An international ethics review committee, founded seven years ago, has several unusual features: it selects its own members, who are independent of the drug industry; it includes members with no medical or paramedical background, such as lay people and lawyers; and it reviews protocols together with the study's sponsor. Membership of 31 from nine European countries enables frequent meetings and...

When several decades ago the IRB system was established trying to balance major moral consideration in research with human subjects, the main impetus were severe cases of unethical behaviour and experiences, often protected by state and institutional administration. The first phase of the IRB aimed at protecting subjects from serious hazards, while in later stages the IRB turned to „lesser risk...

Local review of research by ethics committees in the UK has long been held to be an important right of the local research ethics committee and, even with the introduction of the European Clinical Trials Directive, the governance arrangements for research ethics committees continue to allow for local review of multicentre studies. There is no requirement for local review in either the European U...

Article history: Received: 18-06-2015 Revised: 24-09-2015 Accepted: 11-11-2015

BACKGROUND Many international volunteer groups provide free reconstructive plastic surgery for the poor and underserved in developing countries. An essential issue in providing this care is that it meets consistent guidelines for both quality and safety-a topic that has been addressed previously. An equally important consideration is how to provide that care in an ethical manner. No literature ...

Six evidential sources are examined to investigate how Edwards and Steptoe applied ethical standards to their research leading to the birth of Louise Brown: (i) Their own contemporary writings from 1970 onwards. (ii) Archival evidence from the British Medical Association (BMA), the British Association for the Advancement of Science (BAAS), and correspondence between Edwards and the Ford Foundat...

INTRODUCTION Multidrug-resistant tuberculosis (MDR-TB) poses a serious financial challenge to health systems and patients. The current treatment for patients with MDR-TB takes up to 24 months to complete. Evidence for a shorter regimen which differs from the standard WHO recommended MDR-TB regimen and typically lasts between 9 and 12 months has been reported from Bangladesh. This evaluation aim...

BACKGROUND Local ethical committees in medical sciences in Iran were established in 1999 in order to assess and evaluate the observance of ethical standards throughout the universities and research centers. The purpose of this study is to analyze the situation of local ethical committees in order to develop research ethics guideline. METHODS For this cross-sectional study which has been condu...

In countries having traditional medicine (TM), one of the main challenges for any researcher is research methodology. Current methodologies are different with what was in past. The main purpose of this article is to present the steps (herbs, claims and methodology) of research in TM fields. 1. Assessment of herbs History, method of study, quality assessment, efficacy, safety, toxicity and the...