PROTOCOL TITLE:

INSTRUCTIONS:
 Use this template to prepare a document with the information from the
following sections.
 Depending on the nature of what you are doing, some sections may not
be applicable to your research. If so mark as “NA”. For example, a
local single-site study would not require information in section 6.0.
For subsections, like 1.x or 8.x, you can delete it if it’s not applicable.
 When you write a protocol, keep an electronic copy. You will need to
modify this copy when making changes.
 As you are writing the protocol, remove all instructions in italics so
that they are not contained in the final version of your protocol.

PROTOCOL TITLE:
Include the full protocol title.
PRINCIPAL INVESTIGATOR:
Name
Department
Address
Telephone Number
Email Address
STUDY LOCATION(S):
List each location, name, department and address
Name of locations
Department
Address

VERSION NUMBER:
Include the version number of this protocol.
VERSION DATE:
Include the version date. This is the date this protocol version was finalized.

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Table of Contents
1.0 Objectives......................................................................................3
2.0 Background...................................................................................3
3.0 Inclusion and Exclusion Criteria.....................................................3
4.0 Study-Wide Number of Subjects....................................................3
5.0 Study-Wide Recruitment Methods.................................................3
6.0 Multi-Site Research........................................................................4
7.0 Study Timelines.............................................................................4
8.0 Study Endpoints.............................................................................4
9.0 Procedures Involved......................................................................4
10.0 Data and Specimen Banking.........................................................5
11.0 Data and Specimen Management.................................................5
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects...6
13.0 Withdrawal of Subjects*................................................................6
14.0 Risks to Subjects*..........................................................................6
15.0 Potential Benefits to Subjects........................................................7
16.0 Vulnerable Populations..................................................................7
17.0 Community-Based Participatory Research....................................7
18.0 Sharing of Results with Subjects...................................................7
19.0 Setting...........................................................................................7
20.0 Resources Available.......................................................................8
21.0 Recruitment Methods....................................................................8
22.0 Local Number of Subjects..............................................................9
23.0 Confidentiality...............................................................................9
24.0 Provisions to Protect the Privacy Interests of Subjects..................9
25.0 Compensation for Research-Related Injury...................................9
26.0 Economic Burden to Subjects......................................................10
27.0 Consent Process..........................................................................10
28.0 Process to Document Consent in Writing....................................13
29.0 Drugs or Devices.........................................................................13

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1.0 Objectives
1.1 Describe the purpose, specific aims, or objectives.
1.2 State the hypotheses to be tested.
2.0 Background
2.1 Describe the relevant prior experience and gaps in current
knowledge.
2.2 Describe any relevant preliminary data.
2.3 Provide the scientific or scholarly background for, rationale for, and
significance of the research based on the existing literature and how
will it add to existing knowledge.
3.0 Inclusion and Exclusion Criteria
3.1 Describe how individuals will be screened for eligibility.
3.2 Describe the criteria that define who will be included or excluded in
your final study sample.
3.3 Indicate specifically whether you will include or exclude each of the
following special populations: (You may not include members of the
above populations as subjects in your research unless you indicate
this in your inclusion criteria.)

 Adults unable to consent

 Individuals who are not yet adults (infants, children, teenagers)
 Pregnant women
 Prisoners
4.0 Study-Wide Number of Subjects
4.1 If this is a multicenter study for which you are the lead investigator,
indicate the total number of subjects to be accrued across all sites.
5.0 Study-Wide Recruitment Methods
If this is a multicenter study for which you are the lead investigator and subjects
will be recruited by methods not under the control of the local site (e.g., call
centers, national advertisements), describe those methods. Local recruitment
methods for non-multicenter research are described later in the protocol.
5.1 Describe when, where, and how potential subjects will be recruited.
5.2 Describe the methods that will be used to identify potential subjects.
5.3 Describe materials that will be used to recruit subjects. (Attach
copies of these documents with the application. For advertisements,
attach the final copy of printed advertisements. When advertisements
are taped for broadcast, attach the final audio/video tape. You may
submit the wording of the advertisement prior to taping to preclude

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re-taping because of inappropriate wording, provided the IRB

reviews the final audio/video tape.)
6.0 Multi-Site Research
6.1 If this is a multi-site study where you are the lead investigator,
describe the processes to ensure communication among sites, such
as:

 All sites have the most current version of the protocol, consent
document, and HIPAA authorization.
 All required approvals have been obtained at each site
(including approval by the site’s IRB of record).
 All modifications have been communicated to sites, and
approved (including approval by the site’s IRB of record)
before the modification is implemented.
 All engaged participating sites will safeguard data as required
by local information security policies.
 All local site investigators conduct the study appropriately.
 All non-compliance with the study protocol or applicable
requirements will be reported in accordance with local policy.
6.2 Describe the method for communicating to engaged participating
sites:

