Human Research Protections Research Articles

Amending Federal Regulations to Counteract Language Barriers in the Informed Consent Process

Amending Federal Regulations to Counteract Language Barriers in the Informed Consent Process

Military Injuries-Understanding Posttraumatic Epilepsy, Health, and Quality-of-Life Effects of Caregiving: Protocol for a Longitudinal Mixed Methods Observational Study.

BackgroundVeterans with posttraumatic epilepsy (PTE), particularly those with comorbidities associated with epilepsy or traumatic brain injury (TBI), have poorer health status and higher symptom burden than their peers without PTE. One area that has been particularly poorly studied is that of the role of caregivers in the health of veterans with PTE and the impact caring for someone with PTE has on the caregivers themselves.ObjectiveIn this study, we aim to address the following: describe and compare the health and quality of life of veterans and caregivers of veterans with and without PTE; evaluate the change in available supports and unmet needs for services among caregivers of post-9/11 veterans with PTE over a 2-year period and to compare support and unmet needs with those without PTE; and identify veteran and caregiver characteristics associated with the 2-year health trajectories of caregivers and veterans with PTE compared with veterans without PTE.MethodsWe conducted a prospective cohort study of the health and quality of life among 4 groups of veterans and their caregivers: veterans with PTE, nontraumatic epilepsy, TBI only, and neither epilepsy nor TBI. We will recruit participants from previous related studies and collect information about both the veterans and their primary informal caregivers on health, quality of life, unmet needs for care, PTE and TBI symptoms and treatment, relationship, and caregiver experience. Data sources will include existing data supplemented with primary data, such as survey data collected at baseline, intermittent brief reporting using ecological momentary assessment, and qualitative interviews. We will make both cross-sectional and longitudinal comparisons, using veteran-caregiver dyads, along with qualitative findings to better understand risk and promotive factors for quality of life and health among veterans and caregivers, as well as the bidirectional impact of caregivers and care recipients on one another.ResultsThis study was approved by the institutional review boards of the University of Utah and Salt Lake City Veterans Affairs and is under review by the Human Research Protection Office of the United States Army Medical Research and Development Command. The Service Member, Veteran, and Caregiver Community Stakeholders Group has been formed and the study questionnaire will be finalized once the panel reviews it. We anticipate the start of recruitment and primary data collection by January 2022.ConclusionsNew national initiatives aim to incorporate the caregiver into the veteran’s treatment plan; however, we know little about the impact of caregiving—both positive and negative—on the caregivers themselves and on the veterans for whom they provide care. We will identify specific needs in this understudied population, which will inform clinicians, patients, families, and policy makers about the specific impact and needs to equip caregivers in caring for veterans at home.International Registered Report Identifier (IRRID)PRR1-10.2196/30975

Perspectives on choice of law challenges in multistate precision medicine research.

Federal law establishes minimum standards for protecting human research participants, but many states have enacted laws that may apply to research. Precision medicine research in particular implicates state laws that govern an array of topics, including human subjects research, genetic testing, and both general and genetic privacy and discrimination. Thus, the determination of which state’s laws apply, and under what circumstances, can substantially alter participant rights and protections. To shed light on this topic, we conducted interviews with experts in law, human research protections, and precision medicine research. Our goal was to better understand their experiences with choice of law issues, the effects of state law variation on research practices and stakeholder groups, and approaches to addressing such variation. Interviewees were aware of state-based variation in laws that could be applied to research. However, the extent to which they perceived such variability as problematic differed, as did their perceptions of stakeholder roles and responsibilities for addressing state law variation, and their estimations of requisite knowledge among IRBs and researchers. These divergent perspectives create an ethical and legal quandary, and further empirical and normative work is needed to fully characterize the implications of substantive differences in participant rights and protections.

Ethics in Psychiatric Research.

Ethics in Psychiatric Research.

Key lessons and strategies for implementing single IRB review in the Trial Innovation Network.

