Ethical issues ethics committee

The Ethics Committee shall give its opinion, before a clinical trial commences, on any issue requested. 

The sponsor may not start a clinical trial until the Ethics Committee has issued a favourable opinion and inasmuch as the competent authority of the Member State concerned has not informed the sponsor of any grounds for non-acceptance. The procedures to reach these decisions can be run in parallel or not, depending on the sponsor. 

The use of vertebrates to evaluate tolerability and absorption of drug administered via the vaginal route has been widely criticized on the basis of scientific and ethical considerations. Studies on animals can be substituted by validated in vitro tests as described in the guideline issued by Committee for Proprietary Medicinal Products (CPMP), now Committee for Medicinal Products for Human Use (CHMP) [112], Before an in vitro test can be considered valid, this test must undergo a procedure aimed at establishing its relevance and reliability. The relevance of the alternative test has to be compared with accepted in vivo standard methods. 

The issue of (informed) consent looms large in discussions of the ethics of research involving human subjects and is a principal concern of the Research Ethics Committees that are now the norm in medical research. 

All CTs (phase IV ones included) need ethical approval by independent central or regional ethics committees, as specified by a Decree of the Minister of Health in 1987, to be issued in an amended form in 1999. Phase I-III trials also need authorization by the competent medicine regulatory authority (the NIP or the Executive Office of the National Chief Medical Officer). The documentation needed for authorization does not differ from that in the EU. In short, it consists of the following (if not specified, it may be in English German may also be accepted) ... 

In most cases, the competent ethics committee for clinical tried approved is a central one. Until the new Decree of the Minister of Hecdth on clinical trials is issued, regional ethics committees are responsible for certain humcin phase III trials. This situation may be changed by the Decree. Updated NIP guidelines or information clarifying the recent situation are always available in English. 

The European Commission issued a set of detailed guidelines on the requirements and format of the CTA application for use by NCAs and ethics committees, as well as templates for application forms. Directive 2001/20has also added a small but... 

At the time of writing, the conduct of studies in non-patient volunteers in the UK is not regulated by the Medicines Act (1968). Similarly, studies in non-patient volunteers in the Netherlands, Belgium and some other European countries do not require regulatory approval. This situation is about to change, as the EU Directive issued in 2001 will require to be implemented in all European countries by 2004. All healthy volunteer studies will then require regulatory approval in addition to that of an ethics committee. The Directive, with which all member states must comply, makes no distinction between healthy volunteer studies and clinical trials in patients who may benefit from treatment. However, the precise details of documentation required for authorisation of healthy volunteer studies may vary from country to country it is possible that the application in the UK will be somewhat less detailed than the current Clinical Trials Exemption. 

In 2002,1 agreed to serve as foimding chair of the Ethics Committee of BMES. We formulated a Code of Ethics [6] that was ratified by the membership in 2004. The Code as it was formulated has at least two questionable issues (1) The Code is aspirational, not punitive the Society decided on this course in order to limit financial liability, (2) The Code appears to favor compliance to employers and agencies, even in the face of questionable practices. Whistle blowing or nonviolent disobedience, for example, are not options that appear in the wording of the Code. We have recruited committee members from a variety of professions to bring perspective to the activities of the committee. 

Research involving human participants is typically governed by policies on ethical practices underpinned by a number of principles, eg, merit of the research, informed consent of participants, issues related to vulnerable subjects, privacy of participants, minimization of harm, limitation of deception, avoidance of conflicts of interest, cultural and social sensitivity, and publication of results. Ethics committees routinely require that consideration be given to a range of factors, and require prior decisions on ... 

NBAC (National Bioethics Advisory Committee). 1999. Research Involving Human Biological Materials Ethical Issues and Policy Guidance, Vol. 1. Report and Recommendations of the National Bioethics Advisory Commission. Rockville, MD National Bioethics Advisory Commission. 

The committee deliberately incorporated discussion of communication and ethical considerations into this chapter not only because these issues present some of the most significant challenges with respect to interpretation and use of the biomonitoring data (key considerations in the committee s charge), but because it was the committee s intent to prompt readers to consider these issues as intrinsic in the design of biomonitoring studies. 

Despite the extensive experience with biomedical ethics, the infrastructure of institutional review boards (IRBs), and the equivalent for protection of human subjects (Schulte et al. 1997 but see Soskolne 1997), it is essential to address questions of ethics that may be particular to the design of biomonitoring studies. In this section, the committee considers some practical and research issues in biomonitoring ethics but makes no pretense that the list is exhaustive. Ethical issues can stop specific studies, and the field in general, dead in their tracks. Therefore, it is incumbent on investigators, policy-makers, and others to consider these issues carefully. 

Sixth, committee deliberations raised two ethical issues whose occurrence, seriousness, and resolution were uncertain but that deserve tracking and possible future practical or research action. Only open discussion between scientists and ethicists can promote consensus on the issues, and the committee would be remiss if it did not encourage that discussion by mentioning them here. One question is how to report and respond to those with higher exposure levels when health implications are unknown. Secondly, is it ever appropriate to require biomonitoring of higher risk populations such as those occupationally exposed ... 

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