November 16, 2016
The Radiation Safety Committee (RSC) has determined that five (5) or less of the following FDA approved or cleared scans/x-rays represent no greater than minimal risk and therefore do not require review and approval by the RSC (i.e., you do not need to complete an Application for Human Use of Radiation in Research):
- DEXA scans
- Chest x-rays
- Planar x-rays of extremities (as defined by NRC – hands, forearms, elbows, feet, knees, leg below the knees, and ankles)
- Dental x-rays
“This research study involves exposure to radiation from (insert maximum number scans and type of procedure). Please note that this radiation exposure is not necessary for your medical care and is for research purposes only.
For comparison, the average person in the United States receives a radiation exposure of 0.3 rem (or 300 mrem) per year from natural background sources, such as from the sun, outer space, and from radioactive materials that are found naturally in the earth’s air and soil. The dose that you will receive from participation in this research study is less than amount you receive from these natural sources in one year.
The amount of radiation you will receive in this study has a minimal risk and is below the dose guideline established by The University of North Carolina Radiation Safety Committee for research subjects.”Revised 11/16/2016
Scientific Review Questions Added to IRBIS to Support Scientific Review Committee Review (9/16/2016)
September 16, 2016
As previously announced, beginning September 19, 2016 any new study submitted for IRB review will be required to have scientific review completed and documented. All clinical research conducted at the University of North Carolina at Chapel Hill involving greater than minimal risk must undergo scientific review. Scientific review is a process that evaluates the scientific merit of a clinical trial protocol. To facilitate this process, a new Scientific Review section has been added to the Initial IRB application. Read more...
September 2, 2016
Date new process begins: Monday, September 19, 2016 All clinical research conducted at the University of North Carolina at Chapel Hill involving greater than minimal risk must be submitted for review to the UNC Scientific Review Committee. Scientific review is a process that evaluates the scientific merit of a clinical trial protocol. Beginning Monday, September 19, 2016 any new study submitted for IRB review will be required to have scientific review completed and documented prior to the review. Investigators should anticipate at least 7 business days for this review. Read More...
August 12, 2016
The IRB guidance titled “How to Request a Reliance Agreement” has been updated August 12, 2016, as follows: Page 4 and 5 – Previously the IRB has only required a CV or resume for investigators; this requirement has been extended to all external collaborators regardless of role.