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Tips on Completing the IRB Protocol for Human Subjects Research form
The following are some tips on completing the IRB Protocol for Human Subjects Research form.
I will start at the beginning of the form and work my way through it. The goal is to have it in the
best shape so when the IRB reviews the form, there are no requests for clarification, no
requests for revisions thus facilitating approval of the project. Requests for clarification will only
slow the process.
Please Note: All sections/questions need a response. If a section/question does not apply, state
‘Not applicable’; do not leave it blank.
NOTE: This is for the IRB Protocol form version v2023-12. If you are using an older version of
the form, stop and use the current version of the form. Older versions of the form will not be
accepted by the IRB. They will be sent back and you will be instructed to complete the current
version of the form.
Basic Information
Title of Study:
Short Title:
Principal Investigator
Name:
Principal Investigator’s
Department/Unit:
The short title is required. Do not leave this blank or state ‘N/A’. The short title in eIRB
should be the same as the short title listed here.
Principal Investigator’s Department/Unit should at minimum be College of Nursing.
1.0 Background (Limit 1,000 words):
Provide the scientific or scholarly background for the proposed Human Research. Discuss
relevant prior experience or preliminary data (e.g., existing literature).
A couple of things here. The first is that all acronyms are spelled out the first time used.
The second is that it is in lay language, no jargon. If this is copied and pasted from
another document and there are reference numbers, remember to include the
reference list.
2.0 Lay Summary:
Provide a brief description of the proposed research using terms that someone who is not
familiar with the science or discipline can understand.
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This is a lay summary. It should be fairly short, a paragraph or two, and in lay language.
They are asking for a brief description of the proposed research so this should be
included.
3.0 Purpose:
Describe the purpose, specific aims, objectives, questions to be answered, hypotheses,
and/or primary and secondary study endpoints of this Human Research protocol.
Include a purpose statement. Include specific aims, hypotheses, and/or research
questions as applicable.
4.0 Funding Information
Indicate all sources of funding for the project, including gift funds, departmental funds, or
other internal funding. For each funder, list the name of the funder, and the institutional
proposal number or award number you received from Sponsored Projects. eIRB tip: For
externally funded projects, the institutional proposal or award number provided must be
linked in the “Study Funding Sources” section in eIRB.
For some projects, there is no funding. If there is no funding and you are giving
compensation to participants such as a gift card or raffle for a gift card, the source of the
funds needs to be stated or the IRB will ask the source of the funds. If self-funded,
suggest checking ‘Other’ and for ‘Name of funding source’ state Gift card(s) will be self-
funded.
If you have funding, be careful which option is checked, especially if it asks for an
institutional proposal or award number and it has not been routed through Sponsored
Projects. This will cause a delay when submitted in eIRB.
5.0 Resources Available to Conduct the Human Research:
Describe the resources (facilities, time, emergency resources, etc.) available to recruit,
consent, conduct study procedures, and analyze data.
No specific guidelines for this. If you are using survey software such as REDCap or
Qualtrics, this can be stated. If you need special software to analyze the data, this can
be included. If you are collecting biological samples and need access to a facility to store
and analyze the samples, this can be included. You can include who, by job title, will be
recruiting, consenting, and collecting data.
6.0 Study Population:
6.1 Select all the categories of participants included in the research:
☐
Healthy adults
☐
Non-English-speaking subjects
☐
Non-healthy adults
☐
UA staff/faculty
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☐
Children (under 18 years old) *
☐
UA students
☐
Pregnant women, neonates, and/or
fetuses*
☐
Banner employees
☐
Prisoners*
☐
Refugees
☐
Native Americans, Alaskan Native, and
Indigenous Populations*
☐
Other – please explain:
☐
Adults unable to consent (i.e.,
cognitively impaired adults) *
*Complete and attach the appropriate HSPP Appendices if your subjects include children,
pregnant women, neonates, prisoners, cognitively impaired individuals, or Native Americans
or Indigenous Populations. eIRB tip: appendices should be uploaded in the “Other
Attachments” section in eIRB.
