On July 26, the National Institutes of Health (NIH) issued a revised policy for scientists applying for research grants that use human fetal tissue. Beginning September 25, applications and renewals for extramural grants utilizing fetal tissue must provide a detailed justification that no alternative research methods are possible. Scientists must also articulate how these conclusions were reached.
The notice follows the June announcement from the Department of Health and Human Services (HHS) notifying scientists that fetal tissue research proposals will be subject to a new, more stringent review process. This is in addition to NIH’s two-tier review process that includes peer-review from colleagues and experts in the field, followed by a final funding recommendation from the Advisory Council of the relevant NIH Institute.
Under the new HHS policy, this additional layer of review will be conducted by an Ethics Advisory Board (EAB) based at HHS. The board will be comprised of 14 to 20 people and includes at least one theologian, one ethicist, one physician, and one attorney. A third (but no more than half) of the members must be scientists with relevant expertise. A call for public nominations for EAB members, along with the charter specifying the EAB’s mission and operational characteristics, will be announced in the coming weeks.
The NIH policy specifies how the EAB will consider the scientific justifications in their funding assessments. Additional space will not be provided in applications to accommodate these justifications; they must be incorporated into the 12-page limit for the Research Strategy Approach section. The new restrictions also prohibit trainees—graduate students and post-doctoral fellows receiving training and fellowship funds—from submitting independent research proposals using human fetal tissue.
In a June statement FASEB expressed concern about the proposed third layer of review and will continue to facilitate discussion with the agencies as additional information about the policy’s implementation emerges.