Annotated Protocol Template
Key
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Purple Italics - Original Template Instructions
Black Text - Where you should type
Blue Text - Tips, Tricks
When you are finished, please be sure to delete all of the colored text.
1) Protocol Title
Include the full protocol title as listed on the application form.
Study Title
You don't want to give too much away in the title. This is what will be displayed on SONA. So, it
needs to be descriptive enough to be listed on the application form, but not so much that you
might affect how your participants behave.
2) Investigator(s)
Include the investigator’s name as listed on the application form.
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List investigators here
You need to list everyone that will be involved. I include everyone - from the PIs, other involved
personnel, and everyone who will be doing data collection and analysis. You need to make sure
that all of the names on the application are present on the protocol, as well as the informed
consent and debriefing form. Consistency is key. I also like to note who the PI is.
3) Objectives
Describe the purpose, specific aims, or objectives of the Human Research.
Objectives go here.
Write a one sentence statement that clearly summarizes your purpose.
State the research question or hypotheses to be tested.
H1: State your hypotheses.
Doing this now will save you time during the data analysis stage.
4) Background
Provide the scientific or scholarly background and rationale for the Human Research based on
the existing literature.
Provide a paragraph describing the background.
Do a brief, one paragraph statement that summarizes the rationale based in the literature for your
study.
Describe the relevant prior experience and gaps in current knowledge.
Provide a paragraph summarizing gaps in current knowledge.
Most studies are designed to address some hole in the current body of knowledge. Explicitly
state which unknown you are addressing.
Describe any relevant preliminary data.
Provide a statement describing the preliminary data, if applicable.
If you have collected any pilot data or run any studies in the past, describe very briefly what you
found.
Explain the significance of the Human Research in terms of why this Human Research important
and how will it add to existing knowledge.
Provide a statement about why this research is important.
So, what is the point? What information will be learned by conducting this study? How does that
help the entire field?
Describe the importance of the knowledge expected to result.
Provide a statement about the expected result.
Make a brief statement as to why this study is worthwhile with respect to the bigger picture.
Cite any relevant resources.
Relevant Resources
If you cite anything, put in the full APA citation here.
5) Setting of the Human Research
Describe the setting and location in which the Human Research will be conducted. If applicable,
describe:
 Site-specific regulations or customs affecting the research.
 Local scientific and ethical review structure.
 Composition and involvement of any community advisory board.
 Whether you have secured permission to use the site.
List the location.
Explicitly list the location where you will be collecting data. If you are collecting data oncampus, usually just saying where it is and that it is your space will suffice. If you are collecting
data at a different location, include information as to where, when, if they have their own IRB
and if it's been signed off on, who gave you permission, and if there are any other issues. For
example, if we were to conduct a usability study off-site at Novonics Corp., we would include a
statement similar to this one:
We have also secured permission to run participants off-site at Novonics
Corporation, located in Research Park (12000 Research Pkwy # 128, Orlando, FL
32826-2944) in one of their offices. They do not have a site IRB, however they
have filed with the U.S. Department of Health and Human Services and the Office
for Human Research Protections (DHHS FWA Number 00017287).
6) Resources available to conduct the Human Research
Demonstrate (e.g., based on retrospective data) a potential for recruiting the required number of
suitable subjects within the agreed recruitment period.
Participants will be recruited through the university's SONA system.
We tend to recruit from the online SONA system. You do not need to describe much more than
this. If you do have to recruit elsewhere, you will need to include a detailed recruitment plan.
Where will you be recruiting? How? Have you made an agreement with someone? Who?
Describe/estimate the time that you will devote to conducting and completing the research within
the agreed time period.
This study should take X semesters. Each experimental session should take no longer than Y
hours for participants to complete.
State for how long you will run the study and how long each session is.
Describe the number and qualifications of your staff, their experience in conducting research,
their knowledge of the local study sites, culture, and society.
Research staff is comprised of members from the Z Laboratory, part of UCF's Institute for
Simulation and Training and the UCF Department of Psychology. Researchers are graduate and
undergraduate students working under the guidance of Dr. A, and have been involved with game-
and simulation-based research for several years.
Here, describe the experience level of your researchers.