Include the appropriate appendix if any of the categories with an asterisk (*) is checked.
6.2 For each of the above selected categories, describe the inclusion and exclusion criteria.
Indicate age range, gender, and ethnicity.
Inclusion and exclusion criteria should be clearly stated. For ease of reading, this can be
formatted as a bulleted list. Age range should be stated. If there are no gender and
ethnicity restrictions, it should be stated that all genders and ethnicities will be included
or that there are no restrictions on gender and ethnicity. If the study targets specific
genders and/or ethnicities, that should be stated.
6.3 Describe the total number of subjects to be enrolled locally under this IRB approval. If
obtaining specimens, specify the maximum number of specimens needed for this project.
The total number of subjects anticipated/targeted should be stated. If you are over
sampling because of attrition, state this and state the maximum number you will be
targeting. For qualitative studies, it is not acceptable to state ‘until data saturation’. The
IRB will question this. It can be stated, for example a maximum of 12 participants or
until data saturation. Remember the study will be limited to the maximum number
stated. If you decide later that additional participants are needed, a study modification
may be needed to increase the sample size. So, err on the side of too many participants
rather than too few. It is fine to have fewer participants than stated but not always fine
to have more.
If obtaining specimens, state the maximum number of specimens needed.
7.0 Recruitment Methods:
7.1 Select the methods used to recruit individuals.
☐
Email
☐
Screening of the Electronic Medical
Record (EMR)
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☐ Face to face
☐ Social media
☐ Flyers
☐ SONA System
☐ In person presentations
☐ TV, Radio, Print
☐ Online advertisements
☐
Other – please explain:
☐ Phone calls
Refer to the HSPP Guidance, Recruitment and Advertisements. Provide copies of any materials
used to recruit subjects directly (e.g., recruitment scripts, emails, print/audio/visual
advertisements, or online notices). Please ensure all recruitment materials state the project
has been reviewed and approved by the University of Arizona IRB. eIRB tip: all recruitment
material should be uploaded to the “Recruitment Materials” section in eIRB.
7.2 Explain the recruitment process. Describe how potential subjects will be identified, where
recruitment will take place, when recruitment will occur, and the methods that will be used
to recruit individuals.
Include how participants will be recruited. If by email, state who will send the email. If
by flyer, state where it will be posted. If flyers will be handed to potential participants,
include who will be handing them out. If participants will be recruited on social media,
specify the group/groups you will be posting to and if they are a publicly available group
or a private group. If private, include an approval letter or email from the individual
running the group stating that you have permission to post the recruitment material. If
recruiting face to face or by in person presentations, include a copy of the recruitment
script that will be used. If potential participants will be screened, a copy of the screening
questions should be included and state if screening information will be retained. If
screening information will be retained, potential participants should be consented for
screening.
A couple of things to remember. The IRB prohibits 'cold-calling', the solicitation of
potential participants who had no prior interaction with the research team. Participants
can be contacted via snowball method of recruitment in which potential participants
agree to have their name forwarded to a researcher.
Remember that all recruitment material (flyers, scripts, emails, etc.) must include the
IRB required statement. It may be shortened, but the main concept must remain: An
Institutional Review Board responsible for human subjects research at The University of
Arizona reviewed this research project and found it to be acceptable, according to
applicable state and federal regulations and University policies designed to protect the
rights and welfare of participants in research.
8.0 Diversity, Equity, and Inclusion
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8.1 Explain how the research plan (recruitment, study population, data collection, etc.) is
equitable and represents the demographic makeup for the location in which the research will
be conducted.
This might include the demographic makeup of the location of the research. If in
Tucson, include the demographic makeup of Tucson and how your proposed study
sample will match that.
8.2 Describe whether non-English speaking subjects will be included in the study. If yes,
please explain how your research team is prepared to meet the needs of the population. If
not, please explain why non-English speakers will be excluded from the study population.
This should address non-English speaking participants. If they will be included, state how
you will meet their needs in terms of recruiters/recruitment, translated documents, and
the ability of study personnel to speak the language.
