section i—basic project information

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INTRODUCTORY QUESTIONNAIRE
Expedited Review for
Retrospective Data Collection
Jacksonville – IRB-03
Please provide contact information for a representative
who can answer any questions that the IRB might have
concerning this submission:
This box is for IRB-03 use ONLY.
Name:
Position:
E-mail:
Phone #:
Pager #:
Dept:
2nd
Contact:
name + e-mail or phone number
Project Number:
Form Instructions:
 Make sure your Microsoft Word program is set to display “Hidden Text”. This document
contains helpful information, examples, and instructions that are only visible (and will never
print) when the “Hidden Text” feature is enabled. “Hidden Text” will be displayed
highlighted yellow, italics, and underlined. Go to the “Tools” menu, “Options”, on the
“View” tab make sure “Hidden Text” has a check mark, and click “OK”. (Word 2007 users
can download how to display Hidden Text at: http://irb.ufl.edu/docs/hidden07.doc).
PROJECT TITLE:
Is the risk associated with this study no more than minimal risk and are you seeking
Expedited review and approval?
No – risk is greater than minimal. STOP- Full Board review is required.
Yes – risk is no more than minimal and Expedited review is possible.
Submit 1 Electronic and 1 paper copy (paper copy must be the signed
original) to the IRB-03 office.
PRINCIPAL INVESTIGATOR (PI) INFORMATION
NAME: LAST:
FIRST:
MIDDLE:
UF ID #:
DEGREE:
POSITION:
COLLEGE:
DEPARTMENT:
BOX #:
E-MAIL:
Introductory Questionnaire Retrospective Data
IRB version date: 07/09/2013
PI version date:
Page 1 of 7
PHONE:
FAX:
BEEPER:
OTHER:
**All submissions must include Addendum A– – Research Personnel Assurance.
and the Clinical Trial Website Form–
ALL QUESTIONS MUST BE ANSWERED and
VERSION DATE MUST BE ADDED TO FOOTER
1. Does this project involve materials (data, documents, records, or specimens) that
have been collected solely for non-research purposes (such as medical treatment or
diagnosis - All data to be reviewed and collected exists before the study starts)
Yes – The research involves the collection or study of currently existing data,
documents, and/or records? Go to question 2.
No. STOP- Complete the Full Board and Expedited Review Introductory
Questionnaire
2. Will you enroll prisoners as part of your General or Target sample?
Yes – The research involves enrolling prisoners as part of the General or Target
sample . STOP- Complete the Full Board and Expedited Review
Introductory Questionnaire
No. Go to question 3.
3. Are you seeking a Full Waiver of Informed Consent?
No. STOP- Complete the Full Board and Expedited Review Introductory
Questionnaire
Yes - you must answer the following questions in order to qualify for a Full Waiver
of Informed Consent:
a. Describe and justify why the research could not practicably be carried out without
the waiver:
b. Is this project:
(1) conducted by or subject to the approval of state or local government
officials, and
(2) designed to study, evaluate, or otherwise examine: (i) public benefit or
service programs; (ii) procedures for obtaining benefits or services under
those programs; (iii) possible changes in or alternatives to those
programs or procedures; or (iv) possible changes in methods or levels of
payment for benefits or services under those programs?
Yes – Go to Question 5.
No – answer items (i) – (iii) below.
Introductory Questionnaire Retrospective Data
IRB version date: 07/09/2013
PI version date:
Page 2 of 7
i.
Is the protocol more than minimal risk to the subjects?
Yes
No
ii. Describe why the waiver or modification will not adversely affect the
rights and welfare of the subjects:
iii. Is it appropriate to give subjects additional pertinent information after
participation?
No
Yes – Describe:
4. The study offers the prospect for direct benefit to some or all subjects.
Yes. STOP- Complete the Full Board and Expedited Review Introductory
Questionnaire
No. Go to question 5.
5. Describe the type(s) of subjects to be studied in this project (e.g. healthy volunteers
or patients with specific diseases):
6. Indicate the age range of subjects to be studied:
7. Sex of subjects:
Both – answer item (b) below
Males only – answer item (a) below.
Females only – answer items (a) and (b) below.
a. Provide the rationale for studying a single sex:
b. Are females of childbearing potential included in the project?
No
Yes
8. Will subjects of a specific race or ethnicity be studied?
No – proceed to Question 9.
Yes - answer items (a) through (c) below:
a. Indicate if you will target any of the following ethnic groups:
Hispanic
Non-Hispanic
Will not target a specific ethnic group
b. Indicate if you will target any of the following racial groups?
American Indian/Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
Will not target any specific racial groups
c. Does the condition being studied only occur in the selected group(s)?
Yes
No - provide rationale for selection of specific group(s):
Introductory Questionnaire Retrospective Data
IRB version date: 10/30/2014
PI version date:
Page 3 of 7
9. Will vulnerable populations will be included in this project?
No – proceed to Question 10.
Yes- Indicate which of the following vulnerable populations will be included
and if “target” is selected complete item (a) below.
