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Perfecting Policy on Stem Cells

The National Institutes of Health has a smart and ethical stem cell policy in place, but that doesn’t mean that the agency can’t improve upon the policy once it is put into practice. A new regulatory notice published this week proposes a rules adjustment that would slightly expand the definition of human embryonic stem cells eligible for use in federally funded research. The change demonstrates the progressive policymaking process in action as officials learn from experience, solicit input from the public, and transparently correct imperfections. As well, another proposal for refining the policy recently appeared in the journal Science and suggested expanding the rules for ensuring informed consent from cell donors.

The NIH announced in the Federal Register on Tuesday that it plans to tweak its stem cell guidelines in order to accept a wider array of scientifically promising human embryonic stem cells. Currently, the NIH defines acceptable hESCs as “cells that are derived from the inner cell mass of blastocyst stage human embryos.” This definition excludes stem cells that are cultivated from younger embryos that have yet to reach the 70-100 cell blastocyst stage.

This practical problem with this definition came to light when Massachusetts-based Advanced Cell Technology submitted five lines of pre-blastocyst derived cells for NIH approval [correction: an earlier version of this post erroneous said ACT was Nevada-based]. As a result the NIH reviewed the 40 lines it has already approved and put three of them on hold upon learning that they also came from pre-blastocyst embryos. This hold will remain until the NIH officially changes the regulatory definition to cells derived from embryos “up to and including the blastocyst stage.”

Lana Skirboll, who directs the NIH Office of Science Policy, describes the change in a Nature News article as a “small technical revision.” She also reiterates the NIH commitment to transparency by stating, “If we were going to change a comma in the guidelines we might put out a Federal Register notice.” The notice is open for comments until March 25th.

Bernard Lo and colleagues made a different policy suggestion concerning the informed consent process in a Science Policy Forum. Currently, the NIH only requires informed consent from the in virto fertilization patients donating excess embryos and not from the people who donated the gametes (sperm or eggs) that created those embryos. In the paper Lo et al. write that, “Using embryos for research without permission of third-party oocyte donors could fail to respect donors as persons, breaching a fundamental principle of bioethics.”

The authors examine the possibility of requiring the gamete donors to provide informed consent along with the IVF patients before the embryos are donated for research, but they deem this too cumbersome a remedy. Currently, gamete donors sign a form giving the IVF patient legal authority to determine the use of embryos created with their gametes after infertility treatment has been completed.  This is known as “dispositional authorization” or the granting of “dispositional authority” to the IVF patients.

The problem with this process is that the gamete donors are not always completely aware of all the possible uses, or dispositions, for the embryos, which are numerous and include hESC research, donation to other patients, or destruction. Gamete donors currently do not give explicit informed consent for any of these dispositions when they grant blanket dispositional authority to the IVF patients.  The problem with requiring the gamete donors to give informed consent for all possible dispositions is that the informed consent process itself has numerous built-in requirements including the provision that the gamete donor incur no loss of benefits if they do not give consent.

To avoid additional complications that might diminish other bioethical protections, the authors argue that hESC research be included as part of a disclosure of information regarding disposition. That is, anyone donating sperm or eggs should be informed that one potential use of their tissue may be to procure human embryonic stem cells for research. This could mean simply that hESC research is listed as a possible use on the dispositional authorization form or that literature regarding hESC research be provided to the gamete donors before authorization. The main point being that under this new policy, an IVF clinic, sperm bank, etc. can confirm that donors received information regarding research as a dispositional option.  Gamete donors can choose to grant restricted or unrestricted dispositional authority and the IVF patients can then choose gamete donors based on the level of dispositional authority that they grant.  Thus, the decisions of the gamete donors do not restrict the decisions of the IVF donors.

The policy they propose the NIH adopt was included in the recommended guidelines of the National Academy of Science and the International Society for Stem Cell Research, and is followed by many Institutional Review Boards, a fact that would make it easier for those institutions to accept NIH approved cells for research if the NIH changes its policy.

The authors recommend that previously approved NIH stem cell lines be grandfathered in as long as dispositional authority was granted by the gamete donors, and that there are strong scientific reasons to use the cells, and that other legal requirements are met.

These recommendations, along with the NIH’s regulatory revision, demonstrate that ethical policymaking in this arena is an ongoing process that preserves core bioethical principles such as personal autonomy, human dignity, free scientific inquiry, and administrative pragmatism through open dialogue and transparency.

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