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The article focuses on ethical considerations surrounding the inclusion of individuals with opioid use disorder in research studies, emphasizing vulnerabilities, potential coercion issues, and the need for careful ethical oversight. It highlights the importance of protecting these participants, ensuring informed consent, and mitigating risks associated with stigma and legal concerns related to their participation in clinical trials.

The article explores the challenges of obtaining informed consent in neurological research, highlighting barriers such as cognitive impairments and unrealistic expectations, and suggests strategies like integrating social support, and collaborating with experienced team members.

The article focuses on the responsibility of research ethics committees and their institutions to ensure equitable participant selection and promote diversity in interventional clinical research, emphasizing the importance of balancing inclusion with the protection of vulnerable individuals.

The article explores the ethical considerations and challenges researchers face when deciding whether and how much to pay study participants, highlighting concerns related to both overpayment and underpayment. Topics include the need for clearer guidelines, the importance of respecting participants' time, and the role of Institutional Review Boards (IRBs) in reviewing payment amounts.

The article presents the discussion on residents and medical students being involved in the patient's care. Topics include raising some ethical concerns on whether study participants actually are giving true informed consent; and panel being a group of more than 40 community members, researchers, patients and families, and healthcare providers.

The article focuses on the ethical concerns surrounding the inclusion of adults living with intellectual disabilities in research, emphasizing the importance of considering their capacity for informed, voluntary decision-making and the need for inclusive practices in the informed consent process.

The article focuses on the difficulties in finding clinical trials conducted under the Exception from Informed Consent (EFIC) rule, with only 110 trials identified since the regulation's inception, leading to a lack of transparency, which could be the cause of poor recruitment and early termination.

The article discusses the importance of building trust and personal connections with underrepresented minority communities in clinical trial recruitment, as low levels of trust can lead to lack of participation, further health inequities, and a lack of representative research findings.

The article discusses the consequences of not recruiting enough participant for a clinical study and points that researchers should keep in their mind while starting a study including shortage of staff or funding and participants should know there is a possibility the research might not finish.

The article presents the discussion on group of researchers examining IRB member attitudes toward protecting participants and including participants including conflict in IRB reasoning and decision-making.

It is critical to remember face-to-face contact remains the best way to conduct the process of informed consent. Remote processes should not be used as an alternative if face-to-face contact is safe and practical. [ABSTRACT FROM AUTHOR]

The article presents the discussion on updated tactics for Parkinson's Disease study recruitment. Topics include Schneider and colleagues comparing recruitment processes of three different remote, decentralized Parkinson's disease clinical trials; and research needed for determining best strategies for improving recruitment with particular attention to the recruitment of groups underrepresented in research.

Is it harder for someone near the end of life to participate in research (or to serve as a research advisor) compared to someone with diabetes? A question like this led a group of researchers to explore ethical challenges posed by study recruitment of patient and family advisors for research on end-of-life or palliative care. [ABSTRACT FROM AUTHOR]

Is a study protocol OK to go forward? Or are many changes needed for recruitment, consent, or other processes? IRB decisions often are inconsistent on these points — even at the same institution, and sometimes at the same IRB. [ABSTRACT FROM AUTHOR]

All researchers should consider fraud detection safeguards early in the study planning and design process. Allot the necessary time and resources to ongoing, rigorous data quality checks, and invest in fraud detection technology. [ABSTRACT FROM AUTHOR]

Find consent processes that protect and preserve patients' autonomy to the extent possible, while also allowing medical progress to occur and giving participants access to potentially beneficial therapies. Doing so may require  a more creative process than just following the rules. [ABSTRACT FROM AUTHOR]

To do this effectively, researchers must become familiar with the social media environment relevant to their study population, find the right influencers, and contact those people. [ABSTRACT FROM AUTHOR]

It boils down to trust, communication, education, and building a presence within the community. [ABSTRACT FROM AUTHOR]

Investigators learned age disparities were worse for industry-funded trials; for trials with enrollment criteria restrictions based on age cutoffs or performance status; for trials that evaluated a targeted, systemic therapy; and for lung cancer trials. [ABSTRACT FROM AUTHOR]

Survey respondents with a history of cancer and those who have heard of ClinicalTrials.gov knew more about trials. Such knowledge also was more abundant among college graduates and those who had been asked to participate in a trial. [ABSTRACT FROM AUTHOR]

