University of Pennsylvania  Institutional Review Board
Application for Review of Human Research: IRB Protocol Summary
Biomedical Research
Section II
Note: Delete the instructions – blue text – prior to submitting the application.
Principal Investigator: Full name and degree of Principal Investigator
PROTOCOL TITLE
1. Full Title
Note: A few elements of this protocol summary are intentionally redundant with IRB application Section I since
this summary is designed as a stand-alone document.
2. Brief Title
Brief protocol title understandable to a layperson.
STUDY SPONSORSHIP
1. Funding Sponsor
Identify the agency, organization, company or person providing funds for the research study.
2. Primary Sponsor
Also called the regulatory sponsor, this is the agency, organization, company or person primarily responsible for
initiating and overseeing the research and ensuring the study complies with research standards and federal
regulations. For clinical trials (studies involving drugs or devices) this is typically the FDA IND holder, for device
studies, this is the FDA IDE holder.
 For industry-sponsored trials, typically the pharmaceutical/device/biotechnology company is the regulatory
sponsor.
 For non-industry sponsored trials, the regulatory sponsor is typically the PI or the NIH or an NIHdesignated entity (e.g. for the NCI, CTEP can be the regulatory sponsor if that entity holds the FDA IND or
IDE).
For more information about regulatory sponsor status, INDs and IDEs, see the Penn Manual for Clinical
Research, section on Research Involving Drugs or Devices: www.med.upenn.edu/pennmanual/sp/rdd/index.html.
PROTOCOL ABSTRACT
Brief abstract (250 words or less) describing the study in language understandable to a layperson. Include brief
description of the purpose, target disease/condition if applicable, key eligibility criteria, and main study
interventions.
OBJECTIVES
1. Overall Objectives
Brief statement of the overall objectives of the study.
2. Primary Outcome Variable(s)
Define the primary outcome variable(s) used to support the study objectives; e.g. if the objective is to show that
treatment A is superior to treatment B in the treatment of subjects with essential hypertension, the primary
outcome variable is blood pressure measurement.
3. Secondary Outcome Variable(s)
Define the secondary outcome variables. Such measured variables should also include the timing of
measurement
BACKGROUND
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Describe succinctly and clearly the past findings which justify the plan for this project. A summary of the relevant
literature in the area of interest and reports of previous studies should be included.
CHARACTERISTICS OF THE STUDY POPULATION
1. Target Population
State the clinical condition, disease state, or population characteristic of primary interest, e.g. “Adult subjects with
a diagnosis of Type II diabetes for greater than two years.”
Note: Within the limitations imposed by the diversity of the prospective study population, research should include
sufficient enrollment of persons of diverse ethnic and racial background in order to ensure the benefits and burdens
of research are equitably distributed.
2. Accrual
State the total number of subjects to be enrolled into the study. If the study is a multi-site study, also state the
number of subjects to be enrolled at the Principal Investigator’s site. Note: A multi-center study is a study where
different PIs at different institutions are conducting the same study. Explain how you will have access to a
population that will allow you to recruit the required number of subjects.
Describe the statistical methods or theoretical justification for determining sample size or sampling approach for
the study.
3.. Key Inclusion Criteria
List key inclusion criteria including age range and gender of potential participants.
4. Key Exclusion Criteria
List key exclusion criteria. If subjects are excluded because of age, economic status, gender, race or ethnicity,
provide the justification for exclusion.
5. Vulnerable Populations
(HHS regulations 45CFR46 Subparts B, C, & D for pregnant women, fetuses, neonates; prisoners; and children.
FDA regulations 21CFR50 Subpart D for children)
Specify if the study involves any of the following populations:
 Children (Refer to SOP RR 501 for the definition of children):
 Pregnant women (if the study procedures may affect the condition of the pregnant woman or fetus)
 Fetuses nor neonates
 Prisoners
 Note: If none of the above populations are to be included into the study, write: “Children, pregnant women,
fetuses, neonates, or prisoners are not included in this research study.”
Note: Complete the appropriate supplemental form for each vulnerable population included in the study.
