1. education

Jones International University ®
New Study Application
Request for Institutional Review Board Approval
May 6, 2015
Jones International University
9697 East Mineral Avenue
Centennial, CO 80112
1.800.811.5663
www.jiu.edu
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All rights reserved.
New Study Application - Request for Institutional Review Board Approval 2
TABLE OF CONTENTS
New Study Application .....................................................................................................................................3
Overview ...............................................................................................................................................3
Completing the New Study Application ............................................................................................................ 3
Section 1: Investigator Information .........................................................................................................5
Section 1.b: Additional Investigator(s).....................................................................................................6
Section 2: Project/Study Information ......................................................................................................7
Section 3: Funded Projects ......................................................................................................................8
Section 4: Subject Population .................................................................................................................9
Section 5: Request for Protocol Review ...................................................................................................10
Section 6: IRB Application Evaluation Rubric ...........................................................................................11
Section 7: Signatures ..............................................................................................................................12
Section 8: Attestation Page .....................................................................................................................13
Section 9: Application Portfolio Checklist ................................................................................................14
Section 10: Attachments .........................................................................................................................15
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NEW STUDY APPLICATION
Overview
The IRB application should provide all information necessary for IRB members unfamiliar with the investigator’s field of
research to be able to evaluate the risks and benefits to subjects, how subjects will be recruited, how informed consent
shall be obtained and other important details about the proposed research study. The steps for completing the
Application are outlined in detail in the IRB Handbook, and an abridged version of each step is listed below. For a
complete discussion, including examples, please refer to the IRB Handbook. All are designed to provide clarity regarding
the application document, the application process, and the required documentation that should be included in the IRB
Application Portfolio.
Completing the New Study Application
Step 1: Review the JIU IRB Handbook.
Step 2: Complete the New Study Application Request for IRB Approval
Step 3: Attach all supporting documentation.
Step 4: Submit your completed Application to your Dissertation Chair for approval.
Step 5: Submit your completed, Portfolio to your Dissertation Committee.
Step 6: Submit your completed, Chair-approved IRB Application Package to the IRB.
Step 7: Revise Application, if requested, and resubmit to the IRB.
Step 1: Review the IRB Handbook
The Handbook is designed to provide the background information needed to complete the Application without
additional resources. It is the researcher’s responsibility to read and process the information included in the
Handbook as well as to ask for clarifications from the IRB regarding information that is unclear. Also, the policies and
procedures included in the Handbook are unique to JIU and should not be confused with other organizations that
may also require IRB approval for research, i.e. school district IRBs, etc. The Handbook is located on JIU student and
faculty dashboards on the left side under “My Links/Handbooks and Guides/IRB.”
Step 2: Complete the “New Study Application Request for IRB Approval”
Fill out each section completely. If a criterion is not applicable to your proposed study, indicate “NA.”
Step 3: Attach all supporting documentation.
Supporting documentation includes, but is not limited to, the following:
• Research Proposal
• Research Site or Data Gatekeeper permission
• CITI® certification
• Data Collection Instruments with reliability and validity information
• Informed Consent documents
• Informed Assent documents
• Introduction letters or subject recruitment materials
• Completed Rubric
• Attestation Page
• Signature Page
• Completed Checklist
• Turnitin® report
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Step 4: Submit your completed Application to your Dissertation Chair for approval.
All doctoral candidates must submit their completed portfolios to their Dissertation Chair for final approval.
Step 5: Submit your completed, Portfolio to your Dissertation Committee.
The committee will review and may request additional revisions. If revisions are suggested by the committee, the
updated version must receive final approval from the Dissertation Chair.
Step 6: Submit your completed, Chair-approved IRB Application Package to the IRB.
Submit your complete portfolio to [email protected]. Doctoral candidates must have Dissertation Chair
approval before submitting to the IRB. NOTE: The IRB will not review incomplete applications or materials submitted
one at a time. A complete portfolio is required for review (see Step 3 above).
Step 7: Revise Application, if requested, and resubmit to the IRB.
If the IRB requests additional information or changes to the application, the investigator must provide them in a
timely manner to avoid delays in approval and data collection. NOTE: No data may be collected until the IRB has
granted full approval of a proposed study.
If you have any questions about the information contained in the application or the IRB Handbook, do not hesitate to
contact the IRB for clarifications or additional guidance by contacting [email protected].
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Section 1: Investigator Information
Check one:
Student ☐
Faculty ☐
Principal Investigator’s Name:
School or Department:
Mailing Address:
Telephone #s:
Email:
Staff ☐
Other ☐ Explain:
Last:
School of Education ☐
First:
School of Business ☐
Street:
City:
State:
Home:
Mobile:
JIU:
Other:
ZIP:
Work:
Other:
Evidence of Ethical Research Protocols Training (CITI® certification):
If “Yes” above, is CITI® certification documentation attached?
Yes ☐
Yes ☐
No ☐
No ☐
Dissertation Committee Name (Doctoral Students Only): Attach “Form to Designate a Dissertation Committee” found in
the Dissertation Handbook.
Additional Investigators:
Yes ☐
No ☐
If “Yes” above, complete Section 1.b below.
