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.

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.

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.

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.

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.

Cardiac electrophysiology consultative experience at the epicenter of the COVID-19 pandemic in the United States.

BACKGROUND: The COVID-19 pandemic has greatly altered the practice of cardiac electrophysiology around the world for the foreseeable future. Professional organizations have provided guidance for practitioners, but real-world examples of the consults and responsibilities cardiac electrophysiologists face during a surge of COVID-19 patients is lacking. METHODS: In this observational case series we report on 29 consecutive inpatient electrophysiology consultations at a major academic medical center in New York City, the epicenter of the pandemic in the United States, during a 2 week period from March 30-April 12, 2020, when 80% of hospital beds were occupied by COVID-19 patients, and the New York City metropolitan area accounted for 10% of COVID-19 cases worldwide. RESULTS: Reasons for consultation included: Atrial tachyarrhythmia (31%), cardiac implantable electronic device management (28%), bradycardia (14%), QTc prolongation (10%), ventricular arrhythmia (7%), post-transcatheter aortic valve replacement conduction abnormality (3.5%), ventricular pre-excitation (3.5%), and paroxysmal supraventricular tachycardia (3.5%). Twenty-four patients (86%) were positive for COVID-19 by nasopharyngeal swab. All elective procedures were canceled, and only one urgent device implantation was performed. Thirteen patients (45%) required in-person evaluation and the remainder were managed remotely. CONCLUSION: Our experience shows that the application of a massive alteration in workflow and personnel forced by the pandemic allowed our team to efficiently address the intersection of COVID-19 with a range of electrophysiology issues. This experience will prove useful as guidance for emerging hot spots or areas affected by future waves of the pandemic.

When Is It Ethical for Physician-Investigators to Seek Consent From Their Own Patients?

Classic statements of research ethics advise against permitting physician-investigators to obtain consent for research participation from patients with whom they have preexisting treatment relationships. Reluctance about "dual-role" consent reflects the view that distinct normative commitments govern physician-patient and investigator-participant relationships, and that blurring the research-care boundary could lead to ethical transgressions. However, several features of contemporary research demand reconsideration of the ethics of dual-role consent. Here, we examine three arguments advanced against dual-role consent: that it creates role conflict for the physician-investigator; that it can compromise the voluntariness of the patient-participant's consent; and that it promotes therapeutic misconceptions. Although these concerns have merit in some circumstances, they are not dispositive in all cases. Rather, their force-and the ethical acceptability of dual-role consent-varies with features of the particular study. As research participation more closely approximates usual care, it becomes increasingly acceptable, or even preferable, for physicians to seek consent for research from their own patients. It is time for a more nuanced approach to dual-role consent.

"Paid to Endure": Paid Research Participation, Passivity, and the Goods of Work.

A growing literature documents the existence of individuals who make a living by participating in phase I clinical trials for money. Several scholars have noted that the concerns about risks, consent, and exploitation raised by this phenomenon apply to many (other) jobs, too, and therefore proposed improving subject protections by regulating phase I trial participation as work. This article contributes to the debate over this proposal by exploring a largely neglected worry. Unlike most (other) workers, subjects are not paid to produce or achieve anything but to have things done to them. I argue that this passivity is problematic for reasons of distributive justice. Specifically, it fails to enable subjects to realize what Gheaus and Herzog call "the goods of work"-a failure not offset by adequate opportunities to realize these goods outside of the research context. I also consider whether granting subjects worker-type protections would accommodate this concern.

IRB and Research Regulatory Delays Within the Military Health System: Do They Really Matter? And If So, Why and for Whom?

Institutional review board (IRB) delays may hinder the successful completion of federally funded research in the U.S. military. When this happens, time-sensitive, mission-relevant questions go unanswered. Research participants face unnecessary burdens and risks if delays squeeze recruitment timelines, resulting in inadequate sample sizes for definitive analyses. More broadly, military members are exposed to untested or undertested interventions, implemented by well-intentioned leaders who bypass the research process altogether. To illustrate, we offer two case examples. We posit that IRB delays often appear in the service of managing institutional risk, rather than protecting research participants. Regulators may see more risk associated with moving quickly than risk related to delay, choosing to err on the side of bureaucracy. The authors of this article, all of whom are military-funded researchers, government stakeholders, and/or human subject protection experts, offer feasible recommendations to improve the IRB system and, ultimately, research within military, veteran, and civilian populations.

Raising concerns on questionable ethics approvals - a case study of 456 trials from the Institut Hospitalo-Universitaire Méditerranée Infection.

