Human Subjects Research Research Articles

Evaluating the impact of different hard hats on the peripheral vision of construction workers

Construction safety is always an issue for construction workers. Hence, personal protective equipment plays a critical role in avoiding potential hazards on construction sites. Among these, hard hats protect against head contact with falling objects on construction sites. This study aims to examine the effects of hard hats with different peak lengths on the field of view at different angles in the upward part and to examine the effects of possible field of view losses caused by the hard hat on the reaction times of the workers. A questionnaire was designed and administered to the construction workers. Experiments were then conducted with a group of subjects to assess their peripheral vision level as well as reaction times. The study found that peripheral vision is affected by the peak size of hard hats. The study further revealed that there is a significant relationship between reaction times and hard hat peak size.

Does anesthesia duration or number of cases per patient predict safety events?

The need for dental rehabilitation under general anesthesia is increasing, with varying needs between patients. Mortality has been found to be a rare event in these patients; however other perioperative events can and do occur. Previous studies have established increased incidence of perioperative events with younger, sicker children, and longer anesthetics, however, no studies to date have evaluated if the incidence of perioperative events is more closely associated with one long anesthetic or multiple anesthetics per patient. To evaluate the association of perioperative events related to single anesthetic duration or number of anesthetics per patient for dental rehabilitation. After Children's Wisconsin Human Research Protection Program determined this quality activity did not meet the definition of human subjects research, we performed an epidemiologic observational evaluation by extracting all dental related cases (dental alone or with oral surgeon vs. dental with other specialties) with an associated general anesthesia encounter from Children's Wisconsin electronic data warehouse from June 1, 2015 to December 31, 2021. These cases occurred at a free-standing children's hospital or associated pediatric-only ambulatory surgery center. The risk of perioperative safety events was analyzed for previously identified risk groups such as American Society of Anesthesiologists Physical Status (ASA-PS), patient age, anesthesia case time with the addition of number of dental cases per patient. In this study, 8468 procedures were performed on 8082 patients. Of this cohort, 7765 patients underwent one procedure for dental care while 317 patients underwent a total of 703 dental-related procedures, ranging from two to five procedures per patient. Multivariable logistic regression identified increased risk of perioperative events in patients with ASA-PS 3 (n = 1459, rate 1.78%, p value .001, OR 5.7, CI 2.1-15.5) and ASA-PS 4 (n = 86, rate 5.8%, p < .001, OR 17.2, CI 4.4-67.3), anesthesia duration (p < .001, OR 1.46, CI 1.21-1.76), but no increased risk with number of anesthetics per patient (p value .54, OR 0.81, CI 0.4-1.61). Limiting dental care under general anesthesia to multiple short cases may decrease the risk of perioperative events when compared to completing all treatment in one long operative session.

Limits of ethical non-human subjects research in an applied setting.

Ethical research follows numerous rules and regulations to ensure that all human subjects are protected during the collection and dissemination of research outcomes. Nevertheless, there is often a critical distinction drawn between human subjects research and non-human subjects research (NHSR). The latter can also be described as non-research activities, which typically reduces any oversight even if human subjects are involved. Despite the need to conduct ethical NHSR or non-research activities in an applied setting, there are several ways this determination can be used to circumvent regulatory oversight. In particular, the problem arises because one or more of several key functions become conflated in an applied setting, whereas they would be compartmentalized and independent in controlled or experimental settings. These functions include: 1) ethical oversight; 2) funding; 3) execution; and 4) peer review. The current discussion outlines how NHSR in an applied setting can allow these functions to overlap, and how personnel might stretch the boundaries of ethical conduct even while following existing regulations. As such, the goal is to guide future practices when conducting or reviewing NHSR in an applied setting so that unethical practices do not bias the results.

