Applying for IRB Approval of Research
Principal investigators/researchers submitting proposals involving research and human subjects must complete required forms and submit the project for IRB review prior to submission.
The IRB is charged with overseeing research involving human subjects. The foundational definition for what makes a particular project fall under the purview of the IRB can be found in the “Common Rule,” Department of Health and Human Services regulations, 45 CFR part 46, which has the following definitions:
- Research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
- Human Subjects: a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.
In addition to providing review for all human subjects research performed at Forsyth Technical Community College. Studies from diverse fields ranging from health, social and behavioral sciences, natural sciences, technology and education are regularly reviewed by the Forsyth Tech IRB.
The majority of socio-behavioral studies will fall into expedited, exempt or not-human-subjects research categories. However, the IRB may also determine that a project is actually public health practice, educational practice, or other non-research activity. The IRB uses a very narrow definition of “research,” needing IRB review; oral history, ethnography, and some student projects, for example, may also fall outside this narrow definition. Determining whether a project needs IRB review is often a nuanced and challenging process. Investigators are encouraged to contact the IRB if they are uncertain if their study would require IRB review and/or approval.
Researchers should determine what type of IRB approval they will be seeking: exempt, expedited, or full review (for the criteria for each category, see exemption 
). Researchers should then complete the application and submit one copy to the Institutional Review Board, Office of Institutional Research and Decision Support, Allman Suite 448 or email a copy of the application to Alexa Edwards, adedwards@forsythtech.edu.
If the research is in connection with a federal or private grant and involves human subjects, IRB approval should be sought prior to submission. Once funded, the Grant# and sponsoring agency, along with any changes to the protocol, must be filed with the IRB.
Home institution refers to the institution that the investigator is enrolled or is employed full-time. For investigators employed at Forsyth Tech, Forsyth Tech is the Home Institution and the protocol must be approved by the Dean and VP of the area impacted and included with the IRB application.
If the researcher is a student at another institution:
- Approval or at least provisional approval of the protocol must come from the home institution’s IRB. All documents from the home IRB must be included in the FT IRB application.
- A letter of support from the Forsyth Tech Dean of the Division in which the research will take place must also be provided with the FT IRB application. This signed letter should then be forwarded to the VP of Instruction for signature.
- For non-instructional/educational research, researchers must include a letter of support from the Vice-President for the appropriate area (Business Services, Student Services, etc.).
If the researcher is a full-time employee from another institution:
- The IRB of researcher’s home institution must approve the protocol. All documents from the home IRB must be included in the FT IRB application.
- A letter of support from the Forsyth Tech Dean of the Division in which the research will take place must also be provided with the FT IRB application. This signed letter should then be forwarded to the VP of Instruction for signature.
For non-instructional/educational research, researchers must include a letter of support from the Vice-President for the appropriate area (Business Services, Student Services, etc.) which may be provided by letter or by their signature on the IRB application.
Training
What Training is Required?
All employees, faculty, staff, students and/or agents of Forsyth Technical Community College engaged in the conduct of human subject research must have reviewed and be familiar with the principles of “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research”, along with applicable Federal and State laws and institutional policies regarding Human Subjects Research.
Training Requirement:
Prior to submitting research protocols for review and approval by the Forsyth Tech IRB, all Key Research Personnel listed on the Forsyth Tech IRB application, regardless of their position, must complete the web-based training:https://phrp.nihtraining.com and send copy of completion certificate to the Forsyth Tech IRB Chairperson. Investigators seeking training from another agency must gain prior approval from the IRB Chair.
Participants
Glossary
Biomedical: having to do with the life sciences, medicine, dentistry, nursing, and public health.
Clinical Research: medical research that involves patients and sometimes healthy volunteers. These research studies are designed to uncover better ways to treat, prevent, diagnose, and understand human disease. Sometimes they help patients feel or get better but sometimes they don’t. In rare cases, they studies can make patients worse.
Informed Consent: The dialogue between potential participants and researchers that takes place before anyone decides whether to take part in a study. This process of communication should be free of pressure or rushing, should include all key information and a chance to ask questions and have them answered. Informed consent can be more than just a one-time conversation. As a study goes on, participants can renew their agreement to be in the study, and they can also decide to quit without penalty. The important thing is open and clear communication.
