Extramural Glossary

Terms

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Hold On Award
Block to the release of award funds often implemented in response to human subjects concerns raised by the study section during peer review.
Howard Hughes Medical Institute HHMI  
A non-profit philanthropic funding organization for biological and medical research and science education
Human Embryo Research
Section 513 of the FY 1998 Appropriations Act, P.L. 105-78, signed November 13, 1997, reinstates the current ban that prohibits NIH from using appropriated funds to support human embryo research.
Human Embryonic Stem Cells HESCs  
Human embryonic stem cells are derived from human embryos that develop from eggs that have been fertilized in vitro — in an in vitro fertilization clinic — and then donated for research purposes with informed consent of the donors. They are not derived from eggs fertilized in a woman's body. The embryos from which human embryonic stem cells are derived are typically four or five days old and are a hollow microscopic ball of cells called the blastocyst. The blastocyst includes three structures: the trophoblast, which is the layer of cells that surrounds the blastocyst; the blastocoel, which is the hollow cavity inside the blastocyst; and the inner cell mass, which is a group of approximately 30 cells at one end of the blastocoel. Human embryonic stem cells are isolated by transferring the inner cell mass into a laboratory culture dish that contains culture medium.
Human Fetal Tissue
Any tissue derived from human embryos and fetuses.
Human Pluripotent Stem Cells hPSCs  
Such stem cells have the ability to develop into many different cell types of the body.
Human Subjects
Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. A legally defined term that indicates a living person with whom an investigator directly interacts or intervenes or obtains identifiable, private information. Regulations apply to human organs, tissues, body fluids, and recorded information from identifiable people. See 45 CRF 46.
Human Subjects Assurance
See Institutional assurance of protection for human subjects
Human subjects code
The number that a scientific review group places on a summary statement during an initial peer review that reflects the application of human subjects regulations to a project, and the inclusion of women, children, and racial and ethnic populations. Some codes indicate a human subjects concern that would result in a bar to award.
See Also Human subjects inclusion codes Human subjects involvement codes
Human Subjects Concern
A human subjects term that indicates any actual or potential unacceptable risk or inadequate protection against risk to human subjects.
Human Subjects Exemption Categories
Human subjects inclusion codes
Human subjects involvement codes
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.
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