Multimedia Delivery Can Enhance the Consent Process
New technologies allow prospective subjects to absorb information about a trial at each individual?s pace.
Recent deaths of human subjects at leading medical research facilities and the consequent major lawsuits leveled against those facilities have brought the current consent process under attack. Human subject advocacy groups, federal institutions, trial attorneys, and medical ethiciststo name a few of the interested groupshave all called for an improved consent process.13 Such a process must fully educate subjects about a clinical trial protocol and the trials purpose, risks, and expected results. The financial backers of the trial and the possible financial beneficiaries must be made known, and potential conflicts of interest must be disclosed. The informed consent of the future will verify that the subject truly understands these concepts, and that all concerns have been resolved prior to consent being given. This is the ideal of informed consent that the clinical trials industry seeks and, for its own protection, must soon adopt.
New technologies, such as multimedia presentations, aim to rectify the deficiencies of the current consent process. These presentations educate the subject through a variety of teaching techniquesnarration, illustrations, photos, text, and animationsthat now seem commonplace in our television-based society. More than a quixotic hope for the future, enhanced informed consent technology has already been implemented in several leading research centers. These multimedia technologies claim to deliver benefits to both the investigative team and the subject, and may soon prove to be a revolutionizing force in the consent process.
Problems in the current consent process
Several factors are hampering current efforts to provide research subjects with a comprehensive consent experience. A few of these factors include:
Guidelines for Obtaining Informed Consent for Clinical Research
November 2nd 2003Informed consent is a process, not just a form signed by prospective study subjects. Documents such as the Code of Federal Regulations describe the elements of informed consent, but lack substantive direction on the process of obtaining consent.1-2 The purpose of this article is to provide guidelines for obtaining informed consent. This guide can be useful to anyone involved in clinical research, particularly newcomers to the industry.
A Clinical Development Solution Tailored for Biopharmaceutical Companies
November 1st 2003The rapid evolution of the biopharmaceutical industry has lead more and more companies to focus on the clinical development of their drug candidates, thus presenting the challenge of selecting the optimal strategy for conducting their clinical programs. Typically, biopharmaceutical companies have had three options: out-licensing their product, setting up their own clinical development operations, or outsourcing the clinical development to contract research organizations (CROs).
