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Bioethics Student Scholar Forum

June/July 2009

Featured bioethics student scholar:  Jennifer deSante is a graduate student at the University of Pennsylvania who plans to graduate with a combined Doctorate of Medicine and Masters of Bioethics degree in May 2010.
Can We Screen IVF Patients?
by Jennifer deSante

The birth of Nadya Suleman’s octuplets captured the interest of the country and media.  What began as amazement quickly turned to disbelief, then condemnation, even outrage.  Hardly anyone could understand what would motivate a woman to use in vitro fertilization (IVF) to have fourteen children.  The media became obsessed with Ms. Suleman: following her around town, releasing child services records, even sending Dr. Phil to her house.  As it became clear that this woman had little emotional or financial support to raise these children, people began to attack her for being irresponsible.  But how much responsibility falls on the physician that provided Ms. Suleman with her many cycles of IVF? 
Michael M. Kamrava runs the West Coast IVF Clinic in Beverly Hills, California, where Ms. Suleman received her multiple IVF treatments.  Despite the recent media frenzy, very little is known about Dr. Kamrava and what was actually involved with Ms. Suleman’s IVF procedures.  Was there any form of screening procedure before she began her treatments?  Did a counselor talk with her about her decision to become a single parent?  Was there a psychological screening that might have shown her history of depression?  Was there any concern on the part of the physician for this woman’s emotional, physical, and financial ability to raise a child, let alone fourteen children? 
The case of Nadya Suleman is an exaggerated example of what many bioethicists, lawyers, scholars, and, now, legislators have debated: should IVF be regulated in anyway?  Our country strongly protects reproductive freedom, but how far does the right to parenthood extend?  Now that parenthood can begin in a physician’s office with the participation of multiple adults and a variety of biological technologies, can we regulate this process?  Should we be able to deny certain applicants access to IVF?  Should we limit its use to adults who are capable of raising children?
In this paper, I argue for a legally-mandated, but minimal, screening of all IVF applicants to ensure a safe environment for the future children without discriminating against marginalized populations.  This paper will support a middle standard for screening applicants, somewhere between the screening for natural reproduction (i.e. none at all) and the screening for adoption (extensive and well-regulated.)  First, I will examine the arguments for and against screening applicants for assisted reproduction.  Next I will examine the potential form that this gatekeeping could take, particularly focusing on a comparison with two current models for regulating the right to parenthood: adoption and child protection laws.  Finally, I will present a series of potential scenarios, representing varied populations and the possible threat they pose to child welfare, and examine how a model for gatekeeping might evaluate these applicants.   
There is currently very little in the form of “screening” for IVF applicants.  There are no laws or regulations requiring clinics to screen IVF applicants.  The screening that does exist is informal and purely voluntary, with each fertility clinic regulating access to these technologies as they see fit.  However, a majority of IVF clinics were willing to deny access to at least some potential applicants (Gurmankin et al. 2005.) In fact, four percent of all IVF applicants are turned away; three percent for medical reasons and one percent for psychological, social, or emotional reasons (Gurmankin et al. 2005.)  One estimate has hundreds of applicants turned away because they are unfit parents (Storrow 2006.)  If an applicant is turned away from one IVF clinic it is not hard for them to proceed to another clinic, where they will most likely be accepted (Storrow 2006.)
Currently, it is the individual fertility clinics who decide who has access to IVF, a practice termed “clinical gatekeeping.”  This unregulated model differs from countries like the United Kingdom where there are national laws determining access to IVF, a practice referred to as “legal gatekeeping.”  The professional associations that self-regulate fertility clinics in America, the American Society for Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technologies (SART), offer no official recommendations for screening applicants, although ASRM has issued “ethical pronouncements” in an attempt to advise clinics on how to take parenting ability into account when evaluating applicants (Storrow 2006.)  Many fertility clinics do not have any written guidelines for accepting applicants, or fail to follow the guidelines that they do have (Storrow 2006.)  This is most likely because there is no pressure on clinics to create and follow guidelines.  A lack of guidelines does not mean that physicians do not deny access to IVF to some applicants.  Approximately two-thirds of Israeli gynecologists feel that it is important to screen applicants for IVF, particularly with regard to psychological assessment, criminal record and health status (Yogev et al. 2003.) Still, in practice, the focus is on the rights of the applicants to become parents, and not a concern for the welfare of the future child (Breen 2001.)
