Impact of institutional review board stipulations on turnaround time for approvals of surgical studies.

BACKGROUND: We have examined the number and types of stipulations received following the submission of surgical study protocols to the Institutional Review Boards (IRBs) for review, and their effect on turnaround time for approval. This analysis will enable our organization to improve the quality of applications and design of study protocols, which can streamline the approval process and increase efficiency of the startup phase for clinical research. METHODS: IRB stipulations for 48 surgical studies were analyzed. Various factors were assessed: surgical specialty, type of study by design, clinical trial phase, type of investigational product, type of IRB utilized (local or centralized), study complexity score, type of review (e.g., exempt, expedited, or full board), turnaround time, and number of stipulations received. Statistical analyses were performed to examine associations between the number/type of stipulations received during the IRB review process and any of the aforementioned study-related factors. RESULTS: For analyzed surgical studies, the number of stipulations allotted to a study and time taken for approval had moderate association with the complexity of the study. The turnaround time for approval was the highest for randomized, controlled trials and studies undergoing full board review. CONCLUSION: This study elucidates characteristics that are associated with increased time for IRB approval. Analysis of IRB stipulations can help improve the turnaround time for the approval process, increase efficiency of startup phase, and transition to execution phase faster, which will allow more time for enrollment of research subjects, and increase return on investment made into research and development programs.

Which Benefits Can Justify Risks in Research?

Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose a categorization of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs.

IRBs and the Protection-Inclusion Dilemma: Finding a Balance.

Institutional review boards, tasked with facilitating ethical research, are often pulled in competing directions. In what we call the protection-inclusion dilemma, we acknowledge the tensions IRBs face in aiming to both protect potential research participants from harm and include under-represented populations in research. In this manuscript, we examine the history of protectionism that has dominated research ethics oversight in the United States, as well as two responses to such protectionism: inclusion initiatives and critiques of the term vulnerability. We look at what we know about IRB decision-making in relation to protecting and including "vulnerable" groups in research and examine the lack of regulatory guidance related to this dilemma, which encourages protection over inclusion within IRB practice. Finally, we offer recommendations related to how IRBs might strike a better balance between inclusion and protection in research ethics oversight.

Continuous quality improvement: reducing informed consent form signing errors.

BACKGROUND: Adherence to ethical guidelines and regulations and protecting and respecting the dignity and autonomy of participants by obtaining a valid informed consent form (ICF) prior to participation in research are crucial; The subjects did not add signatures next to the corrections made to signatures or dates on the ICF, Multiple signatures in other fields, ICF missing/missing signature, Incorrect ICF version Signed after modification, Correction tape used to correct signature, Impersonated signature, Non-research-member signature, however, ICFs are often not properly completed, which must be addressed. This study analyzed ICF signing errors and implemented measures to reduce or prevent these errors. METHODS: We used the plan-do-check-act (PDCA) cycle to help improve the correctness and validity of ICF signing. RESULTS: Interim and final reports from January 2016 to February 2020 including 363 ICFs were studied. The total proportion of correct ICF signatures (200, 83.3%) following the PDCA intervention was significantly higher than that before the intervention (P < 0.05). Analysis of the types of signing error demonstrated that signature errors were significantly reduced after the intervention, particularly for subjects did not add signatures next to the corrections made to signatures or dates on the ICF (16, 6.7%) and impersonated signature (0; P < 0.05). CONCLUSIONS: The proportions of other error types-multiple signatures in other fields, missing or unsigned ICF, incorrect signature order, incorrect ICF version, use of correction tape to correct signature, and non-medical profession members signing the ICF-did not differ significantly.

Electronic Structure and Chemical Bonding of the First-, Second-, and Third-Row-Transition-Metal Monoborides: The Formation of Quadruple Bonds in RhB, RuB, and TcB.

