Organ Donor Dilemmas: Pregnancy, Policy and Practical Implications

Organ Donor Dilemmas: Pregnancy, Policy and Practical Implications | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Organ Donor Dilemmas: Pregnancy, Policy and Practical Implications Alexandra Perry, Jace DeGarmo, Kimberly Zaruca, Brian Childs This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6759566/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Research regarding organ donors who are pregnant at the time of death is extremely limited. Organ Procurement Organizations (OPO) responses to these donors is not widely understood, particularly in states with restrictive abortion laws post Dobbs decision of 2022. In an IRB exempt, qualitative study, we invited 25 OPOs from abortion restrictive states and 2 OPOs from non-restrictive states to participate in a confidential survey regarding management of potentially pregnant and deceased organ donors. The electronic survey inquired about jurisdiction and OPO demographics, OPO’s process for handling pregnant and deceased donors, communications with external parties, and relevant laws and policies at the state and OPO level. We received completed surveys from 5 OPOs in abortion restricted states, and one completed survey from an OPO in a non-restricted state. 4/5 restricted OPOs did not have data on the number of pregnant donors they have been presented with in the past three years. None of the restricted OPOs have an official policy in place to handle such cases. The non-restricted OPO shared their specific policy for management of pregnant donors, which includes ethics and medical consults. The OPO comes forward for donation only after a separate decision is made regarding the life of the fetus, irrespective of donation. The combination of the Dobbs decision and the current pressures that OPOs are under regarding resource allocation had a significant impact on OPOs’ willingness to create and discuss policies regarding pregnant donors. Restrictive abortion laws have a chilling effect on OPOs even addressing the issue of organ procurement from potentially pregnant donors as evident in reasons cited for choosing not to participate, for example, stated discomfort with questions being asked and denial to participate per executive leadership. A transparent and proactive policy regarding pregnant organ donors could mitigate potential legal issues and overall discomfort for OPOs that are already under an exorbitant amount of pressure to save as many lives as possible, honor the deceased, and avoid legal repercussions. Medical Ethics pregnancy organ donor organ donation abortion law OPO Introduction 17 people die every day while waiting for an organ, making it crucial that Organ Procurement Organizations (OPOs) perform due diligence on every potential organ donor, especially those who made clear their wish to donate under first person authorization (FPA). Research regarding organ donors who are pregnant at the time of death is extremely limited. OPO responses to these donors is not widely understood, particularly in states with restrictive abortion laws post Dobbs v. Jackson Women's Health Organization (2022) . Donors determined dead by neurological criteria who are pregnant are a unique population of concern because despite the neurological death, the same somatic tissue support used to perfuse the organs for donation can also be used to support a growing fetus. Articles citing a retrospective review of 252 brain-dead patients, estimate the incidence of pregnancy among this population at 2.8% (Esmaeilzadeh et al., 2010; Suddaby et al., 1998). Pregnancy testing is routinely performed on women of childbearing age upon admission to the hospital, leading to many ICU patients, and subsequently patients who are later declared brain-dead, having a known pregnancy status. However, pregnancy in brain death is likely under-reported, due to age ranges considered “child bearing age” varying across institutions, trauma cases that don’t allow time for pregnancy screening, and/or cases in which patients arrive and are promptly determined to be brain-dead. According to the Organ Procurement Transplantation Network (OPTN), there was a 9.6% increase in overall deceased organ donors, reflecting a 13 year upward trend (2024). 80–90% of organs from this increasing number of deceased donors come from donors who are declared brain-dead (Girlanda, 2016). The incidence of pregnancy in brain death is presumably growing, due to an increasing number of drug overdoses in women of child-bearing age (USAFacts, 2023). This paper focused on brain dead pregnant adult donors as the source for organ procurement. The advancements of medicine have ultimately led to better prognosis of many chronic diseases, leading to increasing numbers of patients living with end-stage organ failure that can now greatly benefit from an organ transplant (Saidi and Hejazii Kenari, 2014). The increased demand, and scarcity of organ supply, puts immense pressure on OPOs to maximize potential donations. The OPO tier system set forth by the Centers for Medicare and Medicaid Services (CMS) Final Rule issued in 2020 drastically intensifies the pressure on OPOs to increase donation rates (CMS Newsroom, 2020; 42 CFR Part 486, 2020). Through these guidelines, OPOs with the lowest donation and transplantation rates will be decertified and their DSAs will open for takeover by competing OPOs with higher rates. Consequences for low outcome measures compels OPOs to optimize donation from all attainable donor pools. In contrast, OPOs may feel influenced to approach the potential pool of brain dead but pregnant donors more cautiously due to abortion laws. As of June 2022, individual state laws determine how far along in pregnancy an abortion may be sought. The Supreme Court’s Dobbs v. Jackson Women's Health Organization ruling reversed federal abortion protections, in effect permitting each state to determine the legality of abortions (2022). After this decision, many states enacted new legislation to protect or limit abortion or relied on laws already in place that became active after the ruling. At the time of the study in May of 2024, the following 21 states were considered “restricted” states: Texas, Tennessee, Oklahoma, Missouri, Arkansas, Louisiana, Mississippi, Kentucky, Indiana, Alabama, Idaho, North Dakota, South Dakota, West Virginia, Georgia, South Carolina, Florida, North Carolina, Utah, Nebraska, and Arizona. In this study the term “restricted” refers to states that have made it illegal to abort the fetus prior to 18 weeks of gestation. These laws potentially impact the 29 OPOs with DSAs in those states. General exemptions to these laws include imminent danger to maternal life, and in some states, cases of rape, incest, or significant fetal abnormalities. The term “non-restricted” refers to states that have legislation outlawing abortion at some point after 18 gestational weeks or that protects access to abortion with no gestational limits. None of these statewide laws on abortion explicitly address organ donors who are pregnant and they do not provide any guidance for OPOs faced with pregnant (or potentially pregnant) donors. Operating room protocols for organ procurement from brain dead donors include maintenance of blood pressure and perfusion to the organs until they are ready to be removed (Ghio and Paramesh, 2023). After dissection, the aorta is clamped and ventilation is discontinued. At this point, the maternal somatic tissue support is ended via direct surgical intervention, rather than being withdrawn. This intervention is not done with the goal of terminating the pregnancy, though that would be the end result. That might leave OPOs in unclear legal territory depending on the applicable state abortion laws. In light of an ambiguous and fluctuating legal landscape, with no legal precedent, OPOs also face a conflicting pressure to act conservatively when faced with potential donors who are pregnant. This may mean OPOs walking away from potential donors when they are pregnant because it is unclear whether or not procedures related to organ procurement will be seen as an abortion. The pressure to maximize donations for the sake of a growing waiting list, coupled with the antithetical pressure to act conservatively from a legal standpoint, leaves OPOs with a need for more information so that they can build policy that serves the mission of OPOs while protecting them from legal repercussions. The purpose of this study is to further understand the ways this fluctuating legal landscape impacts OPOs’ policy and response to deceased and potentially pregnant organ donors. We hope to provide OPOs with increased transparency regarding how other OPOs are currently responding to cases of pregnant donors, and how state abortion laws are impacting this. By surveying OPOs serving jurisdictions with varied abortion laws, we hope to add to the collective knowledge base about the OPO community response at large, and give individual OPOs the information they need to build their own policy. Pregnancy in brain dead patients brings up many challenges and points of inquiry, however, the scope of this study focuses on OPO response to pregnant donors. Literature Review Relevant theories and concepts: Organ donation from brain dead individuals who are pregnant is both medically and ethically complex due to the competing interests of the donor, recipient, fetus, and state laws. Drs. Kantor and Hoskins published an article describing three ethical models through which such cases can be viewed (1993). Organ Donation Model: The Organ Donation Model prioritizes the donor’s intent to donate and the saving of lives of potential recipients (Kantor & Hoskins, 1993). 11 Kantor and Hoskins apply the principles of organ donation to these scenarios with the fetus serving as the recipient.Maternal somatic support on behalf of the fetus can be viewed similarly to the somatic organ support commonly applied to the donor in order to maintain perfusion of the organs for donation . In 2018, a Portuguese woman died while 19 weeks pregnant ( BBC News, 2019). The pregnancy was viable, and the hospital’s ethics committee decided to continue prolonged somatic tissue support, resulting in successful delivery at 32 weeks. The ethics committee used the mother’s status as an organ donor as rational to support this decision, arguing that “she would not object to ongoing treatment in a brain-dead state in order to preserve life” (BBC News, 2019). Organ procurement from brain-dead individuals for donation is often preceded by a brief period of somatic tissue support in order to preserve organs and avoid ischemia. In this sense, FPA for donation means agreeing to serve as an incubator in order to prolong the life of another. However, the burden of somatic tissue support varies drastically between support for organs prior to procurement and support for a fetus throughout its gestation. A major theme for this model is the concept of autonomy and considering the wishes of the deceased in the decision making process (Kantor & Hoskins, 1993).In the United States, the decision to donate organs is governed by the Uniform Anatomical Gift Act, which gives individuals the right to donate anatomical parts after death, and prohibits this gift from being revoked after death (Organ Donation and Transplantation Alliance, 2021). FPA is a highly venerated concept in the OPO and transplant community and is underscored by the 2010 resolution by the National Association of Attorney General that states “obligation of all participants in the donation process - hospitals, doctors, procurement organizations, and family members - to comply with the law and to honor, and implement the decision of the donor” (National Association of Attorneys General, 2024). Through the lens of the Organ Donation Model, personal autonomy is key to the decision making process. This model would advocate that maternal somatic support of the fetus is not compulsory, and decisions would be made based on perceived or actual maternal wishes (Kantor & Hoskins, 1993). However, maternal wishes regarding the unique situation of prolonged somatic tissue support for a fetus is often unknown, it is difficult to apply concepts of organ donation directly. Prolonging or preventing donation after death in an attempt to bring the fetus to term can be seen as opposed to this obligation to implement decisions made by the donor, as they were understood by the donor. Furthermore, organs are allocated in the United States to those on the waitlist based on strict principles of justice and medical utility ( Learn How Organ Allocation Works , n.d.). The extension of a woman’s decision to donate organs to include authorization for medical interventions throughout gestation could be seen as an appropriation of the processes in place. Incubator Model The second ethical model for consideration is the Incubator Model, which suggests the decedent no longer has rights and therefore welfare of the fetus takes priority (Kantor & Hoskins, 1993).The deceased mother is comparable to a vessel that supports the growing fetus. As a vessel, the deceased woman’s values and wishes prior to death would become irrelevant. This model provides rationale in support of the American Academy of Neurology’s 2023 recommendation that decisions to provide organ support to a deceased, pregnant donor should focus on the welfare of the fetus, rather than perceived or actual maternal wishes (Greer et al., 2023). In the United States’ and many other places, social and legal principles ensure a deceased person’s wishes are considered posthumously with regards to the physical disposal of the body, as well as the dispensation of the decedent’s property. With this in mind, Kantor and Hoskins point out that this model is “inconsistent with our beliefs about our obligations to the dead” (1993). Ordinary Pregnancy Model The Ordinary Pregnancy Model, as described by Kantor and Hoskins, gives the brain dead and pregnant person the same rights and interests as a living and pregnant person (Kantor & Hoskins, 1993). Whereas first person authorization is important for the Organ Donation Model, formal consent is important for the Ordinary Pregnancy Model. Consent considers risks and benefits to the patient, and recognizes “the woman’s right to self-determination”, including the right to refuse medical interventions (Kantor and Hoskins, 1993). Though these ethical models were published in 1993, Kantor and Hoskins acknowledged the potential overturning of Roe v. Wade , and the implications that would have for The Ordinary Pregnancy Model. After the Supreme Court's decision in Dobbs v. Jackson Women's Health Organization , there are now varied self-determination rights for pregnant individuals under state law (2022). At the start of this study, there were 21 states with legalized restrictions on abortions. Pregnant women have different rights and differing levels of bodily autonomy depending on what state she is in, and what the state abortion laws are. Through the lens of the Ordinary Pregnancy Model, a pregnant and deceased person who wished to become an organ donor would also have different options depending on the state she was in. For example, in a total-ban state, the decedent’s care team may be required to maintain maternal somatic support to attempt full gestation, regardless of what the surrogate decision maker believes the deceased would have wanted. In a state with no abortion restrictions, the decedent’s family would have the option to continue the pregnancy or terminate and proceed directly with organ donation, if organ donation is a goal. The Ordinary Pregnancy Model asserts that the woman’s wishes must be determined before secondarily considering the “presumptive or actual interests of the fetus” (Kantor & Hoskins, 1993). In the current legal climate, the interests of the state must be considered first and the extent of the woman’s right to self-determination must be determined. The patient’s wishes and then the fetal interests can be considered to the capacity possible under state law. Previous Studies A 2010 systematic study conducted by researchers at the university of Heidelberg reviewed 30 cases of brain dead pregnant patients occurring between 1982 and 2010 from around the world (Suddaby et al., 1998). Of the 19 case studies that were analyzed, 12 cases resulted in delivery of viable infants after prolonged maternal somatic support. This support was initiated at about 22 weeks gestation with an average duration of 38.3 days. Of the 12 newborns delivered, 4 were diagnosed with IRDS (now NRDS), 1 was diagnosed with fungemia, and 1 newborn had a premature birth complication, contracted Candida infection and died within 30 days of birth. The other 6 newborns were healthy upon birth and survived the neonatal period. Of the 19 cases, 5 resulted in organ procurement. 3 of these cases occurred after successful delivery and 2 after intrauterine demise. This study highlighted the challenges faced by medical teams to maintain the mother’s health to support the fetus. Such challenges include managing infections, cardiovascular instability, and hormonal imbalances while supporting fetal viability. Although challenging, it is possible to provide somatic support in order to have both the delivery of a viable fetus and procurement of organs for donation. In 1997, a case report was published of a 20 year old, 25 week pregnant woman who was declared brain dead after experiencing an intraventricular and subarachnoid hemorrhage of unknown etiology (Lewis and Vidovich, 1997). The decedent’s next of kin opted to maintain the somatic support until the fetus could be delivered when viable, and organs were to be donated thereafter. 54 days later, after an amniocentesis confirmed sufficient fetal-lung maturity, the baby was delivered at 31 weeks gestation. Immediately following the cesarean section, the heart, liver, pancreas and both kidneys were recovered and matched with 4 recipients. A follow up one year later revealed that the recipients were doing well and had no significant complications. Throughout the case, the OPO made clear efforts to avoid interfering with the primary interest of delivering a viable baby. The OPO only approached the next of kin to discuss donation after the decision had been made to maintain the pregnancy and then served in a consultation role to the critical care team until after the delivery. The OPO also arranged for the organ procurement teams to enter the operating room after the cesarean section was complete to avoid any potential for conflict of interest (Lewis and Vidovich, 1997). With somatic support having the ability to sustain the life of a fetus not yet developed enough to survive delivery, organs can similarly remain supported until the baby has been delivered and transplantation can proceed. In addition, the prolonged somatic support does not seem to diminish the quality of the organ for transplantation, in this case. Because of the OPO’s willingness to pursue donation after delivery, 4 individuals received life saving organs. This case emphasizes the importance of not overlooking these unique potential donors. At the opposing intersection of medical ethics and the law, one would find the Marlise Muñoz case. On November 26, 2013, Marlise Muñoz was 14 weeks pregnant when she was found unconscious by her husband after a suspected pulmonary embolism and was declared brain dead two days later (Humphrey, 2015). 18 Mrs. Muñoz was a paramedic with medical training and had discussed her wish to not be kept on life support with multiple family members, if the need should ever arise. Despite notification of her wishes from her next-of-kin, John Peter Smith Hospital refused to remove the life-sustaining measures, citing Section 166.049 of Texas Health and Safety Code as the basis for their refusal (Humphrey, 2015). According to Section 166.049, life-sustaining treatment is not allowed to be removed from pregnant patients. Ultimately, the courts upheld Mr. Muñoz’s argument that since his wife had been declared dead the obligation to not remove “life-sustaining” measures did not apply. The ruling also stated that the hospital had misunderstood the legal context they cited. The life-sustaining equipment was removed on January 26, 2014 and the gestation had reached 22 weeks. This case raises consequential concerns for the meaning of bodily autonomy post-brain death, and is still applicable today in a post- Dobbs world. It highlights the legal and ethical struggles to balance a woman’s wishes for her body post mortem versus the welfare of the fetus, when the two are in conflict. Assessing this case in today’s legal landscape after the Dobbs decision suggests that the courts in some states might have ruled in favor of the hospital keeping Muñoz on life-sustaining measures for the benefit of the fetus and in direct contradiction of her own wishes. While the argument was upheld that life-sustaining measures do not apply to a deceased body, the ruling disregards that life-sustaining measures would indeed sustain the life of the fetus (Paola, 2015). The crux of the conflict is that life-sustaining measures, in the case ofMuñoz , do not sustain her life; however, these life-sustaining measures do sustain the life of the fetus. This distinction highlights the result that forcing life-sustaining measures on a deceased person inherently transforms them into an incubator, in some cases directly against their expressed wishes. Methods Study Design In a qualitative study, found to be exempt by the Mercer University IRB, OPOs covering abortion restricted states and non-restricted states were invited to participate in a confidential survey regarding management of potentially pregnant and deceased organ donors. The surveys were conducted by researchers at Mercer University School of Medicine, in collaboration with The Carlos and Marguerite Mason Center for Organ Donation and Transplant Education and Policy and We Are Sharing Hope South Carolina (SHSC), an OPO. Survey The survey included four main sections and 21 questions inquiring about jurisdiction and OPO demographics, OPO’s process for handling pregnant and deceased donors, communications with external parties, and relevant laws and policies at the state and OPO level. The surveys were made anonymous with the exception of the level of abortion restriction for the OPO’s donor service area (DSA). Participant Selection: Out of the 29 OPOs with a DSA including restricted states, 25 had contact information available to researchers. Representatives from these 25 OPOs were selected for invitation to participate. An IRB amendment expanded the scope to allow for the inclusion of OPOs covering non-restricted jurisdictions to serve as a comparison point. Following this amendment, 2 additional OPOs from non-restricted states were selected for invitation to participate. Representatives from each OPO were selected for participation from within a national OPO networking program. Representatives were considered “key OPO personnel”, with roles such as Chief Donation Officer, Hospital Program Coordinator, Hospital Services Manager, Chief Operating Officer and similar positions that would allow for the depth of knowledge and authority to answer survey questions. Key OPO personnel were sent introductory emails from a member of the national OPO networking program to inform them of the purpose of the study and of the upcoming invitation to participate. Following introduction, researchers formally invited personnel to participate and survey questions were distributed for consideration after the OPO agreed to participate. Data Collection Participants were initially invited to schedule a virtual interview with researchers to conduct the survey. Due to participant time constraints, and the information gathering required by many of the questions, an IRB amendment allowed participants the additional choice of completing surveys via fillable pdf. OPOs were asked to return completed questionnaires within two weeks of receipt, though more time was given as needed. Up to three follow up attempts were communicated for potential participants. Data Analysis and Privacy All identifying information was removed from survey responses with the exception of the level of abortion restriction of the responding OPO’s DSA. Survey responses were compiled onto a master survey that listed all answers for each question. Responses were analyzed qualitatively by theme and by theme recurrence rates. Findings Participation and response rates are reflected in Table 1. Table 1. OPO participation data Total OPOs invited to participate 25 restricted and 2 non-restricted No response 8 Lost to follow-up after initial interest 5 Declined to participate outright 4 Rescinded participation after receiving survey 4 Completed survey 6 (5 restricted, 1 non-restricted) The survey responses from the 5 restricted OPOs highlighted 5 major themes for consideration: data tracking, pregnancy testing, existing policy, current practice, and lack of response. 