Describe your process to ensure that all persons assisting with the research are adequately
informed about the protocol, the investigational product(s), and their research-related duties and
functions.
All individuals of the research team are CITI certified and research assistants will receive
training as how to conduct this experiment and use all of the associated equipment. They will
also be provided with this protocol document and detailed written instructions.
If your study involves any specialized equipment (EEG, simulators, etc.), discuss if/how they
have been trained. It is also good to mention how your data collectors will be trained as well.
Describe the facilities in which your research will be conducted.
This study will be conducted WHERE?.
Describe briefly where you will conduct your experiment. If you are doing it in the Psychology
building, you can often leave it at that. if you are conducting it off-site, include information as to
the location (e.g., in classrooms at a local high school) and the equipment (e.g., using 25 laptops
with the software).
Where applicable, describe the availability of medical or psychological resources that
participants might need as a consequence of the Human Research.
Often times, your studies will not require this.
7) Study Design
NOTE: Researchers developing multi-faceted protocols (e.g., multiple phases, study groups,
research components, etc.) may want to develop separate “Study Design” sections for each
component of their research rather than trying to combine disparate components into a single
section.
a) Recruitment Methods
The source of participants, including when, where, and how potential participants will be
recruited.
Participants will be UCF psychology undergraduates, recruited through the university's
SONA System.
Somewhat redundant, but state how you will recruit students. You do not have to put
down much more information than the above statement if you are using SONA, however
if you are using a different method, you should be much more detailed and address each
of the items listed above.
The methods that will be used to identify potential participants.
If you are using SONA, you do not have to put anything here as it is already covered by
the above statement. However, if you are recruiting from a different population, you need
to state how you will identify your potential participants (e.g., all high school seniors at a
specific high school taking a certain course).
The expected number of participants needed to complete the Human Research.
Approximately X participants will be recruited (Y in each of our Z conditions).
Base this on a power analysis and your experimental design. You should have cleared this
number in advance with your advisor.
Any materials that will be used to recruit participants. Include copies of these documents
with the application. For advertisements, submit the final copy of printed advertisements.
When advertisements are taped for broadcast, provide the final audio/video tape. You
may 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 tape.
You can submit these documents using the iRIS document upload system. If you need
additional assistance, contact the UCF IRB directly and they will direct you further:
http://www.research.ucf.edu/Compliance/IRB/contact_form.cfm
The amount and timing of any payments to participants.
They will be awarded X.X SONA credits for being part of the study after completing
their assigned session.
Undergraduates often must earn a pre-specified number of SONA credits for their
coursework (or complete an alternative assignment). An in-person study awards 1.0 credit
for an hour. Online studies, however, must award half of the credits compared to their inperson counterparts. So, if your online study takes a full hour to complete, they will be
awarded 0.5 SONA credits.
For research in which biological specimens or tissue samples will be used, describe the
source of the materials (e.g. certified specimen banks, discarded specimens gathered for
non-research purposes, prospectively collected samples, etc.).
Generally, most studies will not collect biological specimens or tissue samples, but you
might (e.g., saliva swab to test for cortisol levels). Be aware of this and if you are,
address all of the issues listed above. I suggest enlisting the help of your advisor to ensure
that you include all of the correct and relevant information.
For research in which biological specimens or tissue samples will be used, describe
whether any individually identifiable information will be associated with the samples.
Same as above. The procedure is likely to include marking the specimens only with a
unique participant number. You will need to detail how records matching participant
numbers of individually identifiable information will be kept (often locked in a secure
location away from where the tissue samples are stored). Please complete this section
with your advisor.
b) Inclusion and Exclusion Criteria
Describe how you will screen for eligibility. Describe the criteria that define who will be
included or excluded in your final study sample.
Only participants that are 18 and older may participate. SONA can be configured to
permit only those who meet this criterion the ability to participate.
c) Study Endpoints
NOTE: This section is only required for biomedical research. It is generally not
applicable to social or behavioral research.
N/A
d) Procedures involved in the Human Research.
Describe the primary and secondary study endpoints. (For example, studies may be
conducted until a certain time point, until a reoccurrence of disease, or certain clinical
condition is met.)
Usually, this is not required for our type of research, although it might be for some
clinical studies.
