UT Health Science Center San Antonio
Common Research Application
Step 2 Continuation – UTHSCSA IRB Application
The Common Application consists of Step 1 – Intent to Conduct Research, Step 2 – Institutional Application and Step 2 Continuation –UTHSCSA IRB
Application (when using UTHSCSA IRB).
These three forms may be submitted in one of two combinations: A) Step 1 alone (Step 2 to follow later) –OR- B) All three together.
Items marked with the
icon indicate fields that the institution and the IRB share.
Using this form – To check the checkboxes, click once on the box. To enter text in the text boxes, click once on the gray box and then
type your response. If you are a Mac user and are having trouble using this form, try this alternate version of the form.
UTHSCSA Tracking Number
Item 40
Is your study eligible for Expedited Review?
☐ No continue to Item 41
☐ Yes submit Form B-1 - Expedited Certification Form
Applicable during initial IRB review of a new study
Item 41
Special Confidentiality
Considerations
Select all applicable
☐ Drug or Substance Abuse research - - -[consider obtaining a certificate of confidentiality]
☐ Certificate of Confidentiality - - - - - - - - [include statement in consent and provide the approval]
☐ Genetic Research - - - - - - - - - - - - - [include risks of genetic research in consent & confidentiality plan in
Step 2 institutional-Data Security plan]
☐ HIV or Hepatitis Screening - -[Review the IRB Instructions - include state reporting requirements in
consent] ☐ Documentation in the Medical Record ----[consider altering the study title to eliminate
increased risk of
research participation disclosure]
☐ N/A – no special confidentiality considerations - continue to Item 42
Item 42
Data Safety Monitoring
☐ A Data Safety Monitoring Plan (DSMP) is required by either:
Select all applicable
☐ A Data Safety Monitoring Plan (DSMP) is required by:
The IRB (because this is a greater than minimal risk study)
☐ A Data & Safety Monitoring Board (DSMB) will be used
☐ N/A – none of the situations listed above apply
The NIH (i.e. grant) or the FDA (i.e. research with IND or IDE)
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Submit
Form R - Monitoring
Participant Safety and Data
Integrity
continue to Item 43
Item 43
Categories
of subjects
Select all
applicable
Note for chart
review
research:
Answer based
on whether
subjects will
fall into a
category at
the time you
are reviewing
the records.
This study includes:
☐ Decisionally Impaired Individuals - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -☐ Decisionally Impaired and Institutionalized Individuals - - - - - - - - - - - - - - - - - - - - - - - - - - - - ☐ Individuals with diminished decision-making capacity - - - - - - - - -- - - - - - - - - - - - - - - - - - - - -
Submit
Form T
Form T
Form T
(not including incompetent or impaired decision making capacity)
☐ Pregnant Women
*Pregnant Women will not be participants at the VA - - - - - - - - - - - - - - - - - ☐ Pregnant Women (for follow-up) - - -- - - - - - -- - -- - - - - - -- - -- - - - - - -- - -- - - - - - -- - -- - - - - -
☐ Fetal Material
*Fetal Material will not be used at the VA - - - - - - - - - - - - - - - - - - - - - - - - ☐ Neonates of uncertain viability or nonviable neonates - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Form U
Form U-Follow
and pregnant
person consent
Form U
Form U
*Neonates will not be participants at the VA
*Prisoners will not be participants at the VA - - - - - - - - - - - - - - - - - - - - - - - -
Form V
Form W
*Children will not be participants at the VA
Form W
☐ Prisoners
☐ Children (17 yrs or less), includes viable neonates - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - ☐
☐
☐
☐
☐
Wards of the State - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - Students under the supervision of any investigator
Employees under the supervision of any investigator
Embryonic stem cell research
Enrollment of non-veterans in VA-approved research, include justification (i.e. insufficient
veterans available to complete study, survey of VA employees, study of active duty):
☐ Other vulnerable population:
Item 44
Research Consent & HIPAA Authorization Wizard
Items 43 – 47 are designed to help you determine the
appropriate waivers and documents.
In Step 1, Item 9 – which answer did you choose?
☐ No – this study does not involve interaction or intervention with living
individuals - continue to Item 45
☐ Yes – this study involves interaction or intervention with living
individuals - continue to Item 46
Item 45
Study does not involve interaction or intervention with living individuals
Will you obtain private identifiable information collected for
☐ No continue to next section
other purposes?
☐ Yes Submit Form F (complete the Waiver of Consent section)
☐ Yes but a Waiver of Consent is not needed because subjects will
provide informed consent or informed consent will be waived as part
of their participation in a contributing protocol (i.e. data
coordinating center activities).
If yes,
Describe the source:
Describe the source of the information: (medical records
of patients seen in PI’s clinic, research records from
HSC2010XXXH, etc.)
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UT Health Science Center San Antonio
Common Research Application
Step 2 Continuation –UTHSCSA IRB Application
If yes,
☐ No continue to next section
Does the information reviewed contain both health
☐ Yes submit Form J – HIPAA Waiver
information and identifiers?
☐ Yes but a HIPPA Waiver is not needed because subjects will
Will you obtain anonymous tissue specimens to test the safety or
effectiveness of an in vitro diagnostic device?
provide authorization or authorization will be waived as part of their
participation in a contributing protocol (i.e. data coordinating center
activities).
☐ No continue to Item 46
☐ Yes contact IRB Associate Director for applicable form(s)
Item 46
Issues related to identifying prospective subjects
Do you plan to review existing information (e.g., clinical or research
records) to identify individuals who may be eligible to participate?
☐ No continue to Item 47
☐ Yes submit Form F (complete the Waiver of Consent
section)
If yes,
Describe the source:
Describe the source of the existing information: (medical
records of patients seen in PI’s clinic, research records from
HSC2010XXXH, etc.)
If yes,
Does the information reviewed contain PHI?
Will individuals who are not members of the study team refer
subjects to study staff? (i.e., clinical providers)
Will participants self-identify? (i.e., response to advertisements, word-of-
☐ No continue to Item 47
☐ Yes submit Form J – HIPAA Waiver
☐ No ☐ Yes
☐ No ☐ Yes
mouth)
☐ No ☐ Yes (attach recruitment materials)
If yes,
Will recruitment materials be used?
Item 47
First Contact - Recruitment
select how and where initial contact will be made with potential subjects; list all applicable
☐
N/A – this study does not involve interaction with living individuals (you answered no - Step 1, Item 9) - continue to Item 54
How will contact be made:
Telephone call
Email
Mail
Waiting room (public)
During scheduled visit (private)
Other method:
From study staff
to participants
☐
☐
☐
☐
☐
☐
From
participants to
study staff
☐
☐
☐
☐
☐
☐
Document1 vSept3-2014
3
Briefly describe the plan to contact subjects including
differences between groups (if any) --include details
regarding relationship with subjects (i.e., members of
treatment team will contact…)
Indicate how special VA rules will
be applied:
Refer to the VA Handbook for additional
information
☐N/A – VA not a study site
☐Although email and telephone may be used as a first contact method at other study
sites above, it will not be used for VA subjects
Item 48
Screening procedures
Will any screening procedures be completed by subjects prior to
obtaining consent?
☐ N/A not obtaining informed consent
☐ No – continue to Item 49
☐ Yes
If yes,
Select all applicable
What type(s) of screening procedures are planned?
☐
☐
☐
☐
Screening questions
Withhold food and/or water overnight
Withhold medication overnight: List
Other: describe
If yes,
How do you plan to handle consent for screening procedures?
Full (long) informed consent will be provided (either verbally or in
writing), however a consent document will not be signed until after
screening
Abbreviated information about the study will be provided to subjects (not
including all required elements of consent) and a consent document will
not be signed until after screening
If recording the answers to screening questions – is the information health
related?
Item 49
How will
you consent
subjects to
participate
in the
research?
