Title : Ethical protection of clinical research participants through quality improvement processes for informed consent
Clinical research is a category of research that utilizes individuals or groups of individuals or their behaviors or materials from humans, such as tissue samples, either directly or indirectly. Examples of clinical research include patient-focused research regarding mechanisms of disease, studies of therapies, technology development, epidemiological and behavioral studies and health services or outcomes studies. The ethical principles of autonomy, beneficence, and justice represent key ethical concerns for human subject protection in clinical research as identified in The Belmont Report of 1979. Informed consent is basic to an understanding of ethics in the research process. All published national and international research ethics codes, regulations and guidelines reflect the principle of informed consent. The use of informed consent in clinical research is for the purpose of maintaining human rights, nationally and internationally Investigators must protect vulnerable research subjects from potential exploitation, and other forms of harm, within the design of the research study. All persons are vulnerable, in the broad sense of the term, since all are susceptible to harm. Vulnerability also encompasses a narrower concept that, at times, and in certain respects,some individuals or groups of individuals are more vulnerable than others. In countriesin compliance with regulations for informed consent processes, researchers explain to potential participants the overall purposes and conditions of the study and their understanding before providing a voluntary consent, free from coercion. Researchers must consider and respect an individual’s gender, ethnicity, culture, language, religious beliefs, and disability during the informed consent procedure. The informed consent process may be complex, and the quality of the process is usually not monitored. The use of informed consent in developing countries also raises difficult issues. Some individual developing countries, including Uganda, India, and Thailand subscribe to the requirements of informed consent, although the process may not meet universal ethical standards. For example, in resource-poor, low-developed countries (LDC’s), attempts at informed consent may be difficult due to a lack of education and health literacy and an appreciation of the value of an individual’s right to decide. In these situations, such constraints may negatively impact the actual use and quality of the informed consent process. Despite the challenges of the informed consent process, clinical research is essential for improving patient care outcomes, worldwide. Achieving this goal, however, implies respect for the rights of human subjects in every study, along with a protective plan for the informed consent process. This presentation examines the current status of informed consent around the globe, focusing on the respect for individual autonomy, beneficence and justice as wellas key ethical concerns for human subject protection. The use of innovative quality improvement methodologies is suggested to protect participant dignity, to improve research and clinical outcomes while safeguarding consent relationships and activities.