Ethics & human research最新文献

The use of patient-reported outcome measures (PROMs) is increasingly common in routine clinical practice. As tools to quantify symptoms and health status, PROMs play an important role in focusing health care on outcomes that matter to patients. The uses of PROM data are myriad, ranging from clinical care to survey-based research and quality improvement. Discerning the boundaries between these use cases can be challenging for institutional review boards (IRBs). In this article, we provide a framework for classifying the three primary PROM use cases (clinical care, human subjects research, and quality improvement) and discuss the level of IRB oversight (if any) necessary for each. One of the most important considerations for IRB staff is whether PROMs are being used primarily for clinical care and thus do not constitute human subjects research. We discuss characteristics of PROMs implemented primarily for clinical care, focusing on: data platform; survey location; questionnaire length; patient interface; and clinician interface. We also discuss IRB oversight of projects involving the secondary use of PROM data that were collected during the course of clinical care, which span human subjects research and quality improvement. This framework provides practical guidance for IRB staff as well as clinicians who use PROMs as communication aids in routine clinical practice.

This article examines the ethics of research design and the initiation of a study (e.g., recruitment of participants) involving refugee participants. We aim to equip investigators and members of IRBs with a set of ethical considerations and pragmatic recommendations to address challenges in refugee-focused research as it is developed and prepared for IRB review. We discuss challenges including how refugees are being defined and identified; their vulnerabilities before, during, and following resettlement that impacts their research participation; recruitment; consent practices including assent and unaccompanied minors; and conflicts of interest. Ethical guidance and regulatory oversight provided by international bodies, federal governments, and IRBs are important for enforcing the protection of participants. We describe the need for additional ethical guidance and awareness, if not special protections for refugee populations as guided by the National Institutes of Health (NIH) Guiding Principles for Ethical Research.

In an earlier essay, I advocated that translational bioethics uses the public's values, determined through social science, in its analysis of translational science technologies. It may be unclear what those values might be, and whether such a translational ethics would necessarily conclude that cutting edge technologies should not be developed. In this essay, I show the public's values relevant to human brain organoids and argue that a translational bioethics analysis using these values would support continued organoid research.

We performed a qualitative review of 50 consent forms posted on Clinicaltrials.gov, examining the content of key information sections. We found that key information disclosures are typically focused on procedures, risks, potential benefits, and alternatives. Drawing upon reviews of the large literature examining the reasons people do or do not take part in research, we propose that these disclosures should be based more directly on what we know to be the real reasons why people choose to take part or refuse participation. We propose key information language for consideration by researchers and institutional review boards.

Human challenge studies, in which human research subjects are intentionally exposed to pathogens to contribute to scientific knowledge, raise many ethical complexities. One controversial question is whether it is ethically permissible to include children as participants. Commentary of the past decades endorses the exclusion of children, while new guidance suggests that pediatric human challenge studies can be ethically permissible. This paper argues that neither children's exclusion nor their inclusion are well justified. I examine and reject three arguments for exclusion, but suggest that these arguments establish pediatric human challenge studies as a complex ethical category of research that requires caution. I then argue for a strong presumption against children's inclusion, by drawing on an analogy to children's inclusion in phase I trials, emphasizing a requirement of necessity, and suggesting that accommodating children's vulnerability promotes an age de-escalation approach for pediatric human challenge studies research. In the final section, I suggest a procedure for ethics review.

Migration research poses several unique challenges and opportunities. Conducting ethical global health practice, especially when studying migrant mental health, is of particular concern. This article explores seven challenges and lessons learned in our mixed-methods study conducted to assess the impact of the migration experience on Haitian migrants’ mental health in Santiago, Chile. The primary challenges were recruiting in a highly mobile population, building trust and community participation, overcoming language barriers, safety considerations during the Covid-19 pandemic, mitigating potential negative impacts of research on the community, providing psychological support, and finding meaningful ways to benefit the community. We propose moving toward a better and more ethical migrant research practice by ensuring language accessibility, hiring community members for the study team, working with local institutions and nongovernmental organizations, and maintaining sustainable connections.

In August of 2023, the National Academies of Science, Engineering, and Medicine published a timely report titled “Toward Equitable Innovation in Health and Medicine: A Framework.” Here, we review some of the key contributions of the report, focusing on two dimensions of equity: input equity and deployment equity. We then use the example of new gene therapies to treat sickle cell disease (SCD) as a case study of input and deployment equity in translational research. The SCD case study illustrates the need for a kind of translational bioethics with deep understanding of lived experiences and clinical realities as well as a high degree of economic and policy sophistication.

In 2019, the revised Common Rule required informed consent documents for research to include a statement about whether clinically relevant research results would be returned to research participants. While there are national discussions regarding the return of results, these do not provide specific guidance about how institutional review boards (IRBs) should address this issue. Through a year-long process involving IRB staff and leadership, science and bioethics faculty members, community IRB members, and others, Indiana University's human research protection program created a framework that offers a clear categorization of types of results for researchers to consider returning, provides language for informed consent documents, and describes an active but intentionally limited role for the IRB. In this article, we describe this framework and its rationale as a model for other universities and, more generally, as a model for balancing the need to protect human subjects with efforts to limit the burdens on researchers and the IRB.

It is a common practice in qualitative research to transcribe audio or video files from interviews or focus groups and then destroy the files at some future time, usually after validating the transcript or concluding the research. We argue that it is time to rethink this practice and that retention of original qualitative data—including audio and video recordings—should be the default stance in most cases.

Indigenous nations and communities in the United States have rights as sovereign governments to exercise control and ownership over all data and information generated by or from the tribes, tribal members, or tribal resources. Indigenous nations exercise these rights through data ownership policies established in response to unethical research practices in research involving Indigenous communities. Most universities in the U.S. have “openness in research” policies to ensure academic freedom to publish freely, exercised by retaining university control of data. Here, we describe our study of cultural ecosystem services in the St. Louis River estuary region (Nagaajiwanaang in the language Ojibwemowin) in Duluth, Minnesota, and Superior, Wisconsin, U.S., an area that includes portions of the 1854 and 1842 Ceded Territories and reservation lands of a local band of Ojibwe (hereafter referred to as “the Band”). In this university-led, Band-supported study, both the university and the Band sought ownership of data collected based on their respective policies, resulting in a research delay of nearly a year. We found that open research policies that do not consider Indigenous sovereignty can hamper collaboration between university researchers and tribal nations, even when there is broad agreement on research goals and objectives. University open research policies that do not explicitly address Indigenous sovereignty fall short of the open research principles they intend to support and should be revised. Formal adoption of principles for ethical research with sovereign tribal governments by universities is needed to improve coordination and trust among university and tribal researchers and members.