization.
13. Use of UPHS services
Does your study require the use of University of Pennsylvania Health System (UPHS) services tests or
procedures whether considered routine care or strictly for research purposes? (UPHS includes all Penn
hospitals and clinical practices, including the Clinical Care Associates network of community practices.
Examples of UPHS services/tests/procedures includes laboratory tests, use of the pathology lab,
radiologic or cardiovascular imaging tests, other diagnostic tests & procedures and associated
professional services, etc.

IF YES, Prospective Reimbursement Billing Analysis required*

IF NO, Prospective Reimbursement Billing Analysis not required
*For studies that utilize UPHS services/tests/procedures, the following is required, effective
October 1, 2009:



Completion and submission of a standardized Prospective Reimbursement Analysis to
the Office of Human Research: ohr@mail.med.uepnn.edu.
If there are plans to charge the cost of clinical services, tests, or procedures to medical
insurance, you must submit a budget worksheet or study activities worksheet highlighting
the routine care costs to be billed to medical insurance.
Details, including accessing the online training for this initiative, are located at:
http://www.med.upenn.edu/ohrobjects/prod/CMS/website/G1/index.html.
14 (a) Primary Focus of Research. The primary focus of your research is best described by which of
the following (Select the single best answer):
Tissue/biospecimen research
Research on human data sets (e.g. medical records, clinical registries, existing research data
sets, medical administrative date)
Epidemiological research
Survey research (the main focus of the research is administration of a survey to research
subjects).
Cognitive or behavioral therapy
Mechanistic or physiologic study in human subjects (T1 Translational research or Phase I drug
study)
Clinical trial (prospectively assigning subjects to health-related interventions to evaluate
outcomes
Quality improvement research (assessment of clinical practices to enhance patient care)
Other
14 (b) Does your protocol require any of the following interventions? Check all that apply.
Cognitive or behavioral therapy
Drug
Device - therapeutic
Device - diagnostic (assessing a device for sensitivity or specificity in disease diagnosis)
Surgical
Diagnostic test/procedure (research-related diagnostic test or procedure)
Obtaining human tissue for basic research or biospecimen bank
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University of Pennsylvania  Institutional Review Board
15. A FINANCIAL INTEREST includes any current or anticipated ownership interest or other financial
relationship with any company or entity that sponsors, provides support, or otherwise has a financial
interest in the conduct or outcome of this research protocol ("Outside Organization"). This includes:
 Service on the Outside Organization’s Board of Directors, or as an officer, manager, owner,
founder, partner, or in any other position of authority;
 Any ownership interest, stock, stock options, or other financial interest in a non-publicly traded
Outside Organization, or in a publicly traded Outside Organization that exceeds 5% ownership
or $10,000 in value, other than stock/stock options held in a mutual, pension, or investment fund
over which the investor has no control with regard to investment decisions;
 Ownership or other financial interest in a drug, device or other product used in this research, or
in a competing product, that is being developed or tested by, or manufactured, supplied or
distributed by the Outside Organization, including, a patent, trademark, copyright, or the receipt
or right to receive royalties or other compensation in connection with the development, licensing
and / or sale of the product;
 Any personal consulting, lecturing / speaking, service on the Scientific Advisory Board, expert
witnessing or other services provided to the Outside Organization for which the person providing
the service receives or has the right to receive compensation or anything of value; and
 Any other financial interest that would reasonably appear to be affected by the conduct or
outcome of this research protocol.
Yes
No
Does any person who is responsible for the design, conduct, or reporting of this research protocol
have a FINANCIAL INTEREST, as defined above, including:
 You and your spouse, parents and any children;
 The spouses, parents and any children of any person responsible for the design, conduct, or
reporting of this research; and
 Any corporation, foundation, trust or other entity controlled or directed by any of the above
individuals?
IF YES, any person identified with a financial interest must complete a Confidential Financial
Disclosure Statement ("Disclosure") and include a copy with your IRB submission.
In addition, for industry-sponsored trials, please attach the documentation submitted to the sponsor
as required by 21 CFR 54.1, if applicable.
16. Please indicate the applicable research committee(s) for this study, and status of any required approval(s):
Research Committee
N/A Pending Not sent Approved
CACTIS: Center for Advanced Computed Tomography Imaging Services
CAMRIS: Center for Advanced Magnetic Resonance Imaging and
Spectroscopy
CTRC Scientific Advisory Committee: Clinical Translational Research
Center
IBC: Institutional Biosafety Committee
RDRC: Radioactive Drug Research Committee
Surgical Services: Approval for research in the Operating Room
Clinical Trials Scientific Review and Monitoring Committee review
and approval for all clinical studies involving cancer patients at the
