Ethics & human research最新文献

Increasingly, new legal measures are restricting the use of gender-affirming care, raising challenges not only for the medical care of transgender/gender-nonbinary individuals, but also for medical research and research ethics. These restrictions may discourage researchers from conducting various types of research with transgender/gender-nonbinary individuals, such as asking about sexual behavior and gender identity or related issues in studies of adolescents and young adults more broadly. Researchers and institutions may also face professional risks in pursuing such research. Thus, restrictions on the use of gender-affirming care have important implications for researchers, institutional review boards (IRBs), institutional officials, policy-makers, and others. Restrictions could have an impact on the design, implementation, and management of research studies, potentially requiring consent form modifications, reconsent of participants, and asking participants about possible resulting physical/legal/social problems. Researchers and IRBs need to carefully assess these shifting legal restrictions. Input from legal experts may be needed concerning the interpretation, implementation, and enforcement of local and federal legal measures for initial and continuing IRB review of research protocols and the assessment of any changes to relevant legal measures. Researchers, IRBs, and others thus need to recognize, address, and develop “best practices” regarding these new restrictions.

Translational and other modern forms of biomedical research often use stored biospecimens and the health records of individuals whose biospecimens will be used in research. As part of the enrollment process for biobank-based research, individuals are frequently asked to provide informed consent for access to and use of their current and future health records. Although individuals might readily agree to give researchers access to their current health records, they might not realize that their future health records could contain new stigmatizing or embarrassing information. Reasonable limits on future health record disclosures in both the U.S. and Europe can address health privacy concerns without impeding research.

Nominal cash and gift card incentives provided to research participants have immediate financial benefits but make no lasting improvements to participants’ lives or social inequities they might experience. Our study examined the acceptability of offering a nonmonetary educational incentive as an added option to research participants as a potential to advance antiracism and address social inequities. Community members (n = 128) completed a quantitative survey; nine of whom also participated in a qualitative interview. Focus group discussions occurred with 11 researchers. Survey data were analyzed to obtain descriptive statistics. Qualitative data were analyzed using an iterative process guided by template analysis. Survey participants’ mean age was 45 years; 39% were white and 30% were Hispanic/Latinx; 80% were male; 39% had completed some college; 45% had a degree; and 71% reported previous paid participation in a research or community program. Of this group, 80% preferred cash or gift card incentives; 16% preferred an educational incentive; and 88% were likely to extremely likely to use educational incentives. Qualitative data indicated that educational incentives were acceptable but should not replace cash incentives; successful implementation would require organizational support. Noncash educational incentives may be acceptable to research participants and researchers and would help address social inequities. Successful implementation would require further research.

The study summarizes and discusses challenges in engaging Sub-Saharan African migrants in Australia in social and health studies using data from 15 discrete projects co-led by the three researchers who authored this article. The projects included cross-sections of the African community, focusing on parents and their children, and were carried out over 11 years (2007 to 2018) in Australia. An African Review Panel (ARP), a community-owned steering committee whose members were drawn from the target communities, oversaw the implementation of these projects. Directed content analysis of textual data, drawing on reflective practice through ARP interactive reflective meeting sessions and bilingual workers’ reflective field notes, was undertaken. Findings and associated learnings were summarized into broad themes around lessons learned from participatory research and ethical challenges. Current guiding ethical principles in research may not cater to all cultures, and there is a need to develop ethical guidelines that are culturally responsive to account for collectivist values related to cultural expression and experiences.

Open science initiatives, intended to democratize access to research products, have made steady progress in shifting the global science culture toward practices like preregistration and data sharing. However, current open science efforts have not yet addressed the special obligation to ensure that research results are made accessible to the portion of the general population who contribute most directly to scientific advances: research participants. In this article, we explore the ethical obligation to communicate aggregate results to research participants and consider elements of open science infrastructure that could be amended for this purpose. We consider open questions for implementation related to the methods, timing, potential harms, oversight, and incentives for communicating aggregate results and pose solutions that could, following the example of open science initiatives, succeed in nudging investigators to reciprocate the efforts of research participants by sharing the scientific findings they helped to advance.

Ethics review boards are increasingly asked to review big health data research proposals using a regulatory framework written prior to the current era of machine learning and artificial intelligence. Traditional consideration of individual identifiability does not account for the growing recognition that almost all data can be reidentified. This leaves the research ethics community performing a “theater of anonymity”: weighing benefit versus risk on the inclusion of participant identifiers alone. The wider research community, including U.S. federal agencies, is pushing for greater transparency and data sharing, stretching the current definition of identifiability to the breaking point. Additionally, shifting attitudes on the balance between privacy and research benefit may make a project more acceptable to individuals and communities than to the ethics boards designed to serve them. Reviewing the human research community's historical and current understanding of identity in terms of research, risk, benefit, and consent may point toward a need for a change in how consent is conceived. Particularly in the context of consent for big health data research, the research ethics community may need to shift its focus from solely considering individuals toward actively considering the interests of the communities most likely to be affected by the research.