4 OPOs responded that they do not track the number or occurrences of pregnant donors. 3 OPOs rely on the hospital to pregnancy test the donors while 2 OPOs complete pregnancy tests on the donors, although they have different age ranges for which this is a requirement. One OPO reported that they test all female donors younger than 55 years old and the other OPO tests all female donors between the ages of 9 to 55 years old. At the time of data collection, none of the 5 restricted OPOs had an official policy for handling organ donors who were pregnant. As for current practice, 2 OPOs stated they handle pregnant donors on a case by case basis. 2 OPOs stated that a path for donation opens after the fetus was delivered or there was a fetal cardiac time of death. 1 OPO responded they were unsure how they would approach a pregnant donor. Between the 5 OPOs, there were 4 specific cases disclosed of a pregnant organ donor case. Of these 4 cases, donation was sought after it was determined that there had been intrauterine demise in 3 of the cases. In 1 case organ donation was sought after delivery of a live newborn. No data was reported on the success of the donation attempts. Although the surveys were distributed once the OPO agreed to participate and they had several weeks to work with their team to gather the information, a large number of the survey questions were answered with “unsure” or “unknown”. In comparison, the OPO covering a non-restrictive DSA reported that they had 0 known pregnant organ donors in the past 3 years, but had 3 in the past 15 years. Out of the 3 pregnant donors, 2 moved forward with donation, and, 1 did not because they were found to be unsuitable. The OPO pregnancy tests all female donors between the ages of 9 years- 55 years old. They have a specific official policy to address donors who test positive for pregnancy: the family and care team, with appropriate consultations, make a decision for the outcome of the fetus irrespective of donation. Once the fetus has been delivered or the decision has been made to terminate the pregnancy, organ donation can proceed. Discussion Interpretation of results Though limited in responses, there is a clear distinction in level of transparency and certainty between restricted OPOs and non-restricted OPOs. The non-restricted OPO was the only responding OPO with an existing policy regarding pregnant organ donors. Their response was transparent and straightforward. Decisions regarding the fetus are made irrespective of donation and without OPO input. Thus, the possibility of organ donation has no effect on the management of a pregnant and deceased organ donor in such cases. A similar approach could be taken in restricted states, with limitations to the decisions regarding the fetus. These limitations will primarily affect the care team and family of the patient(s) rather than the decisions made by the OPO. Based on current guidelines, there are valid legal arguments that procurement of organs from a donor with a viable fetus can be seen as an abortion in the eyes of the law. In response to this legal landscape, there are three routes OPOs could take when drafting pregnant donor policy. The first option is the Avoidant Option. OPOs may decide not to pregnancy test potential donors and proceed without the knowledge of whether or not the donor is pregnant. If a brain dead individual is not known to be pregnant, ceasing somatic tissue support, and/or the procedures required for organ donation will unlikely result in prosecution. Many hospitals perform pregnancy tests on patients believed capable of becoming pregnant in the ICU as standard procedure, making this option impractical. Additionally, survey results show that many OPOs already rely on hospital pregnancy tests for this information. The second option is the Conservative Option. OPOs could choose to ensure pregnancy tests are performed on all potential donors of child-bearing age and sex, and subsequently disengage from all cases involving pregnant donors. This would be a cautious choice for OPOs legally and a cautious choice for media coverage as well. However, this route means walking away from viable organs, contributing to the number of individuals who are dying while waiting for an organ transplant, and potentially decreasing donation and transplant rates and threatening the OPO’s tier position. This also means ignoring the donors’ and/or families’ wishes to donate. First person authorization is legally binding and a highly respected concept in the transplant community. It is vital to the preservation of public trust in the donation process. The third option is the Sequential Option. Restricted OPOs could adopt a protocol where donation is considered only after the fetus is delivered or has reached intrauterine demise. This is similar to the protocol put in place by the responding non-restricted state, with the caveat that decisions regarding the fetus are more limited based on the level of abortion restrictions. Nonetheless, the OPO would not be involved in the decisions regarding the fetus, and this would only impact the events preceding OPO involvement. This echoes the current practice of some responding restricted OPOs, though it is not an official policy. Using option three, a restricted state could essentially follow the same protocol as the non-restricted state, with the exception that decisions made regarding the fetus by the family and care team may not include the choice to terminate a viable pregnancy. OPOs using this option should seek consultations from Ob-Gyn. These consults can evaluate the gestational age of the fetus, viability of the pregnancy, and monitor for fetal demise and cardiac activity. If the fetus is delivered, reaches cardiac time of death, or if consulting physicians deem the fetus no-longer viable, the restricted OPO could then move forward with organ procurement from the brain-dead patient. Following these steps, organ procurement can proceed without breaking restrictive abortion laws, and without stepping outside the bounds of the recommendation from the American Academy of Neurologists regarding pregnancy in brain-dead patients, which recommends that decisions to provide organ support to a deceased, pregnant, potential donor, should focus on the viability and welfare of the fetus (Greer et al., 2023). Limitations The low response rate was a considerable limitation of this study. The OPOs who declined to participate were asked to provide their reasoning for doing so. Specific reasons that OPO personnel gave for opting out included that they were “uncomfortable” providing answers, they “have not experienced pregnant donors”, and multiple OPOs declined “per executive leadership” decision. Several OPOs stated they do not track, and therefore do not know how many or even if they have encountered pregnant donors. This lack of data positions them to be unable to participate in the study, according to the personnel. Another obstacle OPOs encountered was specific guidelines for their participation in outside research. Several OPO personnel had to request the ability to participate in this study. Each attempt was reportedly denied and further explanation as to why the request was denied was not provided. With OPOs being under considerable pressure to maximize donations while remaining conservative in an unclear legal landscape there are additional speculations on factors for lack of engagement. Possible factors impeding OPOs willingness or ability to participate in this study include the absence of case law applicable to the Dobbs v. Jackson Women's Health Organization in regards to organ donation (2022). Without clearer legal proceedings, OPOs are uncertain how utilizing organs from a pregnant donor will be viewed in the eyes of the law. This lack of information understandably reinforces OPOs’ risk adverse nature. An additional factor was the OPO personnel time constraints. With an unpredictable daily schedule it was incredibly difficult to schedule a time to talk with the OPOs. Even with an IRB amendment granted to accept asynchronous surveys, it was reported many times that the personnel had difficulty finding time to complete the survey. Several OPOs requested time extensions to submit the surveys. A final proposed obstacle is the risk adverse nature of OPOs. As stated previously, OPOs are under immense pressure to comply with strict regulations to maintain their accreditation and funding. Inefficiencies are compared against other OPOs regarding successful transplantations and threaten a low tier ranking (42 CFR Part 486, 2020). The recent House and Senate investigations result in concern for the future of underperforming OPOs ( Data on U.S. Organ Procurement Organizations , 2022). Because of their close work with families during organ and tissue procurement, they are often responsible for maintaining public trust in the donation process. Negative media coverage can endanger their public image as well as reduce donation rates. These factors coalesce into a tentative nature of OPOs in which studies conducted by researchers outside of their organizations are met with caution and strict protocols for their participation. Contributions to the Field The actual number of pregnant potential organ donors has proved difficult to pinpoint thus far. However, it is clear that the cases will continue to grow in number, as will the demand for donated organs (Warren et al., 2020). By our estimate, most OPOs have no policy regarding this issue in this untested legal environment. Lack of OPO participation in this study was not due to a lack of interest. OPO personnel asserted interest in learning the results of the study, even when they opted out of participating themselves. Through learning the results of this study, and gaining a more comprehensive understanding of the ways abortion laws impact donation from pregnant donors, OPOs will have a stronger foundation from which to build clear, proactive policies to address such cases. The mission of OPOs and the transplant community relies on public trust, which in turn relies on transparency and continuity of procedure. Continuity of procedure for OPOs is predominantly directed by the Uniform Anatomical Gift Act (UAGA), its purpose being standardization of the donation processes and building a foundation for public trust in donation (Glazier, 2018). With interests of the fetus competing with the sanctity of FPA, pregnant donors represent a gap in UAGA policy. Similarly, organ donors fall into a gap not explicitly covered by restrictive state abortion laws. In light of these gaps, and with public trust of organ donation processes at stake, OPOs must use the information available to them to create transparent policies that maintain the OPO and UAGA mission while respecting state law. Policy developed in response to this issue will have major implications for the future not only of medical ethics, but of donation and transplant ethics. Conclusion There is an overall lack of clarity in regards to how OPOs are to handle such cases in a fluctuating legal landscape. OPOs in restrictive states