Glossary of Terms

a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

Spouse, domestic partner; and dependent children.

Compensation for time, effort, and/or unreimbursed expenses offered to subjects participating in a given research project. Payment should never be considered a benefit for participation. The amount should be related to time, effort, and/or inconvenience for participating in the research.

Any information collected from an individual (including demographics) that there is a reasonable basis to believe could lead to identification of the individual.

An individual’s voluntary agreement, based on adequate knowledge and understanding of relevant information, to participate in research. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution, or agents thereof from liability for negligence.

The signatory on the federal-wide assurance. A high-level official who has the authority to represent the institution in matters related to the human subjects protection program.

A body specifically constituted as required in 45 CFR 46 which provides review and oversight of all human subjects research at George Mason University. This board is charged with protecting the rights and welfare of human subjects recruited to participate in research in which the university is engaged.

Communication or interpersonal contact between an investigator and a research subject.

Physical procedures by which data or biospecimens are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.

An official determination by the IRB that the research has been reviewed and may be conducted within the constraints set forth by the IRB and other institutional and federal requirements.

A formal, written, agreement in which the reviewing IRB agrees to serve as the IRB of record for the relying organization.