Notice Number: NOT-OD-15-158

Key Dates
Release Date: September 23, 2015

Issued by
National Institutes of Health (NIH)

Purpose

The National Institutes of Health (NIH) is informing the research community that it will not fund research in which human pluripotent cells are introduced into non-human vertebrate animal pre-gastrulation stage embryos while the Agency considers a possible policy revision in this area.

Background

The field of regenerative medicine, largely through the use of human pluripotent cells, has progressed to the stage in which some scientists are considering employing early stage animal embryos to grow human tissue and organs. Currently, the NIH Guidelines for Human Stem Cell Research (http://stemcells.nih.gov/policy/pages/2009guidelines.aspx) include the following section that pertains to this type of research:

Section IV. Research Using hESCs and/or Human Induced Pluripotent Stem Cells That, Although the Cells May Come from Eligible Sources, is Nevertheless Ineligible for NIH Funding

This section governs research using hESCs and human induced pluripotent stem cells, i.e., human cells that are capable of dividing without differentiating for a prolonged period in culture and are known to develop into cells and tissues of the three primary germ layers. Although the cells may come from eligible sources, the following uses of these cells are nevertheless ineligible for NIH funding, as follows:

• Research in which hESCs (even if derived from embryos donated in accordance with these Guidelines) or human induced pluripotent stem cells are introduced into non-human primate blastocysts.
• Research involving the breeding of animals where the introduction of hESCs (even if derived from embryos donated in accordance with these Guidelines) or human induced pluripotent stem cells may contribute to the germ line.

Given the rapid expansion of potential research models employed beyond the scope described above, NIH would like to undertake a deliberative process to evaluate the state of the science in this area, the ethical issues that should be considered, and the relevant animal welfare concerns associated with these types of studies.

Implementation

Effective with the date of this Notice, NIH will not fund any new or competing grant applications or contract proposals for research in which human pluripotent cells are introduced into non-human vertebrate animal pre-gastrulation stage embryos. This policy will be in place until NIH issues a subsequent policy notification.

• Current research funding: NIH will not consider requests for administrative supplements or revisions to any grants or modification to R&D contracts that include costs for or involve research introducing human pluripotent cells into non-human vertebrate animal pre-gastrulation stage embryos. Ongoing NIH awards will be addressed with the awardees on a case-by-case basis.
• Peer reviewed competing applications: Any grant applications previously submitted to the NIH and already reviewed (through both the initial and Council levels of review) which propose to introduce human pluripotent cells into non-human vertebrate animal pre-gastrulation stage embryos will be held for funding decisions until NIH has issued a policy notification. At that time, highly ranked applications can be modified, as necessary, to comply with the policy notification to receive full consideration for funding.
• Competing applications/contract proposals pending submission and/or peer review: NIH will not review applications or contract proposals for research proposing to introduce human pluripotent cells into non-human vertebrate animal pre-gastrulation stage embryos until NIH has issued a policy notification.
• Once the policy notification is released, applicants for grants that have not completed initial peer review will have the opportunity to submit additional post-submission material to comply with the policy notification. Provided that the additional material can be sent 30 days before the initial peer review meeting, those grant applications will be reviewed and considered for funding. See NOT-OD-10-115 for instructions and details.
• Once the policy notification is released, offerors for R&D contract proposals shall not submit additional material or information addressing the issue related to this notice after the cutoff date for receipt of proposals, unless directed to do so by the Contracting Officer.
• Applications that completed initial peer review before issuance of this Notice will not proceed to Council review at this time. R&D contracts that have completed peer review and have been determined to be in the competitive range before issuance of this Notice may proceed to negotiations.
• Alternatively, applicants may withdraw the application and submit again at the next available due date.
• No contracts proposing research in which human pluripotent cells are introduced into non-human vertebrate animal pre-gastrulation stage embryos will be awarded until further notice.

Inquiries

For questions regarding a specific application, please contact the assigned NIH program officer.

For questions regarding a specific contract proposal, please contact the assigned NIH contracting officer.

General inquires about this change may be directed to:

Division of Receipt and Referral
NIH Center for Scientific Review
csrdrr@mail.nih.gov
301-435-0715

Or

NIH Review Policy Officer
Office of Extramural Research
ReviewPolicyOfficer@mail.nih.gov