Ethics & human research最新文献

How research during a public health emergency is conducted is recognized as essential to the public health response to that emergency. Such research needs to undergo substantive and meaningful ethical review in a timely manner. Rapid ethical review may be accomplished through a number of mechanisms, including use of local rapid-response institutional review boards (IRBs). We describe use of such a model in the setting of the 2014 Ebola virus disease epidemic and the Rapid-Response IRB's subsequent transition to a multisite single IRB model during the current Covid-19 pandemic. The rapid-response review model is characterized by a small IRB with extensive use of alternate members with specific expertise and by close collaboration with the investigator in an iterative process.

Covid-19 public health measures prompted a significant increase in online research. This approach has several benefits over face-to-face data-collection methods, including lower cost and wider geographical reach of participants. Yet when the online data-collection instrument is a survey, there are also well-documented drawbacks of participant misrepresentation and related data-authenticity issues. However, the scholarly literature has not looked at participant misrepresentation in online focus-group empirical research. This case study communicates a concerning situation that arose during our research project: dishonest participant behavior threatened the integrity and validity of our data collected through online focus-group sessions as well as e-surveys. We describe the study context, initial red flags alerting us to the issue, subsequent investigations, and implications for research ethics, funding, and data quality. We conclude with a discussion of potential steps to safeguard future online focus-group research against similar issues.

The nature of the review of local context by institutional review boards (IRBs) is vague. Requirements for single IRB review of multicenter trials create a need to better understand interpretation and implementation of local-context review and how to best implement such reviews centrally. We sought a pragmatic understanding of IRB local-context review by exploring stakeholders' attitudes and perceptions. Semistructured interviews with 26 IRB members and staff members, institutional officials, and investigators were integrated with 80 surveys of similar stakeholders and analyzed with qualitative theme-based text analysis and descriptive statistical analysis. Stakeholders described what they considered to be local context, the value of local-context review, and key processes used to implement review of local context in general and for emergency research conducted with an exception from informed consent. Concerns and potential advantages of centralized review of local context were expressed. Variability in perspectives suggests that local-context review is not a discrete process, which presents opportunities for defining pathways for single IRB review.

Assessment of risks and benefits of study participation is standard practice preceding the initiation of human subjects research. Although tracking adverse events during research participation is routine, collecting information from participants about what they perceive as benefits is less common. We longitudinally tracked social risks and benefits of participation among a cohort of 241 men who have sex with men participating in a sexual health study to improve participants' experiences and enhance understanding of participant motivations to enroll and attend follow-up. Of the participants who returned for at least one follow-up visit (n = 217, 90%), most (n = 185, 85%) reported positive consequences resulting from participation. Reporting of negative social consequences was rare, and all concerned a stigmatized reaction from someone learning about the participant's involvement in a sexual health study. Better identification of both positive and negative consequences resulting from research participation may improve how researchers design, recruit, and conduct research.

In 2021, we were designing a research study in Sweden in which we planned to use newspaper articles focusing on children and adolescents under the age of eighteen during the Covid-19 pandemic as empirical material. As we developed this study, an ethical question arose: do studies using journalistic articles that may contain health information about individuals as empirical material have to be approved by an ethics review committee? Sweden, in contrast to other countries, requires the approval of an ethics review committee for the use of publicly available material in research when such material might include sensitive personal data such as health-related information. This case study calls for harmonized laws and policies that support global research by clarifying what kinds of empirical material and what types of research must be assessed by national ethics review committees, including with consideration for children's safety and rights.

Translational research has tended to ignore the question of whether receiving a genomic diagnosis provides utility in community care contexts outside of doctors' offices and hospitals. However, empirical research with parents has highlighted numerous ways that a genomic diagnosis might be of practical value in the care provided by teachers, physical or occupational therapists, speech-language pathologists, behavior analysts, and nonphysician mental health providers. In this essay, we propose a new conceptual model of genomic utility that offers the opportunity to better capture a broad range of potential implications of genomic technologies for families in various social and organizational systems. We explore crucial research directions to better understand how redefined utility might affect families and nonphysician professionals.

Informed consent is a cornerstone of ethical human research. However, as cluster randomized trials (CRTs) are increasingly popular to evaluate health service interventions, especially as health systems aspire toward the learning health system, questions abound how research teams and research ethics boards (REBs) should navigate intertwining consent and data-use considerations. Methodological and ethical questions include who constitute the participants, whose and what types of consent are necessary, and how data from people who have not consented to participation should be managed to optimize the balance of trust in the research enterprise, respect for persons, the promotion of data integrity, and the pursuit of the public good in the research arena. In this paper, we report the findings and lessons learned from a qualitative study examining how researchers and REB members consider the ethical dimensions of when data can be collected and used in CRTs in the evolving research landscape.

Chatbots have become increasingly common in diverse settings as a substitute for human conversation. They are being developed and tested for obtaining informed consent for research. An initial study indicated that chatbots saved time and were successful in knowledge transfer, but the informed consent process serves other purposes, such as building trust and respecting the autonomy and dignity of potential research participants. Additional research and possible regulation are necessary before chatbots should be routinely used in health research.

Autism research frequently seeks to evaluate interventions or inform their development. Unfortunately, researchers often assume that autism intervention should reduce autistic traits, effectively setting as a goal of treatment that autistic people attempt to “pass” as nonautistic. A growing body of evidence highlights serious potential harms from passing demands. We discuss why it is important for institutional review boards (IRBs) to scrutinize autism research for clinical passing demands, and we document the existence of such demands in outcome measures commonly employed in autism research. We propose an ethical framework for IRBs and others to make use of in evaluating the ethical appropriateness of particular treatment goals in autism intervention or intervention-adjacent research, emphasizing that treatment goals should be in pursuit of a beneficial nonpassing purpose and be the least burdensome means of accomplishing such a purpose. We also highlight potential promising practices for IRBs, investigators, and other stakeholders seeking to address these issues in autism research.

Over the past 30 years, progress has been made in increasing women's representation in clinical research. However, women continue to be underrepresented in phase I clinical trials—those trials that test the safety and tolerability of investigational drugs, often on healthy individuals. As sex-based differences in adverse drug reactions are often linked to drug dose, pivotal safety information in phase I trials is often insufficiently—and inequitably—captured for females. Yet there has been little attention to how clinical investigators and those charged with overseeing the ethical conduct of these trials perceive the barriers to women's inclusion in phase I trials. To address this gap, we report on 22 interviews with U.S. phase I investigators and institutional review board (IRB) members. Our findings indicate that although these investigators and IRB members acknowledged the importance of including women in clinical trials, they justified women's exclusion from phase I trials by citing the need to manage their reproductive potential. In particular, we identified four key themes that informants used to warrant women's exclusion from phase I trials: the structure of the drug-development system itself, fears about risks to potential fetuses, distrust of women to prevent pregnancy, and concerns about risks and burdens to institutions from resulting pregnancies. We argue that these rationales reflect structural and cultural barriers to women's inclusion in clinical research that ultimately fail to respect female research participants as persons, highlighting the need for broad-based solutions.