Research Protections - Institutional Review Board (IRB)

The IRB is a federally-mandated university committee established to protect the rights and welfare of human subjects participating in research projects. The committee is composed of faculty members from both scientific and non-scientific areas as well as community representatives. The IRB reviews research involving human subjects according to policies set forth by the United States Department of Health and Human Services regulations (45 CFR Part 46) and the U.S. Food and Drug Administration (21 CFR Part 56). Compliance with these federal regulations safeguards human subjects, the institution sponsoring the research project, and researchers. The IRB is registered with the Office for Human Research Protection (DHHS) and holds the Federal-wide Assurance # FWA00001076 which provides assurances that the University will comply with all applicable federal laws and regulations related to research involving the use of humans as participants.  This assurance is valid through February 2, 2012.

Prior to soliciting subjects or collecting any data from human subjects, the  IRB must review and approve any research that involves human subjects, regardless of funding, taking place on Appalachian's campus or undertaken by Appalachian State University faculty, staff or students.  Researchers planning projects with human subjects are encouraged to browse the website and learn about Appalachian's Guidelines for the Review of Research Involving Human Subjects (pdf).

Proposed Update to Student Research and Faculty Responsibility Guidelines

Current Guidelines (Section C) for Student Research and Faculty Responsibility: 
Research conducted by students, such as thesis research and some class projects, may require the approval of the IRB prior to execution. It is the responsibility of faculty supervising research by students or staff to ensure that approval of the Board is obtained. Individual projects conducted primarily for instructional purposes within the context of a formal class, and not designed to contribute to generalizable knowledge, do not meet the definition of “research” as defined in the federal guidelines. Thus, they do not require review by the Board, provided the instructor is prepared to accept professional and ethical responsibility for all research projects conducted in conjunction with the class. Under these conditions, no IRB application need be made but it is the instructor’s responsibility to monitor the ethical propriety of these projects, applying the criteria listed in this document.

DRAFT Guidelines which seeks to clarify the italicized phrase above:

  • Faculty members conducting class-based activities involving human subjects should request IRB review of the activities when there is a chance of public dissemination (i.e. presentation/publication outside of the classroom).  In most cases, this can be accomplished by submitting a single request for IRB review of the class project.
  • Students who are conducting human subject research that will likely be incorporated in a thesis project should submit a request for IRB review.
  • In rare cases data collected in class-based projects that have not undergone prior IRB approval may be used for dissemination.  Petition may be made to the IRB requesting such terms.  In this case, a statement from the instructor of record must include the specific steps taken during data collection that ensured the ethical conduct of this research.  Decisions on these requests will be made on a case-by-case basis.

We are actively seeking input on these DRAFT Guidelines.  Please contact Julie Taubman at 262-7981 or taubmanjl@appstate.edu or Dr. Tim Ludwig at ludwigtd@appstate.edu to provide feedback that will be given to the IRB at its November 10th meeting.

IRB Contact Information

Training

The Appalachian State University IRB requires that all faculty, staff and students complete CITI research education before research proposals can be approved by the IRB.  On 7/10/2009, the IRB began requiring the Refresher CITI training instead of the Basic CITI training.  The Basic training will continue to be accepted and faculty members may choose to require their students to complete the Basic training instead of the Refresher training.  Instructions for completing the CITI training can be found on the training webpage.

Request for Review

Please use the current forms provided below.  The IRB will no longer accept the application for exempt research.  Please submit the appropriate forms electronically to irb@appstate.edu.  A hard copy of the signature page of the form must also be submitted to the IRB at Research and Sponsored Programs, John E. Thomas Building. Please contact us if you have any questions.

  • IRB Application/Request for Review (word): request IRB approval of a new research study involving human subjects. Additional materials used in the study (recruiting materials, questionnaires, etc.) should be submitted with the application.
  • Informed Consent (word): In almost all cases, an informed consent document must be submitted with an IRB Request for Review. Please use this form and modify as needed. For online surveys, please submit the text that will be displayed on the online survey to serve as an informed consent.
  • Request for Renewal of IRB Approval (pdf / word): request a renewal of a previously approved IRB study. A current Informed Consent document must also be submitted.
  • Request for Review of Modification/Addendum to Previously Approved Study (word) : request approval of a modification or addendum to a previously approved study.

Resources

 

>> Return to the Research and Sponsored Programs main page.

>> Return to the Proposal Submission - Grants - Application Process page.