If non-English speaking participants will not be included, state why they will not be
included.
8.3 What methods will you use to collect demographic information from participants? If you
will not collect demographic information, please explain why not.
State the method that will be used to collect demographic information, for example a
Demographic Questionnaire.
If demographic information will not be collected, explain why it will not be collected.
9.0 Consenting Process:
9.1 Indicate the informed consent process(es) and/or document(s) for the study. Check all
that apply.
Written Consent
☐ Informed Consent (ICF) – written or electronically signed form
☐ Parental Permission – written or electronically signed form
☐ Assent (participants under 18) – written or electronically signed form
☐ Combined ICF/PHI Authorization – written or electronically signed form
☐ Standalone Protected Health Information (PHI) HIPAA Authorization – written or
electronically signed
☐ Translated Consent/Assent – written or electronically signed form(s)
☐
Short Consent Form – written or electronically signed form (see guidance on
Short Form
process)
☐ Debriefing Script or Form – document used to properly inform subjects of the study’s
purpose when intentionally deceived
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Oral/Online/Unsigned Consent (Appendix for Alteration/Waiver of Consent or PHI is
Required for upload into eIRB)
☐ Informed Consent – oral script/online/unsigned
☐ Parental Permission – oral script/online/unsigned
☐ Assent – oral script/online/unsigned
☐ Translated Consent/Assent – oral script/online/unsigned
Waivers of Informed Consent and/or PHI Authorization
☐
Waiver of Consent
☐ Full Waiver of PHI Authorization
☐ Partial Waiver of PHI for Screening Purposes
Word versions of all consenting documents are required. Use HSPP template consent forms.
eIRB tip: all consent forms should be uploaded in the “Consent Forms” section in eIRB.
Remember the Appendix for Alteration/Waiver of Consent or PHI is required if you are
requesting a waiver of a signature or waiver of consent. This is to be uploaded in the
‘Other attachments’ section in eIRB
9.2 Describe in detail the consent processes checked above, including any waiting period for
subjects to sign the consent, steps to minimize the possibility of coercion or undue influence,
and the language used by those obtaining consent.
Describe the consent process. If using a Disclosure form, include when/how it will be
presented to participants and if it will be paper or online. If using a Consent form,
include when/how it will be presented to participants and if it will be paper or online. If
the person will sign the consent form, include if this will be an electronic signature or a
physical/wet signature. If participants do not speak or read English, then documents
must be translated into a language they understand or an alternative process available.
Include if a translated consent document will be available to participants if they do not
speak English and how the translation was verified.
9.3 Where will the original signed consent and PHI authorization documents be stored?
Remember that signed consent documents must be stored at the University of Arizona
(University of Arizona policy). One option for storage is the Office of Research &
Scholarship, College of Nursing Room 410. Consent documents signed online should be
stored in an approved secure location such as REDCap.
If using a Disclosure form, state this or state that there will be no signed consent
documents or state Not applicable.
9.4 Acknowledgement of consent form storage.
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☐
I will store original signed consent and/or PHI authorization documents for at least
6 years past the time the study is concluded.
☐
For studies involving minors, I will store original signed consent and/or PHI
authorization documents for at least 6 years after the youngest participant turns 18.
☐
Not applicable – I am not collecting signed documents.
10.0 Research and Data Collection Procedures:
10.1 Select the methods of data collection that will be used in this study (select all that
apply):
☐
Anthropometric measures (e.g., height,
weight, waist circumference,
etc.)