Supplemental forms are available on the IRB website:
 Pregnant women, fetuses, neonates
 Prisoners
 Children
Note: Subjects who become imprisoned or are court-ordered to attend residential alcohol and other drug
treatment facilities will be considered prisoners under Subpart C of the federal regulations 45CFR46. Such
subjects cannot be continued in the research unless an amendment to the protocol is submitted and approved by
the IRB and certification to the federal Office of Human Research Protections if the research is supported by the
Department of Health and Human Services.
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6. Populations vulnerable to undue influence or coercion
When some or all of the participants were likely to be vulnerable to coercion or undue influence such as children,
prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons,
employees or students of Penn describe the additional safeguards have been included in the study to protect the
rights and welfare of these subjects from coercion or undue influence.
NOTE: This section is intended to elicit information regarding additional protections when specific populations are
included in a research study. It is not intended to trigger an exclusion of these populations.
7. Subject Recruitment
Overview the approach to subject identification and recruitment, including referrals from physician offices, clinics,
health fairs, patient informatics databases, advertisement, etc. It is important to note the key personnel involved
in the effort and location of the screening or recruitment activities. List the information to be disseminated to
subjects; e.g. handouts, brochures, and flyers.
 If the research involves no interaction with human subjects (i.e. involves only data and/or specimens)
write, “Not applicable.”
Note: The IRB must approve all recruitment materials, including advertisements, prior to use. Include
recruitment materials and proposed advertisements with the IRB submission application, if available.
Otherwise, submit when available for expedited review. Refer to the IRB Guidance on Recruitment
Materials.
Note: For studies using UPHS patient populations, attending or referring physicians must have a reasonable
opportunity to affect the manner in which their patients are invited to participate. According to the University of
Pennsylvania’s HIPAA policy, in order to recruit subjects into a research study using PHI, “the following contact
methods in descending order of preference are:
 By a physician or other health care professional who has taken care of a patient
 By the Penn School of Medicine using a cover letter agreed upon by a physician who has taken care of
the patient using script approved by the Penn IRB
 By the researcher. Direct recruitment by a researcher who has not taken care of the patient will require
specific Penn IRB approval and will only be allowed when both of the other two alternatives are impractical.
The summary must include investigator justification for direct contact. Include copies of all proposed
letters to subjects and intermediaries.
STUDY DESIGN
1. Phase
Phase I, II, III, or IV
 Write “Not applicable” if phase does not apply.
2. Design
Include design issues such as randomized, blinding (double, single, etc.), placebo-controlled, parallel group or
cross-over, telephone survey, internet research, focus group, etc.)
3. Study Duration
List projected overall duration of the study including:
 Estimated length of time to enroll all subjects and complete the study
 Length of a subject’s participation time in study
 Projected date of completion of the proposed study
DRUGS OR DEVICES
Does the research involve FDA approved drugs or devices used for off-label purposes? If so, what is the off-label
use?
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IND Determination: Answer the following questions. If the answer to any of the following questions is
“Yes,” you are required to submit and Investigational New Drug Application (IND) to the Food and Drug
Administration. If the answer to all the following questions is no, an IND exemption letter is required from
either the FDA or the School of Medicine Office of Human Research.
Will the results be reported to the FDA as a well controlled study in support a new drug indication for use will it be
reported or to support any significant change in the labeling of the drug?
If the drug is lawfully marketed as a prescription drug product, is the investigation intended to support a significant
change in the advertising for the product?
Does the study involve a route of administration or dosage level, use in a subject population, or other factor that
significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug?
For research involving investigational devices, describe the Standard Operating Procedure or plan for device
control. Address how the devices will be stored in such a way that only research staff associated with the protocol
will have access to the devices; and describe measures that will be put into place to ensure that the devices will
only be used in participants of this research protocol. Refer to the Guidance: Device Accountability in Clinical
Research, and the Penn Manual.
