The Guideline for Good Clinical Practice (GCP) of the International Conference of Harmonisation (ICH) is an international standard for the ethical and scientific quality of the designing, conducting, recording and reporting of trials that involve the participation of human subjects. Today, most regulators and funding agencies follow the ICH guidelines. These were drawn up by a small number of r...

The purpose of this paper is twofold: (a) to provide a guideline for occupational therapists to follow in the development of Internet-based services, and (b) to illustrate how this guideline has been applied in the development of an Internetbased service for family caregivers of individuals with Alzheimer’s disease and related dementias (ADRD). With increasing Internet use to access health info...

This article reviews aspects of development of the recently released "Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents" for pediatric care providers that remain in the area of human judgment. Discussed will be the context in which the guidelines were developed, the formal evidence review process, a consideration of how quality grades were establishe...

BACKGROUND Modern standards for evidence-based decision making in clinical care and public health still rely solely on eminence-based input when it comes to normative ethical considerations. Manuals for clinical guideline development or health technology assessment (HTA) do not explain how to search, analyze, and synthesize relevant normative information in a systematic and transparent manner. ...

Quality and ethics need to be embedded into all areas of research with human participants. Good Clinical Practice (GCP) guidelines are international ethical and scientific quality standards for designing, conducting, recording and reporting trials involving human participants. Compliance with GCP is expected to provide public assurance that the rights, safety and wellbeing of participants are p...

Review boards responsible for vetting the ethical conduct of research have been criticised for their costliness, unreliability and inappropriate standards when evaluating some non-medical research, but the basic value of mandatory ethical review has not been questioned. When the standards that review boards use to evaluate research proposals are applied to review board practices, it is clear th...

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 ...

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...