Describe any primary or secondary safety endpoints. (Examples may include evidence of liver toxicity, an inability to tolerate further
chemotherapy, or other side effects related to a drug or device.)
Usually, this is not required for our type of research, although it might be for some
clinical studies.
Describe and explain the study design.
List the steps in order as they will occur. Who says what to who and when?
Describe the overall flow of your study. Be as detailed as possible. Include information
about the consent process, instructions to participants, and what they will be doing. The
more detail here, the better!
Provide a timeline of all procedures being performed, including procedures being
performed to monitor participants for safety or minimize risks.
This is for more detailed studies that may include multiple sessions and/or retention tests.
Detail the time between sessions and address the issues listed above.
Provide the overall duration of the research.
Each session will take no longer than X hours. The study should last approximately Y
semesters.
Describe procedures taken to lessen the probability or magnitude of risks.
The researcher will be sitting nearby at another desk in the room should the participant
encounter any problems. As participants will be sitting at a desk and using a computer the
amount of risk is minimal.
Identify which procedures are being done as part of the Human Research and which are
being conducted anyway for other reasons.
Describe the source records that will be used to collect data about participants.
This could be if, for example, you were conducting a study in an organization and
recruiting for your sample from employees. Personnel records could be used to gather
baseline performance data.
Describe what data will be collected including long-term follow-up.
Data includes X, Y, and Z.
Describe all of the data you will be collecting. If you are using any specialized
equipment, such as EEG, include that here as well. Describe the safety aspects associated
with the equipment as well.
If student/school records are to be used, include a list of specific data to be obtained from
the school and note whether it is identifiable at the student level, in accordance with
FRPA/PPRA requirements.
Describe any plans to conduct audio or video recording of research participants during
the conduct of the research.
e) Data management
NOTE: Data confidentiality issues are a separate topic that is addressed
in section 11 below.
As applicable, describe the following:
 The data and specimens to be sent out or received.
 What information will be included in that data or associated with the specimens.
 Who is responsible for receipt or transmission of the data.
 How specimens and data will be transported.
 The plan to manage the data.
 Any procedures that will be used for quality control of collected data.
 The data analysis plan, including any statistical procedures.
 Provide a power analysis.
Information that is collected will be stored how?
How will it be analyzed? Will it be input into any statistical programs? What kinds of
stats will you run? What is the power analysis? Example:
Data will be electronically input into SPSS (PASW) 19.0. Data will be examined
for outliers and errors and later analyzed using statistical methods such as
factorial ANOVA. We expect a medium effect size (d = .50), and to achieve a
power of .90, we must have at least 65 participants in each condition.
Again, be as detailed as possible here. Talk with your advisor and lab managers as to how
data is managed. Include all of the relevant details and be sure to address everything that
applies to your study from the list above. Include information on what analysis programs
will be used and what tests you expect to run. Also include a power analysis for your
desired level of power based on expected effect size (either from the literature or a pilot
study), the α, and whether it is a one-tail or two-tailed test.
f) Provisions to monitor the data for the safety of participants (Required when
Human Research involves more than minimal risk to participants.)
NOTE: This section is only required when Human Research involves more
than minimal risk to participants. It is not applicable to research that is
not more than minimal risk.
 Describe the plans to periodically evaluate the data collected regarding both
harms and benefits to determine whether participants remain safe.
 Describe who will review the data (e.g. the investigator, a medical monitor, a data
safety monitoring board, etc.).
 Describe what data are reviewed, including safety data, untoward events, and
efficacy data.
 Describe when data are reviewed.
 All participants will be assigned a unique identifier, which will be used for all
collected data.
 There will be no personally-identifiable information associated with this data and
no record kept as to which participant
N/A - This study does not involve more than minimal risk to participants
This type of research does not often involve more than minimal risk. If it does, be sure to
address all of the points listed above.
g) Withdrawal of participants
Describe anticipated circumstances under which participants will be withdrawn from the
research without their consent.
Describe any procedures for orderly termination.
Describe procedures that will be followed when subjects withdraw from the research,
including partial withdrawal from procedures with continued data collection.
Participants will be withdrawn from the experiment if they wish to no longer continue.
Any data collected from these participants will immediately be discarded.