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Section 1.b: Additional Investigator(s)
Fill out this section if additional investigators or research assistants will work on this project. Attach additional pages if
necessary.
Check one:
Student ☐
Faculty ☐
Additional Investigator’s Name:
School or Department:
Mailing Address:
Telephone #s:
Email:
Staff ☐
Other ☐ Explain:
Last:
School of Education ☐
First:
School of Business ☐
Street:
City:
State:
Home:
Mobile:
JIU:
Other:
ZIP:
Work:
Other:
Evidence of Ethical Research Protocols Training (CITI® certification): Yes ☐
If “Yes” above, is CITI® certification documentation attached? Yes ☐
No ☐
No ☐
“I certify that I have undergone training in ethical research protocols and will conduct my work on this project according
to established ethical principles and the protocol contained in this application.”
Additional Investigator Signature
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Section 2: Project/Study Information
Although each section should be self-explanatory, a brief description of each criterion is found on pages 2-3. Complete
descriptions of each criterion can be found in the JIU IRB Handbook. The IRB Manager and other members of the IRB are
available to help the investigator complete this section by contacting [email protected].
Study or Project Title:
Title (continued):
Research Question(s):
Proposed Research Design:
Methodology:
Data Analysis:
Data Collection Instruments:
Type/Name of Instrument:
Reliability/Validity Information:
Permission from owner to use instrument(s):
If “Yes,” is documentation attached?
Yes ☐
Yes ☐
No ☐
No ☐
Research Site(s) or Data Source(s):
Permission from Site/Data Source Gatekeeper:
If “Yes,” is documentation attached?
Yes ☐
Yes ☐
No ☐
No ☐
Anticipated Start & End Dates:
From
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Section 3: Funded Projects
Has this project been submitted for external funding?
Yes ☐
If “Yes,” complete below.
What kind of funding will this project receive?
None ☐
Grant ☐
Contract ☐
Fellowship ☐
Principal Investigator on Project:
Last Name:
No ☐
If “No,” then move to Section 4.
Other ☐ Explain:
First Name:
Funding source:
JIU Index # (if applicable):
Project Title:
Title (continued):
Are the IRB requirements and research protocol(s) in the proposed study identical to those described in the funded
proposal application?
Yes ☐
No ☐ Explain:
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Section 4: Subject Population
Subjects: Check the appropriate boxes below to indicate the subject population(s) who will be involved in the research
project. For a discussion of populations, please see the JIU IRB Handbook.
☐ Adults (competent to consent)
☐ Adults (not competent to consent)
☐ Minors (under 18 years old)
☐ Prisoners
☐ Pregnant Women
☐ Developmentally Disabled
☐ Non-English speaking
☐ Minors (under18 years of age) with cognitive impairment
Describe the population for your study:
Describe the sample for your study:
Describe your protocol(s) for selecting your subjects/sample:
Informed Consent/Assent: Please describe your protocols below or attach if more space is needed.
Risks:
Benefits:
Anonymity:
Confidentiality:
Voluntary Participation:
Data Access/Storage/Security/Destruction:
Vulnerable Populations:
Informed Assent:
Provisions for non-English speakers:
Remuneration:
Form(s) Attached?
Yes ☐
No ☐
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Section 5: Request for Protocol Review
Indicate the type of review you are requesting: Exempt, Expedited or Full Board Review. If you select either Exempt or
Expedited, indicate the expedited review category number that best fits your research. Explain your choice by referring
to the PROTOCOL REVIEW CATEGORIES section found in the JIU IRB Handbook. Your explanations should refer to specific
criteria in your study uniquely associated with review category. Please see the IRB Handbook for Approval Timeframe
and Deadlines.
☐ I am requesting an EXEMPT REVIEW.
☐ Category 1
☐ Category 2
☐ Category 3
☐ Category 4
Attach “Criteria for Exempt Study Review”
Explain why your study is Exempt and how your study fits the selected Exempt category:
☐ I am requesting an EXPEDITED REVIEW.
☐ Category 1
☐ Category 2
☐ Category 3
☐ Category 4
Attach “Criteria for Expedited Study Review”
Explain why your study is Expedited and how your study fits the selected Expedited category:
☐ I am requesting a FULL BOARD REVIEW.
Final decisions about the appropriate level of review rest with the IRB.
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Section 6: IRB Application Evaluation Rubric
N/A
Basic
Developing
Proficient
IRB Application Evaluation Rubric
Advanced
Investigators: Please use the following rubric to ensure that all areas of the application are addressed.
The levels (Advanced, etc.) provided are for doctoral candidate and dissertation chair and committee use only:
• Advanced -Application is exceptional and is ready for review;
• Proficient – Application meets basic requirements and is ready for review;
• Developing or Basic – Application is not yet ready for review (formative feedback for student required)
Chair: If “Developing” or “Basic,” please provide
specific feedback.
