Journal of Empirical Research on Human Research Ethics最新文献

Many institutional review board (IRB) members often classify online sexual and behavioral health surveys as not meeting the minimal risk standard under the Code of Federal Regulation (CFR) due to concerns that answering sensitive or controversial topics may cause discomfort. However, college students' comfortability in responding to such topics remains unknown. Undergraduate college students (n = 123) were asked about their comfort level in answering online survey questions about their sexual behaviors, alcohol use, drug use, and mental health. Additionally, the study examined demographic differences in comfort levels. Few participants reported overall discomfort when answering online survey questions about their sexual and behavioral health, and minimal demographic differences were found. Some IRB members may overestimate the discomfort participants experience when answering surveys about sexual behaviors, substance use, and mental health. Findings support the argument that online sexual and behavioral health surveys may meet the CFR criteria for minimal risk.

While clinical trials are essential to improving public health, little research has examined the range of recruitment techniques used or whether they involve behavioral nudges. Behavioral nudges have been defined as "any aspect of the choice architecture [the manner in which options are presented] that alters people's behavior in a predictable way without forbidding any options or significantly changing their economic incentives"; these may influence individuals' autonomy in deciding to participate. To investigate, the study team conducted 39 semi-structured interviews with clinical trial recruiters at two academic medical centers, asking about their recruitment techniques and any perceived ethical concerns. Through inductive qualitative analysis, five main themes emerged: impact of relationships (among recruiters, healthcare teams, and participants), financial compensation, community benefit, study risks and benefits, and personalized study information. The study then assessed whether these techniques were seen as nudges and explored their ethical implications for informed decision-making.

Human Genomic Research (HGR) has contributed to public health advancement by identifying disease susceptibility and resistance. However, HGR is surrounded by several ethical, legal, and societal concerns. This qualitative research study explored the perspectives of REC members in Ethiopia on the ethical challenges of HGR. Two focus group discussions consisting of nine REC members were conducted on November 24, 2022, and March 22, 2023. A thematic analysis was conducted using MAXQDA Analysis Software. The study highlighted several important ELSIs related to HGR, including the inadequacy of HGR literacy at all levels: research participants, researchers, and RECs; unsatisfactory quality of consent; the vulnerability of HGR participants; and the lack of a legal framework to govern the acquisition, storage, use, and sharing of genomic data. Therefore, improving HGR literacy at all levels and introducing a legal framework to govern the protection of research participants of HGR is urgently needed.

Informed consent (IC) is a critical component in research involving human participants, yet participants' understanding of consent information remains underexplored, particularly in vulnerable populations. This study aimed to assess whether attention deficit hyperactivity disorder (ADHD) was associated with understanding and willingness to sign the IC among detained individuals. This secondary analysis used data from a randomised trial conducted in a Swiss prison (n = 183). Statistical analyses included regression models. There was no significant difference in understanding of the IC between the groups with and without positive screening for ADHD (mean score = 5.2 vs. 4.9 respectively, p = .468). Acceptance of signing the IC was comparable between groups (83.3% ADHD vs. 84.9% non-ADHD, p = .814). Our findings suggest that ADHD did not significantly impair the understanding of the IC or the decision to participate in research among detained individuals. However, the level of understanding was overall low, highlighting the need for tailored approaches to improve understanding in vulnerable populations.

Background: Unwarranted exclusion of people with uncertain or impaired decision-making capacity from participation in research violates principles of justice and fairness and adversely impacts the health and welfare of these populations. Methods: We conducted a cross-sectional study of institutional review board (IRB) policies for investigators and IRB members at 94 top-funded U.S. research institutions to better understand the guidance they provide to investigators who work with populations that have a wide range in decisional capacity. We collected data from publicly available websites and used deductive and inductive methods to develop our coding framework. Results: We found that 41.5% of institutions had policies that require exclusion of people with uncertain or impaired decision-making capacity unless inclusion is scientifically justified. Only 5.3% had policies that require inclusion of these populations unless exclusion is scientifically justified. Eligibility criteria depended upon the risks of research in 54.3% of policies. Guidance on obtaining consent or assent was provided in 77.7% of policies and 44.7% provided guidance on assessing decision-making capacity. 30.9% of policies required that the IRB include a member who is knowledgeable of the needs and concerns of people with uncertain or impaired decision-making capacity when it reviews research pertaining to that population. Conclusion: Some IRB policies at U.S. research institutions may be unfairly excluding people with uncertain or impaired decision-making from research participation. Institutions should review their IRB policies to ensure that these policies protect adults with uncertain or impaired decision-making capacity from harm but also do not exclude them from research unfairly.