If participants choose to withdraw from the study during the course of the session, they
will be allowed to do so without penalty. If they choose to withdraw from the study
through SONA before actually participating, they will be able to do so up until 24 hours
before the study. If they sign up for the study and do not show up or are more than 5
minutes late, they will be marked as “Unexcused No-Show” in the SONA system. This is
to comply with the standard set forth by the UCF Psychology department.
8) Risks to participants
List the risks, discomforts, hazards or inconveniences to the participants. For each, indicate the
probability, magnitude, and duration. Consider physical, psychological, social, legal and
economic risks.
 If applicable, indicate which procedures may have risks to the participants that are
currently unforeseeable.
 If applicable, indicate which procedures may have risks to an embryo or fetus should the
participant be or become pregnant.
Describe the potential risks.
Usually, our research does not have more than minimal risk. It is important, however, that if you
are doing simulator-based research, there is the chance that your participant may experience
some form of simulator sickness. This needs to be addressed here in the protocol and in your
informed consent process.
9) Potential benefits to participants
Describe the benefits that individual participants may experience. For each indicate the
probability, magnitude, and duration of the benefit. Indicate if there is no direct benefit.
Describe the potential benefits.
Many students are required to participate in SONA studies so that they are better able to
understand the research process. This is a benefit, so at the very least you should include this.
10) Provisions to protect the privacy interests of participants
Describe any applicable impact that the study or study procedures may have on participants’
privacy interests. (“Privacy interest” refers to a person’s desire to control access of others to
themselves. It involves consideration of whether the participants will be comfortable with the
Human Research situation. For example, persons may not want to be seen entering a place that
might stigmatize them, such as a pregnancy counseling center that is clearly identified as such by
signs on the front of the building.)
Research will take place in the Psychology building and should not have any impact on
participants' privacy interests.
Describe the steps that will be taken to protect participants’ privacy interests, when applicable.
11) Provisions to maintain the confidentiality of data
Describe the steps that will be taken to abide by promises made to the participant to limit
dissemination of identifiable data.
No personally-identifiable information will be collected. All participants will be assigned a
unique identifier which will be present on all data collection forms, however no records will be
kept as to which participant is linked to what identifier. All information collected will be
essentially anonymous and there will be no way in which data can be linked to specific
participants.
If you do collect data that does require collecting personally-identifiable information, you need
to detail your plan as how to maintain confidentiality (locking a list of IDs with names/phone
numbers in a separate filing cabinet in another room away from the data, destroying these
records after they are no longer needed, limiting access to this information, etc.). Discuss this
with your advisors and your lab managers for more information.
Describe where data will be stored, who will have access to the data, measures taken to secure
the data, and how long data will be stored.
How will data be stored? When will it be destroyed?
12) Medical care and compensation for injury
Note that this section is not applicable for research that involves no more than minimal risk. If
the research involves more than minimal risk to subjects, describe the provisions for medical
care and available compensation in the event of research related injury.
N/A
13) Cost to participants
Describe any financial costs that participants may incur through participation in the research, if
applicable.
N/A
14) Consent process
Note that the process of obtaining informed consent is distinct from the informed consent
document itself.
As appropriate, describe the following:
 The setting of the consent process.
 The role of the individuals listed in the application as being involved in the consent
process.
 The time that will be devoted to the consent discussion.
 Any waiting period between informing the prospective participant and obtaining the
consent.
 Any steps that will be taken to minimize the possibility of coercion or undue influence.
Describe in detail the steps to the consent process. Who does it? When?
Indicate what language(s) other than English are understood by prospective participants or
representatives. If participants who do not speak English will be enrolled, describe the process to
ensure that the oral and written information provided to those participants will be in that
language.
If the Human Research involves a waiver or alteration of the consent process (consent will not be
obtained, required information will not be disclosed, or the research involves deception) review
the “CHECKLIST: Criteria for Waiver or Alteration of the Consent Process” and address each
of the criteria for approval.
If the Human Research involves persons who have not attained the legal age for consent to
treatments or procedures involved in the research (“children”), describe the following:
 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.
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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.
Whether assent will be obtained from all, some, or none of the children, and if some
children, which children will be required to assent.
When assent of children is obtained, describe whether and how it will be documented.
