Unlike some other countries that offer assisted reproductive technologies (ART) to men and women who face infertility, there are no national screening standards for such couples at infertility clinics around the United States. But one group of bioethicists is pushing to change that.

Subjective Screening Standards Found
While one clinic may have one set of guidelines in determining which couples should receive assisted reproductive services, another clinic may have a completely different set of guidelines to follow. One of the ethical concerns is that "the implementation of such restrictions results in a dual standard for parenthood: those with a medical problem, such as blocked fallopian tubes, are required to meet a different standard for parenthood than that applying to fertile couples," writes Andrea Gurmankin, PhD, and her colleagues at the University of Pennsylvania.

It results in potential "unequal treatment of infertile couples," they wrote.

Gurmankin's team at the university's Center for Bioethics published the results of a survey this month of clinics that offer infertility services.¹ They found a wide ranging set of guidelines between clinics. "The majority of programs in the U.S. do not have a formal policy for screening, leaving individual clinics and programs to set their own boundaries," said Gurmankin, the study's lead author who was on the faculty of the University of Pennsylvania at the time of the study, and is now an assistant professor of Society, Human Development, and Health at Harvard University.

What Screening Criteria are Used?
According to Gurmankin and her colleagues, little is known about the qualifications that ART programs use to screen couples for infertility treatment. They say that since fertility clinics play an important role in controlling access to ART in the United States, the need to more openly discuss, and in turn, establish blanket ART candidate-screening guidelines is necessary to ensure equality for prospective parents.

"Different people had told us, just anecdotally, that they thought some clinics paid more attention to certain variables than others in terms of whether they took people on as patients," said Arthur Caplan, PhD, chairman of the department of Medical Ethics at Penn, and one of the study's investigators, in a telephone interview.

Patient Protection or Patient Intrusion?
In the past few years, there has been a resistance to proposed government oversight of ART. Proposals aimed at regulating assisted reproduction issued by President Bush's Council on Bioethics in 2004² drew criticism from patient advocacy organizations like RESOLVE and the American Fertility Association. The debate centered on balancing the need for national regulations with patient privacy.

"There is information that doesn't necessarily have to be provided to the government about these treatments, and they pertain to private decisions that couples are making about embryos," said Erin Kramer, director of Government Affairs at RESOLVE, in an interview last year with Priority Healthcare. "We don't think that's the government's business."

But Caplan views proposed blanket standards for patient selection in ART programs in a different way. "It seems to me there is an obligation to look out for children made by means of technologies in non-traditional family settings," he said. "If you're a single man at [age] 65, and you hire a surrogate to have your baby, the state does have an interest in making sure that you are fit to parent that baby."

What the Survey Uncovered
The study found that there were significant differences across ART programs in their reported likelihood of turning away candidates. Gurmankin and her colleagues determined, for instance, that when program directors were faced with a hypothetical situation in which a prospective mother was addicted to marijuana, about one-third of them reported that they would accept such a couple for ART services. By contrast, about 47% reported that would have denied access to a woman in that instance.

The researchers also found that a couple on welfare is as likely to be granted access to ART services as they are to be denied. "The frequency of these variations highlights the need for a formal policy and common guidelines for candidate screening utilized by all ART facilities," said Caplan.

The research team surveyed 210 clinics around the country for their study. In addition to asking about certain facts relevant to a participating clinic, the survey also asked about the process for screening candidates, such as the representative with whom couples meet, the information collected about the candidates, and the representative who makes the final decision about whether a couple should or should not receive treatment. Questions focused on the number of candidates turned away each year for social/psychological reasons, whether or not relatives would be permitted to serve as gamete donors, philosophies about candidate screening, and the likelihood of turning away candidates with certain attributes.

Among other things, ART programs responding to the survey reported that they had a formal policy that includes the grounds for refusing treatment for a candidate. At nearly two-thirds of those clinics, a group rather than one individual makes the final decision about whether or not to turn a candidate away.

"On average, responding ART programs report turning away 4 percent of their candidates each year—3 percent for medical reasons and 1 percent for emotional, social or psychological reasons," wrote Gurmankin's team.

Need for Screening
Responses also revealed that the majority of ART program directors believe everyone has a right to have a child. "Yet only 43 percent agree with the statement that they do not have the right to stop anyone from attempting to conceive, only 44 percent agree that they do not have the right to decide who is fit to be a parent, and 64 percent believe in their responsibility to consider a parent's fitness before helping them conceive," the researchers wrote.

In the end, Gurmankin's group concluded that most ART program directors believe they have the right and responsibility to screen couples for ART with the aim of protecting a child's safety and welfare, as well as that of the prospective mother.

Bases for Turning Couples Away
Still, the study found that "a substantial number" of ART programs report they are very likely to turn away candidates based on characteristics of which they do not collect relevant information. "Thus, it is unclear how many programs are discharging the responsibility they assign themselves to screen and turn away worrisome candidates," the investigators wrote.

The wide range of guidelines used in ART programs to determine whether a couple should be accepted for treatment or not highlights the need for greater public and professional debate on the criteria that should be adopted, Gurmankin's group stated.

"This variability suggests that as infertile couples navigate through the stressful process of attempting to overcome infertility, they might encounter differences as to where they might or might not be deemed eligible for therapy," the researchers stated.

What's Next?
The first step toward establishing national screening standards would be the creation of a "blue-ribbon panel" charged with issuing specific recommendations, Caplan told Priority Healthcare. But he and his colleagues plan no campaigns to push the issue. The study, he says, speaks for itself. "We put the study out there, and now it's up to others to decide whether they really do want to do it," he said.

1. Gurmankin AD, Caplan AL, Braverman AM. Screening practices and beliefs of assisted reproductive technology programs. Fertil Steril 2005 Jan;83(1):61-7.
2. President's Council on Bioethics. Reproduction and Responsibility: The Regulation of New Biotechnologies.

John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include coverage of health news for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.