The Diaspora Human Genomics Institute Launches the Together for Change Initiative: A Transformative, Historic Partnership to Ensure Health Equity in a Time of Unprecedented Technological Advancements

Abstract: Human subjects research and drug and device development currently base their findings largely on the genetic data of the non-Hispanic White population, excluding People of Color. This practice puts People of Color at a distinct and potentially deadly disadvantage in being treated for sickness, disability, and disease, as seen during the COVID-19 pandemic. Major disparities exist in all chronic health conditions, including cancer. Data show that less than 2% of genetic information being studied today originates from people of African ancestry. If genomic datasets do not adequately represent People of Color, new drugs and genetic therapies may not work as well as for people of European descent. Addressing the urgent concern that historically marginalized people may again be excluded from the next technological leap affecting human health and the benefits it will bring will requires a paradigm shift. Thus, on behalf of underserved and marginalized people, we developed the Together for CHANGE (T4C) initiative as a unique collaborative public-private partnership to address the concern. The comprehensive programs designed in the T4C initiative, governed by the Diaspora Human Genomics Institute founded by Meharry Medical College, will transform the landscape of education and health care and positively affect global Black communities for decades to come.

Avoiding Past Mistakes in Unethical Human Subjects Research: Moving From Artificial Intelligence Principles to Practice

Avoiding Past Mistakes in Unethical Human Subjects Research: Moving From Artificial Intelligence Principles to Practice

Introducing the Theory of Neurosocial Interdependence

Thoughts, emotions, and behaviors are linked fundamentally to the environments one inhabits. The person-in-environment perspective effectively captures these three aspects of the human experience and serves as a central fixture within social work research and practice. Many social workers use this perspective to guide every facet of the work they undertake, from case conceptualization to ethics of human subject research. At the same time, recent advancements in human neuroscience research and neuroimaging technologies have inspired social workers to embrace how the nervous system is integrally interconnected with one’s environments. In turn, human neuroscience has catalyzed more biologically-informed practice and research in the field of social work, centered on elucidating social and psychological developmental domains within systems. The popularity of the person-in-environment perspective and the integration of human neuroscience in the field of social work has created a nexus that heretofore has not been adequately integrated into the literature. The present paper addresses this gap with a novel theory known as neurosocial interdependence, which integrates insights from human neuroscience into the framework of the person-in-environment perspective. This paper also bolsters the development of the theory of neurosocial interdependence by introducing a novel testing instrument and measurement scale, exploring how these tools might be used to implement the theory of neurosocial interdependence within social work research and clinical settings.

Toward human-centered AI management: Methodological challenges and future directions

As algorithms powered by Artificial Intelligence (AI) are increasingly involved in the management of organizations, it becomes imperative to conduct human-centered AI management research and understand people's feelings and behaviors when machines gain power over humans. The two mainstream methods – vignette studies and case studies – reveal important but inconsistent insights. Here we discuss the respective limitations of vignette studies (affective forecasting errors, biased media coverage, and question substitution) and case studies (social desirability biases and lack of random assignment and control conditions), which may lead them to overrate negative and positive reactions to AI management, respectively. We further discuss the advantages of a third method for mitigating these limitations: field experiments on crowdsourced marketplaces. A proof-of-concept study on Amazon Mechanical Turk (Mturk; as a world-leading crowdsourcing platform) showed unique human reactions to AI management, which were not perfectly aligned with those in vignette or case studies. Participants (N = 504) did not differ significantly under AI versus human management, in terms of performance, intrinsic motivation, fairness perception, and commitment. We suggest that crowdsourced marketplaces can go beyond human research subject pools and become models of AI-managed workplaces, facilitating timely behavioral research and robust predictions on human-centered work designs and organizations.

Can AI serve as a substitute for human subjects in software engineering research?

Can AI serve as a substitute for human subjects in software engineering research?

Xenograft recipients and the right to withdraw from a clinical trial.

Preclinical xenotransplantation research using genetically engineered pigs has begun to show some promising results and could one day offer a scalable means of addressing organ shortage. While it is a fundamental tenet of ethical human subject research that participants have a right to withdraw from research once enrolled, several scholars have argued that the right to withdraw from xenotransplant research should be suspended because of the public health risks posed by xenozoonotic transmission. Here, we present a comprehensive critical evaluation of the claim that xenotransplant recipients should be required to waive their right to withdraw from lifelong biosurveillance. We conclude that if xenotransplantation requires participants to waive their right to withdraw, then clinical trials may not be justifiable, given the ethical and legal obstacles involved with doing so. Consequently, if clinical trials are permitted with a right to withdraw, then they may pose a significant public health risk.

Evaluating research ethics committees in Vietnam and Laos: Results of a validated self-assessment tool.