The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network's single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has generated several lessons learned that can benefit the national clinical research enterprise, as we work to improve the conduct of clinical trials. These lessons include distinguishing the roles of the single IRB from institutional Human Research Protections programs, establishing a consistent sIRB review model, standardizing collection of local context and supplemental, study-specific information, and educating and empowering lead study teams to support their sites.

The IRB Reliance Exchange (IREx): A national web-based platform for operationalizing single IRB review.

For decades, the research community called for streamlined Institutional Review Board (IRB) review processes for multisite studies. Department of Health and Human Services and National Institutes of Health (NIH) recognized this need and implemented single IRB (sIRB) of record mandates. However, announcing mandates without sufficient operational guidance and tools is insufficient to foster the desired change. Nearly 4 years into implementation of the NIH's sIRB mandate, operational challenges remain. Fortunately, NIH supports a web-based sIRB platform, the IRB Reliance Exchange (IREx), to facilitate sIRB communication and documentation. IREx has received continuous NIH funding supporting its evolution since 2011 and is now used by over 5,000 Human Research Protection Program and research personnel, 35 sIRBs, and 415 participating sites to operationalize sIRB review and approval on over 400 studies. IREx supports over 2300 reliance relationships with an average of 7 sites per study. The platform is continually used by sIRBs and relying sites, providing a valuable centralized portal for promoting a harmonized sIRB review process. IREx can promote transparency, standardize practice, minimize workflow variation, and mitigate the need for sIRBs to implement significant technical changes to their local electronic systems. IREx has proven to be nimble and adaptable with practice and policy changes over the past decade, as evidenced by continually increasing platform utilization.

Student Subjects in Research

Student Subjects in Research

SNMMI Clinical Trials Network Research Series for Technologists: Ethical Issues and Regulations in the Medical Workplace.

Ethical principles and laws have developed as medical practice and research have grown. This article discusses regulatory policies in patient care and the governing bodies that provide oversight. These include but are not limited to the Food and Drug Administration, Office for Human Research Protection, Code of Federal Regulations, Nuclear Regulatory Commission, Joint Commission, Health Insurance Portability and Accountability Act, Occupational Safety and Health Administration, World Health Organization, and International Conference on Harmonization. This article reviews ethical requirements in clinical research and provides examples of medical mistreatment that forced the development of these rules and regulations. Some include the Nuremberg Code, Declaration of Helsinki, and Belmont Report; good clinical practice; and the Common Rule. Several specific research documents are discussed further in this continuing education series. These guiding documents and principles are important because every patient and research subject deserves a safe environment with safe products and protection of privacy. Individuals deserve to understand their role in medicine and clinical research, have the right to refuse care, make informed decisions, know the risks and benefits included, and ultimately have their individual choices respected.

Comparison of the short-term efficacy of two types of robotictotal mesorectal excision for rectal cancer.

