IRB

Per 45 CFR 46.101, research using certain publicly available datasets does not involve "human subjects." The data contained within these specific datasets are neither identifiable nor private and thus do not meet the federal definition of "human subjects" as defined in 45 CRF 46.101. These datasets include those provided by the DataCore, which are delineated below:

• • Healthcare Cost and Utilization Project (HCUP) from the Agency for Healthcare Research and Quality (AHRQ): admission-level data about hospital admissions, readmissions, and emergency department use.

  • Centers for Medicare & Medicaid Services (CMS) claims data: claims-level data about all claims filed through Medicare.

  • American Hospital Association (AHA) Annual Survey (AHAAS) with Information Technology supplement (AHAIT): annualized survey about hospital demographics.

  • Health Information National Trends Survey (HINTS) from the National Cancer Institute (NCI): person-level survey that asks people general thoughts on cancer and cancer-related topics.

  • Patient-Centered Outcomes Research Institute (PCORI) PCORNET: patient EHR data along with PCORI studies in a unified data model.

  • Epic System’s Cosmos: patient EHR data.

  • IBM’s Truven: a set of clinical datasets of which one is a patient EHR dataset.

  • National inpatient sample (NIS) dataset.

The Ohio State University, Office of Responsible Research Practices (ORRP) has determined that when associated research projects are utilizing the publicly available secondary data provided through the DataCore, they do not qualify as human subjects research. This determination is based upon the following:

• All data in the repository is considered de-identified, publicly available data and the data holder does not otherwise require IRB approval or an exempt determination to release data to investigators.

• The Ohio State University DataCore Repository staff members will follow all terms of use per the Data Use Agreement or data access procedures as established by the data holder.

• A procedure will be established in order that those accessing the Ohio State Data Core Repository will be held to the same requirements outlined in the data holder’s data use agreement/data access procedures.

A copy of the ORRP determination letter is available below.