BACKGROUND: In recognition of their status as a health disparities population, there is growing emphasis on conducting research inclusive of adults with intellectual disability to generate new knowledge and opportunities to improve health and equity. Yet they are often excluded from research, and human research participant protection experts and researchers lack agreement on effective consent protocols for their inclusion.
OBJECTIVE: We sought to identify approaches to consent in US-based social-behavioral research with adults with intellectual disability.
METHODS: We conducted a systematic review on approaches to self-consent with adults with intellectual disability published between 2009 and 2023, identified via searching eight databases and reference list hand searches. We identified 13 manuscripts and conducted a thematic analysis.
RESULTS: Our analysis identified themes related to guiding principles, strategies to enhance informed and voluntary consent, approaches to consent capacity, involving individuals subject to guardianship, and strategies for expressing decisions and enhancing ongoing decisions.
CONCLUSIONS: Manuscripts largely reflected an emphasis on identifying approaches to consent that reflect disability rights principles to promote the right to be included and make one\'s own decisions based on assessment of relevant information, risks and benefits, and to employ reasonable modifications to achieve inclusion. To avoid the risks of exclusion and advance the responsible inclusion of adults with intellectual disability, we make recommendations to align consent approaches anchored in contemporary thinking about human research participant protections, including through integration with disability rights.

A leading concern about single IRB (sIRB) review for multisite studies, as is now required by federal policies, is whether and how sIRBs consider local context in their review. While several types of local context considerations have been proposed, there is no shared agreement among those charged with the ethics oversight of human subjects research as to the goals and content of local context review, nor the types of research studies for which sIRB review might be inappropriate. Through a scoping review of published scholarship, public comments, and federal guidance documents, we identified five assumed goals for local context review: protecting the rights and welfare of local participants; ensuring compliance with applicable laws and policies; assessing feasibility; promoting the quality of research; and promoting procedural justice. While a variety of content was proposed to be relevant, it was largely grouped into four domains: population/participant-level characteristics; investigator and research team characteristics; institution-level characteristics; and state and local laws. Proposed characteristics for exclusion from sIRB requirements reflected both protection- and efficiency-based concerns. These findings can inform ongoing efforts to assess the implications of policies mandating sIRB review, and when exceptions to those policies might be appropriate.

Soft skills are the elementary management, personal, and interpersonal abilities that are vital for an individual to be efficient at workplace or in their personal life. Each work place requires different set of soft skills. Thus, in addition to scientific/technical skills that are easier to access within a short time frame, several key soft skills are essential for the success of a researcher in today\'s international work environment. In this paper, the trainees and trainers of the EU-CardioRNA COST Action CA17129 training school on soft skills present basic and advanced soft skills for early career researchers. Here, we particularly emphasize on the importance of transferable and presentation skills, ethics, literature reading and reviewing, research protocol and grant writing, networking, and career opportunities for researchers. All these skills are vital but are often overlooked by some scholars. We also provide tips to ace in aforementioned skills that are crucial in a day-to-day life of early and late career researchers in academia and industry.

UNASSIGNED: Asia hosts the second-largest international migrant population in the world. In Southeast Asia (SEA), key types of migration are labour migration, forced migration, and environmental migration. This scoping review seeks to identify key themes and gaps in current research on the ethics of healthcare for mobile and marginalised populations in SEA, and the ethics of research involving these populations.
UNASSIGNED: We performed a scoping review using three broad concepts: population (stateless population, migrants, refugees, asylum seekers, internally displaced people), issues (healthcare and ethics), and context (11 countries in SEA). Three databases (PubMed, CINAHL, and Web of Science) were searched from 2000 until May 2023 over a period of four months (February 2023 to May 2023). Other relevant publications were identified through citation searches, and six bioethics journals were hand searched. All searches were conducted in English, and relevant publications were screened against the inclusion and exclusion criteria. Data were subsequently imported into NVivo 14, and thematic analysis was conducted.
UNASSIGNED: We identified 18 papers with substantial bioethical analysis. Ethical concepts that guide the analysis were \'capability, agency, dignity\', \'vulnerability\', \'precarity, complicity, and structural violence\' (n=7). Ethical issues were discussed from the perspective of research ethics (n=9), clinical ethics (n=1) and public health ethics (n=1). All publications are from researchers based in Singapore, Thailand, and Malaysia. Research gaps identified include the need for more research involving migrant children, research from migrant-sending countries, studies on quality of migrant healthcare, participatory health research, and research with internal migrants.
UNASSIGNED: More empirical research is necessary to better understand the ethical issues that exist in the domains of research, clinical care, and public health. Critical examination of the interplay between migration, health and ethics with consideration of the diverse factors and contexts involved is crucial for the advancement of migration health ethics in SEA.