The advantages and disadvantages of robotic technology compared with conventional surgery for low rectal cancer have been discussed extensively. However, a few studies on the efficacy of total mesorectal excision (TME) with different robotic technologies have been reported. The aim of this study was to evaluate the efficacy of two types of robot-assisted TME (R-TME) compared with laparoscopic TME (L-TME). A prospective comparative study was conducted comparing da Vinci R-TME, Micro Hand S R-TME, and L-TME for rectal cancer. This study was registered with "Clinicaltrials.gov" (ID: NCT02752698) and approved by the Association for the Accreditation of Human Research Protection Program (AAHRPP) (Project number: T16007). Between January 2017 and May 2019, patients with rectal cancer (cT1-3NxM0) were prospectively registered in the Third Xiangya Hospital. The integrity of the TME sample served as the primary outcome. Secondary outcomes included the involvement of the circumferential and distal resection margins (CRM and DRM), number of lymph nodes retrieved, blood loss, operative time, conversion rate, comprehensive complication index score, the International Prostate Symptom score, the International Index of Erectile Function, and the Female Sexual Function Index. Of 134 patients with rectal cancer (74 males, mean age [SD] 59.1 ± 8.27years), 46 patients underwent laparoscopic TME, 45 patients underwent da Vinci R-TME, and 43 patients underwent Micro Hand S R-TME. There were no differences in results between the two types of R-TME. Compared with laparoscopic TME, significant reductions in blood loss (median 65.50ml da Vinci; median 66.54ml Micro Hand S vs median 95.04ml L-TME p = 0.037 and p = 0.041, respectively) and conversion rate (2.2% da Vinci; 2.3% Micro Hand S vs 6.8% L-TME p = 0,040 for the comparison daVinci L-TME and p = 0.038 for the comparison Micro Hand S vs. L-TME) with da Vinci Si and Micro Hand S R-TME were noted, and significant increases in operation time (230.05min da Vinci; 235.03min Micro Hand S vs. 205.53min L-TME p = 0.045 and p = 0.043, respectively) was observed. Additionally, more patients underwent TME with sphincter-preserving methods in the two R-TME groups based on the type of operation (da Vinci97.7%; Micro Hand S97.9% vs. L-TME82% resulting in p = 0.033 for the comparison daVinci L-TME and p = 0.035 for the comparison Micro Hand S vs. L-TME). In comparison with L-TME, there was a larger number of lymph nodes retrieved (da Vinci mean 17.54; Micro Hand S mean 17.32 vs. L-TME mean 14.96 p = 0.031 for the comparison daVinci L-TME and p = 0.033 for the comparison Micro Hand S vs L-TME) and less blood loss (da Vinci mean 65.50ml; Micro Hand S mean 66.54ml vs. L-TME mean 95.04ml, p = 0.037 for the comparison daVinci L-TME and p = 0.041 for the comparison Micro Hand S vs. L-TME), and incidence of severe postoperative complications was similar among three TME groups except forthe earlier recovery of urogenital function (mean IPSS scoreda Vinci 7.73±1.35; Micro Hand S7.75±1.47 vs L-TME 14.26±1.41 p<0.001 for the comparison da Vinci L-TME and p<0.001 for the comparison Microhand S vs L-TME) in the two R-TME groups. In our study, compared with laparoscopic surgery, da Vinci or Micro Hand R-TME exhibited similar superiority in the quality of oncologic resection, postoperative morbidity, and recovery of postoperative function.

An Approach to Reviewing Local Context for Exception from Informed Consent Trials Using a Single IRB.

In the context of emergency research, researchers can ask the institutional review board (IRB) to waive the regulatory requirement that individuals provide informed consent when enrolling in research studies. A requirement of the waiver of informed consent is that the reviewing IRB must review and approve a community consultation and public disclosure plan. It is critical that an IRB serving as the single IRB (sIRB) for multisite research be thoroughly versed in the local context concerns for each participating site to determine whether the site's community is being adequately consulted about the research in which individuals will be enrolled under an exception to the informed consent requirement. We designed an sIRB review model for evaluating site-specific community consultation plans that included a local evaluation and feedback step, and we piloted the model with a four-site, pediatric exception from informed consent (EFIC) clinical trial. We identified three key roles for the model: the sIRB, the investigators, and the representative of the institution's human research protection program (HRPP). We successfully collected the information and local input needed to evaluate each site's community consultation plan and applied the information to a thorough IRB review, despite the geographic distance between the study site and the sIRB.