The Arguments for and against Gatekeeping
There are three commonly cited reasons for denying applicants access to IVF: 1) a fear of litigation, 2) a fear of biological failure, and 3) a duty to the patients and society, including a duty to the child (Storrow 2006.)  The first two reasons mentioned come from the expanse of our legal system and the limitations of our medical professions, respectively.  The third reason is based on the physician’s ethical belief that he or she is playing a critical role in the creation of a child and that he or she has a duty to provide a positive family environment for the child.  It is the physician’s interpretation of this duty that determines how stringently he or she will screen applicants for IVF.  If the physician believes he or she has a strong duty to protect the welfare of the future child, he or she will advocate for stringent gatekeeping and a high standard for IVF applicants.  If the physician has a laissez faire attitude towards protecting the welfare of the future child, he or she will accept more lenient gatekeeping and a minimum standard for IVF applicants. 
The most commonly cited argument in opposition to any form of screening of IVF candidates is the right to reproductive freedom, defined as “the freedom to reproduce or not to reproduce in the genetic sense, which may also include rearing or not, as intended by the parties” (Robertson 1994, 415.)  The right to have children is deeply entrenched in Western culture.  In our current society, we have expanded this right even farther.  Our country allows individuals to have children naturally, to use contraceptives to prevent pregnancy, and, with a few constraints, terminate a pregnancy that they do not wish to bring to fruition.  Surely IVF clinics must respect this right to reproduce, particularly in a population that is going to such extreme measures to bring children into this world.  However, there are limitations to this freedom.  Reproductive freedom is considered by most to be a negative right (Robertson 1994.) It ensures that a third party will not interfere with one’s ability to reproduce, but it does not include the right for someone to demand that a third party assist him or her in becoming a parent (Storrow 2006.)
The fear of discrimination is another argument against screening applicants for IVF.  Any time access to a service is limited, there is a concern for discrimination.  This is a particular risk when limitations are based on a subjective evaluation of the applicant.  One of the major concerns with limiting access to IVF is that the fertility clinics will cross the fine line between refusing service on the basis of child welfare and discriminating against marginalized populations (Storrow 2006.) Any refusal of service could be interpreted as a judgment on a category of people based on a stereotype. Crystal Liu sums of the fear of discrimination succinctly: “To assume, in the absence of evidence, that there are categories of people who are incapable of being good parents is discriminatory” (Liu 2009.)  It is easy to imagine that certain populations of applicants, for instance gays and lesbians, interracial couples, and single adults, could be categorically refused IVF services.  Except for the rare instances, for example when applicants have a previous history of child abuse, how can a clinic be certain that the applicant does not deserve access to IVF?  Finally, one has to consider the considerable discrimination targeted towards a marginalized and vulnerable population, for instance the homosexual community, if certain members of their community are repeatedly denied access to IVF.
There are strong arguments in support of screening applicants for assisted IVF.  The intrusion of the physician into the process of procreation is often used as a justification to insert regulations.  Physicians, and IVF clinics, bring their own set of values and interests to the table and these cannot be ignored. As Richard Storrow argues it “There certainly is a distinction to be drawn between unassisted reproduction and assisted reproduction along the lines of the triad of interests that exists in the latter and not in the former.  The interests of physicians are going to be expressed in one way or another in this   context and it seems rational to allow medical personnel to satisfy themselves that they will not be an instrument of harm” (Storrow 2006.)  Physicians have the right to refuse to treat patients based on their code of ethics (Storrow 2006.)  Does this include a right to refuse applicants access to IVF?
It is accepted that a physician has the right to refuse medical treatment based on their clinical expertise in the case of medical futility in a terminally ill patient (Daar 2008.)  Many scholars also acknowledge a physician’s right to refuse treatments, like abortion, that they find ethically unsound (Daar 2008.)  However, some have argued that refusing IVF is different, as the refusal is made based on the physician’s opinion of the patient, not the treatment.  Judith Daar draws a distinction between refusing to perform abortions and refusing IVF.  “…Treatment refusal involving medical futility or abortion share the commonality that what is being refused is based on the nature of the procedure, not the nature of the patient” (Daar 2008.)
