In order to protect the rights of human subjects used in research, UNCW has its own federally mandated Institutional Review Board (IRB). Faculty members from a variety of scientific and non-scientific disciplines and a community representative serve on this committee to review and approve research projects involving human subjects. The Office of Research Services (ORS) is the administrative office that coordinates the activities of the IRB.
According to UNCW IRB policy, all research projects involving human subjects must be approved by the IRB. The research and human subjects decision charts (linked below in FAQ) can help researchers determine if their projects meet the federal definition of research with human subjects. Sponsored Programs will not accept funding for human subject research from an external agency without documentation of IRB approval.
IRB Contact Information:
Institutional Official: Robert D. Roer, 910-962-4117, roer@uncw.edu
IRB Chair: Candace Gauthier, 910-962-3558, gauthierc@uncw.edu
IRB Coordinator: Leanne Prete, 910-962-7774, pretel@uncw.edu
IRB Meeting Schedule and Submission Deadlines
The IRB typically meets on a monthly basis to review protocols subject to full committee review. Following is the 2009 - 2010 meeting schedule and submission deadlines. Researchers must submit their Human Subject Protocol forms by the submission deadline in order to receive IRB review on the desired meeting date. Researchers should plan accordingly to avoid delays.
PROTOCOL SUBMISSION DEADLINE |
FULL COMMITTEE MEETING |
August 12, 2009 |
August 26, 2009 |
September 23, 2009 |
October 7, 2009 |
October 21, 2009 |
November 4, 2009 |
November 18, 2009 |
December 2, 2009 |
January 4, 2010 |
January 13, 2010 |
January 20, 2010 |
February 3, 2010 |
February 17, 2010 |
March 3, 2010 |
March 24, 2010 |
April 7, 2010 |
April 21, 2010 |
May 5, 2010 |
Please note: minimal risk activities involving populations that are not considered vulnerable are generally not subject to full committee review. The IRB determines the appropriate form of review. The following submission deadlines do not apply to protocols qualifying for expedited review, which are accepted on a continuous basis.
IRB Frequently Asked Questions:
1. What are the different levels of IRB Review?
There are three types of IRB review depending on the level of risk involved in the project: exempt, expedited and full IRB review. Projects that qualify for exempt review are projects having such a low level of risk to subjects that further IRB oversight is not required with the exception of protocol amendment forms. Amendment forms are required on exempt studies since a change to the study may alter its exempt status. Projects qualifying for expedited review are also minimal risk to subjects, but may involve other aspects that require continuing IRB oversight and annual renewal of protocol approval. A project may require full review for a number of reasons such as the subjects belonging to a potentially vulnerable population or a higher degree of risk to subjects. According to UNCW IRB policy, researchers may NOT make their own determination as to the appropriate type of review. Only the IRB Chair or designate, can determine which type of review is applicable.
2. Am I doing research as defined by the IRB?
The chart accessible from the link below may help you determine if you are conducting "research" as defined by IRB regulations. As you view this chart, please note the following definitions: Research is defined by the federal goverment as a systematic investigation, including development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Systematic Investigation is defined by the UNCW IRB as a cohesive approach involving data collection (quantitative or qualitative) from one or more individuals and analysis to address a question or test a hypothesis. Generalizable knowledge is defined by the UNCW IRB as the results or outcomes gained from systematic investigation that may be published, archived, presented, or viewed in some way as relevant beyond the specific participant population.
3. Am I working with human subjects as defined by the IRB?
The chart accessible with the following link may help you determine if your research involves the use of human subjects. As you review this decision chart, keep in mind the following definition: Human subject is defined as a living individual, about whom an investigator (whether professional or student) conducting research obtains: 1) data through intervention or interaction with the individual, or 2) identifiable private information.
4. What are the IRB training requirements for researchers?
Any person involved in the design and/or conduct of a human subject research project must complete the approved online human subject protections training program offered by the University of Miami's Collaborative Institutional Training Initiative (CITI). The IRB will not review a protocol until training documentation is on file at ORS. This requirement includes any faculty, staff, students, or collaborators from other institutions.
The new CITI program automatically emails ORSSP when training is completed. You are no longer required to submit hard copies of training certificates to ORS if you complete training through CITI and identify the University of North Carolina Wilmington as the participating institution.
Instructions on how to register for online training and a link to the CITI website
5. What is UNCW's Federalwide Assurance number?
FWA00001025, Expires 10/2/11
A Federalwide Assurance is an agreement with the United States Department of Health and Human Services (DHHS) to conduct human subject research in accordance with certain principles. UNCW's Assurance agrees to comply with the principles outlined in the Belmont Report and the Code of Federal Regulations Title 45, Part 46 Protection of Human Subjects, Subparts A, B, C and D. UNCW has agreed to follow these regulations for all research involving human subjects, regardless of the funding source. See the DHHS website for more information about assurances.
6. Where do I get the forms? Where do I send my completed forms?
If you are unable to retrieve the forms below, all forms can be obtained by contacting Leanne Prete in ORS (910-962-7774 or pretel@uncw.edu). 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.
Human Subjects Protocol Form
Protocol Amendment Form
Annual Protocol Renewal Form
Protocol Closure Form
Informed Consent Resources:
Please note - use of the Informed Consent (or Assent/Permission) Template below is NOT required. 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
Assent/Permission Form Template- intended for minor subjects age 12 -17
Permission Only Template - can be used when minor subjects are too young to assent (generally age 4 and under), when minor subjects respond verbally to a script (generally acceptable for ages 5-6), or when minor subjects have a separate assent form (ages 7-11).
Informed Consent Checklist - required if not using template
Example Consent/Assent/Permission Forms:
Please note: The following are examples only. If you base your consent or assent forms on the following examples, you must also submit a completed Informed Consent Checklist (above) to show that you included all required elements of informed consent.
Example Consent Form - one page in letter format
Example Consent Form - one page with bullet statements
Example Assent Script - use when minor subjects are too young to write, but old enough to provide verbal assent (recommended for ages 5-6)
Example Assent Form - when minor subjects can sign their names but need simple language (recommended for ages 7-11)
Supplemental Forms:
Adverse Event Report
HIPAA Appendix
Requirements for the Use of Protected Health Information (PHI) in Research
Prisoner Participant Form
7. What happens after I submit my forms? How long will it take before I hear something?
After you submit your forms, the regulatory compliance officer will conduct an initial review to make sure the application is complete prior to forwarding to the IRB Chair. The IRB Chair will then review the protocol to determine which type of review is required pursuant to Regulations for the Protection of Human Subjects (Title 45 Part 46) . If the protocol requires review by the full IRB at a convened meeting, the principal investigator is informed usually by phone or e-mail and the protocol is placed on the agenda for the next scheduled meeting. If the protocol can be reviewed by expedited review, or if the IRB Chair determines the protcol is exempt from further review, the IRB Chair conducts the review. The turn-around time for expedited or exempt reviews can be very prompt, sometimes within a week. The IRB Chair sends the approval sheet to the principal investigator along with approved informed consent forms if applicable.
8. How long will it take the IRB to review my protocol?
This depends on the type of IRB review required (see FAQ 1). Certain projects can be reviewed by the IRB Chair when they have very low risk to the study participants. When the IRB Chair can conduct the review herself, the turnaround time is very quick - usually within a week if the protocol is complete and all requirements for approval have been met. When a protocol must be reviewed by the full IRB, the protocol is placed on the agenda for the next scheduled IRB meeting.