Participant observation
☐ Audio/video recording
☐
Benign interventions
Self-health monitoring (e.g.,
☐ Biological specimens – blood draws
☐
Biological specimens – clinically
discarded blood or specimens
Surveys – internet (including online
☐
Biological specimens (urine/feces,
tissue, saliva, skin, hair, nails, nasal swab)
Surveys – telephone
☐ Clinical Data Warehouse (CDW)
☐
Cognitive or behavioral measures,
including daily diaries
Records – billing
☐
Data collected using other
communication/electronic devices (e.g.,
cell phones, pagers, and texting devices)
Records – educational
☐
Data previously collected for research
purposes
Records – employee
☐ Deception
☐
Instrumentation, equipment, or
software not approved by the FDA
Records – mental health
☐ Interviews – focus groups
☐ Interviews – in person
☐ Interviews – virtual/online
☐ Medical records review
☐ MRI/ultrasound with contrast
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☐
MRI/ultrasound without contrast
Radiation Scans (X-Ray, CT Scans,
☐
Non-invasive instruments (e.g., external
sensors applied to the body)
Other activities or interventions –
Attach all surveys, scripts, and data collection forms. eIRB tip: data collection tools should be
uploaded in the “Other Attachments” section in eIRB.
10.2 Description of research procedures.
Provide details of EACH research procedure in chronological order using simple language. Be
clear when identifying which procedures are specifically for research, and which study
population will be completing each study procedure. Include a description of all procedures
already being performed on subjects for diagnostic or treatment purposes.
If there are plans for long-term follow-up (once all research related procedures are complete),
describe what data will be collected during this period. For projects investigating
drugs/devices or treatment plans, describe the tests and procedures that will be done to
accomplish this. If applicable, discuss the randomization ratio, the dosages of drugs being
used, and the investigational treatment plan.
If this is a multisite study where UArizona IRB will oversee an outside site, please briefly
summarize what participating sites will be involved and what their role(s) will be.
Include a detailed description of the study procedures. The recruitment and consent
process has already been stated so they should not be included here. If different groups
of participants will be doing different things, for example intervention and control
group, state what each group will be doing in a separate paragraph. If there are
different phases of the study, they should be clearly labeled. If participants will be
randomized, state the randomization procedure and the odds of being assigned to each
group.
If this is a multi-site study and the University of Arizona IRB will be the IRB of record,
include what research procedures will be conducted at each site. If no research
procedures will be conducted at a site, state the role of that participating site.
10.3 Specify the total estimated time commitment for subject participation, and the
estimated time commitment for each activity.
The estimated time commitment should be stated. If this is a longitudinal study, state
the total time commitment, for example 300 hours over 4 months. Then it should be
broken down, for example 1 hour for baseline data collection, 30 minutes daily for the
intervention activity (specify the activity) for 8 weeks, 30 minutes for time 2 data
collection, 20 minutes daily for the intervention activity (specify the activity) for 4
weeks, 30 minutes for time 3 data collection, and 1 hour for time 4 data collection.
There should be agreement between what is stated in recruitment material, the consent
document, study procedures and what is stated here.
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10.4 If any biological specimens (blood, urine, tissue, etc.) are being collected for research,
state the amount (ml/tsps./tbsp, etc.), method, frequency, and type of specimen to be
collected and what the specimen will be used for.
If no biological specimens will be collected, state this or state Not applicable.
If biological specimens will be collected, state the type of specimen to be collected,
method of specimen collection, amount to be collected, frequency of collection, and
what the specimen will be used for. I recommend stating if the specimen will be used up
in the analysis. If there will be any left after analysis, include what will happen to it, for
example if it will be discarded, kept for additional analysis, or for future research. This
should also be stated in the consent document.
10.5 If the study is a clinical trial, confirm registration with https://clinicaltrials.gov/ has been
completed:
This study is not a clinical trial: ☐
Registration complete: ☐
Registration pending: ☐
11.0 Potential Benefits to Subjects:
11.1 Describe the anticipated benefits of this study to society, academic knowledge, or both.
The broader benefits to society, the discipline, or both should be stated. The broader
benefits stated here should also be stated in the consent document.
11.2 Describe any benefits that individuals may reasonably expect from participation (not
including compensation, which cannot be considered a benefit of participation).
If there are no direct benefits, state this. If there are direct benefits, state them. The
benefits stated here should also be stated in the consent document.
12.0 Risks to Subjects:
12.1 Describe all physical, psychological, social, legal, and/or economic risks that could be
associated with participation in this research.
Risks not directly related to the research need not be included in this section. However, nearly all
human research has some minimal level of risk, such as a loss of confidentiality when identifiable data
is collected.
