Ethics & human research最新文献

CRISPR (clustered regularly interspaced short palindromic repeats) somatic genome editing, an important promissory technology, presents a case study of the movement of basic scientists into translational research. In this paper, we explore how scientists experience the pulls of CRISPR's power and the pushes of economic and societal pressures in adopting new translational roles. Given basic scientists' emerging contact with and influence upon individuals with genetic conditions, we also examine how scientists understand the perspectives of affected populations, both as potential subjects of early experiments and as the patients who could receive future treatments. Finally, we consider the ethical implications of our findings and call for innovative approaches to translational research that help scientists engage with people with genetic conditions in early translational research.

In the context of emergency research, researchers can ask the institutional review board (IRB) to waive the regulatory requirement that individuals provide informed consent when enrolling in research studies. A requirement of the waiver of informed consent is that the reviewing IRB must review and approve a community consultation and public disclosure plan. It is critical that an IRB serving as the single IRB (sIRB) for multisite research be thoroughly versed in the local context concerns for each participating site to determine whether the site's community is being adequately consulted about the research in which individuals will be enrolled under an exception to the informed consent requirement. We designed an sIRB review model for evaluating site-specific community consultation plans that included a local evaluation and feedback step, and we piloted the model with a four-site, pediatric exception from informed consent (EFIC) clinical trial. We identified three key roles for the model: the sIRB, the investigators, and the representative of the institution's human research protection program (HRPP). We successfully collected the information and local input needed to evaluate each site's community consultation plan and applied the information to a thorough IRB review, despite the geographic distance between the study site and the sIRB.

Institutional review boards (IRBs) have been criticized for inconsistency and lack of transparency in decision-making, problems that undermine both trust in their ability to protect human research participants and respect for their decisions among researchers. The absence of robust documentation of their decisions and the inability or unwillingness to share those decisions together represent a missed opportunity for IRBs to learn from one another and advance debates about challenging ethical issues. The concept of IRB precedent, modeled upon the system of legal precedent, has been proposed as a potential solution to these problems. In theory, an IRB faced with a review decision could look back at previous IRB decisions, either its own or those of other boards, made in similar studies or circumstances to guide the present decision. Some IRBs attempt this informally within their institution, but few examples of a structured system of IRB precedent have been described in the literature, and none has been widely adopted. This article describes a pilot project to summarize IRB decisions in a way that could facilitate their use as precedent by creating a documentation tool that meets four criteria—comprehensiveness, validity, searchability, and efficiency. Though this process turned out to be more challenging than expected, we identified key features of such a tool that holds promise for future development and could promote more consistent, robust IRB decision-making and advance discourse in human research ethics.

This article provides pragmatic advice for organizations interested in creating a research ethics consultation service (RECS). A robust RECS has the potential to build capacity among investigators to identify and consider the ethical issues they encounter while conducting their research. Determining whether to establish an RECS should begin with an institutional-needs assessment that includes three key questions: What are the current resources available to research teams to navigate ethical concerns that arise from their research? Is there a demand or perceived need for more resources? Is there institutional support (financial and otherwise) to establish and maintain an RECS? If this results in the decision to establish the consultation service, relevant institutional stakeholders must be identified and consulted, and personnel with the requisite skills recruited. The next step is to establish an RECS and build the infrastructure to process and respond to requests. The RECS's long-term sustainability will depend on a stable source of funding and a mechanism to receive constructive feedback to ensure that the service is meeting the institutional needs it set out to address.

Human research protection programs (HRPP) generate an abundance of data on performance, capacity, and compliance. When used effectively, this information can be instrumental in helping HRPPs meet programmatic and institutional goals, demonstrate growth and success, and improve the HRPP overall. Metrics must be grounded in professional insight so that HRPPs can pair analytics with strategies for future action or improvement. The purpose of this paper is to demonstrate how high-performing HRPPs develop, adopt, and implement a metrics framework that benefits everyday operations and produces real-world results. Through a three-part thematic framework (of insight, data, and action) and by providing case examples and actionable strategies, this article will address how HRPPs iteratively develop and characterize their metrics, build a metrics framework that leverages both quantitative and qualitative data to validate outcomes, and activate human insight to produce meaningful communication, visualization, and dissemination of data.

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.