STUDY PROCEDURES
1. Procedures
 Describe study procedures. Include a table or flow chart, if necessary, showing the schedule of the
procedures and interactions. It is important to distinguish between interventions that are experimental and
carried out for research purposes vs. those that are considered standard of care. In addition, routine
procedures that are performed solely for research purposes should also be identified.
 Describe the follow-up of subjects and identify any procedures that are performed exclusively for research
purposes or performed more frequently than would be clinically indicated (e.g., additional x-ray).
2. Statistical Analysis
Describe briefly the statistical methods used to analyze the data.
 Note: If the statistical methods are described in the detailed protocol, this section may reference the
detailed protocol.
Note: If the research involves no interaction with human subjects (i.e. involves only data and/or specimens
already obtained for a reason other than this research study) write, “This research involves no interaction with
human subjects” and delete the table above.
3. Confidentiality
Confidentiality refers to the subject’s understanding of, and agreement to, the ways identifiable information will be
stored and shared. Confidentiality refers to the researcher’s agreement with the participant about how the
participant’s private information will be handled, managed, and disseminated.
How will confidentiality of data be maintained? Check all that apply.
Paper-based records will be kept in a secure location and only be accessible to personnel involved in the
study.
Computer-based files will only be made available to personnel involved in the study through the use of
access privileges and passwords.
Prior to access to any study-related information, personnel will be required to sign statements agreeing to
protect the security and confidentiality of identifiable information.
Whenever feasible, identifiers will be removed from study-related information.
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A Certificate of Confidentiality will be obtained, because the research could place the subject at risk of
criminal or civil liability or cause damage to the subject’s financial standing, employability, or liability.
A waiver of documentation of consent is being requested, because the only link between the subject and
the study would be the consent document and the primary risk is a breach of confidentiality. (This is not an
option for FDA-regulated research.)
Precautions are in place to ensure the data is secure by using passwords and encryption, because the
research involves web-based surveys.
Audio and/or video recordings will be transcribed and then destroyed to eliminate audible identification of
subjects.
Other (specify):
Describe how the confidentiality of subject will be maintained. Describe if and how the data will be de-identified.
Explain how the data will be kept confidential throughout the course of the research identifying those persons in
possession of and/or who will have access to the data. Explain where and how the data will be stored and
protected during the active research process. Explain what will happen to the data at the conclusion of the study:
if the data will be destroyed, retained and/or shared with other investigators for future research. If video and/or
audiotapes were used in the data collection process describe the disposition of the tapes and/or discs at the
conclusion of the study. For data that is retained or shared with other researchers explain under what conditions
personal identifiers will be used, if at all. Explain under what conditions the data may become part of the subject’s
permanent record, such as an employment or academic record. Explain how this can be mitigated if possible.
4. Privacy
Privacy refers to a person’s desire to control the access of others to themselves, e.g., persons may not want to be
seen entering a place that might stigmatize them. When deveoping strategies for the protection of subjects’
privacy, consideration should be given to:
- Settings in which an individual will be interacting with an investigator
- Methods used to obtain information about participants.
- How to access the minimum amount of information necessary to complete the study.
What precautions will be used to ensure subject privacy is protected?
HIPAA
Describe if data to be collected contain any protected health information (PHI) and specify which PHI is to be
collected. Health information is determined to be PHI if it contains any of the following identifiers:
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Name
Street address, city, county,
precinct, zip code, and equivalent
geocodes
All elements of dates (except year)
for dates directly related to an
individual and all ages over 89
Telephone numbers
Fax numbers
Electronic mail addresses
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Social security numbers
Medical record numbers
Health plan ID numbers
Account numbers
Certificate/license numbers
Vehicle identifiers and serial
numbers, including license plate
numbers
Device identifiers/serial numbers
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Web addresses (URLs)
Internet IP addresses
Biometric identifiers, incl. finger
and voice prints
Full face photographic images
and any comparable images
Any other unique identifying
number, characteristic, or code
Where will research data be stored and how will it be secured? Will the data be disclosed to anyone who is not
listed in Section I of the application? If, so, identify the disclosures (e.g., sponsor, Data and Safety Monitoring
Board, NIH, FDA)
Note: If no PHI is to be collected, write: “No protected health information is to be collected.”
