Protecting Pregnant Women With Substance Use Disorders and Their Neonates Participating in Research

Abstract

This Viewpoint discusses the potential risks faced by pregnant women with substance use disorders who participate in clinical research, including criminal prosecution for drug use while pregnant and custody loss of their children, and proposes changes to research procedures and disclosure provisions to encourage their participation so the evidence base informing their care and addressing the opioid epidemic more generally can advance.

Best Practices for Engaging Pregnant and Postpartum Women at Risk of Substance Use in Longitudinal Research Studies: a Qualitative Examination of Participant Preferences

“…There are significant barriers to recruiting and retaining individuals with overlapping vulnerabilities (i.e., substance use disorders (SUD)) in the pregnancy or postpartum period (Davis, Yao, & Bierer, 2019 ; McHugh Votaw, Sugarman, & Greenfield ( 2018 ) Wetherington & Roman, 1998 ). This may result in challenges for generalizability and therein create a relatively sparse knowledge base about the long-term outcomes for these women and their children including the environmental, mental health, physiological, and neurological factors.…”

“…Careful participant selection and comparison selection were and are necessary to classify effects of prenatal exposures. Protectionist and paternalistic regulations (e.g., the National Research Act of 1974, and federal regulations designating pregnant women as a vulnerable population) excluded women from health research and limited the field’s understanding about how sex and gender shape substance use and SUD (Davis, et al 2019 ; Wetherington & Roman, 1998 ; Institute of Medicine, 1994 ; Institute of Medicine, 1999a ). Research studies on substance exposures during pregnancy expanded rapidly in the past 30 years, in recognition of the cocaine epidemics of the 90s, and the current increases in prenatal opioid and methamphetamine exposures (Gabrhelík, et al 2020 ).…”

“…Despite bioethical, legal, and social concerns regarding the risks and benefits of research participation for pregnant and postpartum women who use alcohol and drugs (Davis, et al 2019 ), the inclusion of vulnerable populations who are marginalized or stigmatized in research on sensitive topics has not demonstrated undue harm or exposure to unacceptable risk, and in fact, has been associated with potential benefits, such as altruism, catharsis, and gained knowledge (Alexander, Pillay, & Smith, 2018 ). Of course, it is important for researchers to adopt careful experimental design and safeguards that will uphold the principal of non-maleficence and protect vulnerable participants from harm (Alexander et al, 2018 ; Sikeweyiya & Jewkes, 2013 ).…”

A Core Outcome Set for Neonatal Opioid Withdrawal Syndrome

“…There were 63 outcomes evaluated. Final core outcomes include (1) pharmacologic treatment, (2) total dose of opioid treatment, (3) duration of treatment, (4) adjuvant therapy, (5) feeding difficulties, (6) consolability, (7) time to adequate symptom control, (8) parent-infant bonding, (9) duration of time the neonate spent in the hospital, (10) breastfeeding, (11) weight gain at hospital discharge, (12) readmission to hospital for withdrawal, and (13) neurodevelopment.…”

“…10,11 The complex ethical and operational considerations for conducting research during pregnancy and the social risk factors for opioid dependency create hesitancies to participate in research, with concerns for child welfare engagement and unwanted sharing of health information. 12 Authors of a recent review highlighted that a limited number of studies included families in study design, primarily outcome selection. 13 In neonatology, clinical trial populations are small, and studies are often underpowered to answer additional effectiveness questions or conduct meaningful subgroup analysis.…”