If the Human Research involves adults who may be unable to consent, describe the
process to determine whether an individual is capable of consent.
If the Human Research involves adults who are unable to consent, describe the following:
 If permission of a legally authorized representative will be obtained:
o 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.)
o Submit a statement from legal counsel describing which individuals are
authorized under applicable law to consent on behalf of a prospective participant
to their participation in the procedure(s) involved in this Human Research.
 To obtain this statement, have legal counsel review the definition of “legally authorized
representative” in 45 CFR 46.102(c) or 21 CFR 50(l). The IRB can provide you a copy of
these regulations. Also provide legal counsel with a copy of the protocol or other
document describing the procedures involved in the Human Research.
Describe the process for assent of the participants. Indicate whether:
 Assent will be required of all, some, or none of the participants. If some, indicate which
participants will be required to assent and which will not.
 If assent will not be obtained from some or all participants, an explanation of why not.
 Describe whether assent of the participants will be documented, and the process to
document assent.
15) Process to document consent in writing
Describe whether and how consent of the participant will be documented in writing.
If the consent process will not be documented in writing (consent will be obtained but the
participant or representative will not sign a consent document) review the “CHECKLIST:
Criteria for Waiver of Written Documentation of Consent” and address each of the criteria for
approval.
Note that, depending on the populations under study, multiple versions of the informed consent
document may be needed.
How will consent be obtained? Is there documentation?
Many studies often will qualify for a waiver of documentation of informed consent. You will still
provide all of the information and answer questions as you normally would, however you would
not require them to sign and date it or store them.
16) Vulnerable populations (Pregnant Women, Minors, Prisoners, Decisionally
compromised adults, others)
If the Human Research involves individuals who are vulnerable to coercion or undue influence,
describe additional safeguards included to protect their rights and welfare.
If the Human Research involves adults unable to consent, review the “CHECKLIST: Criteria for
Research Involving Adults Unable to Consent” and address each of the criteria for approval.
If the Human Research involves persons who have not attained the legal age for consent to
treatments or procedures involved in the research (“children”):
Review the “CHECKLIST: Criteria for Research Involving Children” and address each of the
criteria for approval.
Describe the criteria that will be used to determine whether a prospective participant has not
attained the legal age for consent to treatments or procedures involved in the Human Research
under the applicable law of the jurisdiction in which the Human Research will be conducted.
(E.g., individuals under the age of 18 years.)
Submit a statement from legal counsel describing which persons have not attained the legal age
for consent to treatments or procedures involved in this Human Research, under the applicable
law of the jurisdiction in which this Human Research will be conducted.
To obtain this statement, have legal counsel review the definition of “children” in 45 CFR
46.402(a) or 21 CFR 50(0). The IRB can provide you a copy of these regulations. Also provide
legal counsel with a copy of the protocol or other document describing the procedures involved
in the Human Research.
If the Human Research involves pregnant women, review the “CHECKLIST: Criteria for
Research Involving Pregnant Women” and address each of the criteria for approval.
N/A
17) Drugs or Devices
If the Human Research involves drugs or device, describe your plans to control those drugs or
devices so that they will be used only on participants and be used only by authorized
investigators.
N/A
If you are doing a study on medical equipment or using devices to collect data, then please
complete this section. Include information as to how equipment will be used for research (e.g.,
EEF measurement devices), and how those collecting the data will be trained on those devices.
18) Multi-site Human Research
If this is a multi-site study where you are the lead investigator, describe the management of
information (e.g., results, new information, unanticipated problems involving risk to participants
or others, or protocol modifications) among sites to protect participants.
N/A
Again, if you are conducting multi-site human research, you may include a statement similar to
this: We will be conducting the same procedure using four instructional designers who have
already agreed to volunteer their time from IDEAS Orlando (64 East Concord St., Orlando, FL
32801, http://ideasorlando.com/). Data will be collected by the same training researchers and
transferred immediately back to our lab for entry and storage.
19) Sharing of results with participants
Describe any plans to share the results of the research with participants.
At the end of the session, each participant will be provided with a debriefing form. This form
will have information about the study and list contact information. They will be informed by this
document that they will be able to request study results. This form will also have information
about contacting the IRB about this study.