The National Bioethics Advisory Commission has proposed that regulatory oversight for research with human subjects be extended beyond the protection of individual research participants to include the protection of social groups. To accomplish this, the commission recommends that investigators and ethics review boards a) work directly with community representatives to develop study methods that ...

The digitization and related developments in journal editing and publishing necessitate increasing the awareness of all stakeholders of science communication in the emerging global problems and possible solutions. Journal editors and publishers are frequently encountered with the fast-growing problems of authorship, conflicts of interest, peer review, research misconduct, unethical citations, a...

INTRODUCTION According to the Declaration of Helsinki and other guidelines, clinical studies should be approved by a research ethics committee and seek valid informed consent from the participants. Editors of medical journals are encouraged by the ICMJE and COPE to include requirements for these principles in the journal's instructions for authors. This study assessed the editorial policies of ...

Eight research protocols which had previously been approved by Ethical Research Committees (ERCs) were reviewed in simulated review committees set up during a symposium on medical ethics. Only three protocols were considered to provide fully adequate information to allow ethical review and only one protocol was thought to provide sufficient guarantees on the ethical issues raised by the propose...

The present commentary is based on the following considerations: 1) for the purposes of authorisation, a distinction is drawn between "research" and "intervention". The procedures for authorising the former are more complex, the relevant controls are stricter and approval has to be granted by a Research Ethics Committee (REC); 2) although the debate is still open, it is barely credible to claim...

This report provides practical guidance on refinement of the use of food and fluid control as motivational tools for macaques used in behavioural neuroscience research. The guidance is based on consideration of the scientific literature and, where data are lacking, expert opinion and professional experience, including that of the members of a Working Group convened by the United Kingdom Nationa...

case reports are considered as the lowest level of evidence while at the same time they are frontiers of evidence collection. case reports are professional stories about novel medical events and will worth publication only if they possess complexity, proper data collection, justified diagnosis, and legitimate intervention as well as appropriate language, punctuation, and syntax. a case report m...

OBJECTIVE To analyze ethical aspects of Brazilian articles on human visceral leishmaniasis, published after Resolution CNS 196/1996, and to analyze the policy on Brazilian periodicals on research ethics. METHODS An explanatory study with a bibliographical and documental nature was conducted. Selection of publications on research involving human beings since 1996 was performed in the SciELO Br...

The ethical review of research on human beings, and indeed the ethical review of broader ranges of human activity, is a growth industry. I want to look here at the ethical review of research on humans and raise some questions about the direction it is taking. I am pessimistic about where the institutions that we have set up are leading us and I want to sound a warning note and suggest some chan...