Updates regarding the use of Existing and Archival Data

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 IRB is acquainted with the fact that 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

Under the federal regulations for human subjects (45 CFR Part 46), research involving publicly available data sets are exempt from IRB review:

* as long as the data come from sources that are publicly available
* and the data is deidentified and uncoded and stripped of identifiers.

Therefore, the IRB has determined that investigators who plan to use these publicly available, de-identified sources do not require prior IRB review. These means no application is required.

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.

Go to the IRB website (http://www.umbc.edu/research/HARPO/IRB/IRBspecialtopics.html#archival) for more information about this process and to obtain the list of pre-approved data holders.

Cautionary note # 1: 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 Human and Animal Research Protections Office at 5-2737 or HARPO@umbc.edu.

Cautionary note #2: Data holders whose archives are available on a restricted basis will require the submission of an application for Expedited or full board review.

American Recovery and Reinvestment Act stimulus money and review of human subject or animal use protocols

The recently approved American Recovery and Reinvestment Act (ARRA) will provide opportunities for universities and other institutions to apply for research related monies from the stimulus funds. Federal agencies distributing these funds have or will be providing guidance to respond and submit applications with possible very tight turnaround times.

Unless the grant announcements say otherwise, the Just-in-time principles should apply. These procedures allow an applicant to defer certification of IRB approval of the project’s proposed use of human subjects or verification of IACUC approval of the project’s proposed use of live vertebrate animals.

I have asked the folks in Sponsored Programs to keep me informed in the event the funding agencies have requirements for a quick turn-around of compliance committee review as the distribution and the spending of funds may have to occur within a limited amount of time.

HARPO will be closed

The office will be closed for Spring Break (and furlough day), March 16 and 17, 2009. We'll reopen on March 18, 2009.

HARPO will be closed

The Human and Animal Research Protections Office will be closed March 11 and 12, 2009. The staff of HARPO will be attending a workshop at the Animal Welfare Information Center on both days. Please leave an email at HARPO@umbc.edu or a voice mail at 410-455-2737 and someone will get back to you shortly.