There is an increase in human subject research in developing countries and conducting them in an ethical manner depends on the research ethics oversight in these countries. The purpose of this study is to evaluate the operational, financial, and educational characteristics of research ethics committees (RECs) at institutions in Vietnam and Laos. A validated self-assessment tool designed to assess nine major characteristics of RECs was translated into Vietnamese and Laotian. The translated surveys were delivered to and completed by representatives from RECs at institutions in Vietnam and Laos. The surveys were collected, translated back into English, and scored. The data was analyzed to identify potential areas of strength and areas for improvement. The mean survey score for the 19 RECs surveyed was 165.3 out of a maximum of 200 points with a standard deviation of 22.9. Committees scored the highest in the review of specific protocol items (95.6%), submission arrangements and materials (89.5%), and the policies referring to review procedures (85.6%) domains. RECs scored the lowest in the resources domain (65.5%), with only 26.3% of committees having an annual budget. Nearly all RECs have standard operating procedures (94.7%) and policies for disclosing conflicts of interest (89.5%). Most committees use prior ethics training as a criterion to select REC chairs (78.9%) and members (73.7%), with the majority of committees requiring a training course in ethics (76.5%). 68.4% of committees have continuing education in ethics for members and only 42.1% of committees have a budget for member training. This study demonstrated that RECs in Vietnam and Laos have strong foundational review processes for research protocols. Important areas of improvement include improved institutional oversight, financial and administrative resources, and the continued ethics education for current committee members.

Methods and measures to evaluate the impact of participatory model building on public policymakers: a scoping review protocol

IntroductionPublic policymakers are increasingly engaged in participatory model building processes, such as group model building. Understanding the impacts of policymaker participation in these processes on policymakers is important given that...

Ethics Review Committees of Public Health Institutes in Japan

Recent legislative changes in the wake of the novel coronavirus pandemic have placed an increased emphasis on the research activities of Local Public Health Institutes (PHIs) in Japanese municipalities. However, few studies have examined the ethical review processes of these institutes. We analyzed information on (a) the status and year of establishment of "Ethics Review Committees" (and equivalent committees), (b) the number of review cases for each year, (c) the status of public disclosure of committee activities, and (d) the composition of committee members for 85 PHIs across Japan. Publicly available information from each PHI and the Ministry of Health, Labour and Welfare was used for the analysis. Out of 85 PHIs nationwide, about half of them publicly disclosed the establishment of their committees (41 committees, 48.2%). The number of review cases handled by the committees varied, with some committees having no cases or only one case. Among the committees, approximately 20% still maintained adherence to outdated national research ethics guidelines, and approximately 15% did not specify any guidelines they followed. Furthermore, we identified committees without external members (at least two committees) and those lacking public representation (four committees). There are differences in the operational performance of ethics review committees at PHIs, possibly owing to varying levels of understanding of the guidelines, the degree of proactive engagement in academic research, and the emphasis on human subject research. There is a crucial need to accumulate and share experiences that support the review functions of the committees.

Need for Ethical Governance on the Implementation and Use of Patient-derived Xenograft (PDX) Models for Anti-cancer Drug Discovery and Development: Ethical Considerations and Policy Proposal.

Patient-derived xenograft (PDX) models, in which tumor tissues resected from cancer patients are transplanted into immunocompromised mice, have been recently considered the most reliable preclinical models that quite accurately stimulate the real-world characteristics and microenvironments of tumors in patients. The ethical uniqueness of the PDX model, which lies in the fact that it is a hybrid of living human tumor tissue and a carrier mouse, raises several ethical concerns. This study presents four ethical points for consideration and a model ethical governance policy for the implementation and use of PDX models for research. First, PDX models carrying living tumor tissues originating from individual patients with dignity must be treated ethically as materials and data in compliance with the principle of respect for persons. Second, although PDX models themselves are patentable and can be commercialized, it is a standard view, as represented by the Oviedo Convention by the Council of Europe, that those living tumor tissues carried by PDX models shall not give rise to financial gain since those tissues are human body parts; therefore, they should be treated according to a recent ethical approach with the custodianship model as the trust property of patients of origin and shall not be subjected directly to monetary transactions. Third, PDX models must be treated with due care in an ethical manner in line with experimental animal ethics. Finally, the implementation and use of PDX models for research purposes must comply with national and international regulations on both animal experimentation and human subject research. These four points should be carefully examined and properly institutionalized as an ethical governance policy in each institution that plans on utilizing or implementing PDX models for research.