IRBs and researchers should expand eligibility criteria to diversify representation, remove extraneous inclusion/exclusion criteria, and eliminate some screening tests if they are not strictly necessary, particularly tests that produce many false-negative or false-positive results. [ABSTRACT FROM AUTHOR]

What can be consolidated, made simpler, or translated? What data can be collected outside your research setting? How can you communicate better with prospective and current research participants? [ABSTRACT FROM AUTHOR]

With current treatment methods, many individuals with serious mental illness function well, maintain employment, hold valued roles in their communities, and can consent to and participate in research. [ABSTRACT FROM AUTHOR]

Some IRB members cite uncertainty on whether inclusion of pregnant participants could affect the study's scientific validity. Others acknowledge they rely on the common, default practice of excluding pregnant individuals without requiring justification. Guidance is needed for characterizing the risk level of research procedures in the context of pregnancy. [ABSTRACT FROM AUTHOR]

This study reports data that refutes the U.S. Food and Drug Administration's class warning regarding suicidality risk in patients with epilepsy who are taking the newer antiepileptics, approved since 2008. The class warning should be reconsidered. [ABSTRACT FROM AUTHOR]

Since 2015, when multiple clinical trials were published showing the efficacy of endovascular thrombectomy (EVT) for large vessel occlusion within six hours of stroke onset, additional criteria have been developed to identify those patients who will benefit from EVT beyond six hours. The AURORA investigators collected patient data from six large clinical trials and performed a meta-analysis to determine if a clinical mismatch or an imaging mismatch protocol was better at predicting good outcomes in patients treated between six hours and 24 hours after the onset of clinical stroke symptoms. [ABSTRACT FROM AUTHOR]

Delayed study startup times obstruct the enrollment process for prospective participants in clinical trials with a therapeutic intent. That is an ethical concern. Delays in IRB approval hinder enrollment, data collection and analysis, and submissions to regulatory oversight agencies. It takes longer to learn if new therapies are effective and safe. Updated product labeling and product approvals are held up. This delays the opportunity for individuals and society at large to benefit from research. [ABSTRACT FROM AUTHOR]

When recruiting adolescents online, investigators should think about how they would proceed if recruitment was conducted in person. Researchers would not be able to barge into an in-person group meeting without an invitation, just as they cannot post in a private Facebook group without the moderator's permission. [ABSTRACT FROM AUTHOR]

Despite ongoing efforts to address disparities in Alzheimer's disease and dementia care, much work remains. The authors of a recent report identified some of the barriers diverse populations are facing in accessing and receiving dementia care. [ABSTRACT FROM AUTHOR]

The article presents study on trial of decompressive craniectomy for Traumatic Intracranial Hypertension and comments on the results of the RESCUEicp trial on same.

The article focuses on the application of noninvasive ventilation (NIV) for pediatric patients in acute respiratory failure (ARF). Topics discussed include the pathophysiology of ARF in pediatrics, the advantages of NIV over endotracheal intubation (ETI) and the complications of NIV. The criteria for identifying patients who will benefit from NIV and the factors to consider in predicting a favorable response to therapy are also described.

Children with disabilities can be organ donors, contributing to the supply. Excluding these patients as organ recipients would not be fair. A new policy statement does not consider intellectual and developmental disabilities (IDD) completely irrelevant, but the authors do not consider IDD to be dispositive for listing decisions either. [ABSTRACT FROM AUTHOR]

The term "exception from informed consent" for some clinical trials has been around for decades, but most patients know nothing about it. Researchers set out to explore attitudes about enrolling subjects in studies without consent. [ABSTRACT FROM AUTHOR]

The article reports that high-performance liquid chromatography and immunoassays was used for the analysis of postmortem brain tissue of patients with Parkinson's disease dementia, which revealed deficits in dopamine, serotonin, and noradrenaline innervation.

The article focuses on a research study which concluded that for cancer patients, early palliative care consultation is less costly as compared to advanced cancer diagnosis, and offers views of Diane E. Meier, one of the study's author, on the same.

