IRB FORMS

If you are unable to retrieve the forms below, all forms can be obtained by contacting Leanne Prete in ORSSP (910-962-7774 or pretel@uncw.edu).

INSTRUCTIONS: Please use the current forms provided below. These forms have been updated to properly reflect and document regulatory requirements.

Researchers must submit to Leanne Prete one signed hard copy (send to Hoggard Hall, Room 180 or campus mailbox 5973) and one electronic copy (send to pretel@uncw.edu) of any form along with any supporting documentation (surveys, consent forms, etc.). Click here for UNCW's full mailing address and contact information if you are off campus. Forms must be received at least ten days prior to the desired start date, or by the submission deadline if full review is anticipated. Hand-delivery is recommended for on-campus researchers, as campus mail may delay arrival.

Most Frequently Used Forms:

Human Subjects Protocol Form
Protocol Amendment Form
Annual Protocol Renewal Form
Protocol Closure Form

Informed Consent Resources: Please note - researchers are NOT required to use the Informed Consent (or Assent/Permission) Template below. However, if you do not use the template, you must use the Informed Consent Checklist and submit the checklist with your protocol form to show that all required elements are included on the consent form.

Informed Consent Form Template - for adult subjects (18 and over)
Assent/Permission Form Template - recommended when using minors ages 12 - 17
Permission Only Template - when using a separate assent form for young children (see example forms provided below)

Informed Consent Checklist - required if not using one of the templates above

Example Consent/Assent Forms: The UNCW IRB has created the following example forms to provide researchers with a few consent and assent options. Researchers can use one of these examples or any other format. Researchers must include all elements of informed consent and submit a completed Informed Consent Checklist (unless using one of the templates above). The PI may seek approval from the IRB to waive certain elements of informed consent in special situations. This must be fully explained and justified on the Human Subjects Protocol Form.
Example Consent Form - one-page letter format
Example Consent Form - one-page bullet statement format
Example Assent Form - in simple language, recommended for children ages 7-11
Example Assent Script - for verbal assent, recommended for children under age 7

Supplemental Forms:

Adverse Event Report
HIPAA Appendix
Requirements for the Use of Protected Health Information (PHI) in Research
Prisoner Participant Form
  

Maintained by MJ Carver ()
Copyright Notice | About this Site