Suchergebnisse

Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)'s Pediatric Committee (PDCO) may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs)/ethics committees (ECs) and that clinical trials resulting from negotiations with EMA's PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients.

In Corporate Social Responsibility (CSR), the owners, partners and directors go against the dilemma of choosing between an adaptable and flexible methodology, like the SGE21 Norm, that suggests the designation of a committee of ethical management in charge of ensuring the compliance of the adopted CSR, aligning their strategy and goals. This committee is typically appointed by the administrative council, this is fairly normal in big enterprises, but not so much in medium ones. Therefore, this paper has three main goals: identify the influence of variables of upper management, people that form the organization, clients, vendors, social environment, environmental environment a well as competency in the social responsibility of medium enterprises in Celaya, Guanajuato, Mexico (RSEM) and in the committee of ethical and social responsibility management (CGESR). The third is to identify if the committee of ethical and social responsibility gives the same priority in their management as the owners or directors towards the SGE21 Norm. To this effect, the research is taken from a quantitative focus of the descriptive type and linear regression using the Ordinary Least Square Minimum, using a sample of 82 enterprises and proposing the RSEM and CGESR models.

ABSTRACTEthics guidelines and commentary suggest that a central function of research ethics committees is to assess the scientific merit of the protocols they review. However, some commentators object to this role, and evidence suggests that the assessment of scientific merit is a significant source of confusion and animosity between ethics committees and clinical investigators. In this essay, we argue that ethics committees should assess the scientific value and validity of research protocols and that new decision‐making tools are needed to help them do so in a systematic, transparent, and reliable way. We present a novel ethical framework that can assist in this task.

Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)'s Pediatric Committee (PDCO) may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs)/ethics committees (ECs) and that clinical trials resulting from negotiations with EMA's PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients.

Abstract
The case study is based on a first-person account of the experiences of a community researcher in India involved in community-based participatory development. It highlights the ethical stances taken by the community researcher during primary research that was carried out in remote villages in the state of Bihar among members of a denotified tribal community. It highlights her journey of reflecting on the research engagement, from an ethical perspective, after her engagement in an ethical review committee constituted by the Praxis Institute of Participatory Practices (herein, referred to as Praxis). The case study maps the journey of the researcher and the intrinsic and extrinsic motivations that led her to reflect on her ethical practices while carrying out community research. It also highlights the reflexivity of the researcher during her journey of the research process.

At head of title: 82d Congress, 1st session. Committee print. ; Mode of access: Internet.

An interview with NATO General Ray Henault, Chairman of the Military Committee explores the most important decisions of the Riga Summit for military follow-up, current operations, how the Allies managed to fill the shortfalls necessary to be able to declare full operational capability of the NATO Response Force (NRF) at Riga, possible future missions, solutions to the airlift problem, the capabilities of the Active Layered Theatre Missile Defence, meeting the requirements of the International Security Assistance Force (ISAF) in Afghanistan, and the challenges that ISAF faces. Figures. Adapted from the source document.

In its recent issues the International Review of the Red Cross announced the publication of a work entitled Le Comité international de la Croix-Rouge et la protection des victimes de la guerre by François Bugnion, Deputy Director of the ICRC Department of Principles, Law and Relations with the International Red Cross and Red Crescent Movement.The book has already become the reference work par excellence on the International Committee of the Red Cross in that it analyses, in a combined historical and legal approach, the process whereby the international community came to entrust the Committee with tasks and areas of competence relating to the protection of war victims. It also highlights the interaction between the development of ICRC practice and that of international humanitarian law.

Ethical committee is an effective instrument for resolving moral problems of contemporary university and a form of institutionalisation of its social responsibility. Different models of ethical committees are discussed in the article. Namely, the corporate model, where a university is regarded as a big business entity; the legal model, which settles different intra-organisational conflicts; the expert model, which evaluates the conformity of research projects with universal moral norms; the enlightening model, where the university is regarded as an instrument of insemination of moral values. The choice of the model defines procedural questions, the number of committee members, its representativeness, functions and periodicity of meetings. ; Vieningų veiksmų ėmimosi esant vertybių konfliktui problema gali būti vertinama kaip vienas svarbiausių šiuolaikinės etikos klausimų. Etikos komitetas, regis, yra vienas efektyviausių konsensuso siekimo instrumentų, nes sprendimų priėmimo procesui jis gali suteikti būtiną atstovavimą ir lankstumą. Nors moralinės problemos diskusijos etikos komitete per se negarantuoja jos galutinio išsprendimo, tai gali bent jau nurodyti konkrečias priemones, kuriomis susijusios šalys gali pasiekti konsensuso dėl svarstomos problemos. Pirmieji etikos komitetai buvo įsteigti medicinos institucijose (bioetikos komitetai) ir komercinėse organizacijose (korporaciniai etikos komitetai) XX a. viduryje, kai šiose srityse iškilo patys aštriausi konfliktai tarp deklaruojamų ir tikrų tikslų. Šiuo metu itin aštrias moralines kolizijas išgyvena švietimo sistema. Šiuolaikinis universitetas yra sudėtinga daugybės lygmenų struktūra, orientuota į simultanišką įvairių edukacinių, mokslinių, ekonominių, politinių uždavinių sprendimą. Universitetai susiduria tiek su unikaliais moraliniais iššūkiais, tiek su tradiciniais iššūkiais, panašiais į korporacijų ir mokslinių tyrimų institucijų problemas. Etikos infrastruktūros plėtojimas edukacinės organizacijos lygmeniu ir universiteto etikos komiteto kaip jos koordinacinio centro kūrimas atrodo kaip logiškas šios problemos sprendimas. Vis tik tebelieka klausimų, susijusių su tinkamiausio universiteto komiteto modelio pasirinkimu. Šis pasirinkimas iš esmės priklauso nuo uždavinių, universiteto keliamų komiteto nariams. Komitetas gali būti sukurtas kontroliuoti moralinių normų institucionalizavimą organizaciniu lygmeniu, spręsti vidinius organizacinius konfliktus, rengti etinį mokslinės veiklos tyrimą, vykdyti informacinę ir šviečiamąją veiklą etikos srityje ir t. t. Taigi gali būti išskiriami skirtingi komitetų modeliai: korporatyvinis modelis, kai universitetas vertinamas kaip didelis verslo vienetas; teisinis modelis, kuris sprendžia ginčus tarp darbuotojų; ekspertinis modelis, kuris tinkamas vertinti mokslinių tyrimų projektų atitiktį moralinėms normoms; šviečiamasis modelis, kai universitetas suvokiamas kaip moralinių vertybių skleidimo įrankis. Taigi pirmasis būtinas žingsnis etikos komiteto organizavimo procese yra ne nekūrybingas kitose institucijose egzistuojančių mechanizmų kopijavimas, bet aiškus konkretaus universiteto specifinių tikslų apibrėžimas. Universiteto etikos komitetas gali susitelkti ties vienu iš apibrėžtų tikslų arba mėginti pasiekti kelis iš jų. Kadangi pastarasis variantas ne visuomet įmanomas, viena galimų išeičių yra steigti kelis komitetus pagal skirtingas paskirties sritis.