experience pressures to maximize possible donations in order to maintain accreditation and ability to function within their DSA. Donors who are pregnant at the time of brain death are a potential source of viable organs to meet the unmet demand. However, the combination of the Supreme Court decision in Dobbs v. Jackson Women's Health Organization (2022) and the current pressures that OPOs are under regarding resource allocation had a significant impact on OPOs’ willingness to create and discuss policies regarding pregnant donors. Based on survey results, OPOs in restricted states do not have policy in place regarding this unique donor population. Many OPO personnel expressed keen interest in learning how other OPOs are handling such cases in order to inform their own policy even when they opted out of participating themselves. A transparent and proactive policy regarding pregnant organ donors could mitigate potential legal issues and maintain public trust for beleaguered OPOs. Based on our findings, we recommend that OPOs create policy adhering to the Sequential Model. As discussed, under the Sequential Model, OPOs could pursue organ donation after the fetus is either delivered or intrauterine demise has occurred. The Sequential Model reflects the essence of the current practice of responding OPOs in restricted states. This model adheres to the most conservative interpretation of abortion law, respects the donors’ intent to donate, and supports the OPO mission of maximizing donation rates in order to save as many lives as possible. Declarations Funding Statement: This work received no funding. Ethics Statement: This work involves a qualitative survey or Organ Procurement Organizations. It does not include identifiable human data, and this study was found to be exempt by the Mercer University Institutional Review Board. Consent to Participate: Participation in surveys was voluntary and conducted under an IRB exemption from Mercer University. All participants provided informed consent. Consent to Publish: Not applicable. Author Contributions: Jace DeGarmo and Alexandra Perry conceptualized the study, designed the survey, implemented the survey and wrote the manuscript. Kimberly Zaruca contributed to designing and implementing the survey. Brian Childs supervised study design and implementation. All authors approved the final manuscript. Corresponding Author: Jace DeGarmo; [email protected] References BBC News. (2019, March 29). Portugal baby born to woman brain dead for three months. BBC News. Retrieved December 20, 2024, from https://www.bbc.com/news/world-europe-47741343. Centers for Medicare & Medicaid Services. (2020). Organ Procurement Organization (OPO) conditions for coverage final rule: Revisions to outcome measures for OPOS CMS-3380-F. Retrieved January 3, 2025, from https://www.cms.gov/newsroom/fact-sheets/organ-procurement-organization-opo-conditions-coverage-final-rule-revisions-outcome-measures-opos. Esmaeilzadeh, M., Dictus, C., Kayvanpour, E., et al. (2010, November 18). One life ends, another begins: Management of a brain-dead pregnant mother—A systematic review. BMC Medicine. Retrieved May 13, 2024, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3002294/#B2. Ghio, M., & Paramesh, A. S. (2023, May). Organ donation and OR protocols. Retrieved December 30, 2024, from https://www.ast.org/ceonline/articles/473/473.pdf. Girlanda, R. (2016, September 24). Deceased organ donation for transplantation: Challenges and opportunities. World Journal of Transplantation. Retrieved December 20, 2024, from https://pmc.ncbi.nlm.nih.gov/articles/PMC5036117/. Glazier, A. (2018, August). Organ donation and the principles of gift law. Clinical Journal of the American Society of Nephrology. Retrieved January 3, 2025, from https://journals.lww.com/CJASN/pages/articleviewer.aspx?year=2018&issue=08000&article=00026&type=Fulltext. Greer, D., Kirschen, M., Lewis, A., & Gronseth, G. (2023, October 11). Pediatric and adult brain death/death by neurologic criteria. Neurology Journals. Retrieved May 30, 2024, from https://www.neurology.org/doi/10.1212/WNL.0000000000207740. Humphrey, W. A. (2015). But I’m brain-dead and pregnant: Advance directive pregnancy exclusions and end-of-life wishes. William & Mary Journal of Race, Gender, and Social Justice, 21 (4), 669. Kantor, J. E., & Hoskins, I. A. (1993). Brain death in pregnant women. The Journal of Clinical Ethics, 4 (4), 308-314. Lewis, D. D., & Vidovich, R. R. (1997). Organ recovery following childbirth by a brain-dead mother: A case report. Journal of Transplant Coordination, 7 (3), 103-105. https://doi.org/10.7182/prtr.1.7.3.e47h65u1v846085u. National Association of Attorneys General. (2024, July 2). Resolution in support of respecting and upholding the decisions made by persons who elect to be organ, eye, and tissue donors. Retrieved December 30, 2024, from https://www.naag.org/. Opodata.org. (2025). Data on U.S. Organ Procurement Organizations (OPO). Retrieved January 3, 2025, from https://www.opodata.org/#house-investigations. Organ Donation and Transplantation Alliance. (2021, September 20). Honoring first-person authorization in donation after circulatory death, part 1: The legalities. Retrieved December 30, 2024, from https://www.organdonationalliance.org/insight/honoring-first-person-authorization-in-donation-after-circulatory-death-part-1-the-legalities/. Organ Procurement and Transplantation Network. (2023). Continued increase in organ donation drives new records in 2023; new milestones exceeded. Retrieved December 20, 2024, from https://optn.transplant.hrsa.gov/news/continued-increase-in-organ-donation-drives-new-records-in-2023-new-milestones-exceeded/#:~:text=A%20total%20of%2016%2C335%20individuals,in%20deceased%20organ%20donors%20nationwide. Organ Procurement and Transplantation Network. (2025). Learn how organ allocation works. Retrieved January 3, 2025, from https://optn.transplant.hrsa.gov/patients/about-transplantation/how-organ-allocation-works/. Paola, F. A. (2015, June). Of professionals and potted plants: The case of Marlise Muñoz. The Journal of Physician Assistant Education, 26 (2), 106-108. https://doi.org/10.1097/JPA.0000000000000023. Saidi, R. F., & Hejazii Kenari, S. K. (2014, August 1). Challenges of organ shortage for transplantation: Solutions and opportunities. International Journal of Organ Transplantation Medicine. Retrieved December 30, 2024, from https://pmc.ncbi.nlm.nih.gov/articles/PMC4149736/. Suddaby, E. C., Schaeffer, M. J., Brigham, L. E., & Shaver. (1998). Analysis of organ donors in the peripartum period. Journal of Transplant Coordination. Retrieved January 1, 2025, from https://pubmed.ncbi.nlm.nih.gov/9726218/. Supreme Court of the United States. (2022). Dobbs v. Jackson Women’s Health Organization. Retrieved January 3, 2025, from https://www.supremecourt.gov/opinions/21pdf/19-1392_6j37.pdf. USAFacts. (2023, September 27). Are fentanyl overdose deaths rising in the US? USAFacts. Retrieved January 6, 2025, from https://usafacts.org/articles/are-fentanyl-overdose-deaths-rising-in-the-us/. Warren, A., Kelly, S., Karus-McElvogue, A., & Burnstein, R. (2020, April). Brain death in early pregnancy: A legal and ethical challenge coming to your intensive care unit? Journal of the Intensive Care Society. Retrieved May 30, 2024, from https://pmc.ncbi.nlm.nih.gov/articles/PMC8373278/. Additional Declarations The authors declare no competing interests. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6759566","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":462588171,"identity":"4d04ae2b-9c24-40af-8e12-3d6912244309","order_by":0,"name":"Alexandra Perry","email":"","orcid":"","institution":"Mercer University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Alexandra","middleName":"","lastName":"Perry","suffix":""},{"id":462588172,"identity":"e80a6dd0-9b54-4c6d-aef6-33738fedc28c","order_by":1,"name":"Jace DeGarmo","email":"data:image/png;base64,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","orcid":"","institution":"Mercer University School of Medicine","correspondingAuthor":true,"prefix":"","firstName":"Jace","middleName":"","lastName":"DeGarmo","suffix":""},{"id":462588173,"identity":"d2b48ce0-ffdf-48a1-b2ac-40290ad79e65","order_by":2,"name":"Kimberly Zaruca","email":"","orcid":"","institution":"We Are Sharing Hope South Carolina","correspondingAuthor":false,"prefix":"","firstName":"Kimberly","middleName":"","lastName":"Zaruca","suffix":""},{"id":462588174,"identity":"118d6a12-72a7-4f65-b722-e6fb4a0b2896","order_by":3,"name":"Brian Childs","email":"","orcid":"","institution":"Mercer University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Brian","middleName":"","lastName":"Childs","suffix":""}],"badges":[],"createdAt":"2025-05-27 12:45:07","currentVersionCode":1,"declarations":{"humanSubjects":false,"vertebrateSubjects":false,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":false,"humanSubjectConsent":false,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-6759566/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6759566/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":83567610,"identity":"ed0b134f-409a-4627-bf15-f7604d47bd5a","added_by":"auto","created_at":"2025-05-28 15:28:01","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":408144,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6759566/v1/869b5abe-8bdc-4813-8f79-52544cd1059b.pdf"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003e\u003cstrong\u003eOrgan Donor Dilemmas: Pregnancy, Policy and Practical Implications\u003c/strong\u003e\u003c/p\u003e","fulltext":[{"header":"Introduction","content":"\u003cp\u003e17 people die every day while waiting for an organ, making it crucial that Organ Procurement Organizations (OPOs) perform due diligence on every potential organ donor, especially those who made clear their wish to donate under first person authorization (FPA). Research regarding organ donors who are pregnant at the time of death is extremely limited. OPO responses to these donors is not widely understood, particularly in states with restrictive abortion laws post \u003cem\u003eDobbs v. Jackson Women's Health Organization (2022)\u003c/em\u003e.\u003c/p\u003e \u003cp\u003eDonors determined dead by neurological criteria who are pregnant are a unique population of concern because despite the neurological death, the same somatic tissue support used to perfuse the organs for donation can also be used to support a growing fetus. Articles citing a retrospective review of 252 brain-dead patients, estimate the incidence of pregnancy among this population at 2.8% (Esmaeilzadeh et al., 2010; Suddaby et al., 1998). Pregnancy testing is routinely performed on women of childbearing age upon admission to the hospital, leading to many ICU patients, and subsequently patients who are later declared brain-dead, having a known pregnancy status. However, pregnancy in brain death is likely under-reported, due to age ranges considered \u0026ldquo;child bearing age\u0026rdquo; varying across institutions, trauma cases that don\u0026rsquo;t allow time for pregnancy screening, and/or cases in which patients arrive and are promptly determined to be brain-dead. According to the Organ Procurement Transplantation Network (OPTN), there was a 9.6% increase in overall deceased organ donors, reflecting a 13 year upward trend (2024). 80\u0026ndash;90% of organs from this increasing number of deceased donors come from donors who are declared brain-dead (Girlanda, 2016). The incidence of pregnancy in brain death is presumably growing, due to an increasing number of drug overdoses in women of child-bearing age (USAFacts, 2023). This paper focused on brain dead pregnant adult donors as the source for organ procurement.