University of Pennsylvania that are not monitored under a cooperative
group such as ECOG, GOG, RTOG and NABTT
17. Multi-Site Research
1. Is this a multi-site (multi-center) study where Penn is the lead site or the coordinating center?
No
NOTE: A multi-site study is where different PIs at different institutions are conducting the same study.
Yes NOTE: This section does not apply to industry sponsored, NCI, or cooperative group trials.
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University of Pennsylvania  Institutional Review Board
 If yes, address the site communication plan in Part II, Protocol Summary, Question 6: Management of
Information for Multi-Site Research where a Penn Investigator is the Lead Investigator of a Multi-Site Study, or
Penn is the Lead Site or Coordinating Center in a Multi-Site Study.
 If yes, provide the following information for each location:
Site is Relying on Penn’s
Location and contact information of research site
IRB
IRB Authorization
Agreement Attached
Pending
IRB Authorization
Agreement Attached
Pending
IRB Authorization
Agreement Attached
Pending
IRB Authorization
Agreement Attached
Pending
IRB Authorization
Agreement Attached
Pending
IRB Authorization
Agreement Attached
Pending
Site’s not relying on Penn’s
IRB
IRB Approval Attached
Pending
IRB Approval Attached
Pending
IRB Approval Attached
Pending
IRB Approval Attached
Pending
IRB Approval Attached
Pending
IRB Approval Attached
Pending
2. Is the proposed research fully or partially conducted at a non-Penn site but under the auspices of Penn or its
staff?
No
Yes
NOTE: For research involving collaborations with Children’s Hospital of Philadelphia (CHOP), Penn and CHOP
have entered into a cooperative agreement that allows either CHOP or Penn to serve as the IRB of record
under certain defined scenarios. If the research involves collaboration with CHOP, refer to the agreement on
the IRB website and include the Penn/CHOP Cooperative Agreement Determination Form to the IRB
application to the proposed IRB of record.
 If yes, is the site “engaged” in the research. Read the following to determine if the site is engaged. If the
performance site is engaged in the research, then complete question 3 below.
No
Yes
 If no, a letter of permission from an individual in a decision making capacity will be required with the
supporting documents for this application. (For example, the performance site is a school district or doctor’s
office and the site is not engaged in the research.
An institution becomes engaged in human research when its employees or agents:
(1) intervene or interact with living individuals for research purposes; or
(2) obtain individually identifiable private information for research purposes.
For further information about determining whether non-Penn performance site is “engaged”, refer to the OHRP
guidance document or contact the IRB at 215-573-1206.
3. If the performance site is “engaged” in the research, review each of the categories below and determine which
applies to your research and what must be done to comply. Check all appropriate categories.
Federalwide Assurance
Individual Investigator
IRB Approval
IRB Approval
(FWA)
Agreement
Under limited and defined
The “engaged” site is
The “engaged” site has its
circumstances, Penn will
The “engaged” performance
relying on a Penn IRB or
own IRB or is relying on an
extend its FWA to cover
site does not have an IRB.
Penn is relying on the
IRB other than Penn.
collaborating individual
performance site’s IRB.
investigators.
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University of Pennsylvania  Institutional Review Board
What is Needed
What is Needed
If the research is federally
funded, a Federalwide
Assurance is Required for
each site.
If the research is not federally
funded, no FWA is required.
The institution engaged in the
research will be responsible
for submitting an assurance
to the Office of Human
Research (OHRP).
For federally funded
research, no research may
begin at the individual site
until an FWA is obtained.
What is Needed
Obtain IRB approval from
each site and submit to the
IRB.
No research related
activities may begin at the
site until IRB approval is
obtained and the IRB
approval letter is submitted
to the IRB.
Contact the IRB at Penn. If
both Penn and the
performance site agree that
one IRB will serve as the
IRB of record, Penn will
enter into an IRB
Authorization Agreement
with the performance site.
What is Needed
Contact the IRB at Penn. If
Penn agrees to serve as
the IRB of record for the
individual investigator,
Penn will enter into an
Individual Investigator
Agreement with the
investigator.
If the research is federally
funded, the performance
site is required to designate
the responsible Penn IRB
on the performance site’s
FWA.
REQUIRED SIGNATURES: The department chair’s signature for the individual departments with faculty participating in
this study in addition to the principal investigator and principal investigator’s department chair’s signature are required
below. If additional signatures are required in excess of the number of spots below, please obtain and identify the
appropriate signatures on another sheet and attach it to this form.
Principal Investigator (print)
Signature of Principal Investigator
Date
PI’s Dept. Chair, or Dean if PI is Dept. Chair (print)
Signature of Dept. Chair/Dean
Date
Co-PI (print)
Co-PI’s Signature
Co-PI’s Dept. Chair, or Dean if Co-PI is Dept. Chair
(print)
Signature of Co-PI’s Dept. Chair, or Dean if
Co-PI is Dept. Chair
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Date
Template Version: 2 October 2009