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Revisions to Section A.2 (Subjects)

As part of the IRB’s continuous quality improvement efforts, and to ensure harmony with our revised SOPs (anticipated released date is 2/1/2017), Section A.2 (Subjects) of the IRB application has been revised to collect additional information about the inclusion of vulnerable subjects in research.

Historically, the IRB application provided a single list of “vulnerable or select populations”; regardless of the group(s) included, a single text box was provided for a description of “plans to provide additional protections” for the group(s) selected.  With this revision, population-specific questions have been added and researchers must now provide a justification for involving individuals in these groups.

Announcement-Changes to Section A.2., includes draft SOP 1201 (2017.01.17)

The Compendium of Publicly Available Datasets

The Office of Minority Health (OMH) at the U.S. Department of Health and Human Services (HHS) announced the release of a new resource to aid researchers, public health practitioners and policymakers with data on health and health care disparities and social determinants of health. The Compendium of Publicly Available Datasets and Other Data-Related Resources (Compendium) is a free resource that compiles in one place descriptions of and links to 132 public datasets and resources that include information about health conditions and other factors that impact the health of minority populations.

OHRE Welcomes four new IRB Analysts

Please join us in welcoming IRB Analysts, Celeste Cantrell, Cat Collins, Kathy Seabolt and Hsin-Lei Yao to the Office of Human Research Ethics (OHRE).

Celeste Cantrell received a Bachelor of Science in Biology from UNC-CH and a Master’s in Elementary Education from the University of Phoenix. She has worked in Chapel Hill for over 20 years in the areas of laboratory research, clinical care, education, and clinical trials.

Cat Collins comes to UNC-CH with over five years of experience as a Compliance Officer with the IRB and IACUC at UNC Greensboro and, most recently, at North Carolina A&T State University. At NC A&T, Cat served as the IRB administrator, pre-reviewer, human and animal research ethics trainer/educator, and Research Compliance and Ethics web site content manager. She has also served as a member of the Cone Health IRB at Moses H. Cone Memorial Hospital in Greensboro.

Kathy Seabolt has worked with IRBs for the last 10 years. Prior to coming to UNC, she spent 3 years at Phoenix Children’s Hospital as the IRB Administrator where she was responsible for overseeing two IRBs and the Scientific Review Committee. Prior to that she was the IRB Coordinator for a five hospital health system in Jacksonville, Florida. She also conducts IRB-related research.

Prior to his current position with IRB, Hsin-Lei Yao served in IACUC office (for research animal welfare) at Virginia Commonwealth University for 2 years. Before that, he served as a technology manager in a R&D Office at NCHU in Taiwan. He studied molecular mechanisms guiding progenitor cell differentiation and tumor metastasis as well as biomechanics earlier in his career. He received his college education in Taiwan at NYMU and graduate education at UNC-CH where he received a MS degree in human movement science (biomechanics) and a PhD in biomedical engineering (tissue engineering).

Five or fewer scans/xrays do not need Radiation Safety Committee approval

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
Please note that one procedure could have multiple views/scans (e.g., AP and Lat view for chest x-ray). The following statement must be included in the risk section of the consent form:

“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)

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...