Positive and Negative Social Consequences of Participating in a Sexual-Network Study.

Assessment of risks and benefits of study participation is standard practice preceding the initiation of human subjects research. Although tracking adverse events during research participation is routine, collecting information from participants about what they perceive as benefits is less common. We longitudinally tracked social risks and benefits of participation among a cohort of 241 men who have sex with men participating in a sexual health study to improve participants' experiences and enhance understanding of participant motivations to enroll and attend follow-up. Of the participants who returned for at least one follow-up visit (n = 217, 90%), most (n = 185, 85%) reported positive consequences resulting from participation. Reporting of negative social consequences was rare, and all concerned a stigmatized reaction from someone learning about the participant's involvement in a sexual health study. Better identification of both positive and negative consequences resulting from research participation may improve how researchers design, recruit, and conduct research.

Expanding the role of justice in secondary research using digital psychological data.

Secondary analysis of digital psychological data (DPD) is an increasingly popular method for behavioral health research. Under current practices, secondary research does not require human subjects research review so long as data are de-identified. We argue that this standard approach to the ethics of secondary research (i.e., de-identification) does not address a range of ethical risks and that greater emphasis should be placed on the ethical principle of justice. We outline the inadequacy of an individually focused research ethic for DPD and describe unaddressed "social risks" generated by secondary research of DPD. These risks exist in the "circumstances of justice": that is, a circumstance where individuals must cooperate to create a public good (e.g., research knowledge), and where it is impractical to individually exempt individuals. This requires researchers to emphasize the just allocation of benefits and burdens against a background of social cooperation. We explore six considerations for researchers who wish to conduct research with DPD without explicit consent: (a) create socially valuable knowledge, (b) fairly share the benefits and burdens of research, (c) be transparent about data use, (d) create mechanisms for withdrawal of data, (e) ensure that stakeholders can provide input into the design and implementation of the research, and (f) responsibly report results. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

정신의학연구에서 연구 대상자 보호

Human subject research requires philosophical and ethical considerations due to the potential for researchers’ intention and manipulation, potentially affecting the autonomy of research subjects. Psychiatric research must be conducted more carefully than other types of research due to the vulnerability of the subjects, the social implications of the research, and the requirement of higher ethical responsibilities of researchers. In psychiatric research, it is common practice to obtain consent from a legal representative based on levels of communication and cognitive capacity. However, current regulations do not take into account unique nature of mental illnesses and focus on obtaining consent, which is not sufficient to protect patients in their individual contexts and situations. Therefore, recognizing the vulnerability of patients due to environmental or situational factors, maximizing the patient's autonomy in decision-making, and ensuring that the attending physician is actively involved in the patient’s decision-making process can be recommended to protect the vulnerability of psychiatric subjects and to conduct ethical research. In summary, careful consideration of the subjective context of psychiatric research and its impact on patients, families, and society should be fully discussed before commencing research. Subsequently, informed consent considering differences in communication and cognition level, taking into account the patient's individual circumstances, close monitoring throughout the research process, active participation of the attending physician in the process, and institutional safeguards are necessary.

Missed Opportunities: Substance Use Hotline Operator Uncertainty of State Buprenorphine Prescribing via Telemedicine.

We examined substance use hotline operator certainty of each US state and Washington, DC's endorsement of buprenorphine (initiation and continuation) prescribing via telemedicine. Between March and May 2021, we called hotlines in 50 US states and Washington, DC, requesting information on whether practitioners in that state could initiate or continue buprenorphine treatment for opioid use disorder (OUD) via telephone or video conference. We compared operator responses to state implementation of buprenorphine telemedicine initiation. This study was designated as not human subjects research by the Boston University Institutional Review Board. We spoke with operators in 47 states and Washington, DC. Operators could not be reached in Alaska, California, and Montana. Most operators were uncertain (don't know, probably yes, probably no) whether the state permitted buprenorphine initiation (81%, n = 39) or continuation (83%, n = 40) via telemedicine. Practitioners could initiate buprenorphine prescribing via telemedicine in 7 states (100%) where operators were certain practitioners could initiate buprenorphine, 1 state (100%) where the operator was certain practitioners could not, and 6 states (86%) where operators indicated practitioners probably could not. Most US states and Washington, DC, expanded the role of telemedicine in OUD treatment. However, most operators expressed uncertainty and sometimes communicated inaccurate information regarding whether practitioners could initiate buprenorphine treatment via telemedicine. There is an urgent need for policy mandates institutionalizing the role of telemedicine, and of buprenorphine specifically, in OUD treatment and for resources to train and support substance use hotline operators in this evolving policy environment.

