Assignment 1a: IRB Submission

AssignmentsAssignment 1a: IRB Submission
Summer 1 2022 – Full-term Courses
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Assignment 1a: IRB Submission
Due May 28 by 11:59pm Points 100 Submitting a file upload
Introduction

The next step in the process is to gain approval from the Institutional Research Board (IRB) to move forward with your data collection. All students conducting primary research at the university must submit a proposal to and gain approval from the IRB.

Here are some links to resources:

IRB Review Process Overview Download IRB Review Process Overview
CIU’s IRB Guidebook Download CIU’s IRB Guidebook
Since it has been a couple of months since you have completed your Human Subjects Research Training with CITI, you may need to review it before submitting your proposal.

Instructions

At this point, you have successfully defended your proposal. Based on what was approved by your committee, complete the appropriate form for the methodology being used. The applications listed below are your options, and they are housed on the Axiom Mentor website (Links to an external site.).

Read Submitting Your Review Form on Axiom Mentor Step-by-Step Download Submitting Your Review Form on Axiom Mentor Step-by-Stepfor detailed instructions on how to use this site.

To read over the application options, go to Axiom Mentor (Links to an external site.) and input CIU as the institution ID, and when prompted, input your CIU username and password. You’ll then see the applications listed.

IRB Form A: Application for Exempt Review
IRB Form B: Application for an Expedited Review
IRB Form C: Application for Full Board Review
Due to time constraints, you are encouraged to design a research study that would qualify for either an exempt or an expedited review. You have the option of designing a study that would require a full board review, but this may lengthen the time needed for study completion. CIU’s IRB Guidebook should answer most questions about each of the options.

When you submit your research proposal, double-check that you have answered all the questions and provided the requested documentation so that you avoid unnecessary delays.

When you receive feedback from the IRB Committee, communicate that with your Mentor immediately to determine your next steps. Once you receive the formal approval letter, upload that document here.

Due Saturday of Week Two.

IRB
Info Page Icon
Info Page
Documentation Icon
Documentation
My Protocols Icon
My Protocols
CITI Certification Icon
CITI Certification
INTRODUCTION:

The Columbia International University Institutional Review Board is charged by the Federal Government with protecting human subjects involved in research. The IRB conducts prospective and continuing review of protocols, the informed consent process, and the procedures used to enroll subjects in order to ensure that the human subject research is conducted ethically and in compliance with the Belmont Report, and with applicable federal, state, local and institutional requirements.

Preparing the Research Protocol

For student researchers, your beginning point should be your faculty advisors/mentors. They will guide you in building a solid protocol with the appropriate documentation to demonstrate the protection of research participants in matters regarding:

minimizing risk,
managing informed consent,
and maintaining confidentiality.
All researchers can find the CIU IRB Guidebook as well as the CIU-IRB forms needed to submit protocols to the IRB on this page and the Documentation tab on the left navigation menu. Researchers should thoroughly study the Guidebook and the IRB forms before preparing and submitting a research protocol. The Guidebook is especially helpful in determining which level of IRB review should be requested in the protocol.

File Icon IRB Form A: Exempt Review

File Icon IRB Form B: Expedited Review

File Icon IRB Form C: Full Board Review

Procedure for Submitting a Protocol

File Icon Submitting a Protocol on Axiom Mentor

Need Help?

If you have questions about the process of IRB review, please contact Roxianne D. Snodgrass, Ph.D., CIU’s Director of Institutional Research and IRB Chair. The Director is ready to assist you with any questions that you may have about the IRB review process. Please feel free to call 803-807-5051 or e-mail roxi.snodgrass@ciu.edu for assistance.

OTHER IRB PROCEDURES

Consent and Permission Forms

Consent forms and various other types of permission forms are available by going to this folder under documents:

Root Folder Icon 2-Sample Consent Forms and Other Related Documents
Name Sort order ascending icon Size Dated
File Icon 01_Read Me First 19 K 07/02/2020
File Icon CIU IRB Required Statement for Informed Consent Fo… 20 K 08/06/2020
File Icon Informed Consent for Individual Interview.doc 69 K 07/02/2020
File Icon Informed Consent for Interview at Participating Si… 70 K 07/02/2020
File Icon Informed Consent Lead-In to Online Anonymous Surve… 22 K 05/21/2021
File Icon Recruitment Script.doc 43 K 07/02/2020
File Icon Research Partner_Letter_of_Cooperation.doc 43 K 07/02/2020
File Icon Simplified_Site_Permission.doc 40 K 09/21/2020
File Icon Transcriptionist_ConfidentialityAgreement.docx 21 K 07/02/2020

Amendments/Modifications

Any changes to existing protocols should first be reviewed by the IRB as they may impact the risk/benefit ratio of the protocol. To submit an amendment, go to the view protocol page and click on the “Amendments” tab at the bottom. You will find a button there to upload your amendment. Include in your amendment a summary of the changes. If your changes require modification of your consent form, include your consent form along with the summary and use track changes to highlight the changes you are making.

File Icon IRB Form E: Modification Form

Annual Reports/Continuing Review

Exempt protocols are not required to file continuing reviews on an annual basis but all protocols approved by expedited or full board review procedures are required to submit a continuing review report or termination. Mentor will automatically notify you of an impending report due date. Just go to the view protocol page and scroll down to the set of tabs at the bottom. The Annual Report tab is the first tab visible. Click on the Context Menu and select “Edit” and complete the resulting form.

File Icon IRB Form D: Final Report and Renewal Form

Adverse Events

In the event that a human subject is harmed as a result of participation in your project, it is necessary that you immediately inform the IRB. Go to the view protocol page and click on the Adverse Events tab. There is a button there to upload a description of the event. You should include in your summary your judgment of whether the harm to the subject was a result of their participation in the project or incidental to it. You should also indicate if you think that the event warrants any changes to your protocol or consent form. If so, you should then submit an protocol amendment. It is best to talk with the IRB chair before submitting your amendment.

including a link to the federal regulations and some founding documents on the ethics of research involving human subjects on the

File Icon IRB Form F: Incident Report Form

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