Review of the Procurement Process

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Research involving hES cells will require access to human oocytes and embryos, necessitating some interaction between oocyte and blastocyst donors and people or institutions seeking to procure these materials for use in hES cell research. Individuals and couples who voluntarily and with full information donate somatic cells, gametes, or blastocysts for hES cell research should be assured that their donation is made for meritorious research and that all efforts will be made by those responsible for handling, storing, and using cell lines to protect donor confidentiality. IRB review of the procurement process, combined with a full informed consent process before donation, will facilitate the ethical conduct of this research.

Regardless of the source of funding and the applicability of federal regulations, an Institutional Review Board or its equivalent should review the procurement of gametes, blastocysts, or somatic cells for the purpose of generating new hES cell lines, including the procurement of blastocysts in excess of clinical need from infertility clinics, blastocysts made through in vitro fertilization specifically for research purposes, and oocytes, sperm, and somatic cells donated for development of hES cell lines through nuclear transfer.

Informed Consent of Donors

The donors of sperm, oocytes, or somatic cells used to make blastocysts for research are themselves rarely the subject of the research. Nevertheless, the physical interaction needed to obtain the materials brings them under the purview of the human subjects protections system, and IRB review is required. Thus, their fully informed and voluntary consent is required before such research use.

Institutional Review Boards may not waive the requirement for obtaining informed consent from any person whose somatic cells, gametes, or blastocysts are used in hES cell research.

When donor gametes have been used in the in vitro fertilization process, resulting blastocysts may not be used for research without consent of all gamete donors.

In addition to ensuring voluntary informed consent of all donors, there should be no financial incentives in the solicitation or donation of blastocysts, gametes, or somatic cells for research purposes. Nonfinancial incentives also should be avoided. For example, a donor's decision should not be influenced by anticipated personal medical benefits or by concerns about the quality of later care. Thus, a potential donor should be informed that there is no obligation to make such a donation, that no personal benefit will accrue as a result of the decision to donate (except in cases of autologous transplantation), and that no penalty will result from a decision to refuse to donate.

To facilitate autonomous choice, decisions related to the production of embryos for infertility treatment should be free of the influence of investigators who propose to derive or use hES cells in research. Whenever it is practicable, the attending physician responsible for the infertility treatment and the investigator deriving or proposing to use hES cells should not be the same person.

No cash or in kind payments may be provided for donating blastocysts in excess of clinical need for research purposes.

Women who undergo hormonal induction to generate oocytes specifically for research purposes (such as for nuclear transfer) should be reimbursed only for direct expenses incurred as a result of the procedure, as determined by an Institutional Review Board. No cash or in kind payments should be provided for donating oocytes for research purposes. Similarly, no payments should be made for donations of sperm for research purposes or of somatic cells for use in nuclear transfer.

This recommendation should not be interpreted as a commentary on commercial IVF practices, but as a narrow policy position specifically with respect to hES cell research. Furthermore, as with all the policies recommended by the committee, this policy should be regularly reviewed and reconsidered as the field matures and the experiences under other policies can be evaluated.

It is widely accepted that, whenever possible, donors' decisions to dispose of their blastocysts should be made separately from their decisions to donate them for research. Potential donors should be allowed to provide blastocysts for research only if they have decided to have those blastocysts discarded instead of donating them to another couple or storing them.

Consent for blastocyst donation should be obtained from each donor at the time of donation. Even people who have given prior indication of their intent to donate to research any blastocysts that remain after clinical care should nonetheless give informed consent at the time of donation. Donors should be informed that they retain the right to withdraw consent until the blastocysts are actually used in cell line derivation.

The current regulatory system specifies basic elements of information that must be provided to prospective participants during the informed consent process. In the context of donation for research, disclosure should ensure that potential donors understand the risks involved, if any. Potential donors should be told of all options concerning the handling and disposition of their blastocysts, including freezing for later use, donation to others for reproductive use, research use, or disposing of them in accordance with the facility's policies and practices. To the extent possible, potential donors should be informed of the array of future research uses before giving consent to donate blastocysts for research. Comprehensive information should be provided to all donors that is readily accessible and at a level that will facilitate an informed decision. Written informed consent should be obtained from all those who elect to donate blastocysts or gametes.

