State Laws

The informed consent provisions of the Common Rule state: ''The informed consent requirements in this policy are not intended to preempt any applicable federal, state, or local laws which require additional information to be disclosed in order for informed consent to be legally effective''.19 Some states, such as Minnesota, have laws that directly regulate research.20 These state laws are not preempted by the Common Rule, and so long as the federal and state requirements are not inconsistent with one another, the general rule is that one should comply with all applicable laws.

Virtually all states have some form of medical privacy law or law specifying what constitutes informed consent, and the above provision of the Common Rule indicates that IRBs and researchers are obliged to comply with them. In practice, complying with the informed consent requirements of medical privacy laws has not been an extraordinary impediment to epidemiologic research because states typically do not have provisions regarding the waiver of consent; thus the affirmative federal policy has been assumed to govern. In recent years, however, many states have considered legislation that is more restrictive than the Common Rule with respect to waiver of consent.21 As these laws are implemented, IRBs may find that fewer epidemiologic protocols meet the criteria for waiver of consent.

An even more troubling set of problems for research stems from the increasingly prevalent

20 See, for example, Minn. Stat. Ann. § 144.335(3a)(d).

21 See, for example, 2001 Tex. Sess. Law Serv. ch. 1511 (S.B. 11)

state laws regulating informed consent and information disclosure when genetic testing or genetic information is involved. As health care interventions increasingly use genetic analyses for diagnostic purposes and for selection of appropriate pharmaceutical interventions, it will be increasingly unlikely that any medical record can be presumed not to include genetic information. State genetics laws typically define ''genetic information'' very broadly, so that carrier status, single gene diseases, multiple gene diseases, and genes that merely indicate a susceptibility for a disease all are encompassed by the definition. As a result, records containing such information generally become subject to state law requirements regarding disclosure of such information. Unless federal regulators and institutions sponsoring IRBs are attentive to the implications for epidemiologic research, the social sensitivity of genetic information (popularly thought of in more narrowly predictive terms than the states' broad definitions), may very well be construed as making any records that include information regarding the results of genetic tests ineligible for expedited review. That is, as discussed above, under the 1998 notice from the FDA and the NIH,22 research using data that might be used to disadvantage the data subject is not to be deemed ''minimal risk'' research for purposes of an IRB's expedited review policy. Thus, the breadth of state laws protecting genetic information raises the possibility that routine data-only research will have to be approved and considered by the full IRB—with the potential for fractious ''research vs. privacy'' debates, as discussed above, that may result in the approval of only a fraction of important protocols.

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