Achieving the competencies of an educational researcher

It is a long journey to become a competent educational researcher. The researcher requires both technical and non-technical competencies to become a skilled researcher (Baral, 2021). This editorial does not address the assessment and entrustment of these competencies. Rather it focuses on the competencies required to become an educational researcher. This includes conduct of research, research skills at the workplace, discipline-specific knowledge, professionalism, communication skills, critical thinking, leadership, management, and job market skills.&#x0D; The conduct of research is the practice of scientific investigation with integrity(Iqbal, 2021). It includes but is not limited to collaboration, managing conflicts of interests and commitments, data acquisition and its management, human research protection, mentoring, peer review, publication practices, and research misconduct whereas research skills at the workplace include searching for information, taking notes, time management, problem-solving and communicating results(Marks-Maran, 2015). Can we analyze and systematically develop these research skills? The answer is yes. The Research Skills Development framework developed by John and Kerry is a tool that can analyze and plan a curriculum for the systematic development of research skills (Hendriarto, Mursidi, Kalbuana, Aini, &amp; Aslan, 2021). The framework is based on different facets of student research: curious, determined, discerning, harmonizing, creative, and constructive. These facets vary at different stages of students’ autonomy of researching skills: prescribed, scaffolding, open-ended, and unbounded researching (Willison &amp; O’Regan, 2007).

Physician Perceptions of Pediatric Palliative Care for Children with Cancer in Latin America

Background: The World Health Organization (WHO) designates early integration of palliative care as an ethical responsibility in the management of children with serious illness. While structural barriers may influence provision of pediatric palliative care (PPC) for children with cancer in resource-limited settings, underlying physician perceptions also impede early integration of PPC within cancer care. Methods: The Assessing Doctor’s Attitudes on Palliative Treatment (ADAPT) survey was developed for physicians who care for children with cancer and initially distributed in Eurasia. In this study, the survey was modified for use in Latin America including translation into Spanish and adapted for cultural context. Descriptive statistics were used to summarize the data, along with univariate and multivariable analyses of factors impacting knowledge and comfort in PPC practice. Open-ended questions were analyzed qualitatively to supplement the quantitative data. Findings: A total of ­­­­874 physicians from 17 countries completed the survey. Most physicians (56%) had no formal PPC training and 35% had no access to PPC experts for consultation. On average, providers’ perspectives on PPC were aligned with WHO guidance (­­­83% alignment, range 24% - 100%). However, only 50% of respondents felt comfortable addressing physical symptoms, 34% felt comfortable addressing emotional symptoms, and 25% felt comfortable addressing grief and bereavement for the patient’s family. Provider specialty and previous palliative care training were significantly associated with WHO alignment and physician comfort in addressing patient needs. Ninety-six percent of survey participants desired further education and training in PPC. Interpretation: Despite perspectives aligning with WHO guidance, this study identified opportunities for improving physician training in symptom management and emotional support for children with cancer and their families. These findings will inform the development of targeted interventions to enhance PPC education and improve the quality of care for children with cancer in Latin America. Funding Information: American Lebanese Syrian Associated Charities. Declaration of Interests: All authors declare no competing interests. Ethics Approval Statement: The Office of Human Subjects Research Protections and Institutional Review Board at St. Jude Children’s Research Hospital (Memphis, TN, USA) approved this study as exempt research. Additional local approvals were obtained as needed.

Protocol for DRAUP: a deimplementation programme to decrease routine chest radiographs after central venous catheter insertion

IntroductionAvoiding low value medical practices is an important focus in current healthcare utilisation. Despite advantages of point-of-care ultrasound (POCUS) over chest X-ray including improved workflow and timeliness of results, POCUS-guided...

Depression, Anxiety, and Chronic Fatigue Symptoms in Acute Rheumatoid Arthritis Are Associated With Immune-Inflammatory, Autoimmune, Endogenous Opioid System and Lactosylceramide Signaling Pathways: A Nomothetic Network Approach