\u003c/p\u003e \u003cp\u003eThe advancements of medicine have ultimately led to better prognosis of many chronic diseases, leading to increasing numbers of patients living with end-stage organ failure that can now greatly benefit from an organ transplant (Saidi and Hejazii Kenari, 2014). The increased demand, and scarcity of organ supply, puts immense pressure on OPOs to maximize potential donations. The OPO tier system set forth by the Centers for Medicare and Medicaid Services (CMS) Final Rule issued in 2020 drastically intensifies the pressure on OPOs to increase donation rates (CMS Newsroom, 2020; 42 CFR Part 486, 2020). Through these guidelines, OPOs with the lowest donation and transplantation rates will be decertified and their DSAs will open for takeover by competing OPOs with higher rates. Consequences for low outcome measures compels OPOs to optimize donation from all attainable donor pools.\u003c/p\u003e \u003cp\u003eIn contrast, OPOs may feel influenced to approach the potential pool of brain dead but pregnant donors more cautiously due to abortion laws. As of June 2022, individual state laws determine how far along in pregnancy an abortion may be sought. The Supreme Court\u0026rsquo;s \u003cem\u003eDobbs v. Jackson Women's Health Organization\u003c/em\u003e ruling reversed federal abortion protections, in effect permitting each state to determine the legality of abortions (2022). After this decision, many states enacted new legislation to protect or limit abortion or relied on laws already in place that became active after the ruling. At the time of the study in May of 2024, the following 21 states were considered \u0026ldquo;restricted\u0026rdquo; states: Texas, Tennessee, Oklahoma, Missouri, Arkansas, Louisiana, Mississippi, Kentucky, Indiana, Alabama, Idaho, North Dakota, South Dakota, West Virginia, Georgia, South Carolina, Florida, North Carolina, Utah, Nebraska, and Arizona. In this study the term \u0026ldquo;restricted\u0026rdquo; refers to states that have made it illegal to abort the fetus prior to 18 weeks of gestation. These laws potentially impact the 29 OPOs with DSAs in those states. General exemptions to these laws include imminent danger to maternal life, and in some states, cases of rape, incest, or significant fetal abnormalities. The term \u0026ldquo;non-restricted\u0026rdquo; refers to states that have legislation outlawing abortion at some point after 18 gestational weeks or that protects access to abortion with no gestational limits. None of these statewide laws on abortion explicitly address organ donors who are pregnant and they do not provide any guidance for OPOs faced with pregnant (or potentially pregnant) donors.\u003c/p\u003e \u003cp\u003eOperating room protocols for organ procurement from brain dead donors include maintenance of blood pressure and perfusion to the organs until they are ready to be removed (Ghio and Paramesh, 2023). After dissection, the aorta is clamped and ventilation is discontinued. At this point, the maternal somatic tissue support is ended via direct surgical intervention, rather than being withdrawn. This intervention is not done with the goal of terminating the pregnancy, though that would be the end result. That might leave OPOs in unclear legal territory depending on the applicable state abortion laws.\u003c/p\u003e \u003cp\u003eIn light of an ambiguous and fluctuating legal landscape, with no legal precedent, OPOs also face a conflicting pressure to act conservatively when faced with potential donors who are pregnant. This may mean OPOs walking away from potential donors when they are pregnant because it is unclear whether or not procedures related to organ procurement will be seen as an abortion. The pressure to maximize donations for the sake of a growing waiting list, coupled with the antithetical pressure to act conservatively from a legal standpoint, leaves OPOs with a need for more information so that they can build policy that serves the mission of OPOs while protecting them from legal repercussions.\u003c/p\u003e \u003cp\u003eThe purpose of this study is to further understand the ways this fluctuating legal landscape impacts OPOs\u0026rsquo; policy and response to deceased and potentially pregnant organ donors. We hope to provide OPOs with increased transparency regarding how other OPOs are currently responding to cases of pregnant donors, and how state abortion laws are impacting this. By surveying OPOs serving jurisdictions with varied abortion laws, we hope to add to the collective knowledge base about the OPO community response at large, and give individual OPOs the information they need to build their own policy. Pregnancy in brain dead patients brings up many challenges and points of inquiry, however, the scope of this study focuses on OPO response to pregnant donors.\u003c/p\u003e"},{"header":"Literature Review","content":"\u003cp\u003eRelevant theories and concepts:\u003c/p\u003e\n\u003cp\u003eOrgan donation from brain dead individuals who are pregnant is both medically and ethically complex due to the competing interests of the donor, recipient, fetus, and state laws. Drs. Kantor and Hoskins published an article describing three ethical models through which such cases can be viewed (1993).\u003c/p\u003e\n\u003cp\u003eOrgan Donation Model:\u003c/p\u003e\n\u003cp\u003eThe Organ Donation Model prioritizes the donor\u0026rsquo;s intent to donate and the saving of lives of potential recipients (Kantor \u0026amp; Hoskins, 1993).\u003csup\u003e11\u0026nbsp;\u003c/sup\u003e Kantor and Hoskins apply the principles of organ donation to these scenarios with the fetus serving as the recipient.Maternal somatic support on behalf of the fetus can be viewed similarly to the somatic organ support commonly applied to the donor in order to maintain perfusion of the organs for donation .\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn 2018, a Portuguese woman died while 19 weeks pregnant \u003cem\u003e(\u003c/em\u003eBBC News, 2019). The pregnancy was viable, and the hospital\u0026rsquo;s ethics committee decided to continue prolonged somatic tissue support, resulting in successful delivery at 32 weeks. The ethics committee used the mother\u0026rsquo;s status as an organ donor as rational to support this decision, arguing that \u0026ldquo;she would not object to ongoing treatment in a brain-dead state in order to preserve life\u0026rdquo; (BBC News, 2019). Organ procurement from brain-dead individuals for donation is often preceded by a brief period of somatic tissue support in order to preserve organs and avoid ischemia. In this sense, FPA for donation means agreeing to serve as an incubator in order to prolong the life of another. However, the burden of somatic tissue support varies drastically between support for organs prior to procurement and support for a fetus throughout its gestation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eA major theme for this model is the concept of autonomy and considering the wishes of the deceased in the decision making process (Kantor \u0026amp; Hoskins, 1993).In the United States, the decision to donate organs is governed by the Uniform Anatomical Gift Act, which gives individuals the right to donate anatomical parts after death, and prohibits this gift from being revoked after death (Organ Donation and Transplantation Alliance, 2021). FPA is a highly venerated concept in the OPO and transplant community and is underscored by the 2010 resolution by the National Association of Attorney General that states \u0026ldquo;obligation of all participants in the donation process - hospitals, doctors, procurement organizations, and family members - to comply with the law and to honor, and implement the decision of the donor\u0026rdquo; (National Association of Attorneys General, 2024).\u003c/p\u003e\n\u003cp\u003eThrough the lens of the Organ Donation Model, personal autonomy is key to the decision making process. This model would advocate that maternal somatic support of the fetus is not compulsory, and decisions would be made based on perceived or actual maternal wishes (Kantor \u0026amp; Hoskins, 1993). However, maternal wishes regarding the unique situation of prolonged somatic tissue support for a fetus is often unknown, it is difficult to apply concepts of organ donation directly. Prolonging or preventing donation after death in an attempt to bring the fetus to term can be seen as opposed to this obligation to implement decisions made by the donor, as they were understood by the donor. Furthermore, organs are allocated in the United States to those on the waitlist based on strict principles of justice and medical utility (\u003cem\u003eLearn How Organ Allocation Works\u003c/em\u003e, n.d.). The extension of a woman\u0026rsquo;s decision to donate organs to include authorization for medical interventions throughout gestation could be seen as an appropriation of the processes in place.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIncubator Model\u003c/p\u003e\n\u003cp\u003eThe second ethical model for consideration is the Incubator Model, which suggests the decedent no longer has rights and therefore welfare of the fetus takes priority (Kantor \u0026amp; Hoskins, 1993).The deceased mother is comparable to a vessel that supports the growing fetus. As a vessel, the deceased woman\u0026rsquo;s values and wishes prior to death would become irrelevant. This model provides rationale in support of the American Academy of Neurology\u0026rsquo;s 2023 recommendation that decisions to provide organ support to a deceased, pregnant donor should focus on the welfare of the fetus, rather than perceived or actual maternal wishes (Greer et al., 2023). In the United States\u0026rsquo; and many other places, social and legal principles ensure a deceased person\u0026rsquo;s wishes are considered posthumously with regards to the physical disposal of the body, as well as the dispensation of the decedent\u0026rsquo;s property. With this in mind, Kantor and Hoskins point out that this model is \u0026ldquo;inconsistent with our beliefs about our obligations to the dead\u0026rdquo; (1993).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOrdinary Pregnancy Model\u003c/p\u003e\n\u003cp\u003eThe Ordinary Pregnancy Model, as described by Kantor and Hoskins, gives the brain dead and pregnant person the same rights and interests as a living and pregnant person (Kantor \u0026amp; Hoskins, 1993). Whereas first person authorization is important for the Organ Donation Model, formal consent is important for the Ordinary Pregnancy Model. Consent considers risks and benefits to the patient, and recognizes \u0026ldquo;the woman\u0026rsquo;s right to self-determination\u0026rdquo;, including the right to refuse medical interventions (Kantor and Hoskins, 1993).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThough these ethical models were published in 1993, Kantor and Hoskins acknowledged the potential overturning of \u003cem\u003eRoe v. Wade\u003c/em\u003e, and the implications that would have for The Ordinary Pregnancy Model. \u0026nbsp;After the Supreme Court\u0026apos;s decision in \u003cem\u003eDobbs v. Jackson Women\u0026apos;s Health Organization\u003c/em\u003e, there are now varied self-determination rights for pregnant individuals under state law (2022). At the start of this study, there were 21 states with legalized restrictions on abortions. Pregnant women have different rights and differing levels of bodily autonomy depending on what state she is in, and what the state abortion laws are. Through the lens of the Ordinary Pregnancy Model, a pregnant and deceased person who wished to become an organ donor would also have different options depending on the state she was in. For example, in a total-ban state, the decedent\u0026rsquo;s care team may be required to maintain maternal somatic support to attempt full gestation, regardless of what the surrogate decision maker believes the deceased would have wanted. In a state with no abortion restrictions, the decedent\u0026rsquo;s family would have the option to continue the pregnancy or terminate and proceed directly with organ donation, if organ donation is a goal.