Boron presents an important role in chemistry, biology, and materials science. Diatomic transition-metal borides (MBs) are the building blocks of many complexes and materials, and they present unique electronic structures with interesting and peculiar properties and a variety of bonding schemes which are analyzed here. In the first part of this paper, we present a review on the available experimental and theoretical studies on the first-row-transition-metal borides, i.e., ScB, TiB, VB, CrB, MnB, FeB, CoB, NiB, CuB, and ZnB; the second-row-transition-metal borides, i.e., YB, ZrB, NbB, MoB, TcB, RuB, RhB, PdB, AgB, and CdB; and the third-row-transition-metal borides, i.e., LaB, HfB, TaB, WB, ReB, OsB, IrB, PtB, AuB, and HgB. Consequently, in the second part, the second- and third-row MBs are studied via DFT calculations using the B3LYP, TPSSh, and MN15 functionals and, in some cases, via multi-reference methods, MRCISD+Q, in conjunction with the aug-cc-pVQZ-PPM/aug-cc-pVQZB basis sets. Specifically, bond distances, dissociation energies, frequencies, dipole moments, and natural NPA charges are reported. Comparisons between MB molecules along the three rows are presented, and their differences and similarities are analyzed. The bonding of the diatomic borides is also described; it is found that, apart from RhB(X1Σ+), which was just recently found to form quadruple bonds, RuB(X2Δ) and TcB(X3Σ-) also form quadruple σ2σ2π2π2 bonds in their X states. Moreover, to fill the gap existing in the current literature, here, we calculate the TcB molecule.

Assessment of knowledge, attitude, and practice of antibiotics prescription among healthcare residents at King Abdulaziz medical City, Jeddah, Saudi Arabia.

Introduction: Antibiotic resistance (ABR) is defined as bacteria's resistance to therapy despite therapeutic levels of antibiotics. It is a global health concern. Data on the antibiotic prescription practice of physicians, in general, are limited in Saudi Arabia. Therefore, we aim to assess the knowledge, attitude, and practice of antibiotic prescription between surgical and non-surgical residents at King Abdulaziz Medical City (KAMC). Methods: A cross-sectional study was conducted at KAMC in Jeddah, Saudi Arabia, from September 2019, until March 2020. The questionnaire contained demographic information and 31 questions based on the studied variables: knowledge (17), attitude (4), and practice (10). Results: The response rate was 83 %. Male to female response rates were 54 % and 46 %, respectively. The majority of respondents (72 %) were non-surgical residents. Positive practice skills showed that 55 % of all healthcare residents always used practice guidelines for antibiotic prescription in their daily work (P-value < 0.001). Most residents (50 %) sometimes used delayed prescriptions. Non-surgical residents discussed ABR with patients more than surgical residents (P-value = 0.028). Lack of patient interest was the common cause for not discussing ABR with patients (42 %). Non-surgical residents had significantly more training on antibiotic prescription (p-value = 0.001). The fear of infection spread due to not prescribing an antibiotic was significantly higher in non-surgical residents (P-value < 0.001). Non-surgical residents (76 %) took a past medical history of antibiotic consumption more than surgical residents (24 %) (P-value = 0.003). Antibiotic prescription for residents was not influenced by advertisements (91 %). The most common resistant organisms reported by residents were insignificant between the two groups. The results also showed that the residents' common choice of antibiotics was not statistically different between surgical and non-surgical residents in most antibiotic classes. Conclusions: We found that practice guidelines, formal training, and taking patients' past medical histories were significantly higher among non-surgical residents. In contrast, surgical residents were prescribing more antibiotics due to the fear of the spread of the infection. Proper training is essential for all healthcare residents to overcome differences among different specialties.

Patients' and primary carers' views on clozapine treatment for schizophrenia: A cross-sectional study in Qatar.

Subjective views of clozapine treatment among patients with schizophrenia in the Middle East and North African MENA Region have not previously been assessed. Globally, few studies have assessed the views of carers to clozapine treatment. We conducted a cross-sectional survey, using a clinician administered structured interview, of patients with schizophrenia/schizoaffective disorder prescribed clozapine in Qatar, and their primary carers. Participants were asked to rate clozapine against prior their antipsychotic treatment in terms of specific benefits and side effects. Forty-two patients and 33 carers participated in the study. Of the patients, two thirds were male, approximately half were Qatari and the mean age was 33.9 years. Patients and carers rated clozapine as superior to prior antipsychotic treatment on all 7 potential benefits inquired about. The greatest perceived benefit was improved mood. Patients rated clozapine as less likely to cause extrapyramidal side effects but more likely to cause 18 other potential side effects compared to prior antipsychotic treatment, with the greatest difference being for nocturnal salivation, increased appetite, and constipation. Nearly half of patients (48 %) and two thirds of carers (64 %) stated that they would have preferred to start clozapine earlier in their illness. Sixty percent of patients and 37 % of carers regarded the information that they had received from health professionals on clozapine as inadequate. Less than half of patients and approximately-two thirds of carers had adequate knowledge of haematological monitoring for clozapine. Generally, there were significantly positive correlation between patients and carers regarding the overall side effects of clozapine treatment. Likewise, improvement in hearing voices paranoid thoughts correlated with improved quality of life. In summary, the results show that patients and carers appreciate the benefits of clozapine despite its side effects being problematic. The results support clozapine being offered earlier in treatment and services providing more information on clozapine to patients and carers.

