Any one of the following legally competent persons: spouse; parents; grandparents; children (including adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related by blood or affinity whose close association with the subject is the equivalent of a family relationship. [21 CFE 50.3(m)]
A standing agreement on file with the Office for Human Research Protections that describes in detail the procedures it will use to protect the rights and welfare of the human subjects (see OHRP site)
The Family Education Rights and Privacy Act was enacted in 1974. It is a set of regulations that applies to those institutions that receive funding from the Department of Education. FERPA was written specifically for students and guarantees them the right to inspect and review their education records, the right to seek to amend education records, and the right to have some control over the disclosure of information from those education records. Departments may not release non-directory or personally identifiable information about a student to a third party (parents included) without the student's written authorization.
A developing human from two months after conception to birth. If the delivered or expelled fetus is viable, it is designated an infant [45 CFR 46.203(c)]. The term "embryo" is usually used for earlier phases of development.
An agency within the U.S. Department of Health and Human Services (DHHS) responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, nation’s food supply, cosmetics, and products that emit radiation.
Review of proposed or continuing research (primarily greater than minimal risk research) by a convened IRB meeting, at which a majority of the voting membership is present.
