Ethics & human research最新文献

Although racial and ethnic categories are social constructs without inherent biologic or genetic meaning, race and ethnicity impact health outcomes through racism. The use of racial categories in biomedical research often misattributes the cause of health inequities to genetic and inherent biological differences rather than to racism. Improving research practices around race and ethnicity is an urgent priority and requires education as well as structural change. We describe an evidence-based intervention for an institutional review board (IRB). Our IRB now requires all biomedical study protocols to define racial and ethnic classifications they plan to use, to state whether they are describing or explaining differences between groups, and to provide justification for any use of racial or ethnic group variables as covariates. This antiracist IRB intervention is an example of how research institutions can help ensure the scientific validity of studies and avoid the unscientific reification of race and ethnicity as inherently biological or genetic concepts.

From 2018 to 2020, U.S. federal mandates began requiring the use of a single institutional review board (sIRB) of record for federally funded, multisite studies. With an interest in the efficiency of site activation, we compared the frequency with which local review and approval and three different reliance options (ways to establish a reliance agreement between the sIRB and the relying institution) were used during this period in a multisite, non-federally funded study (ClinicalTrials.gov identifier: NCT03928548). Using general linear models, we analyzed the relationships between local reliance or approval and sIRB of record approval times and (a) the regulatory option selected and (b) relying-site and process characteristics. Eighty-five sites received sIRB approval through 72 submissions (40% using local review, 46% using the SMART IRB agreement, 10% using an IRB authorization agreement, and 4% using a letter of support). Median time to establish a local reliance or study approval and sIRB approval were longest for sites using a SMART IRB agreement. Study-site region and the time of submission were significantly associated with local reliance or approval time, which averaged 129 and 107 days faster for Midwestern (p = 0.03) or Western (p = 0.02) sites, respectively, and 70 days slower for Northeastern sites (p = 0.42) compared with sites in the South, and 91 days slower when regulatory communication was initiated during or after February 2019 compared with before (p = 0.02). Similar relationships between sIRB approval time and region and time frame were observed; in addition, approval time was 103 days slower for sites affiliated with a research 1 (R1) university versus not (p = 0.02). Region of the country, time frame, and R1 university affiliation were associated with variations in study-site activation in a non-federally funded, multisite study.

Educational programs are integral to building health research ethics (HRE) capacity, but no outcomes framework exists to guide them. We empirically developed a competency framework for health research ethics education—the Framework for Research Ethics Studies Competencies and Outcomes (FRESCO)—using mixed methods, including group concept mapping and a survey of international experts. FRESCO includes seven competency domains: (1) Foundational Knowledge; (2) Laws, Regulations, Guidelines, and Policies for Research Oversight; (3) Ethical-Issue Identification, Analysis, and Resolution; (4) Engagement, Communication, and Advocacy; (5) Lifelong Learning, Education, Research, and Scholarship; (6) Coordination, Stewardship, and Responsiveness in HRE Systems; and (7) Impartiality, Honesty, and Responsibility. These domains are detailed in 27 subdomains. Survey respondents rated FRESCO's relevance to HRE highly. FRESCO can be adapted and implemented in educational programs to refine recruitment and selection processes, educational and assessment methods, and performance measures to ensure that HRE educational programs have their intended effects.

Translational bioethics expands the scope of research ethics to include multidisciplinary analyses of the societal implications of new translational science discoveries. Novel health privacy issues are raised by the collection, use, and disclosure of extensive and diverse big data for research on precision medicine. Similar privacy concerns surround the use of artificial intelligence to analyze vast troves of clinical records to improve patient outcomes. Embedding bioethics scholars with translational scientists can improve the technical analyses and timeliness of bioethical inquiries, but they complicate the task of producing independent and rigorous ethical assessments.

Many people with dementia are interested in taking part in research, including when they no longer have capacity to provide informed consent. Advance research directives (ARD) enable people to document their wishes about research participation prior to becoming decisionally incapacitated. However, there are few available ARD resources. This Australian interview study elicited the views of people aged 55 years and older about the content of an ARD form and guidance booklet and processes to support research planning. Participants (n = 25; 55 to 83 years) had interests in dementia research. All participants described the ARD materials as easy to understand, and all expressed willingness to take part in future research. Nearly half believed that an ARD should be legally enforceable, while others saw it as a nonbinding document to guide decisions about their participation in research. Close family members were preferred as proxy decision-makers. The ARD form and guidance booklet may be adapted for use elsewhere.

This paper argues that offering entry into a lottery as an incentive to those who participate in research studies represents a challenge to the principle of informed, coercion-free consent that is considered an essential ingredient of permissible recruitment to studies. This is, first, because information about the chances of winning in this context is normally unavailable to potential participants and, without this, they cannot accurately weigh up the risks and potential benefits of participation. Second, even when this information is available, such an incentive capitalizes, I contend, on the difficulty of weighing up small probabilities, exploiting the fact that people tend to be beset by cognitive biases that make it challenging to make decisions rationally. The resulting conclusion is that we should not view lotteries as more ethical than simply paying participants, when the latter is feasible.

The growing commercialization of science has raised concerns about financial conflicts of interest (COIs). Evidence suggests that such conflicts threaten the integrity of research and the well-being of research participants. Trying to minimize these negative effects, federal agencies, academic institutions, and publishers have developed conflict-of-interest policies. Among such policies, recommendations or requirements to disclose financial COIs to potential research participants and patients have become commonplace. Here, I argue that disclosing conflicts of interest to potential research participants fails to achieve the weighty moral goals that presumably ground such policies. This is so either because disclosure is simply a wrong means for achieving some of the goals in question or because, although disclosure could be an appropriate means for some of those goals, the way in which it is implemented prevents fulfillment of the desirable moral aim.

The Covid-19 pandemic has raised a range of complex challenges for the research community in the United States. This essay uses Covid-19 as a model pandemic illness to consider two such issues that have yet to be fully explored in the ethics literature: first, whether the informed consent process should include a discussion of pandemic risks and, if so, how precisely these risks should be conveyed to potential research participants and, second, whether and under what circumstances vaccination status should be taken into consideration when enrolling subjects in non-pandemic-related studies during a pandemic.

Guidelines from the Office for Human Research Protections regarding categories of research that institutional review boards (IRBs) may review through expedited procedures limit the volume of blood that can be obtained from research participants for minimal risk research purposes. As defined by the Common Rule, minimal risk research is research in which the probability and magnitude of harm or discomfort anticipated are not greater than the probability and magnitude of harm or discomfort encountered from routine clinical tests. For this study, we considered the volume of remnant blood following routine clinical tests in light of the current definition of minimal risk in research. Conducted at a single institution, this was a prospective cross-sectional study that evaluated blood draws from 122 patients. The median daily remnant blood volume was 11.6 (interquartile range [IQR]: 12.3, 15.2) ml for all patients and 12.9 (IQR: 13.1, 16.9) ml for patients admitted to the intensive care unit. Our findings regarding daily remnant blood volume suggest that the currently allowable blood-volume limits to qualify for expedited review or to qualify as not more than minimal risk research involving blood draws from nonhealthy adults are less than what patients experience in routine medical testing. These findings support permitting an increase in the allowable blood-volume limits to meet the regulatory definition of minimal risk research for obtaining expedited IRB review of studies in which blood samples will be collected.