Jacksonville – IRB-03
/ Introductory Questionnaire – Tissue/Data Bank
Please provide contact information for a representative who can answer any questions that the IRB might have concerning this submission:
Name:
Position:
E-mail:
Phone #:
Pager #:
2nd Contact: / name + e-mail or phone number
Group:
Form Instructions:
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  • This form is used to inform the IRB of the formation of a Research Tissue/data bank or a clinical Tissue/data bank from which research projects may be conducted. This form asks questions regarding the nature of the tissue/data being collected and the policies and procedures you will use to ensure subject confidentiality and compliance with Federal Regulations on human research.
  • This form is ONLY for initiation of a Tissue/Data bank and not for the initiation of a research project. Research projects that will use the Tissue/Data stored in this Tissue/Data bank must be reviewed and approved by the IRB via a separate submission.
  • All submissions must be typed.
  • Submissions that do not meet our Submission Acceptability Standards will be returned to the PI. Visit for more information.
  • This form is available on the IRB-01 website at:

Project Title:

Date(s) of deadline(s) for grants or funding related to this project:

Tissue and Data Banks must be reviewed at full Board.

Submit 1 Electronic and 1 paper copy (paper copy must be the signed original) to the IRB-03 office. Email electronic copy to .

Principal Investigator (PI) Information The PI must be affiliated with UF, Shands, or the NF/SG VHS as either faculty, staff, or student. Unaffiliated people cannot be listed as the PI for the protocol.

Name: / Last: First: Middle:
UF ID #: / All researchers must possess a UF ID#. Contact our office if you need to obtain a number.
Degree: / Position:
College: / Department:
Box #: / E-mail:
Phone: / Fax:
Beeper: / Other:

**All submissions must include Addendum A– – Research Personnel Assurance. Place cursor over text and Ctrl+click to follow link

ALL QUESTIONS MUST BE ANSWERED and

VERSION DATE MUST BE ADDED TO FOOTER

1. Is funding required to initiate and/or complete this project?

Yes. Answer Yes if funding will be sought AND it is required in order to initial/complete the project.

No.Answer No if funding will not be sought OR if funding will be sought but is not needed to initiate/complete the project.

2. Will financial or material support (such as personnel, office space, supplies, testing/procedures)be obtained for this project? Regardless of whether or not it is needed to initiate/complete the project.

No. Go to question 3.

Yes – already obtained. Answer a through c below.

Yes – pending. List the deadline date: Answer a through c below.

  1. Indicate the name of the Principal Investigator of the Contract or Grant: Indicate “same” if the name on the contract or grant is the same.
  2. Funding Source:

NIH / DHHS - Is UFJ or Shands the originating site for the grant?

Yes – include two copies of your grant with this submission.

No – the IRB does not need a copy of the grant.

NCI (National Cancer Institute)

Private sponsor: Industry sponsored research may be submitted to IRB-04 (WIRB®). Visit for more information

Department or University

Dean’s Grant

Other:

  1. Division of Sponsored Research Contract or Grant Number (If not applicable enter “Not applicable or N/A”):

3. Indicate the type of tissue/data bank being submitted:

Tissue Bank

Left over tissue collected and stored for clinical purpose.
Describe:

Left over tissue collected for clinical purpose and usually discarded. Describe:

Tissue collected as part of other IRB approved research protocols. Describe:

Data Bank

Data collected and stored as part of the normal hospital or clinic operations or normal clinical care of patients. Describe:

Data collected as part of other IRB approved research protocols. Describe:

4. Where will the tissue/data bank be located? Enter the room number and location of the storage facility.

5. Have you included a copy of all the data fields in the data base being used to track the all data elements for the items in your bank?

Yes.

No. If no, please explain:

SECTION II—USE OF VULNERABLE POPULATIONS

6. Will subjects of a specific race or ethnicity (as defined by NIH) be studied?

No – proceed to Question 7.

Yes - answer items (a) through (c) below:

  1. Indicate if you will target any of the following ethnic groups:

Select all that are appropriate.

Hispanic
Non-Hispanic
Will not target a specific ethnic group

  1. Indicate if you will target any of the following racial groups?

Select all that are appropriate.

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):

  1. Will vulnerable populations will be included in this project?

No –proceed to Question 14

Yes- Indicate which of the following vulnerable populations will be included and if “target” is selected complete 7 a.

General = subjects would be recruited or enrolled only as they exist in the general population; i.e. you can accept subjects from the category but are not specifically selecting subjects because they belong to the category.

Target = These subjects will be specifically targeted to participate in this project and will be actively recruited or enrolled due to their vulnerable status.

