federal agencies that are involved in computer matching activities. These boards, composed of senior agency officials, have responsibility for reviewing matching agreements and programs for compliance with federal privacy laws. They also serve a clearinghouse and reporting function.

These acts and practices create a regulatory framework for the collection and use of data. For researchers, there are exemptions from requiring informed consent in which recipients did not give their consent when the data were collected initially. Agencies, for example, can forego informed consent when the use of the data is compatible with the purposes for which the information was collected and when the agency provides notice of its intentions in the Federal Register. They can also use data when the data will be used solely as a statistical record and will be transferred in a form that is not individually identifiable. In most cases, these procedures were not designed specifically to facilitate research, but they have been used for that purpose.

Common Rule—Institutional Review Boards

Concerns about the conduct of research have led to the development of Institutional Review Boards (IRBs) at universities, at government agencies, and at private organizations that conduct federally sponsored research involving human subjects. IRBs play an increasingly important role in the regulation of organizations that undertake social policy research using administrative data.

The federal “Common Rule,” adopted in 1991, governs nearly all research involving human subjects that is conducted or supported by any federal department or agency.9 Researchers and their institutions must comply with safeguards that ensure that individuals freely consent to participate in such research. Researchers also must ensure that the research employs procedures that are consistent with sound research design and that do not pose unnecessary risk to the research subjects. Finally, there must be adequate provisions to protect the privacy of research subjects and to maintain the confidentiality of individually identifiable private information.

The review of all federally funded research by IRBs is the principal mechanism by which these safeguards are implemented, and informed consent is the primary way that IRBs ensure that human subjects are protected. However, an IRB may waive some or all elements of informed consent under a number of circumstances.10 Research involving the use of educational testing, surveys, and interviews is entirely exempt from review if individual identities cannot be established from the information so obtained. Research involving analysis of existing data is exempt if the information is either publicly available or recorded in a

9  

45 CFR Part 46.

10  

In an effort to simplify the complex regulations governing IRBs, we conflate waiver of informed consent (which does not necessarily mean exemption from IRB review) with exemptions.



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