<P> For the purposes of section II of the NIH guidelines, the following requirements must be met . First, the hESCs should have been derived from embryos created using an in vitro fertilization procedure for reproductive purposes, and no longer needed for this purpose . Second, the donors who sought reproductive treatment have given written consent for the embryos to be used for research purposes . Third, all written consent forms and other documentation must be provided . </P> <P> Documentation must be provided regarding the following: All options available to the healthcare facility regarding the embryos in question were explained to the individual who sought reproductive treatment . No payments of any kind may be offered for the donated embryos . Policies and procedures must be in place at the facility where the embryos were donated to ensure that neither donation nor refusal to donate affects quality of care received by the patient . </P> <P> There must also be a clear distinction between the donor's decision to create embryos for reproductive purposes, and the decision to donate embryos for research . This is ensured through a number of regulations which follow . First, the decision to create embryos for reproductive purposes must have been made without the influence of researchers proposing usage for the embryos to derive hESCs for research purposes . Consent for the donation of embryos should have been given at the time of donation . Finally, donors should have been informed that they have the right to withdraw consent at any time until derivation of stem cells from the embryo, or until the identity of the donor can no longer be linked to the embryo . </P> <P> When seeking consent from the donor, they must be informed of what will become of their donation . The donor must be informed that the embryonic stem cells would be derived from the embryos from research purposes . The donor must also be informed of the procedures that the embryo would undergo in the derivation process, and that the stem cell lines derived from the embryo may be kept for many years . In addition, the donors must be informed that the donation is not made with direction regarding the intended use of the derived stem cells, and the research is not intended to provide direct medical benefit to the donor . The donor is also to be informed that there may be commercial potential resulting from the research performed, and that the donor is not to benefit from commercial development as a result of the donation . The donor is also to be notified if information that could disclose their identity will be available to the researchers . </P>

What are the restrictions on stem cell research