OBJECTIVE: The aim of this study was to review hospital-based health information system (HIS) studies that used qualitative research methods and evaluate their methodological contexts and implications. In addition, we propose practical guidelines for HIS researchers who plan to use qualitative research methods.
METHODS: We collected papers published from 2012 to 2022 by searching the PubMed and CINAHL databases. As search keywords, we used specific system terms related to HISs, such as \"electronic medical records\" and \"clinical decision support systems,\" linked with their operational terms, such as \"implementation\" and \"adaptation,\" and qualitative methodological terms such as \"observation\" and \"in-depth interview.\" We finally selected 74 studies that met this review\'s inclusion criteria and conducted an analytical review of the selected studies.
RESULTS: We analyzed the selected articles according to the following four points: the general characteristics of the selected articles; research design; participant sampling, identification, and recruitment; and data collection, processing, and analysis. This review found methodologically problematic issues regarding researchers\' reflections, participant sampling methods and research accessibility, and data management.
CONCLUSIONS: Reports on the qualitative research process should include descriptions of researchers\' reflections and ethical considerations, which are meaningful for strengthening the rigor and credibility of qualitative research. Based on these discussions, we suggest guidance for conducting ethical, feasible, and reliable qualitative research on HISs in hospital settings.

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.

This case study analyzes the expertise, potential conflicts of interest, and objectivity of editors, authors, and peer reviewers involved in a 2022 special journal issue on fertility, pregnancy, and mental health. Data were collected on qualifications, organizational affiliations, and relationships among six papers\' authors, three guest editors, and twelve peer reviewers. Two articles were found to have undisclosed conflicts of interest between authors, an editor, and multiple peer reviewers affiliated with anti-abortion advocacy and lobbying groups, indicating compromised objectivity. This lack of transparency undermines the peer review process and enables biased research and disinformation proliferation.Our study is limited by a few factors including: difficulty collecting peer reviewer data, potentially missing affiliations, and a small sample without comparisons. While this is a case study of one special issue, we do have suggestions for increasing integrity.

Refugees and asylum seekers may experience challenges related to pre-arrival experiences, structural disadvantage after migration and during resettlement requiring the need for special protection when participating in research. The aim was to review if and how people with refugee and asylum seeker backgrounds have had their need for special protection addressed in national and international research ethics guidelines. A systematic search of grey literature was undertaken. The search yielded 2187 documents of which fourteen met the inclusion criteria. Few guidelines addressed specific ethical considerations for vulnerable groups much less people with refugee and asylum seeker backgrounds. One guideline explicitly addressed vulnerability for refugees and asylums seekers. To ensure members of ethics committees and researchers consider the potential challenges of conducting research with these groups, guidelines may need to be supplemented with a refugee and asylum seeker specific research ethics framework. Such a framework may be necessary to optimally protect people with refugee and asylum seeker backgrounds in research.

Research engaging children and adolescents living with HIV (CALWH) is critical for youth-friendly services and HIV care, and researchers need to ensure that such engagement is ethical. We conducted a systematic review to identify key ethical considerations for the engagement of CALWH in research. The review focused on primary research articles conducted in African countries that examined ethical issues in CALWH engaged in research. Ten studies met the inclusion criteria; the following seven key domains were extracted: 1) justifications for engaging CALWH in research; 2) community involvement; 3) informed consent/assent; 4) caregiver involvement; 5) perceptions of benefits; 6) perception of the risks of involvement; and 7) confidentiality. These domains can inform the ethical engagement of CALWH in research.

YouTube has become a popular source of health care information, reaching an estimated 81% of adults in 2021; approximately 35% of adults in the United States have used the internet to self-diagnose a condition. Public health researchers are therefore incorporating YouTube data into their research, but guidelines for best practices around research ethics using social media data, such as YouTube, are unclear.
This study aims to describe approaches to research ethics for public health research implemented using YouTube data.
We implemented a systematic review of articles found in PubMed, SocINDEX, Web of Science, and PsycINFO following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. To be eligible to be included, studies needed to be published in peer-reviewed journals in English between January 1, 2006, and October 31, 2019, and include analyses on publicly available YouTube data on health or public health topics; studies using primary data collection, such as using YouTube for study recruitment, interventions, or dissemination evaluations, were not included. We extracted data on the presence of user identifying information, institutional review board (IRB) review, and informed consent processes, as well as research topic and methodology.
This review includes 119 articles from 88 journals. The most common health and public health topics studied were in the categories of chronic diseases (44/119, 37%), mental health and substance use (26/119, 21.8%), and infectious diseases (20/119, 16.8%). The majority (82/119, 68.9%) of articles made no mention of ethical considerations or stated that the study did not meet the definition of human participant research (16/119, 13.4%). Of those that sought IRB review (15/119, 12.6%), 12 out of 15 (80%) were determined to not meet the definition of human participant research and were therefore exempt from IRB review, and 3 out of 15 (20%) received IRB approval. None of the 3 IRB-approved studies contained identifying information; one was explicitly told not to include identifying information by their ethics committee. Only 1 study sought informed consent from YouTube users. Of 119 articles, 33 (27.7%) contained identifying information about content creators or video commenters, one of which attempted to anonymize direct quotes by not including user information.
Given the variation in practice, concrete guidelines on research ethics for social media research are needed, especially around anonymizing and seeking consent when using identifying information.
PROSPERO CRD42020148170; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=148170.