5. Tissue Specimens
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Relate if blood and human tissue specimens are to be obtained for research, and if the specimens:
 Were collected during regulator clinical care (for treatment or diagnosis)
 Would have otherwise been discarded
 Are publicly available
 Are collected as part of the research protocol
 Whether this research involves banking of blood, tissue, etc, for future uses
Note: If no blood/tissue specimens are to be obtained for research, write: “Not applicable.”
6. Genetic Testing
If genetic testing is involved, describe the nature of the tests, including if the testing is predicative or exploratory in
nature. If predictive, please describe plan for disclosing results to subjects and provision of genetic counseling.
 Describe how subject confidentiality will be protected
 If no genetic testing is to be obtained, write: “Not applicable.”
RISK/BENEFIT ASSESSMENT
1. Potential Study Risks
Describe and assess any potential risks associated with the research interventions (physical, psychological,
social, economic, monetary, legal or other, loss of confidentiality) and assess the likelihood and seriousness of
such risks. If methods of research create potential risks, describe other methods, if any, that were considered
and why they will not be used.
2. Potential Study Benefits
Assess the potential benefits to be gained by the individual subject, as well as benefits that may accrue to society
in general as a result of the planned work (such as advancement of knowledge). Summary should also state if
there are no direct benefits to subjects as a result of their participation in the study.
3. Alternatives to Participation
Describe the alternatives available to the subject outside the research context.
4. Data and Safety Monitoring
Summarize how safety, privacy, and data integrity will be assessed during the course of the study, including any
planned interim analyses. Describe specific stopping rules, or study intervention unblinding requirements if
applicable.
Who will monitor this study? Check all that apply.
Principal Investigator
Sponsor or contract research organization
NCI sponsored cooperative group
Cancer Center (if mandated by CTSMRC)
Medical monitor
Safety monitoring committee
Data and safety monitoring board
Note: Clinical trials (studies involving assessment of medical interventions) must have a monitoring plan appropriate
for the potential risks and the complexity of the trial. Monitoring plans describe how a monitor, independent of the
study team, regularly inspects study records to ensure the study is adhering to the study protocol and applicable
research regulations and Penn requirements. Rather than describe the full detailed monitoring plan here, summarize
the key attributes of that plan, and attach the more detailed plan to the main study protocol. Monitoring plans do not
necessarily require the use of an independent Data and Safety Monitoring Board (DSMB). Such independent boards
are usually reserved for high-risk phase I studies, or large, multi-center phase III trials. Federally funded studies may
require the use of an independent DSMB. For more information on monitoring plans, see the Penn Manual for
Clinical Research and the section on such plans: www.med.upenn.edu/pennmanual/sp/mpd/index.html.
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5. Management of Information for Multi-center Research where a Penn Investigator is the Lead
Investigator of a multi- center study, or Penn is the lead site in a multi-site study.
Provide a plan for the management of multi-site information that may be relevant to the protection of human
research participants, such as:
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Reporting unanticipated problems involving risks to participants or others.
Reporting of Interim results.
Coordination of protocol modifications.
6. Risk/Benefit Assessment
Assess the ratio of the benefit to be obtained from the study relative to the risks involved. The risks of participation
in the research must be balanced by the potential benefits of the research to potential subjects and/or society.
Note: "Minimal risk" means that the risks of harm anticipated in the proposed research are not greater,
considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of
routine physical and psychological examinations or tests.
SUBJECT COMPENSATION
Summarize any financial compensation that will be offered to subjects, e.g. cash payments, gift card, reimbursement
for travel. The amount of compensation may not constitute an undue inducement to participate in the research. A
prorated system of financial compensation is required in most circumstances. Provide the schedule for
compensation per study visit or session and total amount for entire participation.
INFORMED CONSENT
1. Consent Process
Summarize how informed consent will be obtained, including how, when, where, and by whom it will be obtained.
