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Authors:Valerie J. Flaherman, Victoria Nankabirwa, Amy Sarah Ginsburg Abstract: Journal of Empirical Research on Human Research Ethics, Ahead of Print.
Citation: Journal of Empirical Research on Human Research Ethics PubDate: 2025-02-07T05:10:28Z DOI: 10.1177/15562646241301823
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Authors:Erik Rein-Hedin, Mårten Schultzberg, Folke Sjöberg, Fredrik Huss Abstract: Journal of Empirical Research on Human Research Ethics, Ahead of Print. AbstractThis 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. Citation: Journal of Empirical Research on Human Research Ethics PubDate: 2025-01-27T08:35:55Z DOI: 10.1177/15562646241309142
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Authors:Cheryl K. Stenmark Abstract: Journal of Empirical Research on Human Research Ethics, Ahead of Print. 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. Citation: Journal of Empirical Research on Human Research Ethics PubDate: 2025-01-20T05:27:33Z DOI: 10.1177/15562646251313577
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Authors:Brian J. McInnis, Ramona Pindus, Daniah Kareem, Camille Nebeker Pages: 175 - 185 Abstract: Journal of Empirical Research on Human Research Ethics, Volume 19, Issue 4-5, Page 175-185, October–December 2024. 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. Citation: Journal of Empirical Research on Human Research Ethics PubDate: 2024-10-14T08:11:06Z DOI: 10.1177/15562646241290078 Issue No:Vol. 19, No. 4-5 (2024)
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Authors:Karen M. Meagher, Sara Watson, Lia Kaz, Shawneequa Callier, Anya E.R. Prince, R. Jean Cadigan Pages: 186 - 196 Abstract: Journal of Empirical Research on Human Research Ethics, Volume 19, Issue 4-5, Page 186-196, October–December 2024. We demonstrate the fruitfulness of using card sort activities as an engagement method by detailing community consultation for ethical, legal, and social implications of sociogenomics. Readers are provided with a user-guide for card sort engagement through: (1) an overview of the card sort activity and its merits for engagement, (2) detailed methods of sorting for values-elicitation and prioritization goals, and (3) strategies to design this approach for other participatory research designs. Our intent is to add to meaningful exchanges between community engaged researchers and empirical bioethicists. Citation: Journal of Empirical Research on Human Research Ethics PubDate: 2024-11-12T06:16:29Z DOI: 10.1177/15562646241281802 Issue No:Vol. 19, No. 4-5 (2024)
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Authors:Harriet Nankya, Vincent Pius Alibu, Edward Wamala, Enock Matovu, John Barugahare Pages: 197 - 207 Abstract: Journal of Empirical Research on Human Research Ethics, Volume 19, Issue 4-5, Page 197-207, October–December 2024. To attain effective community engagement (CE) for genetics and genomics research (GGR) is a challenge. This study aimed to analyzed participants’ perspectives on how to attain effective CE for GGR in Uganda. A cross-sectional qualitative study involving in-depth interviews with twenty research ethics committee members and three national research regulators was conducted. GGR is faced with; low genetic literacy among stakeholders, social implications, cultural attitudes towards GGR, and lack of specific guidelines for CE in GGR. Attaining effective CE in GGR should involve; development of guidelines for GGR streamlining CE; boosting stakeholders’ Knowledge in GGR and CE; engagement beyond sensitization; and consensus decision-making. Overall, attaining effective CE in GGR requires addressing the key aspects unique to GGR. Citation: Journal of Empirical Research on Human Research Ethics PubDate: 2024-10-21T10:16:34Z DOI: 10.1177/15562646241289015 Issue No:Vol. 19, No. 4-5 (2024)
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Authors:Masanori Oikawa, Yoshiyuki Takimoto Pages: 208 - 219 Abstract: Journal of Empirical Research on Human Research Ethics, Volume 19, Issue 4-5, Page 208-219, October–December 2024. Through strengthened biobank governance, broad consent has been widely accepted as a means to replace donors’ discretion based on the information of individual research protocols. Trust and other ethical and social notions, such as reciprocity and solidarity, are key concepts that support biobank governance. The types of allowed broad consent are several; however, they remain unclear, and whether these ethical and social notions are associated with public attitudes toward the consent model is not fully understood. This quantitative study examined two hypotheses: narrower and limited broad consent are more accepted by the public, and acceptance rates for broad consent increase with established measures related to biobank governance. This analysis supported both hypotheses, implying that the limited type of broad consent should be considered an important option, and that a specific type of governance is critical in promoting trust, reciprocity, and solidarity between biobanks and the public. Citation: Journal of Empirical Research on Human Research Ethics PubDate: 2024-09-27T08:42:50Z DOI: 10.1177/15562646241286143 Issue No:Vol. 19, No. 4-5 (2024)