A Research Ethics Framework for the Clinical Translation of Healthcare Machine Learning.

The application of artificial intelligence and machine learning (ML) technologies in healthcare have immense potential to improve the care of patients. While there are some emerging practices surrounding responsible ML as well as regulatory frameworks, the traditional role of research ethics oversight has been relatively unexplored regarding its relevance for clinical ML. In this paper, we provide a comprehensive research ethics framework that can apply to the systematic inquiry of ML research across its development cycle. The pathway consists of three stages: (1) exploratory, hypothesis-generating data access; (2) silent period evaluation; (3) prospective clinical evaluation. We connect each stage to its literature and ethical justification and suggest adaptations to traditional paradigms to suit ML while maintaining ethical rigor and the protection of individuals. This pathway can accommodate a multitude of research designs from observational to controlled trials, and the stages can apply individually to a variety of ML applications.

Establishing the doctor of nursing practice project ethical review process to improve standardization, efficiency, and timeliness.

BACKGROUND: DNP Scholarly projects require review for scientific merit and human subject protection. Rapid growth of DNP programs and projects has increased Institutional Review Board (IRB) burden and increased the length of project approval time when most DNP scholarly projects are quality improvement (QI) projects and not deemed Human Subjects Research (HSR). PURPOSE: Develop a process and describe the rationale for creating and implementing a Project Ethical Review Committee (PERC) in the School of Nursing and to evaluate the experience of the first cohort of submissions. PROCESS: Committee was formed using expert consensus approach, in collaboration with IRB. Standards of Procedures and training materials created. OUTCOME MEASURE: 100 projects submitted to committee; 95 deemed QI (95%) and 5 projects considered HSR (5%). First 94 projects were reviewed, and approval letters sent within 8 weeks. DISCUSSION: This paper discusses how PERC ensures rigorous and ethical review process for standardization, timeliness, and efficiency.

The use of dietary supplements for mental health among the Saudi population: A cross-sectional survey.

Introduction: Despite limited evidence about the efficacy and safety of dietary supplements (DSs) for improving mental health, people with or without mental disorders often tend to use them, especially during the ongoing COVID-19 pandemic. Previous studies focused on DS use for maintaining or improving overall health; Therefore, this study aimed to assess the prevalence of DSs for mental health among the SA population and to determine the factors that affect their use. Methods: This cross-sectional study was based on an online survey of Saudi Arabian participants between July and August 2021 with an anonymous, self-completed questionnaire distributed using convenience sampling. The questionnaire included queries related to demographic information, DS use assessment, and mental health evaluation using the Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder 7-item (GAD-7), questionnaire, and the Insomnia Severity Index (ISI). Results: In total, 443 participants from various regions of Saudi Arabia completed the questionnaire. The prevalence of DS use in the Saudi population was 44%. Vitamin D (28%) and melatonin (20%) were the most commonly reported DSs used for mental health. The odds of DS use were three times higher in responders with previous mental health diagnoses (OR: 2.972; 95% CI: 1.602-5.515). Furthermore, the chances of using DSs almost doubled in patients with sub-threshold and moderate to severe insomnia (OR: 1.930; 95% CI: 1.191-3.126 and OR: 2.485; 95% CI: 1.247-4.954, respectively). Conclusion: Responders diagnosed by a specialist with psychiatric disorders or current insomnia had a higher chance of using DSs. Thus, healthcare providers must provide evidence-based information regarding DSs for mental health improvement and encourage the public to consult healthcare professionals before self-medicating for mental health problems.

Tibial alignment following intramedullary nailing via three approaches.

