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 manner such that individuals cannot be identified either directly or through identifiers linked to individuals. Also exempt from the rule is research that is designed to evaluate public benefit or service programs and that is conducted by or subject to the approval of federal department or agency heads. Finally, a waiver of informed consent may be given if the research involves no more than minimal risk to the subjects, the waiver will not adversely affect the rights and welfare of the subjects, and the research could not practicably be carried out without the waiver.
As with the Privacy Act, IRBs place a great emphasis on informed consent, although there are some provisions for waiving consent when anonymity can be assured, when risk is minimal, or when public benefit programs are being evaluated. The emphasis on informed consent is not surprising because IRBs were established initially to oversee medical research which often involves medical procedures. The need for informed consent regarding the procedure to be performed is obvious in this case because of the great potential for harm. Moreover, there may be no other way to protect subjects except through informed consent.
The role of informed consent is somewhat different in the conduct of most social science research, which involves acquiring information about subjects. It is possible, of course, to do harm through the collection of social science data by asking questions that provoke great anxiety or consternation, but the major danger is undoubtedly the possibility that private information will be revealed. In this case, confidentiality may be the primary concern, and some method for controlling the use of the data may be much more important than informed consent regarding its collection . Informed consent is one way to control the use of data, but it is not the only way. Anonymity potentially provides even better protection than informed consent. Other methods for protecting confidentiality also might provide the protections that are needed. For example, the confidentiality of administrative data might be protected without informed consent through the development of procedures such as the Data Integrity Boards and other mechanisms created by the Privacy Act and the Computer Matching and Privacy Protection Act. At the moment, however, IRBs rely heavily on informed consent, and they typically have only a limited understanding of the intricacies of matching administrative data and the laws regarding confidentiality.