IRB approval is required for all research involving human subjects. The Common Rule defines "human subject" at 45 CFR 46.102(f) as follows:(f) Human subject means 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.
Generally, investigators should submit an "Application for Designation of Not Human Subjects Research (NHSR)" to the Office of the IRB (OIRB) for a formal NHSR determination if they want to use data about individuals when that data is (1) neither obtained through intervention or interaction with the individual, (2) nor private and individually identifiable.
However, the UAB OIRB has reviewed the datasets listed below and determined that research involving these datasets does not meet the regulatory criteria for human subjects research. It is not necessary to submit a NHSR application for use of the datasets specifically listed on this page.
Investigators can nominate additional datasets for inclusion on this list by submitting the "Public Dataset Nomination Form." Please provide in your submission as much information as possible to identify the dataset so that the OIRB can appropriately research the dataset and determine, in accordance with the regulations, whether the information in the data constitutes human subjects.
Many of the datasets listed below have a publically available component and a restricted use component. The use of data from the following list of UAB IRB approved public data sets is not considered human subject research as long as the following two criteria are met: Research will NOT involve merging any of the data sets in such a way that individuals might be identified Researcher will NOT enhance the public data set with identifiable, or potentially identifiable data
If the two criteria above are met and the research will involve data from a dataset listed below, no UAB IRB review or approval is needed.
NOTE: If restricted datasets will be used, contact the IRB.
GENEVA Genes and Environment Initiatives in Type 2 Diabetes (Nurses' Health Study/Health Professionals Follow-up Study)http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000091.v2.p1#restricted-access-section
Multi-Ethnic Study of Atherosclerosis (MESA) Cohort(including substudies SHARe, CARe, and ESP Heart-Go)http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000209.v12.p3