Research ethics committees have an important role to play in ensuring the ethical standards and scientific merit of research involving human subjects. There are three important obligations placed on the ethics committee. Firstly, and most importantly, the ethics committee must ensure that the rights of research participants are protected. This is achieved by ensuring that individuals receive su...

The Competent Authority has been notified. The clinical investigator is anxious to begin. Just when the process of conducting a clinical investigation is proceeding as planned, the ethics committee issues an unfavourable opinion. This article discusses the actions that should be taken to avoid this occurrence and how to meet other requirements related to ethics committees.

In 1992, the Joint Commission on the Accreditation of Healthcare Organizations ( JCAHO) passed a mandate that all its approved hospitals put in place a means for addressing ethical concerns. Although the particular process the hospital uses to address such concerns—ethics consultant, ethics forum, ethics committee—may vary, the hospital or healthcare ethics committee (HEC) is used most often. I...

The aim of the Round Table was to make recommendations with regard to the imminent revision of the European Directive on clinical drug trials (2001/20/CE). While recognising the importance of compliance with this Directive, which is not optimal in some member states of the European Union, it would be constructive to simplify further and harmonise its application in every country. Without necess...

This study describes which clinical ethics approaches are available to support healthcare personnel in clinical practice in terms of their construction, functions and goals. Healthcare personnel frequently face ethically difficult situations in the course of their work and these issues cover a wide range of areas from prenatal care to end-of-life care. Although various forms of clinical ethics ...

The same research proposal was submitted to 24 district health authority (DHA) research ethics committees in different parts of the country. The objective was to obtain permission for a multi-centre research project. The study of neonatal care in different types of unit (regional, subregional and district), required that four health authorities were approached in each of six widely separated he...

Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs) are charged with protecting the rights and safety of clinical trial participants. The regulations that guide the review, approval, and conduct of human research refer to these independent boards as IRBs or IECs. In 2001 the Association for the Accreditation of Human Research Protection Programs (AAHRPP) was formed. Sinc...

Race as a variable in research ethics is investigated: to what extent is it morally appropriate to regard the race of research subjects as pivotal for research outcomes? The challenges it poses to deliberation in research ethics committees are considered, and it is concluded that race sometimes must be considered, subject to clearly stated qualifications.

Clinical ethics committees (CECs) are increasing in number in the UK and have mostly developed in response to local interest, as opposed to being mandated as in the USA. However, there is no regulatory framework for UK CECs with no defined educational requirements or specification of core competencies for their members. The UK Clinical Ethics Network has consulted extensively with its members t...