The Clinical Trial Laboratory: Research Compliance for Clinical Research Microbiologists

Abstract

There are many aspects of research compliance that impact clinical researchers whose practice is based in academia, private reference laboratories, or hospital-based diagnostic laboratories. This chapter describes the research compliance responsibilities for human subjects protection laws. It explains the key restrictions of the Health Insurance Portability and Accountability Act (HIPAA) and the definition of conflict of interest. Critical components of clinical research include compliance with human subjects protection laws, the HIPAA, conflict of interest policies, good clinical practices (GCPs), and research integrity. The rights of human subjects are protected by a local Human Subjects Protection Program (HSPP) in collaboration with local and/or national institutional review boards (IRBs). The HSPP’s role is to provide administrative support to the IRB and regulatory expertise to the IRB and to investigators. A conflict of interest (COI) is a situation in which there are conflicting incentives with identified potential for injecting inappropriate considerations into a given decision or evaluation—a potential to compromise or jeopardize the integrity or the credibility of a study’s results. GCP encompasses all aspects of clinical trials involving human subjects. Principles of GCP involve ethical aspects of research including risks and benefits to the human subjects, protection of human subjects, informed consent, confidentiality, and the quality of science employed. Good laboratory practice (GLP) is a system of management controls for nonclinical research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of research.