Under the Common Rule and UW-Madison HRPP Policy, IRB review is required for all human subjects research, defined as:

• A systematic investigation designed to contribute to generalizable knowledge, and
• Involves obtaining information or biospecimens from a living individual through either interaction or intervention, with the individual or access to the individual’s private information, including protected health information (PHI).

In addition, the FDA requires IRB review for the use of de-identified human specimens in clinical investigations of medical devices when the research may generate or collect data that may be submitted to the FDA for review.

IRB review is required for most research studies that use data or biospecimens obtained from human subjects. These research studies may qualify for exemption, expedited review, or require full board review. Some studies may ultimately not fit the definition of research involving human subjects but the IRB must make this determination.

Examples of biospecimen and data research requiring IRB review include, but are not limited to:

• Prospective collection of data or biospecimens for a specific research study
• Prospective collection and storage of data or biospecimens for future research use, including whole genome and whole exome sequencing
• Secondary use of identifiable data or biospecimens
  • Example: Obtaining blood/tissue samples along with identifiers from a biobank or repository
  • Example: Obtaining data, including identifiers, from a health care record for research analysis
• Secondary use of coded data or biospecimens when the investigator collected the specimens him/herself for another research project
• Secondary use of coded data or biospecimens when the investigator has access to the code that would allow linkage of the data or specimens to identifiable information
• Secondary use of de-identified or coded data or biospecimens in a project that will generate or collect data that will or may be submitted to the FDA
  • Example: Testing the efficacy of a diagnostic device using de-identified biospecimens collected as standard of care and no longer needed for clinical diagnostic purposes
• Secondary use of de-identified or coded data or biospecimens in a project conducting whole genome or whole exome sequencing (if you are conducting whole genome and/or whole exome sequencing, please also review the NIH Genomic Data Sharing policy section of the Investigator Manual)
• Secondary use of de-identified or coded biospecimens when the investigator will not have access to the code AND the data generated or collected will not be submitted to the FDA
• Collection and/or use of de-identified biospecimens obtained through standard of care clinical procedures and that are not required for treatment or diagnostic purposes (waste) provided the project will not generate or collect data that may be submitted to the FDA.
  • Biospecimens obtained through standard of care clinical procedures may require analysis by pathology for diagnostic purposes. During this process, pathology will assess what portion of the biospecimen is required for clinical purposes and what portion, if any, is deemed waste and/or can be used for research purposes.
  • If clinical biospecimens are being obtained from UW Health patients, investigators will need to find out whether the specimens require pathology evaluation, can be deemed waste per UW Health policies, or whether an exception to pathology evaluation can be made if the specimen is not deemed as waste.
  • Resources for information on pathology workflows and the need for sign-off to use clinical biospecimens for research include the Department of Pathology and Laboratory Medicine, the UW Carbone Cancer Center, and the Office of Clinical Trials.

Examples of research NOT requiring IRB review include, but are not limited to the following (note that a formal Not Human Subjects Research request can be made to the IRB for documentation purposes, but is not required):

• Secondary use of data from publicly available datasets (e.g., US Census data)
• Use of biological specimens from deceased individuals in a project provided the project will not generate or collect data that may be submitted to the FDA (HIPAA regulations may still apply if PHI is used along with the specimens)
• Some funding agencies may require IRB review and approval for research projects that are not regulated by the Common Rule or the FDA. In these cases, investigators are encouraged to speak directly with the IRB Office to determine the best course of action.