H
Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. The term “Spanish origin” can be used in addition to “Hispanic” or “Latino.”
Human Subjects: The Code of Federal Regulations, Title 45, Part 46, Protection of Human Subjects (45CFR46) defines a human subject as a living person about whom an investigator (professional or student) conducting research obtains (1) data through intervention or interaction with the person, or (2) identifiable private information.
Human Subjects Assurance: A document filed by an institution conducting research on human subjects with the Office for Human Research Protections--HHS which formalizes its commitment to protect the human subjects prior to receiving any HHS grant funding.
Human Subjects Concern: Any actual or potential unacceptable risk, or inadequate protection against risk, to human subjects as described in any portion of an application.
Human Subjects Exemption: Research that qualifies for exemption from coverage by the human subjects regulations includes activities in which the only involvement of those subjects will be in one or more of the following six categories:
(1) Instructional strategies in established educational settings;
(2) educational tests unlinkable to individual persons and with no risks from disclosure;
(3) educational tests on public officials, or absolute federally mandated confidentiality;
(4) existing data/specimens, publicly available, unlinkable to persons;
(5) demonstration projects concerning public benefit or service programs; and/or
(6) taste and quality evaluation of foods without additives exceeding regulated levels.
Human Subjects Risk and Protection Issues: Applicants are required to address the following items in their research plan: Subjects’ involvement and characteristics, sources of materials, recruitment and informed consent, potential risks, protection against risk, and benefits.
