Forms and Templates
Research Compliance will make every attempt to ensure that the forms available here are in compliance with sponsor guidelines. However, the Principal Investigator has ultimate responsibility for compliance. All forms are in a downloadable/executable PC based format.
All new human subject protocols must be submitted through the online IRB system, "IRBIS." IRBIS can be accessed at this link: https://uncw.myresearchonline.org/irb/index.cfm.
Other consent formats are allowed. However, when you use a format other than one of the templates above, you must also complete and submit the Informed Consent Checklist to demonstrate that you remembered to include all of the elements of informed consent that are required by federal regulations:
Human Subjects Informed Consent Checklist
(NOTE: This additional form is NOT required when using one of the approved templates above.)
Alternative Consent Formats - These formats may be more appropriate than the Q&A template above when a study is low risk and uncomplicated, and subjects are adults. If these formats are used, researchers must also complete and submit the Informed Consent Checklist posted above to demonstrate that all required elements of consent were included.
Human Subjects Informed Consent Alternate Format - Bullet Statements Template
Human Subjects Informed Consent Alternate Format - Example Letter Format
The following forms will be accepted through 2016-2017 for existing studies submitted on the old form:
Human Subjects Protocol Amendment Form
Human Subjects Adverse Event Report
Human Subjects Protocol Closure Form
Mac users: For best functionality, we recommend that you save this form to your computer, and open with Adobe Reader. Mac computers will default to open this in Preview, which will not allow you to type in the form. If Adobe Reader is not installed on your computer, it is free and available at https://get.adobe.com/reader/.
Animal Subjects Protocol Long Form - recommended for more complex studies that involve diet manipulation, pain and distress, surgery, and/or drug administration.
Animal Subjects Protocol Short Form - recommended for less complex studies. If the study involves diet manipulation, pain and distress, surgery or drug administration, you may add individual appendices as needed (see below).
Animal Subjects Additional Personnel Appendix
Short Form Appendices:
Animal Subjects Diet Manipulation Appendix
Animal Subjects Pain and Distress Appendix - please consult with attending veterinarian prior to use.
Animal Subjects Surgery Appendix
Animal Subjects Drug Administration Appendix