In the case of screening applicants for IVF, a prospective parent’s right to have children should be weighed against the right of the future child to be protected from harm.  While it is correct that a physician should not refuse care based on a patient’s race, ethnicity, sexual orientation, or medical status, in the case of IVF, the physician must also consider their moral obligation to the child-to-be.  Physicians often feel that the duty includes a responsibility to ensure that the child will be born into a supportive environment. (Bateman 2001.) In fact, sixty-one percent of surveyed Israeli gynecologists felt that a physician providing IVF had a duty to the child-to-be (Yogev et al 2003.)  Some countries, for example the United Kingdom, require their physicians by law to consider the well-being of the future child. The 1990 United Kingdom Human Fertilization and Embryology Act code of practice states that fertility clinics ‘‘must also take into account the welfare of any child who may be born…as a result of treatment” (Peterson 2005).
There are two accepted models for denying the right to parenthood based on child welfare: 1) adoption and 2) child protection laws.  In adoption, the placement of the child is based on what is best for the child (Liu 2009.) The best interest of the child supersedes the right to parenthood. “It is evident, then, that while there is disagreement as to what limitations should be relevant in adoption placements, there is agreement that efforts should be taken to ensure the well being of the child.” (Liu 2009.)  Couples applying for adoption go through extensive screenings and evaluations both before and after they are matched with a child.  It is accepted that adoption placements should be primarily based on what is in the best interest of the child. 
With child protection laws, the standards for parenthood are lower; all that is required is that the child is protected from harm.  The legal system does not routinely relocate children merely because they are not in the “best environment.”  It is only after it has been shown that the child has been harmed that the legal system will break the parent-child ties and override a parent’s right to have a child (Storrow 2006.)
What Form Should Gatekeeping Take
The question remains as to which standard should be used when screening potential IVF applicants: the minimum “protection from harm” standard or the higher “best interests” standard.  In “natural” parenthood, it is presumed that the parents meet the standard for child welfare unless harm to the child is demonstrated.  In adoption, the bar for appropriate child welfare is significantly higher (Storrow 2006.)  One member of the Ethics Committee of the American Society of Reproductive Medicine weighed in on the issue of the “no harm” verses “best interests” standards, though their recommendation does not afford much guidance.  They concluded that IVF clinics should offer their services to all medically-qualified applicants, as long as there is no “clear risk of significant harm.”  They did allow programs the leeway to refuse services if there was a justifiable concern for the child-to-be (Steinbock 2005.) It has been suggested that a range of screening processes is actually the best solution (Steinbock 2005.)  Since it is extremely difficult to form a consensus on who should be denied access to IVF, it is best to leave the decisions to the individual clinics for now. As Bonnie Steinbock points out “…it is extremely difficult, even for experts in the area of child protective services, to predict, in advance, which people will be minimally competent rearers” (Steinbock 2005.)
However, the practical implications of having a variety of screening processes cannot be ignored.  If different clinics have different standards for what is acceptable, it creates an environment where applicants will “shop around” for a fertility clinic that allows them access.  While this is beneficial in cases of discrimination, it is not acceptable when the applicants have been denied access to IVF based on legitimate concerns for child welfare.  Some argue that the “protection from harm” standard is the more appropriate model for screening applicants for ART since the goal of the evaluation is to assess “minimal parental competency” (Storrow 2006.)  With adoption there is already an existing child with its own set of rights (Storrow 2006.)  The same cannot be said for assisted reproduction. 
However, assisted reproduction will, if successful, create a child who will have its own set of rights.  It also results in the creation of a parent-child relationship.  So while physicians at fertility clinics are not concerned about severing the ties between a biological parent and a child (as in adoption), they are concerned with creating a positive and productive parent-child relationship.  While the child whose welfare is at stake does not already exist, it does not mean that, in IVF, the importance of child welfare or the parent-child relationship is any less important.  It is the welfare of this child that creates the need to screen IVF applicants.
The difference between adoption and assisted reproduction lies in the importance of the parent’s reproductive freedom.  Reproductive freedom does not extend to adoption and the right to raise another person’s biological child.  And while the right to reproduce does not extend to the point where adults can demand IVF services, their rights should factor in a decision regarding IVF access.  The “best interest” standard is too constrictive on this reproductive freedom. Richard Storrow argues that “in the context of assisted reproduction, parental interests are not assumed to be subordinate to the child’s in the same way that they are in adoption…the contexts the best interests standard was designed to address” (Storrow 2006.)
