Institutional Research Board
The Mission
The Institutional Review Board (IRB) regulates all research activities involving human subjects on the UNC Asheville campus. The IRB is a committee appointed to ensure rights, safety, and welfare of human research subjects; ensure compliance with all applicable federal and state laws/regulations; and conduct ethical reviews of human research activities including initial, continuation, modification, unanticipated problems and alleged noncompliance. Its primary responsibility is to assure UNC Asheville community (e.g., administrators, contractors, faculty, staff and students) conduct research activities within the University’s commitment to the Federalwide Assurance of Compliance filed with the U.S. Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP).
The University of North Carolina at Asheville is committed to protecting the rights of and ensuring the safety of human subjects participating in research conducted by faculty, staff and students of the University and for research in which UNC Asheville is engaged. This commitment is vested in the Institutional Review Board (IRB), and is guided by the ethical principles described in the “Belmont Report” and in applicable federal regulations.
Purpose
To protect the rights and welfare of human participants of research conducted by members of the UNC Asheville community, including faculty, administrators, and students. This purpose shall be fulfilled by the review of protocols for such research by members of the Institutional Review Board (IRB). IRB members will determine whether such research meet the standards for ethical conduct of research using human participants, as found in The Code of Federal Regulations Title 45 Part 46: Protection of Human Subjects.
Human Subject Concerns
Human Subject Concerns
Research participants are encouraged to express any concerns or complaints regarding involvement in a research study. You may prefer to speak directly to the investigator or members of the study staff. However, if you are unable to contact the investigator or would prefer to report the complaint to the IRB, you may do so.
When reporting a concern or complaint to the IRB, please complete the ‘Report Form for Research Concerns and Complaints’ form and send it to the Office of Research and Sponsored Programs as soon as possible. You may email the form to research@unca.edu or sending it by U.S. mail.
The IRB will process the concern in accordance with its standard operating procedures for subject complaints. This document is provided below for your review and understanding of that the process will look like.
If you have any questions about the process, please feel free to email the Office of Research and Sponsored Programs.
Policy Overview
Policy Overview
There are a number of regulations, policies and guidelines that human subjects research. Each institution involved in human subjects’ research must adhere to the appropriate federal regulation(s) governing the ethical treatment of research participants. Those institutions acknowledging their responsibility and alignment with these practices. In addition to the federal regulations and policies, there may be state and local regulations or policies, and each institution may develop its own policies and guidelines to help manage and implement their specific animal care and use program. All local policies and procedures should comply with the primary guidance documents and be in agreement with the institution’s PHS assurance on file with the Office of Human Subject Protections (OHRP).
In this section of the website, we provide links to federally established policies and standards documents (“Federal Policies & Standards”), and provide a comprehensive listing of UNC Asheville IRB-established procedures aimed at the local implementation of the federal statute. Those UNC Asheville procedures pertaining directly to research and educational activities along with specific IRB functions (such as protocol review) are addressed within the “IRB Standard Operating Procedures.”
IRB Contacts
IRB Administrative Office
333 Zeis Hall, CPO 2030
University of North Carolina at Asheville
Asheville, NC 28804
irb@unca.edu
IRB Chair
Elizabeth Pascoe, Ph.D.
828.251.6827 (telephone)
epascoe@unca.edu
IRB Administrator
Vacant
828.251.6476
Specific Inquiries
For specific information about IRBnet, IRBnet training, outreach and education or to provide information requested by the IRB to assess grant-protocol congruency, contact Elizabeth Pascoe.
For specific information about new protocols, triennial renewals, and SOP’s contact Elizabeth Pascoe.
For specific information regarding documentation on extramural collaborations involving human subjects research contact Elizabeth Pascoe.