Common Rule

As discussed above, the Federal Common Rule was designed to be a mechanism for protecting the

interests of human subjects in federally funded or regulated research. Congress did not enact a law regulating research under its power to regulate matters affecting interstate commerce or even under its authority to safeguard the rights and liberties of individuals under the Constitution. Rather, the law is an expression of a federal policy not to spend federal money on research that is not consistent with certain social values. As a result, the applicability of the Common Rule, and the regulatory authority of the agency administering it, is somewhat odd. It applies to:

* research conducted by the 17 agencies that have adopted the rule;

* recipients of federal research grants as a condition of awarding the grant;

* research that is included in an application submitted to the FDA for approval of a drug, biologic, or certain devices; and

* all research conducted in or by an employee of an institution that has filed a "multiple project assurance'' with the Department of Health and Human Services, whether or not a specific project is federally funded.

Thus, research conducted in private clinics or institutions that do not have federal grants or a multiple project assurance appears to fall outside the scope of the Common Rule, as does research conducted by commercial research organizations that will not be used in a regulatory submission, e.g. many epidemiologic and outcomes studies. But since the records of interest in epidemiologic research often are those collected by institutions subject to the Common Rule, the would-be researcher faces a tremendous Catch-22: the research is not subject to the regulation, and under the law, the researcher has no claim on the time or resources of an IRB for obtaining review of the project or waiver of consent. However, each of the multiple academic medical centers from which the researcher wishes to obtain data is subject to the rule, and must have the proposal reviewed by its own IRB. For example, an epidemiologic researcher who wishes to analyze data from Johns Hopkins, Duke, M.D. Anderson, and Stanford University Medical Centers will have the project reviewed by four separate IRBs each of which must approve the project and waive individual consent in order for it to go forward. In reality, if the researcher is not affiliated with the institution, it may be very difficult to get the IRB to review the proposal without forming a collaborative relationship with someone affiliated with each institution who can get the project on the IRBs' schedules.

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