Changes In Oversight Research Articles

Challenges to the operation of Brazilian LTCIs and changes in oversight

BackgroundDespite 18 years since health surveillance regulations were promulgated in Brazil to govern Long-Term Care Institutions for Older Adults (LTCIs), many institutions fail to comply with the Differentiated Regime for Public Procurement (Resolution No. 502/2021) due to structural and operational conditions. This study aimed to investigate Brazilian LTCI managers’ understanding of challenges that significantly impact institutional operation and gather suggestions for enhancing RDC No. 502/21.MethodsA cross-sectional, exploratory, and qualitative study was conducted, involving 90 managers or technical supervisors from Brazilian LTCIs. Data were collected using a self-administered Google Forms instrument and analyzed through Thematic Analysis based on the Organizing for Quality (OQ) framework.ResultsThe most impactful challenges for LTCIs were healthcare, financing, human resources, relationship with oversight bodies, and family members.DiscussionProposed improvements for RDC No. 502/21 included enhanced professional training, infrastructure revision, increased financial support from the state, realistic oversight/regulations, and tailored monitoring approaches.ConclusionLTCIs in Brazil face numerous challenges, and the suggested improvements aim to adapt regulations to institutional realities. However, considering the regulations’ variability and purposes, further investigation is warranted.

Electronic cigarettes: gateway to understanding the FDA?

Electronic cigarettes: gateway to understanding the FDA?

A supervisão de estágio como analisador da articulação interorganizacional Escola de Enfermagem e Hospital

Este estudo, que reflecte sobre a supervisão de estágios, não constitui uma questão nova no âmbito da Enfermagem. No entanto, a questão como objecto de investigação organizacional aparece no contexto português com alguma novidade. O texto debruça-se sobre as orientações e as práticas de supervisão de estágios em Enfermagem como analisador dos fenómenos de articulação interorganizacional Escola de Enfermagem e Hospital. O percurso desta investigação foi de entrelace entre algumas mudanças na supervisão de estágios e algumas mudanças sociais e políticas das organizações em estudo — Escola de Enfermagem e Hospital —, estabelecendo-se relações sociologicamente pertinentes entre ambas. O valor heurístico deste percurso propiciou a (re)construção de um modelo teórico de análise da articulação interorganizacional Escola de Enfermagem e Hospital, onde se elegeram duas vertentes de análise para a sua compreensão. Será aqui apresentado o ensaio teórico-metodológico deste estudo de caso, que nos permitiu realizar a leitura dos discursos e das práticas em contexto de supervisão de estágio, no Plano da Acção/Sistema da Acção.Palavras-chaveSupervisão de estágios; Articulação Escola de Enfermagem e Hospital; Configurações de articulação

New paradigms for physician-industry relations: Overview and application for SVS members

Relationships between physicians and their industry partners have ranged from spectacular collaborations that produce extraordinary advances in patient care, such as endovascular aneurysm repair, to humiliating scandals such as extravagant trips and bogus "consulting" agreements resulting in legal actions. It is the latter which have led many to call for the end of all physician-industry relationships, and the former which mandate their preservation. While these two examples are representative of extremes at each end of the spectrum of this issue, in reality the majority of physician-industry relationships are far more complex, and the line between appropriate and inappropriate, and ethical and unethical, is hard to draw. The benefits of our relationships with industry are many: partnering to develop new therapies and technologies, educating and training physicians around new therapies and technologies, support of continuing medical education (CME), fellowship training, and patient education. The pitfall and danger of this relationship is that support from industry, be it a meal, a pen, an educational grant, or flattery, may unduly and inappropriately influence physician decision making around a specific company's product. While it is clear that free trips are not within the realm of proper interaction, what about unrestricted educational grants to institutions, or support of CME activities, professional society meetings, and new device training? As a result of the intense scrutiny of relationships between physicians and industry recently, multiple diverse entities (Association of American Medical Colleges, American Medical Association, Accreditation Council for Continuing Medical Education, professional medical associations, academic medical centers, industry, and government) have generated guidelines and policies with very different perspectives, reflective of their different missions. These policies range from vague and lenient, with only basic limitation of the physician-industry relationship, to extremely rigid and strict, with only minimal interaction and mission support permitted. Given the many changes in oversight and expectations for the relationship between physicians and industry, it is important for vascular surgeons to be aware of the background behind these modifications, the evidence that they are needed, and the positions of the diverse organizations and institutions that have already defined their policies on this issue.

Medical ethics. Principles for human gene therapy studies.

The recent revelations of problems in gene therapy trials have clearly indicated that the current federal mechanisms for review, regulation, and oversight of human gene transfer studies require modification. This policy forum discusses the basic principles that form the foundation of clinical research, with the most important being patient protection, and makes recommendations for changes in oversight that will ensure that the highest standards are met.