The University Committee on Activities Involving Human Subjects (UCAIHS) has established guidelines that allow investigators to make use of certain data without UCAIHS review and approval. These types of data include:
All investigators proposing to study public use data currently listed on the Not Human Subjects Checklist or de-identified data derived from other research projects; must complete a simple checklist to ensure that the data being used fit within OHRP’s guidelines for research that does not require IRB review.
In the fall of 2008, the Office of Human Research Protection, which oversees Institutional Review Boards’ (IRB) compliance with federal regulations concerning research involving human subjects, updated its guidance on types of data that do not require review by an IRB. The documents as issued can be found at: Guidance on Research Involving Coded Private Information or Biological Specimens (October 16, 2008) and Human Subjects Regulations Decision Charts (September 24, 2004). Additional guidance for each category of data is available as part of the discussions below.
Investigators proposing the use of public use data not currently listed on the Checklist, de-identified data not derived from other research projects, or research projects including human subjects activities in addition to the use of the above types of exempt data, must submit an Application for Review by UCAIHS.
Research that requires the submission of an application for IRB review may not be started until IRB approval has been granted.
Secondary analysis of public use survey data is one of the most common forms of research conducted by social scientists. The UCAIHS maintains a list of public use data sources for the NYU community and will add to the list as appropriate additional sources are identified. If a data set is not available to the general public, then it is not a public use dataset and a full IRB application must be completed for review. The proposed data set must be on the list of public use data sets listed below.
This policy does not apply to restricted use forms of secondary data that may be provided under special agreements by the above agencies or similar organizations. Such secondary datasets typically include potentially identifying information, unusually sensitive and/or private data, etc. The distinction between public use and restricted use data is generally very clearly stated by the primary source, and use of restricted data requires a clearance process and a confidentiality agreement. Projects that use restricted data must be approved by the UCAIHS through the regular application process; it is likely that most will fall into Exempt category #4.
If a dataset is not listed on the Checklist, contact UCAIHS for assistance in determining if the dataset meets the requirements for a public use dataset. A link to the dataset website must be provided. Researchers who wish to propose an additional agency or data set to the public data sources list should contact UCAIHS by sending an e-mail request to email@example.com with a subject heading of “Request for Addition to Public Use Data List”. If UCAIHS determines the dataset meets the requirements, it will be added to the checklist and an e-mail will be sent to the PI verifying that the named dataset meets these requirements. If UCAIHS determines the dataset does not meet the requirements, an e-mail will be sent instructing the PI to submit a full IRB application for review. No use of the data for research should be made prior to the data being added to the list.
Secondary data derived from already completed research projects does not qualify for review under either Public Use Data or De-Identified Non-Public Data status. Investigators planning to make use of such data must submit an Application for Review to the UCAIHS for review and approval. It is likely that most of these applications will fall into Exempt Category #4.
Many agencies and organizations collect or have available as a result of the provision of services or collecting of information for organization purposes, data that represents information on individuals. These agencies or organizations may agree to make such information available to investigators for research purposes. Investigators who receive any such data that contain identifiers must submit a full Application for Review and receive approval from the UCAIHS prior to acquiring and using the data.
However, data that are de-identified prior to the investigator's receipt and that are not derived from previous research projects may not require review by the UCAIHS if the data meet the following criteria:
Investigators proposing to use de-identified data of this type should complete the Not Human Subjects Checklist to document in the investigator’s files that the research meets the critiera and does not require UCAIHS review.
In the Colleges of Dentistry and Nursing, certain types of biological materials and patient data which have been derived through treatment of patients and have been de-identified prior to the proposed use, may no longer require UCAIHS review and approval.
Applications for the use of biological specimens and de-identified patient chart data should be emailed to Associate Dean Louis Terracio (firstname.lastname@example.org) with an electronic cc: to Dr. Jane McCutcheon (email@example.com) at the NYU College of Dentistry with a subject heading of "Request for Class B Data Status"
|Effective Date:||January 01, 2009|
|Issuing Authority:||Marti Dunne, Associate Vice Provost for Research Compliance & Administration|
|Responsible Officer:||Alison Dewhurst, Director|
|Office Name:||University Commmitte on Activities Involving Human Subjects|