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The publisher's final edited version of this article is available at Hastings Cent Rep See other articles in PMC that cite the published article. Abstract Although pregnant women rely on medical interventions to treat and prevent a wide variety of health conditions, they are frequently excluded or underrepresented in clinical research.
The resulting dearth of pregnancy-specific evidence to guide clinical decisionmaking routinely exposes pregnant women, and their future offspring, to risk of uncertain harms for uncertain benefits.
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The two legal factors regularly cited as obstacles to such research are the federal regulatory scheme and fear of liability. This article reveals a far more nuanced and complex view of the legal context.
First, legal professionals may—at any time from product conception to marketing—influence decisions about research with pregnant women. Second, factors not previously articulated in the literature may prompt legal professionals to slow or halt such research. They include: financial interests, regulatory ambiguity, obstacles lititz pa dating risk management, and site-specific laws unrelated to research.
Any efforts to promote the ethical inclusion of pregnant women in research must acknowledge the role of legal decisionmakers and address their professional concerns.
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Like everyone, pregnant women face medical challenges—including lititz pa dating conditions like preeclampsia; serious chronic diseases like diabetes and depression; infectious diseases like HIV, and now Zika; and life-threatening conditions like drăguț dating cadouri, stroke, and cancer—that can benefit from safe and effective biomedical interventions.
Pregnant women, however, confront a paradox: Although they may need to take prescription medications to treat or prevent serious health conditions, their frequent underrepresentation in—or complete exclusion from—clinical research has resulted in U. Nevertheless, women do use medications during pregnancy, and physicians do prescribe medications to pregnant lititz pa dating.
For example, because pregnancy can affect both the way drugs are metabolized by the body and the way the body responds to drugs, standard dosing of medications can lead to under-treatment of disease, or to drug levels that are unsafe for a pregnant woman, a fetus, lititz pa dating both. It reveals new insights into the role of legal professionals throughout the research pathway, from product conception to market, and it highlights a variety of legal factors influencing decisionmaking that may slow or halt research lititz pa dating pregnant women.
Following a brief background, we discuss those insights, concluding that any attempts to close the evidence gap created by the underrepresentation and exclusion of pregnant women in research, will require targeted attention to the role of legal professionals and the legal factors that influence their decisions. PHASES is a multidisciplinary, National Institutes of Health-funded grant committed to developing engagement-driven ethics guidance for conducting research with pregnant women that is responsive to the range of ethical and legal challenges arising in studies with this population.
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An important aspect of that effort is in-depth examination of the legal context, policies, and practices that can pose obstacles to the conduct of research with pregnant women conducted lititz pa dating originating in the United States. Identification and analysis of those hurdles can illuminate and inform the content and type of guidance that would be most valuable to those in the research enterprise. As other aspects of our project have demonstrated in the context of HIV, 5 guidance will be especially helpful for researchers and institutional review boards IRBs.
Researchers report experiencing legal barriers, whether real or perceived, in attempting to plan or conduct clinical research with pregnant women, and IRBs lacking guidance lititz pa dating decline to approve ethically justifiable research with pregnant women out of an abundance of caution.
In an effort to supplement our knowledge and deepen our understanding of those legal claims and the role that legal decisionmakers play throughout the clinical research pathway, we invited a diverse group of legal professionals with intimate knowledge about different facets of the research enterprise to share their expertise with us in a day-long meeting. They included: former and current este casual dating bine counsels and outside legal counsel to major pharmaceutical companies, prominent academic research institutions, and nonprofit research organizations; former government regulators; and legal academics with directly applicable scholarship and policy experience.
The discussion below summarizes and analyzes major insights from our work to date on legal obstacles to clinical research with pregnant women, incorporating what we learned at the meeting with legal experts. We highlight factors influencing legal decisionmaking that may have the potential to impede research with pregnant women, including financial factors, regulatory ambiguity and inconsistency, obstacles to risk management, and venue-specific laws that may not otherwise be directly relevant to research.
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Meeting attendees emphasized that lawyers may be involved team members at each stage of product development—from pre-clinical conceptualization, to clinical trials, to manufacturing, and ultimately to marketing.
As examples, a commercial entity can embed an in-house lawyer in a product-specific team to lititz pa dating a product idea through each step of the research pathway, or can rely on a lawyer as lititz pa dating member of the executive team who participates in strategic planning at the highest levels. While some general counsels defer decisions about whether to permit research with lititz pa dating women to IRBs, others set an institutional policy about research with pregnant women that either expressly or tacitly precludes it.
Importantly, legally trained professionals do not speak with one voice. Indeed, the plain language of written laws cannot anticipate their every context and application, and thus laws can be subject to varying interpretations.
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Two or more lawyers may interpret the same legal language differently, and as further discussed below, their judgments about proceeding, delaying, or halting a clinical trial may be influenced by factors external to the written law. The potential for variable interpretations is enhanced by the fact that there is always more than one lawyer or regulator involved in decisionmaking throughout the research pathway.
For example, a lawyer on the IRB may view a study with pregnant women as legally appropriate, while a university general counsel lititz pa dating interpret the law differently, or conclude that a more liberal interpretation would be viewed unfavorably within or outside the institution. Ultimately, legal decisionmakers along the research pathway wield significant power: as one attendee anecdotally shared, even one FDA regulator may be in a position to derail a study, even one that has been approved by the IRB and survived scrutiny from internal or external legal counsel, because of different interpretations about legally or perhaps institutionally acceptable levels of risk.
