IRB (Institutional Review Board)
Third Party Access to Existing Data Protocol
Qualtrics Converted to WordUpdated 1/10/2018
Third Party Access to Existing Data Protocol
Q1 IRB (Institutional Review Board)
IF THERE ARE PERSONAL IDENTIFIERS IN THE DATA TO BE ACCESSED, (EVEN IF YOU AREN'T REPORTING THEM) YOU MUST SUBMIT THIS FORM
Please work in the MS-Word version of this document and then copy and paste all of the information into this form.
Faculty: Please make your Department Chair aware of your Protocol submission.
Q2 Today's Date--Your Original Submission Date
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Q3 Revision Dates (s) or Modification Date (s)
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Q4 Responsible Investigator Name [Faculty research mentor, if student research]
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Q5 Responsible Investigator E-mail
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Q6 Department Chair/Program Director Name
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Q7 Student Investigator Name [Do not include student research assistants for faculty research]
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Q8 Student Investigator E-mail
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Q9 Research Assistant Names
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Q10 Research Assistant E-mail Addresses
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Q11 Title of Project
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Q12 CITI Human Subjects Protection Training Completion Report (Upload here)
Q13 Concisely describe how existing data will be involved in the proposed research
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Q14 Professional qualifications [to do the proposed research]
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Q15 Describe Your Funding Source [If the research is grant-supported or contract research]
Enter the Grant Title and Fund Number or Contract Number where applicable.
Note: When funding is received that covers a research project already approved and in progress, please submit a Modification Request to notify the IRB of the new funding.
▢Federal Grant ______
▢Local Government ______
▢Pending ______
▢Private Grant (for profit) ______
▢Private Grant (non-profit) ______
▢School/Department ______
▢Sub-Contract ______
▢Other ______
▢None
Q16 Purpose of the proposed research [Provide an explicit statement of what is and is not known about the topic, indicating what the proposed research is intended to add, stated as benefits to the discipline and to the subjects. The IRB makes a cost/benefit analysis weighing the potential benefits of the research against the potential costs and risks to the subjects.]
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Q17 For the original data collection, was informed consent obtained for:
▢Data use for program evaluation (1) ______
▢Data use for research purposes (2) ______
Q18 If you answered Yes to the above question, please append written evidence
Q19 Upload any additional supporting documents here:
Q20 Upload any additional supporting documents here:
Q21 Upload any additional supporting documents here:
Q22 Provide a specific and meaningful description of the information for which access is requested. Variable lists are appropriate, if the variables are explained. Directly address whether personal identifiers will be included.
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Q23 Explain why the research could not practicably be conducted without access to the data
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Q24 Explain why consent of the subjects could not practicably be obtained
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Q25 If you answered above that consent has not been obtained for data use for program evaluation, please show that the individuals—even if personal identifiers are absent—will not be placed at greater risk by the research [for example by substantial risk of loss of benefits depending upon the results obtained].
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Q26 If personal identifiers are present in the data to be accessed, show how each of the following is present:
Q27An adequate plan to protect identifiers from misuse
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Q28An adequate plan to destroy the identifiers at the earliest opportunity consistent with the research and law
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Q29 Adequate assurances that the data will not be disclosed to any other person or entity except as required by law
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Q30 Adequate oversight of the research project
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Q31 Attach an additional document here [for example, authorization from an agency]
Q32 Attach an additional document here [for example, authorization from an agency]
Q33 Attach an additional document here [for example, authorization from an agency]
Q34 When the information in this protocol is complete, checked, approved by the faculty mentor -- if a student project -- proceed to the submission section.
Q35 Required
- I affirm the accuracy and truth of the information in this document
Q36 Required
- I understand that submission is the first step in the IRB review and authorization process. I will receive a submission confirmation E-mail after I submit this form.
Q37 Please enter a phone number where you can be reached, should we have questions:
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Link to Online Qualtrics Third Party Access to Existing Data Form:
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California State University, Bakersfield