☐
Will not obtain consent
from: (select one)
☐any participant
☐some participants
Select all
applicable
Will obtain consent
without a signature
Documentation section)
☐ submit Form F (complete the Alteration of
Consent and Waiver of Documentation sections]
☐ No– continue to Item 49
☐ Yes submit Form J – HIPAA Waiver
If some participants selected, which
ones?
☐ Submit Form F (complete the Waiver of
If selected,
☐ No
☐ Yes submit Form J – HIPAA Waiver
☐ Yes but a HIPPA Waiver is not needed
Is the information collected for
the study health information?
☐
☐ submit Form F (complete the Waiver of
If selected, select at least one of
the following describing how you
will obtain consent:
☐ Verbal in person
☐ Telephone
☐ Online
☐ Survey (or other data
collection tool)
☐ Other
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Consent section)
OR
☐ Waiver of Consent is not needed because
subjects will provide informed consent or
informed consent will be waived as part of their
participation in a contributing protocol (i.e. data
coordinating center activities).
because subjects will provide authorization or a
waiver of authorization will be obtained as part of
their participation in a contributing protocol (i.e.
data coordinating center activities).
submit Form F (complete the Waiver of
Documentation section)
Also submit either:
the text of the information that will be provided
(i.e., script, consent paragraph)
or an Information sheet -Form D-IS
If selected,
☐
☐
☐
☐
☐
Is the information collected for
the study health information?
Will exclude some of the required elements of consent in
the consent form, information sheet, or consent process
Will obtain full consent
☐ research at non-VA site
using the long consent
☐ research at a VA site
form for:
☐ only collecting biological
specimens or data for a bank or
repository at non-VA site
☐ only collecting biological
specimens or data for a bank or
repository at a VA site
Will use deception during consent – not providing subjects
will all information about the study to prevent potential
biases in the study
Will consent pregnant partners of participants
Will obtain consent for a
research study and an
optional sub-study to
bank specimens and/or
data
Item 50
Initial
Consent Procedure
Select all applicable
Item 51
Waiting period between
informing the
prospective subject and
obtaining consent
☐ No
☐ Yes submit Form J – HIPAA Waiver
submit Form F (complete the Alteration of
Consent and Waiver of Documentation sections)
submit Form D -UTHSCSA Consent
submit Form D-1- VA Consent
submit Form E- Repository Consent
submit Form E-1- VA Repository Consent
Review the deception instructions to determine
whether to submit Form F (Alteration of Consent
section)
☐ sub-study is an external
repository/registry
-submit Pre-filled Form U for Pregnant Partners,
and submit Partner Consent Form
submit Form E- Repository Consent or review the
Informed Consent Instructions for alternatives
☐ sub-study is an internal
repository/registry
Use the approved consent for existing Repository
Study Insert HSC# for Repository:
☐
☐
☐
The IRB Policy on Informed Consent Process will be followed
The IRB Policy on Informed Consent Documentation will be followed
A different consent or documentation procedure will be used as follows:
☐
☐
☐
N/A this study does not involve interaction with living individuals - continue to Item 54
Prospective subjects can take as long as they wish to make a decision
Prospective subjects are expected to make a decision immediately or within a specified
timeframe described here:
Select all applicable
Item 52
Informed
Consent for
Research
Involving
Non-English
Speaking
Subjects
Select one
☐
☐
Only individuals
who speak
English will be
enrolled
Individuals who
do not speak
Select one
☐There is no expected direct benefit for those participating.
☐There is an expected direct benefit for those participating. Excluding non-English
speaking individuals is acceptable because:
Describe:
The translated consent will be submitted to the IRB:
Select one
☐
Immediately following approval of
the English consent.
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English will be
enrolled
☐
☐
Only after a potential non-English
speaking participant is identified.
Since this plan will delay enrollment
pending IRB approval of a translated
consent, provide justification that
prospective non-English speaking
subjects will not be excluded from
beneficial research.
☐
Select one
☐
☐
☐
☐There is no expected direct benefit for
those participating.
