Considering Sex as a Variable at a Research University: Knowledge, Attitudes, and Practices.

Biomedical research has a history of excluding females as research subjects, which threatens rigor, reproducibility, and inclusivity. In 2016, to redress this bias, the U.S. National Institutes of Health (NIH) implemented a policy requiring the consideration of sex as a biological variable (SABV) in all studies involving vertebrate animals, including humans. Unless strongly justified, females and males must be included in all studies and results reported disaggregated by sex. Recent evidence indicates, however, that misunderstandings of the policy and other significant barriers impede its implementation. To shed light on those barriers at our home institution, we conducted a study funded by the Emory University Specialized Center of Research Excellence on Sex Differences (SCORE). In semistructured interviews of Emory principal investigators in the biological sciences, we noted their knowledge of what the policy entails and why it was implemented, their attitudes toward it, and the extent to which it has or has not changed their research practices. Although attitudes toward SABV were generally positive, most researchers face challenges with respect to its implementation. We suggest interventions that can be mounted at the level of home institutions, such as raising awareness of locally available core facilities, to help address these challenges. More training is needed on what the policy asks of researchers, how sex is defined, the nonhormonal ways that sex differences can manifest, and best practices for statistical analysis of sex-based data. Home institutions may also want to explore ways to lessen the stress associated with rollout of SABV policy.

Impossible "Choices": The Inherent Harms of Regulating Women's Testosterone in Sport.

In April 2018, the International Association of Athletics Federations (IAAF) released new regulations placing a ceiling on women athletes' natural testosterone levels to "ensure fair and meaningful competition." The regulations revise previous ones with the same intent. They require women with higher natural levels of testosterone and androgen sensitivity who compete in a set of "restricted" events to lower their testosterone levels to below a designated threshold. If they do not lower their testosterone, women may compete in the male category, in an intersex category, at the national level, or in unrestricted events. Women may also challenge the regulation, whether or not they have lowered their testosterone, or quit sport. Irrespective of IAAF's stated aims, the options forced by the new regulations are impossible choices. They violate dignity, threaten privacy, and mete out both suspicion and judgement on the sex and gender identity of the athletes regulated.

Ethical Controversy About Hysterectomy for a Minor.

One of the most complicated ethical issues that arises in children's hospitals today is the issue of whether it is ever permissible to perform a procedure for a minor that will result in permanent sterilization. In most cases, the answer is no. The availability of good, safe, long-acting contraception allows surgical options to be postponed when the primary goal of such surgical options is to prevent pregnancy. But what if a minor has congenital urogenital anomalies or other medical conditions for which the best treatment is a hysterectomy? In those cases, the primary goal of therapy is not to prevent pregnancy. Instead, sterility is an unfortunate side effect of a medically indicated treatment. Should that side effect preclude the provision of a therapy that is otherwise medically appropriate? We present a case that raises these issues, and asked experts in law, bioethics, community advocacy, and gynecology to respond. They discuss whether the best option is to proceed with the surgery or to cautiously delay making a decision to give the teenager more time to carefully consider all of the options.

Tracking U.S. Professional Athletes: The Ethics of Biometric Technologies.

Professional sport in the United States has widely adopted biometric technologies, dramatically expanding the monitoring of players' biodata. These technologies have the potential to prevent injuries, improve performance, and extend athletes' careers; they also risk compromising players' privacy and autonomy, the confidentiality of their data, and their careers. The use of these technologies in professional sport and the consumer sector remains largely unregulated and unexamined. We seek to provide guidance for their adoption by examining five areas of concern: (1) validity and interpretation of data; (2) increased surveillance and threats to privacy; (3) risks to confidentiality and concerns regarding data security; (4) conflicts of interest; and (5) coercion. Our analysis uses professional sport as a case study; however, these concerns extend to other domains where their use is expanding, including the consumer sector, collegiate and high school sport, the military, and commercial sectors where monitoring employees is viewed as useful for safety or to maximize labor potential.

Cris de Coeur and the Moral Imperative to Listen to and Learn from Intersex People.