Rheumatoid arthritis (RA) is a chronic inflammatory and autoimmune disorder which affects the joints in the wrists, fingers, and knees. RA is often associated with depressive and anxiety symptoms as well as chronic fatigue syndrome (CFS)-like symptoms. To examine the association between depressive symptoms (measured with the Beck Depression Inventory, BDI), anxiety (Hamilton Anxiety Rating Scale, HAMA), and CFS-like (Fibro-fatigue Scale) symptoms and immune-inflammatory, autoimmune, and endogenous opioid system (EOS) markers, and lactosylceramide in RA. Serum biomarkers were assayed in RA patients with (n=59) and without (n=59) increased psychopathology (PP) and 50 healthy controls. There were highly significant correlations between the BDI, FF, and HAMA scores and severity of RA, as assessed with the DAS28-4, clinical and disease activity indices, the number of tenders and swollen joints, and patient and evaluator global assessment scores. A common latent vector (reflective model) could be extracted from the PP and RA-severity scales, which showed excellent psychometric properties. Partial least squares analysis showed that 69.7% of the variance in this common core underpinning PP and RA symptoms could be explained by the regression on immune-inflammatory pathways, rheumatoid factor and anti-citrullinated protein antibodies, CD17, and mu-opioid receptor levels. Depression, anxiety, and CFS-like symptoms due to RA are reflective manifestations of the phenome of RA and are mediated via the effects of the same immune-inflammatory, autoimmune, and EOS pathways and lactosylceramide that underpin the pathophysiology of RA. These PP symptoms are clinical manifestations of the pathophysiology of RA. Funding Information: There was no specific funding for this specific study. Declaration of Interests: The authors declare no conflicts of interest which are relevant to the content of this article. Ethics Approval Statement: The ethics committee (IRB) of the University of Kufa, Iraq (243/2020), which complies with the International Guideline for Human Research Protection, approved the study as required by the Helsinki Declaration.

Administration of the Coronavirus Disease 2019 (COVID-19) Vaccine to Hospitalized Postpartum Patients.

INTRODUCTION Recently published data demonstrate that vaccination against coronavirus disease 2019 (COVID-19) in pregnancy is safe and effective, with antibody transfer through the umbilical cord blood and breast milk.1–4 However, pregnant individuals are less likely than nonpregnant individuals to accept COVID-19 vaccination.5 Research on vaccine acceptance among obstetric populations has shown two factors increase vaccination rates: 1) vaccine availability in the obstetric health care setting, and 2) vaccine counseling from an obstetric clinician.6 We assessed the feasibility of inpatient COVID-19 vaccination among obstetric patients admitted for delivery and compared the characteristics of those who were vaccinated while inpatient with those who were vaccinated before admission. METHODS We performed a retrospective cohort study of all patients admitted for delivery in the first 36 days after Pfizer/BioNTech (BNT162b2) COVID-19 vaccine availability at a single institution to describe rates of eligibility, vaccination counseling, and uptake in the obstetric unit. The COVID-19 vaccine was available to hospitalized obstetric patients if they had not received a COVID-19 vaccination and did not have active COVID-19. Eligible patients were offered vaccination and counseled by obstetricians. Pharmacy staff administered vaccinations in the postpartum unit on weekdays (vaccination was not available on weekends). Second-dose appointments were scheduled before discharge. Characteristics of patients vaccinated before admission, including Area Deprivation Index, were compared with those of patients vaccinated during their admission using χ2, Fisher exact, and Mann-Whitney U tests as appropriate. We included race as a demographic variable in our analysis because of underlying racial disparities in vaccination.7 Area Deprivation Index is a measure of socioeconomic disadvantage in Census block groups; this analysis used the 2019 Area Deprivation Index.8,9 This project was deemed exempt by the Washington University in St. Louis Human Research Protection Office. RESULTS From June 1 to July 6, 2021, there were 329 deliveries: 75 (22.8%) individuals had been vaccinated before admission, and five (1.5%) were not eligible for vaccination due to active COVID-19, resulting in 249 eligible patients (75.7% of deliveries, Fig. 1). From medical record abstraction, we confirmed that 221(88.8%) eligible patients were offered vaccination and underwent counseling. Of the 221, 169 (76.5%) declined and 52 (23.5%) accepted. The vaccine was successfully administered to 43 (82.7%) patients. Six of the nine patients who desired vaccination but did not receive it were discharged over the weekend, when vaccination was not available. There was no explanation in the medical record for the other three patients.Fig. 1.: Patients who were admitted and delivered between June 1 and July 6, 2021, after availability of inpatient, postpartum coronavirus disease 2019 (COVID-19) vaccinations.Perez. Obstetric Inpatient COVID-19 Vaccine. Obstet Gynecol 2021.Compared with those vaccinated before admission, patients who received inpatient vaccination were more likely to be Black, have public insurance, have a hypertensive disorder of pregnancy, and reside in areas with a higher Area Deprivation Index (median [interquartile range]) 87 [65–94] vs 57 [38–80], P<.001 (Fig. 2). They were less likely to be nulliparous and exclusively breastfeeding at discharge (Table 1).Fig. 2.: Area deprivation index of those vaccinated before admission and those vaccinated while inpatient (P<.001).Perez. Obstetric Inpatient COVID-19 Vaccine. Obstet Gynecol 2021.Table 1.: Characteristics of Patients Who Were Vaccinated Before Admission and Those Who Received Vaccination During Inpatient HospitalizationDISCUSSION More than three quarters of patients admitted to our obstetric service for delivery were eligible for vaccination, and most of them were offered vaccination and underwent counseling with an obstetrician. Although vaccine uptake during hospitalization was low, the proportion of patients vaccinated at discharge was 50% higher than at admission. Importantly, inpatient vaccination may improve the health equity of obstetric patients. Patients vaccinated during admission were more likely to be from groups with higher health disparities in both COVID-19 acquisition and vaccination access, in addition to having higher rates of comorbidities that increase risk of severe disease.10,11 Availability of COVID-19 vaccination during obstetric hospitalization presents a feasible opportunity for counseling by obstetric clinicians and convenient timing for first-dose administration. However, given persistently low vaccination rates, strategies to optimize COVID-19 vaccination acceptance among obstetric patients are needed.