 Problems.
 Interim results.
 The closure of a study.
7.0 Study Timelines
7.1 Describe:

 The duration of an individual subject’s participation in the

study.
 The duration anticipated to enroll all study subjects.
 The estimated date for the investigators to complete this study
(complete primary analyses).
8.0 Study Endpoints
8.1 Describe the primary and secondary study endpoints.
8.2 Describe any primary or secondary safety endpoints.
9.0 Procedures Involved
9.1 Describe and explain the study design.
9.2 Provide a description of all research procedures being performed
and when they are performed, including procedures being performed
to monitor subjects for safety or minimize risks.

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9.3 Describe:

 Procedures performed to lessen the probability or magnitude

of risks.
 All drugs and devices used in the research and the purpose of
their use, and their regulatory approval status.
 The source records, including medical or educational records,
that will be used to collect data about subjects. (Attach all
surveys, scripts, and data collection forms.)
9.4 What data will be collected, including long-term follow-up.
9.5 For HUD uses provide a description of the device, a summary of
how you propose to use the device, including a description of any
screening procedures, the HUD procedure, and any patient follow-
up visits, tests or procedures.
10.0 Data and Specimen Banking
10.1 If data or specimens will be banked for future use, describe where
the specimens will be stored, how long they will be stored, when they
will be destroyed (if ever), how the specimens will be accessed, and
who will have access to the specimens.
10.2 List the data to be stored or associated with each specimen.
10.3 Describe the procedures to release data or specimens, including: the
process to request a release, approvals required for release, who
can obtain data or specimens, and the data to be provided with
specimens, including whether those data will be identifiable to
others.
11.0 Data and Specimen Management
11.1 Describe the data analysis plan, including any statistical
procedures.
11.2 Provide a power analysis, if necessary.
11.3 Describe the steps that will be taken to secure the data to maintain
confidentiality (e.g., training, authorization of access, password
protection, encryption, physical controls, certificates of
confidentiality, and separation of identifiers and data) during
storage, use, and transmission.
11.4 Describe any procedures that will be used for quality control of
collected data.
11.5 Describe how data and specimens will be handled study-wide:

 What information will be included in that data or associated

with the specimens?
 Where and how data or specimens will be stored?

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 How long the data or specimens will be stored?

 Who (role on the study) will have access to the data or
specimens?
 Who (role on the study) is responsible for receipt or
transmission of the data or specimens?
 How data and specimens will be transported?
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects
This section is required when research involves more than Minimal Risk
to subjects.
12.1 Describe:

 The plan to periodically evaluate the data collected regarding

both harms and benefits to determine whether subjects remain
safe. The plan might include establishing a data monitoring
committee and a plan for reporting data monitoring committee
findings to the IRB and the sponsor.
 What data are reviewed, including safety data, untoward
events, and efficacy data.
 How the safety information will be collected (e.g., with case
report forms, at study visits, by telephone calls with
participants).
 The frequency of data collection, including when safety data
collection starts.
 Who will review the data.
 The frequency or periodicity of review of cumulative data.
 The statistical tests for analyzing the safety data to determine
whether harm is occurring.
 Any conditions that trigger an immediate suspension of the
research.
13.0 Withdrawal of Subjects*
13.1 Describe anticipated circumstances under which subjects will be
withdrawn from the research without their consent, including
stopping participation for safety reasons.
13.2 Describe any procedures for orderly termination.
13.3 Describe procedures that will be followed when subjects withdraw
from the research, including partial withdrawal from procedures
with continued data collection.
14.0 Risks to Subjects*
14.1 List the reasonably foreseeable risks, discomforts, hazards, or
inconveniences to the subjects related the subjects’ participation in
the research. Include as may be useful for the IRB’s consideration,
describe the probability, magnitude, duration, and reversibility of

