When the UNC Charlotte Institutional Review Board (IRB) has reviewed and approved your IRB protocol, you will receive notification of approval. While the IRB will oversee the conduct of your study from the prospective of the protection of human subjects, it is your responsibility to make certain that your research is conducted in accordance with the Federal regulations which govern research with human beings. This requirement applies to all UNC Charlotte faculty, staff and students.
Please be sure that you are aware of these regulations in the Code of Federal Regulations, 45 CFR 46. A link to the regulations as well as all UNC Charlotte requirements for research with human subjects can be found at the Office of Research Compliance (ORC) website which is also referenced below.
It is the responsibility of the investigator (faculty, staff and/or students) to notify the IRB throughout the course of the research project of any proposed changes in the study protocol, the occurrence of adverse events (if applicable), of intentions to renew the project or the termination of the study.
If you plan to change your study in such a way that your subjects are treated differently than outlined or described in the original approved protocol, you must amend/modify your protocol. Once the amendment has been approved, you may proceed with the alteration of your protocol.
It is important to note that changes in a protocol might, in turn, require a change in the consent form(s) for your project as well.
Unanticipated problems or serious adverse events involving risk to human subjects must be reported to the IRB immediately. A report detailing the problem(s) should be submitted to: Donna Eaton, Director, Office of Research Compliance, 319 Cameron Hall. Please refer to Reporting Adverse Events.
The IRB determines how frequently your study must be reviewed/renewed based on the level of risk to the participants. Your study could be recommended for continuing review every six months or on an annual basis. Regardless of the frequency of review required, you must renew your protocol with the IRB by the anniversary date of the initial approval. The term of approval for your study will be provided on the approval notification. Your protocol must be renewed with the IRB by the date stipulated by the IRB on the Certificate of Approval.
About two (2) months prior to your anniversary date, you will receive reminders from the ORC that your anniversary date is approaching.
Addition or Deletion of Personnel or Investigators
The Compliance Office should be notified of the intention to add or delete personnel to the protocol.
If additional personnel become involved with your project, they must meet the human subjects educational requirement(s) in effect at the time they are brought into the study. New personnel cannot assume their roles in the study until they have completed the online IRB tutorial. Research team members not affiliated with UNC Charlotte may need to complete an Individual Investigator Agreement Form.
In accordance with UNC Charlotte's Policy Statement #306, "Research Utilizing Human Subjects," the Office of Research Compliance oversees the long term storage of original data and consent forms for a minimum of three (3) years.
If you have any questions about the IRB status of your study or questions related to human subjects, please contact: Cat Runden, Compliance Program Manager (IRB), UNC Charlotte, Office of Research Compliance, Phone: 704‑687‑1871, Fax: 704‑687‑0980.