William Paterson University

Institutional Review Board for Human Subject Research

Appendix B: Continuing Review Report

This report is required by the WPUNJ IRB Policy and the Federal Regulations regarding the use of human subjects in research. It must be received by and accepted by the WPUNJ IRB not more than 365 days following the Intial Review or most recent Continuing Review approval date.

Complete all answers as appropriate. Items marked with an "R" are required, you will not be able to submit the report without providing this information.

Please note that this program limits responses in the free text fields to 2500 characters and allow for only limited use of special characters, formatting (such as italics) or paragraphs. If you need to provide more information than will fit in a free text box, please indicated this in the box and then send the information as instructed below.

You will not be able to start this report, save it and return to finish it later. Please review the questions to determine if you have the information you need to complete the report now. If you do not, you can print this to assist you in gathering information before returning to prepare and submit it.

IRB Protocol Number:Required

Date of Initial Review or most recent Continuing Review approval:

Principal Investigator, Title and DepartmentRequired

Campus Mailing AddressRequired

Other Investigators and their departments or institutions (if applicable):

Telephone NumberRequired

Email AddressRequired

Project TitleRequired

Did this research receive support from the University (ART, etc.) or a government or private funding agency? Please identify.

1a. What is the current status of your research?Required
Ongoing. Please provide a statement below on the project to date and your plans for the next 365 days in the space below.
Completed. Please provide a statement below on the project's outcome in the space below.
Terminated Before Completion. Please provide a statement below as to why the research was not completed.
Not Initiated. Please provide a statement below as to why the research was not initiated.

1b. Enter your report on the status of your research here. Please provide appropriate and sufficient details concerning the status of your research as defined in Question 1a. Please do not duplicate responses for other questions that may require responses below for Questions 4 through 7. For “Ongoing” or “Completed” research, your report could include details about the activities you undertook, minor changes or adjustments to your research plan during the project, the identification of people who assisted you in collecting or analyzing data, and your research findings and their use or dissemination. For “Ongoing” research, please also indicate if and how your methodology, forms or anything else as originally included in your protocol will change during the upcoming period – and then forward revised forms as described below. For “Terminated” or “Not Initiated” research, your report may include some of the information as requested for “Ongoing” or “Completed” but should also include an explanation of what happened to conclude your research early.Required

2. How many subjects have been involved in your study since your last report to the IRB?Required

3. How many subjects have been involved in this research since it began?Required

4a. Were any complications encountered as a result of human subject participation in this study. Complications can include expected as well as unexpected deleterious responses to the test procedures, subject matter or other aspects of the research.Required
Yes. Please provide a detailed description in the space below.

4b. Details on complications encountered. If no complication, enter "NA."Required

5a. Has the project changed in any substantive way from what was originally submitted to the IRB and/or since its last review by the IRB?Required
Yes: Please provide desciption in the space below.

5b. Details on substantive changes. If no substantive changes, enter "NA."Required

6a. Has there been additional or new information been determined or presented to you concerning this study which may affect any of your subjects’ willingness to enter into or continue their participation.Required
Yes. Please provide a description below.

6b. Details on additional or new information. If no additional or new information, enter "NA."Required

7a. Are you using the Informed Consent Statement(s) approved for this study?Required
No. Provide a description of the changes below and then send the revised Consent Statement to the IRB as instructed below.

7b. Details on changes to informed consent. If no changes to informed consent, enter "NA."Required

8. What is the anticipated completion date for this research? Please be as specific as possible; if no date is anticipated, enter "ongoing."Required

If you need to provide additional information to the IRB, you may (a) email it to Martin Williams, WPUNJ IRB Administrator, at WilliamsM@WPUNJ.EDU, or (b) mail to Martin Williams / WPUNJ Institutional Review Board / c/o Office of Sponsored Programs / Raubinger Hall, Room 107 / William Paterson University / 300 Pompton Road / Wayne, NJ 07470.

If you have any questions or concerns regarding this form and the requested information, please call the IRB c/o the WPU Office of Sponsored Program (973-720-2852) or email Martin Williams, IRB Administrator (WilliamsM@WPUNJ.EDU).

By submitting this Continuing Review Report, you are affirming that the information provided here is true and correct. An email will be sent to the address listed above to confirm the IRB’s receipt of this report.

THE IRB SUGGESTS THAT YOU PRINT A COPY OF THIS REPORT BEFORE YOU SUBMIT IT. You will not be able to print a copy after you submit it. The IRB will confirm your submission by email and include a copy of the report as it received it.

Thank you for completing and submitting your Continuing Review Report.

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