• Informed consent is an ongoing process that takes place between the investigator/study staff and study
participants. In most cases, this process is initiated with written informed consent at the start of the study;
however, it also takes place as an ongoing dialogue between the investigator/study staff and subjects during
the entire duration of their participation.
• Describe any waiting period between informing the prospective participant and obtaining the consent.
• Describe any steps taken to minimize the possibility of coercion or undue influence.
• Describe the language used by those obtaining consent.
• Describe the language understood by the prospective participant or the legally authorized representative.
• If children or adolescents are enrolled, describe the consent process includes parental permission and
subject assent.
• Will all adult subjects be competent to give informed consent? If not, respond to the following:
o What is the likely degree of impairment? How will competency be assessed (eg, informal
assessment by the investigator, mini-mental status exam, formal psychiatric evaluation)? Note:
The methods of assessment of competence should be based on the population to be studied and
the likelihood of cognitive or decisional impairment in that population.
o Will consent be obtained from a legally authorized representative, from whom will consent be
obtained? Refer to the IRB Policy 705, Surrogate Consent/Authorization for guidance.
o Will subject assent be obtained? If no, provide justification. Note: Respect for persons requires that
assent (or at least lack of active dissent) be obtained in most cases.
2. Waiver of Authorization
NOTE: if the research is subject to FDA regulations, waiver of informed consent is not allowed except as provided
in FDA regulations 21 CFR 50.23 for emergency use of a test article; under 21 CFR 50.24 for planned
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emergency research; or as described in FDA Guidance on Informed consent for In Vitro Diagnostic Device
Studies Using Leftover Human Specimens that are not Individually Identifiable.
If waiver of authorization is sought, summarize the key elements of the justification for a request for the waiver.
Such a justification must conform to one of the three waiver of authorization scenarios below.
Waiver or alteration of required elements of consent: According to HHS CFR 45.46.116(d): An IRB may approve
a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or
waive the requirements to obtain informed consent. In order to qualify for a waiver or alteration to the informed
consent process, please justify each of the following:
 the research involves no more than minimal risk to the subjects;
 the waiver or alteration will not adversely affect the rights and welfare of the subjects;
Explain why this research would not be possible to conduct if the IRB required informed consent of
participants by completing the following statement, If the IRB required informed consent of participants, this
research would not be possible because…
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Also, estimate the number or percentage of participants for whom obtaining consent is anticipated to be
impracticable.
the research could not practicably be carried out without the waiver or alteration; and
whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Where not all research participants would not be available to consent, explain why the research could not be
done if all participants could not consent.
Waiver of written documentation of informed consent: According to HHS CFR 45.46.117(c)(1), an IRB may waive
the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds that the only
record linking the subject and the research would be the consent document and the principal risk would be
potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants
documentation linking the subject with the research, and the subject's wishes will govern. In cases in which the
documentation requirement is waived, the IRB may require the investigator to provide subjects with a written
statement regarding the research.
Describe the information that will be provided to the subjects. You may provide a separate informed consent script
or information sheet.
Waiver of written documentation of informed consent: HHS CFR 45.46.117(c)(2) and (where the research is
subject to FDA regulations) FDA 21 CFR 56.109(c)(1): An IRB may waive the requirement for the investigator to
obtain a signed consent form for some or all subjects if it finds that the research presents no more than minimal
risk of harm to subjects and involves no procedures for which written consent is normally required outside of the
research context (e.g. telephone survey). In cases in which the documentation requirement is waived, the IRB
may require the investigator to provide subjects with a written statement regarding the research. If requesting a
waiver of documentation of informed consent, provide the script or information sheet that will be used.
RESOURCES NECESSARY FOR HUMAN RESEARCH PROTECTION
Describe research staff and justify that the staff are adequate in number and qualifications to conduct the
research. Describe how you will ensure that all staff assisting with the research are adequately informed about the
protocol and their research related duties. Describe access to a population that would allow recruitment of the
targeted number of subjects. If medical or psychological services as a consequence of the research, describe
how the subject will be referred to those services. Describe your facilities and justify that the facilities are
adequate. Verify that there is sufficient time to conduct and complete the research.
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