Immediate acupuncture with GB34 for biliary colic: protocol for a randomised controlled neuroimaging trial

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.

An audit of US FDA warning letters issued to sponsors, institutional review boards and investigators over a six-year period

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.

Expanding State Research Capacity in Child Welfare: The Need for State Institutional Review Boards (IRBs)

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.

Studying Up: Four Modalities, Two Challenges

In her 1973 article “up the anthropologist” Laura Nader called on anthropologists to engage in critical studies of the relationship between powerful institutions and the broader society, using a “vertical slice” approach. But Nader worried that participant observation was hard in the context of studying up, and yet it has been presented as definitive of anthropology’s methodology. This article discusses four methodological strategies for studying up in the light of this concern: insider ethnography; covert ethnography; remote ethnography; and adapted participant observation. The first two have intellectual or ethical liabilities. The last is increasingly normalized. Going forward, anthropologists studying up face two obstacles: first, the increasingly totalizing hold of corporate and government workplaces over their employees, even when they are not at work; and, second, university institutional review boards (irb s) concerned to avoid conflictual or critical research.

#MeToo Online Disclosures: A Survivor-Informed Approach to Open Science Practices and Ethical Use of Social Media Data

With social media data widely available, researchers are increasingly incorporating tweets, posts, and blogs in their work. While easily accessible, the use of “public” posts raises important questions about the ethics of mining, storing, analyzing, and reporting publicly available social media data—especially when gathering sensitive information such as sexual violence disclosures. Online movements including #MeToo and #WhyIDidntReport emerged to shed light on gender-based violence. These movements generate large quantities of data with little consistency and oversight across research groups, disciplines, and review boards on data ethics. With the recent push in social science to publish data to open science databases, the concerns of feminist psychologists and ethical concerns of social media research with survivors have become more salient. In this article, we describe and address these ethical issues by reviewing existing social media sexual assault disclosure research and make concrete recommendations for authors seeking to use social media data. We also seek to address these ethical concerns by noting the work of some feminist researchers, but also by pushing researchers to do more for survivors through a survivor-informed approach to this research in an open science context. We propose four survivor-informed recommendations for research with this vulnerable population: (a) get input from survivors, (b) update ethics review boards, (c) maximize benefits to participants, and (d) utilize study-appropriate datasets with informed consent.

Advantages, Challenges and Limitations of Audit Experiments with Constituents

Audit experiments examining the responsiveness of public officials have become an increasingly popular tool used by political scientists. While these studies have brought significant insight into how public officials respond to different types of constituents, particularly those from minority and disadvantaged backgrounds, audit studies have also been controversial due to their frequent use of deception. Scholars have justified the use of deception by arguing that the benefits of audit studies ultimately outweigh the costs of deceptive practices. Do all audit experiments require the use of deception? This article reviews audit study designs differing in their amount of deception. It then discusses the organizational and logistical challenges of a UK study design where all letters were solicited from MPs’ actual constituents (so-called confederates) and reflected those constituents’ genuine opinions. We call on researchers to avoid deception, unless necessary, and engage in ethical design innovation of their audit experiments, on ethics review boards to raise the level of justification of needed studies involving fake identities and misrepresentation, and on journal editors and reviewers to require researchers to justify in detail which forms of deception were unavoidable.