Submitting Your Application

CITI Online Training: Effective June 1, 2006 all IRB applicants must complete the CITI Online Human Subjects Training course before submitting their IRB applications. (see IRB policy)

Signature: - Check to make sure your application is complete and signed by yourself and your advisor. Applications not signed will be returned.

Informed Consent(s): MUST be on your college departments letterhead upon submission. Applications will no longer be accepted if informed consent and assent documents are not on department letterhead.

Informed Consent Checklist: Submit informed consent which includes all 8 elements of the informed consent. See sample informed consent and OHRP checklist at Informed Consent Procedures.

Questions Addressed: Check to make sure you have answered and addressed question 9 - 15 in your own words.

Vulnerable Populations: Any research involving children requires full board, no exception. May also include prisoners, pregnant women, people with impaired decision making capabilities.

Administrative Review Clarification: Informed consent is a federal requirement to inform and notify research subjects the nature and purpose of the research. Only the designated IRB Chair can make the final determination as to your applications Exempt review status. The IRB Chair may determine that your application does not follow under the Exempt review criteria category and therefore require may require Expedited or Full Board review. Should your application not follow under the Exempt category you will be notified through correspondence. Please ensure that your application is indeed Exempt by reviewing your protocol with your advisor and going through the IRB decision tree.

Permission Letters: - Before you conduct the proposed research you must include in your IRB appication permission from the organization, agency, or entity permission to conduct the research at their facility - An example would be a permission letter from the principle to conduct the proposed research at a particular school or a permission letter from a school district official to conduct your proposed research in a particular school district. If you are accessing student school records the permission letter should include the language to use school and/or student records.

Recruitment and Advertising Materials - Example if you plan on using flyers/advertisements to establish a list of possible research participants, you will need to include that flyer/advertisement.

Child Assent: - Written at a child's language level. This informs the child, much like the informed consent, of what research they will be asked to participate in. Perform a google search to find an approppriate child assent format that fits your research study.

IMPORTANT NOTE : Please note that once you are approved, your research is only good for one year from the date of stamped IRB approval which is indicated on your informed consent (for expedited and full board review only). Once that date passes you may NO longer have any enrollment and you must cease all data collection. You may continue you research if you submit the IRB Renewal Form (listed below) to the IRB Secretary 60 days prior to your research ending.

Application Copies: Submitting the application - We require one original and one copy submitted / Single sided copies only. Do not copy on both sides of paper, do not staple, and please paper clip your application.

IRB Secretary's Application Check List

What If the IRB Requires Changes to my Application?

Use the changes from the resubmission letter/correspondence and review them one by one with your advisor. As you edit/revise your application highlight or check off the changes on the resubmission letter/correspondence and submit a copy the changes you have made with the revised changes to your application

Note: You have 60 days to resubmit the IRB's required changes to your application. After 60 days your application will be closed and you will have to resubmit a new application and be assigned a new IRB number for review through the normal IRB submission process.

You must notify the IRB when your research has ended either by email to mgillesp@csusb.edu, or by correspondence to Office of Academic Research AD-179, Atten: IRB Coordinator, 5500 University Parkway, San Bernardino, CA. 92407. Include your IRB# in all correspondence. You may also call the IRB Secretary at (909) 537-7588 and leave a message. Please include your IRB #

Your IRB approval is only good for (1) year from the date on your approval letter. If you plan on renewing your IRB before the ending date on your informed consent (for expedited and full board review only) fill out the renewal form listed below and submit it at least 60 days prior to your originally stamped informed consent(s) end date.