☐There is an expected direct benefit for
those participating. Any delay in
obtaining a translated consent is
acceptable because:
Describe:
N/A
☐ study does not involve interaction with living individuals (answered no - Step 1, Item 9)
☐ study includes a waiver of informed consent for all subjects (see Item 49)
Item 53 Privacy Protections
Describe the privacy protections that will be used to
ensure privacy is protected during recruitment,
consent, and the research interventions:
Use of drapes or other barriers
Activities occur in a private room
Activities occur in a semi-private room
Other method:
Item 54
Nature of
the Study
Select one
Recruitment
Consent
Research
Intervention
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
☐
Interventional
Primary Purpose
Study Phase
Individuals are assigned by an investigator based on a
protocol to receive specific interventions. Subjects may
receive diagnostic, therapeutic or other types of
interventions. The assignment of the intervention may
or may not be random. The individuals are then
followed and biomedical and/or health outcomes are
assessed.
Select one
☐Treatment
☐Prevention
☐Diagnostic
☐Supportive Care
☐Screening
☐Health Services Research
☐Basic Science
☐Other:
Select one
☐N/A
☐Phase 0
☐Phase 1
☐Phase 1/Phase 2
☐Phase 2
☐Phase 2/ Phase 3
☐Phase 3
☐Phase 4
Observational
Time Perspective
Biomedical and/or health outcomes are assessed in predefined groups of individuals. Subjects in the study may
receive diagnostic, therapeutic, or other interventions,
but the investigator does not assign specific
interventions to the subjects of the study.
Select all that apply
☐Prospective
☐Retrospective
☐Cross-sectional
☐Other:
Repository
Submit Form C-1- Repository Details
A repository or data registry is created to store
specimens and/or data (i.e., materials) for use in future
research. Also referred to as data or specimen
warehouse, or bio-banks.
NOTE: Only choose this option if the repository is NOT
part of another local protocol (substudy)
Coordinating Center
Submit Form Y – Coordinating Center Details
A coordinating center is created to facilitate
collaborative clinical research by addressing the
coordination and integration of all essential
administrative and research data and activities
conducted at multiple individual sites. The coordinating
center has a principal investigator who provides
scientific leadership to the individual sites. The PI may
be a sponsor investigator and holder of an IND or IDE or
the awardee of a large multi-site grant.
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NOTE: Only choose this option if the coordinating
center is NOT part of another local protocol
Item 55
Current Practice
☐ N/A – this study does not test or evaluate an intervention (Step 2 Institutional – Item 28) - continue to
Describe the current local
practice so that the IRB can
understand how the
research interventions
compare.
-orDescribe current practice including any differences at your study sites:
Item 56
Item 56
Will a placebo be used in place of
standard therapy?
☐ No
☐ Yes submit Form O-2 – Use of Placebo in Place of Standard Therapy
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Item 57
Safety precautions for greater than minimal risk
intervention(s) being tested
List the greater then
minimal risk study
intervention(s) being
tested
To add rows use copy &
paste
☐ N/A - this study does not test or evaluate a greater than
minimal risk intervention - - continue to Item 58
Describe the procedures for
protecting against or minimizing any
potential risks
Where appropriate, discuss
provisions for ensuring
necessary medical or
professional intervention or
equipment provided in the
event of adverse events, or
unanticipated problems
involving subjects.
If the safeguards will be
different between/among
groups, describe here
Item 58
List the potential benefits of the study intervention(s) and/or monitoring procedure(s) likely to contribute to enrolled subjects’
well-being. If there are no benefits to enrolled subjects, state “none”.
*All risks and discomforts associated with the intervention(s), study directed drugs, devices, and procedures will be listed in the
informed consent document according to probability (likely, less likely or rare) and magnitude (serious or not serious). If you do
not have a consent document, you must complete the risk table in Form BC (Protocol Template Form).
To add rows use copy & paste
Item 59
Describe the potential benefits or importance of this study to others not enrolled in this study (i.e. what is the clinical relevance
of this study):
Item 60
You must provide a detailed protocol with your IRB
application.
Indicate which of these documents you are including
☐ Sponsor Study Protocol
☐ Protocol Template Form
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