Genomic research is challenged by many ethical issues, especially in low-resource locations. To determine the views and perspectives of research participants regarding these ethical challenges, two hundred and eight potential research participants were interviewed. Views regarding basic genetic knowledge, return of research results and incidental findings and secondary data use were elicited. Overall, 87.5% of participants were aware of genomic research. About 95.7% of participants had poor basic genetic knowledge, while 15.4% had an understanding of the concept of genetic research. Most participants (92.3% and 82.2% respectively) expressed preference for return of research results and incidental findings. One hundred and forty-nine participants (71.6%) expressed reservation regarding future unspecified use of their blood sample and medical information while 76.4% expressed concern regarding data sharing with other researchers. Optimal consideration should be given to participants' preferences in the design of genomic research protocols.

Low and middle-income countries (LMICs) in Eastern Europe are attractive to global companies as sites for clinical trials, but there are gaps in research oversight and limited in-country expertise in research ethics, raising concerns that research participants may be at risk of exploitation and harm. Three NIH Fogarty International Center-funded research ethics training programs in Eastern Europe address these gaps, developed by partnerships between: the Icahn School of Medicine at Mount Sinai (ISMMS) in New York and the Medical Faculty at the University of Belgrade in Serbia; ISMMS and the Iuliu Haţieganu University of Medicine and Pharmacy in Cluj-Napoca, Romania; and Ukrainian Catholic University in Lviv, Ukraine, and Loyola University Chicago. Here we provide an overview of the health systems and research activity in the region as well as the rationales, aims, accomplishments, and future needs of these Master's (Serbia and Romania) and doctoral-level (Ukraine) research ethics training programs.

Ten years have passed since the last regional assessment of the state of Fogarty International Center-funded research ethics education and challenges facing research ethics in Latin America and the Caribbean basin. Program directors and faculty from four international research ethics education programs met in Spring 2024 to discuss their progress, challenges, and future priorities. The themes that emerged from these discussions were the structural difficulties faced by regional ethicists, the use of pedagogical innovations to mitigate different barriers faced by fellows, and the need to anticipate future challenges for the region including climate change.

Several Asian countries, including India, Malaysia, Myanmar, and Pakistan, face challenges aligning rapid healthcare and biomedical research growth with necessary ethics oversight. To help address this, the Fogarty International Center of the United States National Institutes of Health funded initiatives to enhance research ethics capacities in these countries. In India, the Yenepoya University's Master's in Research Ethics program was established in collaboration with Monash University. In Malaysia, the Master of Health Research Ethics (MOHRE) program, based at Universiti Malaya, was developed in collaboration with the Johns Hopkins University. In Myanmar, a Diploma in Research Methodology and Research Ethics (DipRMRE) was introduced in cooperation with the University of Maryland Baltimore. In Pakistan, a Master of Bioethics (MBE) program was designed to address the country's unique ethical challenges in healthcare and research. Graduates from these programs have significantly contributed to health research and policy, enhancing research ethics infrastructure across these diverse Asian countries.

The Middle East Research Ethics Training Initiative (MERETI), established in 2004 with funding from the Fogarty International Center at the NIH, aimed to enhance research ethics capacity in the Middle East North Africa (MENA) region. Initially focused on Egypt, MERETI expanded to other Arab countries, providing advanced training in international research ethics to over 100 individuals. The program emphasized additional skills in research methodology, pedagogy, scientific writing, and leadership. MERETI's training evolved from a one-year program to a two-year model incorporating sequential hybrid/blended and asynchronous online components and, eventually, included a fully online 12-credit graduate certificate in research ethics. The program's impact is demonstrated through the professional achievements of its trainees, which included publishing in peer-reviewed journals, assuming key roles in national research ethics committees and ministries of health and contributing to the development of ethics research practices in their respective countries. MERETI also fostered a sustainable Egyptian network of research ethics committees.