If there are risks, state them. If there are no risks, state no risks. As stated in the red
text, the risk of loss of confidentiality should be considered. However, if the data will be
anonymous and no identifiers will be collected, this may not be a risk. Risks stated here
should also be stated in the consent document.
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12.2 Discuss what steps will be taken to minimize risks to subjects/data.
For each of the risks listed, state the steps to minimize that risk. Steps to minimize the
risks should also be stated in the consent document.
If there are no risks, state no risks.
13.0 Costs, Compensation, and Injury:
13.1 Describe any costs, monetary and non-monetary, that subjects may incur. This includes
time.
If there are costs for participation, they should be stated. For example, if participants
are asked to come to the College of Nursing for data collection, they may, for example,
need to pay for travel to the University but parking will be paid by the study.
For the cost of time, the total time required should be stated. There should be
agreement between what is stated in recruitment material, the consent document, and
what is stated here.
13.2 Discuss the amount of compensation (monetary and/or non-monetary) subjects may
receive. Describe if compensation will be prorated.
If there is no compensation, state this or state Not applicable.
If compensation is offered, the amount of compensation should be stated. If
compensation is offered for completion of each part of the study, for example $10 for
each data collection completed, this should be stated. The amount of compensation
should be fair for the time and effort required, but not excessive. There should be
agreement between what is stated in recruitment material, the consent document, and
what is stated here.
14.0 Privacy of Subjects and Confidentiality of Data:
14.1 Describe steps, if any, to protect the privacy of the subjects throughout their
participation (e.g., during the recruitment process, consent process, and/or research
procedures).
This may include, for example, where recruitment, consenting and data collection will
take place. This should be in a private setting without distraction. Confidentiality of data
may be addressed here as well.
14.2 Will data be kept for future research, including unspecified future research and genetics?
Yes ☐ No☐
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If data will be kept for future research, this should be stated in the consent document. If
data will not be kept for future research, this should be stated in the consent document.
There should be agreement in the statements across documents.
14.3 If yes to the above question, describe future use plans here, including unspecified
research, any storage in a repository (if applicable), and what data will be retained/reused.
If data will not be kept for future research, state this or state Not applicable. If data will
not be kept for future research, this should be stated in the consent document.
If data will be kept for future research, describe plans for future use. This should also be
stated in the consent document. There should be agreement in the statements across
documents.
If data will be stored in a repository, state this and if the data and/or specimens stored
will be identifiable or de-identified. Include the name of the repository if the name of
the repository is known.
14.4 Discuss how study results will be shared with subjects, families, and/or the institution,
both immediately and long-term.
If data will not be shared with participants, state this or state Not applicable.
If results will be shared with participants, state what will be shared and how it will be
shared. Generally, results are not shared with participants. If they are, generally this is in
aggregate form. There may be instances where data will be shared with participants.
This should be clearly stated and should also be stated in the consent document.
14.5 Indicate if the research team will be accessing any of the following records.
☐ Substance abuse records (HIPAA and 42 CFR Part 2)
☐
Medical records (HIPAA)
☐
Educational records (FERPA)*
☐
Employee records (ABOR Policy 6-912)*
☐
Other, specify:
*Access to information from a University of Arizona employee record or FERPA information
requires the written permission of the participants.
14.6 For each record source selected above, list the data elements to be accessed, who will
access them, and how the information will be obtained.
If none will be accessed, state this or state Not applicable.
If any will be accessed, state the specific data elements that will be obtained; who will
obtain the information from the records, for example someone from the study or will
the information be supplied by someone else; and how the information will be
obtained. It should be clearly stated what identifiers will be included. If the identifiers
are not needed, they should not be obtained.