Investigator Information
• Provided & Complete
Project/Study Information
• Title APA compliant
• Research Question(s)
• Methodology
• Data Analysis
• Data Collection Instruments
• Reliability & Validity
• Permission to use instrument
• Research Site or Data Source identified
• Research site/data source permission
• Research Timeline
• Funded Projects Information
• Turnitin®
Subjects
• Population
• Sample
• Selection protocol(s)
Informed Consent/Assent
• Risks or potential harms to subjects
• Benefits to subjects
• Subject anonymity
• Subject confidentiality
• Voluntary Participation
• Data access/storage/security/destruction
• Vulnerable populations
• Informed Assent
• Non-English speakers
• Remuneration
• Forms
Protocol Review Request
• Appropriate review & category
• Explanation
Other:
Doctoral Students ONLY: This rubric must be completed by the chair and your dissertation committee.
Dissertation Chairs and Committee Members: If proposal is not at an “Advanced” or “Proficient” level, please return to
the student for corrections
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Section 7: Signatures
INVESTIGATOR:
“I accept responsibility for the research protocol described herein. I am aware of all procedures to be followed, I will
monitor the research, and I will notify the IRB of any changes or significant problems.
Further, I certify that I have undergone CITI® training in ethical research protocols.”
Principal Investigator’s Signature:
Date:
Principal Investigator’s Name:
DISSERTATION CHAIR AND COMMITTEE: (Required for doctoral candidate research)
“I accept responsibility for the research protocol described herein by the doctoral candidate working under my direction.
I further attest that I am aware of all procedures to be followed, will monitor research and will notify the IRB of any
changes or significant problems. I certify that I have undergone CITI® training ethical research protocols.
In addition, I have completed the required IRB Application Evaluation Rubric (Section 6), and I approve of the candidate’s
proposal.”
Dissertation Chair’s Signature:
Date:
Dissertation Chair’s Name:
Committee Member’s Signature:
Date:
Committee Member’s Name:
Committee Member’s Signature:
Date:
Committee Member’s Name:
Committee Member’s Signature:
Date:
Committee Member’s Name:
ADDITIONAL INVESTIGATOR(S): (if applicable)
“I accept responsibility for the research protocol described herein. I am aware of all procedures to be followed, I will
monitor the research, and I will notify the IRB of any changes or significant problems.
Further, I certify that I have undergone CITI® training in ethical research protocols.”
Additional Investigator’s Signature:
Date:
Additional Investigator’s Name:
Additional Investigator’s Signature:
Date:
Additional Investigator’s Name:
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Section 8: Attestation Page
“I certify that I and each of the key personnel involved in this project have completed an approved training program in
ethical research protocols and certificates on file with the IRB office:
Date Training Completed:
Date:
Principal Investigator: ☐ Certificate attached, or
☐ On-file with JIU IRB
Date:
Dissertation Committee Chair: ☐ Certificate attached, or
(doctoral candidates only) ☐ On-file with JIU IRB
Date:
Additional Investigator(s): ☐ Certificate attached, or
☐ On-file with JIU IRB
And further,
• I agree to use procedures with respect to safeguarding human subjects in this activity that conform to university
policy.
• If significant change in investigative procedure involving human subjects is called for during the activity covered
by this application, I shall seek prior approval for such change from the IRB and agree to follow the advice of the
IRB.
• If my research is subject to the requirements of the HIPAA Privacy Rule, I agree to meet those requirements and
to see that other persons involved in data collection also meet those requirements to the extent they assist me in
this research.
• Where required, I will obtain a HIPAA or FERPA authorization or an IRB waiver of HIPAA or FERPA authorization.
Principal Investigator
Date
Dissertation Chair
Date
Additional Investigator
Date
Additional Investigator
Date
NOTE: The dissertation chair’s signature indicates that s/he has reviewed this application and accepts the responsibility of ensuring
that the procedures approved by the IRB are followed.
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Section 9: Application Portfolio Checklist
Principal Investigators, Dissertation Chairs and Committee Members:
Please use this checklist to ensure that all required portfolio items are included with the application.
1. Application complete, including all signatures:
☐ Yes
☐ No
2. CITI® certification for all key personnel attached:
☐ Yes
☐ No
3. Funded project information included (if applicable):
☐ Yes
☐ No
4. Informed Consent Form attached:
☐ Yes
☐ No
5. Informed Assent Form attached (if applicable):
☐ Yes
☐ No
6. Chapters 1 through 3 (Doctoral Candidates Only)/Research proposal (all other Investigators) attached:
☐ Yes
☐ No
7. Data collection instruments attached:
☐ Yes
☐ No
8. HIPAA or FERPA Forms (Authorization or Waiver) attached (if applicable):
☐ Yes
☐ No
9. All Recruitment Materials for Subjects attached:
☐ Yes
☐ No
10. Other supporting documents attached (if applicable):
☐ Yes
☐ No
11. Research Site/Data Source Gatekeeper letter of permission attached:
☐ Yes
☐ No
12. turnitin® report attached:
☐ Yes
☐ No
Principal Investigator’s Signature:
Date:
Dissertation Chair’s Signature:
Date:
Committee Member’s Signature:
Date:
Committee Member’s Signature:
Date:
Committee Member’s Signature:
Date:
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Section 10: Attachments
Append all required documents to the end of this application.
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