Ethics & human research最新文献

Pregnant individuals are often excluded from research without clear justification, even when the research poses minimal risk of harm to the fetus. Little is known about institutional review board (IRB) decision-making practices when reviewing such research. We conducted a survey of current and former IRB personnel in the United States to elicit their interpretations of “minimal risk”—a formal regulatory category—and to identify factors that may influence IRB decisions to approve or disapprove research involving pregnant participants. Study results revealed some consensus among IRB members about the risk level of individual research procedures and hypothetical study vignettes. However, we uncovered important variations not only in the assessment of risk but also in the willingness of IRB members to approve minimal risk research that includes pregnant women. Based on our findings, guidance is needed to assist IRB members in characterizing risk, applying federal regulations, and appropriately ensuring the inclusion or justified exclusion of pregnant people in research.

At electronic dance music events in Belgium in 2013 to 2015, seemingly intoxicated patients were included without their informed consent in an observational toxicology study when the attending physicians determined that they needed treatment with an intravenous line. All included patients received an information letter inviting them to contact the principal investigator (PI) to obtain more information about the study and/or to inform the PI that they wanted to be excluded from it. Overall, 238 patients were included in the study. Nine participants (4%) responded to the information letter, either on their own or through their parent; none of them asked to be excluded from the study. All respondents expressed their gratitude for the information they received. The opt-out study design seemed to be acceptable to the patient-participants, and it provided a fuller picture of the drug-related medical incidents at such music events than what could likely be achieved through a study that includes only people who explicitly choose to participate. These findings may help institutional review boards when evaluating study designs involving recreational drug use, especially at electronic dance music events. Nevertheless, we warn against extrapolation to other settings where informed consent is difficult to obtain.

Accurate screening of potential research participants is vital to ensuring the scientific, regulatory, and ethical appropriateness of clinical trials. Yet there are no definitive screening tests for many conditions, and many screening tests, even when implemented correctly, yield some inaccurate results. Sponsors, researchers, and review committees thus routinely face the question of when it is acceptable to approve and conduct clinical trials that rely on screening measures that are known to exclude some eligible individuals and to include some ineligible ones. This article calls attention to and proposes preliminary guidance to address this important issue.

Knowledge of genetic mechanisms contributing to neurodevelopmental conditions is advancing. This is informing development of new drugs to treat or ameliorate these conditions, through targeting underlying genetic pathways. Drugs are tested in clinical trials, necessitating parents to engage with decisions about whether to enroll their child. In this article, we consider important ethical issues to anticipate as clinical research opportunities in genetic neurodevelopmental conditions arise. For example, genetic pathways targeted by the drugs may interact with valued character and personality traits. It is essential that recruitment and consent processes are optimized for families who will grapple with whether these novel drug treatments interact with their child's personality and authentic identity. We call for focused social science research and further normative analysis so that parents are better supported to make informed choices. Additionally, clinical research regulators should have a sound understanding of the contextual experiences regarding how this population of parents engages with decisions.

Online communication has emerged as an important vehicle for participant interaction during the course of clinical research. At the same time, such communication has been identified as a source of risks both for participants and the scientific integrity of clinical trials. Although strategies for mitigating these risks have become a focus in the research community, missing from the discussion has been a sustained and sympathetic effort to understand the various benefits of online communication for participants themselves. In this article, we provide a taxonomy of the benefits of online communication for participants and argue that attempts to mitigate the risks of online communication by discouraging or placing limits on such communication are generally unadvisable. Instead, we advance a context-sensitive approach that emphasizes education and several actionable recommendations for preserving the benefits of online participant communities while mitigating the risks.

Recent changes to the Common Rule have helped reduce regulatory burden on researchers conducting minimal risk research. However, in this paper, I propose a way of minimizing burden further within the existing confines of the current regulations. I focus my discussion on the newly created “benign behavioral interventions” category of exempt research, arguing that this exemption from the federal regulations governing research with human subjects should be more expansively interpreted by the Secretary's Advisory Committee on Human Research Protections (SACHRP) than is currently the case. Specifically, I argue against the restriction, advocated by SACHRP, that the exemption exclude “physical (bodily) tasks” unless they are “incidental to the behavioral intervention.” This restriction, I argue, is problematically vague and does no significant moral work. Acceptance of my proposed reinterpretation of “benign behavioral interventions” would, I hope, result in a significant reduction in regulatory burden for minimal risk research.