Intersex people first began to publicly tell their stories in the 1990s. Twenty years on, these narratives, scorching in their candor, attest to a continuing failure to bear witness to or to acknowledge some of the most painful experiences we inflict on one another. More than anecdotes, these narratives provide a first-person reflection on care and thus represent a type of long-term follow-up that is largely absent in clinical literature. Out of respect for their courage, we owe these narratives serious consideration. Clinicians who must make daily decisions that may alter patients' lives may distance themselves from negative outcomes and stories like those told here to avoid professional regret. Honest self-appraisal and accepting regret open the door to feeling guilty, devalued and ashamed, but experiencing these emotions can be a crucial first step in changing clinical practice.

Quality of communication in interpreted versus noninterpreted PICU family meetings.

OBJECTIVES: To describe the quality of physician-family communication during interpreted and noninterpreted family meetings in the PICU. DESIGN: Prospective, exploratory, descriptive observational study of noninterpreted English family meetings and interpreted Spanish family meetings in the pediatric intensive care setting. SETTING: A single, university-based, tertiary children's hospital. SUBJECTS: Participants in PICU family meetings, including medical staff, family members, ancillary staff, and interpreters. INTERVENTIONS: Thirty family meetings (21 English and nine Spanish) were audio-recorded, transcribed, de-identified, and analyzed using the qualitative method of directed content analysis. MEASUREMENTS AND MAIN RESULTS: Quality of communication was analyzed in three ways: 1) presence of elements of shared decision-making, 2) balance between physician and family speech, and 3) complexity of physician speech. Of the 11 elements of shared decision-making, only four occurred in more than half of English meetings, and only three occurred in more than half of Spanish meetings. Physicians spoke for a mean of 20.7 minutes, while families spoke for 9.3 minutes during English meetings. During Spanish meetings, physicians spoke for a mean of 14.9 minutes versus just 3.7 minutes of family speech. Physician speech complexity received a mean grade level score of 8.2 in English meetings compared to 7.2 in Spanish meetings. CONCLUSIONS: The quality of physician-family communication during PICU family meetings is poor overall. Interpreted meetings had poorer communication quality as evidenced by fewer elements of shared decision-making and greater imbalance between physician and family speech. However, physician speech may be less complex during interpreted meetings. Our data suggest that physicians can improve communication in both interpreted and noninterpreted family meetings by increasing the use of elements of shared decision-making, improving the balance between physician and family speech, and decreasing the complexity of physician speech.

A content analysis of posthumous sperm procurement protocols with considerations for developing an institutional policy.

OBJECTIVE: To identify and analyze existing posthumous sperm procurement (PSP) protocols in order to outline central themes for institutions to consider when developing future policies. DESIGN: Qualitative content analysis. SETTING: Large academic institutions across the United States. PATIENT(S) N/A INTERVENTION(S): We performed a literature search and contacted 40 institutions to obtain nine full PSP protocols. We then performed a content analysis on these policies to identify major themes and factors to consider when developing a PSP protocol. MAIN OUTCOME MEASURE(S): Presence of a PSP policy. RESULT(S): We identified six components of a thorough PSP protocol: Standard of Evidence, Terms of Eligibility, Sperm Designee, Restrictions on Use in Reproduction, Logistics, and Contraindications. We also identified two different approaches to policy structure. In the Limited Role approach, institutions have stricter consent requirements and limit their involvement to the time of procurement. In the Family-Centered approach, substituted judgment is permitted but a mandatory wait period is enforced before sperm use in reproduction. CONCLUSION(S): Institutions seeking to implement a PSP protocol will benefit from considering the six major building blocks of a thorough protocol and where they would like to fall on the spectrum from a Limited Role to a Family-Centered approach.

Parental refusal of vaccination and transplantation listing decisions: a nationwide survey.

Many professional societies and research studies recommend complete vaccination before pediatric solid organ transplantation. Nevertheless, incompletely vaccinated children often receive transplants. As the number of parents refusing to vaccinate children for nonmedical reasons increases, pediatric transplantation programs face difficult listing decisions. Given the importance of psychosocial criteria in listing decisions, this study explores how parental refusal of vaccination affects those listing decisions. Surveys were emailed to individuals at 195 pediatric solid organ transplantation programs in the United States, with a 71% response rate. Forty-four respondents (39%) reported that their programs have had cases involving parental refusal of vaccination. In response to hypothetical scenarios, 93 respondents (82%) would list a child not vaccinated for medical reasons, whereas only 54 respondents (47%) would list a child whose parents refused vaccination. Only five respondents (4%) reported that their programs had written policies regarding parental refusal of vaccination. These data reveal inconsistencies across pediatric transplantation programs regarding how parental refusal of vaccination affects listing decisions and raise the issue of whether and how the reason for incomplete vaccination should be factored into listing decisions. We recommend further discussion and the development of written guidelines to unify programs' assessments of incompletely vaccinated pediatric transplantation candidates.

Health beliefs and practices in an isolated polygamist community of southern Utah.

Short Creek is a largely closed and isolated community on the border between Utah and Arizona, made up of the sister towns of Hildale, Utah, and Colorado City, Arizona. Beginning from childhood, the 6,000 or so members of the Fundamentalist Church of Jesus Christ of Latter-Day Saints (FLDS) are brought up in a lifestyle of plural marriage, meaning a marriage among one man and more than one woman, and are surrounded by their peers in "the covenant." A lifestyle of plural marriage is likely to affect the health of community members, but its effects have not been studied because of the community's isolation and distrust of outsiders. This paper addresses several questions that arise in contemplating the health of the Short Creek community: What are the health beliefs in this community, and what are their historical bases? Where do families seek medical care, and for what or at what threshold of illness or injury? What is the attitude of care providers serving this community, and how are the providers viewed by the community? More broadly, this paper examines the ways in which polygamy configures health. In order to meet this objective, this paper aims first to provide a brief account of this community's history and demographic profile, followed by a discussion of health care in this community and how it is affected by the practice of plural marriage, with the data comprised of qualitative interviews with health care providers to the community. The goals of this project are to gain a rich, historically nuanced understanding of the health of community members, and to identify directions for further academic and policy research. Our findings indicate that health in this community is shaped by limited resources, an attitude of health fatalism, and a profound insularity and corresponding isolation from the outside world.

Developing a multidisciplinary team for disorders of sex development: planning, implementation, and operation tools for care providers.

In the treatment of patients with disorders of sex development (DSD), multidisciplinary teams (MDTs) represent a new standard of care. While DSDs are too complex for care to be delivered effectively without specialized team management, these conditions are often considered to be too rare for their medical management to be a hospital priority. Many specialists involved in DSD care want to create a clinic or team, but there is no available guidance that bridges the gap between a group of like-minded DSD providers who want to improve care and the formation of a functional MDT. This is an important dilemma, and one with serious implications for the future of DSD care. If a network of multidisciplinary DSD teams is to be a reality, those directly involved in DSD care must be given the necessary program planning and team implementation tools. This paper offers a protocol and set of tools to meet this need. We present a 6-step process to team formation, and a sample set of tools that can be used to guide, develop, and evaluate a team throughout the course of its operation.

Out of bounds? A critique of the new policies on hyperandrogenism in elite female athletes.

In May 2011, more than a decade after the International Association of Athletics Federations (IAAF) and the International Olympic Committee (IOC) abandoned sex testing, they devised new policies in response to the IAAF's treatment of Caster Semenya, the South African runner whose sex was challenged because of her spectacular win and powerful physique that fueled an international frenzy questioning her sex and legitimacy to compete as female. These policies claim that atypically high levels of endogenous testosterone in women (caused by various medical conditions) create an unfair advantage and must be regulated. Against the backdrop of Semenya's case and the scientific and historical complexity of "gender verification" in elite sports, we question the new policies on three grounds: (1) the underlying scientific assumptions; (2) the policymaking process; and (3) the potential to achieve fairness for female athletes. We find the policies in each of these domains significantly flawed and therefore argue they should be withdrawn.