In an effort to recognize the prospective parents’ right to parenthood, many people argue for a permissive screening process which would only deny access to IVF if there is a significant risk of harm to the child.  They argue that clinics in the US should use “many useful guideposts in the law applicable to the termination of parental rights, an area in which courts on a daily basis are determining what falls below ‘minimally acceptable care’” (Storrow 2005.)  Cases that fail to meet this standard often involve physical abuse, incarceration, severe physical incapacitation, drug abuse, or extreme mental illness (Storrow 2005.) The “protection from harm” standard is a minimal screening test that assumes the parents (or prospective parents) are adequate unless there is proof otherwise.  In this model, the burden is on proving the parents will NOT adequately promote the child’s welfare. 
The ASRM Ethics Committee states that "fertility programs should be attentive to serious child-rearing deficiencies in their patients, and if they have a substantial, non-arbitrary [emphasis added] basis for thinking that parents will provide inadequate child-rearing, they should be free to refuse to provide treatment services to such patients" (Ethics Committee for the American Society of Reproductive Medicine 2005, 565.)  ASRM favors minimal screening modeled after the “protection from harm” standard for wide-spread clinical use. 
This will prevent unsuitable parents from gaining access to IVF, but also appropriately balances the parents’ interest in reproducing with society’s interest in protecting the welfare of the future child (Storrow 2005.)  Furthermore, the “protection from harm” standard will minimize the “unjustifiable denials” that a more strict selection process would create, and allows for greater consistency and neutrality in decisions regarding access” (Storrow 2005.)
With the standard for evaluating applicants in place, it must be decided whether the standards for gatekeeping should be instituted legislatively or by the clinics.  The essence of this decision lies in who we want to make the decision to grant access to IVF.  Some argue in favor of legal gatekeeping, stating that clinical gatekeeping will allow physicians to make decisions based on prejudice and this will lead patients to have a loss of confidence in the profession (Daar 2008.)  Others contend that legal gatekeeping would allow for certain stereotypes and discriminatory practices to become institutionalized and accepted (Steinbock 2005.) 
However, legal gatekeeping could ensure that certain minimum requirements, for instance barring applicants with a record of child abuse, were uniformly enforced.  A set of standards could also ensure that individual clinics do not have complete control over screening IVF applicants.  Clinical gatekeeping could then be used to screen for social and psychological factors that would pose any harm to children, where there is less of a consensus on the applicants’ child-rearing ability.
Possible Scenarios
The first possible applicant to examine under the above gatekeeping model is the applicant with a non-traditional home environment, for instance homosexual couples and single individuals.  In countries with nationalized healthcare, the desire to restrict access to IVF can be financially motivated.  In the United States, most of the arguments against allowing single women and homosexual couples access to IVF arise from beliefs regarding their ability to raise children.  A majority of these arguments stem from a concern that children in these families will be emotionally and psychologically harmed by growing up in a nontraditional environment. 
Initially, there was a similar concern that children born to married couples via IVF would suffer from poor parental bonding and social stigmatization, though this has not been found to be true (Peterson 2005.) Children of lesbian parents develop similarly to children of heterosexual couples, specifically in the context of parent-child relationships, social development, gender identity, and psychiatric development (Liu 2009.)  The same is true for children of gay parents (Tasker 2005.) The desire for single adults and homosexual couples to have children via IVF is the same reason that infertile heterosexual couples seek IVF: a wish to have children genetically related to themselves and, in certain cases, their partner (Bateman 2001.)  Finally, there is no role in society for physicians to limit an individual’s reproductive liberty based on “entrenched ideologies about the family unit and sexuality” (Peterson 2005, 282)  This is especially true when one considers that most societies that use assisted reproduction have divorce rates between forty and fifty percent, making the traditional family environment a shrinking minority (Peterson 2005.)
The second possible applicant is a heterosexual couple where the female partner is over forty years old.  There are varying definitions as to what is considered an age cutoff by fertility clinics, though it is established that infertility rates increase over the age of 35 (American Society of Reproductive Medicine 2007.) Much of the initial data that suggested that women over 40 have a slim chance of becoming pregnant with their own eggs came from two studies that were conducted on fewer than 30 women and involving less than 100 IVF cycles (Gleicher et al. 2007.) New data on younger women with premature ovarian aging suggests that women with diminished ovarian capacity can still achieve successful pregnancies and a majority of IVF clinics are willing to attempt IVF on these women (Gleicher et al. 2007.)  If there is no argument that it is medically futile to attempt assisted reproduction with women over forty, why are they being denied access?  Patient reports indicate that IVF clinics give two primary reasons for denying IVF to older women: 1) pregnancy and IVF are no long indicated for women this age, and 2) artificial insemination is more effective for women this age (Gleicher et al. 2007.)  Both statements have been refuted by data (Gleicher et al. 2007.)