Vulnerable Population / General / Target / If either is checked, you must complete submit the following appendix:
Pregnant Women / Addendum W Place cursor over text and Ctrl+click to follow link
Fetuses / Addendum W Place cursor over text and Ctrl+click to follow link
Children (under 18 years old) / Addendum K Place cursor over text and Ctrl+click to follow link
Prisoners / Addendum P Place cursor over text and Ctrl+click to follow link
Decisionally impaired (cognitively, psychologically, or legally) / Addendum J
Institutional residents (e.g. people living in a nursing home) / Addendum J Place cursor over text and Ctrl+click to follow link
Terminally ill patients / Addendum J Place cursor over text and Ctrl+click to follow link
UF/Shands/VA staff / Addendum J Place cursor over text and Ctrl+click to follow link
UF students / Addendum J Place cursor over text and Ctrl+click to follow link

Introductory Questionnaire Tissue/Data BankPage 1 of 10

IRB version date: 10/30/2014

PI version date:

7a. Ifvulnerable populations are to be targeted please justify:

SECTION III-SUBJECT INFORMATION

  1. Will informed consent for storing tissue/data be obtained?

No – Please describe reason for not obtaining informed consent.

Yes

As part of other IRB approved protocols

A separate consent only for the purpose of storing tissue/data. Please describe the population who will receive this informed consent:

9. Are you seeking a Waiver of Informed Consent, Modification of Informed Consent, or Waiver of Documentation of Informed Consent for any subjects?

No. Go to Question 10.

Yes. Include Addendum H: Waiver or Modification of Informed Consent for Enrolling.Place cursor over text and Ctrl+click to follow link

10. Are you going to seek Informed Consent from any subjects in order to store tissue/data?

No. Informed consent will not be obtained. You must answer “Yes” to Question 9 and includeAddendum H: Waiver or Modification of Informed Consent for Enrolling.Place cursor over text and Ctrl+click to follow link

Yes

As part of other IRB approved protocols. List protocol numbersGo to Question 11.

A separate consent only for the purpose of storing tissue/data.

Answer questions (a) through (h) below.

a. Describe the number and each type of informed consent forms you will use: For example: control subject, caregiver, UF version, etc. If you are targeting people who cannot speak/read English you must also submit translated copies along with either (a) a certification from a translation service or (b) the qualifications of the individual who performed the translation. These consent forms must be attached to this submission.

b. Once potential subjects have been identified for your study, who will seek informed consent from the potential subjects to participate in this project? . (e.g. position, title, classification, type of employee, student, etc)

c. Describe how the people seeking informed consent are qualified to do so: (describe any appropriate training or knowledge about (a) the protocol, (b) the condition being studied, and/or (c) the informed consent process itself

d. What is the general setting where subjects will be asked to consent (for example, in Internal Medicine outpatient clinic, in-patient room, emergency room, research lab, classroom, etc. If you provide an exact location be advised that you cannot do it anywhere else. Otherwise be “generally specific” such as using the examples above)?

e. When will subjects be asked to consent(for example, how many hours or days prior to participating in any research procedures. IRB is concerned with how much pressure the subject is under to make a decision, how much time they have to consider whether or not to participate. Describe your process. You may give a range of times.?

f. Will you use the Informed Consent form as the summary of your consent discussion?

Yes.

No. Explain what will be communicated to the subject:

g. Will subjects be given an opportunity take the consent home to discuss with family members, friends, and/or someone knowledgeable about the protocol? Federal regulations require you to give subjects a copy of the consent to the subject or their representative.

Yes.

No. Describe and justify:

h. Who will give consent (agree to participate on the subject’s behalf and sign the consent form)? Check all appropriate answers:

The subject

Parent(s) of a child subject (must indicate in Question 8 that you are including children and complete Addendum K)Place cursor over text and Ctrl+click to follow link

A legally authorized representative for the subject (must indicate in Question 7 that you are including vulnerable subjects and complete Addendum JPlace cursor over text and Ctrl+click to follow link

or Addendum K):Place cursor over text and Ctrl+click to follow link

  • Health care surrogate – documentation required
  • Attorney in fact – documentation required
  • Judicially appointed guardian – documentation required
  • Proxy:
  • Subject’s spouse
  • An adult child of the subject
  • A parent of an adult subject
  • An adult sibling of the subject
  • An adult relative of the subject
  • A close friend of the subject

Note: if a proxy gives consent you must document in the medical or research records the steps followed to determine the validity of the proxy.

Other - specify:

11. What is the expected length of time that each individual subject will participate? indicate years, months, weeks, days, or hours

12. The study offers the prospect for direct benefit to:direct benefit means that the subjects in the study will benefit by participating in this study

all potential subjects.

some potential subjects.Only refers to subjects in the study, not the general or future population

no subjects.

12. Will the principal investigator or a sub-investigator also provide clinical care to subjects (act as a physician, psychologist, nurse, etc.)?