Adherence to Standards of Clinical Care

Clinical facilities that provide assisted reproductive technology services are obligated to protect the rights and safety of their patients and to behave in an ethical manner. Researchers should not pressure members of the fertility treatment team to generate more oocytes than necessary for the optimal chance of reproductive success. An IVF clinic or other third party responsible for obtaining consent or collecting materials should not be able to pay for or be paid for the material it obtains, except for specifically defined cost-based reimbursements. Such restrictions on payment to those who obtain the embryos discourage the production during routine infertility procedures of excess oocytes that might later be used for research purposes.

No member of the clinical staff should be required to participate in providing donor information or securing donor consent for research use of gametes or blasto-cysts if he or she has a conscientious objection to hES cell research. However, that privilege should not extend to the appropriate clinical care of a donor or recipient.

Consenting or refusing to donate gametes or blastocysts for research should not affect or alter in any way the quality of care provided to prospective donors. That is, clinical staff must provide appropriate care to patients without prejudice regarding their decisions about disposition of their embryos.

Researchers may not ask members of the infertility treatment team to generate more oocytes than necessary for the optimal chance of reproductive success. An infertility clinic or other third party responsible for obtaining consent or collecting materials should not be able to pay for or be paid for the material obtained (except for specifically defined cost-based reimbursements and payments for professional services).

Compliance with All Relevant Regulations

If hES cell research involves transmission of personal health information about the donors, which will increasingly be the case as cell lines approach clinical application, it will be important for investigators, institutions, and IRBs to be aware of any privacy requirements that apply through the Health Insurance Portability and Accountability Act (HIPAA). Authorization should be obtained from donors for the transmission of specific health information, which should be secured to protect donor confidentiality.

Investigators, institutions, Institutional Review Boards, and privacy boards should ensure that authorizations are received from donors, as appropriate and required by federal human subjects protections and the Health Insurance Portability and Accountability Act, for the confidential transmission of personal health information to repositories or to investigators who are using hES cell lines derived from donated materials.

As the level of hES cell research in the United States increases, it is essential that

institutions and investigators adhere to applicable regulatory requirements and, given the increasing frequency of international collaboration in hES cell research, it will be important to monitor regulatory developments in other countries. The ESCRO committees will be charged with ensuring that U.S. investigators follow standards and procedures consistent with current regulations and with the guidelines recommended in this report.

FDA's Good Laboratory Practice regulations pertain to the management of laboratories that are developing products that might eventually be introduced into humans (for example, in a clinical trial). Those regulations do not cover basic exploratory studies conducted to determine whether a test article has any potential utility or to determine its physical or chemical characteristics, but they do encompass in vivo or in vitro experiments to determine their safety—an activity that would be characteristic of the preclinical phase of hES cell research. Failure to conform to FDA regulations, although not itself a violation of law, would render any hES cell lines less useful if they are considered for tissue transplantation or other cell-based therapies.

Investigators and institutions involved in hES cell research should conduct the research in accordance with all applicable laws and guidelines pertaining to recombinant DNA research and animal care.

hES cell research leading to potential clinical application must be in compliance with all applicable Food and Drug Administration (FDA) regulations. When FDA requires that a link be maintained to the donor source, investigators and institutions must ensure that the confidentiality of the donor is protected, that the donor understands that a link will be maintained and that, where applicable, federal human subjects protections and the Health Insurance Portability and Accountability Act or other privacy protections are followed.

Banking of hES Cell Lines

As hES cell research advances, it will be increasingly important for institutions that obtain, store, and use cell lines to have confidence in the value of stored cells, that is, confidence that they were obtained ethically and with informed consent of donors, that they are well characterized and screened for safety, and that their maintenance and storage meet the highest scientific standards.

Institutions that are banking or plan to bank hES cell lines should establish uniform guidelines to ensure that donors of material give informed consent through a process approved by an Institutional Review Board, and that meticulous records are maintained about all aspects of cell culture. Uniform tracking systems and common guidelines for distribution of cells should be established.

The full report lays out recommended standards for any facility engaged in obtaining and storing hES cell lines (see Chapter 5).

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