BACKGROUND: The practice of clinical research is strictly regulated by law. During submission and review processes, compliance of such research with the laws enforced in the country where it was conducted is not always correctly filled in by the authors or verified by the editors. Here, we report a case of a single institution for which one may find hundreds of publications with seemingly relevant ethical concerns, along with 10 months of follow-up through contacts with the editors of these articles. We thus argue for a stricter control of ethical authorization by scientific editors and we call on publishers to cooperate to this end. METHODS: We present an investigation of the ethics and legal aspects of 456 studies published by the IHU-MI (Institut Hospitalo-Universitaire Méditerranée Infection) in Marseille, France. RESULTS: We identified a wide range of issues with the stated research authorization and ethics of the published studies with respect to the Institutional Review Board and the approval presented. Among the studies investigated, 248 were conducted with the same ethics approval number, even though the subjects, samples, and countries of investigation were different. Thirty-nine (39) did not even contain a reference to the ethics approval number while they present research on human beings. We thus contacted the journals that published these articles and provide their responses to our concerns. It should be noted that, since our investigation and reporting to journals, PLOS has issued expressions of concerns for several publications we analyze here. CONCLUSION: This case presents an investigation of the veracity of ethical approval, and more than 10 months of follow-up by independent researchers. We call for stricter control and cooperation in handling of these cases, including editorial requirement to upload ethical approval documents, guidelines from COPE to address such ethical concerns, and transparent editorial policies and timelines to answer such concerns. All supplementary materials are available.

Assessment of patients' satisfaction with the postanesthesia care unit service at University Hospital in Al Khobar, KSA.

Objectives: The quality of health care is individually and subjectively reflected through patients' level of satisfaction, as well as the optimality and effectiveness of the provided postoperative pain management. The provision of postanesthesia care unit (PACU) service in hospitals has led to overall positive outcomes, in addition to the enhancement of patients' satisfaction with the provided pain management service. This study assessed patients' level of satisfaction with PACU service at a university hospital and discussed different factors that might have contributed to the level of satisfaction. Methods: A prospective cross-sectional study was carried out among patients after being discharged from PACU. The study took place at King Fahad Hospital of the University in Al Khobar, KSA between November 2021 and February 2022. The data were collected using a three-section predesigned questionnaire. Results: Two hundred patients were included in this study. Nearly all patients (95.5%) were satisfied with the provided pain management service. Almost all patients (99.5%) indicated that the PACU staff was courteous and professional during the entire pain management service. More patients complained about pain before using analgesia and this difference was statistically significant (Z = 8.642; p < 0.001). The satisfaction rate was significantly higher in the older age group (>45 years) (Z = 2.114; p = 0.035), in patients with American Society of Anesthesiology (ASA) 3 physical status (H = 13.130; p = 0.001), and those with a previous surgical history (Z = 2.139; p = 0.032). Conclusion: This study concluded that the level of patients' satisfaction with PACU service was high, and established a statistically significant association with age, ASA score, and previous surgical history. Healthcare providers should consider patient education and effective communication to increase patients' satisfaction level and improve the overall quality of care.

Pantry clients and Supplemental Nutrition Assistance Program-Education practitioners' perspectives on factors influencing healthy eating policy, system and environmental interventions in food pantries.

The Supplemental Nutrition Assistance Program-Education identified food pantries as a targeted setting for policy, system, and environmental (PSE) interventions to promote healthy eating among households who rely on pantries to supplement their food needs. The present study sought to identify factors influencing capacity and readiness to implement healthy eating PSE interventions in food pantries. Qualitative interviews were conducted via zoom with twenty-six community residents with experience receiving SNAP benefits and twelve SNAP-Ed staff in rural and urban counties in Ohio to identify themes and indicators related to community/organisational capacity and readiness to implement healthy eating PSE interventions in food pantries. Themes and related indicators generated based on inductive and deductive coding of interview transcripts were prioritised and weighted by eleven community nutrition experts during a virtual consensus conference. Five themes emerged; expert-derived weights (scaled low, 0 to high, 1) reflect the perceived importance of each to implementation of healthy eating PSE interventions in food pantries: food pantry capacity and logistics [0⋅252], networks and relationships [0⋅228], community nutrition practitioner capacity [0⋅212], food pantry user characteristics [0⋅156], and stigma and stereotypes [0⋅1⋅52]. Overall, seventeen indicators were identified reflecting these themes. Successful and sustained PSE interventions at food pantries will require a tailored approach that considers food pantries' capacity, needs and opportunities within the community, and capacity of community nutrition practitioners. The themes and indicators identified provide guidance for responsive PSE approaches in food pantries that meet communities where they are.

Method validation of multi-element panel in whole blood by inductively coupled plasma mass spectrometry (ICP-MS).

