Tag Archives: Shinal v. Toms

Balancing State and Federal Informed Consent Law

The passage of the 21st Century Cures Act (“Cures Act”) and revisions to the Common Rule (45 CFR Part 46) (“Common Rule”) in the last year mandated significant changes to informed consent laws.  As a result of these changes, sponsors of research (“Sponsors”), institutions conducting research (“Institutions”), and the institutional review boards (“IRBs”) approving research will need to review policies and practices involving informed consent.  As explained below, a recently published FDA guidance document makes a first step toward implementing some of these changes by permitting waiver of certain consent requirements for low risk research involving human subjects. Additionally, a recent ruling by the Pennsylvania Supreme Court discussed below reminds investigators, Institutions, and Sponsors performing clinical research in Pennsylvania that state informed consent laws and common law must also be considered before conducting clinical research involving human subjects.  The following brief discussion provides some insight into how Sponsors, Institutions, and IRBs should take into account varying sources of law when determining when to require consent for research involving human subjects.

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