Improving the quality of informed consent for clincal research participation.

摘要

This study addressed issues of informed consent for participation in clinical research studies. Informed consent for clinical research is the process for protecting the ethical and legal boundaries of vulnerable populations during the decision making encounter.;Concepts of moral philosophy and the law underlie the understanding and process of the informed consent doctrine. Notable occurrences of unethical research conduct have surfaced throughout the history of scientific research on human subjects. The need for regulatory oversight became apparent early on, to eliminate unethical and inhumane treatment, without regard for individual consent. As a result, bioethicists have linked the process of informed consent to ethical and legal principles of respect and autonomy. In essence, the legal issues of liberty, privacy, self-governance and self-determination correspond to the ethical right of participants to be treated respectfully and to make autonomous choices. Individual choices should be consistent with personal values and preferences. Evidence-based practice is dependent on the effectiveness of clinical research. Sufficient numbers of patients must agree to participate in clinical research studies. At the same time, researchers must provide protection for vulnerable research participants. Individuals who agree to participate in clinical research will complete a humanitarian service to society in furtherance of medical science. At the same time, however, the clinical research process may include benefits and risks that patients have the right to be aware of when they decide whether to participate, or not. Researchers have the responsibility to protect these ethical rights throughout the informed consent process.;The consent process requires the provision of comprehensive explanations to research participants, including the process and scope of the study, along with the participant's responsibilities. There is growing evidence that the quality of the process is often suboptimal, and the rights of participants are not consistently upheld. The issue of potentially ineffective informed consent processes, in which research participants are not fully protected, should be addressed.;Although researchers have examined the effectiveness of knowledge transfer, the results are unpredictable and at times, conflicting. In addition, evidence regarding the quality of existing consent encounters is inadequate. Many Institutional Review Boards (IRBs) rely on the judgment of the researchers for providing appropriate, informed consent, after the consent form as been approved.;Evaluating and monitoring actual informed consent encounters will be useful for improving informed consent relationships and, for protecting individual ethical and legal rights, resulting in an increase in the effectiveness and quality of research and patient care outcomes.