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Many research communities routinely conduct activities that fall outside the bounds of traditional human subjects research, yet still frequently rely on the determinations of institutional review boards (IRBs) or similar regulatory bodies to scope ethical decision-making. Presented as a U.S. university-based fictional memo describing a post-hoc IRB review of a research study about social media and public health, this design fiction draws inspiration from current debates and uncertainties in the HCI and social computing communities around issues such as the use of public data, privacy, open science, and unintended consequences, in order to highlight the limitations of regulatory bodies as arbiters of ethics and the importance of forward-thinking ethical considerations from researchers and research communities.

IntroductionAs the main manifestation of gallstone disease, biliary colic (BC) is an episodic attack that brings patients severe pain in the right upper abdominal quadrant. Although acupuncture has been documented with significance to lead to pain relief, the immediate analgesia of acupuncture for BC still needs to be verified, and the underlying mechanism has yet to be covered. Therefore, this trial aims first to verify the immediate pain-alleviation characteristic of acupuncture for BC, then to explore its influence on the peripheral sensitised acupoint and central brain activity.Methods and analysisThis is a randomised controlled, paralleled clinical trial, with patients and outcome assessors blinded. Seventy-two patients with gallbladder stone disease presenting with BC will be randomised into a verum acupuncture group and the sham acupuncture group. Both groups will receive one session of immediate acupuncture treatment. Improvements in patients’ BC will be evaluated by the Numeric Rating Scale, and the pain threshold of acupoints will also be detected before and after treatment. During treatment, brain neural activity will be monitored with functional near-infrared spectroscopy (fNIRS), and the needle sensation will be rated. Clinical and fNIRS data will be analysed, respectively, to validate the acupuncture effect, and correlation analysis will be conducted to investigate the relationship between pain relief and peripheral–cerebral functional changes.Ethics and disseminationThis trial has been approved by the institutional review boards and ethics committees of the First Teaching Hospital of Chengdu University of Traditional Chinese Medicine, with the ethical approval identifier 2019 KL-029, and the institutional review boards and ethics committees of the First People’s Hospital of Longquanyi District, with the ethical approval identifier AF-KY-2020071. The results of this trial will be disseminated through peer-reviewed publications and conference abstracts or posters.Trial registration numberCTR2000034432.

While the social sciences have made impressive progress in adopting transparent research practices that facilitate verification, replication, and reuse of materials, the problem of publication bias persists. Bias on the part of peer reviewers and journal editors, as well as the use of outdated research practices by authors, continues to skew literature toward statistically significant effects, many of which may be false positives. To mitigate this bias, we propose a framework to enable authors to report all results efficiently (RARE), with an initial focus on experimental and other prospective empirical social science research that utilizes public study registries. This framework depicts an integrated system that leverages the capacities of existing infrastructure in the form of public registries, institutional review boards, journals, and granting agencies, as well as investigators themselves, to efficiently incentivize full reporting and thereby, improve confidence in social science findings. In addition to increasing access to the results of scientific endeavors, a well-coordinated research ecosystem can prevent scholars from wasting time investigating the same questions in ways that have not worked in the past and reduce wasted funds on the part of granting agencies.

The present audit was carried out with the objective of evaluating warning letters (WLs) issued to trial sponsors, clinical investigators and institutional review boards (IRBs) by the United States Food and Drug Administration during a six-year period and compare it with two similar earlier audits. WLs were reviewed and classified as per stakeholders and further categorised as per predefined violation themes. The chi-square test was performed for trend analysis of WLs. A total of 62 WLs were issued to the three stakeholders. The maximum number of WLs were issued to the clinical investigators (36/62, 58.06%), followed by sponsors (19/62, 30.64%), and least to the IRBs (7/62, 11.29%). Among sponsors, lack of standard operating procedures for the monitoring, receipt, evaluation and reporting of post-marketing adverse drug events was the most common violation theme (8/19, 42.1%). Among clinical investigators, deviation from investigational plan was the most common violation theme (31/36, 86.11%.). For IRBs, inadequate documentation was the most common violation theme (6/7, 85.71%). We saw an overall reduction in the number of WLs issued to the stakeholders. Thus, we identified multiple areas on which each stakeholder should work for improvement.

