The IRB (Institutional Review Board) is a federally mandated body established under the DHHS regulations for the Protection of Human Subjects (45 CFR 46). Its purpose is to protect the rights and welfare of human subjects recruited to participate in research activities conducted under the auspices of Clemson University (CU).
The guiding ethical principles of the IRB are embodied in the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979). The principles of respect for persons, beneficence and justice are accepted as critical considerations for the ethical conduct of human subjects research.
University policy requires that all research involving human subjects be reviewed and approved by CU's IRB prior to initiation of the research. This requirement applies to all human subjects research conducted by faculty, staff, and students, on- and off-campus, regardless of the funding support, if any, for the project.
Research involving human subjects includes the recruitment of potential participants in research, collection of data about or from human subjects (including surveys) and the use of existing data (including specimens). Any changes to a project after IRB approval must be submitted for review and approval before implementation. Continuing review is also required at regular intervals for certain protocols.
The CU IRB requires Principal Investigators and all other research team members to complete and document appropriate training in the protection of human subjects. Additionally, the IRB is tasked with monitoring ongoing research for adherence to Federal regulations and institutional policies and procedures.
We at the Clemson IRB are excited about the research being done in our community, and we look forward to working with you.
Effective June 1, 2013, the Office of Research Compliance (ORC) will assign expiration dates to all IRB exempt protocols. The initial expiration date will be determined by the completion date on the application form. If the researcher wants to extend the protocol beyond the expiration date, the PI may request an extension by completing an extension request form.
When amendment requests are submitted by the PI or the IRB initiates status updates, the ORC will assign expiration dates to these existing protocols. This new procedure will allow the IRB staff to manage the protocols more efficiently.
More information is available on the Application Review Process page.