Investigators utilizing human subjects for any reason in their research are charged with the vital responsibility of ensuring ethical standards of conduct. These standards are outlined by a number of governing bodies, particularly the Department of Health and Human Services, Office for Human Research Protections (http://www.hhs.gov/ohrp/) and Office for Civil Rights (http://www.hhs.gov/ocr/) in the United States. Human subjects committees, empowered by these governing bodies, are then designated at the institutional level to provide oversight of human use in biomedical and behavioral research projects. Principle investigators and their teams are then responsible for ensuring the safety and welfare of subjects and compliance with research protocols. This is initially accomplished by working with institutional review boards (human subjects committees in particular) in a detailed application process prior to the initiation of research.

Below is a brief introduction for newcomers to the human subjects committee application, including the informed consent. This general information has been compiled from a number of online sources (last accessed April, 2010). Application format is certainly specific to individual institutions. However, the general guidelines are usually the same, drawn from basic requirements laid forward by, among others, the US Department of Health and Human Services Code of Federal Regulations, Title 45 (Public Welfare), Part 46 (Protection of Human Subjects) (http://www.hhs.gov/ ohrp/humansubjects/guidance/45cfr46.htm) and the Health Insurance Portability and Accountability Act (HIPAA) (http://www.hhs.gov/ocr/hipaa/ and http:// privacyruleandresearch.nih.gov/).