 The purpose of  this study was to identify associations between insurance type and costs and to investigate specified variables’ influence on individuals’ access to adequate coverage. This was a cross sectional study, using secondary data analyses. The study was completed at The Eye Institute (TEI) East Oak Lane Campus in Philadelphia, PA. The study population was all patients seen at TEI East Oak Lane Campus, specifically patients seen at TEI clinic from January 1st, 2019, - to December 31st, 2019, whose encounter generated an insurance claim (n=68,484). The exposure was insurance type and outcomes were patient total amount, billed amount, and pay amount by patient. Data analyses were performed using SAS, version 9.4. In all statistical analyses, p-values were one-sided and considered statistically significant if 0.05 or lower. The study protocol was approved by the Institutional Review Boards of Salus University. The sample represented an older population with an average age of about 55. There was a significant association found between financial class with patient total amount (p<0.0001), billed amount(p<0.0001), and pay amount (p<0.0001). People with managed PPO pay the least, while those on Medicaid and workers compensation pay the most out of pocket. The two Philadelphia zip codes which pay the most out of pocket have two of the lowest average household incomes in the Greater Philadelphia area. Insurance type and out of pocket expenses potentially have a negative effect on patient vision health and affordability of care as well as access to care. These findings contribute to the identification of variables that influence individual’s healthcare accessibility and evidence for opportunities to improve insurance coverage.            

Introduction - Increases in global childhood vaccine delivery have led to decreases in morbidity from vaccine-preventable diseases. However, these improvements in vaccination have been heterogeneous, with some countries demonstrating greater levels of change and sustainability. Understanding what these high-performing countries have done differently and how their decision-making processes will support targeted improvements in childhood vaccine delivery. Methods and analysis - We studied three countries - Nepal, Senegal, Zambia - with exemplary improvements in coverage between 2000-2018 as part of the Exemplars in Global Health Program. We apply established implementation science frameworks to understand the how and why underlying improvements in vaccine delivery and coverage. Through mixed methods research we will identify drivers of catalytic change in vaccine coverage and the decision-making process supporting these interventions and activities. Methods include quantitative analysis of available datasets and in-depth interviews and focus groups with key stakeholders in the global, national, and sub-national government and non-governmental organization space, as well as community members and local health delivery system personnel. Ethics and dissemination - Working as a multinational and multidisciplinary team, and under oversight from all partner and national-level (where applicable) institutional review boards, we collect data from participants who provided informed consent. Findings are disseminated through a variety of forms, including peer-reviewed manuscripts related to country-specific case studies and vaccine system domain-specific analyses, presentations to key stakeholders in the global vaccine delivery space, and narrative dissemination on the Exemplars.Health website.

IntroductionSexual and gender-based violence (SGBV) is a major public health concern in Jordan, especially among youth. Social acceptance of SGBV is alarmingly high, including among youth. Refugee populations may be at particular risk given limited social support and access to health services combined with increased social and economic pressure and vulnerability. Further research is needed to understand how norms are embodied and reproduced at individual, interpersonal and community levels through relationships between partners, families, peers and community leaders. This study seeks to provide data on attitudes and norms in communities and across youth social networks in order to support gender transformative approaches that seek to change harmful social norms that perpetuate acceptance of SGBV.Methods and analysisThis study will collect egocentric data from 960 youth in Jordan (480 men and 480 women) aged between 18 years and 24 years. Individuals will be asked about their perceptions of norms relating to SGBV in their community as well as their perceptions of the attitudes held by up to 15 individuals within their social network. Data will also be collected on the social, economic and demographic variables, refugee status, experience of depression and anxiety, and social support. We will use multilevel analysis to examine individual and group-level associations. We will also assess other network attributes, such as homophily, the role of social engagement, social learning and social support in the transmission of norms and attitudes.Ethics and disseminationEthical approval was obtained from the Institutional Review Boards of the Harvard T.H. Chan School of Public Health and the University of Jordan. Rigorous ethical protections will be followed with regard to confidentiality and respondent safety. We intend to publish peer-reviewed papers of our findings in addition to a variety of tools and resources targeting diverse audiences, including policy and technical briefs.

In 2018, funding for child welfare programs drastically changed under the Bipartisan Budget Act: Family First Prevention Services Act (FFPSA). To pull Title IV-E funding for prevention programs, all states must evaluate outcomes of children and families involved in child welfare. To meet these guidelines, state agencies need research structures, including internal Institutional Review Boards (IRBs). IRBs allow state governments to conduct ethical research, and expand research within the discipline. As researchers pursue careers outside of academia, these structures are pivotal and lead to policy contributions and knowledge in the discipline. This study evaluates the following in all 50 US states: How many states have internal IRBs? How many states have IRBs that are accessible to the state’s child welfare agency? How have states set-up internal IRBs to function within a government context? The analysis found 34 states have at least one federally registered IRB of which 31 appear active within the state. However, only 11 of the 31 states have an IRB accessible to child welfare departments. These 11 states provide a blueprint for how to establish and maintain an IRB that supports child welfare agencies. Three distinct set ups emerged: holistic multi-department IRB, singular department/agency IRB, or those governed by an inter-agency sharing agreement. These findings show multiple states use an internal IRB to support state researchers. However, these IRBs are not currently accessible to the child welfare agency. For agencies to meet the requirements of FFPSA, IRBs must be expanded to the child welfare agency or built within the state.