PURPOSE: The purpose of this study is to evaluate the incidence of malalignment in patients undergoing IMN for tibial shaft fractures treated with the extra-articular lateral parapatellar, suprapatellar, and infrapatellar approaches. METHODS: A retrospective review of an institutional trauma database was completed at a single level 1 trauma academic medical centre. Quality of reduction was assessed using the following three parameters: (1) < 10°of angulation in orthogonal radiographic views (2) < 5 mm of displacement between the major fracture fragments (3) < 5 mm of gap between the major fracture fragments. A good reduction was one that met all 3 criteria, an acceptable reduction met 2 criteria, and a bad reduction met one or none of the criteria. All patients treated consecutively for tibial shaft fractures between June 1, 2019 and June 1, 2020 were identified. The final cohort included 57 tibia fractures in 56 patients. Of the 57 tibia fractures, 8 (14%) were proximal third, 32 (56%) were middle third, and 17 (30%) were distal third fractures. RESULTS: We found no significant difference in angulation, displacement, or gapping with respect to surgical approach utilized or location of fracture (proximal or distal tibia fractures) on one-way ANOVA. Quality of reduction was rated as "good" in 48 (84%) of the cases (19 supra, 13 infra, and 16 lateral). Nine reductions (16%) met only two of the three reduction quality criteria and were considered acceptable reductions. These included 2 suprapatellar (1 > 5 mm displacement, 1 > 5 mm gapping), 4 infrapatellar (4 > 5 mm displacement), and 3 lateral extra-articular parapatellar (2 > 5 mm displacement and 1 > 5 mm gapping). No reductions were determined to be bad according the Baumgaertner et al. criteria. There was no significant difference in the rate of combined fibula fractures or the rate of fibular fixation between the three cohorts. CONCLUSIONS: In conclusion, no significant difference was found in fracture reduction angulation, displacement, and gapping in patients treated with an IMN with respect to approach for diaphyseal or metadiaphyseal tibial shaft fractures.

Tissue-specific expression of insulin receptor isoforms in obesity/type 2 diabetes mouse models.

The two insulin receptor (IR) isoforms IR-A and IR-B are responsible for the pleiotropic actions of insulin and insulin-like growth factors. Consequently, changes in IR isoform expression and in the bioavailability of their ligands will impact on IR-mediated functions. Although alteration of IR isoform expression has been linked to insulin resistance, knowledge of IR isoform expression and mechanisms underlying tissue/cell-type-specific changes in metabolic disease are lacking. Using mouse models of obesity/diabetes and measuring the mRNA of the IR isoforms and mRNA/protein levels of total IR, we provide a data set of IR isoform expression pattern that documents changes in a tissue-dependent manner. Combining tissue fractionation and a new in situ mRNA hybridization technology to visualize the IR isoforms at cellular resolution, we explored the mechanism underlying the change in IR isoform expression in perigonadal adipose tissue, which is mainly caused by tissue remodelling, rather than by a shift in IR alternative splicing in a particular cell type, e.g. adipocytes.

The ethics of quality improvement studies: do the needs of the many outweigh the needs of the few?

Clinical research involving human subjects and quality improvement (QI) projects share a common goal of seeking to improve human health, whether by directly changing the standard of care (research) or by improving the process(es) by which that care is delivered (QI). Whether a QI project requires informed consent (written or oral) is a function of the risk-benefit analysis of the study; such a determination should not be at the sole discretion of the investigators, but should come from an appropriately constituted review board with expertise in the ethics of biomedical research.

Toward a Framework for Assessing Privacy Risks in Multi-Omic Research and Databases.

While the accumulation and increased circulation of genomic data have captured much attention over the past decade, privacy risks raised by the diversification and integration of omics have been largely overlooked. In this paper, we propose the outline of a framework for assessing privacy risks in multi-omic research and databases. Following a comparison of privacy risks associated with genomic and epigenomic data, we dissect ten privacy risk-impacting omic data properties that affect either the risk of re-identification of research participants, or the sensitivity of the information potentially conveyed by biological data. We then propose a three-step approach for the assessment of privacy risks in the multi-omic era. Thus, we lay grounds for a data property-based, 'pan-omic' approach that moves away from genetic exceptionalism. We conclude by inviting our peers to refine these theoretical foundations, put them to the test in their respective fields, and translate our approach into practical guidance.

Accounting for research fatigue in research ethics.

How to account for participants' psychological and emotional exhaustion with research has been under-explored in the research ethics literature. Research fatigue, as it is known, has significant impacts on patients' well-being and their ongoing and future participation in studies. From the perspective of researchers and researched communities, research fatigue also creates selection bias and opportunity costs, negatively impacting the collective scientific enterprise. Institutional Review Boards should systematically consider research fatigue during the research approval process and strive to mitigate it.

Ethical concerns in suicide research: thematic analysis of the views of human research ethics committees in Australia.