Financial interests of the pharmaceutical industry are best served when a product is taken to market with a clear safety and efficacy profile, for an indicated use, in the general adult population rather than a population that raises interconnected legal-financial concerns.
This regulatory bypass mechanism not only allows the product to reach pregnant women without any financial investment in researching the safety or efficacy of the product in lititz pa dating population, it can also buffer the pharmaceutical industry from liability by shifting responsibility to the prescribing physician for any resulting harms.
Research with Pregnant Women: New Insights on Legal Decision-Making
See further discussion of liability, below. The entwinement of legal and financial considerations is not limited to the private sector. The attendees emphasized that when clinical research is conducted at an academic institution, a distinct set of obstacles for including pregnant women in clinical trials arises.
At academic institutions that are willing to consider clinical trials with pregnant women, such research still may not move forward because the legal and financial incentives that promote partnerships with industry sponsors do not align lititz pa dating the participation of pregnant women in research.
Those partnerships are promoted by the federal Bayh-Dole Act, which authorizes academic researchers and institutions to transfer intellectual property from NIH-funded research to private industry. To attract industry sponsors, academic researchers and institutions thus have a strong incentive to conduct research that serves the business interests of private industry.
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For the reasons described earlier, including pregnant women in clinical trials is perceived to be at odds with those financial objectives.
The relevant regulations in Subpart B provide a two-part standard of acceptable imposition of fetal risk in research involving pregnant women. Further, Subpart B does not provide guidance on whether those risks should be understood differently when the woman has a disease or condition, such as HIV, that may have an impact on fetal well-being.
The attendees expressly highlighted those ambiguities. Narrow interpretations of risk and benefit can operate as important red lights in any stage of the drug development process.
Lack of regulatory clarity is magnified in practice, where, as one attendee suggested, decisionmakers can respond to a proposed research protocol by using any uncertainty to preference risk and discount any assertions of benefit. The lack of data thus stymies attempts to assess with any confidence whether protocols meet the regulatory requirements of minimal fetal risk or prospect of direct benefit to the woman or fetus. Notably, attendees explained that the lack of definitional clarity and regulatory guidance with respect to Subpart B compels legal decisionmakers to approach research with pregnant women cautiously, if at all.
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Lawyers must carefully consider the potential for exposing a client to regulatory scrutiny, financial penalties, and reputational damage. Nevertheless, because there is a paucity of relevant and easily accessible precedents of approved research with pregnant women that might serve as a guide through regulatory pathways, legal decisionmakers have scant knowledge of what others in the same or similar position are doing.
All of the foregoing uncertainties can lead legal decisionmakers to default to advising their clients not to initiate or otherwise support research on pregnant women. But, they also stressed that fear lititz pa dating liability is neither the primary nor the only obstacle to including pregnant women in research.
These obstacles to risk mitigation can magnify concerns that legal decisionmakers have about liability related to the inclusion of pregnant women in clinical research.
The attendees emphasized that when legal decisionmakers consider the liability risks posed by research, their assessment is shaped by a number of considerations. The liability concern is not simply that a pregnant woman or her potential offspring may be harmed by an experimental agent, but rather that these harms may take years to manifest, or may appear in future generations.
In this context, lititz pa dating pointed to the American experience with diethylstilbestrol DESa drug prescribed to an estimated 5—10 million pregnant women between the s and s, before the FDA determined in that DES is strongly associated with the risk of clear cell adenocarcinoma and reproductive abnormalities in female offspring.
As a consequence, the manufacturers of DES faced enormous lawsuits over a lengthy period of time, not only from the women who had taken DES, but from their daughters as well. The second, and related, liability consideration that attendees emphasized was that history and context influence the legal advice that lawyers offer.
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The thalidomide tragedy of the s and s, in which thousands of European babies were born with birth defects linked to the widely available anti-nausea drug their mothers took while pregnant, has had a lasting impact on risk perception. Although lititz pa dating tragedy arguably could have been mitigated had pregnant women been included in early testing of thalidomide—a point frequently made in the literature urging the early inclusion of pregnant women in clinical trials 19 —the episode was more often cited by attendees for the proposition that research with pregnant women requires special legal attention because of the magnitude of potential harm to offspring from pharmaceutical interventions.
Lawyers are lititz pa dating to assess risk and offer strategies to mitigate that risk. Attendees highlighted two factors currently challenging their management of liability-related risk.
Although some representatives of pharmaceutical companies, academic research institutions, and non-profit research organizations indicated they had successfully procured such insurance—for example, for HIV-related trials of pre-exposure prophylaxis PrEP and for HIV prevention of mother-to-child transmission—others reported that self-insurance was the only option available to cover any legal or medical costs associated with research-related injuries, regardless of whether the trial included pregnant women.
The second risk-management challenge that attendees described relates to legal risk exposure for pharmaceutical manufacturers that test, and ultimately label, drugs for use in pregnant women.
The practical effect is that potential legal risk for pharmaceutical interventions is thereby shifted downstream to health care providers who prescribe needed drugs to their pregnant patients, and those drugs have not been tested in that population. Relevant laws include those related to the conduct of research as well as all other laws that could possibly be implicated by the proposed research. Attendees commented that some jurisdictions have laws that might make research with pregnant women more difficult, for example, compensation requirements for research-related injuries and heightened paternal consent laws.
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Other jurisdictions have laws that might lead a lawyer to advise against any research with pregnant women in that jurisdiction, for example, fetal protection laws. The prospect of conducting research with any population in international venues prompts a number of legal considerations that were highlighted by the attendees.