GSW’s IRB policies are determined by the United States Department of Health and Human Services, Office for Human Research Protections. The entire code of federal regulations can be found online; this website contains a condensed version of these regulations and some information specific to this institution. It should be noted that these federal regulations are periodically updated; prospective researchers are strongly encouraged to review both the federal regulations and the information on this website for relevant policy changes prior to submitting applications.

For the purposes of this committee, the following definitions (45 CFR 46, § 46.102) are relevant:

• Research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”.  Not all projects that collect information from humans constitute research under this definition; for a listing of the types of projects that may not meet this definition of “research”, see the section titled “Projects Not Requiring IRB Review."
• Human subjects are defined as “living individual[s] about whom an investigator…conducting research (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens”.  Thus, human subjects are considered to include not only living persons, but also information obtained through analysis of human tissue, blood samples, pathology or diagnostic specimens, and medical or other records, including archival and pre-existing data and records of deceased persons.

It is GSW policy that no research involving human subjects may be undertaken until approval has been granted by the IRB. This includes research conducted by GSW faculty, staff, and students as well as any research involving members of the GSW community as subjects, whether or not the researchers are affiliated with GSW.