No – proceed to Question 14.

Yes- select all that may be appropriate:

PI will provide care (e.g. clinical or professional care)

before the study.

during the study.

after the study.

Sub-I will provide care (e.g. clinical or professional care)
before the study.

during the study.

after the study.

13. Are research subjects compensated?

No – proceed to Question 20.

Yes - answer items (a) through (d) below:

Note: you may be required to obtain the subject’s Social Security number in order to compensate them. Verify and insure this is disclosed in the Informed Consent form.

a. Reimbursement of expenses

No

Yes. Describe

b. Monetary compensation/reimbursement or gift certificates

No

Yes: Amount prorated per visit: .

Total amount:

(i)Given the subjects being recruited, could the monetary compensation unduly influence a subject to participate in this study or remain in this study when other factors in the subject’s health/environment would keep the subject from doing so?

No

Yes: Explain:

c. Other compensation. Will any of the drugs, devices, treatment procedures or coupons, etc. be given to the subject free of charge?

No

Yes - list:

d. When will subjects receive any compensation selected in a, b, or c above? Examples include after each study visit, after the subject’s participation in the study is complete, after the study is finished, etc.You should also specify how long (days, weeks, months) it should take for payment to be remitted.

14. Local Enrollment Information (coincides with “Table 1: Local Enrollment Information” in the Continuing Review Report).

Table 1. Local Enrollment Information

# of Subjects
a. How many subjects do you need to complete the study? Most researchers consider this the “N” of their study and it is usually supported by a power analysis. If this is chart review (or tissue) study, how many medical records (or specimens) do you need to analyze? / 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 (either due to adverse event, withdrawal, etc.)? / + 0
c. Will your study include procedures (clinical tests, surveys, etc)being done solely for research purposes in order to determine whether or not the subject meets eligibility requirements (i.e. screening for research purposes)? Answer should be consistent with answer to Question 12.
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 (these subjects would be screen failures)? / + 0
d. 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 (wherever the number of subjects occurs, such as the Introductory Questionnaire, Protocol, and Informed Consent form, as appropriate), 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.)

15. Is this a multi-centered (conducted at more than one institution by different/outside investigators)project?

No.

Yes - list the total number of subjects to be included at all participating sites:

16. How was the sample size determined? (Protocol must support and include this determination)(Check all that apply)

Pilot or feasibility study – limited number of subjects, statistical validity not expected

Statistical power and sample size analysis (include details in protocol)

Tissue or data bank

Comparison with similar studies

Secondary data analysis

Treatment protocol

Practical considerations. Describe:

Other:

17. Describe how you will meet the target accrual (re: your study “n”; how feasible is the study; provide a statement using clinical data, accrual to other studies, information from clinical practice or other quantitative data):

18. Did the study receive outside scientific review? (e.g. other IRB’s)

Yes. Who conducted the review:

No.

19. Briefly identify the Scientific Merits of the study? (Summarize in 1 – 2 sentences why the study is important or needed)

20. Does your study have a (a) Data Safety Monitoring Board or Committee (DSMB / DSMC) or (b) Date Safety Monitoring Plan (DSMP) detailed in your protocol?

Yes – proceed to Question 24

No – Answer (a) through (c) below:

(a) Is this study greater than minimal risk?

No

Yes - Include Addendum N: Data Safety and Monitoring Plan. Place cursor over text and Ctrl+click to follow link

(b) Who will assess the safety of subjects and analyze data?

Principal Investigator

Local committee. Describe:

a. Specific role of the committee:

b. How often will the committee meet?

c. Will a written report be generated? Yes. No.

d. Will you automatically receive this report? Yes. No.

Other:

(c) Are there provisions for interim analysis of the data and early closure of the study?

No.

Yes. Describe:

21. Will you collect data on subjects once they have completed the therapeutic and/or study interventions (off protocol therapy follow-up)? In other words, there are no additional study interventions, but the subject will remain on study and you will collect data from clinical follow-up. You may not collect or report this data unless your protocol/consent indicate this will be done).

No – proceed to Question 25.

Yes - describe what data will be collected and when it will be collected: NOTE: you may reference a page number in the protocol or Informed Consent Form if the information is already listed in one of those documents.

22. What measures will be taken to protect the confidentiality of any information obtained from or about subjects and any others related to the subjects? Confidentiality is an extension of the concept of privacy; it refers to the subject’s understanding of, and agreement to, the ways identifiable information will be stored/handled/managed and shared. Identifiable information can be printed information, electronic information, or visual information such as photographs. This includes what will be done with all tapes, pictures, and personal documentation of the subjects. Note: The IRB must be assured that data will be stored securely and will not be shared inappropriately. If using videotapes, there is standardized videotape consent text available on our web site at: