Navigating ethical and legal challenges in the HEALthy Brain and Child Development Study: Lessons learned from the ethics, law, policy working group.

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. The HBCD study has faced several ethical and legal challenges due to its goal of enrolling pregnant people (including those with substance use disorder) and their newborns. Challenges not fully anticipated at the outset emerged from the rapidly changing legal landscape around reproductive rights in the United States.

Primary Care Patients' and Staff's Perceptions of Self-Rooming as Alternative to Waiting Rooms.

Purpose: Most patients are escorted to exam rooms (escorted rooming) although patients directing themselves to their exam room (self-rooming) saves patient and staff time while increasing patient satisfaction. This study assesses patient and staff perceptions after pragmatic implementation of self-rooming.

Methods: In October-December 2020, we surveyed patients and staff in 25 primary care clinics after our institution expanded self-rooming from 4 specially built clinics during the COVID-19 pandemic.

Voices of Women With Lived Experience of Substance Use During Pregnancy: A Qualitative Study of Motivators and Barriers to Recruitment and Retention in Research.

Despite concerns about negative neurocognitive effects of in utero substance exposure on child and brain development, research in this area is limited. This study gathered perspectives of persons with lived experience of substance use (eg, alcohol, prescription and illicit opioids, and other illicit substances) during a previous pregnancy to determine facilitators and barriers to research engagement in this vulnerable population. We conducted structured, in-depth, individual interviews and 2 focus groups of adult persons with lived experience of substance use during a previous pregnancy.

Prenatal Somatic Cell Gene Therapies: Charting a Path Toward Clinical Applications (Proceedings of the CERSI-FDA Meeting).

We are living in a golden age of medicine in which the availability of prenatal diagnosis, fetal therapy, and gene therapy/editing make it theoretically possible to repair almost any defect in the genetic code. Furthermore, the ability to diagnose genetic disorders before birth and the presence of established surgical techniques enable these therapies to be delivered safely to the fetus. Prenatal therapies are generally used in the second or early third trimester for severe, life-threatening disorders for which there is a clear rationale for intervening before birth.

A socioecological framework for engaging substance-using pregnant persons in longitudinal research: Multi-stakeholder perspectives.

Objective: Understanding the impact of substance use during pregnancy on fetal development and child health is essential for designing effective approaches for reducing prenatal substance exposures and improving child outcomes. Research on the developmental impacts of prenatal substance exposure has been limited by legal, ethical, and practical challenges. This study examined approaches to engage substance-using (with an emphasis on opioids) pregnant persons in longitudinal research, from multi-stakeholder perspectives.

Guiding Ethical Principles in Engineering Biology Research.

Engineering biology is being applied toward solving or mitigating some of the greatest challenges facing society. As with many other rapidly advancing technologies, the development of these powerful tools must be considered in the context of ethical uses for personal, societal, and/or environmental advancement. Researchers have a responsibility to consider the diverse outcomes that may result from the knowledge and innovation they contribute to the field.

How Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?

Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles - the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA - effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.

Making sense of risk.

Although actuarial risk prediction tools are widely used in the American criminal justice system, the lawyers, judges, and correctional workers who consult these products in making decisions often misunderstand fundamental aspects of how they work and what information they provide. This article suggests that the best way to ensure risk assessment tools are being used in ways that are just and equitable is to ensure that those who use them better understand three key aspects of what information they do - and do not - reveal. Doing so requires clarifying what risk is being predicted, explaining what risk levels signify, and enumerating how risk-related information is and is not relevant to specific criminal justice decisions.

Broadening Medical Students' Exposure to the Range of Illness Experiences: A Pilot Curriculum Focused on Depression Education.

Problem: Exposing medical students to a broad range of illness experiences is crucial for teaching them to practice patient-centered care, but students often have limited interaction with patients with diverse illness presentations.

Approach: The authors developed, implemented, and evaluated a self-directed online curriculum followed by a small-group discussion focused on depression education. The curriculum was based on a module created using the Database of Individual Patients' Experiences methodology.

Developing primary care teams prepared to improve quality: a mixed-methods evaluation and lessons learned from implementing a microsystems approach.

Background: Health systems in the United States are increasingly required to become leaders in quality to compete successfully in a value-conscious purchasing market. Doing so involves developing effective clinical teams using approaches like the clinical microsystems framework. However, there has been limited assessment of this approach within United States primary care settings.

A Rigorous Approach to Large-Scale Elicitation and Analysis of Patient Narratives.

Patient narratives have emerged as promising vehicles for making health care more responsive by helping clinicians to better understand their patients' expectations, perceptions, or concerns and encouraging consumers to engage with information about quality. A growing number of websites incorporate patients' comments. But existing comments have fragmentary content, fail to represent less vocal patients, and can be manipulated to "manage" providers' reputations.