BACKGROUND: Suicide research aims to contribute to a better understanding of suicidal behaviour and its prevention. However, there are many ethical challenges in this research field, for example, regarding consent and potential risks to participants. While studies to-date have focused on the perspective of the researchers, this study aimed to investigate the views and experiences of members of Human Research Ethics Committees (HRECs) in dealing with suicide-related study applications. METHODS: This qualitative study entailed a thematic analysis using an inductive approach. We conducted semi-structured interviews with a purposive sample (N = 15) of HREC Chairs or their delegates from Australian research-intensive universities. The interview guide included questions regarding the ethical concerns and challenges in suicide-related research raised by HREC members, how they dealt with those challenges and what advice they could give to researchers. RESULTS: The analysis identified four main themes: (1) HREC members' experiences of reviewing suicide-related study applications, (2) HREC members' perceptions of suicide, suicide research, and study participants, (3) Complexity in HREC members' decision-making processes, and (4) HREC members' relationships with researchers. CONCLUSIONS: Reliance on ethical guidelines and dialogue with researchers are crucial in the assessment of suicide-related study applications. Both researchers and HREC members may benefit from guidance and resources on how to conduct ethically sound suicide-related studies. Developing working relationships will be likely to help HRECs to facilitate high quality, ethical suicide-related research and researchers to conduct such research.

Lessons Learned: Beta-Testing the Digital Health Checklist for Researchers Prompts a Call to Action by Behavioral Scientists.

Digital technologies offer unique opportunities for health research. For example, Twitter posts can support public health surveillance to identify outbreaks (eg, influenza and COVID-19), and a wearable fitness tracker can provide real-time data collection to assess the effectiveness of a behavior change intervention. With these opportunities, it is necessary to consider the potential risks and benefits to research participants when using digital tools or strategies. Researchers need to be involved in the risk assessment process, as many tools in the marketplace (eg, wellness apps, fitness sensors) are underregulated. However, there is little guidance to assist researchers and institutional review boards in their evaluation of digital tools for research purposes. To address this gap, the Digital Health Checklist for Researchers (DHC-R) was developed as a decision support tool. A participatory research approach involving a group of behavioral scientists was used to inform DHC-R development. Scientists beta-tested the checklist by retrospectively evaluating the technologies they had chosen for use in their research. This paper describes the lessons learned because of their involvement in the beta-testing process and concludes with recommendations for how the DHC-R could be useful for a variety of digital health stakeholders. Recommendations focus on future research and policy development to support research ethics, including the development of best practices to advance safe and responsible digital health research.

Getting Interdisciplinary Teams into the Field: Institutional Review Board Preapproval and Multi-Institution Authorization Agreements for Rapid Response Disaster Research.

This article describes an interdisciplinary community resilience research project and presents a case study that supports bringing researchers together before a disaster to develop plans, procedures, and preapproved Institutional Review Board (IRB) protocols. In addition, this article explains how researchers from various academic institutions and their federal agency partners can effectively collaborate by creating an IRB Authorization Agreement (IAA). Such preparations can support interdisciplinary rapid response disaster fieldwork that is timely, ethically informed, and scientifically rigorous. This fieldwork preplanning process can also advance interdisciplinary team formation and data collection efforts over the long term.

Misrepresenting "Usual Care" in Research: An Ethical and Scientific Error.

Comparative effectiveness studies, referred to here as "usual-care" trials, seek to compare current medical practices for the same medical condition. Such studies are presumed to be safe and involve only minimal risks. However, that presumption may be flawed if the trial design contains "unusual" care, resulting in potential risks to subjects and inaccurately informed consent. Three case studies described here did not rely on clinical evidence to ascertain contemporaneous practice. As a result, the investigators drew inaccurate conclusions, misinformed research participants, and subjects' safety was compromised. Before approving usual-care protocols, IRBs and scientific review committees should evaluate the quality and completeness of information documenting usual-care practices. Guidance from governmental oversight agencies regarding evidence-based documentation of current clinical practice could prevent similar occurrences in future usual-care trials. Accurate information is necessary to ensure that trials comply with government regulations that require minimizing research risks to subjects and accurate informed consent documents.

Why IRBs should protect bystanders in human research.

Many types of human research activities present risks and burdens to third parties (e.g., bystanders). Few human protection policies directly address the protection of research bystanders, though some address it in passing. In what follows, I re-iterate reasons why bystanders are entitled to protections. I also argue that Institutional Review Boards (IRBs) are in the best position to signal to researchers and sponsors that bystanders should be protected in research. In some cases, IRB review would consist of evaluating bystander protection strategies directly; in other cases, this might entail merely certifying that another institutions, like a drug regulator, has taken adequate measures to protect the welfare of research bystanders.