Effective Date: February 15, 2019
Expiration Date: February 15, 2024
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Adverse Event – Any untoward or unfavorable medical occurrence involving a human research subject occurring while associated with the subject's participation in the research. An adverse event is not necessarily a mishap if the protocol-related documents or informed consent documents identify the potential for the medical occurrence.
Human Genetic Testing – An analysis of human Deoxyribonucleic acid (DNA), Ribonucleic acid (RNA), chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal and biochemical changes. These tests can include the following:
a. Molecular genetic tests that study single genes or short lengths of DNA or RNA to identify variations or mutations.
b. Chromosomal genetic tests that analyze the entire genome or whole chromosomes or long lengths of DNA or RNA.
c. Biochemical genetic tests that study the amount or activity of proteins or metabolites and wherein any noted changes can indicate changes in (or characteristics of) DNA or RNA.
d. Microbiome testing from human subjects (gut, skin, etc.).
Institutional Official – an individual who has administrative and operational authority to commit institutional resources to ensure compliance with Federal laws, regulations, and guidelines.
Principal Investigator – A civil servant or non-civil servant (e.g., contractors and parties to agreements) researcher who has overall responsibility for all aspects of the funded and/or sponsored research project. Responsibilities for non-civil servant researchers are implemented through a contract or agreement.
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