IRB Common Rule Changes
On January 21, 2019 the VCOM research division will implement changes to comply with new federal guidelines for the Institutional Review Board (IRB). On this date the VCOM IRB must begin reviewing protocols using the revised regulations. These revised regulations are designed to improve protections for human research participants and reduce some burden on researchers.
A few of the key regulatory changes are as follows:
- Abbreviated reviews and removal of annual review requirements for lower risk studies
- A single IRB review for multi-site studies
- Improvements in content required in consent forms to help participants make informed decisions about joining a study
The Office for Human Research Protections (OHRO) has produced a set of videos to help researchers learn about and understand the revised Common Rule. These videos can be viewed by following the link below.
About the IRB
The VCOM Institutional Review Board (IRB) is responsible for protecting the rights and welfare of the human participants in research conducted by faculty at the Institution. To ensure compliance with federal and state regulations, the VCOM IRB is charged with reviewing all research protocols involving human participants conducted by VCOM faculty and staff and/or conducted at VCOM facilities.
VCOM is committed to protecting the rights and ensuring the safety of human subjects participating in research at the College. This commitment is guided by the principles described in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research, often referred to as the Belmont Report. VCOM’s commitment is also guided by the federal regulations 45.CFR.46 (the “Common Rule”), 21.CFR.50, and 21.CFR.56.
This commitment is vested in the VCOM IRB for research involving human subjects, which operates under a Federalwide Assurance on file with the OHRP, a subdivision of the DHHS. All research at the College involving human subjects, regardless of funding source, is under the authority of the VCOM IRB. VCOM’s IRB is also registered at OHRP. More information on federal regulations can be found at the Office of Human Research Protections (OHRP) website.
To fulfill the agreement underlying the assurances, and to satisfy institutional policy, all faculty and staff at the Institutions must submit for VCOM IRB review any human subject research project, regardless of funding source and/or location at which the research will be conducted.
VCOM encourages student research and has many resources in place to aid students in their research endeavors. Note that students conducting research must have a faculty advisor to serve as mentor. Students may not act as principal investigator, but may serve as co-principal investigator while the faculty advisor serves as the responsible individual (principal investigator).
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Email: dgeiger [at] vcom.vt.edu