Assessing the Decision-Making Capabilities of Artificial Intelligence Platforms as Institutional Review Board Members.

Background: Institutional review boards (IRBs) face delays in reviewing research proposals, underscoring the need for optimized standard operating procedures (SOPs). This study assesses the abilities of three artificial intelligence (AI) platforms to address IRB challenges and draft essential SOPs. Methods: An observational study was conducted using three AI platforms in 10 case studies reflecting IRB functions, focusing on creating SOPs. The accuracy of the AI outputs was assessed against good clinical practice (GCP) guidelines. Results: The AI tools identified GCP issues, offered guidance on GCP violations, detected conflicts of interest and SOP deficiencies, recognized vulnerable populations, and suggested expedited review criteria. They also drafted SOPs with some differences. Conclusion: AI platforms could aid IRB decision-making and improve review efficiency. However, human oversight remains critical for ensuring the accuracy of AI-generated solutions.

Adolescents' and Parents' Perspectives on a Novel Decision-Making Process for Return of Results in Genomic Research.

To understand whether they found a two-step decision process helpful and why, adolescent-parent dyads participating in a study investigating return of genomic testing results were asked about their decision-making experience. Responses were qualitatively coded and analyzed using thematic analysis. Adolescents and parents found both joint and independent decision-making stages helpful. Regarding independent decision-making, adolescents appreciated exercising independence, while parents valued both adolescent and parental independence. Joint decision-making allowed each to hear the other's viewpoints. Some found joint decision-making irrelevant but recognized it might help others. Overall, adolescents and parents had similar reasons for finding the two-step decision-making process helpful. Our findings support using such a process for engaging parents and adolescents in challenging research and clinical decisions.

Patients' knowledge about their involvement in clinical trials. A non-randomized controlled trial.

Background: Nowadays, good clinical practice should be established in human research. Patient's rights and autonomy must be respected above the interest of the researcher, making mandatory to raise patient's awareness on the implications of participating in a clinical study. Contrary to popular belief, this is not always the case. This means that, after signing the informed consent form, some patients have difficulties understanding their responsibilities as participants. Materials and methods: This study is a prospective, multicenter, non-randomized controlled trial comparative survey conducted on patients enrolled in a clinical trial to evaluate and improve their understanding after an educational intervention was applied to the research staff. Results: Females were underrepresented in the clinical trials performed in this study, 21.5%. Most of the participants had a low educational level (74.4%). Around 5 and 10% of the research participants were not aware they were part of a clinical study, and more 24% just trusted in the medical decision to be enrolled. After the interventional education, the following items: "given time and resolution of the patient doubts" (p-value = 0.003), "enough written information" (p-value = 0.006), "explanation of the risks of participating in the study," (p-value = 0.047) and understanding of the information provided to them showed an improvement regarding the study in which they were participating. Conclusion: The research participants understanding of their involvement in clinical trials is limited. An educational intervention on the research team can improve the process of empowerment and transit of information.

Providing Public Engagement Training to Build Connections Between the Community and Research Ethics Professionals: A Pilot Project.

There is growing interest for research ethics professionals to engage with members of the public, yet they often lack the training needed to engage effectively. The STEM Ambassador Program provides a promising framework for training research ethics professionals to form authentic community connections and carry out effective engagement activities based on shared interests and values. The experiences of ten research administrators who participated in a pilot of the STEM Ambassador training for research ethics professionals are presented. Post-training surveys of the research administrators indicate that they valued the training and the skills obtained, and intend to continue with public engagement activities with support of their leadership.

"Repeated Hierarchies": Uneven Participation in Research of Ethical Spaces in Hospitals.

We present a case study of uneven participation in a focus group discussion with health care professionals involved in local ethical committees. We conclude that the status of the different participants did not give adequate space for full participation of the members involved. Two commentators were invited to comment on the case study to enable further reflection on the methodology used for the target group. The first reviewer investigated whether research should address power relations and hierarchies of knowledge encountered in the study process. She also discussed whether researchers should be held ethically and politically responsible for the consequences of producing relations and hierarchies. The second reviewer looked at what focus groups say about professional practices in hospitals, what participants are willing (or unwilling) to invest, and what are the conditions for setting up ethical reflection.

"Stop Talking to People; Talk with Them": A Qualitative Study of Information Needs and Experiences Among Genetic Research Participants in Pakistan and Denmark.

This article explores how research participants experienced information practices in an international genetic research collaboration involving the collection of biomaterial and clinical data in both Pakistan and Denmark. We investigated how people make sense of their research participation and the types of information they need and desire. We found great variation in what information exchange does and what participants experience as meaningful. For example, information practices could serve as a source of respect and recognition (in Denmark) or of hope, understanding or help when dealing with suffering (in Pakistan). Policies aimed at harmonizing ethics standards for international research do not encapsulate some of the most important aspects of information practices for the research participants involved. We suggest shifting the focus from standards of one-way information delivery to a more process-oriented form of research ethics, where the contextual exploration of local needs through a mutual engagement with participants gains more ground.

Are Well-Informed Potential Trial Participants More Likely to Participate?

Bearing in mind the importance of the informed consent, flaws in this process may be a barrier to participants' recruitment. Our objective was to determine the relationship between the degree of comprehension of the informed consent document plus the importance given to individual elements by potential participants of a hypothetical trial and their willingness to participate in such trials. We performed an Online Survey simulating an emergency department trial recruitment, posteriorly evaluating participants' ratings of importance and self-assessed comprehension of specific topics of the informed consent document. Only 10% of the sample read the entire document. Some specific topics were associated with willingness to participate in the hypothetical trial, but simple composite additive scores of comprehension and importance were not. We concluded that participants in general do not read the entire informed consent document and that importance given to specific topics may influence willingness to participate.

". . . I've Gone Through This My Own Self, So I Practice What I Preach . . . ".

There has not been enough study of the processes by which site staff help participating community members and potential participants to understand complicated concepts for HIV vaccine trials. This article describes strategies reported in six focus group discussions with Community Advisory Board members, educators, and consent counselors at an active HIV vaccine trial site in South Africa. Thematic analysis identified a considerable range of strategies, and findings suggest that such staff do not only try to promote understanding of critical information but also try to build trust in communicated information, to respect cultural differences, and to promote voluntariness. Findings also suggest occasional tensions between these implicit goals. Actual engagement and consent encounters at HIV vaccine trial sites should be observed, recorded, and analyzed; and the relationship between practices and valued outcomes should be assessed. These efforts may help to make consent-related encounters as "potent" as possible given finite resources.

Ethics Review for a Multi-Site Project Involving Tribal Nations in the Northern Plains.

Increasingly, Tribal Nations are forming ethics review panels, which function separately from institutional review boards (IRBs). The emergence of strong community representation coincides with a widespread effort supported by the U.S. Department of Health & Human Services and other federal agencies to establish a single IRB for all multi-site research. This article underscores the value of a tribal ethics review board and describes the tribal oversight for the Safe Passage Study-a multi-site, community-based project in the Northern Plains. Our experience demonstrates the benefits of tribal ethics review and makes a strong argument for including tribal oversight in future regulatory guidance for multi-site, community-based research.