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Authors:Irene Jonathan, Eliza Akers, Min Shi, David B. Resnik Pages: 220 - 225 Abstract: Journal of Empirical Research on Human Research Ethics, Volume 19, Issue 4-5, Page 220-225, October–December 2024. Background: Historically, some of the worst abuses of human research participants have involved populations which are vulnerable to coercion, harm, or exploitation, such as prisoners, children, and people with compromised decision-making abilities. Although there has been considerable philosophical and ethical debate about how to protect vulnerable populations, there have been only a handful of empirical studies on vulnerable population policies. Methods: We conducted a cross-sectional study on vulnerable population policies from the 105 top funded U.S. academic research institutions. We used deductive and inductive methods to develop our framework for coding the policies. We tested for associations between policies and research and development expenditure rank, public vs. private status, geographic region, and Association for Accreditation of Human Research Protection Programs accreditation (AAHRRP). Results: U.S. academic institutions have a variety of policies for research with vulnerable populations. Every institution in our sample had at least 2 policies for research with vulnerable populations (including a general policy) and most had 8 or more. As expected, the most highly prevalent policies pertained to populations covered in subparts B, C, and D of the Common Rule (pregnant women, fetuses, neonates, prisoners, and children) but other groups were well-represented, including people with disabilities; people with impaired decision-making capacity; students/trainees; and people with limited English proficiency including illiteracy. AAHRRP accreditation was positively associated with eight different types of policies. Conclusion: U.S. academic institutions have a variety of policies for research with vulnerable populations. Additional research is needed to better understand the types of safeguards that institutions have adopted to protect vulnerable populations and the factors that influence policy development. Citation: Journal of Empirical Research on Human Research Ethics PubDate: 2024-10-18T06:48:40Z DOI: 10.1177/15562646241290093 Issue No:Vol. 19, No. 4-5 (2024)
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Authors:Isaac O. Dipeolu, Douglas R. Wassenaar Pages: 238 - 249 Abstract: Journal of Empirical Research on Human Research Ethics, Volume 19, Issue 4-5, Page 238-249, October–December 2024. Journal editors instruct authors to describe human participant protections in original research reports. However, little is known about African biomedical journal authors’ adherence to such journal editors’ instructions. This study investigated changes in editors’ instructions to authors and authors’ reporting of research ethics information in selected African biomedical journals between 2008 and 2017. Twelve selected journal websites and online articles were reviewed in Eastern, Southern, and Western African [ESWA] countries. A pre-tested schema and a checklist were used to collect data from journal websites and articles published in 2008 and 2017, and the data were analysed using descriptive and inferential statistics. Half of the journals requested prospective authors to disclose ethics approval and related issues in their manuscripts between 2008 and 2017. There was a significant increase in instructions to authors regarding information on the protection of research participants within this period; more authors complied with these requirements in 2017 than in 2007. Citation: Journal of Empirical Research on Human Research Ethics PubDate: 2024-09-02T09:06:12Z DOI: 10.1177/15562646241276237 Issue No:Vol. 19, No. 4-5 (2024)
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Authors:Susan L. Murphy, Timothy C. Guetterman, Elizabeth K. Haro, Sana Shakour Abstract: Journal of Empirical Research on Human Research Ethics, Ahead of Print. 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. Citation: Journal of Empirical Research on Human Research Ethics PubDate: 2024-12-18T09:36:15Z DOI: 10.1177/15562646241302396
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Authors:Abdullah Yıldız, Ayşe Kurtoğlu, Berna Arda Abstract: Journal of Empirical Research on Human Research Ethics, Ahead of Print. 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. Citation: Journal of Empirical Research on Human Research Ethics PubDate: 2024-12-05T08:38:04Z DOI: 10.1177/15562646241301824
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Authors:Gabrielle Samuel, Doug Wassenaar Abstract: Journal of Empirical Research on Human Research Ethics, Ahead of Print.