\u003c/p\u003e\n\u003cp\u003eThe Ordinary Pregnancy Model asserts that the woman\u0026rsquo;s wishes must be determined before secondarily considering the \u0026ldquo;presumptive or actual interests of the fetus\u0026rdquo; (Kantor \u0026amp; Hoskins, 1993). In the current legal climate, the interests of the state must be considered first and the extent of the woman\u0026rsquo;s right to self-determination must be determined. The patient\u0026rsquo;s wishes and then the fetal interests can be considered to the capacity possible under state law.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePrevious Studies\u003c/p\u003e\n\u003cp\u003eA 2010 systematic study conducted by researchers at the university of Heidelberg reviewed 30 cases of brain dead pregnant patients occurring between 1982 and 2010 from around the world (Suddaby et al., 1998). Of the 19 case studies that were analyzed, 12 cases resulted in delivery of viable infants after prolonged maternal somatic support. This support was initiated at about 22 weeks gestation with an average duration of 38.3 days. Of the 12 newborns delivered, 4 were diagnosed with IRDS (now NRDS), 1 was diagnosed with fungemia, and 1 newborn had a premature birth complication, contracted Candida infection and died within 30 days of birth. The other 6 newborns were healthy upon birth and survived the neonatal period.\u003c/p\u003e\n\u003cp\u003eOf the 19 cases, 5 resulted in organ procurement. 3 of these cases occurred after successful delivery and 2 after intrauterine demise. This study highlighted the challenges faced by medical teams to maintain the mother\u0026rsquo;s health to support the fetus. Such challenges include managing infections, cardiovascular instability, and hormonal imbalances while supporting fetal viability.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAlthough challenging, it is possible to provide somatic support in order to have both the delivery of a viable fetus \u003cem\u003eand\u0026nbsp;\u003c/em\u003eprocurement of organs for donation. In 1997, a case report was published of a 20 year old, 25 week pregnant woman who was declared brain dead after experiencing an intraventricular and subarachnoid hemorrhage of unknown etiology (Lewis and Vidovich, 1997). The decedent\u0026rsquo;s next of kin opted to maintain the somatic support until the fetus could be delivered when viable, and organs were to be donated thereafter. 54 days later, after an amniocentesis confirmed sufficient fetal-lung maturity, the baby was delivered at 31 weeks gestation. Immediately following the cesarean section, the heart, liver, pancreas and both kidneys were recovered and matched with 4 recipients. A follow up one year later revealed that the recipients were doing well and had no significant complications.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThroughout the case, the OPO made clear efforts to avoid interfering with the primary interest of delivering a viable baby. The OPO only approached the next of kin to discuss donation after the decision had been made to maintain the pregnancy and then served in a consultation role to the critical care team until after the delivery. The OPO also arranged for the organ procurement teams to enter the operating room after the cesarean section was complete to avoid any potential for conflict of interest (Lewis and Vidovich, 1997).\u003c/p\u003e\n\u003cp\u003eWith somatic support having the ability to sustain the life of a fetus not yet developed enough to survive delivery, organs can similarly remain supported until the baby has been delivered and transplantation can proceed. In addition, the prolonged somatic support does not seem to diminish the quality of the organ for transplantation, in this case. Because of the OPO\u0026rsquo;s willingness to pursue donation after delivery, 4 individuals received life saving organs. This case emphasizes the importance of not overlooking these unique potential donors.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAt the opposing intersection of medical ethics and the law, one would find the Marlise Mu\u0026ntilde;oz case. On November 26, 2013, Marlise Mu\u0026ntilde;oz was 14 weeks pregnant when she was found unconscious by her husband after a suspected pulmonary embolism and was declared brain dead two days later (Humphrey, 2015).\u003csup\u003e18\u003c/sup\u003e Mrs. Mu\u0026ntilde;oz was a paramedic with medical training and had discussed her wish to not be kept on life support with multiple family members, if the need should ever arise. Despite notification of her wishes from her next-of-kin, John Peter Smith Hospital refused to remove the life-sustaining measures, citing Section 166.049 of Texas Health and Safety Code as the basis for their refusal (Humphrey, 2015). According to Section 166.049, life-sustaining treatment is not allowed to be removed from pregnant patients. Ultimately, the courts upheld Mr. Mu\u0026ntilde;oz\u0026rsquo;s argument that since his wife had been declared dead the obligation to not remove \u0026ldquo;life-sustaining\u0026rdquo; measures did not apply. The ruling also stated that the hospital had misunderstood the legal context they cited. The life-sustaining equipment was removed on January 26, 2014 and the gestation had reached 22 weeks.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThis case raises consequential concerns for the meaning of bodily autonomy post-brain death, and is still applicable today in a post-\u003cem\u003eDobbs\u003c/em\u003e world. It highlights the legal and ethical struggles to balance a woman\u0026rsquo;s wishes for her body post mortem versus the welfare of the fetus, when the two are in conflict. Assessing this case in today\u0026rsquo;s legal landscape after the \u003cem\u003eDobbs\u003c/em\u003e decision suggests that the courts in some states might have ruled in favor of the hospital keeping Mu\u0026ntilde;oz on life-sustaining measures for the benefit of the fetus and in direct contradiction of her own wishes. While the argument was upheld that life-sustaining measures do not apply to a deceased body, the ruling disregards that life-sustaining measures would indeed sustain the life of the fetus (Paola, 2015). The crux of the conflict is that life-sustaining measures, in the case ofMu\u0026ntilde;oz\u003cem\u003e,\u003c/em\u003e do not sustain her life; however, these life-sustaining measures do sustain the life of the fetus. This distinction highlights the result that forcing life-sustaining measures on a deceased person inherently transforms them into an incubator, in some cases directly against their expressed wishes.\u0026nbsp;\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eStudy Design\u003c/p\u003e\n\u003cp\u003eIn a qualitative study, found to be exempt by the Mercer University IRB, OPOs covering abortion restricted states and non-restricted states were invited to participate in a confidential survey regarding management of potentially pregnant and deceased organ donors. The surveys were conducted by researchers at Mercer University School of Medicine, in collaboration with The Carlos and Marguerite Mason Center for Organ Donation and Transplant Education and Policy and We Are Sharing Hope South Carolina (SHSC), an OPO.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSurvey\u003c/p\u003e\n\u003cp\u003eThe survey included four main sections and 21 questions inquiring about jurisdiction and OPO demographics, OPO\u0026rsquo;s process for handling pregnant and deceased donors, communications with external parties, and relevant laws and policies at the state and OPO level. The surveys were made anonymous with the exception of the level of abortion restriction for the OPO\u0026rsquo;s donor service area (DSA).\u003c/p\u003e\n\u003cp\u003eParticipant Selection:\u003c/p\u003e\n\u003cp\u003eOut of the 29 OPOs with a DSA including restricted states, 25 had contact information available to researchers. Representatives from these 25 OPOs were selected for invitation to participate. An IRB amendment expanded the scope to allow for the inclusion of OPOs covering non-restricted jurisdictions to serve as a comparison point. Following this amendment, 2 additional OPOs from non-restricted states were selected for invitation to participate.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eRepresentatives from each OPO were selected for participation from within a national OPO networking program. Representatives were considered \u0026ldquo;key OPO personnel\u0026rdquo;, with roles such as Chief Donation Officer, Hospital Program Coordinator, Hospital Services Manager, Chief Operating Officer and similar positions that would allow for the depth of knowledge and authority to answer survey questions. Key OPO personnel were sent introductory emails from a member of the national OPO networking program to inform them of the purpose of the study and of the upcoming invitation to participate. Following introduction, researchers formally invited personnel to participate and survey questions were distributed for consideration after the OPO agreed to participate.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eData Collection\u003c/p\u003e\n\u003cp\u003eParticipants were initially invited to schedule a virtual interview with researchers to conduct the survey. Due to participant time constraints, and the information gathering required by many of the questions, an IRB amendment allowed participants the additional choice of completing surveys via fillable pdf. OPOs were asked to return completed questionnaires within two weeks of receipt, though more time was given as needed. Up to three follow up attempts were communicated for potential participants.\u003c/p\u003e\n\u003cp\u003eData Analysis and Privacy\u003c/p\u003e\n\u003cp\u003eAll identifying information was removed from survey responses with the exception of the level of abortion restriction of the responding OPO\u0026rsquo;s DSA. Survey responses were compiled onto a master survey that listed all answers for each question. Responses were analyzed qualitatively by theme and by theme recurrence rates.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFindings\u003c/p\u003e\n\u003cp\u003eParticipation and response rates are reflected in Table 1.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 1. OPO participation data\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 316px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTotal OPOs invited to participate\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 306px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e25 restricted\u003c/strong\u003e and \u003cstrong\u003e2 non-restricted\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 316px;\"\u003e\n \u003cp\u003eNo response\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 306px;\"\u003e\n \u003cp\u003e8\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 316px;\"\u003e\n \u003cp\u003eLost to follow-up after initial interest\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 306px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 316px;\"\u003e\n \u003cp\u003eDeclined to participate outright\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 306px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 316px;\"\u003e\n \u003cp\u003eRescinded participation after receiving survey\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 306px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 316px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCompleted survey\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 306px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e6 (5 restricted, 1 non-restricted)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eThe survey responses from the 5 restricted OPOs highlighted 5 major themes for consideration: data tracking, pregnancy testing, existing policy, current practice, and lack of response. 4 OPOs responded that they do not track the number or occurrences of pregnant donors. 3 OPOs rely on the hospital to pregnancy test the donors while 2 OPOs complete pregnancy tests on the donors, although they have different age ranges for which this is a requirement. One OPO reported that they test all female donors younger than 55 years old and the other OPO tests all female donors between the ages of 9 to 55 years old.