Grants and Sponsored Programs: Research Policies and Regulations

IRB Training Information

Greetings from the Institutional Review Board (IRB). This year the committee is composed of the following individuals:

Arts & Sciences: Matt Chenoweth and Sarah Mergel (Chair)
Business: Jon Littlefield
Education: Gregory Smith
Health Professions: Lynda Ridley
Community: Sandy McKenzie (Hamilton Health)
Provost: Bruno Hicks

We work in conjunction with the Provost and Vice President for Academic Affairs to help ensure the college follows all federal guidelines for human subjects research. As such, the committee oversees the internal training course and reviews all applications for human subjects research. All research involving human subjects in anyway must be reviewed by the IRB; researchers cannot independently determine whether their research falls within the federal guidelines or outside the federal guidelines.

Prior to completing an application, a researcher must complete a training course on protecting human subject participants. For most members of the campus community, our internal training course will provide a solid overview of the Federal Policy for the Protection of Human Subjects (the “Common Rule”). If you are completing a grant application or partnering with a researched at another institution you may need outside training.

Beginning this year, faculty, staff, and students should click on self-registration from the GeorgiaVIEW Homepage and choose Human Subjects Research Training – CO from the list. Once enrolled in the course, review the announcement on the course homepage for more information on completing the training. Employees supervising student research, should let students know how to access the course in GeorgiaVIEW so they can complete training prior to submitting a student application.

With the new training course, individuals who successfully complete the course will be able to save a copy of a certificate of completion. If you previously trained, you can still use your saved quiz results to verify training for your applications. However, you can enroll in the new course and retake the quiz for the formal certificate. You will need a copy of your certificate or quiz results for all applications. The IRB does not keep a formal record of who has completed training.

IRB applications are available through Dynamic Forms. You can find links for the forms on the IRB website (see link below) and in the training course. You can also find sample forms (as PDFs) in the training course so you will know what questions you must answer when you complete an application. The IRB has created a variety of applications to choose from. Here are some scenarios to help guide your choice of application.

If you are employee planning research involving minimal risk to participants and the intention to publish or present your findings, then you will complete the Application for Approval of Exempt Research with Human Subject Participants.
If you are an employee planning research involving minimal risk to participants though you are only planning to collect data for the purpose of improving services at the college, then you will complete the Application for Approval of Institutional Effectiveness Research.
If you are an employee planning to serve as a co-investigator with a colleague at another institution and the principal investigator completes an application at his/her/their institution, then you will complete the Notification of Intent to Serve as a Co-Investigator on a Human Subject Research Project.

The material in the training course should help you determine which application to complete. Approval cannot be given retroactively. Moreover, unapproved human subjects research is a violation of the federal guidelines and can have negative consequences for you as well as the college. Therefore, you need to conclude the IRB process before starting your research. Once your application is approved, save a copy of the PDF of your application for your records.

For additional introductory information on human subjects research, you can visit https://www.daltonstate.edu/academics/irb.cms. Feel free to email irb@daltonstate.edu or smergel@daltonstate.edu with any questions about training or submitting an application.

Sarah K. Mergel, PhD Professor of History

Chair, Institutional Review Board

Dalton State College

(706) 272-2675 smergel@daltonstate.edu

Human Subjects Research Policy

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 irb@daltonstate.edu.

NSF Guidelines

NSF Policy

All Principal Investigators, Co-PIs and senior personnel named on NSF proposals submitted on or after July 31, 2023, and undergraduate students, graduate students and postdoctoral associates and fellows supported on NSF awards must complete RECR training.

Faculty and senior personnel should complete training within 60 days of the receipt of funding. Undergraduate, graduate and postgraduate researchers should complete training within 60 days of salaries being charged to an account.

In July 2023, NSF expanded the required training topics to include data management and mentorship. For proposals submitted on or after July 31, 2023, PIs, Co-PIs, and senior personnel named on resulting award, and postdocs, undergraduates, and graduates charging salary to the resulting award must complete a refresher course with the updated modules.

Individuals may register for the Responsible Conduct of Research training through CITI.

Application Forms

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.