IMPORTANT: Beginning September 6, 2016 all new protocol applications must be submitted using IRBIS online protocol application submission system. Modifications/amendments to new protocols must be submitted through IRBIS.
- Federal categories of research activities eligible for exemption certification
- UNC Charlotte Interpretation of categories 1-3
- UNC Charlotte Interpretation of category 4
In accordance with federal regulations and UNC Charlotte policy, the following research must be reviewed AND approved in advance by the Institutional Review Board (IRB) for Research with Human Subjects:
- Research involving the use of human subjects
- Research involving the use of human subjects data (including publicly available de-identified data sets).
This requirement applies to ALL research projects regardless of the granting agency or the institution to which they are being submitted for funding, and includes those supported by University funds or those without funding.
Faculty members and staff members should consult the Office of Research Compliance early in the preparation of a grant proposal to receive guidance concerning the use of human subjects.
Students who are required to complete human subjects research as a research requirement for advanced degrees (e.g., thesis or dissertation projects) should contact the Office of Research Compliance in the planning stages of their projects to receive guidance concerning the use of human subjects and to determine the level of review as required by Federal regulations. See “Student Research and Faculty Responsibility” below for more information.
All researchers are responsible for compliance with applicable federal and state laws and with institutional policy.
The following guidance document is intended to provide descriptions of activities and associated determinations regarding the requirements to submit to the IRB for approval.
The IRB has the authority to approve, require modifications in, or disapprove any research involving human subjects conducted under UNC Charlotte's auspices.
Approvals cannot be granted retrospectively for any human research conducted without appropriate IRB review and approval.
Investigators will find additional information and guidance in the University Policy #306, "Research Utilizing Human Subjects."
Research investigations conducted by students, such as thesis or dissertation research require IRB approval before implementation. Student class or course projects generally do NOT require IRB approval. For additional information on how to determine if a student project might require IRB review and approval, go to Student Research Projects. If, after reviewing this information, you still have questions, please contact the Compliance Office at 704-687-1871.
Research projects conducted primarily for instructional purposes within the context of a formal class, and not designed to contribute to generalizable knowledge, do not require review by the IRB. In these cases, the class or course instructor oversees all projects conducted in conjunction with the class and is responsible for the professional and ethical implementation of these projects. If a student plans to use a class or course project to also fulfill thesis or dissertation requirements, IRB approval prior to implementing the project and collecting any human subjects data is needed.
In some cases, instructors may still require that students submit for IRB approval as part of the educational process. E.g., as part of the learning experience in a research methods course. However, IRB review of these class projects is not mandated by the human subjects protection regulations.
Before submitting an application for IRB review, students and Responsible Faculty are encouraged to review the Guidance: Examples of Activities that Do and Do Not Require UNC Charlotte IRB Review and Approval document.
Under federal regulations, the IRB determines which of the following classifications applies to a protocol:
- exempt from review by one or more members of the Committee,
- expedited review by the Committee (i.e., limited review by one or more members), or
- full review by the full Committee at a convened meeting.
Certain types of research protocols may be exempt from a higher level of IRB review. The IRB is authorized to decide, consistent with applicable federal laws, guidelines and regulations, whether research protocols may be exempt from a higher level of IRB review or subject to limited or full review by the Committee.
After submitting a protocol, the materials will be sent to the IRB for review. If the project meets one or more of the federal categories for exemption, an Approval of Exemption certificate will be issued to the investigator(s) and the project may be started.
The following guidance document is intended to provide information about the Exempt categories and examples of activities that may meet an Exempt category.
NOTE: Exemption categories DO NOT APPLY when the research activities include:
- Prisoners, fetuses, pregnant women or human in-vitro fertilization;
- The review of medical records if the information is recorded in such a way that subjects can be identified, directly or through identifiers linked to the subjects;
- Survey or interview techniques which include minors as subjects;
- Techniques which expose the subject to discomfort or harassment beyond levels encountered in daily life;
- The deception of the subject
- Research conducted in established or commonly accepted educational settings, involving normal education practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under (2) of this section, if: (a) the human subjects are elected or appointed public officials or candidates for public office; or (b) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
The Committee interprets this provision to exempt from a higher level of review those research protocols in which subjects will exclusively consist of students in a faculty members' own classes. However, where the research intervention requires using students in classes which are the usual responsibility of other faculty or staff members, the research protocol may require review and approval by the Committee (unless the research is exempt under some other provisions of law or University policy).
In addition, research projects conducted by students who are classroom teachers supervised by UNC Charlotte faculty may be exempt from committee review if the research is to be conducted in the teacher's own classroom.
The Committee makes this interpretation based on its belief that the phrase "normal educational practices" is intended to encompass only those situations in which a faculty member, or a student who is also a classroom teacher, conducts research in his or her own classroom.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Research studies involving "Retrospective Chart Studies" will be reviewed by the Chair of the Committee using a streamlined procedure as follows:
The Investigator will:
- state in bold under "Purpose" on the human subjects research Protocol Application form that the proposed research is a "Retrospective Chart Study";
- attach to the human subjects research Protocol Application form evidence of approval (signed letters of permission on official letterhead) from host hospital, facility, or institution ; and
- submit one copy of human subjects research Protocol Application form for review to the Office of Research Compliance
- Research and demonstration projects which are conducted by or subject to the approval of, department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (a) Public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies, (a) if wholesome foods without additives are consumed or (b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U. S. Department of Agriculture.
In summary, if the research is determined to meet one or more of the federal guidelines for exempt status, an Approval of Exemption certificate will be issued to you and you may begin your project.
If the project is not exempt from a higher level of review, the submission will be processed for either expedited (limited) or full board review.
Federal regulations (45 CFR 46.11D and 21 CFR 56.110) permit an expedited review procedure for protocols that meet certain eligibility requirements. Under an expedited review procedure, the review may be carried out by the Chair of the IRB or by one or more experienced reviewers from among members of the Committee. In reviewing the research, the reviewers may exercise all of the authorities of the Committee except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedures described in the next section.