Making Metrics Meaningful: How Human Research Protection Programs Can Efficiently and Effectively Use Their Data.

Human research protection programs (HRPP) generate an abundance of data on performance, capacity, and compliance. When used effectively, this information can be instrumental in helping HRPPs meet programmatic and institutional goals, demonstrate growth and success, and improve the HRPP overall. Metrics must be grounded in professional insight so that HRPPs can pair analytics with strategies for future action or improvement. The purpose of this paper is to demonstrate how high-performing HRPPs develop, adopt, and implement a metrics framework that benefits everyday operations and produces real-world results. Through a three-part thematic framework (of insight, data, and action) and by providing case examples and actionable strategies, this article will address how HRPPs iteratively develop and characterize their metrics, build a metrics framework that leverages both quantitative and qualitative data to validate outcomes, and activate human insight to produce meaningful communication, visualization, and dissemination of data.

The Privatization of Human Research Ethics: An American Story

Abstract In recent decades, there has been a remarkable shift in the governance of human research ethics in the United States. A model once based on review by panels of local volunteers has given way to a system dominated by large, for-profit research ethics committees. America’s reliance on for-profit ethics review is unique among wealthy industrialized countries. How can we account for this anomaly? In this article, I show that for-profit irb s represent only the most visible aspect of the privatization of human research protections in the United States. I suggest that private institutions have emerged as “workaround” solutions to systemic problems, in the absence of comprehensive policy reforms.

An Argument for Reinterpreting the Benign Behavioral Intervention Exemption.

Recent changes to the Common Rule have helped reduce regulatory burden on researchers conducting minimal risk research. However, in this paper, I propose a way of minimizing burden further within the existing confines of the current regulations. I focus my discussion on the newly created "benign behavioral interventions" category of exempt research, arguing that this exemption from the federal regulations governing research with human subjects should be more expansively interpreted by the Secretary's Advisory Committee on Human Research Protections (SACHRP) than is currently the case. Specifically, I argue against the restriction, advocated by SACHRP, that the exemption exclude "physical (bodily) tasks" unless they are "incidental to the behavioral intervention." This restriction, I argue, is problematically vague and does no significant moral work. Acceptance of my proposed reinterpretation of "benign behavioral interventions" would, I hope, result in a significant reduction in regulatory burden for minimal risk research.

