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- Creators: Maienschein, Jane
Description
The inherent risk in testing drugs has been hotly debated since the government first started regulating the drug industry in the early 1900s. Who can assume the risks associated with trying new pharmaceuticals is unclear when looked at through society's lens. In the mid twentieth century, the US Food and Drug Administration (FDA) published several guidance documents encouraging researchers to exclude women from early clinical drug research. The motivation to publish those documents and the subsequent guidance documents in which the FDA and other regulatory offices established their standpoints on women in drug research may have been connected to current events at the time. The problem of whether women should be involved in drug research is a question of who can assume risk and who is responsible for disseminating what specific kinds of information. The problem tends to be framed as one that juxtaposes the health of women and fetuses and sets their health as in opposition. That opposition, coupled with the inherent uncertainty in testing drugs, provides for a complex set of issues surrounding consent and access to information.
ContributorsMeek, Caroline Jane (Author) / Maienschein, Jane (Thesis director) / Brian, Jennifer (Committee member) / School of Life Sciences (Contributor) / Sanford School of Social and Family Dynamics (Contributor) / Barrett, The Honors College (Contributor)
Created2018-05
Description
Intake of alcohol, tobacco, and illicit substances such as marijuana and methamphetamine during pregnancy can have significant deleterious effects on a developing fetus and the resulting infant. The existence of substance-exposed newborns also has negative impacts on society as a whole; these include financial burdens placed on taxpayers and the additional time and resources required by health care professionals, social workers, and law enforcement authorities to properly care for such infants. Existing literature show a strong correlation between prenatal care and improved birth outcomes, including abstinence from or reduction of prenatal substance abuse. The Health Start Program in the state of Arizona attempts to mitigate the incidence of substance-exposed newborns, among other goals, by employing community health workers who identify high-risk pregnant and postpartum women, inform these women about how to receive prenatal care services, educate them on appropriate prenatal and neonatal care, and provide program and referral services to both pregnant and postpartum women. Community health workers interact directly with women most at-risk for prenatal substance abuse and should be well-versed in the understanding of the complex issues related to substance-exposed newborns. In an attempt to discover, analyze, and compile those complex issues with which community health workers should be knowledgeable, this project explores existing federal regulations regarding substance-exposed newborns, compares Arizona’s regulations to Minnesota’s, Virginia’s, and Washington’s, and analyzes prevailing literature in the field about the various implications associated with screening and reporting substance-exposed newborns to law enforcement authorities. After an intensive literature review, this project concludes that the Health Start Program needs a comprehensive resource document which enumerates federal and select state policies, landmark cases involving substance-abusing pregnant women and the precedence set by each, and recommendations from medical and public health experts. The document should also provide clear guidelines by which each stakeholder should abide and why, and recommend potential best practices the state of Arizona could adopt into law based on other state policies which have proven to be effective.
ContributorsTantibanchachai, Chanapa (Author) / Maienschein, Jane (Thesis advisor) / Ellison, Karin (Thesis advisor) / Coursen, Cristi (Committee member) / Arizona State University (Publisher)
Created2015