The article focuses on medical ethics concerning the disclosure of genetic testing results by patients. It mentions that the guidelines issued by Great Britain's General Medical Council, physicians can disclose a patient's genetic information to other family members who are at risk of carrying the same genetic defect. It states that healthcare professionals should maintain patient privacy but should also disclose the genetic information if it benefits other family members.

This paper summarizes and focuses on the National General Practice Study of Epilepsy with emphasis on epilepsy prognosis after initial diagnosis. [ABSTRACT FROM AUTHOR]

In a small, placebo-controlled trial, botulinum toxin treatment showed a significant benefit for postherpetic neuralgia. [ABSTRACT FROM AUTHOR]

Efforts to improve informed consent for research usually focus on consent forms, making them shorter, less complicated, and easier to understand. A recent study revealed most parents decide whether they want their children to participate in research before they ever see a consent form. [ABSTRACT FROM AUTHOR]

Wager et al used machine-learning analyses to identify an anatomic pattern of functional magnetic resonance imaging (fMRI) activity across brain regions, termed a neurologic signature, which was associated with heat-induced pain. In four studies involving a total of 114 participants, thermal stimuli were applied in randomized sequences of varying intensity (trials) to the left forearm of each participant during fMRI scanning. Participants in study 1 underwent 12 trials at each of four escalating heat intensities, which were calibrated for each person from innocuous warmth to three levels of painful heat. The degree of pain that was experienced was rated by each participant. Participants in study 2 underwent a total of 75 trials across six temperatures (44.3° to 49.3° C in 1° C increments), judging whether the temperature stimulus was painful after each trial. Participants in study 3 recently had been romantically rejected, and during escalating heat stimuli and scanning trials, viewed an image of their ex-partner (denoted as "rejecter" trials, which elicit social pain) or an image of a close friend (denoted as "friend" trials). Participants in study 4 received two intravenous infusions of remifentanil, a potent μ-opioid agonist, during fMRI scanning, in two series of trials. Warmth and pain stimuli were applied during each of two infusion series, one in which analgesic use was acknowledged (open-infusion series) and another in which analgesic use was incorrectly denied (hidden-infusion series). In study 1, a machine-learning-based regression technique, LASSO-PCR (least absolute shrinkage and selection operator-regularized principal components regression), was used to predict pain reports from the fMRI activity. The fMRI neurologic signature included significant positive weights in regions including the bilateral dorsal posterior insula, the secondary somatosensory cortex, the anterior insula, the ventrolateral and medial thalamus, the hypothalamus, and the dorsal anterior cingulate cortex. The signature response increased nonlinearly with increasing stimulus intensity during thermal stimulation; but as expected, it was uniformly low for the pain-anticipation and pain-recall periods. The neurologic signature showed sensitivity and specificity of 94% or more (95% confidence interval [CI], 89-98) in discriminating painful heat from non-painful warmth, pain anticipation, and pain recall. In study 2, the signature discriminated between painful heat and non-painful warmth with 93% sensitivity and specificity (95% CI, 84-100). The signature response increased monotonically across the six temperatures, with an expected nonlinear increase with temperature, and it correlated with both the reported level of pain and the stimulus temperature. In study 3, the fMRI signature discriminated between physical pain and social pain with 85% sensitivity (95% CI, 76-94) and 73% specificity (95% CI, 61-84). The neurologic signature response was substantially stronger for physical pain than for any of the other conditions (warmth, rejecter, or friend). Discrimination between the rejecter and friend conditions was no better than would be expected by chance. In study 4, the strength of the signature response was substantially reduced when remifentanil was administered, in parallel with increases in the drug effect-site concentration. [ABSTRACT FROM AUTHOR]

EXECUTIVE SUMMARY. Misdiagnosis is a major ethical concern involving patients in the minimally conscious state who demonstrate behaviors suggestive of consciousness episodically and intermittently. * Minimally conscious individuals may have a higher level of integrative cognitive function than they are able to manifest behaviorally. * Patients who are vegetative can move into a minimally conscious state due to recovery of higher cortical function. * Patients are subject to reimbursement strategies that do not adequately cover their needs. [ABSTRACT FROM AUTHOR]

Research participants reported ethical concerns about how "minimal" risk is determined, when it is appropriate to alter traditional informed consent practices, and how to distinguish between quality improvement and research. [ABSTRACT FROM AUTHOR]