BackgroundSAR444245 (THOR-707) is a recombinant human IL-2 molecule that includes a PEG moiety irreversibly bound to a novel amino acid via click chemistry to block the alpha-binding domain while retaining near-native affinity for the beta/gamma subunits. In animal models, SAR444245 showed anti-tumor benefits, but with no severe side effects, both as single agent and when combined with anti-PD1 comparing with historical data from aldesleukin. The HAMMER trial, which is the FIH study shows preliminary encouraging clinical results: initial efficacy and safety profile with SAR444245 monotherapy and in combination with pembrolizumab support a non-alpha preferential activity, validating preclinical models. The Pegasus Lung Ph2 study will evaluate the clinical benefit of SAR444245 in combination with other anticancer therapies for the treatment of patients with lung cancer or pleural mesotheliomaMethodsThe Pegasus Lung (NCT04914897) will enroll approximately 354 patients in 6 separate cohorts concurrently or sequentially. In cohorts A1 & A2, patients with first line (L) NSCLC will receive SAR444245 + pembrolizumab. In cohort A3, patients with 1L non-squamous NSCLC will receive SAR444245 + pembrolizumab + pemetrexed + carboplatin/cisplatin. In cohort B1 & B2 patients with 2/3L NSCLC who have progressed on a checkpoint inhibitor (CPI)-based therapy will receive SAR444245 + pembrolizumab, or SAR444245 + pembrolizumab + nab-paclitaxel. In cohort C patients with 2/3L CPI naïve mesothelioma will receive SAR444245 + pembrolizumab. SAR444245 is administered IV at a dose of 24 ug/kg Q3W in an outpatient setting until disease progression or completion of 35 cycles. Pembrolizumab is administered at a dose of 200 mg Q3W until PD or completion of 35 cycles. The study primary objective is to determine the antitumor activity of SAR444245 in combination with other anticancer therapies. Secondary objectives include confirmation of dose and safety profile, assess other indicators of antitumor activity, and assess the pharmacokinetic profile and immunogenicity of SAR444245. The study will be conducted in the US, Australia, France, Italy, Japan, Poland, South Korea, Spain, and Taiwan.AcknowledgementsThe Pegasus Lung study is sponsored by Sanofi.Trial RegistrationNCT04914897Ethics ApprovalThis study has been approved by applicable ethics committees or institutional review boards. All participants gave informed consent before taking part.ConsentWritten informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal.

BackgroundEftilagimod alpha (efti) is a soluble LAG-3 protein targeting a subset of MHC class II, thus mediating antigen presenting cell (APC) and CD8 T-cell activation. Such stimulation of the dendritic cell network and resulting T cell recruitment by efti may lead to stronger anti-tumor responses than observed with pembrolizumab alone. We hereby report results of the 2nd line metastatic head and neck squamous cell carcinoma (HNSCC) cohort (part C) of the TACTI-002 phase II trial (NCT03625323).MethodsEligible patients (pts) with HNSCC, unselected for PD-L1 expression with disease progression on or after 1st line platinum-based therapy, received 30 mg subcutaneous efti Q2W for 24 weeks and 200 mg pembrolizumab Q3W for up to 2 years or until disease progression. The study used a Simon’s 2-stage design with objective response rate (ORR) as the primary endpoint (EP). Secondary EPs included tolerability, progression free survival (PFS), overall survival (OS), pharmacokinetics, pharmacodynamics, and immunogenicity. Tumor response was assessed Q9W. PD-L1 was assessed centrally (22C3 clone). The study was approved by ethic committees and institutional review boards.ResultsBetween Mar 2019 and Jan 2021, 39 pts were enrolled (cut-off Apr 2021). The median age was 62 yrs (range 37–84) with 90% male pts. ECOG was 0 and 1 in 33% and 67%, respectively. Primary tumor location at diagnosis was oropharynx (36%), oral cavity (31%), hypopharynx (18%) and larynx (15%) with all PD-L1 subgroups (CPS< 1, ≥1 to ≤19; ≥20) being represented. All pts were pre-treated with platinum-based chemotherapy. Thirty-seven (37) pts were evaluated for response with ORR (iRECIST) of 30% (95% CI 16–47%) with 5 (14%) CRs; 6 (16%) PRs; 3 (8%) SDs; 17 (46%) PDs and 6 (16%) pts not evaluable. Median PFS was 2.1 months and 30+% were progression-free at 6 months. One patient (3%) discontinued due to pembro-related adverse event. The most common (>10%) treatment emergent adverse events were hypothyroidism (21%), cough (18%), asthenia (15%), fatigue (13%), anemia (13%), diarrhea (13%) and weight decreased (13%).ConclusionsEfti in combination with pembrolizumab is safe, showing encouraging antitumor activity in platinum pre-treated, 2nd line HNSCC patients. For further investigation of this combination, a 1st line HNSCC trial (NCT04811027) has been initiated.Trial RegistrationNCT03625323Ethics ApprovalThe study was approved by relevant ethic committees and institutional review boards