In many areas of the social sciences, one of the most commonly used methods of research is the secondary analysis of publicly available files of data. The federal government as well as large data consolidation bureaus and consortiums provide public access to many data sets. Additionally, many federal funding programs as well as social science professional organizations and journals now require that researchers make the data they collect publicly available to encourage scholarly replication of research. Data may also available from previously IRB approved protocols where the data sets do not contain information that could be used to identify individual research participants.
Research Where IRB review is Not Required for Publicly Available Data
Under the federal regulations for human subjects (45 CFR Part 46), research involving publicly available data sets would not require IRB review – no application is required – as long as:
- the data come from sources that are publicly available, and
- the data is deidentified and uncoded and stripped of identifiers.
The IRB has created a list of pre-approved data holders whose archives include publicly available, de-identified data. Review this list and follow the respective links below to learn more about the access and download procedures each data source.
Caution: If you are designing a research project that merges more than one public data set and you recognize that this may increase the risk of identification of individual research participants, please contact the ORPC.
Exempt Determination of Research with Identifiable Private Information
Research projects by investigators who initially have access to identifiable private information and then abstract the data needed for the research in such a way that the information can no longer be connected to the identity of the subjects would fall under exemption category 4 – secondary research use of identifiable private information or identifiable biospecimens where consent is not required. This means that the abstracted data set does not include direct identifiers (names, social security numbers, addresses, phone numbers, etc.) or indirect identifiers (codes or pseudonyms that are linked to the subject’s identity).
NOTE: The collection and analysis of protected health information (PHI) and personally identifiable information not allowed under this exempt category would likely fall under Expedited Category #5 and would require a data use agreement (DUA).
The following are instructions for preparing an application for an exemption determination of secondary data use research:
1) Complete the Collaborative Institutional Training Initiative (CITI) training program
2) Please access the Kuali Protocols Portal to create an application describing the use of secondary use of data. The Kuali Protocol User Guide has a searchable table of contents to the specific sections of Guide to assist you in creating a protocol. The IRB will review from whom the data is obtained, the protective mechanisms planned to protect the identity of persons, and perform an evaluation of the security of procedures.
Review and approval of this protocol will take approximately two-three weeks. The length of time a protocol will take to be approved and an approval letter received depends on the type or level of review required. The ORPC staff, working in concert with the IRB, will make every effort to work with investigators to process proposals promptly. If additional changes are needed, it can take longer depending on reviewer questions or protocol load.
Have a Kuali technical issue or problems with access? Contact the ORPC on this online form and we’ll send your issue to VPR Research Administrative Systems
IRB Application and Pre-review Consultation
The ORPC staff is available to answer any questions regarding the IRB submission process and IRB review of research studies. We also provide pre-review consultation to discuss all aspects of IRB review, from preparing the submission to completion of the study. The ORPC will send comments to investigators within one week if there are revisions required. Final versions are then forwarded to the IRB for review. If you have any questions, please contact us at compliance@umbc.edu.
Protocol Amendments
Investigators are required to inform the IRB of any changes planned for previously approved research. Kuali IRB uses the term “amendment”, rather than “modification”. Please access the Kuali Protocols Portal to create an amendment to a previously approved protocol. These changes must be submitted at least two (2) weeks beforehand. The Kuali Protocol User Guide can assist you in creating this amendment.