Oversight May Reduce Military Health System Leakage: Preventing Inappropriate Interhospital Transfers.

The Military Health System (MHS) offers an example of a socialized healthcare model, operating within a larger "purchased care" civilian healthcare market. This arrangement has facilitated a trend wherein MHS clinicians often transfer moderate-to-complex patients to surrounding civilian hospitals, despite having the capability to care for such patients in-house. In an effort to stem this behavior, two initiatives were introduced at Carl R Darnall Army Medical Center (CRDAMC): A Transfer Policy Statement and Transfer Rounds. The Transfer Policy Statement emphasized that patients ought to be transferred only for capability gaps within the hospital. Transfer Rounds were then used to review the care received by each transferred patient and assess if that care could have been delivered internally. The purpose of this study is to assess the effect of these initiatives on reducing transfers from our hospital. We performed a retrospective chart review from July 2019 through June 2020 to identify the number of total emergency department (ED) transfers, subcategorized as either transfers we had the capability to care for or transfers we did not have the capability to care for. The Transfer Policy Statement was published in August 2019, and Transfer Rounds were instituted in November 2019. We hypothesized that the two interventions would decrease the number of monthly inappropriate transfers. This was assessed by analyzing the proportion of inappropriate to appropriate patient transfers via Cochran and Armitage using SAS 9.4 (SAS Institute, Cary, NC). The projected received an Exemption Determination from the CRDAMC's Human Research Protections Office. The Defense Health Agency approved the data-sharing agreement. Over the study period, a total of 706 transfers met the criteria for analysis. The monthly median for total ED transfers was 64.5 (Interquartile Range (IQR) 45-74); appropriate transfers averaged 29.5 (median, IQR 24.5-36) and inappropriate 25.5 (median, IQR 9-41.5). A statistically significant downward trend in the fraction of inappropriate transfers was demonstrated by Cochran and Armitage (P < .0001). Our analysis supports the hypothesis that implementing a Transfer Policy and Transfer Rounds can significantly reduce the amount of MHS Leakage-that is the number of transferred patients that the MHS could have equally cared for. The effects of reduced patient transfers have many implications for the MHS: patients experience improved continuity of care by remaining in the same hospital system; clinicians maintain and extend their scope of practice by treating more complex patients; and patient flow and ED wait times are reduced by eliminating the transfer process. The financial implications of reduced MHS Leakage were not directly evaluated by our study, however may be assessed in future study.

Comparative analysis of regulatory framework on biobanking to inform policymakers in Central America and the Dominican Republic

Background. The clinical and scientific importance of biobanks has been highlighted. Ethical governance and regulatory oversight for biobanks should be in place to preserve and promote ethical and responsible conduct of research. Methods. This is an analytical documentary study of the regulatory scope concerning biobanks in Central America and the Dominican Republic. From the International Compilation of Human Research Standards 2020 edition of the Office of Human Research Protection Department of Health and Human Services of the United States of America identified the existing guidelines applicable to human research in each of the eight SICA member countries. Regulatory aspects searched for and the analysis was based on the recommendations set forth in Guideline 11 on the collection, storage, and use of biological materials and related data in the International Ethical Guidelines for Research Related to Human Health. Results. There is a lack of specific guidelines for the collection, use, and storage of human biological materials for research purposes, and the creation of biobanks in the countries been studied. No country in Central America and the Dominican Republic region has specific regulations for the creation of biobanks for research purposes. The term "biobank" was not found in the revised regulations. However, there are good examples of ethical governance of research in general in the region been Costa Rica, Panamá, and Guatemala examples of advances towards this direction. Conclusions. There is a need to move forward the governance and regulatory framework of biobanks in Central America and the Dominican which can be seen as an opportunity for international cooperation and regulatory collaborative agenda within this region.