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the risks. Consider physical, psychological, social, legal, and

economic risks.
14.2 If applicable, indicate which procedures may have risks to the
subjects that are currently unforeseeable.
14.3 If applicable, indicate which procedures may have risks to an
embryo or fetus should the subject be or become pregnant.
14.4 If applicable, describe risks to others who are not subjects, e.g., risks
to ethnic or cultural groups, risks to sexual partners of subjects, etc.
15.0 Potential Benefits to Subjects
15.1 Describe the potential benefits that individual subjects may
experience from taking part in the research. Include as may be
useful for the IRB’s consideration, the probability, magnitude, and
duration of the potential benefits.
15.2 Indicate if there is no direct benefit. Do not include benefits to
society or others.
16.0 Vulnerable Populations
16.1 If the research involves individuals who are vulnerable to coercion
or undue influence, describe additional safeguards included to
protect their rights and welfare.
17.0 Community-Based Participatory Research
17.1 Describe involvement of the community in the design and conduct of
the research.
Note: “Community-based Participatory Research” is a collaborative
approach to research that equitably involves all partners in the
research process and recognizes the unique strengths that each
brings. Community-based Participatory Research begins with a
research topic of importance to the community, has the aim of
combining knowledge with action and achieving social change to
improve health outcomes and eliminate health disparities.
18.0 Sharing of Results with Subjects
18.1 Describe whether results (study results or individual subject results,
such as results of investigational diagnostic tests, genetic tests, or
incidental findings) will be shared with subjects or others (e.g., the
subject’s primary care physicians) and if so, describe how it will be
shared.
19.0 Setting
19.1 Describe the sites or locations where your research team will
conduct the research.

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 Identify where your research team will identify and recruit

potential subjects.
 Identify where research procedures will be performed.
 Describe the composition and involvement of any community
advisory board.
 For research conducted outside of the institution and its
affiliates describe:

o Site-specific regulations or customs affecting the

research for research outside the institution.
o Local scientific and ethical review structure outside the
institution.
20.0 Resources Available
20.1 Describe other resources available to conduct the research: For
example, as appropriate:
 Justify the feasibility of recruiting the required number of
suitable subjects within the agreed recruitment period. For
example, how many potential subjects do you have access to?
What percentage of those potential subjects do you need to
recruit?
 Describe the time that you will devote to conducting and
completing the research. (Note: This description is intended to
provide the IRB with information relative to conduct of the
study as relevant for the protection of research subjects, not for
effort reporting.)
 Describe your facilities. (Note: This description is intended to
provide the IRB with information relative to conduct of the
study as relevant for the protection of research subjects, not for
Facilities and Administration considerations.)
 Describe the availability of medical or psychological resources
that subjects might need as a result of an anticipated
consequences of the human research.
 Describe your process to ensure that all persons assisting with
the research are adequately informed about the protocol, the
research procedures, and their duties and functions.
21.0 Recruitment Methods
21.1 Describe when, where, and how potential subjects will be recruited.
21.2 Describe the source of subjects.
21.3 Describe the methods that will be used to identify potential subjects.
21.4 Describe materials that will be used to recruit subjects. (Attach
copies of these documents with the application. For advertisements,
attach the final copy of printed advertisements. When advertisements
are taped for broadcast, attach the final audio/video file. You may

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submit the wording of the advertisement prior to taping to preclude

re-taping because of inappropriate wording, provided the IRB
reviews the final audio/video file.)
21.5 Describe the amount, timing, and method of any payments to
subjects. (E.g., Gift card, ClinCard, check.)
22.0 Local Number of Subjects
22.1 Indicate the total number of subjects to be accrued locally.
22.2 If applicable, include a break-down of subjects by study location or
procedure group.
22.3 If applicable, distinguish between the number of subjects who are
expected to be enrolled and screened, and the number of subjects
needed to complete the research procedures (i.e., numbers of
subjects excluding screen failures.)
23.0 Confidentiality
23.1 If this is a multicenter study, describe the local procedures for
maintenance of confidentiality.

 Where and how data or specimens will be stored locally?

 How long the data or specimens will be stored locally?
 Who will have access to the data or specimens locally?
 Who is responsible for receipt or transmission of the data or
specimens locally?
 How data and specimens will be transported locally?
24.0 Provisions to Protect the Privacy Interests of Subjects
24.1 Describe the steps that will be taken to protect subjects’ privacy
interests. “Privacy interest” refers to a person’s desire to place
limits on with whom they interact or to whom they provide personal
information.
24.2 Describe what steps you will take to make the subjects feel at ease
with the research situation in terms of the questions being asked and
the procedures being performed. “At ease” does not refer to
physical discomfort, but the sense of intrusiveness a subject might
experience in response to questions, examinations, and procedures.
24.3 Indicate how the research team is permitted to access any sources of
information about the subjects. (E.g., What permission does the
research staff have to access medical records or other sensitive
information?)
25.0 Compensation for Research-Related Injury
25.1 If the research involves more than Minimal Risk to subjects, describe
the available compensation in the event of research-related injury.