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAt the time of data collection, none of the 5 restricted OPOs had an official policy for handling organ donors who were pregnant. As for current practice, 2 OPOs stated they handle pregnant donors on a case by case basis. 2 OPOs stated that a path for donation opens after the fetus was delivered or there was a fetal cardiac time of death. 1 OPO responded they were unsure how they would approach a pregnant donor.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBetween the 5 OPOs, there were 4 specific cases disclosed of a pregnant organ donor case. Of these 4 cases, donation was sought after it was determined that there had been intrauterine demise in 3 of the cases. In 1 case organ donation was sought after delivery of a live newborn. No data was reported on the success of the donation attempts.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAlthough the surveys were distributed once the OPO agreed to participate and they had several weeks to work with their team to gather the information, a large number of the survey questions were answered with \u0026ldquo;unsure\u0026rdquo; or \u0026ldquo;unknown\u0026rdquo;.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn comparison, the OPO covering a non-restrictive DSA reported that they had 0 known pregnant organ donors in the past 3 years, but had 3 in the past 15 years. Out of the 3 pregnant donors, 2 moved forward with donation, and, 1 did not because they were found to be unsuitable. The OPO pregnancy tests all female donors between the ages of 9 years- 55 years old. They have a specific official policy to address donors who test positive for pregnancy: the family and care team, with appropriate consultations, make a decision for the outcome of the fetus irrespective of donation. Once the fetus has been delivered or the decision has been made to terminate the pregnancy, organ donation can proceed.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eInterpretation of results\u003c/p\u003e \u003cp\u003eThough limited in responses, there is a clear distinction in level of transparency and certainty between restricted OPOs and non-restricted OPOs. The non-restricted OPO was the only responding OPO with an existing policy regarding pregnant organ donors. Their response was transparent and straightforward. Decisions regarding the fetus are made irrespective of donation and without OPO input. Thus, the possibility of organ donation has no effect on the management of a pregnant and deceased organ donor in such cases. A similar approach could be taken in restricted states, with limitations to the decisions regarding the fetus. These limitations will primarily affect the care team and family of the patient(s) rather than the decisions made by the OPO.\u003c/p\u003e \u003cp\u003e Based on current guidelines, there are valid legal arguments that procurement of organs from a donor with a viable fetus can be seen as an abortion in the eyes of the law. In response to this legal landscape, there are three routes OPOs could take when drafting pregnant donor policy. The first option is the Avoidant Option. OPOs may decide not to pregnancy test potential donors and proceed without the knowledge of whether or not the donor is pregnant. If a brain dead individual is not known to be pregnant, ceasing somatic tissue support, and/or the procedures required for organ donation will unlikely result in prosecution. Many hospitals perform pregnancy tests on patients believed capable of becoming pregnant in the ICU as standard procedure, making this option impractical. Additionally, survey results show that many OPOs already rely on hospital pregnancy tests for this information.\u003c/p\u003e \u003cp\u003eThe second option is the Conservative Option. OPOs could choose to ensure pregnancy tests are performed on all potential donors of child-bearing age and sex, and subsequently disengage from all cases involving pregnant donors. This would be a cautious choice for OPOs legally and a cautious choice for media coverage as well. However, this route means walking away from viable organs, contributing to the number of individuals who are dying while waiting for an organ transplant, and potentially decreasing donation and transplant rates and threatening the OPO\u0026rsquo;s tier position. This also means ignoring the donors\u0026rsquo; and/or families\u0026rsquo; wishes to donate. First person authorization is legally binding and a highly respected concept in the transplant community. It is vital to the preservation of public trust in the donation process.\u003c/p\u003e \u003cp\u003eThe third option is the Sequential Option. Restricted OPOs could adopt a protocol where donation is considered only after the fetus is delivered or has reached intrauterine demise. This is similar to the protocol put in place by the responding non-restricted state, with the caveat that decisions regarding the fetus are more limited based on the level of abortion restrictions. Nonetheless, the OPO would not be involved in the decisions regarding the fetus, and this would only impact the events preceding OPO involvement. This echoes the current practice of some responding restricted OPOs, though it is not an official policy.\u003c/p\u003e \u003cp\u003eUsing option three, a restricted state could essentially follow the same protocol as the non-restricted state, with the exception that decisions made regarding the fetus by the family and care team may not include the choice to terminate a viable pregnancy. OPOs using this option should seek consultations from Ob-Gyn. These consults can evaluate the gestational age of the fetus, viability of the pregnancy, and monitor for fetal demise and cardiac activity. If the fetus is delivered, reaches cardiac time of death, or if consulting physicians deem the fetus no-longer viable, the restricted OPO could then move forward with organ procurement from the brain-dead patient. Following these steps, organ procurement can proceed without breaking restrictive abortion laws, and without stepping outside the bounds of the recommendation from the American Academy of Neurologists regarding pregnancy in brain-dead patients, which recommends that decisions to provide organ support to a deceased, pregnant, potential donor, should focus on the viability and welfare of the fetus (Greer et al., 2023).\u003c/p\u003e \u003cp\u003eLimitations\u003c/p\u003e \u003cp\u003eThe low response rate was a considerable limitation of this study. The OPOs who declined to participate were asked to provide their reasoning for doing so. Specific reasons that OPO personnel gave for opting out included that they were \u0026ldquo;uncomfortable\u0026rdquo; providing answers, they \u0026ldquo;have not experienced pregnant donors\u0026rdquo;, and multiple OPOs declined \u0026ldquo;per executive leadership\u0026rdquo; decision. Several OPOs stated they do not track, and therefore do not know how many or even if they have encountered pregnant donors. This lack of data positions them to be unable to participate in the study, according to the personnel.\u003c/p\u003e \u003cp\u003e Another obstacle OPOs encountered was specific guidelines for their participation in outside research. Several OPO personnel had to request the ability to participate in this study. Each attempt was reportedly denied and further explanation as to why the request was denied was not provided.\u003c/p\u003e \u003cp\u003eWith OPOs being under considerable pressure to maximize donations while remaining conservative in an unclear legal landscape there are additional speculations on factors for lack of engagement. Possible factors impeding OPOs willingness or ability to participate in this study include the absence of case law applicable to the \u003cem\u003eDobbs v. Jackson Women's Health Organization\u003c/em\u003e in regards to organ donation (2022). Without clearer legal proceedings, OPOs are uncertain how utilizing organs from a pregnant donor will be viewed in the eyes of the law. This lack of information understandably reinforces OPOs\u0026rsquo; risk adverse nature.\u003c/p\u003e \u003cp\u003eAn additional factor was the OPO personnel time constraints. With an unpredictable daily schedule it was incredibly difficult to schedule a time to talk with the OPOs. Even with an IRB amendment granted to accept asynchronous surveys, it was reported many times that the personnel had difficulty finding time to complete the survey. Several OPOs requested time extensions to submit the surveys.\u003c/p\u003e \u003cp\u003eA final proposed obstacle is the risk adverse nature of OPOs. As stated previously, OPOs are under immense pressure to comply with strict regulations to maintain their accreditation and funding. Inefficiencies are compared against other OPOs regarding successful transplantations and threaten a low tier ranking (42 CFR Part 486, 2020). The recent House and Senate investigations result in concern for the future of underperforming OPOs (\u003cem\u003eData on U.S. Organ Procurement Organizations\u003c/em\u003e, 2022). Because of their close work with families during organ and tissue procurement, they are often responsible for maintaining public trust in the donation process. Negative media coverage can endanger their public image as well as reduce donation rates. These factors coalesce into a tentative nature of OPOs in which studies conducted by researchers outside of their organizations are met with caution and strict protocols for their participation.\u003c/p\u003e \u003cp\u003eContributions to the Field\u003c/p\u003e \u003cp\u003eThe actual number of pregnant potential organ donors has proved difficult to pinpoint thus far. However, it is clear that the cases will continue to grow in number, as will the demand for donated organs (Warren et al., 2020). By our estimate, most OPOs have no policy regarding this issue in this untested legal environment. Lack of OPO participation in this study was not due to a lack of interest. OPO personnel asserted interest in learning the results of the study, even when they opted out of participating themselves. Through learning the results of this study, and gaining a more comprehensive understanding of the ways abortion laws impact donation from pregnant donors, OPOs will have a stronger foundation from which to build clear, proactive policies to address such cases.\u003c/p\u003e \u003cp\u003eThe mission of OPOs and the transplant community relies on public trust, which in turn relies on transparency and continuity of procedure. Continuity of procedure for OPOs is predominantly directed by the Uniform Anatomical Gift Act (UAGA), its purpose being standardization of the donation processes and building a foundation for public trust in donation (Glazier, 2018). With interests of the fetus competing with the sanctity of FPA, pregnant donors represent a gap in UAGA policy. Similarly, organ donors fall into a gap not explicitly covered by restrictive state abortion laws. In light of these gaps, and with public trust of organ donation processes at stake, OPOs must use the information available to them to create transparent policies that maintain the OPO and UAGA mission while respecting state law. Policy developed in response to this issue will have major implications for the future not only of medical ethics, but of donation and transplant ethics.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThere is an overall lack of clarity in regards to how OPOs are to handle such cases in a fluctuating legal landscape. OPOs in restrictive states experience pressures to maximize possible donations in order to maintain accreditation and ability to function within their DSA. Donors who are pregnant at the time of brain death are a potential source of viable organs to meet the unmet demand. However, the combination of the Supreme Court decision in \u003cem\u003eDobbs v. Jackson Women's Health Organization\u003c/em\u003e (2022) and the current pressures that OPOs are under regarding resource allocation had a significant impact on OPOs\u0026rsquo; willingness to create and discuss policies regarding pregnant donors.