Background: Analytical methods to measure trace and toxic elements are essential to evaluate exposure and nutritional status. A ten-element panel was developed and validated for clinical testing in whole blood. Retrospective data analysis was conducted on patient samples performed at ARUP Laboratories. Methods: A method was developed and validated to quantify ten elements in whole blood by ICP-MS. Fifty microliters of sample were extracted with 950 µL of diluent containing 1 % ammonium hydroxide, 0.1 % Triton X-100, 1.75 % EDTA along with spiked internal standards. Four calibrators were used for each element and prepared in goat blood to match the patient specimen matrix. Samples were analyzed with an Agilent 7700 ICP-MS with a Cetac MVX 7100 µL Workstation autosampler. Results: The assay was linear for all elements with inter- and intra-assay imprecision less than or equal to 11% CV at the low end of the analytical measurement range (AMR) and less than or equal to 4% CV at the upper end of the AMR for all elements. Accuracy was checked with a minimum of 40 repeat patient samples, proficiency testing samples, and matrix-matched spikes. The linear slopes for the ten elements ranged from 0.94 to 1.03 with intercepts below the AMR and R2 ranging from 0.97 to 1.00. Conclusions: The multi-element panel was developed to analyze ten elements in whole blood to unify the sample preparation and increase batch run efficiency. The improved analytical method utilized matrix-matched calibrators for accurate quantification to meet regulatory requirements. The assay was validated according to guidelines for CLIA-certified clinical laboratories and was suitable for clinical testing to assess nutritional status and toxic exposure.

Mass spectrometry quantitation of immunosuppressive drugs in clinical specimens using online solid-phase extraction and accurate-mass full scan-single ion monitoring.

Introduction: Therapeutic drug monitoring (TDM) of immunosuppressants is essential for optimal care of transplant patients. Immunoassays and liquid chromatography-mass spectrometry (LC-MS) are the most commonly used methods for TDM. However, immunoassays can suffer from interference from heterophile antibodies and structurally similar drugs and metabolites. Additionally, nominal-mass LC-MS assays can be difficult to optimize and are limited in the number of detectable compounds. Objectives: The aim of this study was to implement a mass spectrometry-based test for immunosuppressant TDM using online solid-phase extraction (SPE) and accurate-mass full scan-single ion monitoring (FS-SIM) data acquisition mode. Methods: LC-MS analysis was performed on a TLX-2 multi-channel HPLC with a Q-Exactive Plus mass spectrometer. TurboFlow online SPE was used for sample clean up. The accurate-mass MS was set to positive electrospray ionization mode with FS-SIM for quantitation of tacrolimus, sirolimus, everolimus, and cyclosporine A. MS2 fragmentation pattern was used for compound confirmation. Results: The method was validated in terms of precision, analytical bias, limit of quantitation, linearity, carryover, sample stability, and interference. Quantitation of tacrolimus, sirolimus, everolimus, and cyclosporine A correlated well with results from an independent reference laboratory (r = 0.926-0.984). Conclusions: Accurate-mass FS-SIM can be successfully utilized for immunosuppressant TDM with good correlation with results generated by standard methods. TurboFlow online SPE allows for a simple "protein crash and shoot" sample preparation protocol. Compared to traditional MRM, analyte quantitation by FS-SIM facilitates a streamlined assay optimization process.

Analysis of road traffic injuries presented to the emergency department in the Eastern Province of Saudi Arabia: a hospital-based study.

The increasing incidence of road traffic injuries (RTIs) has contributed to the disability and death of millions of people on both a national and global level. This retrospective study was conducted at King Fahad University Hospital (KFUH), Khobar, Saudi Arabia, and included all patients who presented at the emergency department due to road traffic accidents (RTAs) between January 1st, 2022, and December 31st, 2022. Patient data was retrieved from the health information system at KFUH. Descriptive and inferential analysis were performed with several variables analyzed using multivariate logistic regression and factorial ANOVA (MANOVA). During this period, 921 patients were treated at the hospital's emergency department. Of these, 611 (66.3%) were men and 310 (33.7%) were women. The most frequently affected age group was 16-25, representing 427 (46.4%) cases. Most patients were Saudi citizens (837, 90.9%). Among the patients, 19 (2.1%) required surgical treatment within 24 hours of the RTA, and 29 (3.1%) were admitted to the surgical intensive care unit (SICU). There were eight fatalities, representing 0.9% of the cases. January had the highest number of RTAs (12.7%). Moreover, 463 individuals (50.3%) had some form of injury, the most common type being lacerations and abrasions (n=228, 24.8%). Upper limb fractures were the most frequent type of fracture, occurring in 73 cases (7.9%). Being male (P=0.001), non-Saudi (P=0.014), and experiencing accidents during June and July (P=0.002) were associated with an increased prevalence of injury. Mortality had a statistically significant relationship with different patient age groups (P=0.014), patient citizenship (P=0.005), and length of hospital stay (P<0.001).