Vulnerable Population
General
Target
Pregnant Women
Fetuses
Children
Decisionally impaired
Institutional residents
Terminally ill patients
UF/Shands/VA staff
UF students
a. If vulnerable populations are being targeted please justify:
10. Describe who will identify subjects for this research:
a. By what authority does this person(s) have access to the subjects’ medical
records?
b. Is the PI (or other Invsstigators) the subjects’
Physician
Instructor or Advisor
Supervisor
Other
11. Indicate which method(s) the individual(s) listed in Question will use to identify
subjects:
Medical Records
Clinical Database
Patient care meetings, rounds, tumor board meetings, etc.
Other
If you select any of the methods listed above to identify or recruit subjects,
you must include the Request for HIPAA Waiver of Authorization for
Research.
Introductory Questionnaire Retrospective Data
IRB version date: 10/30/2014
PI version date:
Page 4 of 7
12.
Table 1. Local Enrollment Information
# of
Subjects
a. How many subjects do you need to complete the study?
0
b. How many additional subjects might be enrolled/included in this
project but might discontinue participation in the study before
completing all study interventions/interactions?
+0
c. Will your study include procedures being done solely for research
purposes in order to determine whether or not the subject meets
eligibility requirements ?
No. Leave the answer to this question zero.
Yes – how many additional subjects do you believe will need
undergo these screening procedures and will not count toward
the numbers listed in questions a and b above ?
d.
+0
TOTAL (a+b+c) = 0
The total number in line “d” above is the total number of subjects that the IRB is
approving you to include in this project. Do not exceed this number. If you want to
enroll more subjects than is listed above you must revise your paperwork, submit a
revision to the IRB, and receive approval before exceeding the number above. Failure
to do this is equivalent to enrolling subjects without IRB approval. If subjects must sign
an Informed Consent form, this is the total number of subjects who may sign a consent,
and/or if you have a waiver of consent, this is the total number of records/specimens
that you may examine.
(Form note: the total number in line “d” should update automatically when you print the document. If not,
“right click” on the number with your mouse and select the “Update field” option in the menu window that
appears.)
Introductory Questionnaire Retrospective Data
IRB version date: 10/30/2014
PI version date:
Page 5 of 7
13. What is the date range for the data you will be collecting?
14. Is this a multi-centered project?
No.
Yes - list the total number of subjects to be included at all participating sites:
15. What measures will be taken to protect the confidentiality of any information
obtained from or about subjects and any others related to the subjects?
Paper-based records will be kept in a secure location and only be accessible to
personnel involved in the study.
Computer-based files will only be made available to personnel involved in the
study through the use of access privileges, passwords, and encryption.
As of 09/2009, all investigators using computer based records must include
Addendum T.
Prior to access to any study-related information, personnel will be required to
sign statements agreeing to protect the security and confidentiality of identifiable
information.
Whenever feasible, identifiers will be removed from study-related information.
A waiver of documentation of consent is being requested (see question 3)
because the only link between the subject and the study would be the consent
document and the primary risk is a breach of confidentiality.
Other (specify):
16. Will any data be shared outside of the University of Florida?
No.
Yes - What measures will be taken to protect the confidentiality of any
information obtained from or about subjects that will be sent outside of the
University of Florida
16. Describe any additional measures that will be taken to protect subject confidentiality
after the research is completed:
No identifiers are collected in this study
Data is de-identified during the course of the study. Identifiers are destroyed
during the course of the study (paper document s shredded, electronic files
deleted).
Data is de-identified after the completion of the study and identifiers are
destroyed at this time (paper document s shredded, electronic files deleted).
Other:
17. How long will this project remain open?
Introductory Questionnaire Retrospective Data
IRB version date: 10/30/2014
PI version date:
Page 6 of 7
18. Where are you going to conduct this project? Select all appropriate answers:
a.
University of Florida- Jacksonville
Shands
Health Science Center Clinic – list
Satellite Clinic – list
Other: - list
b.
Gainesville
Shands at Gainesville
Other:
Note: If you select Gainesville you must email the following to Sherri
Mizrahy and Tiffany Pineda (cc: Sheila Austin)in the subject line:1)
an additional, EXACT copy of your submission 2) a cover letter
indicating you have submitted this project to IRB-03 and that you
are requesting joint review.
(1)
c.
Other UF site - list
d.
Non-UF site
Department of Health
Other: - list
(i) Will employees of the outside location assist with collecting and
reporting data, or disclosing identifiable information to you without
subject consent?
No
Yes – these activities make those outsiders engaged in the
research. Answer (1) and (2) below.
(1) Describe exactly what the outsiders will be doing for the
research:
(2) Indicate how these outsiders will receive IRB review and
approval for their involvement:
Another IRB. Attach a copy of their IRB approval.
Unaffiliated Investigator Agreement (UIA) attached. List
these investigators:
Federal Wide Assurances (FWA) #:
Introductory Questionnaire Retrospective Data
IRB version date: 10/30/2014
PI version date:
Page 7 of 7
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