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14.7 Indicate where data will be stored:
☐
Box@UA
☐
OnCore
☐
Box@UA Health
☐
PACS medical imaging software
☐
Clinical Data Warehouse (CDW)
☐
Password Protected Drive
☐
Cloud Server
☐
REDCap
☐
Department Drive
☐
Transmitting/receiving subject data
to/from an outside group
☐
Department Office
☐
UA Records Management & Archives
☐
Encrypted Drive
☐
Banner Server/Platform, specify:
☐
External Drive (hard drive, USB, disk)
☐
Soteria
☐
Google Suite for Education
☐
HIPAA Research Computing Service
☐
Other, specify:
14.8 For EACH of the storage locations checked above, discuss the type of data to be stored,
including if the data will be identifiable, coded, or de-identified upon storage.
If data will be coded, specify who will maintain the code, where it will be stored, and when it
will be destroyed. If data will be de-identified, explain if there is any possibility that the data
could be re-identified.
Definitions:
• Identifiable: The identity of the subject is or may be readily ascertained.
• Coded: Data are separated from personal identifiers through use of a code. As long as
a link to identifiers exists, data is considered identifiable and not de-identified.
• De-i
dentified: A record in which all identifying information is removed.
This asks for multiple pieces of information. First it asks the type of data to be stored,
including if data will be identifiable, coded, or de-identified upon storage. If only
anonymous surveys are being collected and stored in Box@UA, this should be stated. If
coded questionnaires (link between a study number and identifying information) and/or
coded specimens are being collected, with questionnaire data stored in Box@UA Health
and specimens stored in the Biological Laboratory, this should be stated. If data will be
coded, include who will maintain the code, where it will be stored and when it will be
destroyed. It is best that the list is destroyed at the conclusion of the study. If data will
be de-identified, explain if there is any possibility the data could be re-identified.
If the study includes audio and/or video recorded interviews/focus groups, include that
the recordings will be deleted once transcription is complete and the transcripts have
been checked for accuracy. This should also be stated in the consent document. If there
is a reason to retain the recordings after transcription, this will need to be justified.
14.9 If collecting biological specimens, please describe the storage location for the specimens,
including if they will be identifiable, coded, or de-identified upon storage.
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If biological specimens will not be collected, state this or state Not applicable.
If biological specimens will be collected, state the type of specimens that will be
collected, where they will be stored, and if they will be identifiable, coded, or de-
identified upon storage.
14.10 Storage of research records (research records should be maintained for whichever of
the following time periods is the longest, select one):
☐
I will store research records for at least 6 years past the time the study is
concluded.
☐ For studies involving minors, I will store research records for at least 6 years after
the youngest participant turns 18.
☐
I will store research records for the length of time required by law or study
sponsor, please specify:
14.11 Describe what security controls (e.g., administrative, physical, technical) are in place to
make sure data/specimens are secure.
This may include secure locations where data/specimens will be stored, encryption of
data especially if it will be transmitted to or from an outside group.
14.12 Indicate how data/specimens will be shared with collaborating entities:
☐ Data and/or specimens will not be shared between UA and any outside group or
collaborating entity.
☐ Data/or specimens will be transmitted and/or disclosed to an outside group or a
collaborating entity.
☐
Data and/or specimens will be received from an outside group or a collaborating
entity.
☐ PHI will be transmitted to or received from an outside group or a collaborating
entity. *
☐ A Limited Data Set will be transmitted or received from an outside group or a
collaborating entity. *
☐
Data/specimens will be sold to pharmaceutical companies.
*If you will be transmitting or receiving any PHI, or a Limited Data Set, as a part of your
project, please go to the following link to review the Data Use Agreement (DUA) from the
HIPAA Privacy Program.
Please note: a Data Use Agreement is needed if PHI or a Limited Data Set will be
transmitted or received.
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14.13 Describe what information will be shared, who it will be shared with, and how it will be
shared (e.g., secure file transfer, REDCap, etc.). Also include information about future use
sharing and repositories. Specify if the shared data will be identifiable, coded, a limited data
set, or de-identified.
If data will not be shared with an outside group or collaborating entity, state this or
state Not applicable. If data will be shared, include a description of the data that will be
shared; if the data shared will be identifiable, coded or de-identified; who it will be
shared with; and how it will be shared, for example, if it will be in a central location with
all having access to it or encrypted and sent. If any identifiable information will be
shared, this should be clearly stated. If a transcription service is being used to transcribe
interviews or focus group data, include the name of the transcription service. Also
include information about future use sharing and repositories.