Some argue that older women have a decreased chance of living long enough to raise children to adulthood.  These people feel that the tragedy of losing one’s mother would be too great a harm.  With the current life expectancy in the mid-seventies and rising, it seems unlikely that there will be a large number of women giving birth in their forties who will die before their children reach adulthood (Arias 2007.) Furthermore, there is no proven data that children who lose their mothers before adulthood are so intensely harmed by the experience that it would have been better to remove them from their parents’ home under child protection laws when they were children.  Under the “protection from harm” standard, this does not meet the requirements for endangering child welfare and, therefore, these applicants should not be denied access to IVF.  
The third possible applicant expands on the previous debate: a couple where one of the parents has a serious physiologic illness.  Again, the primary concern here is the harm caused the child by having a parent die early in one’s life, is too great to allow this person access to IVF.  Though this is an easy concern to dismiss when based merely on the age of the mother, it is more serious when there is a very real possibility the parent will die.  In fact, seventy-two percent of Israeli gynecologists felt that serious illness was a legitimate screening question for applicants for IVF (Yogev et al 2003.)  However, a serious illness still does not mean that death is certain.  A decade or two ago, there were many convincing arguments that people with HIV should not receive access to IVF as they would not live long enough to raise the children.  People with HIV are living longer now thanks to better treatments.  Improvements in HIV treatments are so drastic that the British Medical Journal now recommends allowing HIV positive women access to IVF (Dickens 2001.) Advances in medicine make it impossible to view any diagnosis as a guaranteed death sentence.  Eventually it may be possible for people with cancer, neurodegenerative diseases, and kidney failure to live long lives and raise their children to adulthood.  Furthermore, the harm done to a child by having an ill parent is not so great, nor so certain, to justify denying access to assisted reproduction.
The fourth possible applicant is a couple where one of the partners is again ill, this time with a severe mental illness.  Approximately two-thirds of Israeli gynecologists favored psychological screening for potential applicants (Yogev et al. 2003.)  While most psychiatric illnesses can be well managed with medications and therapy, there are some that are recalcitrant to medical interventions.  For the purpose of this paper, severe mental illness will be defined as one resistant to medical management.  Psychiatric diseases this severe in a parent can significantly impact young children growing up in the home.  A study in Canada found that poor maternal mental health put young child at a significantly increased risk for developmental delays (Tough 2008.) Uncontrolled mental illness creates an unstable home situation and internal family tension.  None of this is sufficient in itself to fail the “protection from harm” standard.  However, severe mental illness can often predispose an individual to episodes of violence, sometimes without the individual’s recognition of this.  Because of this risk, applicants with uncontrolled mental illness need to be carefully examined and screened to ensure that the future child would be protected from harm.  If the mental illness is severe enough that situation fails the “protection from harm” standard, it is reasonable to refuse IVF to the applicant.  Perhaps severe mental illness is not great enough to warrant legal gatekeeping, but it surely is one of the examples where there is a “well-substantiated concern” and physicians should go above the minimum standards for refusal (Steinbock 2005.)  
The final possible applicant is the individual with a known history of inflicting child, spousal, or sexual abuse.  This is perhaps the one clear situation where the applicant fails the “protection from harm” standard.  A future child would clearly be at significant risk for danger.  In the survey of fertility clinics, only 81 percent said they would turn away a prospective couple where the man had been abusive to an existing child (Gurmankin et al. 2005.)   One has to wonder why the other nineteen percent feel a child abuser meets the minimum standard for parental competency.  This situation meets the minimum standard.  Child abuse is a legitimate reason for enacting child protection laws and is an ethical reason for terminating a parent-child relationship.  This small population of prospective applicants should be denied access to IVF.  In fact, this is one of the only times where legal gatekeeping would be justified.   
The ethical and practical implications of limiting a person’s ability to reproduce, in however limited a manner, must be carefully considered before being enacted.  Because of the serious ramifications of screening applicants for assisted reproductive technologies and IVF, it is important to thoroughly consider why we would wish to deny certain populations access to these technologies.  Once we have clearly delineated the reasons for gatekeeping, and determined which reasons are ethically acceptable, we can begin to monitor access to assisted reproductive technologies.
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