LAUNCHING THE PORCHLIGHT PROJECT

Abstract The Porchlight Project (PLP) is a 5-year study designed to evaluate the real-world efficacy of dementia capable training and respite delivered by volunteers for older people living in the community throughout Minnesota and in select regions of North Dakota. Volunteer regions managed by the Lutheran Social Services of Minnesota (LSS-MN) throughout Minnesota and North Dakota were randomly assigned to receive the dementia training and volunteer support of PLP or the usual care control condition with standard volunteer training. The purpose of this presentation is to describe the process involved in establishing the PLP within LSS-MN’s routine programming for volunteers and embedding key outcome measures within LSS-MN’s standard data collection process for volunteers, their clients, and their clients’ caregivers. Various challenges to PLP integration included: human subjects research categorization for an evaluation such as the PLP; achieving survey response rate goals; and establishing a baseline data collection interval prior to volunteer training completion. Strategies to proactively address these challenges to promote successful embedding of the program include creation of a PLP coordinator position within LSS-MN, who is responsible for the day-to-day programming of the project, as well as the development of a robust, yet flexible protocol. The flexibility allows for navigating LSS-MN programmatic activities, such as changes to the LSS-MN internal database, fluctuation in staffing and/or volunteers, revisions to survey follow-up procedures and correspondence, and consideration for those who will not complete training (e.g. non-English speakers, etc.). This presentation will also feature baseline descriptive data from the evaluation.

Calcium and vitamin D homoeostasis in male fertility.

Calcium and vitamin D have well-established roles in maintaining calcium balance and bone health. Decades of research in human subjects and animals have revealed that calcium and vitamin D also have effects on many other organs including male reproductive organs. The presence of calcium-sensing receptor, vitamin D receptor, vitamin D activating and inactivating enzymes and calcium channels in the testes, male reproductive tract and human spermatozoa suggests that vitamin D and calcium may modify male reproductive function. Functional animal models have shown that vitamin D deficiency in male rodents leads to a decrease in successful mating and fewer pregnancies, often caused by impaired sperm motility and poor sperm morphology. Human studies have to a lesser extent validated these findings; however, newer studies suggest a positive effect of vitamin D supplementation on semen quality in cases with vitamin D deficiency, which highlights the need for initiatives to prevent vitamin D deficiency. Calcium channels in male reproductive organs and spermatozoa contribute to the regulation of sperm motility and capacitation, both essential for successful fertilisation, which supports a need to avoid calcium deficiency. Studies have demonstrated that vitamin D, as a regulator of calcium homoeostasis, influences calcium influx in the testis and spermatozoa. Emerging evidence suggests a potential link between vitamin D deficiency and male infertility, although further investigation is needed to establish a definitive causal relationship. Understanding the interplay between vitamin D, calcium and male reproductive health may open new avenues for improving fertility outcomes in men.

Evaluating the Decisional Capacity for Informed Consent of Transition age Children to Adolescents in Human Subject Research.

This study aimed to evaluate children's capacity for informed consent. We translated into Azerbaijani language and adapted the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC). We enrolled four healthy groups: children aged 11, 12, and 13 years and adults. We provided the participants with information about the simulated research proposal and a related informed consent form. Subsequently, they were administered the UBACC. The mean total UBACC scores were 11.9 (11-year-olds), 12.7 (12-year-olds), 14.0 (13-year-olds), and 16.0 (adults). The gradual increase in the mean UBACC scores with age suggests the continuous maturation of the capacity to comprehend the informed consent process. There was no specific cutoff age to decide whether the children were competent enough to provide informed consent.