APPLICATION TO REQUEST CONTINUING REVIEW OF A RESEARCH PROTOCOL INVOLVING HUMAN SUBJECTS

Kean will no longer require comprehensive continuing review for research studies identified as minimal risk and approved by IRB on or after January 21, 2019. Instead, researchers will complete an annual Progress Report and submit it to IRB office. Amendments and modifications will still need to be submitted, reviewed, and approved by the IRB prior to their implementation. In addition, unanticipated problems, protocol deviations, and other Reportable Events will still need to be submitted to the IRB.

Submission of this application must occur 60 days prior to expiration of currently existing research protocol to avoid the possibility of a lapse in IRB approval. Any research study that has not received continuing review and written approval by the end of its current approval period is automatically considered expired and all research and research-related activities must cease.

Background:

In accordance with DHHS Guidance on Continuing Review, the IRB starts with the working presumption that the research, as previously approved, does satisfy all of the criteria for IRB approval of research. The IRB will focus on whether there is any new information provided by the investigator, or otherwise available to the IRB, that would alter the IRB’s prior determinations, particularly with respect to the IRB’s prior evaluation of the potential benefits or risks to the subjects. The IRB will also assess whether there is any new information that would require revision of the protocol and/or the informed consent document.

General Information

Applicant Name

Department

Home Address

Phone

Research Project Title

Current Approval End Date

Protocol # (from current approval letter)

*Students applying for IRB continuing review must complete the student section. NOTE: Student applications that are not signed by the Faculty Advisor will not be reviewed.

A. PROTOCOL DESCRIPTION FOR CONTINUING REVIEW

Provide responses to the following:

1. A brief summary of the protocol currently being used. HIGHLIGHT any changes to methodology that have occurred since data collection started, and any amendments or modifications to the research since the last IRB review.

Student Applicants

2. The number of subjects enrolled to date. Explain any variation from the number of subjects in the original application.

3. A summary of any unanticipated problems and available information regarding adverse events. If there have not been any unanticipated problems, state this.

4. A summary of any withdrawal of subjects from the research since the last IRB review.

5. A summary of any complaints about the research since the last IRB review.

6. Any other relevant information, especially updated information about risks associated with the research.

7. A summary of any recent literature that may be relevant to the research.

Required Attachments

Please upload a single PDF File

Click here for a guide on how to combine PDF files.

If you are proposing changes to any of the currently approved documents (consent form, debriefing
form, recruiting materials, surveys, etc.), a copy of the current document as well as the newly
proposed document must be attached.

* Combine all the documents into a single PDF file in this specific order:

Advisor Signature Page (if needed). Click Here to download.
Extra Co-PIs Signature Page (if needed) Click Here to download.
CITI Training Certificates
Consent and Debrief Forms (Assent and video/audio included)
Site Permission
Copies of all measures, survey instruments, interview questions, recruitment letters or emails, advertisements
Permission to use measures created by a different researcher.
All other documents.

Upload File

SUBMITTING YOUR REVISED APPLICATION

Include the revisions that were made to your original application. Indicate the appropriate section titles and numbers of revised fields/answers if applicable.

By signing this form, I certify that I am familiar with Kean University policies and federal and state regulations regarding the protection of human subjects in research. I will not begin this study until I receive a written notice of approval, without provisions, from the IRB. I will conduct this study following the approved protocol. I will report any adverse events or emergent problems to the IRB; will obtain IRB approval before implementing any modifications of protocol; and, will request continuing review and approval for any activities beyond the study end date.

Applicant Signature

Date

Thanks for submitting!

Ex:

General Information > Phone Number (updated phone number)

A. PROTOCOL DESCRIPTION FOR CONTINUING REVIEW > Section 4 (Updated summary of withdrawal of subjects)

A. PROTOCOL DESCRIPTION FOR CONTINUING REVIEW > Section 5 (Updated summary of complaints)