General issues concerning clinical research.

Safety of research subjects is paramount.  Modern clinical research practice and requirements, which are codified in the Nuremberg Code, Declaration of Helsinki, Belmont Report, and in federal regulations, these include:

• Subjects must willingly consent to participate and can withdraw from a study at any time. Special care must be taken when working with subjects with diminished autonomy.
• Clinical research must provide potential benefits to society, though not directly to the subjects.
• Experiments must be designed and conducted to avoid injury to subjects.
• Clinical research is distinct from medical care.
• Ethical committees must review, approve, and monitor research involving humans, to protect the rights and welfare of the subjects. Members weigh risks against benefits, payments to subjects, statistical power, individuals conducting the study, consent document, and so on.

Clinical research is a highly-regulated environment, including federal requirements governing Institutional Review Board (IRB) review and approval of human subjects research, Health Insurance Portability and Accountability Act (HIPAA) privacy and security requirements (UVA policy on the electronic storage of highly sensitive data), U.S. Food and Drug Administration (FDA) rules, restrictions on financial conflicts of interest, etc.

The conduct of human subjects research is a partnership between investigators and the clinical research staff.  The expertise and dedication of the Principal Investigator (PI) to the research project is of overriding importance.  However, successf ultimately depends on a clinical research coordinator (CRC), who interacts with research subjects, the IRB, the FDA, and sponsor (if applicable), the department finance office, clinical laboratories, and research pharmacy.  CRCs are usually, but not always, trained as nurses, physicians' assistants, or nurse practitioners.  Coordination and open communication between the PI and CRC are necessary in order to negotiate the clinical research process from protocol development to final reporting and publication.