The article by Robert J. Kenney Jr. addresses how federally funded research institutions can conduct research involving human embryonic stem cells (hESC) without violating the prohibition on federal funding for such research, as set by the Bush administration in 2001. This prohibition, which limits the use of federal funds to research involving only certain pre-approved hESC lines, has created challenges for institutions seeking to pursue broader stem cell research supported through non-federal funds. The article provides an in-depth examination of the National Institutes of Health (NIH) guidance, which clarifies that institutions may engage in non-federally funded hESC research as long as they strictly adhere to federal cost accounting principles—principally those found in OMB Circular A-21—ensuring that no federal funds, whether direct or indirect, support ineligible hESC projects.
The NIH guidance does not require physical segregation of laboratories or special accounting beyond existing federal requirements, offering practical relief to institutions but emphasizing the need for rigorous internal protocols, training, and documentation to avoid even inadvertent commingling of funds. The article explores potential legal, political, and reputational consequences of violations, commonly centering on repayment of misallocated funds but potentially extending to suspensions of federal funding in high-profile cases. It further analyzes ambiguous or complex scenarios not directly addressed by the guidance, such as the use of federally funded equipment or facilities, mixed projects involving both eligible and ineligible hESC lines, and the handling of donated materials. Kenney concludes with recommendations urging institutions to develop clear policies, provide cost allocation training, monitor compliance closely, and remain responsive to evolving government interpretations, given the sensitivity and ongoing scrutiny surrounding stem cell research funding in the United States.
