Human Subjects Research (IRB)
Dalton State College will comply with all federal laws and regulations as well as any policies mandated by the University System of Georgia governing the use of humans in research. All the information on the Application for Approval of Research with Human Subject Participants, the Application for Approval of Exempt Research with Human Subject Participants, the Student Application for Approval of Research with Human Subject Participants and the Class Application for Approval of Research with Human Subject Participants meets the college’s regulatory obligation as outlined in the Federal Policy for the Protection of Human Subjects (the “Common Rule”). The Office of the Provost and Vice President for Academic Affairs serves as the administrative Human Subjects Research Office and will maintain all records concerning the application and approval of research projects falling within the scope of the Common Rule.
According to federal guidelines, human subjects research involves living individuals about which researchers obtain and study information or biospecimens through intervention or interaction with the subjects. Additionally, the data collected is intended to be part of a systemic investigation designed to contribute to generalizable knowledge. When researchers interview subjects in order to learn more about the specific individuals studied (such as in the case of historical scholarship or literary criticism) the Common Rule does not apply.
Research involving human subjects as part of a systemic investigation and associated in any way with Dalton State College must be reviewed by the college’s Human Subjects Institutional Review Board (IRB) regardless of the nature or location of the research. The purpose of the review is to ensure researchers have taken the necessary precautions to protect the rights and welfare of participants in their research. The committee reviews applications to ensure researchers have looked to minimize the risks to the subjects, they have ensured the risks are reasonable in relation to the anticipated benefits, they have developed a procedure to obtain informed consent in line with federal guidelines, and they have a plan for protecting the privacy of the subjects’ information during and after the collection of the data.
The Common Rule allows institutions to exempt some research from ongoing committee review during the period of interaction with the human subjects. Research activities that pose more than a minimal risk to the subjects require ongoing review by the IRB; research activities that pose only a minimal risk to the subjects do not require ongoing review. The Provost and Vice President for Academic Affairs will notify researchers at the time of approval if their study will require ongoing review. Researchers should review their approval documentation for any conditions placed on the approval to ensure the protection of the participant’s privacy and welfare.
The Common Rule also identifies some human subject research that is exempt from the federal guidelines. However, only the IRB can designate a project as exempt under these guidelines. Therefore, all research activities involving human subjects must be presented to the IRB for consideration. To determine whether research could be exempt, researchers should review the exemptions to the regulatory requirements described in the Common Rule, §46.104(d). Researchers may also wish to complete the NIH InfoPath Questionnaire on research involving human subjects to help determine the possible status of their research involving human subjects.
If you have questions about the nature of human subject research or the process of submitting an application, please contact the IRB at email@example.com.
Prior to completing any application, researchers must complete a training course on protecting human subject participants. Dalton State employees can find more information about the training requirements through GeorgiaVIEW in the Annual Mandatory Training for All Employees course; Dalton State students should contact their supervising instructor for more information on how to satisfy the training requirement; and, all other researchers should contact the IRB at firstname.lastname@example.org for more information on training options. Researchers should save a copy of their training certification to upload with their application(s). For more information on training options, see Human Subjects Training Information.
Only after completing the required training and determining whether their proposed investigation might fall within one of the exemption categories should researchers complete one of the applications for human subject research listed below. For more information on exemption categories, see Common Rule Exemptions Information. Students who design their own research projects should fill out the appropriate student application; professors who design projects for all students to complete as part of the coursework should fill out the class application.
- Application for Approval of Research with Human Subject Participants
- Application for Approval of Exempt Research with Human Subject Participants
- Student Application for Approval of Research with Human Subject Participants
- Student Application for Approval of Exempt Research with Human Subject Participants
- Class Application for Approval of Research with Human Subjects Participants
- Application for Approval of Institutional Effectiveness Research
- Application to Amend a Human Subject Research Project