Researchers get access, but question added bureaucracy

More than ever, emphasis is on informed consent

Now that the National Institutes of Health (NIH) moved forward to enable federal funding of embryonic stem cell research, fertility clinics, hospitals, and health systems providing fertility services likely will face more questions from couples who have excess embryos about the possibility of contributing those unused embryos to clinical research.

What are the responsibilities of fertility clinics to inform their clients of the potential of this new research? When should they present this information? How can these providers participate with researchers while complying with federal law and protecting their patients’ current and future genetic interests?

"First, most people need to understand that this research is already going on with private funding," advises Mary Anderlik, JD, PhD, research professor at the Health Law and Policy Institute at the University of Houston Law Center. "By allowing federal funding, this will bring the research out into the open. The NIH guidelines will establish standards for appropriate conduct. But, all kinds of research not permitted under the guidelines is already being conducted, it is just not being examined with such scrutiny."

Federal funding will just mean that more researchers will be able to use embryonic stem cells in research, she says.

Legal challenges may be in the offing

All of this concern may be premature, however. Although the NIH sought extensive public comment from religious groups, bioethicists, researchers, and others in the medical and scientific communities, strong opposition remains to the use of federal dollars to support research using stem cells derived from human embryos.

Rep. Jay Dickey (R-AK), who for the past four years has co-sponsored an amendment to the NIH appropriations bill that would prohibit funding of any research resulting in the destruction of human embryos, says that he and others will oppose the agency’s plan in Congress this fall. Further, Dickey says he and colleagues may file suit against the Department of Health and Human Services on the grounds that permitting embryonic stem cell research violates the federal ban on funding research that destroys or clones a human embryo.1

To fund research that uses cells created through the destruction of human embryos, even though the actual destruction of embryos is not performed with federal funds, is moral hairsplitting, he and others argue.

It is difficult to predict whether such a challenge could be successful, says Robert I. Field, director of the Health Policy Program at the University of the Sciences in Philadelphia.

"I can see the arguments on either side," he says. "The cells would not be there, but for the embryo. Or, you can say that the research involving stem cells is sufficiently removed from that process. I don’t know what a court would say."

Anderlik also says the situation presents a difficult legal dilemma, but feels that the courts are more likely to rule in favor of the NIH.

"If, ethically, [opponents] feel that the embryo is essentially a human being, and they are opposed to the destruction of human life, then they could call for a total ban on this type of research," she says. "But, no one is really making that argument."

The NIH position has a good chance of prevailing, even if opponents take the issue to court, she contends.

The agency did a good job of addressing the concerns raised by medical ethicists and the research community — mainly that federal funding would create a large, private market for human embryos that would result in buying and selling the embryos, or that it would encourage creation of embryos solely for research, adds Field.

"I think these regulations are consistent with the intent of the federal prohibition, which is to prevent the sale of embryos for research purposes," he says.

The process created by the NIH is very similar to the regulations governing organ donation, he says. "The protections in the guidelines are similar to the protections you see in organ donation and transplantation. If they work for organs, and I think they do, then they will probably work in this area, as well."

Informed consent

A key issue for health care providers and fertility clinics — and ultimately ethics committees — is at what point is it permissible to approach couples that have excess embryos about donating them for research, adds Field.

The guidelines prohibit physicians who treat patients for fertility problems from being the person responsible for deriving cells from the em-bryos. And, the scientists who derive the stem cells from the embryos must be able to document that the decision of a couple or a person to donate extra embryos must occur separately from their decision to create the embryos for fertility purposes.

"It will require institutions to pay careful attention to how they craft the informed consent forms in these situations," he notes.

An unanswered question is what becomes of embryos that are abandoned by their "parents" who no longer need them, but don’t want to make a decision about what to do with them. The guidelines only permit donation of embryos with the informed consent of those who created the embryos.

"You could certainly say, better to use them for medical research than to simply destroy them," says Field, noting that some clinics have policies about how long they will store embryos. "They kind of exist in a never-never land. What is the status of these things? They do have the potential to develop into human beings; they don’t have the potential of an embryo implanted in a woman’s uterus. What is the obligation of the facility to these embryos? Is there an obligation to find a woman who wants to bring them to term?"

Potential harm to donors

Another ethical problem Field sees, that is not addressed in the current guidelines, is the issue of information that is possibly disclosed about the embryo donors.

The NIH guidelines specifically state that the donors can receive no financial benefit for donating their embryos, and the donors must be informed whether any identifying information about them accompanying the embryos is available to either the beneficiary or the researchers using the stem cells. "One of the interesting things I noticed, is who benefits financially if there is commercial potential [of the results of the research]," says Field. "The donor will not receive any benefits. Even if you don’t pay them out right, some places might try to offer them stock options or some other benefit. I can see why the NIH wants to make it clear that none of that can be involved. But, is it fair for the doctor to make a fortune if someone can cure Alzheimer’s based on a line of stem cells derived from your embryo?"

This issue is further complicated by the fact that genetic information extracted from research on the stem cells potentially could be linked back to the donors, for better or worse. An embryo’s stem cells could provide information leading to a cure for Parkinson’s — or worse — could indicate a genetic flaw or weakness.

The published guidelines mention this in a section covering the comments received from the public on genetic identifiers. Some respondents were concerned that appropriate documentation of compliance with the informed consent guidelines would necessitate linking identifying information with the embryos. And, some noted that removal of identifiers completely would prevent some genetic studies or development of therapeutic materials.

"The guidelines have been modified to clarify that the term identifier’ refers to any information from which the donor can be identified directly or through identifiers linked to the donors," responds the NIH. "However, since information identifying the donors may be necessary if the tissue or cells are to be used in transplantation, the guidelines have been modified to state that informed consent should notify donors whether or not identifiers will be retained."

Field says it is likely that it will be some time before the level of progress of the research reaches the point at which genetic information about the donors will be a widespread concern. But, he adds, that issue, as well as the question of who benefits from the research applications, will need to be examined further.

Researchers get the most gain

The guidelines currently make clear that the donors can receive no benefit from donation, must be informed that their identifying information may be retained, and must be informed that the stem cells derived from the embryo may have the potential for commercial development.

"What if a cell line is derived from stem cells that, for some reason, produce better brain tissue than others," he asks. "Who benefits from developing it for commercial purposes? The document covers the back door in that it says the donor can have no stake in the marketability of it. But, it doesn’t get at the issue of, is it fair for the researcher to get everything?"


1. Zitner A. United States to fund controversial stem cell research. Los Angeles Times. Aug. 24, 2000:A-19. n

Robert Field, University of the Sciences in Philadelphia, 600 S. 43rd St., Philadelphia, PA 19104.

Mary Anderlik, Health Law and Policy Institute, University of Houston Law Center, 4000 Calhoun Road, Houston, TX 77204.

Gregory Stock, UCLA Program on Medicine, Technology and Society, UCLA School of Medicine, NPI, 760 West-wood Blvd., Box 9, Los Angeles, CA 90024-1759.

Carl Gulbrandsen, Wisconsin Alumni Research Foundation (WARF), 614 Walnut St., Madison, WI 53705. Telephone: (608) 263-2500. Fax: (608) 263-1064.