STNM01, the RNA oligonucleotide targeting carbohydrate sulfotransferase 15, as second-line therapy for chemotherapy-refractory patients with unresectable pancreatic cancer: An open label, phase I/IIa trial.

Background: The impact of stroma-targeting therapy on tumor immune suppression is largely unexplored. An RNA oligonucleotide, STNM01, has been shown to repress carbohydrate sulfotransferase 15 (CHST15) responsible for tumor proteoglycan synthesis and matrix remodeling. This phase I/IIa study aimed to evaluate the safety and efficacy of STNM01 in patients with unresectable pancreatic ductal adenocarcinoma (PDAC). Methods: This was an open-label, dose-escalation study of STNM01 as second-line therapy in gemcitabine plus nab-paclitaxel-refractory PDAC. A cycle comprised three 2-weekly endoscopic ultrasound-guided locoregional injections of STNM01 at doses of 250, 1,000, 2,500, or 10,000 nM in combination with S-1 (80-120 mg twice a day for 14 days every 3 weeks). The primary outcome was the incidence of dose-liming toxicity (DLT). The secondary outcomes included overall survival (OS), tumor response, changes in tumor microenvironment on immunohistopathology, and safety (jRCT2031190055). Findings: A total of 22 patients were enrolled, and 3 cycles were repeated at maximum; no DLT was observed. The median OS was 7.8 months. The disease control rate was 77.3%; 1 patient showed complete disappearance of visible lesions in the pancreas and tumor-draining lymph nodes. Higher tumoral CHST15 expression was associated with poor CD3+ and CD8+ T cell infiltration at baseline. STNM01 led to a significant reduction in CHST15, and increased tumor-infiltrating CD3+ and CD8+ T cells in combination with S-1 at the end of cycle 1. Higher fold increase in CD3+ T cells correlated with longer OS. There were 8 grade 3 adverse events. Interpretation: Locoregional injection of STNM01 was well tolerated in patients with unresectable PDAC as combined second-line therapy. It prolonged survival by enhancing T cell infiltration in tumor microenvironment. Funding: The present study was supported by the Japan Agency for Medical Research and Development (AMED).

Pre-analytical sample handling standardization for reliable measurement of metabolites and lipids in LC-MS-based clinical research.

The emerging disciplines of lipidomics and metabolomics show great potential for the discovery of diagnostic biomarkers, but appropriate pre-analytical sample-handling procedures are critical because several analytes are prone to ex vivo distortions during sample collection. To test how the intermediate storage temperature and storage period of plasma samples from K3EDTA whole-blood collection tubes affect analyte concentrations, we assessed samples from non-fasting healthy volunteers (n = 9) for a broad spectrum of metabolites, including lipids and lipid mediators, using a well-established LC-MS-based platform. We used a fold change-based approach as a relative measure of analyte stability to evaluate 489 analytes, employing a combination of targeted LC-MS/MS and LC-HRMS screening. The concentrations of many analytes were found to be reliable, often justifying less strict sample handling; however, certain analytes were unstable, supporting the need for meticulous processing. We make four data-driven recommendations for sample-handling protocols with varying degrees of stringency, based on the maximum number of analytes and the feasibility of routine clinical implementation. These protocols also enable the simple evaluation of biomarker candidates based on their analyte-specific vulnerability to ex vivo distortions. In summary, pre-analytical sample handling has a major effect on the suitability of certain metabolites as biomarkers, including several lipids and lipid mediators. Our sample-handling recommendations will increase the reliability and quality of samples when such metabolites are necessary for routine clinical diagnosis.

Creating a Practical Transformational Change Management Model for Novel Artificial Intelligence-Enabled Technology Implementation in the Operating Room.

Objective: To identify change management (CM) strategies for implementing novel artificial intelligence and similar novel technologies in operating rooms and create a new CM model for future trials and applications inspired by the abovementioned strategies and established models. Methods: Key phases of technology implementation were defined, and strategies for transformational CM were created and applied in a recent CM experience at our institution between October 15, 2020 and October 15, 2021. We appraised existing CM models and propose the newly created model. Results: The key phases of the technology implementation were as follows: (1) team assembly; (2) committee approvals; (3) CM; and (4) system installation and go-live. Key strategies were (1) assemble team with necessary expertise; (2) anticipate potential institutional cultural and regulatory hurdles; (3) add agility to project planning and execution; (4) accommodate institutional culture and regulations; (5) early clinical partner buy-in and stakeholder engagement; and (6) consistent communication, all of which contributed to the new CM model creation. Conclusion: Key CM strategies and a new CM model addressing the unique needs and characteristics of operating room novel technology implementation were identified and created. The new model may be customized and tested for individual institution and project's needs and characteristics.