\u003c/p\u003e \u003cp\u003eBased on survey results, OPOs in restricted states do not have policy in place regarding this unique donor population. Many OPO personnel expressed keen interest in learning how other OPOs are handling such cases in order to inform their own policy even when they opted out of participating themselves.\u003c/p\u003e \u003cp\u003eA transparent and proactive policy regarding pregnant organ donors could mitigate potential legal issues and maintain public trust for beleaguered OPOs. Based on our findings, we recommend that OPOs create policy adhering to the Sequential Model. As discussed, under the Sequential Model, OPOs could pursue organ donation after the fetus is either delivered or intrauterine demise has occurred. The Sequential Model reflects the essence of the current practice of responding OPOs in restricted states. This model adheres to the most conservative interpretation of abortion law, respects the donors\u0026rsquo; intent to donate, and supports the OPO mission of maximizing donation rates in order to save as many lives as possible.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFunding Statement:\u0026nbsp;\u003c/strong\u003eThis work received no funding.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics Statement:\u003c/strong\u003e This work involves a qualitative survey or Organ Procurement Organizations. It does not include identifiable human data, and this study was found to be exempt by the Mercer University Institutional Review Board.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent to Participate:\u0026nbsp;\u003c/strong\u003eParticipation in surveys was voluntary and conducted under an IRB exemption from Mercer University. All participants provided informed consent.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent to Publish:\u0026nbsp;\u003c/strong\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contributions:\u0026nbsp;\u003c/strong\u003eJace DeGarmo and Alexandra Perry conceptualized the study, designed the survey, implemented the survey and wrote the manuscript. Kimberly Zaruca contributed to designing and implementing the survey. Brian Childs supervised study design and implementation. All authors approved the final manuscript.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCorresponding Author:\u0026nbsp;\u003c/strong\u003eJace DeGarmo; [email protected]\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eBBC News. (2019, March 29). Portugal baby born to woman brain dead for three months. \u003cem\u003eBBC News.\u003c/em\u003e Retrieved December 20, 2024, from https://www.bbc.com/news/world-europe-47741343.\u003c/li\u003e\n\u003cli\u003eCenters for Medicare \u0026amp; Medicaid Services. (2020). \u003cem\u003eOrgan Procurement Organization (OPO) conditions for coverage final rule: Revisions to outcome measures for OPOS CMS-3380-F.\u003c/em\u003e Retrieved January 3, 2025, from https://www.cms.gov/newsroom/fact-sheets/organ-procurement-organization-opo-conditions-coverage-final-rule-revisions-outcome-measures-opos.\u003c/li\u003e\n\u003cli\u003eEsmaeilzadeh, M., Dictus, C., Kayvanpour, E., et al. (2010, November 18). One life ends, another begins: Management of a brain-dead pregnant mother\u0026mdash;A systematic review. \u003cem\u003eBMC Medicine.\u003c/em\u003e Retrieved May 13, 2024, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3002294/#B2.\u003c/li\u003e\n\u003cli\u003eGhio, M., \u0026amp; Paramesh, A. S. (2023, May). Organ donation and OR protocols. Retrieved December 30, 2024, from https://www.ast.org/ceonline/articles/473/473.pdf.\u003c/li\u003e\n\u003cli\u003eGirlanda, R. (2016, September 24). Deceased organ donation for transplantation: Challenges and opportunities. \u003cem\u003eWorld Journal of Transplantation.\u003c/em\u003e Retrieved December 20, 2024, from https://pmc.ncbi.nlm.nih.gov/articles/PMC5036117/.\u003c/li\u003e\n\u003cli\u003eGlazier, A. (2018, August). Organ donation and the principles of gift law. \u003cem\u003eClinical Journal of the American Society of Nephrology.\u003c/em\u003e Retrieved January 3, 2025, from https://journals.lww.com/CJASN/pages/articleviewer.aspx?year=2018\u0026amp;issue=08000\u0026amp;article=00026\u0026amp;type=Fulltext.\u003c/li\u003e\n\u003cli\u003eGreer, D., Kirschen, M., Lewis, A., \u0026amp; Gronseth, G. (2023, October 11). Pediatric and adult brain death/death by neurologic criteria. \u003cem\u003eNeurology Journals.\u003c/em\u003e Retrieved May 30, 2024, from https://www.neurology.org/doi/10.1212/WNL.0000000000207740.\u003c/li\u003e\n\u003cli\u003eHumphrey, W. A. (2015). But I\u0026rsquo;m brain-dead and pregnant: Advance directive pregnancy exclusions and end-of-life wishes. \u003cem\u003eWilliam \u0026amp; Mary Journal of Race, Gender, and Social Justice, 21\u003c/em\u003e(4), 669.\u003c/li\u003e\n\u003cli\u003eKantor, J. E., \u0026amp; Hoskins, I. A. (1993). Brain death in pregnant women. \u003cem\u003eThe Journal of Clinical Ethics, 4\u003c/em\u003e(4), 308-314.\u003c/li\u003e\n\u003cli\u003eLewis, D. D., \u0026amp; Vidovich, R. R. (1997). Organ recovery following childbirth by a brain-dead mother: A case report. \u003cem\u003eJournal of Transplant Coordination, 7\u003c/em\u003e(3), 103-105. https://doi.org/10.7182/prtr.1.7.3.e47h65u1v846085u.\u003c/li\u003e\n\u003cli\u003eNational Association of Attorneys General. (2024, July 2). \u003cem\u003eResolution in support of respecting and upholding the decisions made by persons who elect to be organ, eye, and tissue donors.\u003c/em\u003e Retrieved December 30, 2024, from https://www.naag.org/.\u003c/li\u003e\n\u003cli\u003eOpodata.org. (2025). \u003cem\u003eData on U.S. Organ Procurement Organizations (OPO).\u003c/em\u003e Retrieved January 3, 2025, from https://www.opodata.org/#house-investigations.\u003c/li\u003e\n\u003cli\u003eOrgan Donation and Transplantation Alliance. (2021, September 20). \u003cem\u003eHonoring first-person authorization in donation after circulatory death, part 1: The legalities.\u003c/em\u003e Retrieved December 30, 2024, from https://www.organdonationalliance.org/insight/honoring-first-person-authorization-in-donation-after-circulatory-death-part-1-the-legalities/.\u003c/li\u003e\n\u003cli\u003eOrgan Procurement and Transplantation Network. (2023). \u003cem\u003eContinued increase in organ donation drives new records in 2023; new milestones exceeded.\u003c/em\u003e Retrieved December 20, 2024, from https://optn.transplant.hrsa.gov/news/continued-increase-in-organ-donation-drives-new-records-in-2023-new-milestones-exceeded/#:~:text=A%20total%20of%2016%2C335%20individuals,in%20deceased%20organ%20donors%20nationwide.\u003c/li\u003e\n\u003cli\u003eOrgan Procurement and Transplantation Network. (2025). \u003cem\u003eLearn how organ allocation works.\u003c/em\u003e Retrieved January 3, 2025, from https://optn.transplant.hrsa.gov/patients/about-transplantation/how-organ-allocation-works/.\u003c/li\u003e\n\u003cli\u003ePaola, F. A. (2015, June). Of professionals and potted plants: The case of Marlise Mu\u0026ntilde;oz. \u003cem\u003eThe Journal of Physician Assistant Education, 26\u003c/em\u003e(2), 106-108. https://doi.org/10.1097/JPA.0000000000000023.\u003c/li\u003e\n\u003cli\u003eSaidi, R. F., \u0026amp; Hejazii Kenari, S. K. (2014, August 1). Challenges of organ shortage for transplantation: Solutions and opportunities. \u003cem\u003eInternational Journal of Organ Transplantation Medicine.\u003c/em\u003e Retrieved December 30, 2024, from https://pmc.ncbi.nlm.nih.gov/articles/PMC4149736/.\u003c/li\u003e\n\u003cli\u003eSuddaby, E. C., Schaeffer, M. J., Brigham, L. E., \u0026amp; Shaver. (1998). Analysis of organ donors in the peripartum period. \u003cem\u003eJournal of Transplant Coordination.\u003c/em\u003e Retrieved January 1, 2025, from https://pubmed.ncbi.nlm.nih.gov/9726218/.\u003c/li\u003e\n\u003cli\u003eSupreme Court of the United States. (2022). \u003cem\u003eDobbs v. Jackson Women\u0026rsquo;s Health Organization.\u003c/em\u003e Retrieved January 3, 2025, from https://www.supremecourt.gov/opinions/21pdf/19-1392_6j37.pdf.\u003c/li\u003e\n\u003cli\u003eUSAFacts. (2023, September 27). Are fentanyl overdose deaths rising in the US? \u003cem\u003eUSAFacts.\u003c/em\u003e Retrieved January 6, 2025, from https://usafacts.org/articles/are-fentanyl-overdose-deaths-rising-in-the-us/.\u003c/li\u003e\n\u003cli\u003eWarren, A., Kelly, S., Karus-McElvogue, A., \u0026amp; Burnstein, R. (2020, April). Brain death in early pregnancy: A legal and ethical challenge coming to your intensive care unit? \u003cem\u003eJournal of the Intensive Care Society.\u003c/em\u003e Retrieved May 30, 2024, from https://pmc.ncbi.nlm.nih.gov/articles/PMC8373278/.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"Mercer University","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"pregnancy, organ donor, organ donation, abortion law, OPO","lastPublishedDoi":"10.21203/rs.3.rs-6759566/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6759566/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eResearch regarding organ donors who are pregnant at the time of death is extremely limited. Organ Procurement Organizations (OPO) responses to these donors is not widely understood, particularly in states with restrictive abortion laws post Dobbs decision of 2022.\u003c/p\u003e \u003cp\u003eIn an IRB exempt, qualitative study, we invited 25 OPOs from abortion restrictive states and 2 OPOs from non-restrictive states to participate in a confidential survey regarding management of potentially pregnant and deceased organ donors. The electronic survey inquired about jurisdiction and OPO demographics, OPO\u0026rsquo;s process for handling pregnant and deceased donors, communications with external parties, and relevant laws and policies at the state and OPO level.\u003c/p\u003e \u003cp\u003eWe received completed surveys from 5 OPOs in abortion restricted states, and one completed survey from an OPO in a non-restricted state. 4/5 restricted OPOs did not have data on the number of pregnant donors they have been presented with in the past three years. None of the restricted OPOs have an official policy in place to handle such cases. The non-restricted OPO shared their specific policy for management of pregnant donors, which includes ethics and medical consults. The OPO comes forward for donation only after a separate decision is made regarding the life of the fetus, irrespective of donation.\u003c/p\u003e \u003cp\u003eThe combination of the Dobbs decision and the current pressures that OPOs are under regarding resource allocation had a significant impact on OPOs\u0026rsquo; willingness to create and discuss policies regarding pregnant donors. Restrictive abortion laws have a chilling effect on OPOs even addressing the issue of organ procurement from potentially pregnant donors as evident in reasons cited for choosing not to participate, for example, stated discomfort with questions being asked and denial to participate per executive leadership. A transparent and proactive policy regarding pregnant organ donors could mitigate potential legal issues and overall discomfort for OPOs that are already under an exorbitant amount of pressure to save as many lives as possible, honor the deceased, and avoid legal repercussions.\u003c/p\u003e","manuscriptTitle":"Organ Donor Dilemmas: Pregnancy, Policy and Practical Implications","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-28 15:19:56","doi":"10.21203/rs.3.rs-6759566/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"27178222-84b8-4456-bd90-5c6f8698b2e2","owner":[],"postedDate":"May 28th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":49181940,"name":"Medical Ethics"}],"tags":[],"updatedAt":"2025-05-28T15:19:57+00:00","versionOfRecord":[],"versionCreatedAt":"2025-05-28 15:19:56","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6759566","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6759566","identity":"rs-6759566","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}