Good Clinical Practices informed consent

Once the animal studies are completed human studies can commence, moving through phase I (up to 50 naive patients to establish a sufficient immune response) phase (several hundred patients in several locations) to phase III in which expanded studies on as many as thousands of patients. The trials require to be randomized and closely controlled by being blinded to avoid bias in interpretation. The patients all have to provide informed consent and strict adherence to good clinical practices in accordance with ethical principles is required to ensure risk-benefit considerations justify the risks associated with all trials of this type. The safety of the patients is an overall requirement and trials must be supervised by the appropriate independent ethics committee or the local Institutional Review Board. 

Clearly, other chapters in this book could have appeared in this section. An early chapter in this book is on informed consent its location is designed to indicate the supervening importance of that particular application of autonomy, beneficence and equipoise. Ethical behavior is also at the very centre of good clinical practices . The chapter on publishing clinical trials also examines some of the ethical aspects of that activity. Dr Belsey also enters into this area with his chapter on advertising and marketing . 

Good Clinical Practice (GCP) regulations in the United States and the ICH guidelines, which meet safety, ethical and efficacy requirements, are comprehensively covered in the clinical research development chapters. Investigator, sponsor, and monitor obligations are detailed and applied practically. Institutional Review Boards (IRBs), Independent Ethics Committees (IECs), and Informed Consent (IC) will be discussed fully along with the... 

This was a single-center, randomized, active-controlled, double-blind parallel-groups study performed at ABG. The clinical protocol was reviewed and approved by the Western Institutional Review Board (Olympia, WA), and the study was perlbrmcd according to Good Clinical Practice standards. Each subject provided writtrai informed consent. 

On the basis of the available prechnical data and on predefined clinical trial plans, ethics committees will evaluate whether the anticipated benefits and risks would justify clinical testing. In addition, local regulatory authorities must be informed and may deny consent. The clinical trial product must be made in compliance with Good Manufacturing Practices with increasing demands (e.g. regarding the qualification of equipment and facihties, product specifications, and validation of methods) as the trials proceed to later phases. 

---