Information About and For IRBs

The involvement of college and university Institutional Review Boards (IRBs) with respect to the use of ICPSR data varies with the level of access. IRBs are specially constituted review bodies established to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.

In general, IRBs must review proposals involving secondary analysis of ICPSR restricted data and ICPSR enclave data. However, some universities have policies exemption such secondary analysis projects from review. The application and agreements researchers complete and submit to ICPSR must include an approval by their IRB for their research project or an indication from the IRB that their research project is exempt from IRB review.

Whether IRBs need to review proposals involving secondary analysis of public-use files, such as those distributed on ICPSR's Web site, is not clear in the federal regulations governing these types of files; consequently, IRBs are interpreting their roles and responsibilities in different ways. Many IRBs are attempting to establish clear guidelines for such projects; some have taken the step of declaring research projects exempt from IRB approval when the projects involve secondary analysis of existing datasets from preapproved sources, such as ICPSR.

To assist IRBs and the social science community in addressing this issue, ICPSR has provided a statement defining its approach to confidentiality concerns in archived data. Also provided is a series of links to related information that may further assist IRBs in the decision-making process.

• ICPSR Statement on Safeguarding Confidentiality

• Examples of IRB Exemption Language

• ICPSR Confidentiality Procedures and Requirements

• Additional Information