Journal of Empirical Research on Human Research Ethics最新文献

Informed consent is a guiding ethical principle when conducting research involving human participants. Yet, consent forms are often skimmed or ignored, jeopardizing informed consent. In two experiments, we test four interventions designed to encourage participants to read online consent forms more carefully. Experiment 1 employed a 2 (length: short or long) by 2 (timing: fixed or free) by 2 (quiz: present or absent) between-participants design. We measured instruction-following and comprehension of the consent form. Results showed that fixed timing and a quiz led to greater instruction-following, but consent form length had no effect. Experiment 2 employed a 2 (length: short or long) by 3 (delivery format: live, audiovisual, standard written) between-participants design. Once again, length had no effect, but both live and audiovisual formats increased instruction-following and comprehension. We recommend that researchers consider using fixed timing, adding a quiz, and/or using alternative delivery formats to help participants make an informed decision.

Behavioral and social science research (BSSR) studies are less stringently regulated compared to drug and device studies. At our university, internal quality assurance activities revealed BSSR studies have more, but similar, issues compared to other studies. However, most institutional resources are tailored to support drug and device research, leaving an evidence gap regarding effective strategies for fostering rigorous BSSR study conduct. Two campus units partnered to undertake a two-phase study. First, we characterized compliance issues based on BSSR study audit data. Second, we conducted interviews with behavioral researchers and others to discuss contributors to compliance issues and potential mitigating strategies. Through thematic analysis, we identified problems at that can be addressed at individual, study team, and university systems levels. Study results outline potential strategies to reduce compliance issues.

This study validates the Attitudes Toward Plagiarism (ATP) scale and investigates the interrelationships among its three constructs: positive attitudes, negative attitudes, and subjective norms regarding plagiarism. Data were collected from 720 students across two universities in Bangladesh. Exploratory factor analysis (EFA) was conducted on data from one university (n = 412), followed by confirmatory factor analysis (CFA) on data from another university (n = 308). The EFA extracted 20 items from the original 29-item ATP scale, while the CFA retained a 17-item version. Both analyses confirmed the ATP's original three-factor structure. Pearson's correlation and structural equation modeling (SEM) were performed using the total sample (n = 720) to examine the relationships among the constructs. The results of Pearson's correlation showed significant positive correlations among the ATP constructs. SEM analysis revealed that subjective norms significantly influenced positive attitudes, and positive attitudes significantly mediated the relationship between subjective norms and negative attitudes toward plagiarism.

This study examined the characteristics, experiences, motivations, and preferences of healthy volunteers participating in Phase I clinical trials in Sweden. A descriptive, cross-sectional survey was conducted among 135 healthy volunteers who had participated in at least one Phase I clinical trial from 2021 to 2024. Volunteers considered trial personnel, financial compensation, and regulatory review and approval as highly important factors in their decision to participate. Willingness to participate varied depending on trial characteristics, with greater reluctance for trials involving discomfort or perceived higher risks. Experiences, motivations, and preferences were comparable irrespective of age, gender, occupation, or income. Participants had disproportionately low incomes but reported financial satisfaction comparable to the general population. Unlike findings in other regions, there was no overrepresentation of migrants or the unemployed. Insights from this study can help guide trial design considerations to facilitate equitable recruitment and reduce the burden of participation.

Prospective research participants do not always retain information provided during consent procedures. This may be relatively common in online research and is considered particularly problematic when the research carries risks. Clinical psychology studies using the trauma film paradigm, which aims to elicit an emotional response, provide an example. In the two studies presented here, 112-126 participants were informed they would be taking part in an online study using a variant of this paradigm. The information was provided across five digital pages using either a standard or an interactive format. In both studies, compared to the control condition, participants in the interactive condition showed more retention of information. However, this was only found for information about which they had been previously asked via the interactive format. Therefore, the impact of adding interactivity to digital study information was limited. True informed consent for an online study may require additional measures.

The scope of medical training has expanded to encompass clinical skills and the ability to conduct and interpret scientific research. Therefore, medical students must develop an awareness of research and publication ethics to advance in their careers. This study aimed to understand medical students' perceptions of their first encounter with a research ethics committee. Qualitative methods were used to conduct three focus group interviews with students, and the data were thematically analysed. Findings revealed that the students had limited knowledge prior to their encounters, initially found the experience instructive yet challenging and negative, and later recognised its value. Students suggested enhancements to the practical and functional aspects of ethics committees and emphasised the need for ethics counselling in research.

This project evaluated the online implementation of a Responsible Conduct of Research/Professional Ethics Training for graduate students. The program was offered as a video-streamed remote, real-time training with an in-person option. Effectiveness of the remote program was evaluated using multiple measures: perceptions of ethical dilemmas, ethical decision-making, and reactions to the training. Pre-post training comparisons indicated participants' scores were lower after training on some outcomes. Results comparing training modalities suggest post-training reductions in scores were largely driven by remote participants. In-person participants performed significantly better on several measures compared to remote participants. All participants had favorable reactions to the program. Results suggest that putting an ethics training online may require an innovative approach to program development, better planning and preparation by the training institution, and more research, to determine the most effective way to proceed.

The research team, prospective participants, and written materials all influence the success of the informed consent process. As digital health research becomes more prevalent, new challenges for successful informed consent are introduced. This exploratory research utilized a human centered design process in which 19 people were enrolled to participate in one of four online focus-groups. Participants discussed their experiences with informed consent, preferences for receiving study information and ideas about alternative consent approaches. Data were analyzed using qualitative methods. Six major themes and sixteen sub-themes were identified that included study information that prospective participants would like to receive, preferences for accessing information and a desire to connect with research team members. Specific to digital health, participants expressed a need to understand how the technologies worked and how the volume of granular personal information would be collected, stored, and shared.