15.0 Additional Questions (complete as applicable):
If any of the questions are not applicable, state Not applicable.
15.1 Subject Injury: 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. If the Human Research has a clinical trial agreement, this language should reflect what
is stated in the agreement.
For most projects, this is not applicable. If this does not apply, state Not applicable.
15.2 Withdrawal of Subjects: Discuss how, when, and why subjects may be removed from the
study. If abrupt withdrawal is necessary, discuss how subjects will be withdrawn so that they
are not put at increased risk. Discuss what happens if a subject is withdrawn from one part of
the study but asked to continue with other parts, such as ongoing follow-up.
This should be addressed. Most of the time participants will not be withdrawn from the
study by the PI rather participants will withdraw from the study. If participants will be
withdrawn, state why and state if data collected to that point will be retained or
deleted. If participants request to be withdrawn from the study, address if data
collected to that point will be retained or deleted. This should also be stated in the
consent document.
15.3 Monitoring for Subject Safety: Provide a brief lay discussion of your plan to monitor for
subject safety. Describe what safety information will be collected, including serious adverse
events, how safety information will be collected, and the frequency of collection including a
timeline of when the data and review(s) will occur, who will review the information, and the
plan for reporting findings.
If there will not be a way to monitor for subject safety, please explain.
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There should be a response. It may be restating the risks and steps to minimize risks, but
this involves those risks/events that are not anticipated, the adverse events. If there will
not be a way to monitor for participant safety, provide an explanation.
15.4 Data Management Plan: Please discuss the data management plan, if required by your
funder. For additional resources, reference the HSPP Data Management webpage. If your
sponsor/funding agency requires a Data Management Plan, please upload the approved copy
in eIRB. This section and the informed consent form should contain all pertinent information
including:
• What data/metadata will be shared (imaging, survey; raw data or derived;
protocol, data form; etc.)
• What repository will be used (if known)
• How will data be stored (in a de-identified or identifiable format)
If this does not apply, state Not applicable. If the project is funded and the funding
agency requires a data management plan, outline the data management plan. Upload a
copy of the data management plan in the “Other Attachments” section in eIRB.
15.5 International Research: Describe site-specific regulations or customs affecting the
research, local scientific and/or ethical review structures that differ, and if community
advisory boards are involved. If so, describe their composition and involvement. For research
being conducted outside of the US, please explain any local laws, regulations, or customs the
IRB needs to be aware of.
Authorization from sites where research will take place is required with the application.
Permission to conduct research outside of the country requires review by the
UA Travel
Registry.
If this does not apply, state Not applicable. If the study is international, this needs to be
fully addressed.
Additional items needed for review:
• Word version of applicable subject material: Consent document(s), PHI Authorization
Form(s), Recruitment Material, Data Collection Material, Participant Material
• Appendix for Alteration/Waiver of Consent or PHI, if using a Disclosure form
• Current PI CVs or biosketch
• Advisor approval (Advisor Attestation if the PI is a student or medical resident)
• Department/Center/Section Review approval
• Scientific/Scholarly review approval
• Responsible physician approval (if the PI is conducting medical procedures for which
he/she is not clinically certified to perform)
• Additional approvals, as needed (e.g., RAP/Banner feasibility, Export Control, Radiation,
COI, CATS, Cancer Center SRC, school district approval, tribal approval, etc.)
16
• The appropriate appendices if children, pregnant women, neonates, prisoners,
cognitively impaired individuals, or Native Americans or Indigenous Populations will be
enrolled
Other items as applicable:
• HSPP Appendices
• Data Monitoring Plan or Data Management Plan
• Drug/Device information
o Applicable Drug or Device Appendix
o Investigator's Brochure, drug product sheet, device manual, user's manual,
instructions for use, package insert, IND/IDE documentation, FDA 1572 form,
510k indication, FDA exemption, sponsor determination of device risk, etc.
• Sponsor Protocol and MOPs that are used in the study