sistencies in how research is defined, who reviews it, and how it is monitored. The OHRP needs to be revitalized and refocused to carry out the three functions already within its purview. As a fourth, new function, the national registry should be housed within the OHRP as well.

IRBs or other independent review committees would still review studies at the local level, making the initial assessments of risk and approving or rejecting individual studies based on detailed information about the study. A revitalized OHRP would be more involved in investigating and intervening when problems occur and promoting consistency on a nationwide basis, thus filling critical voids in the current oversight system. To ensure that research involving prisoners is conducted in an ethically responsible way, the OHRP needs greater resources and broader powers than presently exist. The enforcement division of the OHRP, for example, presently consists of fewer than four full-time positions, and its responsibilities encompass all research (not just prisoner research) conducted under existing regulations.

Because there is no central repository for the collection of data regarding research involving prisoners, it is difficult or impossible to quantify the number of such studies underway at any given time, the number of prisoners involved, the types of studies being conducted, the subject of inquiry in this research, the incidence of protocol deviations, or the occurrence of adverse outcomes (see Chapter 2). A national registry would help the OHRP provide technical assistance and training as well. With this registry, the OHRP and others would have access to valuable information about the kinds of research being conducted, problems and adverse events that have been identified, and the types of protections appropriate for different research projects in various correctional settings. Additionally, as the national body charged with the enforcement of the governing regulations, the OHRP could provide authoritative interpretations of the regulations and their application in various circumstances. In its charge to enforce governing regulations, when less formal procedures prove inadequate, the OHRP must have the authority to initiate legal action to compel compliance, including discovery and subpoena power to uncover abuses and enforce regulations. Anyone should be able to report alleged violations of prisoner-subject rights to the OHRP without fear of retaliation (the OHRP would have to be able to invoke whistle-blower protection for people who disclose problems), substantially improving the safeguards to prisoners who agree to participate in research.

Revitalizing the OHRP to take on these four oversight functions would, however, leave a gaping hole in the national oversight structure that must be acknowledged and remedied. The OHRP’s jurisdiction regarding research involving prisoners is limited to studies funded by the DHHS, Social Security Administration (SSA), and Central Intelligence Agency (CIA). The remaining federal agencies and nonfederal and private entities are not

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