Citation: Journal of Empirical Research on Human Research Ethics PubDate: 2024-11-27T06:06:50Z DOI: 10.1177/15562646241296712
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Authors:Marije aan het Rot, Ineke Wessel Abstract: Journal of Empirical Research on Human Research Ethics, Ahead of Print. 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. Citation: Journal of Empirical Research on Human Research Ethics PubDate: 2024-08-28T03:03:39Z DOI: 10.1177/15562646241280208
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Authors:Tanya Doherty, Max Kroon, Catherine Pereira-Kotze Abstract: Journal of Empirical Research on Human Research Ethics, Ahead of Print. This is a correspondence letter in response to an article published in the journal: Flaherman VJ, Nankabirwa V, Ginsburg AS. Promoting Transparent and Equitable Discussion of Controversial Research. Journal of Empirical Research on Human Research Ethics 2023; 18(4): 248–9. Citation: Journal of Empirical Research on Human Research Ethics PubDate: 2024-04-08T05:28:54Z DOI: 10.1177/15562646241246369
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Authors:Gungor Buket First page: 226 Abstract: Journal of Empirical Research on Human Research Ethics, Ahead of Print. Clinical studies are reviewed by clinical research ethics committees (CRECs) in order to ensure that they are conducted within the framework of good clinical practice and that the rights of volunteers are respected. Research type, department, status, scope, principal investigator's characteristics and CREC decisions were all evaluated. A total of 1044 research applications were found to have been submitted. In addition, 14.6% of the applications were clinical trials and 48.8% were retrospective studies. Of all the researchers, 50.4% of them were found to have indicated an incorrect type of research. The very low number of interventional clinical trials suggests that researchers tended to be hesitant about conducting such trials or did not have the means to do so. The fact that the applications were often submitted by indicating a wrong type of research method also signifies the investigators’ lack of knowledge in this regard. Citation: Journal of Empirical Research on Human Research Ethics PubDate: 2024-08-09T08:32:59Z DOI: 10.1177/15562646241273162
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Authors:Hinpetch Daungsupawong, Viroj Wiwanitkit First page: 236 Abstract: Journal of Empirical Research on Human Research Ethics, Ahead of Print.
Citation: Journal of Empirical Research on Human Research Ethics PubDate: 2024-08-09T08:33:29Z DOI: 10.1177/15562646241273804
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Authors:Elsayed Abdelkreem, Maha Emad Ibrahim, Sawsan Elateek, Fatma Abdelgawad, Henry J. Silverman First page: 250 Abstract: Journal of Empirical Research on Human Research Ethics, Ahead of Print. Problem: Investigations regarding perceptions of the institutional research integrity climate in the Arab Middle East remain underexplored. Subjects: We surveyed faculty from three Egyptian universities. Method: We utilized the Survey of Organizational Research Climate (SOuRCe) tool, which incorporates seven subscales that measure different aspects of the research integrity climate. Responses were obtained from a 5-point Likert scale. Findings: Of the 228 participants, the subscales ‘Regulatory Quality’ and ‘[Lack of] Integrity Inhibitors’ received the highest mean scores, whereas the lowest scores pertained to ‘Departmental Expectations,’ ‘Integrity Socialization,’ and ‘Responsible Conduct of Research´ indicating areas in need of improvement. Conclusions: Academic leaders should set fairer expectations for research and funding for their researchers, ensure junior researchers are socialized into research integrity practices, and promote effective RCR training and availability of RCR policies. We identify specific targeted interventions to enhance the research integrity climate within these institutions. Citation: Journal of Empirical Research on Human Research Ethics PubDate: 2024-08-09T08:29:30Z DOI: 10.1177/15562646241273097
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