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25.2 Provide a copy of contract language, if any, relevant to

compensation for research-related injury.
26.0 Economic Burden to Subjects
26.1 Describe any costs that subjects may be responsible for because of
participation in the research.
27.0 Consent Process
27.1 Indicate whether you will you be obtaining consent, and if so
describe:

 Where will the consent process take place

 Any waiting period available between informing the
prospective subject and obtaining the consent.
 Any process to ensure ongoing consent.
 Describe:

o The role of the individuals listed in the application as

being involved in the consent process.
o The time that will be devoted to the consent discussion.
o Steps that will be taken to minimize the possibility of
coercion or undue influence.
o Steps that will be taken to ensure the subjects’
understanding.

Non-English Speaking Subjects

 Indicate what language(s) other than English are understood

by prospective subjects or representatives.
 If subjects who do not speak English will be enrolled, describe
the process to ensure that the oral and written information
provided to those subjects will be in subjects’ preferred
language. Indicate the language that will be used by those
obtaining consent and by those communicating any relevant
future research information.

Waiver or Alteration of Consent Process (consent will not be

obtained, required information will not be disclosed, or the
research involves deception)

 Ensure you have provided sufficient information for the IRB to

make these determinations.
 If the research involves a waiver of the consent process for
planned emergency research, ensure you have provided
sufficient information for the IRB to make these
determinations.

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Subjects who are not yet adults (infants, children, teenagers)

 Describe the criteria that will be used to determine whether a

prospective subject has not attained the legal age for consent
to treatments or procedures involved in the research under the
applicable law of the jurisdiction in which the research will be
conducted. (E.g., individuals under the age of 18 years.)
 Describe whether parental permission will be obtained from:

o Both parents unless one parent is deceased, unknown,

incompetent, or not reasonably available, or when only
one parent has legal responsibility for the care and
custody of the child.
o One parent even if the other parent is alive, known,
competent, reasonably available, and shares legal
responsibility for the care and custody of the child.

 Describe whether permission will be obtained from individuals

other than parents, and if so, who will be allowed to provide
permission. Describe the process used to determine these
individuals’ authority to consent to each child’s general
medical care.
 Indicate whether assent will be obtained from all, some, or
none of the children. If assent will be obtained from some
children, indicate which children will be required to assent.
 When assent of children is obtained describe whether and how
it will be documented. The IRB allows the person obtaining
assent to document assent on the consent document and does
not routinely require separate assent documents and does not
routinely require children to sign assent documents, although
such option is available in the template consent document
referenced in Section 29 below.

Cognitively Impaired Adults

 Describe the process to determine whether an individual is

capable of consent. The IRB allows the person obtaining assent
to document assent on the consent document and does not
routinely require separate assent documents and does not
routinely require cognitively impaired adults to sign assent
documents, although such option is available in the template
consent document referenced in Section 28 below.

Adults Unable to Consent

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 List the individuals from whom permission will be obtained in

order of priority. (E.g., durable power of attorney for health
care, court appointed guardian for health care decisions,
spouse, and adult child.)
 Describe the process for assent of the subjects. Indicate
whether:

o Assent will be required of all, some, or none of the

subjects. If some, indicate which subjects will be required
to assent and which will not.
o If assent will not be obtained from some or all subjects,
an explanation of why not.
o Describe whether assent of the subjects will be
documented and the process to document assent. The IRB
allows the person obtaining assent to document assent on
the consent document and does not routinely require
separate assent documents and does not routinely require
subjects to sign assent documents, although such option
is available in the template consent document referenced
in Section 28 below.
 Describe the process for obtaining consent from subjects who
were previously unable to consent for themselves.

Adults Unable to Consent

 For HUD, uses provide a description of how the patient will be
informed of the potential risks and benefits of the HUD and
any procedures associated with its use.
28.0 Process to Document Consent in Writing
28.1 Describe whether and how consent of the subject will be documented
in writing.
28.2 (If you will document consent in writing, attach a consent document
in your application. If you will obtain consent, but not document
consent in writing, attach a consent script in your application. You
may use the consent form template to create the consent document or
script.)
29.0 Drugs or Devices
29.1 If the research involves drugs or devices, describe your plans to
store, handle, and administer those drugs or devices so that they will
be used only on subjects and be used only by authorized
investigators.
29.2 If the drug is investigational (has an IND) or the device has an IDE
or a claim of an abbreviated IDE (non-significant risk device),
include the following information:

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 Identify the holder of the IND/IDE/Abbreviated IDE.

 Identify/List the National Clinical Trial Number (NCT)
 Explain procedures followed to comply with USFDA sponsor
requirements for the following:
Applicable to:
Abbreviat
USFDA
IND Studies IDE studies ed IDE
Regulation
studies
21 CFR 11 X X
21 CFR 54 X X
21 CFR 210 X
21 CFR 211 X
21 CFR 312 X
21 CFR 812 X X
21 CFR 820 X

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